cyrilzakka/clinical-trials huggingface dataset:
The StepSmart Project: A Pedometer Based Phased Intervention to Encourage Physical Activity in Schools

A school based pedometer competition among Year 9 pupils (12 - 14 years old) to promote physical activity (PA).

The intervention is separated into three main phases.

Phase One: A 10-week school competition using pedometers and a range of non-financial incentives e.g. t-shirts, pens, badges etc. (April - June 2015).

Phase Two: End of school competition but participants will still keep the pedometers. We will set them various challenges over the summer to keep active (July - Oct 2015).

Phase Three: Removal of all extrinsically motivation factors. Focus on PA maintenance.

Eligibility Criteria:
Inclusion Criteria

* aged 12-14 years
* enrolled in participating school

Exclusion Criteria

* Unable to give informed consent
* Presence of an underlying medical conditions
* Already enrolled in a physical activity intervention
Endometriosis: Sexual Dysfunction and Adaptation Strategies Among Couples

The primary objective of this study is to evaluate the presence/absence and description of persistent sexual troubles following surgical treatment for endometriosis for women, and their partners.


Eligibility Criteria:
Inclusion Criteria:

* The patient (and her partner) must have given his/her informed and signed consent
* The patient (and her partner) must be insured or beneficiary of a health insurance plan
* Couples for whom the woman has formerly undergone surgical treatment for endometriosis, and for the partner agrees to respond to questionnaires for this study

Exclusion Criteria:

* The patient (or her partner) is participating in another study
* The patient (or her partner) is in an exclusion period determined by a previous study
* The patient (or her partner) is under judicial protection, under tutorship or curatorship
* The patient (or her partner) refuses to sign the consent
* It is impossible to correctly inform the patient (or her partner)
* The patient is pregnant
* The patient is breastfeeding
* The patient was surgically treated for endometriosis, but was single.
Cerebellar TMS and Satiety in Prader-Willi Syndrome

This study uses a noninvasive technique called transcranial magnetic stimulation (TMS) to study hyperphagia and satiety in Prader-Willi syndrome.

TMS is a noninvasive way of stimulating the brain, using a magnetic field to change activity in the brain. The magnetic field is produced by a coil that is held next to the scalp. In this study, the investigators will be stimulating the brain to learn more about how TMS might improve hyperphagia in Prader-Willi syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Prader-Willi syndrome

Exclusion Criteria:

* contraindications for TMS or MRI including :
* history of neurological disorder
* history of head trauma resulting in loss of consciousness
* history of seizures or diagnosis of epilepsy or first degree relative family history of epilepsy
* metal in brain or skull
* implanted devices such as a pacemaker, medication pump, nerve stimulator or ventriculoperitoneal shunt claustrophobic in MRI
Predictive Value of Postoperative Prognostic Nutritional Index Trajectory on 1-year Mortality After Off-pump Coronary Artery Bypass Surgery

This study investigated the changing pattern of postoperative Prognostic Nutritional Index (PNI) after off-pump coronary artery bypass surgery using a trajectory analysis. The investigators aimed to investigate the correlation between postoperative PNI recovery patterns and mortality in patients undergoing off-pump coronary artery bypass surgery.


Eligibility Criteria:
Inclusion Criteria:

• Patients aged ≥ 18 years who underwent off-pump coronary artery bypass surgery

Exclusion Criteria:

* Patients without PNI value between 1 and 3 days after surgery
* Patients without PNI value between 20 and 60 days after surgery
De-Adoption of Beta-Blockers in Patients With Stable Ischemic Heart Disease

Patients with heart disease are often prescribed many medications and these patients may experience drug interactions or negative drug related side effects. With newer medications and treatments available, it is not well known whether older drugs, such as beta-blockers, are still an effective and safe option for treating heart disease. Some evidence suggests beta-blockers should be continued, whereas other evidence suggests beta-blockers might cause unnecessary harm. The study hopes to determine whether continuation or discontinuation of beta-blockers will affect long term cardiovascular outcomes. The study investigators will also examine how beta-blockers continuation or discontinuation affects several quality of life measures.

Patients will be randomized to continue β-blocker therapy or discontinue β-blocker therapy. Patients will be followed remotely for approximately four years for adherence, events and outcomes assessments, and completion of multiple web-based quality of life questionnaires.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>21 years
2. Documented Coronary Artery Disease (CAD) defined as:

   * Myocardial Infarction at least 6 months prior; or
   * Stable ischemic heart disease (defined using one of the following tests suggestive of significant coronary artery disease):

     i. Positive exercise stress test ii. Positive Nuclear perfusion scan iii. Positive exercise or pharmacologic echocardiographic stress test iv. Positive magnetic resonance imaging coronary perfusion scan v. Coronary computed tomographic angiography Angiogram with stenosis ≥ 70% (or left main coronary artery ≥ 50%) or significant function disease based or positive fractional flow reserve testing by CT (FFRCT); vi. Invasive coronary angiography with ≥ 70% (or left main coronary artery ≥ 50%) or significant function disease based or positive fractional flow reserve testing (FFR) or instant wave free ratio (IFR),
   * Previous Percutaneous Coronary Intervention (PCI, at least 6 months prior if revascularization is performed for an MI); or
   * Previous Coronary Artery Bypass Grafting (CABG, at least 6 months prior if revascularization is performed for an MI)
3. Able and willing to provide informed consent

Exclusion Criteria:

1. Left Ventricular Ejection Fraction \< 40% or current hospitalization for heart failure
2. Myocardial infarction \<6 months prior to randomization
3. Indication for β-blocker as determined by the treating physician (such as atrial or ventricular arrhythmias or ongoing angina not controlled by another agent)
4. Uncontrolled hypertension or uncontrolled angina symptoms (per the Investigator's discretion)
5. Non-compliance with medical therapy
6. Life expectancy \<1 year
7. Participation in another trial related to β-blockers or other anti-anginal drugs
The Use of Near Infrared Spectroscopy in the Diagnosis of Acute Compartment Syndrome in Injured Soldiers

The purpose of this study is to define the reliability and accuracy of Near Infrared Spectroscopy (NIRS) in the detection of intra-compartmental tissue perfusion in injured and noninjured extremities over time. The investigators hypothesize that this technology, combined with vital signs, intracompartmental pressures and clinical examinations, will be useful in diagnosing acute compartment syndrome (ACS), monitoring patients at risk for ACS, and evaluating the adequacy of fasciotomy in patients treated for ACS.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* male or female
* active duty servicemen who have been evacuated from OIF or OEF through LRMC

Exclusion Criteria:

* patients not willing to provide consent
* patients in whom application of NIRS monitoring is viewed as an impediment to casualty care
Position Sense, Force Control and Pain Intensity in Basal Thumb Osteoarthritis

In practice, a single test is used to quantify thumb proprioception. Previous studies have found a decrease in joint position sense (JPS) and force sense (FS) in patients diagnosis of thumb carpometacarpal osteoarthritis, but no correlation have been stabilize between JPS, FS and pain intensity perceived by the patient during activity daily life (ADL).

The goal of the study is compared joint position error (JPE) with joint force sense error (JFSE) in subjects with carpometacarpal (CMC) joint osteoarthritis and investigated a possible correlation between thumb pain intensity and thumb proprioception in patients with CMC joint OA.

Forty-five subjects over 18 with thumb CMC joint OA in the dominant hand grade 1-3 according o the Eaton Classification Stage will be evaluated for thumb active joint position sense (JPS) test and Force sense test to measure proprioception function. For measurement of JPS, the subjects will blindfolded and repositioned their thumb to a target position, which will be determined by the examiner previously. For force sense, participants will should reproduce pinch force measure with dynamometer. The severity of pain with activity will be measured according to the visual analog scale (VAS).

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years; Diagnosis of grade I, II or II thumb CMC joint OA in their dominant hand according to the Eaton Classification Stage; A minimum pain rating of 4/10 on the Visual Analogue Scale (VAS) during activities of daily living (ADLs) at the time of the initial evaluation; Ability to read and understand the patient information sheets and exercises

Exclusion Criteria:

* Neurological disorder affecting the upper limb; Treatment for hand or thumb pain in the same limb in the last 6 months (including injections to the wrist, fingers, or thumb); Fracture or significant hand injury; Previous surgery to the wrist or hand; Hand/finger tenosynovitis; Dupuytren disease; Cognitive impairment that inhibited an understanding of the informed consent and exercise program; Fixed thumb adduction contracture or blindness.
Bioequivalency Study of Protriptyline 10 mg Tablets Under Fasted Conditions

The objective of this study was to prove the bioequivalence of Protriptyline 10 mg tablets under fasted conditions


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Protriptyline or any comparable or similar product.
Young Women Diagnosed With Early Stage Ovarian Cancer: A Focus on Fertility Issues and Sexual Function

The purpose of this study is to ask youn women diagnosed with ovarian cancer who have undergone surgery that will allow them to have children in the future, on issues such as: education about their options to keep their ability to have children, after-chemotherapy treatment decision making, and reproductive history. The second purpose is to determine the effect of an early diagnosis of ovarian cancer on the sexual functioning of women.

* Participants will be asked to complete a questionnaire either in the clinic or at home and return it to the research staff by mail or in person.
* The study will involve being asked questions about the following: Fertility history; sexual history after being diagnosed with cancer; decision to have surgery that will allow them to have children; education they may or may not have received about the surgery that saved their ability to have children.
* Answers to all questions will be kept confidential and participants will be identified by a number only.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with stage I or II invasive ovarian cancer, that underwent fertility sparing surgery
* Women who were premenopausal prior to diagnosis
* 40 years of age or younger at the time of ovarian cancer diagnosis
* Completed therapy for early stage cancer
* No evidence of recurrence
* No history fo known infertility prior to diagnosis
* No other significant medical conditions that would affect fertility
Use of Intrapyloric Botulinum Injections in Children

This study aims to evaluate the effect of intrapyloric botulinum toxin in children with feeding disorders.

Chronic vomiting and feeding difficulties are common in young children and have a negative physical and psychosocial impact for patients and families. Currently there is no straightforward treatment algorithm for these issues, and management often involves multiple medication trials and procedures. Intrapyloric botulinum toxin injection has been proposed as a treatment for nausea and vomiting in adults, but there is minimal prior research on use in children and no prior research on use in children with feeding disorders. The aims of this study are: (1) to determine the efficacy of intrapyloric botulinum toxin injection for reducing gastrointestinal symptoms in children, (2) to determine the efficacy of intrapyloric botulinum injections for improving feeding outcomes in children, and (3) to define predictors of response to intrapyloric botulinum toxin injection.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic nausea, vomiting, or feeding intolerance undergoing upper endoscopy with or without intrapyloric botulinum injections.
* Age between 30 days and 18 years.

Exclusion Criteria:

* Significant uncontrolled inflammation on upper or lower endoscopy
* Known inflammatory bowel disease
* Uncontrolled thyroid disease
* Current opioid use
Improving Emergency Management of Status Epilepticus

In the trial the effectiveness of pre-briefing physicians with the current guideline on Status epilepticus (SE) treatment or a consolidated "one page" guideline regarding quality enhancement of the physician's clinical performances is investigated.

Status epilepticus (SE) is a life-threatening neurological emergency defined as a state of continuous seizure or multiple seizures without full recovery of sensory, motor and/or cognitive function for at least 30 minutes. To achieve high quality management of SE, the American Epilepsy Society published an evidence-based guideline for the treatment of SE, which serves as reference for most national guidelines, but analyses regarding practicability, strict adherence, correct translation into clinical practice, and identification of recommended treatment steps at risk of being modified or missed are lacking. Simulator-based studies offer a platform for the design of standardized clinical scenarios that enable detailed investigations regarding the effect of the implementation and practicability of treatment guidelines.

This randomized controlled intervention study performed at the simulation center of the medical intensive care units (ICUs) at the University Hospital Basel is to investigate the effectiveness of pre-briefing physicians with both the current guideline on Status epilepticus (SE) treatment or a consolidated "one page" guideline regarding quality enhancement of the physicians' clinical performances..

Physicians from different medical specialties and with different duration of clinical experience will be enrolled. Participants will be randomly assigned to one of the following three pre-briefing groups: (1) no pre-briefing prior to the simulation training; (2) pre-briefing with the current SE treatment guidelines; (3) pre-briefing with the consolidated "one page" SE treatment guideline.

Eligibility Criteria:
Inclusion Criteria:

* Physicians from different medical specialties working at the University Hospital Basel

Exclusion Criteria:

* None
Texts for Diabetes Control Among Homeless Persons

This mixed method study includes a Randomized Controlled Trial (RCT) and qualitative methods to assess the impact of a SMS text strategy in diabetes control among persons who experience homelessness.

Diabetes mellitus (DM) is common among persons experiencing homelessness (PEH), often inadequately managed, and carries significant costs. SMS strategies for DM have not been tested among PEH despite the accessibility of mobile phones. This study uses a SMS strategy to offer better communication, education, and information management; improve outreach; facilitate care coordination; explore barriers to care; and support behavior changes. This mixed-methods (RCT and qualitative) study will be implemented in shelter-clinics in New York City in collaboration with community organizations, allowing for sustainability and scalability. Aim 1 will evaluate the efficacy of a 6-month SMS program for DM management versus an attention control on changes in HbA1c and adherence to DM self-care activities, medications, and appointments at 9 months in adult PEH with uncontrolled DM (n=100). Outcomes will be measured at 0, 3, 6, \&9 months. Aim 2 will assess patients' and providers' attitudes, acceptability, and experience of the program through semi-structured interviews with PEH and providers.

Eligibility Criteria:
Inclusion Criteria:

* Homeless person age ≥ 21
* Diagnosed with type 2 DM
* Most recent visit HbA1c ≥ 8%
* English/Spanish speaking
* Connected to study sites' shelter-clinics for care

Exclusion Criteria:

* Pregnant or within 3 months postpartum
* Has an uncontrolled severe illness
* Has had a heart attack or stroke in the previous 6 months
* Inability to read/respond to texts
* Inability to provide informed consent
* Receiving inpatient care for severe substance abuse
Nutritional Support in Patients Undergoing Surgical Treatment of Colorectal Cancer

According to available data, 30-60% of patients are undernourished at hospital admission. The significance of the perioperative nutrition has already been studied in the 1930s. The outcomes of published studies demonstrated that patients with basic nutrient deficiencies have a higher frequency of postoperative complications and have a significantly longer recovery period.

The main aim of the this prospective clinical trial is to evaluate the loss of muscle mass and strength of the patient, the self-sufficiency and the possibility of returning to normal activities, in relation to pre-operatively served nutritional supplements in patients undergoing elective surgery for colorectal cancer.

Malnutrition is a pathological condition of the body caused by a deficiency of essential nutrients. The main feature is protein deficiency, which is caused by disruption of protein and energy balance and needs in the body. According to available data, 30-60% of patients are undernourished at hospital admission. The significance of the perioperative nutrition has already been studied in the 1930s. The outcomes of published studies demonstrated that patients that patients with basic nutrient deficiencies have a higher frequency of postoperative complications and have a significantly longer recovery period.

In 1992, a randomized clinical trial "Peri-operative nutritional support" showed that 85% of hospitalized seniors have malnutrition. The study demonstrated the need for nutritional training to prevent complications and clearly showed a relationship between malnutrition and reconvalescence length and mortality rate. In 2004, another large randomized trial ("Randomized clinical trial of the effects of preoperative and post operative oral nutritional supplements on clinical course and cost of care") confirmed the relationship between malnutrition and the incidence of all perioperative complications. Several other studies, which have been realized within the last decade, confirmed the positive effect of good nutritional condition on postoperative morbidity and mortality.

To the best of the investigator's knowledge, all clinical trials dealing with the issue of preoperative nutrition (published up to now) were primarily focused on the research of the relationship between malnutrition and the frequency of postoperative complications.

The main aim of the this prospective clinical trial is to evaluate the loss of muscle mass and strength of the patient, the self-sufficiency and the possibility of returning to normal activities, in relation to pre-operatively served nutritional supplements in patients undergoing elective surgery for colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* resection of colon or rectum due to colorectal cancer

Exclusion Criteria:

* generalization of the disease
* intestinal co-morbidity
* duplicate malignancy
TCM Daoyin in the Treatment of Patients With Anxiety State

In recent years, the number of people with symptoms of anxiety are on the rise. TCM Daoyin is a promising intervention for anxiety. This study is designed to allow researchers to better understand the changes in anxiety symptom, brain activity, and immune function during patients with anxiety states receiving TCM Daoyin intervention. Thus, the aims of the prospective randomized study are: (1) to examine the effects of TCM Daoyin training on reducing symptoms of anxiety, (2) to measure brain activity by using functional magnetic resonance imaging (fMRI), and (3) to assess Immune function.

Anxiety is one of the most common mental health problems in the world. But there is a lack of sufficient no-drug intervention for relieving the anxious symptoms. The study focuses on mild and early anxiety disorder, which symptoms are not sufficiently severe, numerous, or persistent to justify a diagnosis of an anxiety disorder.

TCM Daoyin is a form of mind-body exercise with a profound philosophical foundation rooted in Chinese culture. Previous studies have provided some evidence of beneficial effects on TCM Daoyin for anxiety, such as Baduanjin and Liuzijue. However, the effects and neurophysiology mechanisms of TCM Daoyin on patients with anxiety state are yet to be further investigated.

This is a two-group prospective, randomized, assessor-blinded trial, planning to enroll 20 participants (10 for TCM Daoyin intervention group receiving health education plus a TCM Daoyin training program, and 10 for health education control group only receiving health education).

The aims of the prospective randomized study are: (1) to examine the effects of TCM Daoyin training on reducing symptoms of anxiety, (2) to measure brain activity by using functional magnetic resonance imaging (fMRI), and (3) to assess Immune function.

Eligibility Criteria:
Inclusion Criteria:

* Subject with a primary mental health complaint of anxiety.
* Anxiety 14≤HAMA-14≤29, Depression 7≤HAMD-17\<14.
* Subject has no history of psychotropic medication or has been off medication for more than 6 months.
* Right-handed, aged 18 to 65, male or female.
* Subject has a clear mind and the ability to lead an independent life.
* Subject agrees to participate in fMRI scan and provide signed informed consent.

Exclusion Criteria:

* Subject with definite clinical diagnosis of anxiety disorder and depression disorder by ICD-10.
* Subject with bipolar disorder, psychotic disorder (e.g., schizophrenia), organic mental disorder (e.g., Alzheimer's disease).
* Subject with alcohol abuse, substance dependence and suicidal ideation in past-year, or currently taking psychiatric medication, or current serious suicidal attempt.
* Subject with serious current unstable medical illness.
* Subject has claustrophobia, or any contraindication unable or unwilling to participate in fMRI scan.
* Subject is clinically unable to participate in TCM Daoyin training program.
* Subject is pregnant or lactating women.