cyrilzakka/clinical-trials huggingface dataset:
Effectiveness and Safety of Probiotics in Protecting Liver Function

To evaluate the effectiveness and safety of using probiotics to protect the liver function of long-term alcohol consumers


Eligibility Criteria:
Inclusion Criteria:

1. A history of long-term heavy alcohol consumption, equivalent to ethanol intake ≥40g/day for over 1 year. The conversion formula is: ethanol (g) = volume of ethanol-containing beverage (mL) × ethanol content (%) × 0.8 (specific gravity of ethanol);
2. Body Mass Index (BMI) between 18kg/m² and 25kg/m²;
3. Voluntarily signed a written informed consent form, agreeing to participate in this study;
4. Agreed to comply with the study protocol and restrictions;
5. Subjects (including male participants) have no plans for conception from 14 days prior to screening until 6 months after the end of the trial and voluntarily agree to use effective contraception.

Exclusion Criteria:

1. Patients with various types of viral hepatitis, autoimmune liver disease, drug-induced liver damage, vascular liver disease, genetic metabolic liver disease, or primary liver cancer;
2. Individuals who have recently consumed substances with similar functions to the tested product, potentially affecting the study results;
3. Patients with severe allergies or immune deficiencies;
4. Pregnant, breastfeeding, or women with plans for pregnancy;
5. Individuals with severe diseases of vital organs such as cardiovascular, pulmonary, hepatic, renal conditions, or those with diabetes, severe thyroid disorders, metabolic diseases, malignant tumors, or severe immune system disorders;
6. Individuals who have used antibiotics within the past two weeks;
7. Participants who did not comply with the required consumption of the tested product or missed follow-ups, making it impossible to evaluate the effectiveness;
8. Other participants deemed unsuitable by the researchers.
A Predictive Model for Inadequate Bowel Preparation Before Colonoscopy: Development and Validation

About 30% of patients were reported to suffer inadequate bowel preparation.

Risk factors, such as diabetes, constipation, history of intra-abdominal or pelvic surgery, etc, have been demonstrated to be important predictors for inadequate bowel preparation. The aim of the study is to create and verify a predictive model for inadequate bowel preparation in Chinese.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing colonoscopy.
* patients older than 18 years.

Exclusion Criteria:

* patients referred for emergency colonoscopy.
Effect of Immunization Education Program on Parental Vaccine Hesitation

Not administering vaccines due to vaccine hesitancy is both a potential public health problem and a difficult and risky situation for healthcare professionals. Health sector workers play a very important role in vaccinating families. As public awareness increases, interest in these vaccines is likely to increase. Made works; It shows that healthcare professionals and physicians establishing trust and communicating effectively with vaccine recipients and parents is one of the most effective ways to eliminate vaccine hesitations. They stated that in order for childhood vaccines to be administered at a high rate, effective communication should first be established with parents. This project aimed to determine the effect of the immunization education program on parents' vaccine hesitancy. The project is designed as a randomized controlled study and will consist of experimental and control groups. An education program regarding immunization will be applied to the parents in the experimental group. The originality of this project is the evaluation of the effect of the immunization education program applied to parents whose children are hospitalized on vaccine hesitancy. Although studies on vaccine hesitancy in parents have increased in recent years, most of them consist of descriptive studies aimed at determining the level of vaccine hesitancy and affecting factors. No intervention studies on the effect of immunization education in parents on vaccine hesitancy have been found.

The aim of the research will be carried out using a parallel group (experiment-control) randomized controlled design, which is one of the experimental methods, to determine the effect of the immunization education program on parents' vaccine hesitancy.

Goals:

* To examine the effect of the immunization education program on parents' vaccine hesitancy,
* To compare the average scores of the vaccine hesitancy scale between the parents in the experimental group and the control group in the project.

Eligibility Criteria:
Inclusion Criteria:

* Having a child between the ages of 0-6,
* admitted to the pediatric ward,
* who have not previously received training on immunization
* Parents who volunteered to participate in the study

Exclusion Criteria:

* illiterate
* parents with mental retardation, vision and hearing impairment
Coronary Atherosclerosis Evaluation by Arterial Wall Magnetic Resonance Imaging (MRI)

The overall goal of this study is to use MRI to:

* Examine the relationship between known risk factors for cardiovascular disease and coronary artery wall thickness;
* Examine the relationship between coronary artery wall thickness and other markers of subclinical coronary atherosclerosis, such as carotid wall thickness and coronary calcium scores; and,
* Examine the feasibility of measuring the progression of coronary artery wall thickness over time in a subset of participants.

Each enrolled participant will undergo MR Imaging of the coronary arteries in conjunction with their routine MESA follow-up visit. The MRI will last approximately 45-60 minutes

Eligibility Criteria:
Inclusion Criteria:

* Prior enrollment in the MESA Study at the Hopkins MESA Field Center or the Northwestern University MESA Field Center
* Male or Female adult equal to or older than 45 years of age
* Willing/able to provide informed consent

Exclusion Criteria:

* Any known contraindications to MRI (i.e. severe claustrophobia, pacemaker, etc.)
* Metal in the eyes
A Comparative Split-Face Study of the Effects of a Retinol Alternative Cream on Improving Facial Skin Aging

This study will evaluate the efficacy of the DIME TBT Cream in improving the appearance and hydration of aged skin in comparison to a retinol cream. This study will last for 60 days. The study will be conducted as a single-arm trial in which all participants will use both the test product and the positive control product (0.1% Retinol Clinical Trial Lotion). Participants will be required to undertake questionnaires at Baseline, Day 30, and Day 60. Photos will be taken at Baseline, Day 30, and Day 60, and expert skin grading will take place at Baseline and Day 60.


Eligibility Criteria:
Inclusion Criteria:

Females aged 18-65. Have one or more of the following: visible fine lines and wrinkles, dry skin, reduced skin elasticity, or generally unhealthy skin.

Must be willing to use two different skincare products, one on each side of their face for the duration of the trial.

Have a smartphone or camera to take before-and-after selfies.

Exclusion Criteria:

Anyone not in good health. Anyone who has any chronic health conditions such as oncological or psychiatric disorders.

Anyone who has any known serious allergic reactions that require the use of an Epi-Pen.

Anyone who is pregnant, breastfeeding, or wanting to become pregnant over the next three months.

Anyone who cannot/ will not commit to the study protocol. Anyone with a history of substance abuse.
Efficacy and Safety Study of Norethindrone Acetate Transdermal Delivery System in Contraception

The purpose of this study is to determine whether NEA TDS is effective in the prevention of pregnancy. The safety of this product will also be evaluated.

An Open Label Study to Evaluate the Contraceptive Efficacy and Safety of Norethindrone Acetate Transdermal Delivery System.

Eligibility Criteria:
Inclusion Criteria:

* Healthy females
* 18-45 years
* Regular, consistent menstrual cycles between 25 and 35 days
* Sexually active and at risk of becoming pregnant

Exclusion Criteria:

* History of infertility
* Known contraindications to progestogen administration
* Pap smear suggestive of a high-grade precancerous lesion(s)
* Clinically significant deviation from normal in any of the screening tests or exams
Safety, Pharmacodynamics, and Pharmacokinetics of BIBT 1011 BS in Healthy Subjects

A study to assess safety, pharmacokinetics and the effect of BIBT 986 BS, given as BIBT 1011 BS, on coagulation parameters.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects as determined by results of screening
* Signed written informed consent in accordance with good clinical practice (GCP) and local legislation
* Age ≥ 18 and ≤ 45 years
* Body Mass Index ≥ 18.5 and ≤ 29.9 kg/m2

Exclusion Criteria:

* Any finding of the medical examination (including blood pressure, pulse rate and ECG) deviating from normal and of clinical relevance
* History or current gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological, hormonal disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders
* Chronic or relevant acute infections
* History of

  * allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
  * any bleeding disorder including prolonged or habitual bleeding
  * other hematologic disease
  * cerebral bleeding (e.g. after a car accident)
  * commotio cerebri
* Intake of drugs with a long half-life (\> 24 hours) within 1 month prior to administration
* Use of any drugs which might influence the results of the trial within 10 days prior to administration or during the trial
* Participation in another trial with an investigational drug within 2 months prior to administration or during trial
* Smoker (\>10 cigarettes or 3 cigars or 3 pipes/day) or inability to refrain from smoking on study days
* Alcohol abuse (\> 60 g/day)
* Drug abuse
* Blood donation within 1 month prior to administration or during the trial
* Excessive physical activities within 5 days prior to administration or during the trial
* Any laboratory value outside the clinically accepted reference range
* History of any familial bleeding disorder
* Thrombocytes \< 150000/µl
Evolusion Study Using the Zyga SImmetry Sacroiliac Joint Fusion System

Sacroiliac joint pain reduction and radiographic evidence of SIJ fusion will be collected to evaluate clinical performance of the SImmetry Sacroiliac Joint Fusion System.

This is a prospective, non-randomized post market study designed to evaluate fusion and pain reduction following the use of the SImmetry System. This study will be conducted at up to 40 sites and 250 total subjects will be enrolled and followed through 24 months. Data will be collected pre-operatively, implant, and at specified follow-up time points through 24 months.

Eligibility Criteria:
Key Inclusion Criteria:

* At least three positive provocative tests for SIJ pain
* Non-operative management of SIJ pain for ≥ 6 months prior to surgery
* At least one positive diagnostic SIJ injection resulting in a ≥ 50% decrease in pain
* VAS back pain score of ≥ 60 mm
* The subject is at least 18 years of age

Key Exclusion Criteria:

* Trauma causing fracture of the sacrum or iliac bones or has had spinal trauma leading to a neurological deficit, or pelvic soft tissue or bony tumors
* Pregnant or is planning on becoming pregnant in the next two years
* Chemical dependency abuse problems as evidenced by a history of abusing drugs which is documented in their past medical history or is elicited from an interview.
* Receiving or seeking worker's compensation, disability remuneration, and/or involved in litigation related to low back or SIJ pain
* History of significant emotional or psychosocial disturbance
Pharmacometabolomic of Trabectedin in Soft Tissue Patients

This perspective, mono institutional study is addressed to find potential serum and urine biomarkers predictive of the pharmacokinetic and pharmacodynamic profile of soft tissue sarcomas patients treated with trabectedin.

This investigation enrolled patients with unresectable and/or metastatic soft tissue sarcoma not responsive to the first-line treatment based on anthracycline/ifosfamide. Patients underwent trabectedin monotherapy that was administered intravenously at the dose of 1.3 mg/m2 every 21 days.

Single overnight fasting urine and blood samples were collected on day-1 of the first trabectedin administration.

Plasma pharmacokinetics was performed during cycle 1. Blood samples, drawn from a site separate from the drug infusion site, were obtained prior to the infusion (basal) at 2, 8, 24 (end of infusion) and 0.5, 1.0, 4.0, 8.0, 24.0 after the end of the infusion. Plasma concentrations of trabectedin were measured by liquid chromatography, tandem mass spectrometry assay (LC-MS/MS) and the pharmacokinetic parameters (Cmax, Clearance, AUC and T1/2) were calculated from the concentration-time curve using a non-compartmental model.

Metabolomics profiles were explored by LC-MS/MS in predose urine and serum and encompassed a total of 192: a) 45 amino acid derivatives, virtually involved in a wide set of biochemical pathways; b) 40 different acylcarnitines, principally involved in the cellular energy metabolism; c) 15 lysophosphatidylcholine metabolites, 77 phosphatidylcholine derivatives, and 15 sphingomyelins, involved in fatty acid metabolism and cellular signaling. The identification of predictive metabolomics biomarkers is performed using univariate and multivariate statistical analyses.

Eligibility Criteria:
Inclusion Criteria:

* Advanced Soft Tissues Sarcoma STSs (unresectable and/or metastatic disease).
* One previous systemic treatment with ananthracycline ± ifosfamide.
* Measurable disease, as defined by RECIST criteria.
* ECOG PS ≤2.
* Age ≥18 years.
* A minimum of 3 weeks since prior tumor directed therapy
* Recovery from toxic effects of prior therapies to NCI CTC Grade 1 or lower.
* Adequate haematological, renal liver function.
* Ability and willingness to provide informed consent

Exclusion Criteria:

* Pregnant or breast-feeding women
* Prior exposure to Trabectedin.
* Peripheral neuropathy, Grade 2 or higher.
* Known CNS metastases.
* Active viral hepatitis or chronic liver disease.
* Unstable cardiac condition, including congestive heart failure or angina pectoris, myocardial infarction within one year before enrolment, uncontrolled arterial hypertension or arrhythmias.
* Active major infection.
* Other serious concomitant illnesses.
Evaluation of the Efficacy and Safety of Oxacom® in Patients With Pulmonary Arterial Hypertension

A multicenter, randomized, double-blind, placebo-controlled, phase II-III clinical trial to evaluate the efficacy and safety of the study drug in adult patients with pulmonary arterial hypertension (PAH).

The trial will evaluate the efficacy and safety of both single and multi-dose (seven-day) administrations of the study drug in three dosages: 0.03 mg/kg, 0.10 mg/kg, and 0.17 mg/kg.

The trial is an observer-blinded trial, since the appearance of the study drug and Placebo differs from each other. Patients included in the trial, as well as trial coordinators, investigators, and study center staff will be blinded. The only unblinded staff in the study centers will be those who preparing IP/Placebo and administering IP/Placebo to the study patients.

The trial will include 200 patients with PAH, who will be sequentially included in the trial in two stages.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of PAH II or III functional class according to WHO classification
* Symptomatic PAH group 1 according to clinical classification
* Patients who have not previously received any PAH-specific therapy OR patients who have received endothelin receptor antagonists and/or iloprost/selexipag at stable doses for at least 3 months prior to the initial right heart catheterization.
* Ability to perform reproducible 6-min walking test at the screening with a distance from 150 to 450 m.

Exclusion Criteria:

* as per the study protocol
Impulsivity and Time Perception

Cannabis smokers having begun prematurely their consumption (before 16 years) present a persistent impulsivity much later after have stopped their consumptions. The literature highlights that the impulsivity promotes the passage towards a compulsive consumption, and the loss of control. To explain this phenomenon, some authors hypothesized that impulsivity would lead the subjects to overestimate the duration of events and to choose immediate rewards than preferred but delayed rewards. This hypothesis questions the role of the temporal anticipation in the impulsive choices. In a first hypothesis, the temporal impulsivity could be an endogenous deficit bound to the reward, and would be responsible for disorders of the temporal anticipation. In this case, the disorders should be observed especially when the subject anticipates a reward. Alternately, a disorder of the temporal anticipation could provoke impulsivity, and in this case, would be present with or without reward. To separate these hypotheses, we propose to test the capacities of temporal anticipation of non-smokers and early smokers of cannabis by means of a behavioral task " Hazard function task ", which allow to measure the capacity of a subject to anticipate the apparition of an event on the basis of a temporal cue. The neuronal correlates will be measured by a recording EEG of the wave ' CNV ' (fix a quota for denial of variation) which reflects the temporal accumulation and the processes of anticipation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers Man or woman of age between 18 and 50 years-old
* Absence of consumption of cannabis and tobacco for 1 year and absence of substance use disorder in history
* Matching in age and sex to the group consumers of cannabis
* Early consumers of cannabis (at the beginning of the consumptions before 16 years)
* Man or woman of age between 18 and 50 years old
* Statement of more than three consumptions a day of cannabis for at least one year and consumption of cannabis having begun before the age of 16 years.
* Urinary analysis is positive for the presence of cannabis
* Positive auto-questionnaire CAST: 2 positive answers to CAST questionnaire
* Hospitalized or not

Exclusion Criteria:

* Presence or history of a severe and invalidating somatic pathology (neurological, cardiovascular, lung, metabolic, renal, hepatic, gastro-intestinal)

  * History of cranial trauma with loss of consciousness.
  * substance use disorder except the substance tested in the protocol (cannabis).
  * Invalidating sensory disorders in particular visual: glaucoma, any retinal pathology. Visual acuteness 0.8
  * History of general anesthesia in the previous 3 months the study
  * Any evolutionary neurological or psychiatric pathology
  * Subject under guardianship
  * pregnancy
  * Feeding
Effects of Eccentric Training Intervention in Older Adults

Sarcopenia leads to loss of muscle mass and muscle strength during the aging process. It has been reported that eccentric training has some positive effects on the preservation of eccentric strength, with less delayed onset muscle soreness (DOMS) in older groups, and lower metabolic costs.

This is prospective study. The goals of this study are to:

1. Examine the effects of eccentric training on physical function (gait speed, stair climb, chair stand) in older adults.
2. Examine the effects of eccentric training on muscle strength (Isometric strength, Isokinetic strength, power) in older adults.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who can agree voluntarily
* Older men/women: Age (60 - 80 yrs)

Exclusion Criteria:

* Uncontrolled hypertension
* Acute coronary syndrome
* Subjects who took drugs which can affects neuromuscular system
* Subjects who cannot agree voluntarily
Women With Polycystic Ovary Syndrome (PCOS)

Metabolic profile in women of different body composition with polycystic ovary syndrome.

Will be performed case-control study with women with Polycystic Ovary Syndrome, according to the Rotterdam criteria and body mass index between 18 to 29.9. The control group will consist of women without Polycystic Ovary Syndrome, with a body mass index of 18 to 29.9 and no other comorbidities. In both groups collect anthropometric data such as age, weight, height, waist circumference and blood pressure. Exams will be requested: metabolic profile (total cholesterol (mg/dL) and fractions, triglycerides (mg/dL), blood count, liver function (U/L) and classical glycemic index (mg/dL); hormonal profile - insulin (uIU/ml), luteinizing hormone (IU/L), follicle stimulating hormone (IU/L), thyreostimulating hormone (uIU/ML), total and free testosterone (ng/ml), 17-hydroxyprogesterone (ng/ml), dehydroepiandrosterone (ng/ml), prolactin (ug/ml). Body composition (BMI) will be performed by absorption technique of two low energy beams emitted by X-ray - full body densitometry (DEXA). Expected result: To evaluate visceral fat and truncal of patients with diagnosis of Polycystic Ovary Syndrome without obesity.

Eligibility Criteria:
Inclusion Criteria:

* Polycystic Ovary Syndrome , body mass index of 18 to 29.9, without contraceptive use.

Exclusion Criteria:

* Hypothyroidism, hyperprolactinaemia (defined as serum prolactin levels greater than 25 ng/mL)
* Cushing's syndrome
* Nonclassical congenital adrenal hyperplasia (defined as serum 17-hydroxyprogesterone levels greater than 1.2 and 5.2 ng/mL in the follicular and luteal phase, respectively) and current or previous (within the last three months) use of oral contraceptives and other hormonal
* Antidiabetic and antiobesity drugs.
An ACT-Based Physician-Delivered Weight Loss Intervention

The purpose of the present study was to conduct a pilot RCT to test the feasibility of a physician-delivered ACT-based intervention for emotional eaters with overweight/obesity against standard care at a network of weight loss clinics. Participants were randomized to receive either standard care at the clinics or the ACT intervention.

The purpose of the present study was to conduct a pilot RCT to test the feasibility of a physician-delivered ACT-based intervention for emotional eaters with overweight/obesity against standard care at a network of weight loss clinics. Psychology clinical PhD students trained physicians in the delivery of the brief manualized intervention and were available for regular consults. The intervention consisted of eight, 5-10 minute sessions that could be easily incorporated into the physician's current practice. Over the duration of the ACT intervention, physicians met individually with patients to teach them various techniques to address and improve mindfulness, acceptance, and values clarification and commitment, all of which emotional eaters have been found to struggle with (Forman \& Butryn, 2014). The proven habit formation technique of if-then planning (Gollwitzer, 1993) was used throughout these sessions in order to train emotional eaters to habitually use ACT techniques and to change the maladaptive habit of eating in response to negative emotions.

Eligibility Criteria:
Inclusion Criteria:

* Only participants considered to be emotional eaters, as assessed by a score of 3.25 or higher on the Dutch Eating Behavior Questionnaire (DEBQ), were recruited for the study (van Strien, Herman, Anschutz, Engels, \& de Weerth, 2012).

Exclusion Criteria:

* Not being an emotional eater.
* Participants who did not speak, write, and read in English fluently were excluded from the study, as well as those who were pregnant.