cyrilzakka/clinical-trials huggingface dataset:
Ocriplasmin Research to Better Inform Treatment (ORBIT)

This is a multicenter, prospective, observational, Phase 4 study that will assess clinical outcomes and safety of JETREA® administered in a real-world setting for the treatment of symptomatic vitreomacular adhesion (VMA) by assessing anatomical and functional outcomes in 1500 patients recruited across approximately 120 USA retina sites.

The sites will prospectively enroll consecutive patients eligible for participation in the study. Informed consent will be obtained prior to any data being collected. This study is observational; therefore, all treatment decisions and assessments are at the discretion of the patient's treating physician and are not mandated by the study design or protocol. Patients will be enrolled at a routinely scheduled visit, on the day of JETREA® administration after the JETREA® injection. No specific visits, examinations, laboratory tests or procedures are mandated as part of this study. There is no pre-set visit schedule, and the frequency and timing of actual patient visits is at the discretion of the treating physician following standard of care. All available and relevant data will be collected prospectively.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years or older diagnosed with symptomatic VMA treated with JETREA ® at the physician's discretion in a manner consistent with the product label.
* Willing and able to provide written informed consent

Exclusion Criteria:

* Patients who are treated with JETREA® for medical conditions outside of the US product label.
* Concurrent participation in a research study that prescribes ocular treatment, imaging and/or interventions
Treatment of Hypoparathyroidism With Synthetic Human Parathyroid Hormone 1-34

This study has been important in establishing synthetic human parathyroid hormone 1-34 (PTH) as a beneficial treatment for hypoparathyroidism, superior to conventional therapy with calcium and calcitriol. Providing synthetic human parathyroid hormone 1-34 (PTH) to patients who are unresponsive to conventional therapy has enabled severe cases of hypoparathyroidism to be managed effectively with the investigational drug, PTH. The primary goals of this study are to (1) provide long-term PTH therapy to patients who do not respond to conventional therapy; (2) understand the long-term effect of therapeutic PTH replacement on kidney function and bone mineral density; (3) study and track linear growth and bone accrual in children with hypoparathyroidism. (4) determine if subjects reach a normal level of peak bone mass and if the timing of this is comparable to normal age-matched healthy controls.

Vitamin D and its analogs, the conventional treatment for hypoparathyroidism, are associated with chronic hypercalciuria due to their lack of calcium-retaining effect in the kidney. This side effect usually occurs even while maintaining the serum calcium in the normal range and may lead to calcium deposition in the kidney (nephrocalcinosis) and renal insufficiency. This study examines the long-term effects of subcutaneous parathyroid hormone (PTH) therapy on calcium metabolism, bone, and renal function. Our previous short-term pilot study comparing subcutaneous PTH with calcitriol demonstrated a significant decrease in urinary calcium excretion during PTH therapy. Based upon these results, we hypothesized that treatment with PTH is more physiologic and provides improved long-term metabolic control. Additionally, treatment with PTH may avoid the adverse side effects on the kidney that are associated with conventional therapy. Patients initially come to the Clinical Center for a two week inpatient evaluation. Subsequent follow-up will occur semiannually on an outpatient basis.

Eligibility Criteria:
* INCLUSION CRITERIA:

This study will include patients (ages 17-69) with biochemically confirmed hypoparathyroidism.

EXCLUSION CRITERIA

Women who are pregnant will be excluded.
Study to Investigate the Interaction Between FG-4592 and Rosiglitazone in Healthy Adult Subjects

The primary purpose of this study is to assess the effect of multiple doses of FG-4592 on the plasma pharmacokinetic of rosiglitazone in healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adult males, 18 to 45 years
* Body weight ≥ 75 kg
* Good health
* Non-smoker
* Blood pressure not greater than 140/90 mm Hg

Exclusion Criteria:

* Positive for any of the following: Human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg) or anti-hepatitis C virus antibody (anti-HCV Ab)
* Blood donation or significant blood loss within 60 days prior to Day 1
* Use of prescription and over the counter medications/herbal preparations is not allowed within 14 days prior to Day 1 and through treatment phase
* History or presence of alcoholism or drug abuse within 2 years prior to Day 1
* Consumption of alcohol within 7 days prior to Day 1 or during treatment phase
* Positive urine drug/alcohol testing at screening or check-in visit
Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA)

T follicular helper (TFH) cells represent a T cell subset dedicated to the activation of B cells. They have been involved in the pathogenesis of autoimmune diseases in humans such as lupus and Sjögren disease. We recently showed that TFH are implicated in the activation of autoreactive B lymphocytes during ITP. Autoimmune hemolytic anemia (AIHA) is an autoimmune disease due to antibodies targeting red blood cells. To date, the role of TFH in the pathogenesis of AIHA is not known.

We hypothesize that AIHA is associated with an increase in the number and/or function of TFH, that could participate in the activation of autoreactive B lymphocytes.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of warm AIHA defined by

  * Hemoglobin \<11 g/dl
  * Low haptoglobin level
  * Positive direct antiglobulin test (IgG or IgG + complement)
  * Reticulocyte count \>120 G/L
* Patients

  * naive to treatment for hemolytic anemia or a in relapse
  * Older than 18 years
  * Able to understand written and spoken French
* Persons who have provided written consent

Control population

* Patients who have given consent
* Patients over 18 years
* Patients with cold agglutinin disease (progressive AIHA and different treatments of warm autoantibody AIHA) can be included as a sub-group of controls
* Patients with non-auto-immune hemolytic anemia (constitutional of enzymatic origin, membrane-related,...) can be included as a sub-group of controls

Exclusion Criteria:

* Patients without national health insurance
* Pregnancy or breast-feeding women
* Adults under guardianship
* Patients with cancer or malignant hemopathy
* Patients with an on-going infection
* Patients treated with corticoids or immunosuppressants
Effectiveness of Polymyxin B Sulphate + Prednisolone + Benzocaine + Clioquinol in Acute and Sub-acute Dermatitis Eczematous

Dermatitis eczematous is a recurrent pruritic skin disorder which has a significant morbidity and impaired quality of life due specially pruritus and physical visible skin lesions. The purpose of this trial is evaluate the effectiveness of two different topic associations of drugs.

Study design:

* Experiment duration: 22 days
* 2 visits (days 0,7,15 and 22)
* Reducing eczema area and severity index evaluation
* Adverse events evaluation
* Double blinded, non-inferiority, prospective parallel-group, intend to treat trial.

Eligibility Criteria:
Inclusion Criteria:

1. Patients must be able to understand the study procedures agree to participate and give written consent.
2. Patients with acute or subacute dermatitis with a minimum of 3 symptoms.

Exclusion Criteria:

1. Pregnancy or risk of pregnancy.
2. Lactation
3. Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study).
4. Sunlight over exposure in the last 15 days.
5. Any pathology or past medical condition that can interfere with this protocol.
Study to Understand Risk Information to Support and Empower

The aim of this trial is to test components of a digital health outreach intervention to promote uptake of postpartum screening and lifestyle programs for diabetes prevention among patients with gestational diabetes (GDM). The outreach intervention, designed to be interactive and delivered online, includes standard health information plus up to four theory-based components, targeting motivational and logistical barriers to engaging in diabetes preventive care during the postpartum period. The trial leverages the Multiphase Optimization Strategy (MOST) using a randomized factorial study design.


Eligibility Criteria:
Inclusion Criteria:

* Current pregnancy complicated by gestational diabetes mellitus (GDM)
* Age: 18 years and older
* Contact with the Kaiser Permanente Northern California (KPNC) Regional Perinatal Service Center
* Able to communicate in English

Exclusion Criteria:

* Diagnosis of diabetes before pregnancy
* Maternal or infant current hospitalization
* Pregnancy loss
* History of eating disorder
* Previously requested not to receive research invitations
Evaluation of Intranasal Naltrexone and Naloxone

This study will be to determine the pharmacokinetics of naltrexone and naloxone when administered via intranasal separately and in combination in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 18 to 55 years of age, inclusive.
* Provide written informed consent.
* Body mass index (BMI) ranging from 18 to 30 kg/m2, inclusive.
* Adequate venous access.
* No clinically significant concurrent medical conditions determined by medical history, physical examination, clinical laboratory examination, vital signs, and 12-lead ECG.
* Agree to use a reliable double-barrier method of birth control from the start of screening until one week after completing the study. Oral contraceptives are prohibited.
* Agree not to ingest alcohol, drinks containing xanthine \>500 mg/day (e.g., Coca Cola®, tea, coffee, etc.), or grapefruit/grapefruit juice or participate in strenuous exercise 72 hours prior to admission through the last blood draw of the study.

Exclusion Criteria:

* Contact site for more information
Dietary Macronutrient Manipulation and Substrate Oxidation During Exercise

This study will investigate the effect of dietary macronutrient manipulation on glycogen (stored carbohydrate) levels in the muscle and substrate oxidation during exercise. The investigators will investigate the hypothesis that manipulating the macronutrient content of the diet will alter the levels of glycogen in the muscle and, in turn, substrate oxidation during exercise.

One way to help reduce body fat is to expend more energy from the oxidation of fat as a fuel. Exercise is one way to increase fat oxidation. The extent to which exercise facilitates the use of fat as a fuel may be influenced by an individual's dietary intake.

This study aims to establish the effect of dietary macronutrient manipulation on muscle glycogen levels and substrate oxidation during exercise. Participants will undertake three separate trial periods. During each trial period participants will consume a diet containing different macronutrient compositions. For each of the trials the investigators will assess how the macronutrient composition of the diet affects muscle glycogen level and substrate oxidation during exercise.

Eligibility Criteria:
Inclusion Criteria:

* Good general health
* Non-smoking - currently and for the past 5 years
* Fitness - V̇O2max 40-60 ml/kg/min
* Body mass index (20-25 kg/m2)

Exclusion Criteria:

* Known or suspected intolerance to the dietary interventions or their stated ingredients.
* Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.
* Previous participation in this study.
* Recent history (within the last year) of alcohol or other substance abuse.
* An employee of the sponsor or the study site or members of their immediate family.
* Abnormal / extreme habitual dietary practice / intake
* Recent (≤3 months) dietary practice that may be deemed as low and/or high in macronutrients will be excluded.
* The taking of any prescribed medication
A Randomized Controlled Trial of Open Surgical vs. Rapid, Minimally-invasive Voluntary Adult Male Circumcision

To identify a minimally-invasive surgical circumcision technique for men, which is easy to learn and perform, is safe, and is associated with high patient satisfaction and excellent cosmetic results.

Voluntary medical male circumcision (VMMC) is a priority preventive intervention for HIV transmission. Currently, the most widely used VMMC technique in South Africa is open surgical circumcision.

According to the Framework for Clinical Evaluation of Devices for Adult Male Circumcision (WHO, 2011): "WHO and other health authorities wish to identify one or more devices that (a) would make the VMMC safer, easier, and quicker; (b) would have more rapid healing than current methods and/or might entail less risk of HIV transmission in the post-operative period; (c) could be performed safely by health-care providers with a minimal level of training; and (d) would be cost-effective compared to standard surgical methods for male circumcision scale up."

This randomized controlled trial compares the open surgical technique to an alternative minimally-invasive technique using a disposable Unicirc device with tissue adhesive. The investigators postulate that VMMC using the Unicirc device meets WHO criteria for the ideal method to scale up: it is an easier technique to learn and perform, requires less intraoperative time, is safer for both surgeons and patients, heals quicker, and is more cost effective than other currently available techniques. The disposable nature of the device is an immense advantage as it eliminates the need to sterilize and can therefore be used in resource-limited settings. It also reduces the chances of infection caused by contaminated instruments.

The study will randomly assign participants to one of two groups:

* Unicirc device with tissue adhesive: 100 men
* Open surgical circumcision: 50 men

The participants will be evaluated during follow-up visits at 2 days, 7 days, 14 days, and 28 days after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men at least 18 years of age requesting circumcision
* No anatomical penile abnormalities or infections
* Able to provide informed consent to participate
* Willing to participate in follow-up visits

Exclusion Criteria:

* Current illness
* Penile abnormality or infection which contraindicates or would complicate circumcision
* History of bleeding disorder
* Past reaction to local anesthetic
Compare the Oncological Benefit of Deep Neuromuscular Block in Gastric Cancer Obesity Patient

This study is designed to evaluate the impact of muscle relaxation during laparoscopic gastrectomy on oncological benefit, especially with obese patients over BMI 25. The primary endpoint is number of harvested lymph node that is critical point regarding quality of surgery in gastric cancer treatment. The secondary endpoint is intraoperative bleeding, surgeons' satisfaction.

The patients were randomly assigned to two groups using a computer-generated randomization table : 196 persons

* Deep neuromuscular block group (98persons)
* Moderate neuromuscular group (98persons)

This study is designed to evaluate the impact of muscle relaxation during laparoscopic gastrectomy on oncological benefit, especially with obese patients over BMI 25. This is a randomized controlled trial comparing deep NMB with moderate NMB in laparoscopic subtotal gastrectomy in obese patients with gastric cancer. The design of the study is blinded (the surgical team and the research team are all blinded to the treatment); the attending anesthesiologist is not blinded. The primary endpoint is number of harvested lymph node that is critical point regarding quality of surgery in gastric cancer treatment. The secondary endpoint is intraoperative bleeding, surgeons' satisfaction.

The patients were randomly assigned to two groups using a computer-generated randomization table : 196 persons

* Deep neuromuscular block group (98persons)
* Moderate neuromuscular group (98persons) The patients are assigned to the deep NMB group or the moderate NMB group. The clinical research coordinator (CRC) uses a computer randomization program to determine the degree of muscle relaxation of each patient. Stratified block randomization is used to guarantee even distribution, which means that all participating hospitals are assigned moderate or deep NMB randomly in a 1:1 ratio. The CRC notifies the anesthesiologist of the degree of muscle relaxation just before the operation. Surgeons are blinded to the degree of muscle relaxation: They can enter the operating room after the muscle relaxation has been performed. A train-of-four (TOF) monitor is placed out of the surgeon's visual field. The anesthesiologist injects sugammadex after confirming the absence of the surgeon. The ward staff members who evaluate patient outcomes are blinded to the degree of muscle relaxation.

Eligibility Criteria:
Inclusion Criteria:

* Gastric cancer patients with laparoscopic subtotal gastrectomy
* 19-75 years
* Body mass index(BMI) \> 25kg/m2
* American Society of Anesthesiologists I-III

Exclusion Criteria:

* American Society of Anesthesiologists Class IV
* End stage renal disease (ESRD) patient
* Patients with allergy to muscle relaxants
* Patients with diseases that may affect muscle relaxation
Berlin Registry of Right Heart Interventions

The present study evaluates patients after interventional therapy of valvular diseases of the right heart. Follow-up examinations include medical history taking, laboratory measurements and an echo. The aim is to assess the different interventional therapies and their impact on patient's outcome.

The subject of the study is to register interventional therapies of right heart diseases (such as "cardioband" and "edge-to-edge" techniques of the tricuspid valve) performed in Berlin/ Brandenburg (primarily at the Charité, Universitätsmedizin Berlin). Based on the development and the increasing use of interventional therapies in tricuspid and pulmonary valve diseases, the impact on the patients' symptoms and life expectancy after interventions will be investigated. The aim is to identify patient subgroups that benefit the most.

Primary endpoints: Total mortality, cardiovascular mortality, heart failure hospitalization.

Secondary endpoints: NYHA class, NTproBNP, liver and kidney function (laboratory measurements), valve function, cardiac function, and cardiac morphology.

Eligibility Criteria:
Inclusion Criteria:

* Patients with planned or recent valve interventions of the right heart (tricuspid regurgitation/ stenosis, pulmonary regurgitation/ stenosis)
* \>18 years
* Written, documented consent

Exclusion Criteria:

* Patients in care or unable to consent
* Patients who are unable to comply with follow-up examinations
* Patients who are detained in an institution
Helicobacter Pylori Eradication and Irritable Bowel Syndrome: A Prospective Study

H. Pylori is frequently observed in patients with irritable bowel syndrome(IBS). However, the effect of H. pylori eradication on IBS is not clear.

Patients with IBS symptoms using Rome IV criteria will be included. Testing for H. pylori will be done. Patients with H. pylori will receive triple therapy and followed after two weeks for eradication and assessment of IBS symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Patients newly diagnosed with IBS and H.pylori

Exclusion Criteria:

* Patients received previous treatment of H.pylori
* Patients receiving treatment for IBS.
Daily Chlorhexidine Bathing and Infection Rates in Critically-ill Patients

Healthcare-associated infections are a major cause of morbidity among critically ill patients. Bathing critically ill patients with cloths impregnated with the broad-spectrum antimicrobial agent chlorhexidine-gluconate may decrease healthcare-associated infections. The purpose of this study is to evaluate the effect of daily bathing with disposable chlorhexidine-impregnated bathing cloths, as compared to daily bathing with disposable standard non-chlorhexidine-impregnated bathing cloths, on the rates of healthcare-associated infections in critically-ill patients.

Hypothesis: Daily bathing of the skin with chlorhexidine-impregnated bathing cloths will result in reduced rates of healthcare-associated infections in patients admitted to intensive care units (ICU).


Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to the medical, surgical, trauma, cardiovascular and neuro adult intensive care units at Vanderbilt University Medical Center

Exclusion Criteria:

1. Being cared for in the burn ICU or patients with TEN/SJS or burns being cared for in one of the non-burn intensive care units.
2. Patients with known allergy to chlorhexidine gluconate
3. Age \< 18 years old
4. Patients where daily bathing would not be safe
An Investigator Initiated Trial to Evaluate the Safety and Feasibility of the DyNETIC-35 Stent for Iliac Lesions Via a Trans-radial Approach

This feasibility study with a 30 day follow up period will assess the safety and feasibility of the Dynetic-35 stent for the treatment of peripheral iliac artery lesions via a trans-radial approach.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is ≥ 18 years
2. Subject is capable (no legally authorized representative allowed) to provide written informed consent as approved by the Institutional Review Board (IRB)/Ethics Committee (EC) of the respective clinical site prior to any study related procedure
3. Subject has provided written informed consent before any study specific test or procedure and is willing to comply with all protocol and follow-up requirements
4. Subjects have a target lesion(s) with ≥ 70% stenosis (visual estimate) located in the iliac arteries
5. Target lesion is a de novo, restenotic or occluded lesion
6. Reference lumen (vessel) diameter between 5mm and 10 mm
7. The target lesion can be successfully crossed with a guide wire
8. Patient is eligible for transradial access
9. Subject has symptomatic iliac artery disease defined as Rutherford category 2 or higher

Exclusion Criteria:

1. Subject is pregnant and/or breastfeeding or planning to become pregnant during the course of the study.
2. Subject is with a current medical condition with a life expectancy of less than one year.
3. Pre-existing target iliac artery aneurysm or perforation or dissection
4. Any medical condition that in the opinion of the investigator poses an unacceptable risk for implant of a stent according to the study indications like, sensitivity to metal ions, intolerance to contrast or antiplatelet, anticoagulant or thrombolytic medications required per the protocol
5. Abdominal aortic aneurysm (AAA) contiguous to the iliac artery target lesion requiring treatment
6. The subject is currently participating in an investigational drug, biologic, or another device study and has not reached their primary endpoint yet
7. Subjects with small diameter upper extremity arteries that posed a contraindication to the use of 6F sheath
8. Severe stenosis or calcification of upper extremity arteries
9. Patient height precluding transradial access with a 170 cm long catheter shaft
10. Patient with a history of aortic arch atheroembolism
11. Infrainguinal outflow lesions that need to be treated during the same index procedure
12. Patients with negative bilateral Allen or barbeau tests (Note: vascular access should be done via the left hand where possible)
13. Subject has IFU listed contraindication(s)
14. Subject has in-stent restenosis