cyrilzakka/clinical-trials huggingface dataset:
UniVRse: VR-CBT for Students With Social Anxiety

The goal of this pilot randomised controlled trial is to evaluate the effectiveness of the UniVRse VR-CBT programme in students with social anxiety. The aims of this trial are:

1. To determine whether a full trial is justified;
2. To establish the effect size on the co-primary outcomes for a sample size calculation for a definitive trial;
3. To address questions concerning study recruitment, retention, and acceptability.

Participants will complete a baseline assessment (T0) and then be randomly allocated to receive either UniVRse VR-CBT or join the wait-list control group. UniVRse VR-CBT uses graded exposure techniques delivered using VR to help students feel more confident in university-based situations. Data will be collected post-intervention (T1) along with exit interviews to assess participant experience.


Eligibility Criteria:
Inclusion Criteria:

For participants to be eligible to take part, they must be:

* A current student at the University of Westminster;
* Able to read and communicate in English;
* Wanting help to feel more confident at university;
* Deemed to have context-specific social anxiety as defined by a response of 'moderate' or 'often' on one of the subscales from any one of the following items from the MLSAS-SR: 5, 12, 17, and 9. These items reflect the highest level (i.e. most anxiety-invoking) of each of the four scenarios within the UniVRse programme:

  * Asking a question in a lecture in person
  * Delivering a presentation on your own in front of the class
  * Speaking using my mic during online seminars
  * Speaking up during small group discussions in person

Exclusion Criteria:

Persons will be excluded from the study if meet any of the following criteria:

* Have photosensitive epilepsy;
* Have a visual impairment that cannot be corrected with glasses;
* Have a balance disorder;
* Have a significant auditory impairment;
* Have current and active suicidal plans;
* Are currently accessing or have confirmed plans to access another psychological intervention during the course of the study.

Participants will be excluded from providing a saliva sample (required for the cortisol measurement) if they meet any of the following criteria:

* Are pregnant;
* Currently breastfeeding;
* Taking any medications;
* Have any other serious medical condition;
* Think that they currently have COVID-19. These participants may still participate in the wider UniVRse trial if they meet all of the aforementioned main trial inclusion/exclusion criteria.
Study of Professional and Individual Factors of Covi-19 and Impact on Return to Work

Started on January 9, 2020 with the announcement of the discovery of a new SARS-CoV-2 coronavirus, the Covid-19 pandemic is responsible as of June 21, 2020 for 160,377 confirmed cases in France, 29,640 deaths and 9,823 hospitalizations. The Grand Est region is one of the regions in France that was most precociously and strongly affected by the epidemic, in particular the Strasbourg University Hospital. Faced with the heavy use of the healthcare system, hospital staff of all categories are an essential resource to be preserved. Several studies have shown the significant impact of Covid-19 on doctors and caregivers. In order to better protect these personnel and avoid contamination that could be harmful to their health but also because of the consequences in terms of staff, it is necessary to better understand the risk factors for transmission of this infection, the means of protection, the evolution of the disease and the determinants of the return to work. Few studies have explored on such a large workforce and in detail the professional risk factors for developing Covid-19 within different groups of hospital professionals including also non-caregivers and the evolution when returning to work in an outpatient population.


Eligibility Criteria:
Inclusion criteria:

* Major subject (≥18 years old)
* Professionals from the University Hospitals of Strasbourg (HUS)
* Professionals who had been working at the HUS at the time of the diagnosis of SARS CoV-2 infection.
* Subject having not expressed, after being informed, opposition to the reuse of their data for research purposes

Exclusion criteria:

- Subject who expressed their opposition to participating in the study
Machine Learning for Reclassification of Obesity

The goal of this study is to employ or develop computational modeling techniques for the precise reclassification of obesity into subgroups. Clinical features, risks of noncommunicable diseases, as well as weight loss effects of bariatric surgery will also be studied and compared within the subgroups.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with overweight/obesity
2. Patients with normal weight as controls

Exclusion Criteria:

1. had ever been performed with a bariatric surgery before the study's first visit is scheduled;
2. had taken exogenous insulin, medication that affects glucose metabolism, or uric acid drugs currently;
3. being diagnosed with type 1 diabetes, secondary diabetes, hereditary disease, or severe disease (e.g. malignant tumor, heart failure, liver failure, etc.);
4. in gestation of lactation;
5. did not have the complete data for model;
6. for normal-weight controls, patients with diabetes or hyperuricemia were excluded.
Medtronic 670G Insulin Pump and the Impact on Glycemic Control, Quality of Life, and Compliance

Analyze the Medtronic 670g pump on glycemic control

An Analysis of the Medtronic 670g Insulin pump use in clinical practice and the impact on glycemic control , quality of life, and compliance

Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* Documented History of Type 1 Diabetes Mellitus
* 3 months continuous use of the Medtronic 670g pump system
* given written informed consent

Exclusion Criteria:

* Less than 3 months use of the Medtronic 670g pump system
* Taking any other medication, other than the insulin used in the Medtronic 670g pump, to manage their diabetes
* having medical conditions or taking medications that would preclude subject involvement or affect the outcomes being measured, in the opinion of the Investigator
Cesarean Rate in Parturients Without Neuraxial Analgesia

Currently, it is certain that neuraxial analgesia in early stage of labor and delivery dose not increase the risk of Cesarean section. However, given ethical reasons, whether such a medical procedure could increase the Cesarean rate compared with those who did not received neuraxial analgesia or not is yet to be known. It is difficult to perform such a study in occidental countries because they have a higher rate of labor analgesia. On the contrary, the rate of labor analgesia in China is up to date only 1%, so it can be done easily. The investigators hypothesized that no neuraxial analgesia itself were a risk factor to Cesarean section. Therefore, the investigators design this study to compared the effect of neuraxial analgesia on the rate of Cesarean delivery with those who did not received neuraxial analgesia.


Eligibility Criteria:
Inclusion Criteria:

* Age \>= 19yr, \<=40 yr
* Height 140 - 170 cm
* Singleton pregnancy
* Uncomplicated pregnancy
* Chinese

Exclusion Criteria:

* Multiple gestations
* Pregnancy-induced hypertension
* Diabetes mellitus
* Chronic pain
* Allergic to opioids and/or local anesthetics
* Failed to performing inter lumbar space catheterization
* Organic dysfunction
* Contraindications for neuraxial analgesia
Comparison of Laparoscopic Cornuostomy and Wedge Resection for Interstitial Pregnancy

This retrospective study is to find out the best way to treat patient with cornual pregnancy in the aspect of further pregnancy outcome.

To find out the best way to treat patient with cornual pregnancy in the aspect of further pregnancy outcome, the investigators compared the outcomes of laparoscopic wedge resection (LWR) and laparoscopic cornuostomy (LC) by the retrospective chart review.

Eligibility Criteria:
Inclusion Criteria:

* All women with cornual pregnancy who were admitted to the Department of Obstetrics and Gynecology of the Far Eastern Memorial Hospital for laparoscopic surgeries between January 2008 and June 2016 were enrolled

Exclusion Criteria:

* The person who was pregnant at the time of the operation
* After receiving IVF course of treatment
* Patients with uterine horns undergoing open surgery
The Effect of Changing the Eating Speed on Energy Intake

It was hypothesized that eating a meal slowly would lead to a lower meal energy intake and lesser feelings of hunger and desire to eat and higher levels of fullness after the meal compared to eating the same meal more quickly.


Eligibility Criteria:
Inclusion Criteria:

* Men and women ages 19-65 years.

Exclusion Criteria:

* Severe obesity (BMI ≥ 40 kg/m2),
* dieting,
* taking medications that affect appetite,
* participating in \> 150 min/wk of vigorous physical activity,
* smoking,
* drinking heavily (men: \> 14 alcoholic drinks/wk; women: \> 7 alcoholic drinks/wk),
* self-reported disordered eating,
* depression,
* type 1 or 2 diabetes,
* adrenal disease, or
* untreated thyroid disease.
Continued Safety Monitoring of Solanezumab (LY2062430) in Alzheimer's Disease

This study is an open-label extension study in Alzheimer's patients who have completed participation in either solanezumab Clinical Trial H8A-MC-LZAM (NCT00905372) or H8A-MC-LZAN (NCT00904683).


Eligibility Criteria:
Inclusion Criteria:

* Meets National Institute of Neurological and Communicative Disorders and Stroke/Alzheimer's Disease and Related Disorders Association (NINCDS/ADRDA) criteria for probable Alzheimer's Disease
* Has completed participation in solanezumab Study LZAM or Study LZAN through 80 weeks
* Must continue to have a reliable caregiver who is in frequent contact with the patient for the entire study
* Must have good vein access to administer infusions
* Agrees not to participate in studies of any other investigational compounds for the duration of their participation in Study LZAO

Exclusion Criteria:

* Are currently enrolled in, or discontinued within the last 30 days from, a clinical trial involving an investigational drug or device or off-label use of a drug or device (other than the study drug/device used in this study), or concurrently enrolled in any other type of medical research judged not to be scientifically or medically compatible with this study
* Meets LZAM or LZAN discontinuation criteria at the end of treatment in LZAM or LZAN study
A Study of Pemetrexed in Small Cell Lung Cancer, Which Has Returned

The purposes of this study are to determine 1) the safety of pemetrexed and any side effects that might be associated with it 2) whether pemetrexed can help patients with small cell lung cancer live longer 3) whether pemetrexed can make tumors smaller or disappear and for how long and 4) to see if patients feel better while taking pemetrexed


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of small cell lung cancer
* One prior treatment with chemotherapy or immunotherapy with greater than 3 weeks since the prior treatment
* At least 18 years of age
* Estimated life expectancy of at least 12 weeks
* Ambulatory and capable of self-care(eg, up and about greater than 50% of waking hours)

Exclusion Criteria:

* Have received treatment within the last 30 days with a drug that has not received FDA approval for any indication
* Less than 2 weeks from radiation therapy
* Other serious illness that would compromise the safety of the patient
* Most second primary malignancies treated less than 5 years previously
Interaction Study of Clopidogrel 300/75 mg Given Alone or Concomitantly With Omeprazole 80 mg in Healthy Subjects

Primary objective:

* Assess the effects of clopidogrel (300 mg loading dose followed by 4 days 75 mg/day) on Adenosine diphosphate (ADP)-induced platelet aggregation when given concomitantly with omeprazole 80 mg/day compared to given alone in healthy male and female subjects

Secondary Objective:

* Compare the pharmacokinetic profiles of clopidogrel and its active metabolite when clopidogrel is given either alone or concomitantly with omeprazole

The total study duration per subjects is 8 - 9 weeks broken down as follows:

* Screening: 2 to 21 days before the first dosing
* Period clopidogrel/placebo: 7 days including 5 days treatment
* Period clopidogrel/placebo + omeprazole: 12 days including 10 days treatment
* Washout between periods: at least 14 days after last dosing with respect to clopidogrel treatment
* End of study: 7 to 10 days after the last dosing

Eligibility Criteria:
Healthy subject:

* as determined by medical history, physical examination including vital signs and clinical laboratory tests:
* with a body weight between 50 kg and 95 kg if male, between 40 kg and 85 kg if female, and with a Body Mass Index (BMI) between 18 and 30 kg/m²

Exclusion Criteria:

* Evidence of inherited disorder of coagulation/hemostasis functions
* Smoking more than 5 cigarettes or equivalent per day
* Abnormal hemostasis screen
* unability to abstain from intake of any drug affecting hemostasis throughout the whole study duration
* Any contraindication to clopidogrel and/or omeprazole

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Predictors of Postoperative Pain

The purpose of the study is to prove that pain scores generated from painful stimuli applied preoperatively may help identify the inter-individual variability in pain perception.

Psychological factors and experimental pain models such as as electrical, pressure, heat, or cold stimuli have been identified as predictors of pain intensity and opioid consumption postoperatively. This study will investigate, in addition to the factors described above, the ability of pain scores generated from painful stimuli postoperatively in predicting postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing abdominal hysterectomy through a pfannenstiel incision
* American Society of Anesthesiologists (ASA)Class I-III

Exclusion Criteria:

* Patients with a history of psychiatric disease
* Diabetic or alcoholic patients who may have impaired sensation due peripheral neuropathies
* chronic opioid or nonsteroidal antiinflammatory drug use
* chronic pain conditions
Glyburide and Metformin for the Treatment of Gestational Diabetes Mellitus. Systematic Review

Since the publication in the New England Journal of Medicine (NEJM) in 2000 of the Langer's trial comparing glyburide vs insulin in the treatment of gestational diabetes mellitus (GDM), additional studies of oral agents for the treatment of GDM have been published (observational, randomized controlled trials (RCT), and trials using other drugs like metformin).

Some meta-analysis to summarize the evidence have been published: Nicholson 2009 (including 4 RCT addressing different drugs), Dhulkotia 2010 (including 6 RCT addressing different drugs, the meta-analysis combining all drugs altogether), Gui 2013 (including 5 RCT addressing metformin vs insulin).

Oral agents are increasingly used for the treatment of GDM. Investigators aim to update the evidence on RCTs comparing glyburide and metformin vs insulin or between them and summarize this evidence using meta-analysis tools. Specifically, investigators aim at producing distinct meta-analyses for each one of the three drug comparisons. This information is not available in the literature since the most recent systematic reviews specifically dealing on oral agents for the treatment of GDM have addressed a single drug comparison (Gui 2013) or have combined different drug comparisons into a single meta-analysis (Dhulkotia 2010)

This project involves the systematic review of RCT addressing the use of glyburide or metformin for the treatment of GDM. The review will include RCT comparing these drugs versus insulin or making direct comparisons between the two oral agents in pregnant women with GDM.

Investigators have pre-specified a series of maternal and fetal outcomes of interest.

A comprehensive electronic search strategy will be complemented with a search of bibliographies from relevant studies and the contact of authors from the eligible studies regarding issues on study design or information on primary outcomes.

The risk of bias of included studies will be analyzed and this information used to perform sensitivity analyses. If possible, data from original studies will be pooled into relative risks for dichotomous outcomes and mean differences for continuous outcomes.

Heterogeneity will be explored for all the analyses. Analyses will be undertaken using a fixed effects model that will be repeated using a random effects model in case of substantial heterogeneity.

Results of the systematic review will be published following PRISMA guidance.

Eligibility Criteria:
Inclusion Criteria:

* RCT
* GDM
* comparing Glyburide vs Insulin, Metformin vs Insulin or Metformin vs Glyburide
* data on fetal and/or maternal outcomes
* full text available

Exclusion Criteria:

* significant overlap with other articles of the same group
Acupuncture for Pre-Procedure Anxiety

It is common for patients undergoing spinal injections to report anxiety prior to the injection. Although sedation, general anesthesia, and medications can be used to reduce anxiety, the use of sedative agents during the procedure can increase the risk of spinal cord injury. The purpose of this study is to see if receiving acupuncture before a spinal injection can effectively reduce patients' anxiety. Only patients who are scheduled to receive a spinal injection at this institution will be eligible for the study.


Eligibility Criteria:
Inclusion Criteria:

* Age 18+
* Spine pathology that meets criteria for lumbar epidural injection

Exclusion Criteria:

* Unable to provide consent
* Contraindications to acupuncture (e.g., rash, skin infection, sensory loss in ear)
* Previous experience of acupuncture
* Age \<18
* Pregnant women
* Non-English or Non-Spanish speaking
Translating Healthy Lifestyle Interventions for Cancer Survivors

Investigators proposed to refine and test the feasibility and acceptability of a 4-month multi-modal lifestyle intervention in African American female breast or endometrial cancer survivors diagnosed with type 2 diabetes.

Recent systematic reviews and meta-analyses of cohort studies show that physical activity can reduce mortality and morbidity in diabetes and obesity-related cancers. Yet, there have been few efforts to promote physical activity within the context of female cancer survivorship, particularly among women with diabetes. In response, investigators proposed to refine and test the feasibility and acceptability of a 4-month multi-modal lifestyle intervention in African Americans (AA) with diabetes and who are breast or endometrial cancer survivors. This web-based, lifestyle intervention, coupled with coaching calls and in-person exercise sessions, may be an effective way to promote physical activity and healthy survivorship. The primary goal is for participants to participate in 30 minutes of moderate-to-vigorous physical activity five times a week. The investigators' aims : i) refine a theory-driven healthy lifestyle intervention, that is delivered via computer technologies and periodic in-person group exercise sessions with appropriate content, literacy demand and graphics, ii) assess the preliminary effects of the intervention on the primary outcome of level of moderate to vigorous physical activity (MVPA), as measured by accelerometry; weight, glycosylated hemaglobin and evaluate the effect of eating behaviors, wellbeing/functioning (quality of life, depressive symptoms, self-efficacy), compliance/adherence to protocol and acceptability on response to the intervention.

Eligibility Criteria:
Inclusion Criteria:

* African American women, ages 30
* No evidence of pregnancy, as evidenced by negative urine pregnancy test.
* Diagnosed with type 2 diabetes by their provider
* Diagnosed with Stage I-III breast or endometrial cancer
* Completed treatment for breast or endometrial cancer at least 4 months and no more 5 years ago English-speaking
* Agree to participate in all aspects of the semi-structured interview (Aim 1)
* Agree to participate in all aspects of the feasibility study, including group sessions (Aim 2)
* Access to the internet via phone or computer
* Access to a working phone for personal use

Exclusion Criteria:

* Non-English speaking
* Recent epilepsy, cardiac event or stroke in last 6 months,special nutritional needs (e.g. current evidence of malignancy; HIV)
* History of epilepsy, cardiac event or stroke within the last year
* Known diagnosis of HIV
* Known new malignancy
* Less than 4 months or more than 2 years post treatment of Stage I-III breast or endometrial cancer.
* No diagnosis of type 2 diabetes
* No self-report of African American race/ethnicity
* No access to a phone for personal use
* No access to the internet via computer or mobile phone
Hyperpolarized Xenon-129 MRI in Idiopathic Pulmonary Fibrosis

Idiopathic pulmonary fibrosis has a poor prognosis with limited treatment options. The Investigator hypothesize hyperpolarized Xe129-MRI can be performed in patients with IPF and repeated over time which will detect deficiencies related to perfusion in the lung.

Idiopathic pulmonary fibrosis has a poor prognosis with limited treatment options. Idiopathic pulmonary fibrosis (IPF) is a subtype of interstitial lung disease (ILD) that can lead to chronic hypoxic and ventilatory respiratory failure and early death.1 While current treatments slow disease progression, they do not improve symptoms or quality of life and are often poorly tolerated due to significant side effect profiles. Therefore, there remains an unmet need for more tolerable therapies with an acceptable side effect profile that slows progression and improves patient-centered outcomes.

Functional imaging is a promising tool for assessing treatment response in IPF. Longitudinal decline in forced vital capacity (FVC) and time-to-event outcomes like hospitalization and death have been traditional clinical trial endpoints in IPF. However, these endpoints are time and resource-consuming. Thus, there has been significant interest in using other trial endpoints, the most promising of which is lung imaging. The study group employed hyperpolarized xenon-129 magnetic resonance imaging (Xe129-MRI) to quantify and localize deficits in pulmonary ventilation and perfusion in chronic obstructive diseases. It has recently extended this to pulmonary fibrosis. However, to implement Xe129-MRI as an endpoint in a mechanistic clinical trial, the investigator proposes to demonstrate the feasibility of employing this procedure over time in patients with IPF. The investigator hypothesizes that hyperpolarized Xe129-MRI can be performed in patients with IPF and repeated over time, which will detect deficiencies related to perfusion in the lung.

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent 18 years of age or greater Clinical diagnosis of IPF

Exclusion Criteria:

* Continuous oxygen use at home
* Oxygen saturation less than 92% on the day of MRI procedure
* Pregnancy or lactation
* Claustrophobia, inner ear implants, aneurysm or other surgical clips, metal foreign bodies in eye, pacemaker or other contraindication to MR scanning. Subjects with any implanted device that cannot be verified as MRI compliant will be excluded.
* History of congenital cardiac disease, chronic renal failure, or cirrhosis. • Chest circumference greater than that of the xenon MR and/or helium coil. The circumference of the coil is approximately 42 inches.
* Inability to understand simple instructions or to hold still for approximately 10-15 seconds.
* History of respiratory infection within 2 weeks prior to the MR scan
* History of MI, stroke and/or poorly controlled hypertension.