cyrilzakka/clinical-trials huggingface dataset:
Cranberry Extract and Urinary Infection Prevention: a Clinical Trial

The purpose of this clinical trial study is to assess, among young and sexually active women presenting recurrent urinary tract infection (UTIs), efficacy of an optimal dose of cranberry extract quantified and standardized to 37 mg/day of Proanthocyanidins (PACs), compared to a control dose quantified and standardized to 2 mg/day of PACs on mean number of new UTIs during a 6-month follow-up period.

Cranberry juice, fruit (fresh and dried), functional foods, and cranberry dietary supplements are promoted for prevention of urinary tract infections (UTIs) on the basis of their content of cranberry proanthocyanidins (PACs) with "A-type" interflavan bonds. Several clinical trials have assessed efficacy of cranberry-derived products, essentially with cranberry juices, but discordant results have been found. Lack of compliance but mostly lack of standardization in product concentrations can account for the variability among results. Indeed, most clinical trials do not report quantity of PACs. According to most recent studies, quantification of PACs requiring standardized and reproducible methods should be at least 37 mg/day. It can be hypothesized that efficacy of cranberry extract in UTIs prevention among young women can be strongly increased using optimal dosage (standardized to 37 mg/day of PACs). The purpose of this clinical trial study is to assess, among young and sexually active women presenting recurrent UTIs, efficacy of an optimal dose of cranberry extract quantified and standardized to 37 mg/day of PACs, compared to a control dose quantified and standardized to 2 mg/day of PACs on mean number of new UTIs during a 6-month follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Healthy and sexually active women
* Aged between 18 to 45 years old
* Recurrence of 2 UTIs in the past 6 months or 3 in the past year
* Do not have consumed cranberry juice, polyphenols or antioxidant supplements in the last 2 weeks
* Internet access

Exclusion Criteria:

* Women who have personal history of acute or chronic renal failure
* Women who have personal history of urogenital system anomalies, urogenital tractus surgery or intestinal diseases causing malabsorption (e.g., Crohn and celiac diseases)
* Women who have personal history of kidney stones, taking anticoagulant medication or have taken anticoagulant medication in the last month
* Women presenting cranberry allergy or intolerance
Study Evaluating Nelotanserin for Treatment of REM Sleep Behavior Disorder in Subjects With Dementia (DLB or PDD)

This study seeks to evaluate the safety and efficacy of Nelotanserin for the treatment of Rapid Eye Movement (REM) Sleep Behavior Disorder (RBD) in subjects with dementia with Lewy bodies (DLB) or Parkinson's disease dementia (PDD).

This is a double-blind, randomized, placebo-controlled, parallel-arm study in subjects with DLB or PDD who have RBD.

Subjects who meet the randomization criteria will be randomized 1:1 to receive Nelotanserin or placebo for 28 days during the double-blind period.

Eligibility Criteria:
Inclusion Criteria:

* Adult subjects at least 50 years of age, with a diagnosis of DLB or PDD and RBD based on Diagnostic and Statistical Manual of Mental Disorders Fifth Edition (DSM-5) diagnostic criteria
* Presence of frequent REM sleep behavior episodes
* Mini Mental State Examination score ≥ 18

Exclusion Criteria:

* Subjects have a current diagnosis of significant psychotic disorders including, but not limited to, schizophrenia or bipolar disorder
* Subjects' RBD symptoms are secondary to or better accounted for by another medical condition, psychiatric disorder, or substance abuse
* Subjects with a current serious and/or unstable cardiovascular, respiratory, thyroid, gastrointestinal, renal, hematologic or other medical disorder
Daxor - Blood Volume Analysis

The purpose of this study is to better understand blood volume status and whether knowledge of it can change and improve heart failure care.

The purpose of this study is to better understand measurements of various parameters of congestion, the most significant of which is blood volume analysis. Blood volume analysis (BVA) measures how much blood is in the investigator's arteries and veins and is performed by using an IV and injecting a small amount of a radioactive material (I 131-labeled albumin). The study also involves blood tests, urine tests, blood pressure monitoring, an ultrasound, and measurement of lung fluid volume (by way of a vest). There will also be a 30-day follow-up phone call to assess symptoms and discuss any changes in medication.

Eligibility Criteria:
Inclusion Criteria:

- Admission for acute decompensated heart failure to the cardiology service at Duke Hospital, Durham, North Carolina

Exclusion Criteria:

* Age \< 18 years
* Ongoing pregnancy
* Recent acute MI or hemodynamic instability: Acute MI (STEMI or Type I NSTEMI) within 7 days
* Post heart transplantation or ongoing mechanical circulatory support
* Progressive cardiogenic shock
* Patients with Ventricular Assist Devices
* End stage renal disease
Evaluation of Faisability, Safety and Effectiveness and of Discogel in Patients With Aneurysmal and Simple Bone Cysts

There is no consensus in the scientific literature for the treatment of aneurysmal and simple bone cysts. Some scientific articles with utilisation of sclerosis agents for the treatment of aneurysmal bone cysts: Ethibloc no longer marketed, pure Ethanol, Aetoxisclerol.

The aim of this work is therefore the evaluation of Discogel® in the treatment of Discogel®, which appears to be a safe and efficacity of method.

Eligibility Criteria:
Inclusion Criteria:

* Patient with aneurysmal or simple bone cyst who benefit a sclerotherapy by Discogel

Exclusion Criteria:

* Refusal
Pre-Mix Insulin Lispro Treatment for Type 2 Diabetes Patients Who Consume a Light Breakfast

This study is designed to look at how best to start and then gradually intensify (as needed) the insulin lispro premix regimen in type 2 diabetes patients who consume a light breakfast.


Eligibility Criteria:
Inclusion Criteria:

* Diabetes Mellitus, Type 2
* have been receiving metformin plus at least one other oral antihyperglycemic medication (OAM) (sulfonylurea or Thiazolidinedione \[TZD\]) without insulin, for at least 90 days prior to Visit 1
* glycosylated hemoglobin (HbA1c) greater than or equal to 7.0% and less than 11.0%
* regularly consume a light breakfast (less than 15% of total daily calorie intake)
* capable and willing to follow the protocol
* give written consent

Exclusion Criteria:

* are taking a TZD whose country label does not allow in combination with insulin
* are taking any glucose-lowering agents (other than specified in the inclusion criteria above)
* have a body mass index greater than 40 kg/m\^2
* have a history of severe hypoglycemia in past 24 weeks
* are pregnant or may become pregnant
* women who are breastfeeding
* have significant cardiac disease
* have significant renal or liver disease
* undergoing therapy for a malignancy
* contraindications to study medications
* have an irregular sleep/wake cycle
Reducing Disparities in Primary Prevention of Cardiovascular Disease

Cardiovascular disease (CVD) is the leading cause of disparities in years of life lost by race and low socioeconomic status. Statins have been shown to decrease the risk of cardiovascular events among individuals with high CVD risk. Yet, despite increased statin use and overall declining CVD rates, disparities in statin use and disparities in the control of high cholesterol by race, ethnicity, and socioeconomic status have persisted.

Objective: To improve the appropriate use of statins for primary cardiovascular disease prevention among high risk individuals at community health centers through a system of population health management that uses electronic health record (EHR) data to identify patients for targeted education and outreach.

Aim 1: Conduct a randomized controlled trial among individuals with 10-year risk for myocardial infarction or coronary death of 10% or higher to determine if the population health management intervention, compared to usual care, results in higher rates of documented statin treatment discussions within 6 months (primary process outcome), higher rates of statin prescribing within 6 months (secondary process outcome), and higher rates of significant low-density lipoprotein cholesterol (LDL-C) lowering defined as a follow up LDL-C ≥30 mg/dL lower than baseline (primary clinical outcome).

Aim 2: Interview patients who received the intervention to identify barriers to success

Aim 3: Assess the overall costs of the intervention and the costs per each patient who achieves significant LDL-C lowering compared to patient who received usual care.


Eligibility Criteria:
Inclusion Criteria:

* men \>= 35 and women \>= 45 years old
* LDL-C completed in the past 5 years
* Not currently prescribed lipid lowering medication
* \>= 1 face to face visit to a study site in the 6 months prior to the start of the study or a visit during the enrollment period
* The 10-year risk of coronary death or myocardial infarction (based on Framingham Risk Score) is at least 10% and the LDL-C is above 100 mg/dL

Exclusion Criteria:

* Previously diagnosed with any of the following: coronary disease, peripheral arterial disease, carotid artery disease, abdominal aortic aneurysm, or diabetes mellitus
* Primary language is not English or Spanish
A National Study of Intravenous Medication Errors

To identify the key issues around use of computerized patient infusion devices (called "smart pumps").

To develop strategies that will improve the prevention of intravenous errors that will be broadly applicable.

The investigators will conduct a national study using the general methodology developed by Husch et al. to allow a rapid assessment of the frequency and types of medication errors at an institution.

The key questions the investigators will address are:

1. What are the frequency and types of intravenous medication errors?
2. How much variability is there by frequency and type among settings?
3. After review of the initial data, what strategies appear to have the greatest potential for reducing intravenous medication error frequency?
4. How effective is an intervention including a bundle of these strategies at multiple sites?

Overall Study Design: This is a multi-hospital study to investigate medication errors using smart pumps. The proposed study will be conducted over three phases for a total of 36 months phases. In Year 1, an observational study will be conducted by investigators at ten multiple hospital sites. The investigators will prospectively compare the medication, dose, and infusion rate on the IV pump with the prescribed medication, doses, and rate in the medical record. Preventability with smart pump technology will be retrospectively determined based on a rigorous definition of currently available technology. The investigators will also make comparisons across sites by overall rate and degree of variability among sites.

Then, in Year 2, these results will be evaluated, and a consensus process including a face-to-face meeting will take place to evaluate the types of events and to develop an intervention which will be implemented at multiple sites. After a run-in period, the intervention will be tested in Year 3 at the sites, and the data will be analyzed, and the investigators will produce a report and a set of recommendations.

Eligibility Criteria:
Inclusion Criteria:

* Patients if they receive any IV fluid or medication on the day of observation in the study units.

Exclusion Criteria:

* patients who are under 21 years old.
Effects of Spironolactone on Cardio- and Cerebrovascular Morbidity and Mortality in Hemodialysis Patients

Aldosterone receptor blockers reduce cardiac-related morbidity and mortality. Recently, we demonstrated that long-term low-dose spironolactone is clinically safe in many hemodialysis (HD) patients. In the present study, we assess whether low-dose spironolactone treatment reduces the high incidence of cardio- and cerebrovascular (CCV) morbidity and mortality in HD patients. The investigators' hypothesis is that aldosterone receptor blockade by spironolactone reduces the risk of both CCV morbidity and death among HD patients.


Eligibility Criteria:
Inclusion Criteria:

* Hemodialysis patients undergoing 4-hour-long HD thrice a week for at least 2 years
* With an average serum potassium level (immediately before dialysis on the first day of the week) of \<6.5 mEq/l over the previous 2 months
* With a 24-hour urine output of \<500 ml

Exclusion Criteria:

* A history of noncompliance
* Unstable vascular access
* Hypotension
* Hepatic failure
* Active cancer
* Any life-threatening disease other than ESRD
A Phase II, Study To Evaluate The Efficacy And Safety Of PH-797804 In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).

PH-797804 is a potent ant-inflammatory drug that may reduce the inflammation that is associated with COPD. PH-797804 will be dosed to patients with COPD to evaluate its potential safety and efficacy profile in COPD.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects between, and including, the ages of 40 and 80 years.
* Subjects with a diagnosis, for at least 6 months, of moderate to severe COPD (GOLD) and who meet the criteria for Stage II-III disease, subjects must have had stable disease for at least 1 month prior to screening.
* Subjects must have a smoking history of at least 10 pack-years and be current smokers or ex-smokers that gave up \> 6 months ago.

Exclusion Criteria:

* More than 2 exacerbations of COPD requiring treatment with oral steroids in the preceding year or hospitalization for the treatment of COPD within 3 months of screening or more than twice during the preceding year.
* History or presence of significant cardiovascular disease.
* ECG abnormalities.
* Significant concomitant clinical disease that could interfere with the conduct, safety or interpretation of results of this study.
* Evidence of organ or blood disorders.
Surgical Versus Conservative Treatment of Acute Mallet Fingers; a Randomised Controlled Trial

The investigators are investigating if surgical treatment of injuries to the tendon which straightens the finger tip gives a better functional outcome than treatment with a splint while the tendon heals.

The investigators will randomise patients to receive splinting of their finger while their tendon heals or have surgical intervention. Surgical intervention will entail fixing the tendon with bone anchors and splinting. Conservative treament involves splinting while the tendon heals. We will then monitor the functional outcome of the hand using the DASH questionare over 18 months.

Eligibility Criteria:
Inclusion Criteria:

* soft tissue mallet finger
* acute injury

Exclusion Criteria:

* ASA 3 or above
* Unable to give informed consent
* Infection in digit affected
Evaluation of the Safety and Effectiveness of the Investigational Product in Improvement of the Appearance of Wrinkles and General Aspect of the Skin

The study investigates the safety and effectiveness of SILIMED® brand MEDGEL ANTIAGE with indication for improvement of the appearance of wrinkles and general aspects of the skin.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged between 30 and 55 years old;
* Participants with all skin types (normal, dry, combination and oily);
* Participants with mild to moderate signs of aging, according to Lanier's classification;
* Participants with melanic and/or vascular dark circles;
* Participants with bags around their eyes;
* Users of products from the same category;
* Intact skin in the product analysis region (face);
* Participants who agree NOT to use any other topical products on the test area during the study period;
* Agreement to comply with the trial procedures and to attend the clinic on the specified days and times;
* Understand, consent and sign the informed consent.

Exclusion Criteria:

* Participants diagnosed with COVID-19 in the last 4 weeks or showing symptoms such as fever, dry cough, tiredness, body aches or other discomfort;
* Pregnancy/lactation or intention to become pregnant during the study period;
* Use of the following topical or systemic medications: immunosuppressants, antihistamines, non-steroidal anti-inflammatory drugs, and corticoids up to 30 days before selection or considering immunosuppressants, the interval should be 3 months before selection;
* Atopic or allergic history of health products;
* Pathologies and/or active skin lesions (local and/or disseminated) in the assessment area;
* Skin marks in the experimental area that interfere with the evaluation of possible skin reactions (vascular malformations, scars, increased hairiness, large amounts of nevus, sunburn);
* Immunosuppression by drugs or active diseases;
* Decompensated endocrinopathies;
* Participants with known congenital or acquired immunodeficiency;
* Relevant medical history or current evidence of alcohol or other drug abuse;
* Known history or suspected intolerance to products in the same category
* Intense sun exposure up to 15 days before the assessment;
* Aesthetic or dermatological treatment in the evaluation area up to 04 weeks before selection;
* Professionals directly involved in carrying out this study;
* Other conditions considered by the evaluating physician as reasonable for disqualification from participating in the study. If yes, it should be described in observation in the clinical record
Assessing the Effect of Abstinence Period on Semen Parameters

The goal of this study is to learn about the impact of abstinence periods on sperm quality in healthy males 20-45 years of age with no significant comorbidities who are able to produce a semen sample via masturbation. The main question it aims to answer is:

• Do shorter abstinence periods result in improved semen quality?

Participants will provide semen samples for analysis following abstinence periods of 7 days, 5 days, 2 days, 1 day, and 3 hours.

Participant Duration: Total length of time on study per subject is 14 days (including 5 days of visit required for sample production). Subjects do not need to complete the visits in order but need to document abstinence period prior to sample production. No follow up will be needed after the study.

Primary Objective: The primary objective is to examine the differences in semen analysis parameters after varying abstinence periods (7 days, 5 days, 2 days, 1 day, 3 hours).

Secondary Objectives: The secondary objective(s) is to assess changes in sperm DNA fragmentation after varying abstinence periods (7 days, 5 days, 2 days, 1 day, 3 hours).

Eligibility Criteria:
Inclusion Criteria:

* Males, aged 20-45 years
* Healthy, no significant comorbidities
* Able to produce a semen sample by masturbation
* Total sperm count ≥ 1 million sperm
* Abnormal sperm DNA fragmentation (TUNEL assay value ≥ 20%)

Exclusion Criteria:

* Age \< 20 or \> 45 years
* Significant comorbidities, including significant cardiac, pulmonary, gastrointestinal, hematologic, or neurologic disease
* Total sperm count \< 1 million sperm
* Aspermia (semen volume = 0)
* Normal sperm DNA fragmentation (TUNEL assay value \< 20%)
A Study to Determine the Long-Term Safety, Tolerability and Biological Activity of SAR421869 in Patients With Usher Syndrome Type 1B

Primary Objective:

To evaluate the long-term safety and tolerability of SAR421869 in patients with Usher syndrome Type 1B

Secondary Objective:

To assess long-term safety and biological activity of SAR421869

The total duration of study period is up to 15 years.

Eligibility Criteria:
Inclusion criteria :

Provide signed and dated written informed consent (and if appropriate assent) and any locally required authorization eg, Health Insurance Portability and Accountability Act (HIPAA).

Must have been enrolled in protocol TDU13600. Must have received a subretinal injection of SAR421869

Exclusion criteria:

Did not receive SAR421869 as part of the TDU13600 protocol.
Phase 1 Study of MGD010 in Healthy Subjects

The primary goal of this Phase 1 study is to assess the safety and tolerability of one MGD010 intravenous (IV) infusion in healthy adult volunteers.

This is a Phase 1 study to evaluate the safety, tolerability and PK of MGD010, a CD32B x CD79B DART bi-specific antibody-based molecule. This study will be conducted as a double-blind, randomized, placebo controlled, single ascending dose study among healthy subjects.

Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 50 years of age
* Body mass index (BMI) of 18 to 30 kg/m2, inclusive

Exclusion Criteria:

* Women of child-bearing potential;
* Women who are pregnant or breast-feeding
* Any significant acute or chronic medical illness
* Any major surgery within 4 weeks of study drug administration
* Active or latent tuberculosis (TB)
* Active or latent Hepatitis B, Hepatitis C or HIV infection
* History of allergy to monoclonal antibodies, any significant drug allergy (such as anaphylaxis), or hypersensitivity to any components of the test or reference investigational product formulation.
* Evidence of organ dysfunction or any clinically significant deviation from normal
* Vaccination with any live vaccine, or use of any prescription drugs, within 4 weeks of study drug administration
* Known history of infection or exposure to Hepatitis A virus
Impact of Body Mass Index on Positive End-expiratory Pressure Guided by Electrical Impedance Tomography for Patients Under General Anaesthesia

The induction of general anaesthesia is associated with a fall in lung volume due in particular to a decrease in muscle tone and the formation of denitrogenation atelectasis. Many recent studies insist on the need to apply a so-called "protective" strategy of intraoperative ventilation, which combines the use of recruitment manoeuvres, reduced tidal volume (Vt) (6-8ml/kg) and positive expiratory pressure (PEEP) to prevent these phenomena. However, the setting of PEEP remains debated and several authors agree on the need to individualize ventilatory parameters, particularly in obese patients, without describing the individualization tools.

In the ICU, it has been shown that electrical impedance tomography (EIT) can be used to individualise the PEEP level in a simple and non-invasive way. Therefore, we wish to determine whether the use of this technique during general anaesthesia allows for the individualization of PEEP, and whether the value determined is correlated with the body mass index (BMI).


Eligibility Criteria:
Inclusion Criteria:

* Adult patient
* Patient who received general anesthesia with orotracheal intubation.
* Patient who has undergone surgery of the following types: : abdominal surgery by laparotomy or laparoscopy, emergency or scheduled

Exclusion Criteria:

* NA