cyrilzakka/clinical-trials huggingface dataset:
The Effects of Lactose Intolerance on Gastrointestinal Function and Symptoms in a Chinese Population

Lactose is a carbohydrate found in milk,and Lactase Deficiency (LD) is a condition in which the small intestine cannot digest this carbohydrate due to absent or insufficient amounts of lactase.Individuals with LD may be intolerant of lactose in the diet and experience abdominal cramps, bloating and diarrhea; however the response is variable.Some tolerate moderate amounts of lactose without adverse effect,whereas others experience severe symptoms in response to even small doses. These problems may be representative of wider issues regarding individual tolerance to diet containing ubiquitous poorly absorbed, fermentable carbohydrates (such as: fructose, fructans)and be relevant to symptom generated in patients with diarrhea predominant irritable bowel syndrome (D-IBS).

This project will investigate the effects of diet,lifestyle stress and psychiatric dietary on the development of functional gastrointestinal symptoms. Lactose will be used to assess tolerance to dietary challenge, a test that is particularly relevant in a Chinese population with a high prevalence of lactase deficiency.

Study #1: Questionnaire study in general Chinese population (n=2000).

Study #2: Physiologic study in patients attending gastroenterology clinic (n=600) including in subgroups assessment of genetic factors,tolerance to lactose challenge and assessment of visceral sensitivity.

Study #3: Assessment of appropriate dosage of lactose hydrogen breath test in a population with high-prevalence of lactase deficiency.

Study #4: Impact of a determined dietary intervention on abdominal symptoms compatible with D-IBS.

study #5: The association of visceral sensitivity induced by LI with mucosal immune activation and psychological factors in D-IBS patients

Eligibility Criteria:
Inclusion Criteria:

1. Aged at least 16 years old and not more than 75 years old.
2. Ability to communicate with the investigator, complete study questionnaires (with help of investigator) and provide informed consent.

Exclusion Criteria:

1. Progressive, severe disease requiring active medical management (e.g. advanced cardiac, liver, renal or neurological disease, advanced cancer)
2. History of significant gastrointestinal pathology (other than gastro-oesophageal reflux disease and functional bowel diseases)
3. History of gastro-intestinal surgery (except appendicectomy, cholecystectomy, hernia repair).
4. Evidence of active drug or alcohol abuse
Testing of Radiofrequency Coil for Clinical 19F MRI

Testing of a dual tuned proton/fluorine MRI radio frequency coil

Images were collected from plastic fluorine phantoms taped to the upper thigh of health volunteers.

This trial was performed as part of an application for a Health Canada Investigational Device Exemption (Protocol # 226949)


Eligibility Criteria:
Inclusion Criteria:

* Healthy Volunteer

Exclusion Criteria:

* MRI incompatible patient
* claustrophobia
Virtual Reality Alcohol Avoidance Training

The approach-avoidance training program (AATP) has shown preliminary promise as an add-on to standard treatment for alcohol dependence. However, knowledge is lacking as to whether the effectiveness of AATP can be enhanced further when performed in a typical drinking situation. The main aim of this study is to investigate whether approach-avoidance training implemented in a virtual reality bar environment is superior to the classical joystick PC-version of the AATP.

The study will be implemented as a randomized controlled trial. A total of 135 consecutively enrolled alcohol use disorder (AUD) patients, recruited from alcohol inpatient clinics in Germany, Poland and Denmark, will be randomized into one of three groups at the start of standard alcohol treatment: group A) stimuli-relevant AATP as usual; group B) stimuli-relevant ATTP in virtual reality, and group C) treatment as usual (TAU; control group). Treatment outcomes will be assessed at pre-treatment, post-treatment and 3-month follow-up. Generalized mixed-models will be applied to compare the trajectories of the groups over time on drinking, craving and impulsiveness outcomes.

Eligibility Criteria:
Inclusion Criteria:

* signed written informed consent
* meeting the diagnostic criteria for alcohol use disorder
* fluent in language of the participating country (German, Polish or Danish)
* completion of detoxification (if needed)
* enrolled in standard treatment within two weeks

Exclusion Criteria:

* any sensory or motor deficits complicating the provision of the AAT (e.g. color-blindness, fine or gross motor deficits in upper extremities)
* meeting diagnostic criteria for other substance use disorders
* severe psychiatric or neurological illness (e.g. psychotic disorders, mental retardation, dementia) or terminal somatic illness
Prevalence and Environmental Risk Indicators for Periodontitis. A Cross-sectional Study

Periodontitis is a biofilm-mediated chronic inflammatory disease with a multi-factorial etiology; it belongs to the group of diseases classified as "Non-communicable Diseases" (NCDs). According to the results of the Global Burden of Disease Study of 2017, it is the sixth most prevalent disease worldwide and it constitutes a heavy burden on health costs.

Risk factors for such disease include non-modifiable risk factors, i.e. familiarity, diabetes, cardiovascular diseases, metabolic syndrome, as well as modifiable risk factors, i.e. diet, stress and low physical exercise. Given the significant impact of oral health on the quality of life and overall well being of the individual, many studies investigated the importance of risk factors for oral health. In particular, there is some evidence that more severe manifestations of periodontitis are associated with lower physical activity (De Oliveira Ferreira et al., 2019), poor sleep quality (Karaaslan \& Dikilitaş, 2019) and more perceived stress (Coelho et al., 2020). With regards to diet, despite the high number of studies demonstrating an anti-inflammatory effect of the Mediterranean Diet, no study has ever investigated the adherence to Mediterranean Dieta to the oral health status.

From a methodological standpoint, investigations regarding environmental factors are mainly carried out through questionnaires administration, whose validity and reproducibility had been previously demonstrated. The novelty introduced by the present study would be a complete analysis of the effects of lifestyles (diet, sleep quality, physical exercise, perceived stress) on the periodontal status of the individual.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 70 years old;
* ability and willingness to give informed consent.

Exclusion Criteria:

* pregnancy or lactation;
* inability to communicate either in English or Italian;
* inability or unwillingness to give informed consent.
Effectiveness And Safety Of Oral Anticoagulants Among Obese Patients With Non-Valvular A-Fib In VA Patients With Medicare

The overall objective of this analysis is to understand patient characteristics, the use of treatment, and clinical outcomes among obese (overweight) and severely obese patients with non-valvular atrial fibrillation (NVAF) who initiate therapy with OACs (oral anti-coagulants). The aim of this study is to compare all DOACs (direct oral anti-coagulants) to warfarin.

However, the primary analysis will be conducted among apixaban vs warfarin patients only. If sample size permits, we will also conduct other DOAC vs warfarin and DOAC vs DOAC analysis.


Eligibility Criteria:
Inclusion Criteria:

* Obese or severely obese.
* Initiated an OAC from July 1, 2013 - December 31, 2017; the first DOAC pharmacy claim date during the identification period will be designated as the index date. The first warfarin prescription date will be designated as the index date for patients without any DOAC claim.
* Individuals ≥18 years old as of the index date.
* Had 6 months continuous health plan enrollment with medical benefits (Parts A \& B) for at least 6 months pre-index date (baseline period).
* At least 1 diagnosis of AF prior to or on index date, identified by any medical claim associated with an International Classification of Diseases, Ninth Revision, Clinical Modification (ICD-9-CM) code of 427.31 or International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) code of I480-I482, and I4891.
* Had body weight or BMI value reported within ±6 months of the index date.

Exclusion Criteria:

* Had medical claims indicating a diagnosis or procedure of rheumatic mitral valvular heart disease, heart valve replacement/transplant, venous thromboembolism, or transient AF 6 months prior to or on the index date.
* Had hip/knee replacement surgery within 6 weeks prior to or on the index date.
* Were pregnant during the study period.
* Had an OAC prescription during the 6 months pre-index date.
* Had follow-up time equal to 0 days.
* Had more than one OAC on the index date.
Assesment of the Efficiency and Safety Helicobacter Pylori Therapy With or Without Saccharomyces Boulardii

This study assesses the effect of quadruple therapy for H. pylori, with the addition of probiotics Saccharomyces boulardii. In addition, he assesses whether this combination reduces the frequency of adverse effects of eradication therapy, and whether it affects the compliance.

Standard triple therapy for H. pylori infection proved to be insufficiently effective, primarily due to antibiotics resistance.Therefore, the latest Maastricht consensus suggests using bismuth-quadruple or non-bismuth-quadruple therapy, in regions with high clarithromycin resistance. The addition of probiotics with eradication therapy has never become a standard treatment. However, the Maastricht consensus suggest that the addition of probiotics could increase the effectiveness of quadruple therapy.

The study was designed as a prospective, double-blind, randomized, case-control intervention study.

Eligibility Criteria:
Inclusion Criteria:

* Dyspepsia
* Patients not treated for H. Pylori
* Age of 18-50 years
* Positive urea breath test

Exclusion Criteria:

* Alarm symptoms (anemia, persistent vomiting, hematemesis, dysphagia, significant weight loss, palpable mass in abdomen)
* Gastric cancer
* Immunosuppressive therapy
* Use of acetylsalicylic acid
* Severe renal failure
* Severe liver failure
* Immunodeficiency
* Proven malignant disease
* Penicillin allergy
* Allergy to any component of dietary supplement (Saccharomyces boulardii and Vitamin D)
* Chronic alcoholism
* Pregnancy
* Lactation
Study to Assess the Safety, Pharmacokinetics, and Efficacy of Baloxavir Marboxil in Healthy Pediatric Participants With Influenza-Like Symptoms

This study will evaluate the safety, pharmacokinetics, and efficacy of baloxavir marboxil compared with oseltamivir in a single influenza episode in otherwise healthy pediatric participants (i.e., 1 to \<12 years of age) with influenza-like symptoms.


Eligibility Criteria:
Inclusion Criteria:

* Aged 1 to \< 12 years at randomization (Day 1).
* Written informed consent/assent for study participation obtained from participant's parents or legal guardian, with assent as appropriate by the participant, depending on the patient's level of understanding
* Participant able to comply with study requirements, depending on the patient's level of understanding
* Participant with a diagnosis of influenza virus infection confirmed by the presence of all of the following:
* Fever ≥ 38 degree celsius (tympanic temperature) at screening
* At least one respiratory symptom (either cough or nasal congestion)
* The time interval between the onset of symptoms and screening is ≤ 48 hours

Exclusion Criteria:

* Severe symptoms of influenza virus infection requiring inpatient treatment
* Concurrent infections requiring systemic antiviral therapy at screening
* Require, in the opinion of the investigator, any of the prohibited medication during the study
* Previous treatment with peramivir, laninamivir, oseltamivir, zanamivir, or amantadine within 2 weeks prior to screening
* Immunization with a live/attenuated influenza vaccine in the 2 weeks prior to randomization
* Concomitant treatment with steroids or other immuno-suppressant therapy
* Known HIV infection or other immunosuppressive disorder
* Uncontrolled renal, vascular, neurologic, or metabolic disease (e.g., diabetes, thyroid disorders, adrenal disease), hepatitis, cirrhosis, or pulmonary disease or participants with known chronic renal failure.
* Active cancer at any site
* History of organ transplantation
* Known allergy to either study drug (i.e., baloxavir marboxil and oseltamivir) or to acetaminophen
* Females with child-bearing potential
* Participation in a clinical trial within 4 weeks or five half-lives of exposure to an investigational drug prior to screening, whichever is longer
French Cohort Study of Chronic Heart Failure Patients With Central Sleep Apnoea Eligible for Adaptive Servo-Ventilation (PaceWave, AutoSet CS, AirCurve 10CS): Predictive Factors of Poor Compliance (FACE)

The purpose of this study is to determine the predictive factors of poor compliance to sleep disordered breathing therapy in chronic heart failure patients treated for central sleep apnea. To characterize nocturia pathophysiology associated with SDB in this population. To use telemonitoring data to define predictive factors of poor compliance.


Eligibility Criteria:
Inclusion Criteria:

* Adult Patient with Chronic Heart Failure
* Central Sleep Apnea requiring Adaptative Servo-Ventilation therapy
* Patient is able to fully understand study information and signed informed consent

Exclusion Criteria:

* Contra-indications to Adaptative Servo-Ventilation therapy
* Respiratory Failure or Hypercapnia inconsistent with Adaptative Servo-Ventilation therapy
Pilot Study in Multi-Coil Repetitive Transcranial Magnetic Stimulation (rTMS) for Treatment Resistant Depression

The purpose of this study is to assess the efficacy of a Deep Shaped-Field repetitive transcranial magnetic stimulation (DSF-rTMS) system in the treatment of depression.


Eligibility Criteria:
Inclusion Criteria:

* Major depressive disorder (MDD)
* Mild to moderate level of resistance or intolerance to antidepressant treatment in the current episode.
* Will not become pregnant during study.

Exclusion Criteria:

* Seizure disorder.
* History of brain injury or active CNS disease.
* Metal implants on or in brain, spinal cord, ear, eye or heart.
* Current use of proconvulsant medications (e.g., bupropion).
* Other significant psychiatric disorder.
* Substance use disorder (not including caffeine or nicotine).
* 7 or more failed treatment attempts for depression in one's lifetime.
* Have failed to clinically remit to an adequate trial of ECT or TMS.
Evaluation of Quality of Life in Patients With Type 1 Diabetes Mellitus During the Covid-19 Pandemic

During the COVID-19 pandemic, the time spent at the home of patients has increased because of national quarantine policies and patients' fear of getting sick. For this reason, in this ongoing process, patients have been unable to go to work regularly due to their chronic diseases (being on administrative leave) and their fear of going out. These reasons have prevented being physically active. The aim of the study is to evaluate the physical activity level, quality of life, glucose control, anxiety, depression, fear of hypoglycemia and loneliness perceptions of patients with type 1 diabetes mellitus during the COVID-19 pandemic period and compared with healthy controls.


Eligibility Criteria:
Inclusion Criteria:

* Having been diagnosed with Type 1 Diabetes Mellitus
* Willing to participate in the study
* Participants whose native language is Turkish

Exclusion Criteria:

* Unwilling to participate in the study
* Having a cognitive disorder
* Not being literate
* Individuals who do not have sufficient knowledge and functional levels to fill out the online form
Retrospective Digital Computer Analysis of Keratoconus Evolution - REDCAKE

The purpose of this study is to create a database of keratoconic eyes with two or more corneal topographies/tomographies, at least 5 months apart

Title: Keratometry values such as K1, K2 and the angle between these two; Value and location of the thinnest corneal point; Pachymetry progression (radial change of pachymetry); IS value (i.e., ratio of average curvature in superior and inferior sections)

Description:

The primary endpoint is to obtain a database, containing at least two valid corneal biometry measurements (Scheimpflug) recorded at least 5 months apart, for a predetermined number of suitable keratoconus patients.

These data will be used to create a personalized three-dimensional model of the cornea at each time point, which permits classifying corneas according to shape and stage, as well as assessing the influence of patient age, gender, family history and ophthalmic habits (e.g. eye rubbing) on keratoconus progression. Based on corneal changes over time, an estimate of the underlying biomechanical changes will be made. All these data will then be combined to develop software for automated keratoconus detection and progression risk assessment to help ophthalmologists decide when to perform crosslinking on their patients.

The primary variables are the elevation parameters derived directly from the Scheimpflug measuring device export files, along with the demographic and medical information (if available).

Time frame: 5 months

Once a predictive model for keratoconus progression speed based on multiple measurements, this can be improved to make predictions based on a single measurement. Furthermore, the database obtained in this work will also be a valuable resource to analyse the variation in keratoconus shape, which may lead to an improved classification of keratoconus types

Eligibility Criteria:
Inclusion Criteria:

* Age between 12-40 years.
* Clinically diagnosed mild or moderate keratoconus in one or both eyes
* Two or more Scheimpflug measurements (type Pentacam HR, Pentacam AXL, Ziemer Galilei, CSO Sirius) of good technical quality, separated at least five months apart.

Exclusion Criteria:

* Corneal scarring present in both eyes.
* Known corneal or retinal pathologies, apart from keratoconus
* Known ocular procedures/ treatments (including crosslinking)
* Known systemic diseases (e.g. diabetes, MS, HIV/AIDS, hypertension,...), except allergies
* Change in contact lenses between measurements (e.g. start wearing lenses, change from corneal to scleral lenses, etc.)
* Fluorescein drops instilled into the eye before Scheimpflug measurement.
Utilizing MRI for Earlier Diagnosis of Rheumatoid Arthritis

MRI has been shown to be helpful in identifying patients who present with undifferentiated inflammatory arthritis who will develop RA within a one year follow up period. The absence of other clinically apparent symptoms often causes delays in diagnosis of RA. The use of the MRI in conjunction with the physical examination has the potential to reduce diagnostic delay. Earlier diagnosis would allow for earlier treatment implementation for better patient outcomes.


Eligibility Criteria:
Inclusion Criteria:

≥ 18 years old

Undifferentiated inflammatory arthritis suspected to be early RA (≥1 joint with synovitis and ≥1 other tender joint)

Symptom duration ≤1 year

Exclusion Criteria:

Unwillingness or inability to return to Mayo Clinic Rochester for research follow-up visits

Current or previous use of DMARDS

Taking ≥10 mg of prednisone a day

Contraindications to contract enhanced MRI

History of another definite autoimmune or inflammatory rheumatic disease

History of psoriasis

History of inflammatory bowel disease

Unsuitably as deemed by the principal investigator
Efficacy of Metronidazole Prophylaxis Against Clostridium Difficile-Associated Diarrhea in High Risk Adult Patients

The purpose of this study is to test if metronidazole prophylaxis is effective in decreasing the incidence of hospital induced Clostridium Difficile diarrhea among patients at high risk for this infection.

Clostridium Difficile infection or C. Diff (CDI) is an infection that causes severe diarrhea. Risk factors for this infection include hospitalization, the use of antibiotics, along with medications that decrease the acid in the stomach. This infection leads to a disease which is difficult to treat and can cause serious complications including death in rare cases. This infection also increases medical costs by prolonging hospital stays.

Metronidazole (known by the brand name Flagyl) is an antibiotic that has been available for decades and has been used to treat this disease. Flagyl is approved by the Food and Drug Administration for the treatment of C. diff infection. Recent research by the investigators group has shown that hospitalized patients who took Flagyl had a decreased chance of getting C. Diff infection. However, high quality studies are needed to better evaluate whether the investigators can prevent C. Diff infection in high risk patients with the use of Flagyl.

The purpose of this study is to assess if metronidazole prophylaxis is effective in decreasing the incidence of hospital induced Clostridium Difficile diarrhea among inpatients at high risk for this infection.

High risk patient population are as defined below: taking a broad spectrum antibiotics (piperacillin/tazobactam-Zosyn; Ciprofloxacin).

Eligibility Criteria:
Inclusion Criteria:

* Inpatients \>55
* Proton Pump inhibitor / Histamine-2 Blocker
* On broad spectrum antibiotics (Zosyn and/or Ciprofloxacin). These two antibiotics are selected based on current hospital formulary/use
* Anticipated hospital stay \>48 hours
* Mental capacity (able to give informed written consent).

Exclusion Criteria:

* Admission for CDI
* Existing diarrhea at admission
* Passed prophylactic window (\>48 hours on broad spectrum antibiotics)
* Unable to take PO at the time of evaluation for study entry
* No more than 14 days of broad spectrum antibiotics anticipated
* Medications with serious interactions/contraindications to that would be taken together with metronidazole (ex. Warfarin, disulfiram, phenytoin, calcineurin inhibitors)
* Inflammatory Bowel Disease
* Admission for colonic bowel surgery or h/o total/Subtotal colectomy)
* Hospice
* Mortality expected \<7days
* Previous CDI in the past 6 months
* Intensive care admission due to the difficulty of monitoring them
* Allergy to Metronidazole or other Antibiotics in protocol
* Patients with neuropathy
* History of heavy ethyl alcohol intake(greater than 3 drinks daily) or intake in past 24 hours,Solid organ transplant.