cyrilzakka/clinical-trials huggingface dataset:
Effects of Docosahexaenoic Acid (DHA) on Cardiovascular Disease on Diabetic Patients

Aim: to determine the effects of DHA supplementation:

* on the platelet function through their aggregation and the pathway of arachidonic acid metabolism
* on redox status on cells and plasma
* on inflammation in 16 type 2 diabetic patients in a cross-over study comparing DHA (400 mg/day for 2 weeks) vs Sunflower oil (placebo). Each period is separated by a wash-out period of 6 to 9 weeks.


Eligibility Criteria:
Inclusion Criteria:

* woman
* Type 2 diabetes
* Menopausal or aged between 55 and 75 years old
* Recent HbA1c between 6.5-10%
* Oral anti-diabetic drugs or insulin therapy
* Hypertension or antihypertensive drug

Exclusion Criteria:

* Tobacco
* Excessive drinking
* Post-menopausal hormonal treatment
* Treatment by acetylsalicylic acid, clopidogrel, gliclazide, ticlopidine, NSAID
* Secondary cardiovascular prevention
* antioxidant using
* Fish intake \>2 times a week
* Anemia \<10g/L
* Thrombopenia \<110g/L
* Creatinine clearance \<30 ml/min and/or proteinuria \>1g/L
Efficacy and Safety of DLBS2411 in Healthy Volunteers

This is a 3-arm, double-blind, randomized, controlled, parallel and dose ranging clinical study for 3 days of therapy to investigate the effect of DLBS2411 in gastric pH regulation as well as its safety in healthy volunteers.

DLBS2411 has similar mechanism of action with proton-pump inhibitors (PPIs). However, it is hypothetically more potential than PPIs in suppressing gastric acid as our previous preclinical studies with DLBS2411 have proven its effects not only on the activity of H+/K+ ATPase, the enzyme that regulates proton pump in stomach, but also on its gene expression. It is hypothesized that DLBS2411 may benefit on gastric pH regulation in healthy volunteers.

There will be 3 groups of treatment; each group will consist of 18 subjects with the treatment regimens :

* Treatment I : 1 caplet of DLBS2411 250 mg and 1 placebo caplet of DLBS2411, once daily
* Treatment II : 2 caplets of DLBS2411 250 mg, once daily
* Treatment III : 2 placebo caplets of DLBS2411, once daily

Clinical examination to evaluate the investigational drug's efficacy will be performed by a 24-hour-gastric pH monitoring after the first dose of study drug administration. Besides, the pH of the gastric fluid will also be measured at the end of study (Day 3 of treatment). Safety examination will be performed at baseline and at end of study. The occurrence of adverse event will be observed during the study.

All subjects will be under direct supervision of a medical doctor during the study period.

Eligibility Criteria:
Inclusion Criteria:

* Male subjects with age of 18-45 years
* Healthy as confirmed by vital signs, clinical and laboratory assessments (normal blood pressure, normal plasma glucose level, normal values of all hematological parameters, adequate liver and renal function)
* BMI 18-25 kg/m2
* Able to take oral medication

Exclusion Criteria:

* Gastric pH ≥ 4 at screening
* Currently being an active smoker and suffering from chronic alcoholism
* History of or currently peptic ulcer
* Having clinical diagnosis of Zollinger Ellison syndrome
* Taking any H2RAs, PPIs, antacids, or gastric mucosal protectors within 2 weeks prior to screening
* Taking any other medicines, supplements, or herbals within 3 days prior to screening
* History of gastro-intestinal disturbances necessitating long-term treatment with any acid suppressing medication, antacids, or gastric mucosal protectors
* The presence of any chronic diseases
* Currently being afflicted by serious infection(s)
* Participation in any other clinical studies within 30 days prior to screening
IVUS CHIP China Registry

The goal of this observational study is to learn about in patients with complex coronary lesions undergoing PCI. The main question\[s\] it aims to answer are: the clinical efficacy and safety of an IVUS-guided approach in patients with complex coronary lesions undergoing PCI, as well as clinical outcomes up to 2 years. Participants will be treated with IVUS-guided PCI.


Eligibility Criteria:
Inclusion Criteria:

1. The patient must be ≥18 years of age
2. Patients with an indication for PCI of at least one lesion satisfying any of the following criteria:

   1. Angiographic heavy calcification
   2. Ostial lesions
   3. True bifurcation lesions involving side-branches \>2.5mm
   4. Left main lesions
   5. Chronic total occlusion
   6. In-stent restenosis
   7. Long-lesions (estimated stent length \> 28mm) OR Patient with an indication for PCI for any lesion and in need for elective mechanical circulatory support assisted PCI
3. Presenting with silent ischemia, stable angina, unstable angina or non-ST-elevation acute coronary syndrome (NSTE-ACS)
4. All lesions must be suitable for treatment with 2nd generation drug eluting stents (or drug-coated balloons when indicated, e.g., in-stent restenosis, branching of bifurcation lesions)
5. The patient is willing and able to cooperate with registry procedures and follow-up until registry completion
6. Subject is able to confirm understanding of risks, benefits and treatment alternatives and he/she provides informed consent prior to any protocol-related procedure, as approved by the appropriate Ethics Committee

Exclusion Criteria:

1. ST-elevation myocardial infarction or cardiogenic shock within prior 7 days
2. Known untreated severe valvular heart disease
3. Requiring PCI in a diseased aorto-coronary bypass
4. Known contraindication or hypersensitivity to anticoagulants
5. Absolute contraindications or allergy that cannot be pre-medicated, to iodinated contrast or to antiplatelet drugs, including both aspirin and P2Y12 inhibitors
6. Non-cardiac co-morbidities with a life expectancy less than 1 year
7. Currently participating in a clinical trial that is not yet at its primary endpoint. The patient is not allowed to participate in an investigational device or drug study until the trial primary endpoint time point is achieved and may only be enrolled once in the study
8. Women who are pregnant or who are breastfeeding
9. Subject's circumstances that will not allow appropriate consenting procedures or follow-up activities (per investigator's discretion)
Impact of Commercial "Sleep Lotion" on Salivary Melatonin Levels and Sleep Quality in Undergraduates

The goal of this clinical trial is to test an over-the-counter "sleep lotion" in healthy undergraduate college students. The main questions it aims to answer are:

* Does an over-the-counter "sleep lotion" containing melatonin actually increase melatonin levels in participants compared to a placebo (control) lotion?
* Does an over-the-counter "sleep lotion" containing melatonin improve the quality of participants' sleep compared to a placebo (control) lotion?

Participants will:

* provide three saliva samples on each of two nights
* apply melatonin-containing "sleep lotion" on one night and a placebo (control with no melatonin) lotion on the other night
* answer questionnaires about gender, race, ethnicity, medication use, exercise, and sleep quality

Melatonin is a hormone secreted by the pineal gland in the brain that regulates sleep. There are many over-the-counter products such as bubble baths, room sprays, and lotions that claim they contain melatonin and promote sleep. This study is a randomized, controlled, double-blind crossover trial to compare the impact of a commercial "sleep lotion" vs. a control lotion on melatonin levels detectable in saliva in healthy undergraduate students. Participants will provide saliva samples on two nights, one week apart, one hour before bedtime. The sample collections will take place just before and twice after applying 1) a melatonin lotion and 2) a placebo control lotion (order randomized). The investigators will determine whether the melatonin lotion affects the natural rise of melatonin before bedtime. A second dependent variable will be the quality of sleep on both nights. Potential confounding independent variables, such as gender, race, ethnicity, medication use, and exercise will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* 18 to 24 years old
* current University of Redlands student

Exclusion Criteria:

* Pregnancy
* currently taking any sleep medications
* allergies or sensitivities to scented lotion
Holter of Movement in Patients with Multiple Sclerosis in Controlled Environment.

ActiSEP is a multicentric academic study. Ambulant patients with multiple sclerosis may be included on a voluntary basis. We plan to include a group of approximately 20 patients with MS.

This study include a unique evaluation in the laboratory of analysis of human movement. A set of tasks will be performed by patients wearing of two magneto-inertial sensors.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed MS diagnosis,
* Over 18 years old,
* Ambulant patients,
* Signed informed consent,
* No clinical and / or radiological relapse within 3 months.

Exclusion Criteria:

* Patients with excessive cognitive disorders, limiting the understanding of task or with apparent communication difficulties hindering data collection.
* Any other previous or present pathology having an impact on motor function.
* Recent surgery or trauma (less than 6 months) in the upper or lower limbs
One Month Degarelix/Comparator Treatment for Prostate Cancer in Chinese Population

One month degarelix/comparator treatment for prostate cancer in Chinese population


Eligibility Criteria:
Inclusion Criteria:

* Chinese male over 18 years
* Adenocarcinoma of the prostate
* Relevant disease status based on lab values and as judged by the physician
* Life expectancy of at least a year

Exclusion Criteria:

* Previous hormonal treatment for prostate cancer
* Considered to be candidate for curative therapy
* Risk or history of any serious or significant health condition
* Has received an investigational drug within the last 28 days and no previous treatment with degarelix
Effectiveness of Iliopsoas Positional Release Versus Conventional Exercises in the Management of Sub-acute Back Pain.

Recommended treatment for chronic non-specific LBP is exercise therapy, behavioral therapy including pain management, or a combination of these; There is not enough evidence to establish recommendations for which one is the most appropriate.

The primary objective of this study is to explore the effects of Ilio-psoas Release on Sub-acute back pain, ROM \& functional disability

Following the screening, participants will be randomized to receive the experimental or the controlled treatment in a1:1 ratio. Computer-generated random numbers will be used for Randomization. After obtaining the basic information, a unique code will be provided to each included patient. The outcome assessor will be blinded to the type of treatment. Patients and investigator could not be blinded due to the nature of treatment.

Group "A "(experimental group) will receive Positional Release Technique on Painful Iliopsoas(Both if Necessary) Group "B" (control group) will receive conventional physical therapy treatment consisting of hot pack, TENS, Ultra Sound along with back strengthening exercises.

All patients will be Assessed for Pain , ROM and Functional Activities before and after treatment sessions.

Visual Analogue Scale(VAS) and Modified Schober Test will be used for pain and ROM respectively. Roland-Morris Questionnaire (RMQ) will be used for functional activities.

Eligibility Criteria:
Inclusion Criteria:

* Sub-acute (pain for \> 1.5 month)
* Age 18-40 years
* Willing to participate
* Both gender will be recruited.

Exclusion Criteria:

* Any history related to spinal surgery
* Previous administration of epidural injections
* LBP due to specific pathology
* Neurological deficits (like stroke)
* Clinical disorder contraindicated to exercise
Effects of Fruit Consumption on Risk Factors of Chronic Disease

Acute, randomized, placebo controlled, double blind, postprandial crossover study in male subjects. 4 intervention arms consisting of control, orange juice, whole orange, and processed whole orange to determine the effect of the interventions on the primary measure of flow mediated dilatation (FMD) and additional biomarkers of health. The study will also identify and quantify the main micronutrients and phytochemicals in each of the products and will identify and quantify the main micronutrients and phytochemicals and their metabolites in the subjects' plasma and/or urine. A subset of the study population (n=24) will be invited to participate in an additional arm of the main study which is summarised below.


Eligibility Criteria:
Inclusion Criteria:

* Males due to potential hormonal fluctuations in female subjects
* Aged 30-65years
* Fasting total cholesterol in the upper half of the normal range (6.0-8.0 mmol/l) or triacylglycerol \>0.8 mmol/l or a BMI 25-32 kg/m2.
* Not having suffered a myocardial infarction/stroke in the past 12 months
* Not diabetic (diagnosed or fasting glucose \> 7 mmol/l) or suffer from other endocrine disorders
* Not suffering from renal or bowel disease or have a history of choleostatic liver or pancreatitis
* Not on drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation
* No history of alcohol misuse
* Not planning or on a weight reducing regime
* Not taking any fish oil, fatty acid or vitamin and mineral supplements
* Non smokers
* Not suffering from depression as indicated by the Brief Symptom Inventory (Appendix 11).
* Not suffering from mild cognitive impairment or dementia according to the MMSE (score ≥ 25).

Exclusion Criteria:

* Females
* Medication for hypertension, hyperlipidaemia, inflammation or hypercoagulation

  * Hypertension - ACE Inhibitors (e.g. Captopril, Cilazapril), Angiotensin Receptor Blockers (Valsartan), Calcium Channel Blockers (Amlodipine, Nicardipine), Diuretics (Chlortalidone) or Beta blockers (Sotalol, Bisoprolol).
  * Cholesterol lowering (Pravastatin, Simuvustatin)
  * Anticoagulants (Warfarin)
  * Inflammation - NSAID's (Tiaprofenic acid, Sulindac, Ibuprofen), Corticosteroids(Betamethasone)
* Strict vegetarians
* Smokers
* Those on or planning a weight reducing regime
* Blood glucose, haemaglobin or liver enzymes outside of the normal range
* Unable to consume study meals
* Those suffering from depression as indicated by the Brief Symptom Inventory (Appendix 11).
* Those suffering from mild cognitive impairment or dementia as indicated by the MMSE (score \< 25).
Comparing Nicotine Delivery, Subjective Effects, and Sensory Experiences of Tobacco Users Using Oral Nicotine Products and Electronic Cigarettes [ZYN Study]

To pilot test the appeal of non-tobacco oral nicotine products in cigarette smokers, smokeless tobacco users, and oral nicotine users.

This study will assess the use, nicotine delivery, subjective response, and sensory appeal of an oral nicotine product (ZYN) compared to electronic nicotine delivery systems (ENDS, Vuse Alto) in cigarette smokers, smokeless tobacco users and oral nicotine users.

Eligibility Criteria:
Inclusion Criteria:

* Current daily cigarette smoker as determined by:

  1. Smokes \>5 cigarettes/day for \>1 year OR
  2. Current daily smokeless tobacco or oral nicotine user as determined by:

  a. Uses \>=5 units/day for \>=1 year
* b. Uses portioned moist snuff, loose moist snuff and/or nicotine patches
* Willingness to abstain from using cigarettes/ST (smokeless tobacco) for 8-10 hours (overnight abstinence) prior to study visits (verified by exhaled-air carbon monoxide \< 10ppm).
* Self-report fair or better physical health.
* Self-report fair or better mental health.
* Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related products

Exclusion Criteria:

* Currently uses other tobacco or nicotine products (e.g., ENDS) \> 2 days/week.
* Self-report having active, untreated medical/psychiatric conditions History of serious side effects from nicotine or from any nicotine replacement therapies.
* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
* Nursing female participants.
* Vulnerable populations, such as cognitively impaired adults, individuals who are not yet adults, pregnant women, and prisoners.
* Unwilling or unable to follow protocol requirements.
* Any condition which in the Investigator's opinion deems the participant an unsuitable candidate to receive study drug.
* Previous use of the study products (ZYN or Vuse Alto; on! or General Slims).
Post Intensive Care Unit Atrial Fibrillation

Atrial fibrillation (AF) is a common heart rhythm disorder in the intensive care unit (ICU). It can be precipitated by multiple factors but it is unclear whether AF persists after discharge from the ICU, and long term. This study will investigate whether AF recurs up to one year after ICU discharge.

Atrial fibrillation (AF) is the most common heart rhythm disorder encountered in the intensive care unit (ICU). It can be precipitated by multiple factors present in critically ill patients, such as tissue hypoxia, metabolic disorders etc. There is a paucity of data regarding the persistence of AF in these patients after discharge from the ICU, and in the longer term. Therefore, this study will investigate whether AF recurs up to one year after ICU discharge using an implantable ECG Holter device in adult patients discharged alive from the ICU, with documented new onset AF.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* New onset atrial fibrillation diagnosed in the ICU (12 lead ECG or documented episode of atrial fibrillation lasting at least 30 seconds)
* Patient hospitalized in the ICU with at least one of the following two criteria:

  * orotracheal intubation for mechanical ventilation
  * AND/OR treatment with amines (vasopressors or inotropic agents)
* Written informed consent
* Patient affiliated to a social security regime (or beneficiary thereof)

Exclusion Criteria:

* Documented history of atrial fibrillation
* patients admitted to the ICU after cardiothoracic surgery
* Patients with life expectancy \<12 months
* Patients under legal or judicial protection
* Patients with no social security coverage
* Patients within the exclusion period of another clinical trial
Management of Postoperative Pain in France: a Prospective National Study

Managing postoperative pain is an ongoing challenge. Therefore, frequent surveys are needed to constantly evaluate and improve perioperative pain care. The French reference audit was published in 2008. Ten years later, the French AlgoSFAR survey of 70 centres and 3,315 patients highlighted a clear improvement in practices. However, these data have never been published in a referenced journal due to significant methodological biases.

In 2024, we do not have recent French data based on rigorous methodology in the field of postoperative pain management.

The objective of this study is to reassess postoperative pain management in France. This is a prospective national survey. The proposed methodology will make it possible to provide a relevant snapshot of the practices and quality of care. Secondarily, areas for improvement can be identified and these results will also help in the drafting of future recommendations.

100 centres representative of the French map of surgical centres will be contacted.

Inclusions will take place over 2 days, identical for all centres. All patients eligible for inclusion during this period will be included.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients benefiting of a scheduled surgery during the inclusion period in a participating centre.

Exclusion Criteria:

* Patients under 18 years old
* Patient's refusal
* Patients deprived of liberty
* Patients undergoing intracranial neurosurgery or cardiac surgery
* Expected surgery duration \< 30 minutes
* urgent surgery
Hypotonia and Neurofibromatosis Type 1 (NF1) Glioma

Currently, optic pathway gliomas (OPG) are detected based on abnormal findings made during annual ophthalmologic exams. However, because these exams are annual, it is possible for healthcare providers to miss the point at which a child's vision begins to decline (potentially indicating an OPG). If at-risk children are screened for hypotonia early in life, those children who are hypotonic may undergo magnetic resonance imaging (MRI) to evaluate for OPG before they are showing ophthalmologic symptoms. This would enable healthcare providers to discover vision loss earlier and treat symptomatic OPGs earlier, thereby allowing us a better chance of preventing further vision loss in children with OPGs.


Eligibility Criteria:
Inclusion Criteria:

* Patient must be seen at the St. Louis Children's Hospital NF Clinic
* Diagnosis of NF1
* Between 1 and 7 years of age, inclusive
* Diagnosed with hypotonia
* Legally authorized representative/guardian must be able to understand and willing to sign an IRB-approved informed consent document
* Must have an MRI scan ordered by a treating physician

Exclusion Criteria:

* Normal tone on clinical exam
* Known allergy to gadolinium or the sedative, propofol, used during MRI
* Poor kidney function defined as a known renal disease or elevated BUN and creatine
* Requiring intubation for anesthesia
The RESHAPE-HF1-FU Study

To evaluate the safety and efficiency of the MitraClip system in the treatment of patients with clinically significant mitral regurgitation with New York Heart Association (NYHA) Functional Class II to IV chronic heart failure.

The purpose of the RESHAPE-HF1-FU Study is to follow up the safety and effectiveness of the MitraClip System in the treatment of clinically significant Functional Mitral Regurgitation (FMR) in patients with New York Heart Association (NYHA) Functional Class III or IV chronic heart failure, former participants in the RESHAPE-HF Trial (Abbott Vascular).

Eligibility Criteria:
Inclusion Criteria:

* Former participant in the RESHAPE-HF Trial (Abbott Vascular)
* Subject agrees to return for all required follow-up visits
* The subject has been informed of the nature of the study and agrees to the study's provisions and has provided written informed consent as approved by the respective clinical site's Ethics Committee

Exclusion Criteria:

* Withdrawal of Informed Consent
* Subject belongs to a vulnerable population