cyrilzakka/clinical-trials huggingface dataset:
Trial Comparing Home-based Cardiac Rehabilitation With Comprehensive Centre-based Cardiac Rehabilitation in Patients Older Than 65 Years With Coronary Heart Disease. The HOMEBASE Trial

Hypothesis: Home-based cardiac rehabilitation is as effective as comprehensive centre-based cardiac rehabilitation in patients older than 65 years.

Participation in cardiac rehabilitation is known to reduce mortality and morbidity and increase health related quality of life. However, participation rate are low among elderly cardiac patients with coronary heart disease. Home-based cardiac rehabilitation could be an attractive alternative to the centre-based programmes but studies investigating the effect of these programmes are limited and even less is known about the effect among the elderly.

Eligibility Criteria:
Inclusion Criteria:

1. Event of coronary heart disease (new myocardial infarction, CABG or PCI)

Exclusion Criteria:

1. Care home patients.
2. Serious disability incompatible with rehabilitation.
3. Social circumstances incompatible with participation.
A SMART Design to Improve Sleep Disturbance in Adolescents With Neurodevelopmental Disorders

The objective of this K01 study was to pilot a sequential, multiple assignment, randomized trial (SMART) design to compare the impact of a sequence of sleep interventions, based on participant treatment response, to optimize sleep health in adolescents 10-18 years of age with neurodevelopmental disorders (NDDs).

The investigators conducted a sequential, multiple assignment, randomized trial (SMART) pilot feasibility study to inform implementation of a future full-scale SMART design that will be used to construct adaptive biobehavioral sleep intervention strategies involving melatonin, a behavioral sleep intervention (The Bedtime Bank), and their combination for the management of sleep disturbance in adolescents with neurodevelopmental (NDDs). Participants completed 1 week of baseline data collection, and than were randomly assigned to either melatonin or The Bedtime Bank. Response (\>/= 18 minute average nightly increase in total sleep time \[TST\]) was measured at Week 4 and Week 8. Participants who responded (\>/= 18 minute average nightly increase in TST) at Week 4 remained on the assigned intervention. Participants who were non-responsive at Week 4 were re-randomized to a different sleep intervention or combined interventions.

Eligibility Criteria:
Inclusion Criteria:

* Age 10-18 years and consistently living with parental (or legal guardian) supervision.
* Diagnostic report of confirmed NDD diagnosis (ASD or ADHD).
* Documentation of adolescent being classified as non-intellectually impaired (e.g. IQ\>70).
* Parent report of adolescent spending less than or equal to 8 hours in bed per night on 3 or more nights per week in the past month or a composite score greater than 41 on the Children's Sleep Habits Questionnaire.
* Medication-free or on a stable dose of medications (no changes within 30 days prior to enrollment) with parental agreement to avoid changes in current medication (unless provider directed) during study participation.

Exclusion Criteria:

* Unwillingness to stop melatonin 2 months prior to enrollment in the study.
* Parent report of adolescent with a known sleep disorder (e.g. sleep apnea).
* Adolescents who are not able to take oral medication.
* Adolescents who are visually impaired with known inability to detect light.
* Adolescents with an NDD with known genetic etiology (e.g. Angelman syndrome).
* Unwillingness to wear actigraph daily and complete daily sleep diary throughout the 9-week trial.
Comparison of iLivTouch and FibroScan for the Assessment of Liver Fibrosis and Steatosis in Adult Patients in the US

This is a multi-center, cross-sectional, and prospective study that will recruit patients from multiple hospitals or outpatient clinics in the USA to the comparison of iLivTouch and FibroScan for the assessment of liver fibrosis and steatosis in adult patients.

Clinical phase: Phase IV investigator-initiated study Study centers planned: Approximately 4 centers in different regions of the USA

Objectives:

1. Primary Objectives To evaluate the consistency of Liver Stiffness Measurement (LSM) and Ultrasound/Controlled Attenuation Parameters (UAP/CAP) between iLivTouch-FT9000 and FibroScan 530 devices.
2. Secondary Objectives

   1. To compare the operational features of the two devices, reflected in the success rate of examination and number of effective examinations.
   2. To compare LSM obtained from each device with liver stiffness estimated by APRI, FIB-4, and SAFE scores.
   3. The number of adverse events, serious events, and percentage of subjects with events will be calculated for AE, SAE, AE of special interest, and AE leading to study withdrawal.

Eligibility Criteria:
Inclusion Criteria:

* a. Adults aged above 18 years old who have at least one indication for TE examination determined by the physicians;
* b. Patients who have test results for platelet count, ALT, AST, globulin, HBA1c, and total bilirubin (TBIL) levels within 60 days;
* c. Patients who are willing to participate in the clinical study and can sign ICF.

Exclusion Criteria:

* a. Excessive drinking history within 90 days: For women-140 grams of alcohol per week or more; For men-210 grams of alcohol per week or more;
* b. Patients with alanine aminotransferase (ALT) or aspartate aminotransferase AST \>100 U/ml (or 2.5 × upper limit of normal (ULN) and/or total bilirubin (TBIL) \> 1.8 mg/d (or \>1.5 × ULN =1.2 mg/d);
* c. Patients with a history or current evidence of decompensated liver cirrhosis;
* d. Patients with various space-occupying tumors and cysts in the right liver;
* e. Patients with other serious systemically diseases or a history of malignant tumors;
* f. Patients with ascites;
* g. Patients with a non-healing wound on the right upper abdomen at this moment;
* h. Patients with intracavitary implantation of instruments;
* i. Pregnant women (urine pregnancy test should be performed for all women with child-bearing potential during screening);
* j. Any history of organ transplantation and existing functional grafts (except corneal or hair transplantation);
* k. Lack of or limited legal capacity.
Factors Influencing Wound Healing After Anal Fistula Surgery

The objective of this observational study is to analyze the factors influencing wound healing after anal fistula surgery and to assess the effectiveness of interventions in improving overall patient outcomes post-surgery. The primary questions this study aims to answer are:

1. Does the use of the growth factor (New Epi) contribute to accelerating wound healing, reducing the risk of infection, and enhancing patient recovery speed after surgery?
2. Do other factors, such as infection, nutritional status, diabetes, surgical methods, patient age and overall health, immune status, and lifestyle habits, affect the healing of surgical wounds?


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years old.
* Have undergone anal fistula surgery with complete surgical records.
* No significant surgical contraindications, such as:Acute infection or inflammation,Severe cardiopulmonary insufficiency,Coagulation disorders,Immunodeficiency,Local skin lesions.
* Understand and are willing to participate in the study.Willing to sign the informed consent form.

Exclusion Criteria:

* Patients under 18 years of age.
* Pregnant or breastfeeding women.
* Individuals with pre-existing severe heart, liver, or kidney diseases.
* Individuals with active infections or systemic diseases.
* Individuals who have previously undergone similar surgeries.
* Individuals with immune dysfunction (such as HIV infection).
The Effect of Aerobic Exercise on Genetic Molecules

The aim of this study is to compare the effects of high intensity interval exercise and moderate intensity continuous exercise on some genetic molecules in patients with type 2 diabetes mellitus.

Volunteers with type 2 diabetes mellitus will be evaluated in terms of any contra-indication that will restrain them from making exercise. 90 male or female volunteers who are suitable in terms of inclusion/exclusion criteria will be invited for the study. Volunteers will be randomly distributed to one of the 3 groups. Each group will contain 30 participants. 1. group will make aerobic exercise which is in the form of high intensity interval exercise 2.group will make aerobic exercise which is in the form of moderate intensity continuous exercise 3. Control group. Exercise groups will be cycling under observation in the hospital setting. Control group will make simple stretching exercises at home. Participants will be requested to complete a 3 months of exercise. They will be evaluated before and at the end of the 3 months of exercise with blood tests to measure genetic molecules related with metabolism.

Eligibility Criteria:
Inclusion Criteria:

Clinica diagnosis of type 2 Diabetes mellitus less than 10 years and more than 1 year.

* must have appropriate medical therapy and diet.
* must not be treated with insulin.
* must be exercising less than 210 minutes/ week

Exclusion Criteria:

* prominent cardiovascular disease
* coronary artery disease
* moderate to severe valvular disease
* atrial fibrillation
* untreated hypertension
* congenital heart disease
* retinopathy
* neuropathy
* macro albuminuria
* cerebrovascular disease
* ejection fraction less than 40
* body mass index greater than 35.
* prominent ischemic changes in EKG at rest or during exercise.
* cigarette or alcohol addiction
* on drugs that interferes with body fat distribution (such as insulin, thiazolidinediones
Hypofractionated Versus Conventional Fractionation Radiotherapy

This study was designed to evaluate the acute toxicity and quality of life of hypofractionated radiation versus conventional when regional node irradiation is indicated after breast-conserving surgery or mastectomy.

Investigators hypothesize that hypofractionated radiotherapy is equal effective and safe as conventional radiotherapy in breast cancer patients undergoing regional nodal irradiation.

Eligible breast cancer patients are randomized 1:1 into the following two groups:

1. Hypofractionated therapy: 40 Gy in 15 fractions of 2.67 Gy in breast or chest wall and nodal drainage with Concurrent boost 48.0 Gy / 3.2 Gy daily in tumor bed, in case of conservative surgery;
2. Standard fractionation: 50 Gy in 25 fractions in breast or chest wall and nodal drainage with sequential tumor bed boost with 10 Gy in 5 fractions in tumor bed in case of conservative surgery.

Patients will be followed for 6 months after radiotherapy to evaluate acute toxicity and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Female;
* Older than 18;
* Breast cancer stage T1 - T3;
* At least 1 lymph node positive;
* Treated with mastectomy or conservative surgery;
* Negative surgical margins;
* No distant metastasis;
* No supraclavicular or internal mammary nodes metastases;
* Adjuvant systemic therapy with chemotherapy, endocrine therapy or anti-HER2 (Human - - Epidermal Growth Factor Receptor 2) treatment is accepted;
* Signed informed consent.

Exclusion Criteria:

* Positive surgical margins;
* Concomitant chemotherapy;
* Supraclavicular or internal mammary nodes metastases;
* Distant metastasis;
* Previous thoracic radiotherapy;
* Bilateral breast cancer;
* Patients with collagen diseases;
* Unable or unwilling to sign inform consent.
Serotonin/Dopamine Antagonism of Cocaine Effect: 1 - 1

The purpose of this study is to evaluate use of risperidone with cocaine abusers. Study measures incorporate an appropriate integration of behavioral and neurobiological indices.


Eligibility Criteria:
Please contact site for information.
Evaluation of the "Breatheasy" in Pre-hospital Care

In the emergency department, a sick child is usually seen first by the nursing staff. Their job is to quickly assess how sick the child is and what immediate care is needed. The nurse will usually use suitable devices to check vital signs, such as body temperature, pulse rate and blood oxygen levels. However, normally the respiratory rate has to be manually counted (this is the average number of breaths taken each minute) because there is no suitable device which can automatically do this assessment. To overcome this problem we have produced a noncontact device that can automatically measure respiratory rate in children. The device has been designed using the latest technology and works by directly sensing the air coming from the nose or the mouth when held at about 20 cm from the face. It has been tested on adults and children and compared to the usual methods of measuring respiratory rate. We have used comments and Suggestions from members of the public and healthcare professionals from hospital, general practice and the ambulance service to help us develop the device. With this study, we explore the applicability and usefulness of the device in a range of difference clinical and nonclinical settings. Its performance will be carefully evaluated on children and adults in children's nurseries, schools, university, hospital emergency departments, general practice surgeries and ambulances. In the future, when using the device nursing staff will easily be able to measure each child's respiratory rate so that the most seriously ill children will be identified earlier and get correct treatment more quickly. This will ensure that the right children get admitted to intensive care units sooner and, in some cases, deaths will be prevented.


Eligibility Criteria:
Inclusion Criteria:

- Any adult or child within each setting, of any age with any clinical condition, as this will reflect clinical practice.

Exclusion Criteria:

* Patients deemed too unwell to consent to the procedures or requiring emergency treatment will not be approached.
* For the purposes of this feasibility study, families whose first language is not English will be excluded, to save translation and interpretation costs.
Evaluation of Serum Tumor Endothelial Marker1 as a Potential Biomarker for Colorectal Cancer Diagnosis and Cancer Progression

Aim of work

1. measurement level of serumTEM1 in CRC patients by ng/ml using ELISA kits .
2. find relation between serum TEM1 level and staging of CRC patients .
3. measurement of serum CEA , CA19-9 levels by ng/ml so we can can compare their levels with serum TEM1 level in CRC patients .

Colorectal cancer (CRC) is a serious health problem, a challenge for research, and a model for studying the molecular mechanisms involved in its development. Colorectal cancer is the third most common cancer in the world with approximately 1.4 million new cases and almost 700,000 associated deaths reported per year. The incidence, morbidity, and mortality rates of CRC are expected to increase due to population aging and profound adverse effects of many life style-related factors.

Tumor growth is dependent on the complex and multistage angiogenesis. Tumor blood vessels are characterized with abnormal morphology and function compared to normal blood vessels. Except for disorganized structure, abnormal basement membrane, and increased leakiness, tumor vascular cells express unique protein named (Tumor endothelial marker 1 (TEM1)- endothialin-CD248) .

Tumor endothelial marker is a transmembrane glycoprotein which expression is significantly higher in tumor vasculature (5-,10-, and 20-fold) compared to the vessels of healthy tissues. It was suggested TEMs could discriminate between tumor and nontumor vascular cells.

Tissue overexpression of TEM1 was found in patients with CRC compared to healthy controls as well as in rectal cancer tissues when comparing tumor, lymph nodes, metastasis (TNM) stage I with other stages: TNM II, III, IV , Although the biology of TEM1 is intensely studied, including clinical studies with anti-TEM1 molecules, Only one study (2020) determined the potential usefulness of serum TEM1 in CRC. Pietrzyk (2020) revealed that TEM1 demonstrated higher levels in the serum of the patients with CRC than healthy individuals and reported that TEM1 could act as a potential diagnostic, progression, and prognostic serum biomarker for patients with CRC. Most commonly used serum markers for diagnosis and monitoring of CRC are carcinoembryonic antigen (CEA) and carbohydrate antigen 19-9 (Ca 19-9). However, these markers show insufficient sensitivity, especially at early stages of CRC. Therefore, finding sensitive and specific, noninvasive, serum biomarkers is a prerequisite for early CRC diagnosis.

Eligibility Criteria:
Inclusion Criteria:

1-newly diagnosed CRC patients.

Exclusion Criteria:

1. chemotherapy
2. radiotherapy
3. surgical treatment
4. heart failure
5. angina
6. liver cirrhosis
7. renal cell carcinoma
8. gastric cancer.
An Open-Label Study of the Safety, Tolerability, and Pharmacokinetics of Oral NNZ-2591 in Angelman Syndrome

A study of the safety, tolerability and pharmacokinetics of NNZ-2591 and measures of efficacy in children and adolescents with Angelman syndrome

The primary purpose of this study is to investigate the safety, tolerability and pharmacokinetics of treatment with NNZ-2591 oral solution, 50mg/L, in children and adolescents with Angelman syndrome. The secondary purpose is to investigate measures of efficacy of subjects will receive treatment of 50mg/mL orally administered NNZ-2591 for a total of 13 weeks

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of AS with a documented disease-causing genetic etiology known to impact maternally derived UBE3A expression in brain.
2. Males or females aged 3-17 years
3. Body Weight of \>12Kg
4. Subjects with a Clinical Global Impression - Severity (CGI-S) score of 3 or greater
5. Not actively undergoing regression or loss of skills, defined as no persistent loss of previously acquired developmental skills for a period within 3 months of the Screening visit
6. Each subject must be able to swallow the study medication provided as a liquid solution.
7. Caregiver(s) must have sufficient English language skills.

Exclusion Criteria:

1. Mosaicism for disease-causing mutation.
2. Clinically Significant abnormalities in safety laboratory testing or vital signs at screening
3. Abnormal QTcF interval or prolongation at Screening.
4. Positive for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and previous COVID 19 infection with last 12 months that required hospitalization.
5. Unstable or changes to Psychotropic treatment 2 weeks prior to screening .
6. Excluded concomitant treatments
7. Actively undergoing regression or loss of skills.
8. Unstable seizure profile.
9. Current clinically significant renal conditions and abnormalities
10. Current clinically significant cardiovascular, hepatic, gastrointestinal, respiratory, endocrine disease, or clinically significant organ impairment.
11. Current clinically significant hypo or hyperthyroidism, Type 1 or Type 2 diabetes mellitus requiring insulin (whether well controlled or uncontrolled), or uncontrolled Type 1 or Type 2 diabetes.
12. Has planned surgery during the study.
13. History of, or current, cerebrovascular disease or brain trauma.
14. History of, or current catatonia or catatonia-like symptoms.
15. History of, or current, malignancy.
16. Current major or persistent depressive disorder (including bipolar depression).
17. Significant, uncorrected visual or uncorrected hearing impairment.
18. Allergy to strawberry.
19. Positive pregnancy test
20. Subject is judged by the Investigator or Medical Monitor to be inappropriate for the study
Managing Aftercare for Stroke (MAS): MAS-II - A Longitudinal Complex-interventional Study in Post-rehabilitation Stroke Patients

After discharge from hospital, the current healthcare system in Germany allows considerable flexibility (therefore complexity) of patient access and mobility between multiple care providers in the community setting. The investigators believe this aftercare could be better coordinated by a specialized coordinated stroke aftercare service. Comprehensive coordinated multidisciplinary care is a proven concept with proven benefits in both acute and rehabilitation care provided in stroke units and neurorehabilitation centres. In this study, the investigators postulate that a similar coordinated approach to care can be extended to the phase after in-patient rehabilitation has ended (i.e. "long-term management" as opposed to "early supported discharge") for disabled patients with stroke living in the community.


Eligibility Criteria:
Inclusion Criteria:

* Patients with ischemic stroke
* Age ≥18 years
* At the time of V1 completion of rehabilitation or no rehabilitation planned
* Informed consent signed by patient or legal representative
* stroke patients with a stratified mRS score
* within six months after the index event

Exclusion Criteria:

* Unwillingness to participate in "AmbulanzPartner"
* Unwilling to have pseudonymized data stored, analysed, and anonymously published
* Patients being committed to psychiatric institutions or prisons
Effect of Patient Education on Functions in Patients With Non-specific and/or Degenerative Low Back Pain

The aim of this study is to investigate effects of interdisciplinary group based patient education in patients with low back pain.

The patients will be recruited to four group based patient education lessons during a two months period. The study is a randomized controlled trial and the patients will be randomized to standard treatment or standard treatment and patient education. The patient education will be led by physiotherapists, nurses and physicians. The outcomes are functions, pain, quality of life, self-efficacy, and depression. The data are reported in questionnaires.

Design: Randomized controlled trial; intervention study. Patients: Patients with low back pain; referred to Nordsjaellands Hospital, Denmark. Inclusion criteria: adults, low back pain minimum scored 4 on numeric rating scale, able to conduct exercise training. Exclusion criteria: unable to understand Danish, psychiatric disorder, dementia, approaching operation, current or approaching settlement regarding working ability or compensation as a result of low back pain. Intervention: Randomization to usual care or usual care and four times two hours group based patient education with an interdisciplinary focus on self-management of low back pain. The patient education will be delivered by physiotherapists, nurses and physicians. Outcome: functions, pain, quality of life, self-efficacy, and depression. The data are reported in questionnaires. Sample size: 74 participants.

Eligibility Criteria:
Inclusion Criteria:

* adults
* low back pain minimum scored 4 on numeric rating scale
* able to conduct exercise training

Exclusion Criteria:

* unable to understand Danish
* psychiatric disorder
* dementia
* approaching operation
* current or approaching settlement regarding working ability or compensation as a result of low back pain