cyrilzakka/clinical-trials huggingface dataset:
Prospective Study of the Impact of Sleeve Gastrectomy on Gastro-esophageal Junction Function

Improved results for sleeve gastrectomy could be possible if more was known about the surgical / mechanical factors that affect outcome.

Effectiveness of sleeve gastrectomy is between gastric banding and gastric bypass. However, a proportion of patients that undergo surgery, report troublesome and persistent dysphagia, pain, new onset or worsening of gastro-esophageal reflux (GER) requiring treatment. Improved results for sleeve gastrectomy could be possible if more was known about the surgical / mechanical factors that affect outcome. Current investigations based on traditional intra-luminal imaging (endoscopy) and radiology (UGI series) may not provide adequate preoperative assessment of esophago-gastric dynamics. Current practice in the creation of a sleeve gastrectomy involves the use of a bougie or endoscope around which the sleeve is stapled. There is no consensus on the diameter of this bougie and this intraoperative calibration may alter the gastro-esophageal junction (GEJ) anatomy, does not provide real time physiology feedback, and allows only for a rough approximation of the size of the sleeve providing no information about the distensibility and pressure gradient of the newly created gastric tube as it is filled. A more distensible sleeve will have lower intra-gastric pressure, and thus will theoretically be expected to reduce the incidence of side effects. As laparoscopic sleeve gastrectomy is performed with increasing frequency, there is a need for development of tools to assist the surgeon in modeling properly and standardize the gastroplasty. This study will be based on a strict assessment of the anatomical and functional characteristics of the "ideal "gastric sleeve, using existing imaging modalities (endoscopy - CT scan- MRI - HRM).

Eligibility Criteria:
Inclusion Criteria:

* Patient, male or female over 18 years old
* Patient scheduled to undergo a sleeve gastrectomy for obesity
* Patient with surgical indication validated by the obesity multidisciplinary meeting (RCP)
* Patient able to understand the study and to provide written informed consent
* Patient registered with the French social security regime

Non-inclusion criteria:

* Patient unable to give written informed consent
* Patient presenting contra-indication to the conduct of an MRI (claustrophobia, implantable medical devices)
* Patient presenting risks of allergic reaction to MRI contrast agents (gadolinium)
* Patient presenting, in the investigator's judgment, a condition or disease preventing their participation to study procedures
* Patient pregnant or breast-feeding
* Patient within exclusion period from other clinical trial
* Patient having forfeited their freedom of an administrative or legal obligation
* Patient being under guardianship
Reattachment of the SPR Versus the Bone Block Procedure for Recurrent Peroneal Tendon Dislocation

Clinical outcomes between reattachment of the superior peroneal retinaculum (SPR) and the bone block procedure were compared in this study to elucidate which procedure was safer and more effective.

From 2012 to 2016, 25 patients with recurrent peroneal tendon dislocation underwent the bone block procedure(group A), and another 22 patients underwent reattachment of the SPR (group B). American Orthopaedic Foot and Ankle society (AOFAS) ankle-hindfoot score, Ankle Activity Score (AAS), time to return to sports activity, rate of return to sports level, range of motion (ROM) of the ankle, rate of recurrence, and overall patient satisfaction were collected to evaluate outcomes between the two groups.

Eligibility Criteria:
Inclusion Criteria:

* a traumatic recurrent peroneal tendon dislocation requiring surgery
* a lack of response to at least 3 months of conservative treatment

Exclusion Criteria:

* the presence of an acute peroneal tendon dislocation
* a concomitant anterior talofibular ligament rupture
The Study of the Relationship Between TWEAK/Fn14, JAK/STAT3 and IDO in the Immune Microenvironment of Endometrium in Repeated Implantation Failure

The purpose of this study is to find out the possible relationship among TWEAK/Fn14, JAK/STAT3 and IDO as well as their roles in the dysfunction of immune micro-environment of endometrium in people diagnosed as repeated implantation failure after in vitro Fertilization-embryo transfer(IVF-ET).

We will use the technology of Western-blot and Immunohistochemistry to find out the relationship of the expression of TWEAK/Fn14, JAK/STAT3 and IDO in endometrium . Also, we will use technology of Western-blot and Immunohistochemistry to determine whether there are differences of the the expression of TWEAK/Fn14, JAK/STAT3 and IDO in endometrium between RIF group and control group.

The purpose of this study is to find out the possible relationship among TWEAK/Fn14, JAK/STAT3 and IDO as well as their roles in the dysfunction of immune micro-environment of endometrium in people diagnosed as repeated implantation failure after in vitro Fertilization-embryo transfer(IVF-ET).

We will use the technology of Western-blot and Immunohistochemistry to find out the relationship of the expression of TWEAK/Fn14, JAK/STAT3 and IDO in endometrium . Also, we will use technology of Western-blot and Immunohistochemistry to determine whether there are differences of the the expression of TWEAK/Fn14, JAK/STAT3 and IDO in endometrium between RIF group and control group.

Eligibility Criteria:
Inclusion Criteria:

- Women who had a history of implantation failures in at least three consecutive IVF attempts, in which 1-2 embryos of high grade quality are transferred in each cycle without diagnosis of any specific cause of implantation failure.

Exclusion Criteria:

- antiphospholipid syndrome (APS), endocrine disorder (diabetes, thyroid dysfunction), genetic disorders, uterine malformations, or any current infections
Cognitive Bias Modification for Perfectionism and Intolerance to Uncertainty

This study will examine the impact of cognitive bias modification (CBM) on perfectionism and intolerance to uncertainty. Undergraduate students will be recruited and randomly assigned to either experimental or placebo-control groups. Each group will attend four sessions of CBM over four weeks.

Background. Cognitive bias modification (CBM) is an intervention aiming to systematically change the biases in cognitive processing using experimental paradigms. CBM was found effective with a variety of disorders and transdiagnostic variables. Although there are few studies focusing on transdiagnostic variables like perfectionism and intolerance to uncertainty, further research needs to be done for the generalizability of these results. It was aimed in this study to test the effectiveness of CBM for perfectionism and intolerance to uncertainty with a sample of undergraduate students in Turkey.

Sample size was determined using G\*power for a medium to large effect size based on previous studies and it was planned to include 28 undergraduate students who have a score of \>70.5 in the Brief Symptom Measure in the study. Participants will get either 3-course credits or a 100 TL bookstore gift card for their full participation. After getting informed consent from participants, they will be randomized to either active or control condition. Participants will be blind to their intervention condition. Following randomization, baseline measurements will be collected. After the baseline measures were collected, links for interventions will be e-mailed to the participants according to their assigned group. Participants will get an email including the link for the study every week. Interpretation bias scores of participants for perfectionism and intolerance to uncertainty will be collected before the first intervention session and after the last intervention session. These sessions will last approximately 25 min. Participants will attend the session without an assessment in the second and third week and these sessions will last approximately 15 min. After four sessions, post-tests will be sent to the participants. Questionnaires will also be collected one month after the intervention was done.

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years old
* Have a score of \>70.5 in Brief Symptom Measure
* Being an undergraduate student
* Fluent in Turkish
* Access to the internet by computer

Exclusion Criteria:

* Having any psychiatric disorder
* Receiving a psychiatric/psychological treatment
Association of AGTR1 and ACACB Gene Polymorphism and Diabetic Nephropathy in Type 2 Diabetes

India is the "Diabetes Capital of the World" with 41 million Indians having diabetes, with every fifth diabetic in the world being an Indian and type 2 Diabetes Mellitus (T2DM) constitutes the major chunk of diabetes. One of the most severe complications of diabetes is the development of diabetic nephropathy. Diabetic nephropathy (DN) is the leading cause of end-stage renal disease (ESRD) worldwide. There are many identifiable risk factors of diabetic nephropathy like hyperglycemia, hyperlipidemia, hypertension, and proteinuria, the genetic factor is the main among all. Long-term observational studies show that nearly 30-35% of type 2 diabetic patients develop nephropathy, irrespective of glycemic control. The regional variation in diabetes prevalence and in the proclivity for diabetes induced renal disease; along with reports of familial clustering of nephropathy suggest a possible genetic basis. The renin-angiotensin system (RAS) has been strongly implicated in the pathogenesis of progressive renal diseases. In addition, the blockage of angiotensin II with either ACE inhibitor or an angiotensin type-I receptor antagonist has been found to prevent or delay the progression of renal injury associated with diabetes 5 and now these drugs are first-choice drugs for the treatment of diabetic subjects with hypertension. The genes encoding the renin-angiotensin system (RAS), such as angiotensin-converting enzyme (ACE), angiotensinogen (AGT) and angiotensin II receptor type 1 (AGTR1), have been reported to be the most probable candidate genes for diabetic nephropathy. As there is no data available for AGTR1 polymorphism and DN in the north Indian T2DM, its out attempt to fill the scientific gap.


Eligibility Criteria:
Group:-1: Patients with diabetic nephropathy

Inclusion criteria:

* Type 2 Diabetes and duration of more than or equal to 5 years.
* Age between 30 to 85 years.
* Presence of both albuminuria and retinopathy.

Exclusion criteria:

* Patients with diagnosis of type 1 diabetes
* Any known nondiabetic renal disease.
* Patients who had a MI or had undergone CABG within 3 month.
* Patients who had a CVA or had undergone PTCA in the previous 3 months.
* Patients who had had a transient ischemic attack within the previous 3 months.
* Patients who had any history of heart failure before enrollment.
* Patients with UTI.
* Pregnant patient.

Group:-2: Patients without diabetic nephropathy Same characteristic as group 1 but no evidence of diabetic nephropathy.
Effects of a Physical Education Programme in Preschool Children

Unlike other European countries, Italian kindergartens do not include the physical education teacher in the school organic personnel. This is frequently associated with the lack of opportunities to perform physical education by preschool children. The aim of this study was to analyse the effects of a specific 16-week-long physical education programme (PEP) of 16-week length on the development of locomotor and object control skills in preschool children.

We conducted a school-based non-randomised controlled trial to evaluate the effect of a specific 16-week-long physical education program (PEP) on the quotient of gross motor development (QGMD) in preschool children. This study involved 119 children who were clustered in a control group (CG, n= 29, age: 52.1±8.65 months; height: 1.1±0.07 m, body weight: 19.2±5.55 Kg, BMI: 16.9±3.16) and an intervention group (IG, n= 90, age: 57.4±9.42 months; height: 1.1±0.06 m, body weight: 19.3±3.65 Kg, BMI: 16±1.75). Participants were assessed for locomotor ability and object control skills using the Italian version of gross motor development test, before and after the experimental period.

Eligibility Criteria:
Inclusion Criteria

* preschool children

Exclusion Criteria:

* Age \< 40 months
* Age \> 67 months
Impact Evaluation of the Wise Guys Program

The purpose of this study is to evaluate the impact of the Wise Guys program on the delaying sexual initiation on adolescent males in Eastern Iowa.

This study uses a randomized controlled design to compare the impacts of the Wise Guys Program to the "business-as-usual" school curriculum. The Wise Guys multi-session curriculum is delivered in different formats that range in length from 5 to 12 weeks and topics covered include communication and masculinity, dating violence, abstinence and contraception, and sexually transmitted infections. Study participants are 7th grade boys attending a participating school in either the Davenport Iowa or North Scott Community school districts. This study is being conducted as part of the national Personal Responsibility Education Program evaluation funded by Administration for Children and Families within the U.S. Department of Health and Human Services.

Eligibility Criteria:
Inclusion Criteria:

* 7th grade student in participating schools
* Male
Robotic Minimally Invasive Inguinal Hernia Repair With Dexter

This study aims to confirm the perioperative and early postoperative safety and clinical performance (efficacy) of the Dexter Robotic System, in patients undergoing primary transperitoneal unilateral or bilateral inguinal hernia repair.


Eligibility Criteria:
Inclusion Criteria:

* Aged \> 18 years
* Patients planned to undergo elective robot-assisted and laparoscopic surgery for primary unilateral or bilateral inguinal hernia repair using one camera port, two ports for the manipulating instruments, and additional ports as needed.
* Able to provide Informed Consent according to local regulation

Exclusion Criteria:

* Morbidly obese patients (BMI \> 40)
* Any relative and absolute contraindications for the use of conventional endoscopes and endoscopic surgical instruments
* Need for robotic stapling, advanced energy delivery, ultrasound, cryoablation and microwave energy delivery
* Bleeding diathesis
* Pregnancy
* Patients with pacemakers or internal defibrillators
* Any planned concomitant procedures
* Patient deprived of liberty by administrative or judicial decision or under legal guardianship
* Participation in another interventional clinical trial
Use of Ibandronate in Diabetic Patients

The purpose of this study is to examine whether monthly oral administration of ibandronate to postmenopausal osteoporosis patients with type 2 diabetes differs in safety and efficacy compared to patients without diabetes.

There are two major considerations in the use of bisphosphonates in diabetic patients.

* The low rate of bone turnover in diabetic patients is at risk of side effects such as excessive inhibition of bone turnover associated with the use of bisphosphonates.
* A decrease in osteocalcin following bisphosphonate use may lead to deterioration of glucose metabolism.

The efficacy of ibandronate in T2DM is not thought to be significantly different based on previous studies, but there is few study on ibandronate.

Eligibility Criteria:
Inclusion Criteria:

* age of at least 55 years at the time of screening
* postmenopausal woman
* diagnosis of osteoporosis

Exclusion Criteria:

* history of osteoporosis treatment
* underlying disease (e.g., heart failure, liver disease, renal disease, or malignancy)
* the use of drugs that affect bone metabolism (e.g., steroids, immunosuppressants, gonadotropin-releasing hormone agonists, aromatase inhibitors, thiazolidinedione drugs, anticonvulsants, and antidepressants)
* history of adverse effects of bisphosphonate or difficulty taking the drug due to an inability to sit or the presence of upper gastrointestinal disease
Inspiratory Muscle Training Efficiency Before Bronchoscopic Procedure

The aim of this study is to examine the effectiveness of inspiratory muscle training (IMT) before bronchoscopic procedure in Chronic Obstructive Pulmonary Patients (COPD). Patients with a diagnosis of COPD, who are listed for a bronchoscopic procedure and referred to the pulmonary rehabilitation (PR) clinic, will be randomly divided into two groups. Standard PR exercise program will be applied to both groups. In addition to the standard program, IMT will be applied to one of the groups. The effect of IMT on exercise program gains will be examined.

* Cases diagnosed with COPD by a chest diseases specialist at Yedikule Chest Diseases and Thoracic Surgery Training and Research Hospital will be included in the study.
* The cases meeting the inclusion criteria will be randomized and divided into two groups, called the standard rehabilitation group (PRGr) and the inspiratory muscle training group (IMTGr).
* Initial exercise sessions and all evaluations of all cases will be performed in the hospital. The 2nd and 3rd training repetitions will be held at their homes via online synchronized videoconferencing. The exercise video will be sent to the smart phones of the cases who have completed 3 training sessions. Participants will be called once a week by phone and exercise follow-up will be carried out.
* All subjects will continue to exercise 5 days a week for 2 months. The standard PR consists of breathing exercises, peripheral muscle strength and self walking training. In addition, IMT was applied to IMTGr.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 18-75
* Having a diagnosis of COPD diagnosed according to clinical diagnostic criteria according to -American Thoracic and European Respiratory Societies (ATS-ERS) and being a candidate patient for bronchoscopic lung volume reduction procedure
* Presence of dyspnea on exertion
* Stable clinical state at the time of inclusion without infection or exacerbation in the previous 4 weeks
* Ability to use a smart phone

Exclusion Criteria:

* Patients with severe comorbid diseases, unstable coronary artery disease, collagen vascular diseases and needing high flow oxygen therapy (˃ 3-4 L \\min).
* A history of effort-related syncope or any comorbidity (such as severe orthopedic or neurological deficits or unstable heart disease) that precludes exercise training.
* Participation in a pulmonary rehabilitation program within the past 12 months.
Assessing the Feasibility of a Prevention m-Health App Intervention for Informal Caregivers of Outpatients

The present quasi-experimental study aims to compare the level of preventive behaviours amongst caregivers who will be instructed to operating one mHealth App or given a relevant instruction manual. To achieve this, a comparison between the behavior of caregivers before and after the intervention and a comparison between the two groups (intervention group with the control group) will be performed. Specifically, data within the two groups will be collected via an online questionnaire consisting of three parts: prior to the intervention (baseline), two (2) and four (4) months after the intervention. The self-administered questionnaire consists of fifty-two (52) questions and uses three valid and reliable scales with a part that was developed via a bibliography research and consultations from experienced specialists. The questionnaire scales have been translated from the English language to Greek.


Eligibility Criteria:
Inclusion Criteria:

* The main adult caregiver is able to provide care / support to a bedridden patient.
* Willingness to participate in the study.
* Basic knowledge of the Greek language such that the user can understand the intervention and be able to complete the self-administered questionnaire.
* Possession of a mobile Android or iOS device.
* The patient is bedridden for no longer than four (4) months.
* During the assessment for predicting the risk of patient PUs development, the score according to the BRADEN scale must be between medium to severe risk (≤ 18).

Exclusion Criteria:

* The user does not have basic knowledge of the Greek language such that he/she is not able to understand the intervention or complete the self-administered questionnaire.
* Possession of a different mobile device other than Android and iOS or no possession of a mobile device.
* The patient is bedridden for four (4) months or longer.
* A mild risk score using the BRADEN scale (15-18).
Preoperative Inspiratory Muscle Training in Esophageal Resection

The PREPARE study is the first multicenter randomized controlled trial to evaluate the hypothesis that preoperative inspiratory muscle training leads to decreased pulmonary complications in patients undergoing esophageal resection.

Rationale: Esophageal resection is associated with high incidences of postoperative pulmonary pneumonia. Numbers of 30% are reported in literature. Postoperative complications can result in prolonged hospital stay and increased health care costs. In cardiac surgery patients a reduction of postoperative pneumonia of 50% is reported as a result of a preoperative inspiratory muscle training program. While in some surgical centers IMT is already used in the preoperative phase in patients undergoing esophageal resection, the effect of this promising intervention has not yet been investigated in a randomised and controlled study design in large surgical populations other than cardiac surgery.

Primary objective: Investigate the effect of a preoperative inspiratory muscle training program on the incidence of postoperative pneumonia in patients undergoing esophageal resection.

Study design: Prospective multicenter randomised controlled clinical trial.

Main study parameters/endpoints: A significant reduction in incidence of postoperative pneumonia.

Eligibility Criteria:
Inclusion Criteria:

* (Cognitively) capable to understand and perform a preoperative IMT program
* Surgery is scheduled at least 2 weeks after signing informed consent, since the patients need to be able to follow the intervention program for at least 2 weeks
* Willing to sign the informed consent form

Exclusion Criteria:

* Unable to communicate in Dutch language
* Age \< 18 years
* Participating in a conflicting trial concerning esophageal resection