cyrilzakka/clinical-trials huggingface dataset:
Ginsenoside Improve Metabolic Syndrome

Aim : Investigated the effects of Korean red ginseng supplementation on metabolic parameters such as cholesterol, blood pressure and glucose.

Randomized Control Trial.

Methods : A randomized, double-blind, placebo-controlled, single-center study in 60 subjects who are not taking drugs that could affect metabolic and vascular function. Subjects will be randomized into a Korean red ginseng (3.0g/d) group or placebo group for a 4-week study.

We will collect anthropometric measurements, blood for laboratory testing, inflammatory marker, hormones and mitochondrial DNA copy number.

Subject : Older than 40 years of age, presented with metabolic syndrome. Subjects were excluded if they were taking drugs that could affect metabolic and vascular function, including BP control drug, anti-diabetic drugs and lipid-lowering drugs.

Measurement : We will collect anthropometric measurements and blood for laboratory testing at the initial(week 0) and final (week 4)visits. Serum levels of blood glucose, insulin, total cholesterol, HDL-cholesterol,triglyceride, and DNA copy number of mitochondria.

Eligibility Criteria:
Inclusion Criteria:

* metabolic syndrome

Exclusion Criteria:

* Taking drug for lipid-lowering, BP control and anti-diabetic.
Sonographic Differences in Brain Measurements Between Normal and Intrauterine Growth Restriction (IUGR) Fetuses

Intrauterine growth restriction is being suspected in cases where the fetal estimated weight is less then the 10 th percentile for its gestational age. Abdominal circumference is the most influenced measurement in this cases. Head circumference on the other hand can be or not be influenced. Previous studies have shown that transverse cerebellar diameter (TCD) is constant to gestational age and is not influenced by IUGR.Other showed lower TCD in IUGR fetuses. We would like to study the differences in cerebellar, vermian and corpus callosum growth between normal to IUGR fetuses and between symmetrical and asymmetrical IUGR. In this observational study we will include pregnant women between 28-37 gestational week with a singleton otherwise normal pregnancies. We will measure the fetal TCD, vermian distances and the CC, abdominal circumference, head circumference and femur length. we will compeer these measurements according to the following groups:normal fetuses, symmetrical and asymmetrical IUGR.


Eligibility Criteria:
Inclusion Criteria:

* singleton,
* 28-37 GA,
* well dated pregnancy.

Exclusion Criteria:

* multifetal pregnancies,
* no first trimester dating,
* fetuses with known chromosomal or structural anomalies.
Single Dose Versus Double Dose Tamsulosin 0.4 and Solifenacin 5 in Management of Stent Related Symptoms

This study was a randomized clinical trial conducted on 64 Egyptian patients from the outpatient clinic at Ain Shams University Hospital over a six-month period from 3/2024 to 9/2024.The study population was randomized into 2 groups. Group A included 32 patients with stent related symptoms receiving double doses of tamsulosin (Tamsulin® 0.4 mg 2 capsules taken together per day) and Solifenacin 10mg (Sofenacin® 10mg tab taken once daily).Group B included 32 patients with stent related symptoms receiving a standard dose of tamsulosin (0.4 mg once daily) and solifenacin (5 mg once daily).


Eligibility Criteria:
Inclusion Criteria:

- We included patients older than18 years of age, with presence of a double-J (DJ) stent in place, suffering from lower urinary tract symptoms (LUTS).Patients younger than 18 years of age, patients with a history of prostate or bladder surgery, lower urinary tract procedures, cancer, neurological conditions, pelvic radiation, diabetes, kidney dysfunction (acute or chronic), a solitary kidney, congenital urinary anomalies, or those taking medications such as α-blockers, beta-blockers, calcium channel blockers, 5-alpha reductase inhibitors, PDE5 inhibitors, anticholinergics, or nitrates were excluded. Additionally, patients with cardiac issues, residual stone fragments after surgery, multiple or bilateral ureteral stones, long-term or bilateral stents requiring frequent changes, interstitial cystitis, chronic cystitis, prostatitis, pregnant or breastfeeding women, and those unavailable for follow-up were also excluded from the study.

Exclusion Criteria:

-
A Study to Learn PF-07817883 Blood Levels After Administration of Tablets of Study Drug to Healthy Adult Volunteers

The purpose of this study is to estimate the oral bioavailability of 3 new formulations of PF-07817883 (test) relative to reference tablet formulation in healthy adult participants under fasted conditions. The study will also assess the safety and tolerability of test and reference tablet formulations in healthy adult participants.

This is a Phase 1, open-label, randomized, 4-period, 4-sequence crossover study in healthy adult participants evaluating the rBA of 3 new PF-07817883 test oral formulation(s) compared to PF-07817883 reference oral formulation. Approximately 12 participants will be enrolled in this study with approximately equal number of participants randomized to 1 of 4 sequences.

Eligibility Criteria:
Inclusion Criteria:

* Male and female participants aged 18 years or older, at screening who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and standard 12-lead ECG.
* BMI of 16 to 32 kg/m2; and a total body weight \>45 kg
* Capable of giving signed informed consent.

Exclusion Criteria:

* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior, laboratory abnormality, or other conditions and situations that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).

  1. Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
  2. History of HIV infection, hepatitis B, or hepatitis C; positive testing for HIV, HBsAg, or HCVAb. Hepatitis B vaccination is allowed.
* Positive test result for SARS-CoV-2 infection at admission
Metformin in Intrahepatic Cholestasis of Pregnancy

This is a pilot study aimed at comparing the effect of metformin versus ursodeoxycholic acid in women with intrahepatic cholestasis in pregnancy. The study will be conducted in three NHS hospital sites, over an 18 month period.

Intrahepatic cholestasis is a condition that affects pregnant women. It is characterised by itching, usually in the third trimester of pregnancy and is associated with an increase in the liver enzymes and bile salts. This can be associated with maternal and neonatal morbidity, and rarely perinatal mortality.

The investigators propose to assess and compare the effect of Metformin versus Ursodeoxycholic acid on lowering liver enzymes and bile salts, improving maternal morbidity and improving neonatal outcomes.

This study is a pilot study that will be conducted at 3 NHS hospital sites where patients will randomly assigned to receive either Metformin or Ursodeoxycholic acid. There will be 20 patient in each arm. Recruitment will commence in February 2017 and will run for an 18 month period.

Eligibility Criteria:
Inclusion Criteria:

1. 20+0 to 40 weeks' gestation on day of randomisation
2. Itching with a raised serum bile acid above the upper limit of normal
3. Normal anomaly scan at 20 weeks
4. Aged 18 years or over
5. Able to give written informed consent
6. No known pre-existing liver disease

Exclusion Criteria:

1. Decision already made for delivery within the next 48 hours
2. Known allergy to any component of the ursodeoxycholic acid or metformin tablets
3. Patients already on metformin for other conditions
Impact Evaluation of a Family-based Intervention With Burmese Migrant and Displaced Children and Families in Tak Province, Thailand

The study will evaluate the impact of a family-based intervention on the well-being of Burmese migrant and displaced children and families living in Tak province, Thailand. The methodology used in the impact evaluation study is a randomized waitlist controlled trial.

The study hypothesizes that participation in a family-based intervention will lead to improved parenting practices and child and family outcomes, as follows.

Primary hypotheses:

1. Parents/caregivers participating in the family-based intervention will report increased knowledge and use of positive parenting skills compared to control;
2. Parents/caregivers participating in the family-based intervention will report less use of physical punishment and other harsh forms of discipline compared to control;
3. Parents/caregivers and children participating in the family-based intervention will report higher levels of family functioning and cohesion compared to control.

Secondary hypotheses:

1. Parents/caregivers and children participating in the family-based intervention will report lower levels of externalizing and internalizing child behaviors compared to control;
2. Parents/caregivers and children participating in the family-based intervention will report higher levels of child resilience and psychosocial well-being compared to control;
3. Parents/caregivers participating in the family-based intervention will report lower levels of alcohol use compared to control.


Eligibility Criteria:
Inclusion Criteria:

* Of Burmese origin
* Currently living in one of 20 target communities in Tak province, Thailand
* Primary caregiver to at least one child aged 8 to 12 years
* Child aged 8 to 12 years
* Participating in the family intervention

Exclusion Criteria:

* Children living in orphanages, boarding houses, factories or other institutions
* Persons with severe cognitive or physical disability who are impaired and unable to understand and give informed consent
A Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-severe Systemic Disease Activity

Primary Objective:

To evaluate the effect of dazodalibep on systemic manifestations of Sjögren's Syndrome (SS) in participants with moderate-to-severe systemic disease activity.

Secondary Objectives:

1. To evaluate the effect of dazodalibep on patient reported outcomes (PROs) in participants with SS.
2. To evaluate the safety and tolerability of dazodalibep in participants with SS

Acquired from Horizon in 2024.

Eligibility Criteria:
Key Inclusion Criteria:

* Diagnosed with Sjögren's syndrome (SS) by meeting the 2016 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) Classification Criteria.
* Have an European Alliance of Associations for Rheumatology Sjögren's Syndrome Disease Activity Index (ESSDAI) score of \>= 5 despite symptomatic or local therapy at screening.
* Positive for either anti-Ro autoantibodies or rheumatoid factor (RF), or both at screening (as per the central laboratory test).

Key Exclusion Criteria:

* Medical history of confirmed deep vein thrombosis, pulmonary embolism, or arterial thromboembolism within 2 years of screening.
* Active malignancy or history of malignancy within the last 5 years, except in situ carcinoma of cervix treated with apparent success with curative therapy \> 12 months prior to screening OR cutaneous basal cell carcinoma following presumed curative therapy.
* Individuals with any severe or life-threatening cardiovascular (including vasculitis), respiratory, endocrine, gastrointestinal, hematological, psychiatric, or systemic disorder or any other condition that would place the individual at unacceptable risk of complications, interfere with evaluation of the IP, or confound the interpretation of participant safety or study results.
* Individuals who have a positive test for hepatitis B, hepatitis C, or HIV infection. A positive test for hepatitis B at screening is defined as: (1) positive for HBsAg OR (2) positive for either HBcAb or HBsAb and HBV DNA detected above the LLOQ by reflex testing by the central laboratory at screening.
* Active TB or untreated (per local guidelines) latent TB
* Individuals with a history of more than one episode of herpes zoster and/or any opportunistic infection in the last 12 months, and active infection requiring systemic treatment at the time of screening or through randomization, or history of more than 2 infections requiring intravenous (IV) antibiotics within 12 months prior to screening.
* Individuals who have received a live (attenuated) vaccine within the 4 weeks prior to randomization or plan to receive a live vaccine during their participation in the study.
* Last administration of experimental or investigational biologic or oral agents \< 6 months prior to screening.
* Individuals who have had previous treatment with any biologic B-cell-depleting therapy (eg, rituximab, ocrelizumab, inebilizumab, ofatumumab, or ianalumab) within 12 months or other B-cell-targeting therapy (eg, belimumab) \< 3 months prior to screening.
Coronary Calcium Scoring Versus Standard Care for Emergency Department Chest Pain Patients

This research asks whether coronary calcium scoring, a non-invasive test based on computed tomography scanning, is a better way to diagnose chest pain patients than other currently used methods. Three of four patients will undergo calcium scoring and the remaining patients will receive standard care.


Eligibility Criteria:
Inclusion Criteria:

* complaint of chest pain or pressure
* intermediate risk by HEART score
* clinical indication for non-invasive cardiac imaging
* free of known coronary artery disease

Exclusion Criteria:

* hemodynamic instability
* electrocardiogram suggestive of acute ischemia or myocardial infarction
* unremitting chest pain
* serum troponin levels greater than three times the laboratory threshold
* unable to give his/her own written, informed consent
* pregnant women
* weight \> 182 kg
* unable to lie supine for scan
* coronary calcium score, coronary CTA or non-contrast thoracic CT within the last year and available for review
* unable to comply with 30 day follow-up
Using IVR to Maintain ACS Patients on Best Practice Guidelines

The purpose of this study is to determine whether interactive voice response (IVR) technology can be used to bring post discharge care for acute coronary syndrome (ACS) closer to best practice guidelines (BPGs).

The study hypothesis is that ACS patients who are contacted by IVR technology will be more likely to receive care as recommended in the BPGs than those followed by usual care.

Acute coronary syndrome (ACS) is a significant public-health problem in Canada and worldwide with 20,000 Canadians dying of myocardial infarction and 42,000 dying of coronary artery disease in 1999. Large clinical trials have provided evidence for the development of standardized best practice guidelines (BPG) and compliance with these guidelines have significantly improved survival. Despite the development and dissemination of BPG, their application in patients with ACS is suboptimal. This randomized control trial will use 2 groups: IVR and usual care. Patients in the IVR group will receive 5 automated calls at 1,3,6,9 and 12 months consisting of predetermined questions related to medication management, smoking cessation, diet, exercise and education as recommended by the ACC/AHA BPG for ACS. Responses are captured in a database allowing for interventions to maintain patients on BPG as needed.

Eligibility Criteria:
Inclusion Criteria:

* Patients discharged from LHSC with ACS (acute myocardial infarction, STEMI, NSTEMI or unstable angina)
* Patients who have a land line telephone service at home
* Patients who speak English

Exclusion Criteria:

* Patients discharged to a care facility or transferred to another health care institution
* Patients who cannot provide informed consent
Partial Nephrectomy in Low Pressure

The main objective is to prospectively assess the impact of low insufflation pressure using AirSeal system (7mm Hg) during RAPN on post-operative patient pain (main location and intensity), 24 hours after surgery. The study will be conducted among 15 centers of the French research network on kidney cancer UroCCR.

Minimally invasive route for PN is recommended to offer patients ERAS and day-case pathways leading to the best possible recovery. In this setting, pain management is crucial and every innovation supposed to offer a benefit has to be assessed. For transperitoneal laparoscopic procedures, the level and stability of the insufflation pressure will influence the quality of the pneumoperitoneum and may impact the feasibility of the surgery as well as intra and post-operative outcomes. It is universally recognized that the lower insufflation pressure, the better. However, a balance has usually to be found between technical feasibility of the surgery and lowest acceptable insufflation pressure. The AirSeal system aims to generate a stable pneumoperitoneum even in case of active gaz succion by the surgeon's assistant. The investigators then hypothesize that RAPN would be feasible and safe even in low pressure (7mm Hg) and may decrease post-operative patients' pain.

The investigators plan to describe the feasibility of Low Pressure RAPN at 7mm Hg (LP-RAPN) and assess its intra and post-operative outcomes including pain and recovery on a patient perspective. This will be achieved comparatively to RAPN performed at standard insufflation pressure of 12 mm Hg and through a single blinded randomized trial design.

The project has been developed and will be conducted within the framework of the French research network on kidney cancer UroCCR (www.uroccr.fr). INCa has been supporting this multidisciplinary network since 2011 and the web-based shared clinical and biological national database on kidney cancer UroCCR will be used.

Eligibility Criteria:
Inclusion Criteria:

* Male or Female aged of 18 and over
* Planned transperitoneal RAPN for tumor with AirSeal system.
* Affiliation to or beneficiary of the French social security
* Patient in capacity and willing to accurately report pain-killer intakes in the first postoperative 7 days.
* Free, informed and written consent signed by the patient and the investigating physician (at the latest on the day of inclusion and before any examination required by the research).

Exclusion criteria:

* Daily chronic pain-killers intake for another indication than the kidney tumor and intended to be maintained at the time of surgery
* Person deprived of liberty
* Person under trusteeship, curatorship or legal guardianship
* Refusal of consent or participation in the UroCCR project and the P-NeLoP ancillary trial

Exclusion Criteria:

-
Investigation of the Effectiveness of Neuromuscular Exercise Program Accompanied With Degenerative Meniscal Tear

The aim of the study was to investigate the effect of exercise program added to the treatment on physical function, postural balance, muscle strength, pain and gait in individuals with meniscal damage.


Eligibility Criteria:
Inclusion Criteria:

* Age between 20-65 years.
* Having a meniscus tear.
* Volunteering to participate in the study.

Exclusion Criteria:

* Being diagnosed with a psychiatric illness.
* Having a neurological disease that may interfere with treatment.
* Having undergone meniscal surgery before.
* Having received physical therapy in the knee area in the last 6 months.
* Benefiting from any other treatment during the study.
Study With CIN-107 Following Multiple Oral Ascending Doses in Healthy Subjects

This is a randomized, double-blind, study to assess the safety, tolerability, PK, and PD of multiple oral doses of CIN-107 when administered to healthy adult subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy subjects between the ages of 18 and 55 years, inclusive, in good health based on medical and psychiatric history, physical examination, ECG, orthostatic vital signs, and routine laboratory tests (blood chemistry, hematology, coagulation, and urinalysis).
2. Body mass index (BMI) between 18 and 30 kg/m2, inclusive.
3. Nonsmokers who have not used nicotine-containing products for at least 6 months prior to the Screening Visit.

Exclusion Criteria:

1. Actively participating in an experimental therapy study; received experimental therapy with a small molecule within 30 days of Day 1, or 5 half-lives, whichever is longer; or received experimental therapy with a large molecule within 90 days of Day 1, or 5 half-lives, whichever is longer.
2. A personal or family history of long QT syndrome, Torsades de Pointes, or other complex ventricular arrhythmias, or family history of sudden death.
3. History of, or current, clinically significant arrhythmias as judged by the Investigator, including ventricular tachycardia, ventricular fibrillation, or atrial fibrillation.
4. Prolonged QTcF (\>450 msec) based on the average of triplicate ECGs.
5. Seated blood pressure higher than 150/90 mmHg or lower than 90/50 mmHg.
6. Resting heart rate higher than 100 bpm or lower than 50 bpm , sinus node dysfunction, or clinically significant heart block.
7. Temperature (T) greater than 37.6o C (99.68o F, measured orally), and respiration rate less than 12 and greater than 20 breaths/minute.
8. Postural tachycardia (ie \>30 bpm upon standing) or orthostatic hypotension (ie, a fall in systolic blood pressure (SBP) of ≥20 mm Hg or DBP of ≥ 10 mm Hg when a person assumes a standing position).
9. Serum potassium \> upper limit of normal of the reference range (ULN) and serum sodium \< lower limit of normal of the reference range (LLN).
10. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) values \> 1.2 ULN.
11. Positive for human immunodeficiency virus (HIV) antibody, hepatitis C virus (HCV) antibody, or Hepatitis B surface antigen (HBsAg).
12. A known history of porphyria, myopathy, or an active liver disease.
13. Positive drug or alcohol test result or a history of alcoholism or drug abuse within 2 years prior to the first dose of study drug as defined by the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition: DSM-IV.
14. Typical consumption of ≥14 alcoholic drinks weekly.
15. Surgical procedures within 4 weeks of check-in or planned elective surgery during the study period.
16. Currently undergoing treatment with weight loss medication or prior weight loss surgery (eg, gastric bypass surgery).
17. Pregnant, breastfeeding, or planning to become pregnant during the study.
Study to Assess the Potential for Adrenal Suppression Following Treatment With DSXS in Patients With Atopic Dermatitis

this study is to evaluate the potential of DSXS to suppress HPA axis function in patients with moderate to severe atopic dermatitis.

The objective of this study is to evaluate the potential of DSXS to suppress HPA axis function in patients with moderate to severe atopic dermatitis.

The secondary objectives are to evaluate to evaluate adverse event (AE) profiles of DSXS administered to patients with moderate to severe atopic dermatitis.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a definite clinical diagnosis of stable atopic dermatitis

Exclusion Criteria:

* Patient is under the age of 2