cyrilzakka/clinical-trials huggingface dataset:
A Dose-Response Safety Study of ENX-102 in Patients With GAD

This is a randomized, double-blind, placebo-controlled study to evaluate the safety and tolerability of ENX-102 and determine a dose-response for the effects of ENX-102 in patients with GAD


Eligibility Criteria:
Key Inclusion Criteria:

* Male or female, inclusive of any gender identity, aged 18 to 65 years, inclusive
* Diagnosed with GAD according to the DSM-V, confirmed by MINI
* Experiencing clinically significant generalized anxiety as measured by HAM-A score ≥18 and at least moderately severe core symptoms of anxious mood and tension as measured by HAM-A Items 1 and 2, respectively, with scores each ≥2

Key Exclusion Criteria:

* Clinically predominant psychiatric diagnosis other than GAD per the MINI
* Any past/lifetime or current diagnosis of a neurocognitive disorder or psychotic disorder, or current posttraumatic stress disorder, obsessive compulsive disorder, or bipolar disorder
* Ingested prohibited medication within 5 half-lives prior to Day 1
* Current or recent moderate or severe substance use disorder as assessed by the MINI
* Unwilling or unable to abstain from alcohol or other recreational psychoactive substances such as marijuana during participation in the trial
* Has significant progressive disorders or unstable medical conditions
* Is unable to comply with the requirements of the study or, in the opinion of the Investigator, is unsuitable for the study
A Program to Reduce Inappropriate Medications Among Older Adults With Alzheimer's Disease: Implementation Phase 2

Potentially inappropriate prescribing includes the use of medications that may no longer be necessary or that may increase the risk of harm. Inappropriate prescribing can increase the overall symptom burden, and negatively affect health-related quality of life and function. The inappropriate prescription of certain drug categories such as sedative/hypnotics, antipsychotics, and strong anticholinergic agents poses particular risks for older adults, and may be more common among those with Alzheimer's disease and Alzheimer's disease- related dementias (AD/ADRD) due to a higher prevalence of multimorbidity and more frequent prescription of five or more medications. The D-PRESCRIBE-AD (Developing a PRogram to Educate and Sensitize Caregivers to Reduce the Inappropriate Prescription Burden in Elderly with Alzheimer's Disease) study will test a health plan-based intervention using the NIH Collaboratory's Distributed Research Network, which employs the Food and Drug Administration (FDA) Sentinel System infrastructure. The overarching goal of this randomized controlled trial is to assess the effect of a patient/caregiver- centered, multifaceted educational intervention on potentially inappropriate prescribing in patients with AD/ADRD. The research hypothesis is that education on inappropriate prescribing among patients/caregivers and their providers can reduce medication-related morbidity in patients with AD/ADRD and improve medication safety for this vulnerable population. The study population will include community-dwelling patients with AD/ADRD, identified based on diagnoses codes of AD/ADRD or use of a medication for Alzheimer's Disease, who have evidence of potentially inappropriate prescribing the three drug classes above. The trial will evaluate the effect of mailed educational interventions, including the effect of a second reminder mailing, designed to spur patient/caregiver-provider communication about medication safety (versus usual care) on the proportion of patients with inappropriate prescribing, the primary outcome of this study. The trial will be conducted in two large, national health plans.


Eligibility Criteria:
Patient Inclusion Criteria:

1. Diagnosis of AD/ADRD based on a combination of AD/ADRD codes or treatment with a pharmacologic therapy used for AD (e.g., donepezil, rivastigmine, galantamine, and memantine) in the 365 days prior to or on cohort entry date.
2. Evidence of potentially inappropriate prescribing with antipsychotics, sedative-hypnotics, and strong anticholinergics within the past 3 months
3. Age ≥50 years of age as of cohort entry date
4. Continuous medical and pharmacy insurance coverage for at least the prior year

Patient Exclusion Criteria:

1. Evidence of residing in a nursing home or skilled nursing facility or receiving palliative care.
2. Incomplete/missing prescriber ID or incomplete contact information for either patient or prescribing provider.
3. On "do not contact" list

Provider Inclusion Criteria:

1. Prescribing provider associated with most recent prescribing of target drug.
Effectiveness of Using Interactive Consulting System to Enhance Informed Choice

To compare the performance of an interactive chatbot versus senior ophthalmologists for enhancing informed decisions made by cataract patients. The chatbot was built based on large language models, and could generate medical expert-level responses.

Cataract surgery is the only way to treat age-related cataract. For patients at early or moderate stages, cataract surgery is an elective surgery without objective indications. Therefore the patients are uaually not aware whether they should receive the surgery. The number of trained and qualified ophthalmologists are limited in China and lots of patients cannot have detailed consultation with ophthalmologists. As a result, many patients still have doubts about whether they should receive cataract surgery or not. In this study, we aim to assess the effectiveness of an interactive chatbot based on large language models versus senior ophthalmologists to enhance informed decisions made by cataract patients.

Eligibility Criteria:
Inclusion Criteria:

1. Individuals aged 45-80 years who have been resident in the selected study district for more than six months;
2. A definite diagnosis of age-related cataract;
3. Having not received cataract surgery;
4. Willing to participate the study and provide informed consent.

Exclusion Criteria:

1. Bilateral blindness (presenting distance visual acuity worse than 3/60);
2. Having ocular, hearing or mental disorders precluding reading or telephone interview;
3. Ocular disorders other than cataract leading to permanent vision loss that could not be corrected through cataract surgery;
4. Having cataract surgery contraindication.
A Study on Intima Media Thickness (IMT) in Middle-aged Subjects

This is an observational study to measure the thickness of artery walls in the neck (intima media thickness IMT) by ultrasound examination in middle-aged subjects with central obesity. The purpose of this study is to obtain local data how common asymptomatic atherosclerosis is, and to investigate the association between Cardiovascular Disease risk factors and intima media thickness (IMT) in the Hong Kong population. Results from this study may enhance the public awareness of asymptomatic atherosclerosis and understand its role in the development of Cardiovascular Disease in Hong Kong.


Eligibility Criteria:
Inclusion Criteria:

* Male or female aged 55 years or above.
* Waist circumference: male more than 90 cm; female more than 80 cm.

Exclusion Criteria:

* Any known chronic diseases requiring long-term medication such as hypertension, diabetes and hyperlipidemia.
* Presence of known cardiovascular diseases including cerebro-vascular disease, coronary heart disease and peripheral artery disease.
* Presence of any active major diseases that may interfere the physical conditions and body weight of subjects during the study period, which include malignancy, infection, renal or liver function impairment, recent major surgery (within 3 months).
The Effect of an Application-based Health Intervention (FoodCoach) on Food Purchases in Switzerland

The FoodCoach study is a 9-week randomized controlled trial from the University of St.Gallen and the University Hospital of Bern, supported by the Swiss National Science Foundation #188402 and by Sanitas Management AG. Sanitas Management AG supports the recruiting of study participants without interfering with the study content.

FoodCoach aims to investigate the effectiveness of improving people's food shopping healthiness by providing automated food shopping recommendations. The results of the study could possibly help improve the health status of the Swiss population and beyond in a low-cost and automated manner.

The investigators collect participant grocery data via the loyalty card programs "Migros Cumulus" and "Coop Supercard" after obtaining participants' informed consent. From this data, the investigators generate automated recommendations that are based on the Nutri-Score framework and expertise of dieticians at the University Hospital of Bern. After sign-up, participants are randomized into a treatment and a control group. The treatment group receives automated recommendations via the FoodCoach Web Application, while the control group only receives a report about their food shopping by email after the intervention phase. Both groups need to finish the same onboarding survey where the investigators collect basic demographic information. After the intervention, the treatment group will receive a post-study survey containing two parts via email. Part 1 includes questions about the ease of use, interface and satisfaction and usefulness of the FoodCoach app. Part 2 includes questions about the participants' weight and height, the motivation to shop healthily and sustainably. The control group will receive a post-study survey which only contains part 2 as described before via email.


Eligibility Criteria:
Inclusion Criteria:

* Participants need to be at least 18 years old by the time they join the study.
* Participants need to participate in at least one of the two loyalty card programmes, i.e., Migros Cumulus and/or Coop Supercard.
* Participants need to be German- and/or English-speaking, as the FoodCoach application is in German and English.

Exclusion Criteria:

* Younger than 18 years old by the time the participants join the study.
* Do not participate in at least one of the two loyalty card programmes, i.e., Migros Cumulus and/or Coop Supercard.
* Not German- and/or English-speaking, so that the participants cannot understand the content of the app.
The ALERT-Pilot Study

the algorithm of artificial intelligent to diagnose myocardial infarction through prior surgery Electrocardiogram was established. The accuracy of using artificial intelligent to diagnose acute ST-segment elevation myocardial infarction and judge criminal vascular was evaluated.


Eligibility Criteria:
Inclusion Criteria:

1. age≥18 years old;
2. the admitting doctor's diagnosis is ST-segment Elevation Myocardial Infarction.

Exclusion Criteria:

1. the admitting diagnosis is non-ST-segment Elevation Myocardial Infarction.
2. default data;
3. pregnancy, mental disorder, kidney failure;
4. except for criteria mention above, including some improper condition considered by investigators.
Changes in Gastrointestinal Microbiota Using VSL#3 in Patients With IBS-D

Aim

To compare changes in gut microbiota of IBS patients and healthy controls using next generation sequencing method like Illumina sequencing based on 16S rDNA profiling.

The major objectives of the study are:

To characterize type of bacterial species and compare diversity of the host's gut microbiota in 20 Irritable bowel syndrome (IBS) patients with 16 healthy controls (HCs) using high through put culture-independent method like Illumina sequencing.

To study modulation of gut microbiota profile after treatment with probiotics (VSL #3) for 8 weeks.

To study the improvement of symptoms after modulation of gut microbiota with probiotics (VSL #3) for more than 8 weeks.

Introduction

The role of the commensal flora in many disease states, including irritable bowel syndrome, inflammatory bowel disease, and even obesity, is now accepted and will undoubtedly lead to new therapeutic strategies. The recently NIH-initiated Human Microbiome Project will allow better understanding of the role of this complex intestinal community in human health and disease. On the clinical side, we are exploring the more common pathogenic bacterial strains in Irritable bowel syndrome patients and use of probiotics in this functional gastrointestinal disease. We are taking support from Genotypic institute, Bangalore for Illumina sequencing facility.

Asian Institute of Gastroenterology, the parent institution, is a 200 bed tertiary care referral hospital providing services to patients with GI diseases, with a daily attendance of 400 out-patients and 200 in-patients. The long term goals of the investigators, involving basic researchers and clinicians, include development of technological resources and applications of biotechnology for use in clinical trials to improve survival rates of patients with GI diseases. The major volume of the outpatient cases comprise of patients with irritable bowel syndrome. Altered GI microbiota may contribute to IBS symptoms and studying dysbiosis in gut microbiota is an important to develop therapy for IBS.

Eligibility Criteria:
Inclusion Criteria:

* Patients satisfying Rome III Criteria

Exclusion Criteria:

* Antimicrobial medication during last 2 months
* Probiotics medication during last 2 months
* Pregnant or lactating patients
* Previous major or complicated abdominal surgery
* Positive test for HIV, HBV or HCV
Association Between Food/Nutrient Intake and Sleep Quality in Middle Aged and Older Population

Sleep is essential to health. Quality of sleep, measure through indexes of sleep, is related to the incidence of obesity, type 2 diabetes, cardiovascular disease, hypertension, and premature death. Sleep pattern changes as people age. They tend to have a harder time falling asleep and more trouble staying asleep than when they were younger. Studies have shown that food/nutrient intake may be associated with sleep duration, quality, and patterns. Singapore's population is aging rapidly and improving their indexes of sleep may result in their health promotion.

Sleep is essential to health and indexes of sleep including duration, quality, and patterning are related to the incidence of chronic diseases and premature death. Changes in sleep patterns are a part of the aging process and as people age, they tend to have a harder time falling asleep and more trouble staying asleep than when they were younger. Certain cross-sectional studies have shown that food/nutrient intake may be associated with sleep duration, quality, and patterns. In the last decade, Singapore's population has grown older. However, limited research examined the association between food/nutrient intake and indexes of sleep in middle-aged and older population in Singapore. Therefore, with a growing number of elderly, studies on improving their sleep quality can play a significant role in improving their quality of life. This is a cross-sectional study and subjects require a 1-day visit (one time visit ONLY). Generally healthy middle-aged and older population will be recruited and after the phone screening and validated subjects will complete the medical history questionnaire and to be brought on the day of visit. During the visit, subjects will stay approximately 3-h to complete the testing. After completing the consent form, fasting-state blood collection and general health assessment will be conducted. Then subjects will be asked to complete the questionnaires to assess sleep quality and dietary intake.

Eligibility Criteria:
Inclusion Criteria:

1. Ability to give an informed consent
2. Age 50 to 75 years
3. Not taking dietary supplements which may impact the outcome of the interests (I.e. dietary protein and vitamin supplements)
4. Not having significant dietary changes for the past 1 year (i.e. weight loss, vegetarian diet)
5. Having sufficient venous access to allow the blood collection
6. Willing to follow the study procedure

Exclusion Criteria:

1. Unable to give an informed consent
2. Age \< 50 years
3. Taking dietary supplements which may impact the outcome of the interest (i.e. dietary proteins and vitamin supplements)
4. Having/had significant dietary changes for the past 1 year
5. Not having sufficient venous access to allow the blood collection
6. Unwilling to follow the study procedure
A Study to Assess Drug-Drug Interaction Between ABBV-903 and Midazolam in Adult Healthy Volunteers

The main objective of this study is to assess the drug-drug interaction and pharmacokinetics of ABBV-903 and Midazolam in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

* BMI is ≥ 18.0 to ≤ 32 kg/m2 after rounding to the tenth.
* Negative test result for SARS-CoV-2 infection upon initial confinement
* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.

Exclusion Criteria:

* History of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), endocrine, renal, hepatic, gastrointestinal, hematologic or psychiatric disease or disorder, or any uncontrolled medical illness.
* History of diseases aggravated or triggered by ultraviolet radiation and no history of abnormal reaction photosensitivity or photoallergy to sunlight, or artificial source of intense light, especially ultraviolet light.
Study of ALXN2050 in Healthy Adult Participants of Japanese Descent

This is a Phase 1 bridging study being conducted to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ALXN2050 after both single- and multiple-dosing in healthy participants of Japanese descent.


Eligibility Criteria:
Key Inclusion Criteria:

* Medically healthy with no clinically significant or relevant abnormalities as determined by medical history, physical or neurological examination, vital signs, 12-lead electrocardiogram, screening clinical laboratory profiles.
* Participants must be of Japanese descent defined as:

  * First generation (born to 2 Japanese parents and 4 Japanese grandparents);
  * Born in Japan, and not have lived outside Japan for greater than 5 years;
  * Lifestyle, including diet, must not have significantly changed since leaving Japan.
* Participants must be able to speak, read, and understand the Japanese and English languages.
* Body mass index within the range 18.5 to 30.0 kilograms (kg)/meter squared, inclusive, with a minimum body weight of 50.0 kg at Screening.

Key Exclusion Criteria:

* History of any medical or psychiatric condition or disease that, in the opinion of the Investigator or designee, might limit the participant's ability to complete or participate in this clinical study, confound the results of the study, or pose an additional risk to the participant by their participation in the study.
* History of significant multiple and/or severe allergies.
* Any previous procedure that could alter absorption or excretion of orally administered drugs.
* Participation in another investigational drug or investigational device study within 5 half-lives (if known) or 30 days prior to the first dose of study intervention, whichever is longer.
* Body temperature ≥ 38.0°Celcius, at Screening or prior to the first dose of study intervention.
* History of drug or alcohol abuse within 2 years prior to the first dose of study intervention or positive drugs-of-abuse or alcohol screen at Screening or Day -1; current tobacco/nicotine users or smokers or a positive cotinine test at Screening.
* Donation of whole blood from 3 months prior to the first dose of study intervention, or of plasma from 30 days prior to the first dose of study intervention; receipt of blood products within 6 months prior to the first dose of study intervention.
Using Digital Technology Versus Conventional Relining Procedure for Correction of Loose Maxillary Complete Denture

This study aimed to evaluate the use of computer added designning / computer added manufacturing (CAD/ CAM ) technology versus conventional relining procedure for treating ill-fitted loose maxillary complete denture and its effect on patient satisfaction, denture retention, and denture adaptation to oral tissues.

Twelve edentulous patients suffering from loose maxillary complete dentures were selected, the dentures were adjusted for taking the relining impressions, the impressions were scanned and the STL files were used for milling new dentures (Group A), then the relining impression went through the conventional laboratory steps of processing (Group B). Both groups were evaluated regarding patient's satisfaction by a specially designed questionnaire, retention values were measured by a digital force gauge at denture insertion appointment and two weeks later, finally dentures adaptation to the oral tissues were compared using geomagic software.

Eligibility Criteria:
Inclusion Criteria:

* Patients with completely edentulous maxillary and mandibular ridges with a normal skeletal relationship (class I) have a moderate-to-highly well-rounded maxillary edentulous ridge without severe undercuts to minimize the effect of undercuts on retention values.
* Patients' main complaint was a loose or "falling" denture, but with proper esthetics, centric relation and the correct vertical dimension of occlusion (VDO).

Exclusion Criteria:

* Patients with significant skeletal problems (class II or III) or who went through severe osseous surgery or any hereditary or acquired osseous abnormality find it challenging to place the denture properly on the supporting ridge.
* If the patient suffers from xerostomia, excessive flabby ridges, any pathology of the oral mucosa, or any inflammatory changes, candidiasis, hyperplasia, neurological disorders and malignancies
* If the denture creates a major speech problem, poor esthetics, or an unsatisfactory jaw relationship.
Food Pharmacy at Oregon Health & Science University (OHSU) Knight Cardiovascular Institute (KCVI)

Participants in the intervention group of this study will receive weekly home deliveries of fruit \& vegetables for 3 months. The primary objective of this study is to determine if increased access to fruits and vegetables leads to sustained dietary changes, measured through changes in the Healthy Eating Index (HEI). Secondary objectives are to determine whether increased fruit and vegetable access (increased HEI) ultimately leads to improved cardiovascular (CV) health indicators (e.g., body mass index, waist circumference, blood pressure, and levels of blood lipids and hemoglobin A1c).


Eligibility Criteria:
Inclusion Criteria:

* Age 19 years and older
* Established patient at OHSU Center for Preventive Cardiology
* Not requiring changes to medication regimen for the 6-month study duration
* Must be eligible to register with produce delivery company (reside in Portland-metro area; have access to a computer with internet service; able to read English)

Exclusion Criteria:

* Triglycerides \> 500 mg/dL
* Heavy alcohol use (\> 3 drinks/day)
* Uncontrolled hypertension (BP \> 140/90)
* LDL-C \> 160 mg/dL
* Uncontrolled diabetes mellitus (HbA1c \> 8%)
* Failure to provide informed consent
* Current pregnancy
* Healthy Eating Index (HEI) score of ≥ 80
Evaluation of Inhaled Treatment in Sinusitis

The purpose of this study is to determine whether inhaled corticosteroid (specially nebulized) could be a good alternative to oral corticosteroid and whether they are effective in the treatment of sinusitis


Eligibility Criteria:
Inclusion Criteria:

* Nasal/Sinus polyps

Exclusion Criteria:

* Previous sinus surgery
* Age under 18y
* Use of antibiotics