cyrilzakka/clinical-trials huggingface dataset:
GaStroEsophageal effeCt of indobUfen Versus aspiRin in Patients Undergoing Dual antiplatElet Therapy

The dual antiplatelet therapy based on aspirin plays an important role in the treatment of patients with coronary heart disease. Although aspirin is widely used and effective, it has many limitations in the long-term including increased risk of bleeding. In patients with coronary heart disease and gastroesophageal reflux disease, the symptoms of gastroesophageal reflux are usually aggravated after the application of aspirin. As an antiplatelet drug, indobufen can reversibly and selectively inhibit platelet cyclooxygenase-1 (COX-1), thereby blocking the synthesis of thromboxane B2 (TXB2) and exerting its antiplatelet effect, and it does not affect the production of prostaglandins and endothelial prostacyclins in gastrointestinal mucosa. It has less gastrointestinal injury and lower risk of bleeding. This project is to study the effects of indobufen or aspirin on gastric acid secretion and gastroesophageal reflux in patients with coronary heart disease and gastroesophageal reflux disease treated with dual antiplatelet therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age 18-75 years
* Patients with stable and unstable angina pectoris receiving dual antiplatelet therapy (combined with clopidogrel)
* Coronary angiography indicating ≥50% stenosis in \>2.0 mm vessels
* Gastroesophageal Reflux Disease Diagnostic Questionnaire Score (≥8)
* Signed informed consent

Exclusion Criteria:

* Acute myocardial infarction within 1 month before admission
* Patients undergoing treatment related to gastroesophageal reflux disease (e.g. proton pump inhibitors, etc.)
* Patients receiving other antiplatelet drugs (such as cilostazol) and oral anticoagulants
* Patients with cardiogenic shock (systolic blood pressure \<90 mmHg and/or diastolic blood pressure \<60 mmHg), severe heart failure (killip grade ≥3), hepatic insufficiency (AST/ALT more than twice the upper limit of normal value caused by non-cardiac diseases), prior stroke and renal dysfunction (GFR \<60 ml/min)
* Those with active hemorrhage, hemorrhagic diseases or tendency to bleeding, especially those with a history of cerebral hemorrhage
* People who are known to be intolerant or allergic to aspirin, indobufen or clopidogrel
* Patients with malignant tumors or with life expectancy \<2 years
* Pregnant women, lactating women, women of childbearing age who do not take effective contraceptive measures, or those who plan to conceive during the trial, or those who have positive results of HCG examination before the trial
* Those who have participated in other clinical trials or are currently participating in other clinical trials within one month before the trial
* According to the judgement of the researchers, patients could not complete the study or comply with the requirements of the study (e.g. memory or behavioral disorders, mental disorders, alcohol dependence, prior defaults)
Study on the Efficacy of Slow Release Insulin in Cystic Fibrosis Patients With Glucide Intolerance and Clinical Decay

The purpose of this study is to evaluate whether the anticipated use of glargine in CF patients with glucose intolerance may prevent the worsening of nutritional status and pulmonary function.

Diabetes mellitus may often complicate the cystic fibrosis course, and it is usually preceded by a condition defined as glucose intolerance, during which a significant decay of patient's general conditions is observed. A slow release insulin (glargine) has become available in the market for diabetic patients: its characteristics allow for a single daily dose, and no need of repeated daily monitoring of glycemia.

In this randomized controlled clinical trial we evaluate whether the anticipated use of glargine in CF patients with glucose intolerance may prevent the worsening of nutritional status and pulmonary function.

Eligible patients who will accept to participate to this study will be randomly allocated in the group who will or will not receive glargine as additional supportive therapy. Patients will in any case continue the CF therapy prescribed by their treating physicians and their usual diet. All the patients will be evaluated every three months to assess their nutritional, pulmonary and glycometabolic status. The follow-up will continue until the 18th month after the study entry.

Eligibility Criteria:
Inclusion Criteria:

* Ascertained diagnosis of CF
* Age ≥ 10 years
* Glucide intolerance: 2 pathologic OGTT ( at 120' glucose value: \>140 mg% and \<200 mg%) at 2-6 months' interval between each other
* At least one of the following conditions:

  * BMI (body mass index) \< 10th centile for age and sex (according to Rolland Cachera 1991)
  * Loss of one BMI centile class for age and sex in the last year (according to Rolland Cachera 1991)
  * FEV1 ≤ 80% of predicted
  * FEV1 decrease ≥ 10% in the last year

Exclusion Criteria:

* Specific contraindications for the use of glargine
The Effect of Psyllium and Wheat Bran on Body Weight in People With Parkinson's Disease and Constipation Symptoms

This is a 10-week randomized, controlled study to compare the safety and efficacy of two common fiber supplements, psyllium and wheat bran in terms of changes in body weight, nutrition status, and bowel function in patients with Parkinson's Disease who have constipation symptoms. After a 2-week run-in period, participants will be randomized to receive 10 grams daily of psyllium, coarse wheat bran, or maltodextrin (placebo) for 8 weeks. Nutritional and neurological evaluations will be conducted at the beginning and end of the 8-week intervention period.


Eligibility Criteria:
Inclusion Criteria:

* Physician-diagnosed Parkinson's disease
* Age 40-85 years
* Drug naïve or on stable dosage of PD medications with no plans to change for the duration of the study protocol
* Hoehn \& Yahr stage \< 4 in the clinical "ON" state
* Using laxatives (Miralax, Dulcolax, sennosides, etc.) regularly over the past 1 months (≥ 2 days per week)
* Complete informed consent in English
* Maintain habitual diet and exercise routine throughout study period
* Consume the study intervention twice per day during the eight-week intervention period
* Complete daily and weekly questionnaires, and all dietary recalls over approximately 10 weeks
* Fast (no food or drink, except plain water, coffee, or tea) at least 12 hours before each study visit

Exclusion Criteria:

* Atypical or secondary Parkinsonism
* Underweight (BMI \<18.5)
* Inability to swallow study supplement due to swallowing concerns
* Currently using a fiber supplement
* Use of another investigational product within 3 months of the screening visit
* Being treated for a physician-diagnosed GI disease or condition other than constipation, gastroparesis, gastroesophageal reflux disease, or diverticular disease
The Evaluation of the Effectiveness, Safety and Tolerability of Treatment, Using a PSMA-Lu177, in Patients with ACC- an Open, Non-commercial Clinical Trial

Non-commercial phase 2 clinical trial to evaluate the effectiveness, safety and tolerability of treatment using prostate-specific membrane antigen (PSMA) labeled with 177Lutetium in patients with recurrence and/or metastases in adenoid cystic carcinoma originating from the salivary glands of the head and neck region.

Patients with PSMA receptor expression confirmed by PET/CT after administration of 68Ga-PSMA I\&T will be eligible for treatment.

It is planned to enroll 32 patients diagnosed with non-resectable recurrence and/or dissemination in the course of ACC, whose general condition and life expectancy justify qualification for diagnosis using PSMA 68Ga and treatment with lutetium (177Lu) vipivotide-tetraxetan

The Study assumes the administration of 6 cycles of treatment (lutetium \[177Lu\] vipivotide-tetraxetan) at 6-week intervals.

If toxicity occurs, the activity of the next dose of the preparation will be modified or its next administration will be delayed by a maximum of 4 weeks.

After completing 6 cycles of therapy, the participant enters the observation phase, which will last until recurrence of the disease is diagnosed or for 2 years after the end of therapy.

Eligibility Criteria:
Inclusion criteria:

* Signing the informed consent form to participate in the study
* Patients with inoperable, locoregionally advanced or metastatic, histopathologically confirmed adenoid cystic carcinoma of salivary gland
* Age over 18 years
* WHO performance status 0 to 2
* PSMA expression confirmed by PET/CT using 68Ga-PSMA;
* Presence of measurable disease according to RECIST 1.1 criteria
* Adequate function of: bone marrow, liver, kidneys:

bone marrow: neutrophils \>1500x10\^9/L; thrombocytes \>150,000x10\^9/L, hemoglobin \>9 g/dl liver: bilirubin \<2xULN; aminotransferases \<3xULN (in patients with liver metastases \<5xULN) kidney: eGFR \>50 ml/min albumin \>2.5 mg/ml

* For women of reproductive age: confirmed negative pregnancy test
* The need to use of a highly effective method of contraception

Exclusion criteria:

* Pregnancy or breastfeeding
* Lack of effective contraception during childbearing age
* Patients with metastases to the brain, meninges or heart
* Severe or significant additional diseases in the opinion of the investigator
* Urinary tract obstruction and/or hydronephrosis.
* Concomitant treatment of another cancer
* Myelosuppressive or nuclear treatment later than 4 weeks after qualification
* Previous treatment with 177Lutetium-labeled PSMA
Functional Magnetic Resonance Imaging (fMRI) Vascular Reactivity in Cerebral Cavernous Malformations (CCM)

The goal is to characterize vascular reactivity and cardiac pulsatility of normal appearing white matter in patients with CCM during hypercarbia/hypocarbia using quantitative real-time high-speed multi-echo fMRI to develop prognostic biomarkers for CCM formation


Eligibility Criteria:
Inclusion Criteria:

1. All familial CCM subjects presenting at UNMH who can consent to our study.
2. Adult Male/Female patients ages \>18 years old

Exclusion Criteria:

1. Individuals ages \<18 year
2. Subjects with a known fear of dyspnea or enclosed spaces will be excluded from this study as well as those with metal implants, COPD, heart conditions, and hypercapnia.
3. Subjects who have contraindications to MRI such as harboring incompatible ferromagnetic objects implanted in the body.
4. Pregnant women (screening for pregnancy will be performed by oral questionnaire. MRI is safe in pregnancy but the study will exclude pregnant subjects, as the effects of respiratory challenge cannot be predicted in such subjects. Since these effects are proportional to the stage of gestation, oral history will be sufficient to assure safety.)
5. Prisoners.
6. People unable to consent.
7. People unable to participate due to prior neurological deficits.
8. Subjects with underlying pre-existing pulmonary illness; such as asthma, COPD, pulmonary hypertension, will be excluded.
9. Cognitively impaired and/or participants not able to speak English language will not be included in the study (This pilot study involves performing motor and verbal tasks while in the MRI, in addition to undergoing a respiratory challenge, that requires understanding instructions clearly. We do not have current capabilities to include a translator who would be available at all stages of the study to include subjects who do not speak English.)
ACUVUE® OASYS® 1-DAY vs DAILIES TOTAL1®

The purpose of this study is to compare the lens fit characteristics, specifically lens centration, of ACUVUE® OASYS® 1-DAY (AO1D) contact lenses and DAILIES TOTAL1® (DT1) contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Must sign informed consent form;
* Adapted, current daily disposable soft contact lens wearer who typically wears lenses every day, or at least 5 days per week, 6 hours per day;
* Symptoms of contact lens discomfort as defined by the Symptomatology (Eligibility) Pre-screening questionnaire;
* Prescription within -1.00 Diopter (D) to -6.00D to be fitted with study contact lenses;
* Cylinder equal or lower than -0.75D in both eyes;
* Vision correctable to 20/25 or 0.1 logMAR (Logarithmic minimum angle of resolution) or better in each eye at distance with both study lenses at Visit 1;
* Can be successfully fitted with both study lenses at Visit 1;
* Willing to wear lenses every day or at least 5 days per week, 6 hours per day and attend all study visits;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
* Use of systemic or ocular medications for which contact lens wear could be contraindicated as determined by the Investigator;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* Fitted with monovision;
* Prior refractive surgery;
* History of herpetic keratitis, ocular surgery, or irregular cornea;
* Pregnant or lactating;
* Use of mechanical eyelid therapy or eyelid scrubs within 14 days before Visit 1 and not willing to discontinue during the study;
* Participation in any clinical study within 30 days of Visit 1;
* Current DT1 or AO1D lens wearer;
* Other protocol-specified exclusion criteria may apply.
Effect of a Quality Improvement Initiative to Address Social Determinants of Health on Rehospitalization Rates in Patients With Heart Failure

The objective of this program is to improve post-acute care coordination for necessary social services for patients leaving the hospital after recovering from an episode of decompensated heart failure.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-99 years
* Resident of Missouri or Kansas
* Current inpatient admission for acute heart failure

Exclusion Criteria:

* Under 18 years or over 99 years of age
Glucose Metabolism and Sleep in People With Family History of Type 2 Diabetes.

The use of sugar and starch-like foods for energy (carbohydrate metabolism) changes when people sleep. However, it is still not known if differences in the amount of nighttime sleep have an effect on the carbohydrate metabolism of people who have a relative with type 2 diabetes (parent, sibling, or grandparent). This study is being done to test the hypothesis that individual differences in habitual sleep duration may be related to differences in the carbohydrate metabolism of people who have a history of type 2 diabetes in their family.

On two consecutive inpatient days, the participants in this study will undergo two different tests. The first test will determine how much insulin can their body produce in response to an intravenous glucose infusion over a period of several hours. The second test will determine how effective is the action of the sugar-processing hormone, insulin, in their body when it is infused intravenously together with glucose over a period of several hours.

Eligibility Criteria:
Inclusion Criteria:

* regular sleep habits
* BMI 20 to 27 kg/m2
* at least one parent, sibling or grandparent with type 2 diabetes
* no regular exercise habits

Exclusion Criteria:

* active smoker
* night or shift work
* have highly variable sleep habits
* have a hormonal disorder
* have a sleep disorder
* have an active medical problem
* women only: use of birth control pills
* women only: irregular menstrual periods or pregnancy
* use of medications/compounds that can disrupt sleep
Effectiveness of Intracavitary Manual Lymphatic Drainage

The aim of this study was to determine the effectiveness of Intracavitary Manual Lymphatic Drainage (IMLD) in the reduction of the perineal trauma and the symptoms of vaginal edema, the prevention of complications during the expulsive and the improvement in the postpartum recovery, compared to conventional treatment during the gestation, in women with the second partum. The weekly treatment is performed from the 25th gestational week in women with vulvar edema.


Eligibility Criteria:
Inclusion Criteria:

* A sample of 49 second-trimester pregnant women with gestational edema with more than 18 years of age

Exclusion Criteria:

* Primiparous women
Effect of Salpingectomy During Conservative Hysterectomy

The study compares the effect of bilateral salpingectomy associated with conservative hysterectomy on ovarian function to the standard hysterectomy with conservation of both ovaries and tubes in terms of hormone assays, ovarian ultrasound evaluation, complications, quality of life.

Hysterectomy is one of the most common gynecologic procedures performed in clinical practice. In this study we focused on non menopausal patients under 52 years having hysterectomies for benign disease : uterine leiomyomas, adenomyosis, endometriosis, dysfunctional uterine bleeding, genital prolapse, cervical dysplasia... with failure of conservative treatment.

the standard procedure during hysterectomy with conservation of the ovaries has been the preservation of fallopian tubes with the clamps placed as close to the uterine corpus as possible. this is suggested to decrease interference with the vascular structures in the mesosalpinx and mesovarium. however it is unclear whether tubal conservation at the time of hysterectomy has any influence on ovarian blood flow or ovarian reserve. another point to be considered is the occurrence of post-hysterectomy carcinoma in the preserved fallopian tube, theoretically, these cases could be prevented if tubal excision is performed during hysterectomy The study compares the effect of bilateral salpingectomy associated with conservative hysterectomy on ovarian function to the standard hysterectomy with conservation of both ovaries and tubes in terms of hormone assays, ovarian ultrasound evaluation, complications, quality of life.

impact of treatments on ovarian reserve are tested by measuring AMH at baseline and 3 days, 6 weeks and 6, 12 months after surgeries.

quality of life is also assessed at these time points, with a questionnaire (Women Health Questionnaire WHQ).

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years and less than 52 years
* indication of a conservative hysterectomy for benign disease
* signed informed consent
* non menopausal women (AMH \>0,21 ng/ml)

Exclusion Criteria:

* pregnancy
* desire of future pregnancy
* menopausal status
* patient unable to give informed consent
* any physical or psychiatric condition that could impair with patient's ability to cooperate with post operative data collection
* previous salpingo and /or oophorectomy (unilateral or bilateral)
* genital cancer disease or atypical endometrial hyperplasia
* hyperandrogenia
* any ovarian mass that needs surgical exploration
* any immunotherapy that could interfere with immunological tests
Metabolic Changes in Healthy Subjects with Acute Binge Drink

The goal of this double-blinded, randomized trial is to investigate the effects of acute binge drinking on liver function, liver fat content, and lipid metabolism in healthy young subjects. The main questions it aims to answer are:

1. If acute binge drinking could alleviate liver injury and hepatic steatosis.

The goal of this double-blinded, randomized trial is to investigate the effects of acute binge drinking on liver function, liver fat content, and lipid metabolism in healthy young subjects. The main questions it aims to answer are:

1. If acute binge drinking could alleviate liver injury and hepatic steatosis.

Participants will be randomized into two groups (n=40) and provided vodka (1 g/kg body weight) or an equal amount of non-alcoholic beverages with the same taste and colour but without alcohol, respectively. 15 minutes later, they are successively provided with the same breakfast. Venous blood samples were collected at 0h, 1h, 3h, 5h, 6h, 12h, and 24h from each subject, respectively.

Eligibility Criteria:
Inclusion Criteria:

1. male aged 18-30 years;
2. body mass index (BMI) ranging from 18.5 to 28 kg/m²;
3. having prior experience with binge drinking or hangovers, as assessed using the Personal Assessment of Maximum Drinking Capacity Survey Questionnaire

Exclusion criteria

1. with alcohol intolerance or alcohol dependence;
2. with serious health conditions, such as liver, kidney, cardiovascular, or gastrointestinal diseases;
3. vegetarians;
4. smokers;
5. with a history of drug use, including antihistamines, antihypertensives, antidiabetics, anxiolytics, and central nervous system depressants;
6. who had used antibiotics within two weeks prior to the trial;
7. who had consumed alcohol, alcoholic beverages or alcohol-containing foods within one week before the trial.
Text-message Program to Reduce Risky Sexual Behavior in Young Adult Female Emergency Department (ED) Patients

The US preventative services task force (USPSTF) recommends behavioral counseling in the primary care setting for prevention of sexually transmitted diseases, however, screening and counseling rarely occur. Text messaging (TM) is increasingly being used as a tool to affect behavior change in patients, but its effect on patients that report at-risk sexual behavior in the emergency department (ED) is unknown. The investigators seek to assess the feasibility of ED-based screening of young adult females for at-risk sexual behavior and enrolling them in a 3 month trial using TM to deliver information and skill building to improve health behavior.


Eligibility Criteria:
Inclusion Criteria:

* Female
* Age 18-25 years
* AUDIT-C score \> 2
* (Drugs or alcohol prior to last sex OR No condom with last sex OR \> 1 partner in last 3 months)

Exclusion Criteria:

* No personal cell phone with SMS features
* Prisoner
* Pregnant or planning in next 3 months
* Current or past drug/alcohol treatment or psychiatric treatment