cyrilzakka/clinical-trials huggingface dataset:
A Study of CDPATH™ to Help Manage and Treat Crohn's Disease

CDPATH™ is a tool to help predict the potential for developing Crohn's disease related complications in certain adult participants within 3 years. The main aim of the study is to explore the use of CDPATH™ to describe a participant's risk profile and to have discussions with their doctor about the potential path of their Crohn's disease. The number of visits will be decided by the study clinic according to their standard practice.

The tool being tested in this study is called CDPATH™. CDPATH™ is being used to provide a graphical representation of an individual participant's risk of developing a CD-related complication within three years, leveraging known participant risk factors based on clinical, serologic and genetic variables to help people categorize risk who have CD. This study will gather data on the use of the tool in real-world settings to inform practical use of CDPATH™.

The study will enroll approximately 200 patients. Participants and health care providers (HCPs) will be surveyed to understand their satisfaction with the CDPATH™ process and with their treatment choice.

This multi-center trial will be conducted in the United States. The overall time to participate in this study is 36 months. Participants will make multiple visits to the HCP's clinic, and data will be collected approximately every six months up to 3 years, based on the timing of routine follow-up appointments for assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Has an initial diagnosis of CD established within five years prior to screening by clinical and endoscopic evidence and corroborated by a histopathology report (if available).
2. Has agreed to use the CDPATH™ tool.
3. Has reliable access to the internet and is willing to answer electronic patient-reported outcomes (ePROs) throughout the study.

Exclusion Criteria:

1. Has had known complications from CD including but not limited to: bowel stricture, CD-related intra-abdominal abscess, internal penetrating disease (known fistula other than perianal fistula), non-perianal surgery, bowel resection, or stricturoplasty. A perianal fistula or abscess without other signs of penetrating disease is allowed.
2. Has had any non-CD-related abdominal surgery.
3. Has received investigational biologic or nonbiologic agents for the treatment of CD in an investigational protocol. Approved biologic or nonbiologic agents for CD are allowed.
4. Has previously used CDPATH™ or PROSPECT results to assess CD risk for complications.
GR Defect in Peripheral Blood Mononuclear Cells in COPD

T.to investigate a possible mechanism of the glucocorticosteroid receptors (GR) defect in patients with severe COPD by studying the effect of dexamethasone (Dex) on GR- binding, interleukin production (IL-6/IL-8) and MKP-1 expression in peripheral blood mononuclear cells blood (PBMC)


Eligibility Criteria:
Inclusion Criteria:

* Patients with severe (stage III, Gold) to very severe (stage IV, GOLD) COPD or subjects who are healthy smokers or subjects who are non-smokers
* Written informed consent

Exclusion Criteria:

* Current upper respiratory tract infections
* Any significant disease or disorder (e.g. cardiovascular, pulmonary (other than asthma), gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the investigator, may either put the subject at risk because of participation in the study, or may influence the results of the study, or the subjects ability to participate in the study
* Subjects not considered capable, as judged by the investigator, of following instructions of the study, e.g. because of a history of alcohol or drug abuse or any other reason
A Study to Learn About the Tests Looking for a Gene Mutation in Adults With Lung Cancer in China (ELEGANT)

The main aim of this study is to examine the percentage of people with lung cancer who carry a certain gene mutation (epidermal growth factor receptor exon 20 insertions - EGFR ex20ins) and their frequency in Chinese participants with Non-small cell lung cancer (NSCLC) after having been tested for the gene mutation.

Data from the participant's electronic medical records at the hospital will be collected.

This is a non-interventional, retrospective, observational study of the Chinese participants with locally advanced or metastatic NSCLC with EGFR ex20ins mutation. The primary objective of this study is to explore the prevalence of EGFR ex20ins, subtypes of EGFR ex20ins and their frequency in Chinese participants with locally advanced or metastatic NSCLC.

The study will enroll approximately 10800 patients. Participants will be enrolled in the following two cohorts:

* Cohort 1: Participants With Positive EGFR ex20ins Detection
* Cohort 2: Participants With Positive and Negative EGFR ex20ins Detection

The data will be collected retrospectively using the participant electronic medical records and next-generation gene sequencing (NGS)/polymerase chain reaction (PCR) kit instructions.

This multi-center trial will be conducted at 15 sites across China. The overall time to participate and data collection will be approximately 12 months.

Eligibility Criteria:
Inclusion Criteria:

Cohort 1 and 2:

1. Participants with a diagnosis of locally advanced or metastatic NSCLC, clinical staging of IIIB-IV.

Cohort-1:

1. Participants who have received NGS testing and have EGFR ex20ins positive result.

Cohort-2:

1. Participants who have received NGS testing

Exclusion Criteria:

1. Incomplete information, including key demographic characteristics, clinicopathological characteristics, and genetic testing information.
Evaluation of Anterior Tibial Knee Translation in Healthy Women With and Without Hormone Therapy

Women are recognized as being at greater risk of ACL injury, with a risk 6 times higher than that of men. Hyperlaxity is a risk factor for ACL injury, but the pathophysiological basis for this is poorly studied. Hormonal impregnation and certain periods of the menstrual cycle (ovulatory phase) are risk factors for ACL injury. It therefore seems interesting to study the influence of hormonal impregnation on ligament laxity. To date, to our knowledge, no study has investigated such a relationship.


Eligibility Criteria:
Inclusion Criteria:

* Female between 18 and 40 years of age;
* No history of surgery on the 2 lower limbs;
* No change in contraceptive method in the last 6 months;
* Signature of informed consent ;
* Social security affiliation;
* D14 of her menstrual cycle (+/-1 day) (the first day of the cycle (D1) being considered as the first day of menstruation), except for those on unregulated micro-progestogen contraception.

Exclusion Criteria:

* Pregnancy or breastfeeding (check with urine pregnancy test);
* Menopause;
* Surgery: tubal ligation, oophorectomy, adnexectomy, hysterectomy;
* History of inflammatory joint disease, systemic or localized to the knee;
* History of microcrystalline or infectious pathology localized to the knee;
* History of fracture, severe sprain or dislocation of the knee joint;
* History of osteoarticular or congenital diseases that may lead to ACL laxity (e.g. Marfan syndrome, trisomy 21, Ehlers-Danlos syndrome, etc.);
* Signs of hyperlaxity (Beighton test \> 4);
* BMI \> 25 ;
* Daily alcohol consumption above the thresholds recommended by Public Health in France (more than 2 glasses per day);
* Intense or unusual physical exercise during the last 72 hours before the inclusion visit;
* Inability to understand the protocol;
* Women under guardianship, curatorship or deprived of liberty.
GS-5885 Alone or in Combination With GS-9451 With Peginterferon Alfa 2a and Ribavirin in Treatment Chronic Genotype 1 Hepatitis C Virus

This is a Phase 2b, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating Response Guided Therapy with GS-5885 Alone or in Combination with GS-9451 with Peginterferon Alfa 2a and Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1 Hepatitis C Virus Infection.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 18-70 years of age
* Chronic HCV infection
* Subjects must have liver biopsy results (≤ 2 years prior to Screening) indicating the absence of cirrhosis.
* Monoinfection with HCV genotype 1
* HCV RNA \> 10\^4 IU/mL at Screening
* HCV treatment naïve
* Candidate for PEG/RBV therapy
* Body mass index (BMI) 18-36 kg/m2, inclusive
* Agree to use two forms of highly effective contraception methods for the duration of the study and for 7 months after the last dose of study medication. Females of childbearing potential must have negative pregnancy test at Screening and Baseline.

Exclusion Criteria:

* Pregnant female or male with pregnant female partner
* Exceed defined thresholds for leukopenia, neutropenia, anemia, thrombocytopenia, thyroid stimulating hormone (TSH)
* Diagnosis of autoimmune disease, decompensated liver disease, poorly controlled diabetes mellitus, significant psychiatric illness, severe chronic obstructive pulmonary disease (COPD), HIV, hepatitis B virus (HBV), hepatocellular carcinoma or other malignancy (with exception of certain resolved skin cancers), hemoglobinopathy, retinal disease, or are immunosuppressed.
* Subjects with current use of amphetamines, cocaine, opiates (e.g., morphine, heroin), or ongoing alcohol abuse are excluded. Patients on stable methadone or buprenorphine maintenance treatment for at least 6 months prior to Screening may be included into the study.
Statistical Analysis of Prevalence, Incidence, Comorbidities and Medical Expense in Epileptic Children in Taiwan Based on National Health Research Insurance Database.

Epilepsy is a common disease in pediatric neurology. In recent years, due to the promotion of Taiwan's health insurance and the advancement of related medical treatments and anti-epileptic drugs, the prevalence, incidence, and related comorbidities of childhood epilepsy in Taiwan are expected, as well as the number of epilepsy patients in different regions or different age groups. and medical costs may change. This study aims to collect data from the National Health Insurance Database through the National Institutes of Health, review relevant data on childhood epilepsy patients from 2001 to 2013, and analyze trends to discuss the impact of universal health insurance and medical progress on childhood epilepsy patients. Impact.


Eligibility Criteria:
Inclusion Criteria:

1. Targets aged 0\~19 (\<=19) in the home country
2. Diagnosis code includes ICD9: 345.XX, ACODE:A225 (including outpatient and inpatient)
3. Between 2001 and 2013, those who had seen a doctor three times in a row with epilepsy diagnosis codes and used anti-epileptic drugs

Exclusion Criteria:

* Exclude those who sought medical treatment for epilepsy from 2001 to 2013, but the number of medical visits (outpatient + hospitalization) \<3 times, and exclude those who did not take medication from 2001 to 2013.
Group Medical Visits for Latina Women With Urgency Urinary Incontinence

This is a mixed methods study to compare group medical visits (GMVs) to usual care for Spanish speaking Latina women with urgency urinary incontinence. Patients will be randomized to GMVs and to usual care. At the conclusion of each series of GMVs we will hold a focus group for participants.The primary outcome will be improvement in urgency urinary incontinence symptoms.

Urinary incontinence, though its effects can be personally devastating, exists most often as a quality of life issue. As such, partnering with the patient toward shared medical decision making is of the utmost importance. Research suggests that Latina women with pelvic floor disorders are overwhelmed by the amount and speed of information presented by healthcare providers and respond by placing healthcare decisions within the hands of the provider.

Group medical visits have demonstrated improved quality of life, improved healthcare self-efficacy and closed outcomes gaps in low income groups. We propose a mixed methods study to compare group medical visits (GMVs) to usual care for Spanish speaking Latinas presenting to gynecology clinics at LAC+USC. The study will consist of a randomized control trial of GMVs compared to usual care. In addition we will hold focus group for participants of the GMV arm to gain insight into the patient experience of GMVs and how to improve the visits. The primary outcome will be improvement in urgency urinary incontinence symptoms as measured by the OABq SF. Additionally, changes in quality of life and healthcare self-efficacy will be measured before and after the intervention.

Eligibility Criteria:
Inclusion Criteria:

Patients seen in the Urology, Gynecology or Urogynecology clinics at LAC+USC Medical Center, with a diagnosis of OAB, UUI or MUI not undergoing surgical management, who are able to give informed consent.

Exclusion Criteria:

Non-Spanish speaking, pregnant, unwilling or unable to follow protocol, diagnosis of neurogenic bladder or radiation cystitis or presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.
Clinical Outcomes Study Using a New Implantable Neurostimulation System for Chronic Intractable Pain

The primary objective of this study is to investigate patient satisfaction with treatment using a new implantable neurostimulation system for chronic pain of the trunk and/or limbs.


Eligibility Criteria:
Inclusion Criteria:

* Chronic intractable pain of the trunk and/or limbs
* Documented history of trunk and/or limb pain of at least 180 days
* Overall pain intensity of at least 5 on a 0-10 numerical rating scale (OPI-NRS-11) over the past 180 days based on subject recall
* Pass study site's routine psychological/psychiatric evaluation within 180 days before signing the informed consent
* Subject is willing and able to comply with all protocol-required follow-up evaluations
* 18 years of age or older when written informed consent is obtained
* Subject signs informed consent

Exclusion Criteria:

* Unable to operate the Precision Spectra™ System either by self or with a caregiver
* Primary source of pain is cancer-related, pelvic, visceral, anginal or migraine
* Overall pain intensity of always 10 on a 0-10 numerical rating scale (OPI-NRS-11) over the past 180 days based on subject recall
* Is a high surgical risk
* Currently on any anticoagulant medications that cannot be discontinued during perioperative period
* Subject requires Magnetic Resonance Imaging (MRI) while implanted with lead(s) and/or the Precision Spectra IPG
* Subject is participating (or intends to participate) in another investigational drug or device clinical trial that may influence the data that will be collected for this study
* Subjects already implanted with an active implantable device(s) to treat their pain (IPGs, implantable drug pumps, etc) or pacemaker or Implantable Cardiac Defibrillator
* Patient is a woman who is pregnant (a urine pregnancy test must be performed within 7 days prior to the stimulation trial procedure in women of child-bearing potential) or nursing or intends to become pregnant during the course of the trial.
* Failed to achieve satisfactory relief during the stimulation trial phase
Single Low-Dose of Supplement Amino Acid

The purpose of the study is to confirm the results of a prior study that demonstrated pills containing two amino acids which are in foods increased growth hormone and insulin-like growth factor-1.

Oral supplementation with a key combination of derivatives that has been shown to increase human growth hormone in healthy volunteers peaking at 90 minutes and IGF-1 at 8 hours post-administration.

Eligibility Criteria:
Inclusion Criteria:

* healthy males and healthy females
* Between 18 and 70 years

Exclusion Criteria:

* Pregnant or nursing
* Taking any chronic medication including birth control pills.
Sleep Extension for Metabolic Health

The study aims to examine the effects of a sleep extension intervention on the metabolic and cardio-vascular profile of obese people who present traditional diabetes risk factors, and who are habitually sleep deprived. Participants randomized to the intervention arm will complete a 6-week sleep extension intervention, whilst the control group will maintain their habitual sleep schedule. It is hypothesized that the sleep extension intervention will significantly increase total sleep time, and will be accompanied by significant metabolic-related changes.

Recent epidemiological (survey) research, conducted in both in healthy populations and among those with existing chronic disease, shows that insufficient sleep can significantly contribute to ill health (including diabetes, heart disease and obesity). These findings have also been accompanied by credible explanatory mechanisms emphasising the role of sleep in regulating appetite, satiety, glucose and daytime stamina. Sleep extension, therefore, is a largely unexplored pathway for improving individual health, and reducing an existing risk of diabetes. If successful, increased sleep duration and quality could be adopted as an achievable public health intervention.

The study aims to recruit a total of 20 men, overweight, presenting traditional risks of developing diabetes, who are habitually short sleepers. Participants are then randomized, stratified by weight status, to a sleep extension group, or a control sleep monitoring group. Baseline measures include sleep actigraphy, continuous glucose monitoring, blood pressure, and a mixed-meal tolerance test; after the 6-week intervention, the same measures are repeated.

Eligibility Criteria:
Inclusion Criteria:

* Age: 25 to 55 years (inclusive)
* Gender: Men
* BMI \> 25kg/m2
* Average self-reported sleep duration of ≤ 6h per 24h
* Stable daily sleep/wake schedule
* Health risk screening score ≥ 2

Exclusion Criteria:

* Diagnosed sleep disorder as per DSM-5: e.g. insomnia, restless legs syndrome, moderate/severe Obstructive Sleep Apnoea; Epworth Sleepiness Score: \<5
* Diagnosed chronic conditions, or medication, likely to interfere with regular sleep: T2D, chronic fatigue syndrome, fibromyalgia, COPD, uncontrolled depression/anxiety, other severe psychiatric illness, substance abuse.
* Night/evening shift work , regular time-zone travel, other circumstances preventing regular sleep schedule (e.g. very young children, carer at night for sick relatives etc)
Magnetic Steering Improves Small Bowel Capsule Endoscopy Completion Rate

Patients referred for magnetically controlled capsule endoscopy (MCE) in the participating center from June 2017 to November 2017 were prospectively enrolled. Magnetic steering of MCE was performed after standard gastric examination. Capsule endoscopy completion rate (CECR), gastric transit time (GTT), pyloric transit time (PTT) and rapid gastric transit rate (GTT ≤ 30 min) were compared with the historical control group enrolled from January 2017 to May 2017.

Background and aims: Capsule endoscopy is currently available as a noninvasive and effective diagnostic modality to identify small bowel abnormalities, while the completion rate ranged from 75.1% to 95.6%. A novel magnetically controlled capsule endoscopy (MCE) system could facilitate the capsule to pass through pylorus thereby reducing the gastric transit time (GTT). The investigators perform this study to determine the potential improvement in capsule endoscopy completion rate (CECR) under magnetic steering vs standard mode.

Methods: Patients referred for magnetically controlled capsule endoscopy (MCE) in the participating center from June 2017 to November 2017 were prospectively enrolled. Magnetic steering of MCE was performed after standard gastric examination. Capsule endoscopy completion rate (CECR), gastric transit time (GTT), pyloric transit time (PTT) and rapid gastric transit rate (GTT ≤ 30 min) were compared with the historical control group enrolled from January 2017 to May 2017.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients aged over 18
* With gastrointestinal complaints
* Scheduled to undergo a capsule endoscopy for both stomach and small bowel

Exclusion Criteria:

* No surgical condition or refusing abdominal surgery to take out the capsule in case of capsule retention
* Implanted pacemaker, except the pacemaker is compatible with MRI
* Other implanted electromedical devices or magnetic metal foreign bodies
* Pregnancy or suspected pregnancy
Telmisartan as an Adjunctive Treatment for Metabolic Problems in Patients With Schizophrenia

This is a 12-week, randomized, double-blinded, placebo-controlled trial of telmisartan 80 mg/day as an adjunctive to clozapine or olanzapine therapy, in 70 schizophrenia subjects to examine telmisartan's effect on glucose metabolism, weight, food intake, resting energy expenditure, and body composition. In addition, the study will examine insulin's effects on psychopathology and cognition.

Potential subjects will be identified by their clinicians at the Freedom Trail Clinic, or Massachusetts General Hospital. Approximately 70 subjects will be enrolled.

The specific aims include:

Primary Aims:

1. Examine the efficacy of telmisartan added to regular doses of clozapine or olanzapine in improving insulin resistance.
2. Examine the efficacy of telmisartan in reducing fasting triglycerides.

Secondary Aims:

1. Examine the effects of telmisartan on negative symptoms, positive symptoms, and cognitive function.
2. Examine telmisartan's effects on lipids, body composition, and waist/hip ratio.
3. Examine telmisartan's effects on inflammatory biomarkers including C-reactive protein (CRP) and interleukin 6 (IL-6).

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-65 years
2. Diagnosis of schizophrenia, any subtype or schizoaffective disorder, any subtype
3. Treatment with clozapine or olanzapine for at least 6 months
4. Stable dose of antipsychotic agent for at least one month
5. Well establish compliance with out-patient medications
6. Females subjects will be eligible to participate in the study if they are of non-childbearing potential or of child-bearing potential and willing to practice appropriate birth control methods (complete abstinence from sexual intercourse, female sterilization, sterilization of male partner, implants of levonorgestrel, injectable progestogen, oral contraceptives, intrauterine devices, or double barrier methods of contraception using spermicide with either a condom or diaphragm) during the study.

Exclusion Criteria:

1. Inability to provide informed consent
2. Current substance abuse
3. Psychiatrically unstable
4. Significant medical illness including severe cardiovascular, hepatic, renal disease
5. Current insulin treatment of diabetes
6. History of immunosuppression
7. Current or recent radiation or chemotherapy treatment for cancer
8. Chronic use of steroids
9. Pregnancy or breast feeding
10. Use of diuretics, digoxin, warfarin because the possible drug-drug interaction of telmisartan