cyrilzakka/clinical-trials huggingface dataset:
Abdominal Binder and Steps Trial

Large lower abdominal incisions are still used in many types of common gynecologic surgeries. Patients may experience pain and restrictions to ambulation because of this, which can make healing after surgery harder and more complicated. Abdominal binders, through their added abdominal support, may provide a low cost intervention to help people heal. The study team aims to investigate the effects of abdominal binders on walking in the post- gynecologic surgery period.

Laparotomy is a commonly utilized modality for abdominal entry in benign gynecologic surgery despite preference for minimally invasive techniques when surgically feasible. As with other major abdominal surgeries, patients may experience pain and restrictions to ambulation related to the abdominal incision that complicate the postoperative period. Abdominal binders, through their added abdominal support, may provide a low cost, noninvasive intervention to enhance this vital recovery period. Though the use of abdominal binders have been studied extensively in the postcesarean section patient, no report to date exists assessing the effects on abdominal binders in the postoperative course of benign gynecologic surgeries. The study team aims to investigate the effects of abdominal binders on ambulation in the postoperative period after laparotomy for benign gynecologic surgery. The primary outcome is quantitative ambulation via electronic step counter. Secondary outcomes include time to ambulation, quantitative narcotic utilization, visual analogue pain scale, subjective overall wellbeing. With 85% power the study team attempts to calculate a 1200 step difference in means between abdominal binder and control groups using 67 patients per study arm.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Female
* Patients undergoing benign hysterectomy or myomectomy via low-transverse laparotomy.

Exclusion Criteria:

* ASA classification of three or higher
* Malignancy
* Non-English speaking
Sodium Sources and Sodium Intake in a Representative Sample of Spanish Children

Previous evidence shows that sodium intake in Spanish adult population is over the recommended limits and this high sodium intake is related with difficulties in body weight control and blood pressure control.

The aim of this study is to stablish a direct relationship between salt intake and the health parameters previously mentioned in a representative sample of Spanish schoolchildren between 7-11 years old. The investigators are applying a 3-day dietary records to collect dietary data, and collecting 24-h urine samples in order to analyse biochemical indicators of sodium intake and other nutrients. Anthropometric data are also being recorded and body composition is also analysed using bioimpedance technique.

Specific Aims

1. To stablish the average sodium intake in Spanish children, using a 24-h urine sample and validated dietary questionnaires.
2. To compare 24-hour urinary sodium measurement to the dietary survey method
3. To study the relationship between sodium intake and blood pressure levels in Spanish scholars.
4. To analyze the relationship between sodium intake and overweight/obesity in Spanish children using anthropometric and bioimpedance analysis measures.
5. To identify main food sources of sodium in the diet of Spanish schoolchildren and the use of discretionary salt.
6. Provide new data for monitoring sodium intake in Spanish schoolchildren and design campaigns to reduce their intake.
7. To provide reference data of sodium intake on a representative sample of the Spanish child population for European and international databases.

Eligibility Criteria:
Inclusion Criteria:

* Age between 7 and 11 years old

Exclusion Criteria:

* Those who have any clinical problem, which may modify the results of the analysis: metabolic or chronic diseases (liver, kidney, diabetes, hypothesis or hyperkalemia), pharmacological treatment during the 3 months prior to the study with corticosteroids, insulin, diuretics or other drugs that may modify blood pressure figures, surgery or serious infectious diseases in the previous 6 months.
* Those who were not in the school when the measures were taken.
Long-term Follow-up of Glutamic Acid Decarboxylase (GAD) Gene Transfer in Parkinson's Disease

The objective of this study is to evaluate the long-term safety of AAV-GAD delivered bilaterally to the subthalamic nuclei (STN) in participants with Parkinson's disease.

The duration of individual participation in this study will be approximately 54 months for participants who received AAV-GAD in Study MGT-GAD-025 and approximately 60 months for participants who received sham surgery in Study MGT-GAD-025.

Eligibility Criteria:
Inclusion Criteria:

* Previously enrolled in Study MGT-GAD-025.

Exclusion Criteria:

* None
Low Carbohydrate Small Intestine Study

The investigators will recruit probands with a ileo- or colostoma that are otherwise in good general health and analyse the stomal fluids for their microbiota composition. Sampling will be performed over a time span of 28 days, after 14 days probands will modify their base-line diet to a low carbohydrate diet.

Additionally to stoma fluids which will be analyzed for their microbiota composition the investigators will also collect skin samples to analyze for microbiota composition and urine to analyze for metabolite composition.

Low carbohydrate diet will allow for consumption of 80g complex carbohydrates per day, simple sugars will have to be avoided completely

Eligibility Criteria:
Inclusion Criteria:

* Ileostomy or colostomy
* Good general health
* Written informed consent

Exclusion Criteria:

* Major metabolic diseases that prevent adherence to low carbohydrate diet
* Participation in other clinical trial interfering with study protocol
Folic Acid Supplementation in Phenytoin Induced Gingival Overgrowth

Phenytoin, a common anti-seizure drug, leads to cosmetically unacceptable side effect of gingival overgrowth in a significant number of patients. There is some evidence of therapeutic effect of folic acid in cases of established phenytoin induced gingival overgrowth. In this study, the aim is to study the prospective preventive effect of low dose oral folic acid supplementation on phenytoin induced gingival overgrowth in epileptic children.


Eligibility Criteria:
Inclusion Criteria:

* Age: 6-15 yr
* Started on phenytoin within 1 mo of enrollment

Exclusion Criteria:

* Not willing to participate
* On other folic acid antagonists e.g. anti-neoplastic drugs for \>/= 2 wks during last 3 months
* Pre-existing gingival over-growth due to other cause
Effect of Smartphone Application (MED-AD) on Medication Adherence Among Patients With Cardiovascular Disease in Oman

This study aims to:

1. Investigate the impact of MED-AD intervention on medication adherence among CVD patients, compared to patients receiving text message reminders or routine care alone at baseline, 6 months, and 12 months later.
2. Evaluate the effectiveness of MED-AD intervention on clinical outcomes among patients with CVD, compared to the outcomes of patients receiving text or routine care alone at baseline, 6 months, and 12 months later.

This study is a prospective randomized controlled clinical trial (RCT) with three arms:

1. MED-AD intervention: MED-AD is a smartphone application that will use the following strategies (pill reminders, Medication Adherence Report, medication intake confirmation, Medical Appointment Reminder, and educational notifications) to enhance medication adherence
2. Text message reminders: Participants will receive short text message (SMS) reminders to remind them to take medications as prescribed once daily
3. Routine care only: Participants will receive routine care that does not include text messages or reminders and education through an application.


Eligibility Criteria:
Inclusion Criteria:

1. diagnosed with at least one CVD (i.e., HTN, IHD, hyperlipidemia),
2. prescribed at least one medication for at least one year,
3. Omanis aged 18 years or older,
4. registered in the selected healthcare center, and 5) agreed to participate in the study

Exclusion Criteria:

1. have a severe cognitive impairment,
2. are unable to provide informed consent,
3. cannot read, and 4) do not have a smartphone with a compatible operating system (ios or Android).
Electronic-Nutrition-Optimizer for Personalized Prevention

This study aims to develop and validate a tool for immediate nutrition assessment and to test its user feasibility in routine clinical practice for health promotion.

Small changes in diet have been shown to have an important impact on health and the risk of age-related chronic diseases, such as cardiovascular disease, diabetes, frailty and dementia. However, this knowledge has not yet been implemented into routine clinical practice, because practical tools that allow a comprehensive nutrition assessment in the clinical care setting are missing. In addition, doctors are generally not educated in giving nutritional advice to patients. In this pilot project, we aim to push forward and enable the potential of nutrition as a core primary prevention strategy for people at risk of developing chronic diseases. This will be achieved by using, as a stepping stone, the electronic 216-food-item food frequency questionnaire which was developed for the European DO-HEALTH study and was tested in over 2000 adults. The investigators want to extend this tool to not only capture the personal dietary intake, but also to produce an immediate report, comparing the personal diet to the Mediterranean and MIND diet patterns and providing a patient's intake of protein and other nutrients. The report will additionally indicate the patient's diet-related, personalized risks of cardio-vascular disease, diabetes, frailty and cognitive decline, and recommend dietary changes to reduce these risks.

Eligibility Criteria:
Inclusion Criteria:

1. Stable inpatients from the Department of heart surgery, or Center for senior trauma patient at the university hospital Zurich (inpatient group)
2. Ambulatory volunteers who can visit the center for aging and mobility (CAM) independently ("outpatients" group)
3. ≥50 years

Exclusion Criteria:

1. If already involved in another ongoing interventional clinical trial, except an interaction with this intervention can be excluded
2. People with an impaired short-term memory (MMSE \<24)
3. Patients following a specific diet recommended by a medical professional, due to diseases such as diabetes, chronic diseases of the gastrointestinal tract, severe kidney disease, or patients allergic to the main components of the Mediterranean diet/MINDdiet (olive oil, nuts)
4. Outpatients: HbA1C ≥6.5% Inpatients: HbA1C ≥6.5% or diagnosed diabetes mellitus if HbA1C is not available in KISIM
5. BMI \> 30 kg/m2
6. Individuals per se not willing to change diet
7. Instable clinical conditions (e.g. acute infection) at enrolment
8. Patients with active cancer (except non-melanoma skin cancer) or current cancer treatment or any other advanced severe disease
9. Living in a nursing home and/or receiving prepared meals (i.e. usually not eating home cooked meals)
10. Inability to read and or speak German necessary to understand the instructions
A Case-control Study on the Clinical Characteristics of 28-day and 90-day Death From Severe Anthrax

This study is a clinical, multi-center, retrospective, case-control study. Patients clinically diagnosed with severe anthrax who meet the inclusion and exclusion criteria will be included in this study for analysis. Respiratory, circulation, nerve and other vital signs of patients with severe anthrax during hospitalization were recorded, and clinical data such as blood routine, blood biochemistry, coagulation function, myocardial injury, therapeutic drug use, and survival time of patients were recorded, as well as the survival situation of patients 28 days and 90 days after discharge.


Eligibility Criteria:
Inclusion Criteria:

1. The typical bacilli with capsules were found in smear examination and culture of various secretions, excretions, blood and cerebrospinal fluid.
2. Multiple organ dysfunction (MODS) in brain, heart, liver, kidney, coagulation or more than one organ failure.

Exclusion Criteria:

There are other conditions that affect short-term survival.
"Impact of Pelvic Floor Prehabilitation Using Biofeedback on the Severity of the Low Anterior Resection Syndrome in Patients Undergoing a Total Mesorectal Excision for Rectal Cancer"

There is currently no specific treatment and only few measures to prevent the low anterior resection syndrome (LARS). The LARS often results in a severe alteration of quality of life. This study is designed to assess pelvic floor prehabilitation using biofeedback in the prevention of LARS following total mesorectal excision for cancer. The pelvic floor rehabilitation with biofeedback has already been tested postoperatively in patients suffering from LARS with heterogeneous results. However, this rehabilitation has never been evaluated in the prevention of LARS.

The prehabilitation is an innovative concept currently evaluated in the prevention of functional complications following orthopedic surgery and also prostate surgery. In high-risk abdominal surgery, cardiopulmonary prehabilitation offers satisfying results in terms of morbidity and mortality rates. This study will be the first to assess pelvic floor prehabilitation in the prevention of LARS.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 80 years old
* Total mesorectal excision with colorectal or coloanal anastomosis protected by an ileostomy or a colostomy for rectal cancer
* Absence of anastomotic leakage or stenosis
* Informed consent to participate in the study
* Social security insurance affiliation

Exclusion Criteria:

* History of anal incontinence and/or fecal urgency and/or chronic diarrhea requiring a specific treatment before rectal cancer management
* Absence of ileostomy or colostomy
* Anastomotic leakage
* Sensorial or cognitive disorders impeding pelvic floor rehabilitation exercise
* Pregnant women
* Minors
* Adults under guardianship
Stress Toolbox for Healthcare Providers in Mexico

The goal of this randomized wait-list clinical trial is to test in patient facing Mexican healthcare providers the efficacy of the Integrated Toolbox for Healthcare Providers (ISTH) on psychological functioning, well-being, occupational performance, and peripheral inflammation.

The main questions this study aims to answer are:

* Does assignment to the ISTH predict reduced psychological distress and increased well-being?
* Does assignment to the ISTH predict improved occupational outcomes and social-emotional competencies?

Participants will be randomly assigned to either the ISTH, a 12-week synchronous and app-based well-being training or to a wait-list control condition and complete assessments 8 times over the nine-month study period.

Researchers will compare the ISTH and the wait-list control group across time to evaluate ISTH impacts.

Using the random permuted block method, healthcare providers from up to six Mexican states in three tiers of healthcare facilities (low, middle, and high resource) will be randomly assigned to either the 12-week ISTH intervention or wait-list control.

The ISTH consists of eight, two-hour synchronous sessions (via ZOOM) that are recorded and available to participants on a private Youtube channel for one week. Class learning is reinforced through content provided on a special version of the Healthy Mind Program app designed for this study. Weeks 8-12 of the intervention are app only, with a final two-hour synchronous session at week 12. All study content (i.e., intervention, assessments) are in Spanish.

All participants will be asked to complete a baseline assessment battery, shorter assessments after weeks 1, 3, 5, and 8, and a battery of assessments after week 12 (post-intervention), after week 24 (three-month follow-up), and after week 36 (six-month follow-up).

Researchers will randomly sample from participants opting into the dried blood spot substudy 510 participants (255 per condition) for dried blood spot collection at baseline, after week 12, and after week 24. Researchers will randomly sample from participants opting into the patient satisfaction substudy patient satisfaction reports from 4-10 of their patients at baseline, after week 12 (post-intervention) and after week 24 (three-month follow-up). Researchers will prioritize that selected participants who opted into both substudies are enrolled in the substudies.

Healthcare systems/clinics within: Nuevo León, Coahuila, Oaxaca, Querétaro, Campeche, Jalisco, and Sonora may participate.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years old
* Employee in a participating healthcare system in a participating Mexican State

Exclusion Criteria:

* \<18 years old
* Not in a participant healthcare system in a participating state
* Does not work in a qualifying healthcare provider role
* Does not have regular access to reliable internet and/or a smartphone capable of downloading the Healthy Minds Program app
Telaprevir Exposure and Severe Anemia in HCV Infected Patients Treated by Tri-therapy

The risk of severe anemia is increased in patients treated by tri-therapy compared to patients treated by bitherapy. The underlying mechanisms involved in this toxicity remain unexplored but could also depend on the global exposure of telaprevir. The trough concentration or AUC of telaprevir could therefore be a predictive factor of the onset of anemia in patients treated by ribavirin/PEG-INF/telaprevir. The early measurement of telaprevir and ribavirin concentrations could help to manage HCV tri-therapy to improve tolerance and SVR.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman older than 18 yr. 2- HCV genotype 1 infection as confirmed by a positive viral load 6 months after the selection visit or confirmed by the mean of a liver biopsy within 1 year before screening for the study.

  3- Patient with one of the following criteria: Patient naive of any treatment against HCV infection Or Prior null responder patient: patient previously treated by ribavirin/PEG-INF for at least 12 weeks and whom HCV viral load decline was \<2 log at week 12 Or Prior partial responder patient: patient previously treated by ribavirin/PEG-INF for at least 12 weeks, who never had a negative viral load while the viral load decline was \>2 log at week 12 Or Prior relapser patient: patient previously treated by ribavirin/PEG-INF for 48 weeks, with a negative viral load at the end of treatment and a positive viral load 6 months later 4- Patient who has stopped his treatment for at least 12 weeks 5- Patient who had a liver biopsy or a Fibroscan within the 24 months before the start of the study with a Metavir fibrosis score F ≥ 3.

  6- Patient who fulfills criteria for telaprevir treatment as defined by the licence 7- Patients who accepts to use 2 contraceptive methods until 6 months after the end of the treatment 8- Patient who had given his written informed consent 10- Patient insured under the french social security system

Exclusion Criteria:

1- Infection/co-infection by HCV genotype different than genotype 1 2- Patient with a medical contraindication to PEG-INF or ribavirin 3- Patient with history of allergy or intolerance to telaprevir 4- Patient using contraindicated drugs 5- Patient with history of decompensated liver disease and/or presenting biochemical measurements as follows at the inclusion visit:

* International Normalized Ratio (INR) \> 1,5
* Albumin \<3,3 g/dl
* Total bilirubin\>1,8 N apart for patient with Gilbert syndrome 6- Liver disease from other causes 7- Patient with hepatocellular carcinoma or history of cancer 8- Patient with a history of graft transplantation and treated by immunosuppressive drugs 9- Patient who are regularly treated by corticosteroids 11- Patient with hemophilia or coagulation troubles 12- HIV or HBV co-infection 14- Patient with body mass index\> 30 kg/m2.
Cardiovascular Risk Factors And Intensive Dietary Counselling

The Intensive Dietary Counselling (IDC) intervention is a prevention and health promotion activity. It is being implemented by the Andalusian Health Service to reinforce basic intervention advice on healthy diet and exercise. The IDC intervention is aimed at the prevention of diseases of the heart and blood vessels (e.g. heart failure, heart attack and stroke).

The main objective of the present study is to assess adherence to the IDC intervention and, consequently, its effectiveness on the prevention of the above mentioned diseases.


Eligibility Criteria:
Inclusion Criteria:

* Age between 40-65 years
* Presence of any cardiovascular risk factors (Hypertension, Hypercholesterolemia, tobacco smoking, diabetes, obesity)

Exclusion Criteria:

* Currently diagnosed with any vardiovascular disease
* Currently involved in any other clinical trial
* Cognitive impairment that prevents from providing an informed consent
The Effect of Vitamin K Supplementation on Bone Health in Adult Crohn's Disease Patients

To assess the impact of a 12 month vitamin K supplementation intervention on bone health in adult Crohn's disease patients

To assess the impact of 12 months of vitamin K1 supplementation (plus vitamin D and calcium supplementation to avoid deficiency of these problematic nutrients) at a level which leads to dramatically (i.e greater than 70%) reduced levels of undercarboxylated osteocalcin - a functional marker of vitamin K status, on vitamin K status, the rate of bone formation and bone resorption, using biochemical markers of bone turnover, and bone mineral density in adult patients with longstanding Crohn's disease.

Eligibility Criteria:
Inclusion Criteria:

* long-standing Crohn's disease - disease diagnosis \> 5 years
* in clinical remission at baseline - Harvey-Bradshaw score (\< 5)
* aged between 18-70 years

Exclusion Criteria:

* use of steroid medications to treat disease or flare up
* use of blood thinning medications (warfarin, heparin, asprin, dicoumarol derivatives) which may influence vitamin K metabolism
* use of bisphosphonates, calcitonin medications (to treat osteoporosis)
* use of experimental drugs (in the last 30 days) or inclusion in another intervention trial
* bone mineral density \< -2.5 (indicative of osteoporosis) or previous diagnosis of osteoporosis
* use of vitamin/mineral/fish liver oil dietary supplements
* use of other alternative supplements (i.e herbal)
* if the patient is under 18 or over 70 years of age
* presence of a significant acute or chronic coexisting illness (cardiovascular, immunological or a condition which in the investigator's judgement, contraindicates involvement in the study)
* presence of malignant or any concomitant end-stage organ disease