cyrilzakka/clinical-trials huggingface dataset:
The Long-term Effect on Intestinal Absorption and Safety of Treatment With Glepaglutide in Patients With Short Bowel Syndrome

The purpose of this trial is to investigate the long-term effect of glepaglutide on the intestinal absorption, nutritional status of participants with Short Bowel Syndrome (SBS). The trial will also investigate whether glepaglutide is safe during long-term use. All participants in the trial will receive glepaglutide injections.

Participants will have 14 visits with the study doctor. At 2 of these, participants will spend 48 hours at the trial site, one visit at the start of the trial and one after 24 weeks of treatment with glepaglutide. At all visits, participants will meet with trial staff and will have blood tests along with other clinical checks and tests done. Participants will be asked about their health and medical history.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial
* Age greater than or equal to 18 years and less than or equal to 90 years at screening
* Stable condition of SBS either with intestinal failure (SBS-IF) or intestinal insufficiency. For patients with SBS-IF, a stable condition is defined as less than 25 percent change in parenteral support (PS) volume or energy content for 4 weeks prior to screening.
* Stable body weight (less than 5 percent change in weight in the 3 months prior to screening)
* Wet weight of fecal excretion greater than or equal to 1500 grams per day demonstrated during a hospital stay prior to screening

Exclusion Criteria:

* More than 2 SBS-related or PS-related hospitalizations (e.g., catheter-related bacteremia/sepsis, bowel obstruction, severe water-electrolytes disturbances, etc.) within 6 months prior to screening
* Poorly controlled inflammatory bowel disease (IBD) that is moderately or severely active or fistula interfering with measurements or examinations required in the trial
* Current bowel obstruction
* Known radiation enteritis or significant villous atrophy, e.g., due to active celiac disease
* Cardiac disease defined as: decompensated heart failure (New York Heart Association \[NYHA\] Class III-IV), unstable angina pectoris, and/or myocardial infarction within the last 6 months prior to screening
* Any history of colon cancer. History of any other cancers (except margin-free resected cutaneous basal or squamous cell carcinoma or adequately treated in situ cervical cancer) unless disease-free state for at least 5 years
* Use of glucagon-like peptide-1 (GLP-1), GLP-2, human growth hormone (HGH), somatostatin, or analogs thereof, within 3 months prior to screening
The Effect of Sugammadex on the Outcome After Colorectal Cancer Surgery

This study is retrospective study. The purpose of this study is checking the effect of sugammadex on the outcome after colorectal surgery. The outcome is compared among the 2 groups, sugammadex group and non-sugammadex group. The primary parameters of outcome are length of stay, readmission rate, postoperative complications, time interval for first successful oral intake.

Abdominal surgery, like colorectal surgery, needs more than moderate neuromuscular block during surgery. After the surgery, reversal agent of neuromuscular blocking agent is given almost every pateints who underwent general anesthesia.

Classic reversal agent is cholinesterase inhibitor, like pyridostigmine and neostigmine. Its action mechanism is competetive antagonist of rocuronium. But cholinesterase inhibitor cannot make complete reversal in moderate or deep neuromuscular block. Its incomplete reversal which is called residual block cause respiratory complications and prolongation hospital stay.

Sugammadex has different mechanism compared to cholinesterase inhibitor. It captures neuromuscular agent, especially rocuronium, and prevent rocuronium's action. Even in deep neuromuscular block, sugammadex can reverse the action of rocuronium, and its reversal effect is fater and more reliable compared to cholinesterase inhibitor.

Previous studies focused on only short term outcome of sugammadex, like postanesthetic care unit (PACU) discharge time, respiratory complications in PACU.

But in this study, longer term outcome will be comapred between sugammadex group and cholinesterase inhibitor group (pyridostigmine).

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 21\~80
* Subjects who took colorectal surgery due to colon or rectal cancer from Jan, 2012 to Dec, 2017

Exclusion criteria

* Emergency surgery
* Paraplegia or quadriplegia
* Bedridden state d/t various reason
* Neuromuscular disease
* Combined operation wth other surgery
Continuous Positive Airway Pressure (CPAP) Mode Impact on Clinical Blood Arterial Pressure

Background: Continuous positive airway pressure (CPAP) is the first line therapy for obstructive sleep apnea syndrome (OSAS). Two positive airway pressure (PAP) modalities can be used: Fixed pressure, in which the effective pressure is set and kept constant all night, and auto CPAP devices where the positive pressure changes during the night depend on patient's requirements.

Hypothesis: Pressure variations associated with autoCPAP functioning can lead to sleep fragmentation and alterations in sleep structure. This can limit blood pressure dipping during sleep and then impact clinical blood pressure reduction.

Main objective: To compare in a randomized controlled trial 4 months clinical blood pressure (BP) evolution depending on CPAP mode: fixed pressure versus autoCPAP. Secondary outcomes: Evolution of arterial stiffness, biological parameters, quality of life and symptoms.

Methods: Patients will be randomised depending on CPAP mode. Baseline and 4 months evaluation will include: 24-h ambulatory blood pressure monitoring, clinical BP measurements and carotid-to-femoral pulse wave velocity (PWV). Patients will also complete quality of life and symptoms questionnaires.

2 interim analysis will be carried out when 150 and 220 patients respectively will have completed the study. The Peto's method will be used to correct the p-values.


Eligibility Criteria:
Inclusion Criteria:

* age between 18 and 80 years
* patients who gave written informed consent
* patients who subscribed a social insurance
* SAOS patients who need CPAP treatment.

Exclusion Criteria:

* cardiac failure known and treated
* central Apnea syndrome
* patients who stopped CPAP treatment in the previous year
* pregnant women
* patients under guardianship
* imprisoned patients, patients in hospital
* patients included in an other clinical study
Efficacy of Preoperative Intra Gastric Balloon in Morbidly Obese Patients Selected for Gastric By-pass

To demonstrate, during a prospective randomized medico-economic study, in morbidly obese patients (BMI \> 45 kg/m²) selected for a laparoscopic gastric by-pass that, in comparison to usual care, a temporary intra-gastric balloon (6 months) decreases medical costs and peri-operative morbidity.

On inclusion, comorbidities associated with obesity will be recorded. After recording of the informed consent patients will be randomized in two groups: usual care or intra-gastric balloon. In the latter, a second randomization will be performed between air-filled balloon or water-filled balloon. Six months later, after withdrawal of the balloon (if required), laparoscopic gastric by-pass will be performed. Thereafter, patients will be followed during 6 months.

On each visit, inclusion, 3 months, 6 months, surgery, 1 month and 6 months post surgery, a medical and biological evaluation will be systematically performed.

The main criteria of judgement is the rate of admission in ICU during more than 24 hrs during the 30 days following surgery.

The secondary criteria of judgement is: the differences in pre-operative weight loss between the 2 groups, number of complications occurring during the 30 days after surgery, differences in different scales of quality of life (SF36, IWQOL-lite), differences in operative time, length of hospital stay, readmissions, and medical cots between the two strategies. Efficacy and tolerance of each type of balloon (air-filled or water-filled) will be compared in the intra-gastric balloon group.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years
* Patients with morbid obesity with BMI \> 45 kg/m² requiring a gastric by-pass by laparoscopy.
* No efficacy of previous treatment on obesity
* Firmed informed consent

Exclusion Criteria:

* Patients in whom laparoscopy is contra-indicated
* Indication of gastric by-pass by laparoscopy retained without multidisciplinary advice
* Morbid obesity present since less than 5 years
* Severe associated pathology, non-related to obesity, impairing vital prognosis on a short or mean time
* Past history of gastric surgery, or gastric complication related to gastric lap-band
* Lack of health insurance
* Patient refusing to be followed 6 months before and after surgery
* Drug abuse
* Pregnancy or foreseeable pregnancy during the study
* Patients taking anticoagulant agents or steroids
* Patients with hiatal hernia \> 4 cm
* Patients with active ulcerated esophagitis (grade C-D in Los Angeles Classification)
* Patients with duodenal or gastric ulcer
* Patients with gastric or esophageal varices
* Patients with NSAIDs not taking PPI
* Patients with bulimia
Primary Versus Secondary Closure of Stoma-Reversal Skin Wound

to compare infection rate stoma reversal skin wound after primary or secondary closure

There will be two groups. In group A, skin will be stitched with prolene while in group B skin will be left open to follow up till 1 month and wound observed for infection according to CDC guidelines.

Eligibility Criteria:
Inclusion Criteria:

* . All patients who undergo ileostomy or colostomy reversal will be included

Exclusion Criteria:

* included patients with reversal of stoma through laparatomy, post-operative anastomotic leak and co-morbidities like diabetes, Chronic liver disease, chronic kidney disease etc
"I am a Physically Active Person!": A Randomized Controlled Trial Aimed to Increase Levels of Physical Activity Self-Definition and Physical Activity Among a Sample of Inactive Adults

This explanatory sequential mixed methods study investigated if an intervention can increase the physical activity identity and physical activity (PA) of inactive individuals. The intervention condition focused on increasing participant's physical activity self-definition (PASD) through educational sessions and group discussions on the five direct and indirect determinants of PASD (perceived enjoyment, perceived wanting, perceived commitment, perceived trying, perceived ability). The control condition was given general health behaviour education sessions. Researchers conducted interviews with some of the participants after the intervention was completed.


Eligibility Criteria:
Inclusion Criteria:

* Must be insufficiently active (\<150 minutes of moderate-vigorous PA per week)
* Scored below the mean in PASD
* Medically safe to participate in PA
* Intention to engage in PA over the next 6 weeks
Evaluation of the Efficacy of Topical Ophthalmic Steroids in a Modified Conjunctival Allergen Challenge (CAC) Model

The purpose of this study is to evaluate the effectiveness of the modified Conjunctival Allergen Challenge (CAC) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication,

Prednisolone, assessed by the following measures:

* Ocular itching
* Conjunctival redness

Prospective, single center, randomized, double-masked, placebo controlled study. Subjects will be randomized to one of the following treatment arms to dose four times per day (QID) for 8 days between Visits 4 and 5.

* Prednisolone phosphate
* Tears Naturale II Ophthalmic Solution (Placebo)

Duration:

Approximately 19 days

Controls:

Artificial Tears (Tears Naturale® II)

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age \& either sex, any race
* Willing and able to follow all instructions
* Positive history of ocular allergies
* Reproducible positive ocular allergic reaction induced by conjunctival allergen challenge

Exclusion Criteria:

* Have planned surgery during trial period
* Female currently pregnant, planning a pregnancy or lactating
* Use of disallowed medications
* Have ocular infections, or ocular conditions that could affect study parameters
* Have moderate to severe dry eye
* Have used an investigational drug or device within 30 days of start of study
* Female that is currently pregnant, planning a pregnancy or lactating
Hormone Replacement Therapy (HRT) Website Tool

The purpose of this study is to evaluate a prototype web-based module for patients to generate appropriate and focused health information along with a customized set of questions to take to their health care provider for discussion on hormone replacement therapy.

Patient-centered care may be enhanced by medically accurate, personalized health information generated by specialized software on the Internet. This study assessed the effect of a web-based interactive tool about menopausal hormone therapy (HT) on patient and provider communication and satisfaction.

The controlled, randomized evaluation of the TalkToYourDoc(sm) (TTYD) interactive website module on communication, satisfaction and efficiency of office visits involved 288 women born between 1930 and 1960 and 26 health care providers in an outpatient, academic setting. Women were randomized after stratification by HT use to usual care or access to the TTYD website. The TTYD website built a personalized series of questions based on participant input regarding health status and generated a printout of health issues, medications and questions about HT for participants to bring to the visit with their health care provider.

Results of the study found that women who participated in the intervention were more likely to come prepared to the clinic appointment with appropriate questions (80% vs. 96%) than women receiving usual care. Participants found the website easy to use, the questions generated were useful in the discussion of HT, and they felt that providers had a positive response to the printout. Providers felt that women who participated in the intervention were more engaged in the discussion and asked more relevant questions regarding HT. Providers had a higher level of satisfaction with the discussion with intervention participants, and felt that these office visits were more efficient.

Therefore, it was determined that the TalkToYourDoc(sm) module enhanced communication between women and their providers, led to greater visit satisfaction for both patient and provider, and improved visit efficiency.

Eligibility Criteria:
Inclusion Criteria:

* Women born between 1930 to 1960
* Scheduled appointment at the OB/GYN or Family and Community Medicine out-patient clinics between 11/9/2004 to 12/2/2005

Exclusion Criteria:

* Men
* Current pregnancy
* Diagnosed cancer
Strain Index Ratio as a Biomarker for Mechanical Complication of Hemorrhagic Myocardial Infarction

Hemorrhagic Myocardial infarctions are at high risk for mechanical complications including cardiac rupture. Prediction of vulnerable myocardial segments is an important step for the stratification of hemorrhagic MI patients. Wall motion index ratio is an important parameter to determine regions of high vulnerability within the 17-segment LV model of hemorrhagic MI.


Eligibility Criteria:
Inclusion Criteria:

* Index STEMI
* Primary PCI
* Able to complete Cardiac MR - STRAIN Protocol

Exclusion Criteria:

* Contraindication to CMR (Contrast Hypersensitivity, Metallic Implants, Abnormal Rhythms, breathing difficulties)
The 10-year Follow-up of the Delta-TT Trial.

This 10-year follow-up study aims to further investigate long-term migration patterns of the uncemented Delta-TT cup and H-MAX S stem, comparing outcomes between ceramic and polyethylene liners. Given the predictive value of early RSA migration patterns at the 2-year mark for identifying implants at risk of aseptic loosening, we hypothesize that the Delta-TT cup will demonstrate good stability at the 10-year postoperative mark. Besides, it is hypothesized that migration of Delta TT-cups is comparable between ceramic and polyethylene liners.

The primary objective of this study is to measure the long-term stability of the Delta TT cup, combined with either a ceramic or cross-linked polyethylene liner, by means of RSA at 10-years postoperatively.

Secondary objectives are to measure long-term stability of the H-MAX S stem, by means of RSA at 10-year postoperatively. Furthermore the study aims to measure implant survival rates and patient-reported outcomes for both the Delta-TT cup and H-MAX S stem, comparing outcomes between the ceramic and polyethylene group.


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in the initial Delta-TT trial

Exclusion Criteria:

* Patient is unable or unwilling to sign the Informed Consent specific to this study.
* Patient is unsuitable for participation in the study based on the investigator's judgement.
Brief Interventions for Drop-out Re-engagement

We will evaluate a series of interventions intended to help individuals who drop out of substance abuse treatment re-engage in order to improve treatment outcome.

We propose a 5-year Stage I behavioral therapy development study to: 1) prospectively evaluate risk factors for premature drop-out from outpatient treatment; 2) develop and test a manual of single session phone-and office-based interventions to re-engage these individual in treatment.

Eligibility Criteria:
Inclusion Criteria:

* admission to outpatient treatment

Exclusion Criteria:

* need for hospitalization
Improving Sleep Health in Adults With Overweight or Obesity

This study will examine the feasibility and acceptability of the Transdiagnostic Intervention for Sleep and Circadian Dysfunction (TranS-C) in adults with poor sleep and excess weight. Additionally, the study will explore if TranS-C improves sleep health and cardiovascular outcomes.

Aim 1 (Primary): Examine the feasibility and acceptability of TranS-C among adults with poor sleep health and excess weight.

Aim 2 (Exploratory): Explore the effect of TranS-C on the sleep health of adults with poor sleep and excess weight.

Aim 3 (Exploratory): Explore the effect of TranS-C on the cardiometabolic health of adults with poor sleep and excess weight.

Eligibility Criteria:
Inclusion Criteria:

* Currently own and regularly use a smart phone
* Body mass index \>27 and ≤ 43
* Poor sleep health on one or more of the sleep health dimensions

Exclusion Criteria:

* Presence of an unstable condition requiring physician-supervised diet and exercise
* Physical limitations precluding ability to engage in moderate-intensity physical activity
* Pregnant or intention to become pregnant during study
* Current treatment for a serious mental illness
* Being a current shift worker
* Reported alcohol intake \> 4 drinks/day for males and \> 3 drinks/day for females
* Current participation in a formal weight loss program, loss of ≥ 5% weight in past 6 months, or current use of weight loss medication
* History of bariatric surgery
* Planned extended vacations, absences, or relocation during study
* Another member of household is a participant in the study
* Score \> 32 on the Eating Habits Checklist, an eating disorder scale
Self-help Application for Eating Disorder

The purpose of this study is to determine whether mobile-based self-help CBT-E treatment for eating disorder can reduce eating disorder symptoms compared to the waitlist group


Eligibility Criteria:
Inclusion Criteria:

1. Aged 13-22 years
2. Owns a smartphone
3. Experienced at least one episode of binge eating over the past 4 weeks

Exclusion Criteria:

1. diagnosed with anorexia nervosa
2. BMI ≤ 17.5
3. having developmental disabilities, including autism, intellectual disabilities, schizophrenia, or other psychosis
Non Alcoholic Fatty Liver Disease Influence of Statin Therapy

Aim:

1. To determine the prevalence of fatty liver in a cohort of patients hospitalized with chest pain in the Cardiology department.
2. To assess the effect of statins on the prevalence of fatty liver by a cross sectional survey of patients hospitalized with chest pain.

Consecutive patients hospitalized with chest pain will be recruited at the cardiology department. Patients with an inflammatory condition, recent infection or history of alcoholism will be excluded. After signing an informed consent each patient will undergo an ultrasound examination for diagnosis of fatty liver. Information regarding BMI, hypertension and use of medications will be collected on each patient. Blood samples for fasting glucose, hemoglobin A1C, lipid profile, ESR, and CRP and liver function tests will be collected from each participant. Prevalence of fatty liver in patients who have been taking statins for 6 months or more statins will be compared to patients who have been taking statins for a lesser period and to those who do have not taken statins using a multivariate regression analysis.

Serum samples will be frozen and kept for future ongoing research.

Eligibility Criteria:
Inclusion Criteria:

* Cardiology patient
* Age above 18

Exclusion Criteria:

* Age below 18
Comparison of a Metal Backed Fixed-Bearing Tibial Baseplate and an All-Polyethylene Tibia in Total Knee Arthroplasty

This study is designed to compare prospectively, in a randomized Level 1 evidence fashion, the clinical, functional, and radiographic results of a modular polished tibial (MPT) tray with a moderately cross-linked polyethylene (XLK) insert to an all-polyethylene tibial (APT) design with GVF polyethylene. Comparing these two designs will afford us information in the following areas:

1. Does a MPT/XLK design have improved wear characteristics over a nonmodular APT/GVF design?
2. Is there a clear clinical advantage to the MPT/XLK design in certain patient populations that justify its use over the APT/GVF design?

Answering these questions will allow surgeons to use both designs appropriately in different demand populations.

This study is designed to address the questions of whether an MPT/XLK design offers improvement in wear characteristics, Knee Society scores, KOOS, WOMAC, SF-36, or radiographic measures, over an APT design. The investigator's primary hypothesis is that there will be no difference in these outcome measures at a minimum two year follow-up. A secondary hypothesis based on the long-term follow-up of this group, up to twenty years, is that there will be no difference in implant survival.

Summary is detailed

Eligibility Criteria:
Inclusion Criteria:

* generally accepted clinical and radiographic criteria for total knee arthroplasty

Exclusion Criteria:

* Significant angular or bony deformity necessitating structural bone grafting or more extensive modular designs will be excluded at the discretion of the principle investigator
* Routine contraindications to TKA (active sepsis, Charcot arthropathy)
* Patients whose mental function preclude them from responding to our standard questionnaires