cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficacy of CRD007 in Adult Asthma Subjects

This is a double-blind, randomised, placebo-controlled, parallel group, Phase 2 trial evaluating CRD007 administered orally b.i.d for 14 weeks for the treatment of asthma. CRD007 will be given as add on to a background of commonly used controller medication, i.e. inhaled corticosteroid (ICS) with or without long-acting beta2-agonist (LABA). By gradually reducing the background controller medication, the efficacy and safety of CRD007 will be evaluated on top of several dose levels of this medication.

The present trial will include subjects with diagnosed asthma. The trial involves a total of 11 visits (Visit 1-2 are screening visits, visit 3 randomisation visit, visits 4-10 treatment visits and visit 11 follow-up visit).

The subjects will be monitored by medically qualified staff every second week at clinic visits, where the reduction of their background controller medication will be reduced, if their asthma is controlled.

Between visits to the clinic the subjects have to complete a diary.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Age ≥18 years old
* Diagnosis of asthma according to Global Initiative for Asthma (GINA) Guidelines
* Atopic phenotype as assessed by the investigator
* Treated with ICS and LABA for at least 12 weeks prior to Visit 1with protocol defined daily doses
* Blood eosinophils ≥0.15\*109/L at Visit 1
* Demonstration of forced expiratory volume at one second (FEV1) \>60% of the predicted value at Visit 1
* Demonstration of ACQ6 ≥ 0.5 and ≤1.5 at Visit 1
* Reversibility of at least 12% and 200 mL in FEV1

Exclusion Criteria:

* Lower respiratory tract infection \<6 weeks prior to Visit 1
* Current smokers
* Significant concurrent, uncontrolled medical condition as defined by the protocol
* Others, as defined in the protocol
Global Non-interventional Heart Failure Disease Registry

The clinical characteristics, initial presentation, management, and outcomes of patients hospitalized with new-onset (first diagnosis) heart failure (HF) or decompensation of chronic HF are poorly understood worldwide. REPORT-HF is a global, prospective, and observational HF disease registry designed to characterize patient trajectories longitudinally during and following an index hospitalization for acute HF.


Eligibility Criteria:
Inclusion Criteria:

Patients at least 18 years old, or older for those countries where the adult age is above 18 years of age, hospitalized with a primary diagnosis of acute heart failure.

Exclusion Criteria:

1-Concomitant participation in any/a clinical trial with any investigational treatment (for any sponsor).

2. Use of investigational drugs within 5 half-lives of enrollment, or until the expected pharmacodynamic effect has returned to baseline, whichever is longer.
Metachronous Acquired Contralateral Cryptorchidism in Patients With a History of Unilateral Cryptorchidism.

The present study aims to calculate the risk of a patient with a history of cryptorchidism developing cryptorchidism on the contralateral side.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 13 years or older, previously operated on for cryptorchidism.

Exclusion Criteria:

* Diagnosis of endocrine disease or any polymalformative syndrome.
* Synchronous bilateral cryptorchidism.
Arrhythmogenic Risk Assessment in Coronary Artery Ectasia Patients

The investigators thought to explore arrhythmias outcome - hidden arrhythmias, ECG features: Tp-Te interval and Tp-Te/QTc ratio, fQRS among patients with coronary artery ectasia as compared to normal coronary artery patients.

All patients will be subjected to:

A. Full history taking:

- Including age, sex, history of DM, HTN, dyslipidemia and Body surface area.

B. Holter monitoring for 24 hours:

* Heart rate variability
* Hidden arrhythmias
* Hidden ischemia by monitoring ST segment changes

C. Twelve lead ECG:

* fQRS in baseline ECG
* QT dispersion.
* Tp-Te interval and Tp-Te/QTc ratio
* Tp-Te dispersion

Eligibility Criteria:
Inclusion Criteria:

* Subjects with suspected CAD who are referred for elective coronary angiography and/or interventions

Exclusion Criteria:

1. Patients with a history of cardiomyopathy and myocardial infarction (MI), left ventricular hypertrophy (LVH), pathological Q wave on ECG, typical left bundle block or right bundle block, incomplete right bundle block, or paced rhythm on ECG.
2. Patients with severe renal impairment
3. Post CABG patients
4. Patients of acute coronary syndrome
Use of Dapagliflozin to Reduce Burden of Atrial Fibrillation in Patients Undergoing Catheter Ablation of Symptomatic Atrial Fibrillation

This is a multicenter trial to evaluate the impact of treatment with dapagliflozin versus placebo following catheter ablation of atrial fibrillation (AF) on the burden of AF during 6-12 months of follow-up. This prospective, randomized, multicenter, placebo-controlled trial aims to enroll 25 subjects with AF (paroxysmal or persistent) who are scheduled to undergo catheter ablation of patients.

This is a multicenter trial to evaluate the impact of treatment with dapagliflozin versus placebo following catheter ablation of AF on the burden of AF during 6-12 months of follow-up. This prospective, randomized, multicenter, placebo-controlled trial aims to enroll 25 subjects with AF (paroxysmal or persistent) who are scheduled to undergo catheter ablation of patients. All enrolled subjects will be required to have a cardiac implantable electronic device (CIED) capable of assessing the burden of AF. Following catheter ablation for AF and functional CIED subjects will be randomized to treatment with dapagliflozin 10 mg once daily versus placebo. The primary endpoint for the trial will be AF burden assessed at 6-12 months following catheter ablation of AF. The Investigational Drug Services at the University of Rochester will be in charge of dispensing all study related drugs to subject.

Eligibility Criteria:
Inclusion Criteria

* Eligible for treatment with dapagliflozin per current FDA-approved indications, including: 1) heart failure (NYHA class II-IV) with reduced left ventricular ejection fraction (\<50%), or 2) type 2 diabetes mellitus and established cardiovascular (CV) disease or multiple CV risk factors, or 3) as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, 4) adults with chronic kidney disease at risk of progression as defined by the National Kidney Foundation as estimated GFR \<60 ml/minute/1.73 m2.
* Scheduled to undergo ablation of symptomatic paroxysmal or persistent AF prior to date of randomization per current guideline indications.
* A glycated hemoglobin level \< 10.5% during the past 6 calendar months prior to consent only in patients with type 2 diabetes mellitus
* Age \> 18 years
* Existing functional CIED or planned to undergo CIED implant as SOC before or within 24 hours following the AF ablation procedure and prior to randomization date.

Exclusion Criteria

* Type 1 diabetes mellitus
* History of diabetic keto-acidosis
* Child Pugh Class C liver disease
* Last measured estimated GFR \< 25 ml/minute/1.73 m2
* Pregnancy, plan to become pregnant \<1 year after consent or breast feeding
* Current therapy with an SGLT2 inhibitor
* Hypersensitivity to dapagliflozin
* On heart transplant list or likely to undergo heart transplant
* Unwilling or unable to cooperate with the protocol
* Participation in other clinical trials (observational registries are allowed with approval).
* Unwilling to sign the consent for participation
* Life expectancy \<1 year after consent date for any medical condition
Glyburide and Metformin for Gestational Diabetes Mellitus (GDM)

This is a pharmacokinetic and pharmacodynamic study evaluating glyburide, metformin, and combination treatment for gestational diabetes mellitus.

Gestational diabetes mellitus (GDM) is a common complication of pregnancy. Multiple treatment regimens are currently used for the management of GDM. Following failure of diet therapy, insulin, glyburide and metformin are all used in the treatment of GDM with the oral medications providing comparable outcomes with insulin but easier route of administration and schedule. The proposed work will evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of glyburide and metformin alone and in combination in order to lay the foundation in establishing dosage and response information that could be utilized in designing a phase III randomized trial that will ultimately evaluate GDM treatment optimization.

Eligibility Criteria:
Inclusion Criteria:

Gestational Diabetes Subject Selection

1. Pregnant women (singleton pregnancy)
2. Gestational diabetes mellitus
3. Able to give written informed consent
4. Drug treatment is required for GDM
5. Gestational age 20-32 weeks

   * Gestational diabetes diagnosis must occur after 20 weeks and prior to 32 weeks gestation
   * Randomization and treatment initiation must occur no later than 32 weeks gestation
6. Willing to avoid ethanol
7. 18-45 years of age

Type 2 Diabetes Mellitus Subject Selection

1. Able to give written informed consent
2. New diagnosis of type 2 diabetes mellitus
3. Plan to receive metformin for treatment of type 2 diabetes mellitus
4. 18-45 years of age
5. Female
6. Negative pregnancy test
7. Hemoglobin A1C \> 7%

Healthy Pregnant Women

1. Able to give written informed consent
2. Pregnant women (singleton)
3. Normal 1-hour glucose tolerance test
4. 20-32 weeks gestation
5. 18-45 years of age

Neonates: All the infants of the pregnant women participating in this study will be included

Exclusion Criteria:

Women with GDM and T2DM

1. Women taking medications expected to interact with glyburide, metformin or alter blood glucose concentrations
2. Serum creatinine \> 1.2 mg/dL
3. Hematocrit \< 28%
4. Allergy to glyburide, metformin or sulfa
5. Significant hepatic disease
6. Congestive heart failure or history of MI
7. Moderate to severe pulmonary disease
8. Adrenal or pituitary insufficiency

Healthy Pregnant Women

1. Receiving any hypoglycemic agents
2. Receiving corticosteroids
3. Known kidney, liver, heart, pulmonary, adrenal or pituitary disease
4. Hematocrit \< 28%

Neonates

1. Infants that are not viable or too ill for blood sample collection will be included for clinical outcomes data collection, but will be excluded from other research activities.
2. Infants \< 1.5 kg will be included for clinical outcomes data collection, but will be excluded from blood sample collection.
Effect of GLP-1 on Insulin Biosynthesis and Turnover Rates

The gut hormone glucagon like peptide-1 (GLP-1) has been shown to have important effects on maintaining the function and health of the insulin producing beta cells. This hormone is known to increase the production rate of new insulin as well as increase the release of insulin into the blood.

We will measure the rate of new insulin production in subjects with Type 2 diabetes compared to non diabetic subjects. We hypothesize that subjects with Type 2 diabetes make less insulin in response to GLP-1 compared to non diabetic subjects.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 Diabetes
* Non diabetic

Exclusion Criteria:

* Currently taking medication such as thiazolidinediones, metformin, Exenatide, or sitagliptin
* Chronic condition such as chronic heart failure CHF), Coronary Artery Disease (CAD), or chronic renal failure (CRF)
* Anemia
To Find Effectiveness of Stretching Versus Soft Tissue Mobilization in Coccydynia in Postpartum Females

This research is to determine the effectiveness of stretching versus soft tissue mobilization in coccydynia patients.The main purpose of the study is the the development of evidence based therapeutic protocols for postpartum coccydynia patients to improve functional impairment, range of motion, and reduction of pain.

The study design is randomized controlled trial.The interventions were carried out twice a week for three weeks with each session lasting approximately 20 min.Group A contains 34 patients and received STM focusing on mobilizing soft tissue to enhance circulation reduce scar tissue and improve functional flexibility.Group B received both STM and stretching twice a week for three weeks with each session lasting approximately 20 min.During entire treatment the therapist kept close eye on patient discomfort.The significance of the study lies in it's potential to enhance more effective non invasive treatment to alleviate symptoms

Eligibility Criteria:
Inclusion Criteria:

* diagnosed by orthopedic surgeon with sign and symptoms of coccydynia and radiograph X ray for confirmation.: postpartum females after 2 to 3 months after delivery
* office working females
* aged 20 to 35 years
* females with c section

Exclusion Criteria:

* FEMALES with vaginal delivery
* experience severe post operative pain
* active pelvic or abdominal infections
* ovarian cyst, fibroids,or obstructive endometrial polyps
* neurological conditions
The Effect of Vitamin C on Growth Hormone Secretion

Obesity is associated with reduced growth hormone (GH) secretion. GH secretion is regulated by nutritional stimuli including fasting, insulin, glucose and free fatty acids. However, the role of micronutrients, such as vitamins, on GH secretion has not been investigated in much detail. Vitamin C levels are also reduced in obesity, and the investigators recently demonstrated a possible role for dietary vitamin C intake in the regulation of GH secretion in two preliminary retrospective studies. The investigators therefore propose a more detailed prospective physiological study to examine the effects of increasing dietary vitamin C intake on GH secretion in a physiologic, intervention study. The investigators hypothesize that increasing vitamin C concentrations in obese subjects with sub-optimal plasma vitamin C levels and reduced GH secretion will increase GH secretion.


Eligibility Criteria:
Inclusion Criteria:

1. Men and women age 18-60
2. BMI ≥ 30 kg/m2
3. Waist circumference ≥ 102 cm in men and ≥ 88 cm in women
4. Plasma vitamin C concentration ≤ 23 µmol/l
5. Peak stimulated GH ≤ 4.2 µg/l upon GHRH-arginine stimulation test

Exclusion Criteria:

1. History of hypopituitarism, pituitary surgery, pituitary/brain radiation, recent traumatic brain injury or any other condition known to affect the GH axis.
2. History of severe chronic illness including anemia, chronic kidney disease, liver disease, oxygen dependent COPD or HIV
3. Subjects on testosterone, glucocorticoids, anabolic steroids, GHRH, GH or IGF-1 within 3 months of enrollment
4. Use of dietary supplements including vitamin C or once daily multi-vitamins
5. Subjects with Hgb \< 912 g/dL, SGOT \> 2.5x upper limit of normal or Creatinine \> 1.5 mg/dL
6. Subjects with poorly controlled diabetes, defined as HbA1c \> 8%.
7. Changes in lipid lowering or anti-hypertensive regimen within 3months of screening
8. Subject is currently enrolled in another investigational device or drug trial(s), or subject has received other investigational agent(s) within 28 days of baseline visit
9. Any condition judged by the patient's physician to cause this clinical trial to be detrimental to the patient.
Minimal Inflation Tourniquet Pressure Using Induced Hypotension

Limb occlusion pressure (LOP) and arterial occlusion pressure (AOP) are the terms that mean the lowest tourniquet pressure required to stop the arterial blood flow into the limb distal to the cuff. LOP can be determined manually or automatically by slow cuff inflation until disapper of pulsation with Doppler flow-meter or pulse oximeter

The advantages of the tourniquet during upper or lower limb procedures are providing bloodless operative field and so less intra-operative blood lossIt has been reported that using the lowest effective inflation pressure minimize tourniquet induced nerve injury .). Limb occlusion pressure (LOP) and arterial occlusion pressure (AOP) are the terms that mean the lowest tourniquet pressure required to stop the arterial blood flow into the limb distal to the cuff. LOP can be determined manually or automatically by slow cuff inflation until disapper of pulsation with Doppler flowmeter or pulse oximeter .AOP can be estimated by a formula (AOP = \[SBP + 10\]/KTP) using patient's systolic blood pressure (SBP) and tissue padding coefficient (KTP) values. In both methods, addition of a safety margin to LOP or AOP is recommended for potential hemodynamic fluctuations during surgery

Eligibility Criteria:
Inclusion Criteria:

* • ASA physical status I and II.

  * Male and female patient
  * Age group 20-50 years old

Exclusion Criteria:

* • Patient who refuse to participate in the study

  * Patients with contraindication of using the tourniquet (e.g. peripheral vascular disease or coronary artery disease sickle cell anemia neuromuscular disorders,)
  * Contraindications of using induced hypotensive anesthesia (cerebrovascular disease, Impaired kidney function , chronic liver disease, pregnancy).
  * Patients on medications inﬂuencing blood ﬂow such as nitrogycerine
  * Surgery extends more than 90 minutes.
  * Hypertensive patients
Human and Digital Support Study

The overall purpose of this study is to help determine how best to incorporate small amounts of human and digital support into a meditation app. 32 participants will be enrolled and can expect to be on study for up to 4 weeks.

The overall purpose of this study is to help determine the feasibility and acceptability of incorporating small amounts of human and digital support into a meditation app. Ultimately, the investigators hope this work will help to develop digital tools that can reduce symptoms of depression and/or anxiety. The meditation app of interest is the Healthy Minds Program (HMP). The HMP app provides training in four pillars of well-being (Awareness, Connection, Insight, Purpose) through a combination of podcast-style didactic material and guided meditation practices.

Participants will be randomly assigned to receive or not receive an initial coaching call with a team member. Participants will also be randomly assigned to receive or not receive access to email-based support. All participants with receive text messages encouraging them to engage in the practices taught in the app.

Participants will complete a set of questionnaires at baseline and post-test (following the 4-week intervention period). Questionnaires and items will be selected from the set of questionnaires included in this application. The average length of time to complete questionnaires will be within 15 to 30 minutes. Participants will also receive short daily surveys.

Eligibility Criteria:
Inclusion Criteria:

* Adults (age ≥18) who have recently downloaded the HMP app
* Elevated symptoms of depression and/or anxiety

  * Patient Health Questionnaire - 9 (PHQ-9) ≥ 5
  * General Anxiety Disorder - 7 (GAD-7) ≥ 5

Exclusion Criteria:

* Current suicidal or self-harm ideation (PHQ-9 item 9 \> 0)
* Current or past psychotic disorder
* Current of past bipolar disorder
A Prospective Study to Evaluate the Specificity of the Cobas TaqScreen MPX Test for Use on the Cobas s 201 System for Screening Plasma Pools From Source Plasma Donors for the Presence of HBV DNA, HCV RNA, and HIV-1 RNA

This study will evaluate the specificity of the cobas TaqScreen MPX Test for the simultaneous detection of HBV DNA, HCV RNA and HIV-1 Group M in a minimum of 100,000 individual donor samples in 96-unit pools.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults 18-65 years of age
* Fulfil criteria for plasma donation

Exclusion Criteria:

* Do not fulfil criteria for plasma donation
Effectiveness of Treating HIV-Positive Patients With an HIV Vaccine (Remune)

The purpose of this study is to see if it is effective to add an HIV vaccine (Remune) to the anti-HIV drug combination of Combivir (zidovudine plus lamivudine) and nelfinavir.

All patients begin HAART at study entry (Day 1). Patients with a plasma HIV-1 RNA level less than or equal to 2,000 copies/ml at Week 8 are randomized to receive Remune or Incomplete Freund's Adjuvant (IFA) at Week 9. Patients who do not achieve a plasma HIV-1 RNA level of less than or equal to 2,000 copies/ml at Week 8 are not randomized and are terminated from the study. These patients are eligible to receive funding for up to a 3-month supply of nelfinavir (Viracept) and Combivir. Randomized patients receive Remune or IFA at Week 9 and approximately every 12 weeks thereafter until study completion (when the last patient reaches Week 48). Patients are considered virologic failures if they (1) fail to achieve a virologic response by Week 48 or (2) after achieving a virologic response, have a virologic relapse. Regardless of their previous response status, patients whose plasma HIV-1 RNA level increases to greater than 2,000 copies/ml while they are receiving protocol-specified HAART are eligible to receive salvage therapy and continue to receive Remune or IFA until study completion. Study visits occur at screening, Day 1, Weeks 4, 8, 9, 12, and then every 4 weeks thereafter until the last patient reaches Week 48. Patients who complete this study are eligible to participate in a rollover study.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are HIV-positive.
* Are at least 13 years old (consent of parent or guardian required if under 18).
* Have a viral load of at least 10,000 copies/ml.
* Have a CD4 count of at least 250 cells/mm3.
* Have never taken any anti-HIV drugs before.
Hemp Seed Awareness

Hemp is a plant of the Cannabaceae family. Cannabis sativa, derived from female flowers, is the first illicit substance used by adolescents and is a major public health problem. Its psycho-active effects come from tetrahydrocannabinol (THC).

Unlike recreational cannabis, industrial hemp derived from cannabis sativa has a high level of cannabidiol (CBD) but a negligible level of tetrahydrocannabinol. Its seeds are now consumed in various forms and generate increasing interest. Seeds have many nutritional benefits.

It seems important to take an interest in hemp, given the recent expansion of medical cannabis and the increasing use of cannabis for recreational purposes. It is incriminated in various allergies (contact dermatitis, asthma, rhinoconjunctivitis) but also in the occurrence of anaphylaxis to certain foods by cross-allergy in atopic subjects, in association with an Lipid-Transfer Proteins (LTP protein), present in the flower of Cannabis sativa.

Unlike the allergy to recreational cannabis, the allergenicity of hemp seeds is little studied.

Hemp seed can cause severe anaphylactic reactions. In all reported cases, the prick-tests were positive for the seeds. Often, patients had never been in contact with hemp seeds but had already been exposed to cannabis by respiratory or manual routes.

The investigators hypothesize that sensitization by the skin or respiratory route (cannabis smokers, passive exposure to cannabis, workers exposed to hemp, etc.) could lead to the development of a food allergy to hemp seed.


Eligibility Criteria:
Inclusion Criteria:

* Major patient
* Patient referred to the Allergology Unit of the Hospital of Angers, in consultation or in Hospitalization - for conducting prick-tests
* Patient affiliated or beneficiary of a social security scheme
* Patient with informed consent

Exclusion Criteria:

* Pregnant women, parturients
* Persons deprived of liberty by administrative or judicial decision
* Persons receiving psychiatric care under duress
* Adults under legal protection measure
* People out of state to express consent
* people not able to understand French language
* Patients whose skin reactivity prevents interpretation of tests (patients who cannot interrupt anti-histamines or have severe eczema)