cyrilzakka/clinical-trials huggingface dataset:
Effects of Antidepressants on Sexual Functioning

The purpose of this trial is to study the effects of two depression medications on sexual functioning.


Eligibility Criteria:
Inclusion Criteria:

* Primary diagnosis of Major Depressive Disorder (MDD) with current duration lasting 12 weeks but no greater than 2 years.
* Subjects must engage in sexual activity that leads to orgasm at least once every two weeks.
* Subject must have normal orgasmic function and be willing to discuss with investigator.

Exclusion Criteria:

* Subjects that have arousal or orgasm dysfunction.
* Has previously failed to respond to two adequate trials of antidepressants in past 2 years.
* Subject has other unstable medical disorders.
* Subject has a positive urine test for illicit drug use at screening.
Safety and Efficacy Study of a New Formulation of Acetylcysteine Injection

The primary purpose of this study is determine if a new formulation of Acetadote is at least as effective as the current formulation in the prevention and treatment of acetaminophen overdose related liver injury.

The primary objective of this study is to demonstrate non-inferiority of efficacy determined by the proportion of subjects who develop hepatotoxicity when treated with a new formulation of Acetadote and the proposed new dosing regimen compared to the rate of hepatotoxicity with the current formulation of Acetadote and the current dosing regimen.

Eligibility Criteria:
Inclusion Criteria:

1) Any subject requiring treatment with acetylcysteine for acute acetaminophen toxicity

Exclusion Criteria:

1. History of allergy or hypersensitivity to acetylcysteine or any component of Acetadote.
2. Exposed to investigational drugs within 30 days before Clinical Trial Material (CTM) administration.
3. Pregnant or nursing.
4. Less than 12 years of age.
5. Have a baseline alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>1000 U/L.
6. Have a baseline International Normalized. Ratio (INR) \> 2.0
7. Be on dialysis or having existing renal injury such that the volume of the study drug administration would render the patient unsuitable for the study, in the opinion of the investigator.
8. Have congestive heart failure such that the volume of the study drug administration would render the patient unsuitable for the study, in the opinion of the investigator.
9. Inability to understand the requirements of the study. Subjects must be willing to provide written informed consent or consent of parent/legal guardian (as evidenced by signature on an informed consent document approved by an Institutional Review Board \[IRB\]), and agree to abide by the study restrictions. (If the subject is incapacitated, informed consent will be sought from a legally acceptable representative).
10. Refusal to provide written authorization for use and disclosure of protected health information.
11. Be otherwise unsuitable for the study, in the opinion of the Investigator.
Effect of Daily Intake of SATIOSTAT Over 6 Weeks on Weight Loss, Glucose Tolerance, Gastrointestinal Tolerance and Gut Microbiota.

SATIOSTAT is a composition comprising a specific dietary fibre component (a mixture of hydrocolloids with excellent safety profiles and a long history of use in humans) and a lipid component (long-chain fatty acids). The goal of this combination is to achieve long-acting delivery of long-chain fatty acids to the intestinal lining, triggering the sustained release of satiety-signals from intestinal cells, and consequently reducing appetite and lowering food intake in humans.

Over a period of 6 weeks, volunteers will ingest SATIOSTAT as meal replacement at lunch and as first course at dinner. Once before and after these 6 weeks the investigators will carry out an oral glucose challenge, measure satiation hormones and examine faeces (gut microbiota). Volunteers will fill in a food diary and a questionnaire for gastrointestinal symptoms and quality of life. The whole study will take approximately 8-10 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Obese volunteers (BMI \> 30kg/m2)
* Otherwise healthy
* Informed Consent as documented by signature (Appendix Informed Consent Form)

Exclusion Criteria:

* Food allergies, food intolerance
* Evidence of relevant cardiovascular, pulmonary, renal, hepatic, pancreatic, gastrointestinal, metabolic, endocrinological, neurological, psychiatric or other diseases at screening
* Chronic or clinically relevant acute infections
* Clinically relevant abnormalities in chemical, haematological or any other laboratory parameters
* Participation in drug trials within 2 months before start of the study
* Neurological or psychiatric disease or drug or alcohol abuse, which would interfere with the subjects proper completion of the protocol assignment
* Pregnancy: although no contraindication pregnancy might influence metabolic state. Women who are pregnant or have the intention to become pregnant during the course of the study are excluded. In female participants of childbearing age not using safe contraception (oral, injectable, or implantable contraceptives, or intrauterine contraceptive devices) a urine pregnancy test is carried out upon screening.
* Antibiotic therapy within the last 3 months before inclusion
* Substance abuse, alcohol abuse
* Inability to follow procedures due to psychological disorders, dementia or insufficient
* Knowledge of project language (German).
* Participation in another study with investigational drug within the 30 days preceding and during the present study.
Study on Treating by Eating: Role of AGEs on Mucosal Barrier and Microbiome.

This is an exploratory study aimed at healthy volunteers to investigate the impact of differential cooking methods on global and gut inflammation, intestinal permeability, and the gut microbiota. The investigators hypothesize that a short dietary intervention of baking and grilling of food for 2 weeks as opposed to steaming and boiling of food for 2 weeks will result in measurable differences in blood, stool and urine samples that guide towards gut and overall health and disease. All food will be provided, together with detailed cooking instructions. Food logs including photographs will be used to check whether participants complied with the study.

The investigators aim to better understand the role of cooking methods in human health, so that this can be implemented in preventive strategies and dietary treatments for specific patient groups.

This is a pilot project aimed at healthy volunteers to investigate the impact of differential cooking methods on systemic and intestinal inflammation, permeability, and the gut microbiota, using a randomised cross-over design. The investigators hypothesize that a short dietary intervention of baking and grilling of food for 2 weeks (high-Advanced Glycation End Products (AGEs) diet) as opposed to steaming and boiling of food for 2 weeks (low-AGEs diet) will result in measurable differences in inflammatory, cardiometabolic and microbial markers in blood and stool as well as changes in intestinal permeability through their effect on dietary AGEs. All food will be provided, together with detailed cooking instructions. Food logs including photographs will be used to assess and check adherence to the intervention.

The investigators aim to better understand the role of cooking methods and thermal treatments in human health, so that this can be implemented in preventive strategies and dietary treatments for specific patient groups.

Eligibility Criteria:
Inclusion Criteria:

* Overall healthy
* Adhering to an omnivorous diet
* Body Mass Index (BMI) between 18.5 - 30 kg/m2
* Able to provide consent.

Exclusion Criteria:

* Participants with chronic illnesses including diabetes mellitus, cardiovascular disease, or cancer; eating disorders, irritable bowel syndrome; inflammatory bowel diseases, and previous bowel surgery (except for appendectomy).
* Current smoking
* Participants taking nonsteroidal anti-inflammatory drugs (NSAIDS), proton pump inhibitors, antacids, or laxatives one month before enrollment or antibiotics, prebiotics or probiotics six months before the start of the trial.
* Pregnancy of lactation
Multicenter Open-label Randomized Controlled Trial (RCT) to Compare Colistin Alone Versus Colistin Plus Meropenem

The purpose of this study is to determine whether the addition of meropenem to colistin is better than colistin alone in the treatment of clinically significant infections caused by multi-drug resistant bacteria


Eligibility Criteria:
Inclusion Criteria:

* Adult inpatients
* Clinically significant, microbiological-documented infection caused by carbapenem-resistant and colistin-susceptible Gram-negative bacteria and identified according to CDC criteria- blood stream infections, hospital acquired pneumonia, ventilator associated pneumonia, and urinary tract infections
* Patient recruitment will occur only after microbiological documentation and susceptibility testing. Patients will be included within 96 hours of the time the index culture was taken (typically within 48 hours of isolate identification), regardless of the antibiotic treatment administered during this time period.

Exclusion Criteria:

* Previous inclusion in the trial. Patients will be included in the RCT only once for the first identified episode of infection
* Pregnant women
* Epilepsy or prior seizures
* Known allergy to colistin or a carbapenem
Efficacy Study of Hydroxychloroquine to Treat High-risk Coronary Artery Disease.

The purpose of this study is to evaluate whether treated with hydroxychloroquine could improve therapeutic effect for patients with high-risk coronary artery disease.

This double blind, placebo, randomized controlled trial is going to assess if hydroxychloroquine could improve the high sensitivity C-reaction protein, blood lipid, blood glucose and blood pressure, also whether hydroxychloroquine could affect the secretion of inflammatory cytokines and the M1/M2 phenotype polarization of macrophages in patients with high-risk coronary artery disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients have been diagnosed coronary artery disease by coronary angiography or CT angiography.
* coronary artery disease with hypertension or diabetes or hyperlipidaemia(LDL\>1.8mmol/L)
* High sensitivity C-reactive protein \>1mg/L.
* On guideline-based secondary prevention of coronary heart disease medications≥1 months.
* No use of steroids, antibiotics, immunosuppressors a week before treatment.

Exclusion Criteria:

* Retinal disease.
* Chronic hepatopathy(ALT\>120U/L).
* Renal dysfunction (eGFR\<60).
* Moderately severe anemia, thrombocytopenia and leukocytopenia.
* Other contraindications for hydroxychloroquine.
* Active hemorrhage.
* Cancer or life expectancy\< a year.
* New York Heart Association (NYHA) functional class≥class III, Percutaneous Coronary Intervention or Coronary Artery Bypass Grafting in plan.
* Pregnancy and lactation.
Tailored Interactive Intervention to Increase CRCS

The primary goal of this research project is to conduct a 5-year prospective randomized trial of a theory-based intervention to increase patient completion of colorectal cancer screening (CRCS) among patients ages 50 to 64 years old.

Specific Aim 1: Identify behavioral, social, and environmental factors associated with CRCS in male and female patients ages 50 to 64 years old in a primary care practice in Houston, Texas.

1.1. Update literature reviews of CRCS adherence. 1.2. Conduct secondary analysis of relevant data from other projects. 1.3. Conduct focus groups with primary care patients to determine their knowledge, attitudes, and beliefs about CRCS and to gather data to use for development of the educational intervention.

Specific Aim 2: Develop a personal computer (PC)-based tailored interactive intervention based on the transtheoretical (stages of change) model to increase CRCS in accordance with American Cancer Society (ACS) CRCS guidelines.

Specific Aim 3: Evaluate the effectiveness of the PC-based tailored interactive intervention for increasing CRCS through a randomized controlled trial.

Specific Aim 4: Analyze the relationship between a number of predictor variables and CRCS completion in order to develop a more complete conceptual framework for understanding screening adherence.

Specific Aim 5: Conduct a cost-effectiveness analysis of the PC-based tailored interactive intervention for increasing CRCS in a primary care setting.

Eligibility Criteria:
Inclusion Criteria:

* Receive primary care at the KSC Main Campus in Houston, Texas.
* Must have been patients at KSC for at least one year prior to enrollment in the study
* Be 50 to 64 years of age
* Have had CRC or adenomatous polyps
* Must agree to schedule a routine physical examination with their primary care provider and to complete a baseline interview

Exclusion Criteria:

-Have never been screened or be due for CRCS according to the ACS guidelines
A Study of the Efficacy and Safety of Dulaglutide (LY2189265) in Participants With Type 2 Diabetes

The purpose of this study is to evaluate the efficacy and safety of investigational doses of once weekly dulaglutide when added to metformin in participants with type 2 diabetes with inadequate blood sugar control.


Eligibility Criteria:
Inclusion Criteria:

* Have type 2 diabetes mellitus (T2DM) for at least 6 months
* Have been treated with stable metformin dose for at least 3 months
* Have HbA1c ≥7.5% and ≤11.0% at study entry
* Have body mass index (BMI) ≥25 kilograms per meter squared (kg/m\^2)

Exclusion Criteria:

* Have type 1 diabetes mellitus
* Have used any glucagon-like peptide-1 receptor agonist (GLP-1 RA) or insulin, not including prior short term insulin use (≤14 days)
* Have been taking any other medicine for diabetes (other than metformin) during the last 3 months
* Have used in the last 3 months (or plan to use) prescription weight loss medications
* Have disorders associated with slowed emptying of the stomach contents, or have had any stomach surgeries for the purpose of weight loss
* Current participation in or intent to begin during the study an organized diet and/or exercise weight reduction program (other than the lifestyle and dietary measures for diabetes)
* Have acute or chronic hepatitis, signs and symptoms of any other liver disease other than nonalcoholic fatty liver disease (NAFLD), or alanine transaminase (ALT) level \>2.5 times the upper limit of the reference range, as determined by the central laboratory at study entry; participants with NAFLD are eligible for participation in this trial
* Had chronic or acute pancreatitis any time prior to study entry
* Have had a heart attack or stroke in the past 2 months, or have heart failure that significantly limits their physical activity
* Estimated glomerular filtration rate (eGFR) \<30 milliliters/minute/1.73m\^2 (or lower than the country-specific threshold for discontinuing metformin therapy per local label), calculated by the Chronic Kidney Disease-Epidemiology (CKD-EPI) equation, as determined by the central laboratory at study entry and confirmed at lead-in
* Have a personal or family history of medullary thyroid carcinoma or personal history of multiple endocrine neoplasia syndrome type 2
* Have proliferative retinopathy or maculopathy requiring acute treatment according to the opinion of the investigator
Comparison of ASA and CFS in Anesthesiology

In addition to the regular ASA classification, patients would also be assigned the Clinical frailty scale (CFS) during preoperative examinations in anesthesiology clinics. The aim is to compare the usefulness of ASA and CFS categorization for predicting perioperative and postoperative complications and length of postoperative stay in elective surgeries.

CFS significantly correlates with complications in patients treated in emergency department. This study is expected to provide information on how CFS correlates with complications and length of stay in elective surgeries.

In addition to the regular ASA classification, patients would also be assigned the Clinical frailty scale (CFS) during preoperative examinations in anesthesiology clinics.

The respondents are all elective patients over 65 years of age who have not had previously recorded mental difficulties that interfere with their daily life. Patients suffering from senile dementia would not be excluded from this study.

After the treatment was completed, the medical history of each patient would be reviewed and statistically processed.

The aim is to compare the usefulness of ASA and CFS categorization for predicting perioperative and postoperative complications and length of postoperative stay in elective surgeries.

Eligibility Criteria:
Inclusion Criteria:

* All elective patients older then 65 years

Exclusion Criteria:

* Earlier mental difficulties that affect everyday life, senile dementia is not exclusion criteria
Dexamethasone Treatment for OSA in Children

This is a double-blinded clinical trial of children diagnosed with moderate to severe obstructive sleep apnea (OSA) on a baseline polysomnogram (PSG). Participants will receive a 3-day course of dexamethasone, an oral steroid, or placebo control and undergo two PSGs to assess the efficacy of dexamethasone, as a treatment to manage the severity and symptoms in children with moderate to severe OSA.

Obstructive sleep apnea (OSA) is a common sleep-related breathing disorder affecting neonates to adolescents characterized by intermittent partial and complete upper airway obstruction leading to apneas.

The first line of treatment for OSA in young children is an adenotonsillectomy (AT). However, there are long surgical wait times for ATs, up to 3-6 months after a baseline polysomnogram(PSG). This leaves many children untreated, leading to a higher risk of learning deficits and long-term health effects.

Oral corticosteroids have long been used to treat airway inflammation and reduce inflammation of adenoid and tonsil tissue in-vitro. However, there is a lack of knowledge of oral steroids' efficacy in managing OSA. Additionally, the role of the nasal epithelium and the mechanism of action of dexamethasone role at a molecular level is unknown.

The primary objective is to evaluate the efficacy of Dexamethasone in reducing the severity and symptoms of moderate to severe OSA in children in this proof-of-concept exploratory trial.

Participants will be screened by their baseline PSG, followed by 3 study visits conducted at SickKids. Participants will receive a 3-day course of oral dexamethasone or placebo at their first baseline study visit. During baseline, participants will undergo an otolaryngology assessment, a nasal brushing, and questionnaires. Participants will return 2 to 4 weeks after the intervention to the Hospital for Sick Children for a follow-up study visit which includes a repeat PSG, otolaryngology assessment and questionnaires. If no AT is performed within 6 months, participants will return for a third study visit for a repeat PSG, otolaryngology assessment and questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Polysomnogram diagnosed with moderate to severe Obstructive sleep apnea (OAHI \>5 events/hour)
* Aged 2-10 years
* Presence of adenotonsillar hypertrophy
* Ability to take oral medication and be willing to adhere to the dosing regimen
* Informed consent provided in accordance with institutional policies

Exclusion Criteria:

* Previous adenotonsillectomy
* Presence of symptoms of an upper respiratory tract infection
* Co-existing central sleep apnea
* Hypertension
* Prior or current evidence for abnormal glucose tolerance
* Contraindication for dexamethasone or components of dexamethasone oral suspension,
* Treatment with nasal or systemic corticosteroids within 4 weeks prior to the intervention
* OSA with associated oxygen desaturations \<90% for 2 continuous minutes
* Need for non-invasive ventilation long-term due to underlying disease
* Current systemic fungal infections
* Patients with clinically relevant varicella exposure
A Cognitive Behavioral Digital Therapeutic InterventiON for Glycemic Control in Type 2 Diabetes Mellitus

Randomized, controlled, pragmatic trial with open-label extension evaluating BT-001, an investigational digital therapeutic intended to help patients with type 2 diabetes improve their glycemic control.

The study intervention, BT-001 (the App), will be dispensed at enrollment to the Immediate Intervention App Use arm of the trial. Patients randomized to the Delayed Intervention App Use arm will be provided a "control App" with diabetes control, and then the BT-001 App after 180 days. Each participant is assigned to one 90-day treatment cycle of BT-001. Over the 12-month intervention period, study participants will be able to opt into up to 3 additional treatment cycles of BT-001. Study schema is included at the end of this section

Eligibility Criteria:
Inclusion Criteria:

* Current (within 3 months prior to enrollment) HbA1c \>=7.01%
* Possession of and ability to use Android or iPhone mobile phone
* Speaks and reads in English
* Willing to measure frequent fasting finger glucose measurements as part of the App utilization

Exclusion Criteria:

* Current use of insulin other than a long-acting insulin analogue or human NPH insulin
* HbA1c \>=11%
* Cognitive impairment or degenerative neuropsychiatric condition (e.g. Alzheimer's, dementia, mixed dementia, other significant memory loss, schizophrenia), or any other condition that in the Investigator's opinion may prevent patient from completing study activities
* Any terminal medical condition with life expectancy of \< 1 year.
The Use of Atropine 0.01% in the Prevention and Control of Myopia (ATOM3)

Study of low dose atropine in preventing the onset and progression of myopia in high risk children with pre-myopia or low-myopia.

High risk children (with family history of myopia) with low hyperopia or low myopia will be randomized to atropine or placebo, with 2 -2.5 year treatment and 1 year washout.

Eligibility Criteria:
Inclusion criteria

1. One parent with myopia (\<-3D in at least one eye)
2. SE +1.00D to -1.50D
3. Astigmatism \< = 1.50D
4. Distance vision logMAR 0.2 or better in both eyes
5. Intraocular pressure of not greater than 21 mmHg
6. No allergy to atropine, cyclopentolate, proparacaine and benzalkonium chloride

Exclusion Criteria:

1. Any eye or systemic disease that affect vision or refractive error
2. Conditions where topical atropine contraindicated
3. Previous use of atropine or pirenzepine
4. Known past/current amblyopia or strabismus