cyrilzakka/clinical-trials huggingface dataset:
A Clinical Trial to Evaluate the Effect of ConcenTrace Trace Mineral Drops on Gut Health

This is a virtual single-arm trial that will last 12 weeks. Participants will take the drops daily and complete questionnaires at Baseline, Week 4, Week 8, and Week 12. Gut health, bowel movements, stool looseness, constipation, bloating, and regularity will be evaluated at the Baseline and at each check-in. Likert scale responses will be statistically compared from Baseline to each check-in. Participant responses and product feedback will be presented as percentage scores.


Eligibility Criteria:
Inclusion Criteria:

* Be male or female. Be aged over 18. Have a BMI less than 35. Have issues with digestion, heartburn, indigestion, gas, or constipation. Be willing to maintain their standard dietary pattern, activity level, and body weight for the duration of the study.

Be generally healthy - must not live with any uncontrolled disease.

Exclusion Criteria:

* Any person with a pre-existing chronic condition that might prevent the participant from adhering to the protocol, including any oncological and psychiatric disorders.

Anyone taking any prescribed medication targeting the gut. Anyone taking any supplements targeting the gut within the past month. Anyone with any known severe allergic reactions. Women who are pregnant, breastfeeding, or attempting to become pregnant. Anyone unwilling to follow the study protocol.
Search for Fragility Indicators Among People Aged 50+ With Chronic HIV Infection

The frailty and frail elderly was defined in 2001 by Fried as a physiological state of heightened vulnerability to external shocks. 5 criteria for classifying the elderly in 3 categories: frail, pre-frail and not frail. The prevalence of frailty in the general population was estimated to be 7%, 10% and 20% for over 65 years and 45% for over 85 years. This concept is explored in some chronic diseases, in order to prevent the loss of autonomy and tailor the treatment. In the carrier population of HIV, a North American retrospective study showed the frailty syndrome manifested as early as 10 years before, than in the general population. Furthermore various studies show in this specific population, increased incidence of diseases linked to age, suggesting an accelerated and premature aging.

objectives: The objective of this study is to determine the prevalence of frailty defined Fried syndrome in a population of subjects aged 50 and over Holders of chronic HIV infection.


Eligibility Criteria:
Inclusion Criteria:

* Patient with HIV and followed in the southeastern France area

Exclusion Criteria:

* In patient HIV infected patient
* HIV patient disabled (spastic)
* HIV infected for less than a year
Probiotics in Primary Care

Antibiotics are lifesaving medicines and generally safe, yet unwanted side effects are common. While destroying illness-causing 'bad' bacteria, antibiotics can upset the protective 'good' bacteria in the body. This research will test if taking a probiotic with prescribed antibiotics will decrease the chance of having bothersome antibiotic-associated side effects.

Objectives Several studies have demonstrated that probiotics can be helpful in preventing antibiotic-associated diarrhoea in hospitalized patients. However, the extent to which probiotics may benefit healthy adults taking a course of antibiotics has not been investigated in primary care. Furthermore, patient willingness to take a probiotic supplement concomitantly with antibiotics has not been explored. We aimed to conduct an exploratory study using probiotics in adults requiring an acute course of antibiotic therapy.

Methods Patients prescribed antibiotics for treatment of acute infections in an outpatient family practice setting were randomized to receive either a probiotic or placebo concurrently. Patients completed adherence diaries and daily symptom checklists to assess gastrointestinal and vaginal (women) symptoms and collect information about adherence.

Eligibility Criteria:
Inclusion Criteria:

* adults 18 - 79 years of age with infection requiring an oral antibiotic.
* Must be able to be contacted via telephone.

Exclusion criteria:

* pregnancy,
* breast-feeding,
* those receiving tube feeding,
* those with diarrhea as a current symptom of present illness, and pre-existing illnesses that contribute to diarrhea such as inflammatory bowel disease,
* irritable bowel syndrome, colitis or celiac disease.
* Those undergoing active cancer treatments with chemotherapeutic or radiation therapy,
* immunocompromised persons,
* history of cardiac valvular disease,
* those taking a laxative or stool softener on a daily basis, as well as
* persons treated with an antibiotic in the previous 60 days,
* new antibiotic prescription that exceeds a 10 day course, or regular use of a probiotic within the previous three weeks (including daily ingestion of yogurt).
Medication Development in Alcoholism: Investigating PPAR Agonists

The primary hypotheses under test are that alcohol dependent subjects treated with fenofibrate will report decreased craving for alcohol following cue-exposure in the laboratory and report less drinking post treatment relative to placebo.


Eligibility Criteria:
Inclusion Criteria:

* Male or female volunteers, 18-65 years of age
* Meets DSM-V criteria for Alcohol Use Disorder ≥ moderate severity and DSM-IV criteria for current alcohol dependence
* Subjects will not be seeking treatment because the medication studies are not treatment trials
* Subjects must be abstinent a minimum of 3 days (but not more than 7 days) prior to the human lab session
* Negative BAC and a CIWA score of \< 9 at screening and time of lab session to eliminate acute alcohol or withdrawal effects on dependent measures
* In acceptable health in the judgment of the study physician, on the basis of interview, medical history, physical exam, ECG, urine test and lab tests
* Females with childbearing potential must have a negative serum pregnancy test on the screening visit with a negative urine pregnancy test at randomization and agree to use an effective method of birth control for the study duration and two weeks thereafter.
* Subjects must be able to complete and understand questionnaires and study procedures in English and sign an informed consent
* Willingness to comply with the provisions of the protocol and take daily oral medication

Exclusion Criteria:

* Subjects with a medical condition that contraindicates the administration of fenofibrate or that will increase potential risk as determined by the Study Physician.
* GGT more than 3 times the upper limit of normal
* Female subjects with childbearing potential who are pregnant, nursing, or refuse to use an effective method of birth control for the duration of the study and two weeks thereafter
* Meets DSM-V criteria for a major Axis I disorder including mood or anxiety disorders or substance use disorders (e.g., cocaine, amphetamines, heroin, PCP) other than alcohol or nicotine
* Has a positive UDS at screening or Visit 3 (laboratory session)
* Treatment within the month prior to screening with an investigational drug, vaccine or drugs that may influence study outcomes, or drugs that may pose a safety risk as determined by the Study Physician.
* History of hypersensitivity to the study drugs or the ingredients
Heart Failure With Preserved Ejection Fraction: Evaluation and Recognition by CMR

Heart failure with preserved ejection fraction (HFpEF) is a common and growing condition with a poor prognosis but the pathophysiology and management are still being investigated. The PREFER-CMR project aims to evaluate and validate the application of novel 4D cardiac magnetic resonance flow dynamic methods to measure left ventricular pressures and validate these measurements with direct pressure measurement by coronary angiography. This is a prospective observational study of patients with HFpEF undergoing clinical evaluation with coronary angiography who will also undergo contemporaneous cardiac MRI. The primary outcome will be the level of agreement between the two methods using angiography as the reference method.

Heart failure with preserved ejection fraction (HFpEF) is prevalent, increasing in incidence and has a poor prognosis. Accurate left ventricular (LV) haemodynamic assessment is needed to diagnose and manage patients with HFpEF. The reference method for assessment is an invasive study using catheters to measure intra-ventricular pressure but this is rarely done due to its invasive nature, high procedural costs and lack of expertise, despite the fact that haemodynamic guided therapy is associated with reduced re-hospitalisation and mortality. Non-invasive methods of LV haemodynamic assessment are inaccurate. The Investigators have developed an accurate four-dimensional flow cardiac magnetic resonance (4D flow CMR) protocol which is non-invasive and addresses the issues with existing practices to evaluate HFpEF. This observational-analytical study aims to assess the utility of a non-invasive 4D flow CMR protocol for haemodynamic assessment of HFpEF, to generate clinical data to support future clinical trials, clinical translation and patient benefit. This research study will involve generating a precise haemodynamic model using invasive and non-invasive data of prospectively recruited patients. This model will be also optimised in clinical patients with arrhythmias. Also, observational data will be collected to test the model's prognostic value.

Eligibility Criteria:
Inclusion Criteria:

1. Adults: age≥18 years.
2. Typical HF symptoms (NYHA stage\>I) within the last six months.
3. Raised NTproBNP (\>400 pg/ml)
4. EF\>50 % with the absence of structural heart disease on TTE (except left ventricular hypertrophy or left atrial enlargement).

Exclusion Criteria:

1. Patients unable/unwilling to provide informed consent.
2. Bodyweight\>120 kg or inability to lie flat/still.
3. Contraindication for invasive workup (allergy to contrast, severe renal insufficiency with estimated glomerular filtration rate (eGRF)\<30 ml/min).
4. Contraindications for a contrast-enhanced CMR study (allergy to contrast, incompatible devices or implants, severe claustrophobia).
5. Previous medical history of EF \<50%
6. Pregnancy

The extended observational arm of the study will have wider eligibility criteria

- Patients undergoing cardiac MRI for clinical indications irrespective of EF
Transmasculine Quality of Life and Sexual Function at Pre and Post Gender-affirming Hormonal Therapy

The goal of this prospective observational study is to evaluate the short-term effect of testosterone therapy on these issues among hormone naïve TM individuals.

The main questions that aim to answer are :

1. Comparison quality of life in transgender men at pre and post testosterone therapy
2. To evaluate the most affected domain of quality of life (QOL) and FSFI of this participants

Participants will be ask to complete two questionnaires: the World Health Organization Quality of Life BREF THAI (WHO-QOL-BREF-THAI) and the FSFI (female sexual function index) before testosterone administration and both questionnaires will be re-evaluated at 12 weeks after initiation of testosterone therapy

This study was designed as a single-center, prospective trial at King Chulalongkorn Memorial Hospital, Bangkok, Thailand between September 2022 to February 2024.

All hormone-naïve TM aged above 18 years who planned to start testosterone at Gender Health Clinic, King Chulalongkorn Memorial Hospital, Thailand were approached. All the enrolled participants will be received information about the study and written consent was obtained from all participants before the start of the study. The demographic data were recorded. Blood samples of serum estradiol, total testosterone and other laboratory investigations will be assessed including complete blood count, liver function test and lipid profiles. Then, the WHOQOLBREFTHAI questionnaire and Thai version of Female sexual function index questionnaire (FSFI) will be assessed before testosterone administration. All TM participants will be received 250 mg of testosterone enanthate intramuscularly every 4 weeks for 12 weeks. After 12 weeks of treatment, another laboratory investigations and 2 questionnaires, (WHOQOLBREFTHAI and FSFI) will be assessed again.

Eligibility Criteria:
Inclusion Criteria:

* compatible with Diagnostic and Statistical Manual of Mental Disorders, 5th Edition (DSM-5)
* had never used testosterone therapy before the enrollment

Exclusion Criteria:

* history of abnormal hormone functions
* ongoing treatment or current use of medications that affect hormone functions
* diagnosis of psychiatric illnesses beyond gender dysphoria by a psychiatrist
* prescription of psychiatric or neurological medications within the past 3 months up to the present study participation
* presence of chronic illnesses or severe age-related conditions, such as chronic kidney disease, chronic liver disease, or any type of cancer
Determination of Rates and Reasons for Non-Adherence to Anti-Arrhythmic Therapy for Atrial Fibrillation

The purpose of this study is to determine if follow-up by a pharmacist over the telephone improves adherence and short term clinical outcomes in the patient with atrial fibrillation prescribed an oral anti-arrhythmic medication. This study will also identify the reasons people stop taking their anti-arrhythmic therapy. A pharmacist will provide medication counseling about their anti-arrhythmic therapy, then will follow-up by telephone on a monthly basis to assess adherence over one year.


Eligibility Criteria:
Inclusion Criteria:

* Prescribed a new anti-arrhythmic medication for atrial fibrillation
Evaluating Implant Stability Using Three Devices Osstell®, Periotest® and AnyCheck®

A prospective observational study guided by the guidelines of Strengthening The Reporting Of Observational Study in Epidemiology (STROBE) in 2014, that will be conducted to evaluate implant stability using three devices; Osstell®, Peiotest® and AnyCheck® and comparing the results.

In this study, 40 dental implants will be installed in osteotomy sites for patients with single or multiple missing tooth or teeth based on radiographic findings (CBCT).

The primary stability will be measured immediately after implant installation using three devices :

1. Osstell : based on resonance frequency analysis (RFA).
2. Periotest: based on damping effect.
3. AnyCheck: based on tapping motion. Secondary stability will be measured after 12 weeks using the same devices mentioned above.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy patients over 18 years of either gender, having single or multiple missing teeth in the maxilla and/or mandible.
2. Patient with adequate vertical bone height and width for implant placement based on preoperative radiographic findings (CBCT).
3. Ability to tolerate conventional surgical and restorative procedures.
4. Patients who are willing to comply with the study and give their consent.

Exclusion Criteria:

1. Active infection or inflammation in the implant zone.
2. Presence of any uncontrolled systemic diseases.
3. Patients with a history of radiotherapy to the head and neck.
4. Any patient requires advanced and complicated surgical techniques such as sinus lift and bone graft.
Prospectively Assessing Pain After Breast Surgery

Reducing post-operative pain and reducing the use of opioid narcotics are independently valuable goals. Before studying newer techniques that may help us achieve these goals, we need objective data on how much pain normally occurs after breast surgery done with standard-of-care techniques. This study was designed to obtain baseline data.

Breast surgeons may be able to reduce post-operative pain and the need for opioid narcotics by utilizing regional anesthesia techniques (modified regional blocks) during surgery. To test this hypothesis, we need baseline (pre-intervention) data on how much pain patients experience when breast surgery is done without blocks.

In this study, we will gather data on (1.) pain pills used after surgery, and (2.) pain scores in the recovery room. This will allow us to establish how much pain normally occurs after axillary surgery (sentinel node biopsy or axillary dissection), with or without concurrent lumpectomy, done by a participating breast surgeon.

After analyzing this data, our plan is to do a second study, with a new group of patients, to assess whether there is any change in outcome after surgeons implement these new techniques.

Eligibility Criteria:
Inclusion Criteria:

1. Provision of signed and dated informed consent form.
2. Stated willingness to comply with all study procedures and availability for the duration of the study.
3. Female, age 18 or older.
4. Scheduled for axillary surgery (sentinel node biopsy or axillary dissection), with or without concurrent lumpectomy.
5. Able to take oral narcotics and be willing to adhere to the prescribed regimen.

Exclusion Criteria:

1. A history of chronic pain
2. Any previously diagnosed chronic pain syndrome.
3. Prior use of narcotics, on more than 5 days in the past 3 months or 10 days in the past year.
Brief Intervention for OCD Fears

The study will test the efficacy of propranolol or placebo, administered after reactivation of a previously acquired obsessive-compulsive disorder (OCD) fear, in reducing fear and avoidance in OCD.

Twenty subjects with OCD will be enrolled in the study. Participants will complete baseline assessments of fear and avoidance. Participants will be randomly assigned to a single dose of propranolol 40mg or placebo, administered immediately after a fear reactivation procedure. Primary outcome assessment will be OCD symptoms and avoidance behavior in a behavioral avoidance task 2 weeks after the intervention

Eligibility Criteria:
Inclusion Criteria:

* Principal Diagnosis of Obsessive-Compulsive Disorder

Exclusion Criteria:

* History of other serious psychiatric disorder
* Current Major Depressive Disorder
* Women who are pregnant or nursing
* Current use of psychiatric medication
* Persons planning to start another treatment during the study period
* Any significant medical condition that might increase the risk or participation or use of medications that might negatively interact with propranolol
A Study to Evaluate ACT-132577 in Healthy Male Subjects

The primary purpose of this study is to investigate the rate and routes (urine and feces) of elimination of ACT-132577, and the mass balance in urine and feces


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent in a language understandable to the subject prior to any study-mandated procedure;
* Healthy male subjects aged between 45 and 65 years (inclusive) at screening;
* Body mass index of 18.0 to 28.0 kg/m2 (inclusive) at screening;
* Healthy on the basis of physical examination, cardiovascular assessments and laboratory tests.

Exclusion Criteria:

* Values of hepatic aminotransferase (alanine aminotransferase and/or aspartate aminotransferase) \> 3 × upper limit of normal range at screening;
* Hemoglobin \< 100 g/L at screening;
* Known hypersensitivity to ACT-132577 or drugs of the same class, or any excipient of the ACT-132577 drug formulation;
* Known hypersensitivity or allergy to natural rubber latex;
* Previous exposure to ACT-132577;
* Treatment with another investigational drug within 3 months prior to screening or participation in more than 4 investigational drug studies within 1 year prior to screening;
* Any circumstances or conditions, which, in the opinion of the investigator, may affect full participation in the study or compliance with the protocol;
* A radiation burden of \> 0.1 milliSievert (mSv) and ≤ 1.0 mSv in the period of 1 year prior to screening; a radiation burden of ≥ 1.1 mSv and ≤ 2.0 mSv in the period of 2 years prior to screening, etc. (add 1 year per 1 mSv).
Phase I Pilot Study of Ad5-CB-CFTR, an Adenovirus Vector Containing the Cystic Fibrosis Transmembrane Conductance Regulator Gene, in Patients With Cystic Fibrosis

OBJECTIVES: I. Assess the safety and efficacy of gene transfer into the nasal epithelium using Ad5-CB-CFTR, an E1-deleted adenovirus vector containing the cystic fibrosis transmembrane conductance regulator gene, in patients with cystic fibrosis (CF).

II. Determine whether ion transport abnormalities in CF airway cells can be corrected.

PROTOCOL OUTLINE:

Groups of 3 patients receive 1 of 4 doses of Ad5-CB-CFTR, a recombinant E1-deleted adenovirus serotype 5 vector containing the cystic fibrosis transmembrane conductance regulator gene. Ad5-CB-CFTR is administered to 1 nasal cavity and the vehicle alone is administered to the opposite nasal cavity as the control.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics-- Cystic fibrosis No mild genetic mutations, i.e., normal nasal chloride ion permeability At least 2 weeks since decrease in pulmonary function --Prior/Concurrent Therapy-- At least 3 months since systemic cortisone At least 1 month since other therapeutic research study, e.g., DNAse --Patient Characteristics-- Other: Adequate endocrine, liver, kidney, and cardiac function Adenovirus antibody seropositive No pregnant or nursing women Negative pregnancy test required of fertile women Adequate contraception required of fertile patients
Cellular Immunotherapy Study for Brain Cancer

The purpose of this research study to determine if treating recurrent malignant gliomas with another person's (donor) immune system cells known as aCTL cells, will be safe. This study will also try to determine if persons who receive aCTL's are more or less likely to survive their brain tumor than persons who had similar tumors in the past. Approximately 15 patients will be enrolled at UCLA.


Eligibility Criteria:
INCLUSION CRITERIA

To participate in this clinical trial, patients must meet the following eligibility criteria:

1. Subjects must have a histologically proven diagnosis of malignant glioma or meningioma and been treated with prior standard radiation and chemotherapy. There must be evidence of unequivocal progression by MRI.
2. Tumor must be amenable to resection, and surgical resection must be clinically indicated.
3. Age at least 18 years.
4. Karnofsky performance scale score \>60.
5. Adequate hematologic function: a) systemic white blood cell count greater than 2 x 103/mm3, b) platelet count greater than 100,000/mm3, c) hematocrit greater than 25%.
6. Adequate renal function, with creatinine less than two times the upper limit.
7. Adequate hepatic function, with SGOT, alkaline phosphatase, and total bilirubin \< 2x upper limit of normal.
8. Patients must have an expected survival of at least three months.
9. Patients must not have a history of HTLV, HIV, syphilis by RPR, hepatitis B and C.
10. Patients must sign an informed consent.

EXCLUSION CRITERIA

Patients will be excluded from the trial if the patients:

1. have multifocal tumors, bihemispheric tumors, infratentorial tumors, or non-surgically accessible tumors.
2. have prior tumor resections where the ventricles were extensively breached.
3. are pregnant or breast-feeding women.
4. are females of child-bearing potential unable or unwilling to practice adequate birth control methods.
5. have contraindications for brain MRI scanning (e.g., intra-ocular metal fragments, cerebral aneurysm clips, pacemaker).
6. have concurrent malignancy, excluding curatively treated basal or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix.
7. have concurrent systemic infection.
8. have any clinically significant, uncontrolled medical illness, as determined by the investigators.
9. are unwilling or unable to comply with procedures required in this protocol.