Search trials – HealthDB

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Recruiting

TUBectomy With Delayed Oophorectomy in High Risk Women to Assess the Safety of Prevention

BRCA1 Gene Mutation BRCA2 Gene Mutation RAD51C Gene Mutation RAD51D Gene Mutation +2

The aim of the project is to evaluate the risk-reducing salpingectomy with delayed oophorectomy as an alternative for risk-reducing salpingo-oophorectomy in high risk women with respect to ovarian cancer incidence.

Начало: 01.03.2020 Край: 17.02.2040 Възраст: 25–50 г. Prevention

Australia, Belgium, Brazil +12 University Medical Center Nijmegen NCT04294927

Recruiting Phase 2

A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain

Osteoarthritis, Knee Diabetic Neuropathic Pain Chronic Low-back Pain

The purpose of the chronic pain master protocol is to compare independent pain interventions and establish an overarching structure for the disease-state addenda (DSA) and intervention-specific appendices (ISAs). The ISAs may start independently of other ISAs as interventions become available for clinical testing.

Начало: 30.01.2020 Край: 01.04.2027 Възраст: от 18 г.

Puerto Rico, United States Eli Lilly and Company NCT05986292

Recruiting Phase 2

A Study Evaluating the Activity of Anti-cancer Treatments Targeting Tumor Molecular Alterations/Characteristics in Advanced / Metastatic Tumors.

Malignant Solid Tumor

This trial is a multicenter, open-label, biology driven, phase II study using a sequential Bayesian design, aiming to assess the efficacy and safety of different Matched Targeted Therapy (MTT) in independent and parallel cohorts of treatment. Patients will be assigned to a treatment cohort based on molecular alterations/characteristics detected on tumor sample from primary tumor or metastatic lesion. In this protocol, several MTTs treatment cohorts are planned. This study is designed with the flexibility to open new MTTs treatment cohorts and to close existing MTTs treatment cohorts that demonstrate no clinical benefit. Each treatment cohort will be driven separately even though procedures, quality control and reporting, will be common. The protocol will be amended in order to include new treatments or combinations that emerge as being of interest for patients with advanced/metastatic cancers. All eligible patients will receive study drugs as long as patient experiences clinical benefit in the opinion of the investigator, or until unacceptable toxicity, or until symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data and clinical status, or withdrawal of consent. Patients will be permitted to continue study treatment after progressive disease according to RECIST v1.1 if they meet all of the following criteria and following validation of the Sponsor: * Evidence of clinical benefit as assessed by the investigators, * Absence of symptoms and signs (including worsening of laboratory values; e.g., new or worsening hypercalcemia) that indicate unequivocal progression of disease, * No decline in ECOG Performance Status (PS) that can be attributed to disease progression.

Начало: 28.01.2020 Край: 01.10.2027 Възраст: от 18 г.

France Centre Leon Berard NCT04116541

Recruiting Phase 2

A Master Protocol (LY900023) That Includes Several Clinical Trials of Drugs for Children and Young Adults With Cancer

Neoplasms Child Adolescent

The main purpose of the master is to help the research sites and sponsor carry out several clinical trials more efficiently by providing a common research protocol. Individual clinical trials under this master protocol define drug/disease-specific research goals and activities to test them. New studies will be added as new drugs emerge against different cancers. Participation in the trial will depend on how long the benefit lasts.

Начало: 22.01.2020 Край: 01.05.2027 Възраст: 1–39 г. Treatment

Australia, Belgium, France +7 Eli Lilly and Company NCT05999994

Recruiting

Feasibility of the InnoVein Valve and Delivery System for Chronic Venous Insufficiency

Chronic Venous Insufficiency

This objective of this feasibility study is to evaluate the safety of the InnoVein Valve and Delivery System for treatment of chronic venous insufficiency.

Начало: 15.01.2020 Край: 15.01.2027 Възраст: от 18 г. Treatment

Australia InnoVein NCT04253301

Recruiting Phase 1

Safety of Belimumab in People With Idiopathic CD4 Lymphopenia and Autoantibodies (Phoebe)

Idiopathic CD4 Lymphopenia

Background: People with Idiopathic CD4 lymphopenia (ICL) have lower numbers of a type of white blood cell called CD4 cells. White blood cells fight against infections. Low levels of CD4 cells may make a person more likely to get sick. There are no approved treatments for ICL. Researchers think a drug called belimumab may be able to help in specific situations. Objective: To see if belimumab is safe for people with ICL. Eligibility: People ages 18-70 who have ICL and are participating in NIH protocol 09-I-0102 (EPIC) Design: Participants will be screened with: Medical and medication history Physical exam Questionnaire about mental health and depression Blood and urine tests Participants will have a baseline visit. This will include some repeats of the screening tests. They may also have leukapheresis: Blood will be taken from a needle in one arm and passed through a machine that separates out the white blood cells. The rest of the blood will be returned through a needle in the other arm. Participants will receive 8 doses of belimumab through IV: A needle will insert a thin plastic tube into an arm vein. Belimumab will be given through the IV line. The first 3 doses will be given every 2 weeks. The other 5 will be given once every 4 weeks. Participants will have a physical exam and blood and urine tests at each dosing visit. They will be monitored for up to 4 hours after the infusion. Participants will have 3 follow-up visits, at around 8, 16, and 24 weeks after the last dose of belimumab. They will have a physical exam and blood and urine tests. Once they finish this protocol and they will continue to be followed under 09-I-0102 (EPIC study).

Начало: 13.01.2020 Край: 25.03.2027 Възраст: 18–70 г.

United States National Institute of Allergy and Infectious Diseases ( NCT04097561

Recruiting

Medtronic SYMBIOSIS Post-Market Registry for Patients Undergoing Cardiac Surgery

Cardiovascular Diseases

The purpose of this observational, multi-center prospective, post-market registry is to confirm real-world device safety and performance, to ensure the continued acceptability of identified risks, and detect emerging risks.

Начало: 09.01.2020 Край: 31.12.2026

Austria, Belgium, France +5 Medtronic Cardiac Surgery NCT04241328

Recruiting

Day Case Colectomy: Optimizing Short Stay-surgery.

Monitoring, Physiologic

HRV measurement of patients recovering from laparoscopic colorectal resection for any pathology.

Начало: 01.01.2020 Край: 31.12.2027 Възраст: 18–100 г.

Finland Joint Authority for Päijät-Häme Social and Health Care NCT04996511

Recruiting

Oncologic, Cosmetic and Patient Reported Outcomes in Value-Based Breast Surgery (OnCoPRO Value)

Breast Cancer Breast Carcinoma in Situ Breast Cancer Invasive Breast Asymmetry

The study aspires to provide outcomes on surgery, quality of life and time-to-event outcomes following the development and validation of a standardised surgical assessment tool in a shared decision-making framework for patients with pre-invasive or invasive breast cancer with breast conservation.

Начало: 01.01.2020 Край: 30.12.2032 Възраст: от 18 г.

Australia, Sweden, United Kingdom Uppsala University NCT06401304

Recruiting

KEYMAKER-U01 Umbrella Master Study: Studies of Investigational Agents With Either Pembrolizumab (MK-3475) Alone or With Pembrolizumab PLUS Chemotherapy in Participants With Non-small Cell Lung Cancer (NSCLC) (MK-3475-U01/KEYMAKER-U01)

Carcinoma, Non-Small-Cell Lung

This study is referred to as the "umbrella master protocol" for pembrolizumab (MK-3475) in the treatment of non-small cell lung cancer (NSCLC). This pembrolizumab NSCLC umbrella master protocol uses a platform design and consists of this master screening study and additional substudies. Each substudy will enroll a different population of NSCLC participants.

Начало: 19.12.2019 Край: 13.02.2032 Възраст: от 18 г.

Hungary, Israel, Italy +6 Merck Sharp & Dohme LLC NCT04165798

Recruiting Phase 4

Investigational MRI Clinical Software and Hardware

Image, Body

Patients and healthy volunteers will be scanned in order to test new sequences.

Начало: 19.12.2019 Край: 31.01.2028 Възраст: 18–90 г.

United States Northwestern University NCT05215132

Recruiting

Reproductive Axis Maturation in the Early Post-Menarchal Years

Reproductive Physiological Processes Pediatrics Adolescent Health Adolescent Development

Background: Most adult women with irregular periods of unknown cause report symptoms dating back to early adolescence. This study aims to learn how girls' periods change in the 2 years after their first period. We are also looking at girls who may have a condition called PCOS. This will help researchers learn what healthy puberty looks like and how they can spot signs of hormone problems early on. Objective: To learn how long it takes girls to develop regular menstrual cycles after their first period. Eligibility: Healthy girls ages 8-14 who either (1) haven't had their first period but show signs of puberty, such as breast development and hair in the genital area; or (2) had their first period in the past 6 months Girls at risk for PCOS age 8-14 who have a mom or sister with PCOS Girls with irregular menstrual cycles age 11-17.5 To compare with the girls, we are looking at women \>=18-34 years old with PCOS, Healthy women \>= 18-34 years old without PCOS, and Mothers of pediatric participants age 18-65 Design: Both parents or guardians must allow their daughter to participate. They must attend all study visits with her. Participants will first be screened by phone. Those who qualify will be screened in person. They will have a physical exam. They will give blood and urine samples. They will have an ultrasound of their abdomen. They will fill out questionnaires. They will sit in a BOD POD for 6 minutes: This is an egg- shaped machine that takes body measurements. They have the option to provide DNA samples. Participants will have sets of visits at home or at the clinic about every 6 months. The number of visits in each set will depend on their menstrual cycle. Then they will have a final visit. Visits will include repeats of the screening tests. There are additional parts that participants may choose to be involved in depending on how involved they want to be. At home, participants will collect their urine daily to measure hormones. They will keep a diary of their periods. Adults: Women with known PCOS will complete the same Screening Visit as the girls and will collect dried urine specimens at home for 8 weeks; The Healthy control women group will complete the same Screening Visit as the girls and collect dried urine specimens at home for 2 menstrual cycles; The Mothers of pediatric participants group will complete a Screening Visit (informed consent, urine pregnancy test) and collect vaginal swab specimens at home for 2 menstrual cycles (approx. 8 weeks)....

Начало: 19.12.2019 Край: 01.07.2029 Възраст: 8–65 г.

United States National Institute of Environmental Health Sciences (NI NCT03986021

Recruiting

Self Reported Pain in Women While Undergoing Treatment for Non-metastatic Breast Cancer

Breast Breast Cancer

The overall purpose of this study is to investigate whether younger subjects report pain with pegfilgrastim (or biosimilar substitution) more often and/or at higher levels (greater intensity) than older subjects.This study will be carried out throughout the course of your chemotherapy treatment, which will be prescribed by your study doctor. Participation in this study will not affect your cancer treatment.

Начало: 17.12.2019 Край: 01.01.2041 Възраст: от 18 г.

United States Wake Forest University Health Sciences NCT04174742

Recruiting

Melanoma Margins Trial-II: 1cm v 2cm Wide Surgical Excision Margins for AJCC Stage II Primary Cutaneous Melanoma

Cutaneous Melanoma, Stage II

Patients with a primary invasive melanoma are recommended to undergo excision of the primary lesion with a wide margin. There is evidence that less radical margins of excision may be just as safe. This is a randomised controlled trial of 1 cm versus 2 cm margin of excision of the primary lesion for adult patients with stage II primary invasive cutaneous melanomas (AJCC 8th edition) to determine differences in disease-free survival. A reduction in margins is expected to improve patient quality of life.

Начало: 17.12.2019 Край: 31.12.2034 Възраст: от 18 г. Treatment

Australia, Canada, Ireland +7 Melanoma and Skin Cancer Trials Limited NCT03860883

Recruiting Phase 1/2

A Study of Oral Nuvisertib (TP-3654) in Patients With Myelofibrosis

Myelofibrosis

This study is a Phase 1/2, multicenter, dose-escalation, open-label trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of nuvisertib (TP-3654) in patients with intermediate or high-risk primary or secondary MF.

Начало: 16.12.2019 Край: 30.04.2030 Възраст: от 18 г. Treatment

Australia, Belgium, Canada +5 Sumitomo Pharma America, Inc. NCT04176198

Recruiting

Patient Experience and Acceptance of Horizontal Rotation

Cancer

Patients will complete validated psychometric questionnaires to quantify their experience of being rotated at different speeds using the Nano-X patient rotation system.

Начало: 14.12.2019 Край: 01.06.2025 Възраст: от 18 г. Basic science

Australia University of Sydney NCT02995603

Recruiting

Selective Laryngeal Reinnervation for Bilateral Vocal Fold Paralysis

Bilateral Vocal Cord Paralysis

This is a prospective observational study examining the treatment outcomes of selective laryngeal reinnervation procedures for patients with bilateral vocal fold paralysis.

Начало: 10.12.2019 Край: 31.12.2030 Възраст: 18–70 г.

United States Weill Medical College of Cornell University NCT03980275

Recruiting

Pragmatic Randomised Trial of High Or Standard PHosphAte Targets in End-stage Kidney Disease (PHOSPHATE)

Kidney Failure, Chronic Hyperphosphatemia

During end-stage kidney disease, clinical guidelines suggest reducing elevated phosphate levels in the blood. However, the effect of lowering blood phosphate levels on important patient-centred outcomes has never been tested. This trial will evaluate whether compared to high levels, lowering blood phosphate levels would reduce death or major events due to heart disease, improve physical health, and be cost-effective.

Начало: 10.12.2019 Край: 31.12.2028 Възраст: от 18 г. Treatment

Australia, Brazil, Canada +5 The University of Queensland NCT03573089

Recruiting

Detection and Amelioration of Gamma Oscillation Abnormalities in Blast-Related Brain Injury

mTBI

Combat Veterans of post-9/11 conflicts have experienced serious cognitive and emotional problems resulting from exposure to blasts. Recent work suggests that a critical factor influencing the consequences of blast exposure is distance from the blast, rather than the presence or absence of concussion symptoms. Exposure to blasts from a distance of \10 m. So far, the effects of blast-related brain injury on the brain are poorly understood, as to date the effects of blast exposure have received little research focus. The investigators propose to use oscillations in the gamma band (30-100 Hz) of the electroencephalogram (EEG; brain waves) to detect and remediate neural circuit dysfunction related to blast injury in Veterans. If successful, this project could lead to new approaches to detect and remediate the effects of blast exposure on Veterans and aid in their functional recovery.

Начало: 02.12.2019 Край: 30.06.2028 Възраст: 18–65 г.

United States VA Office of Research and Development NCT03836976

Recruiting Phase 4

PECS Study for CIED Implantation Surgery

Pain, Postoperative Child Adolescent

We aim to determine whether pectoral nerve block (PECS) performed after induction of anesthesia but before surgical incision results less opioid use in the post operative period compared with local infiltration alone in children undergoing Cardiac Implantable Electronic Device (CIED) surgery.

Начало: 01.12.2019 Край: 01.01.2028 Възраст: 3–18 г.

Canada The Hospital for Sick Children NCT04577690

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