cyrilzakka/clinical-trials huggingface dataset:
Telerehabilitation Versus Supervised Pilates Training in Lipedema Women

1. Pilates Exercise: The Pilates method is a low-intensity form of movement based on body control, which works the body in a complete way, promoting physical and mental health. PET is different when compared to traditional exercises, which, in turn, tend to isolate the working muscles and have specific training approaches using repetitive motions.
2. Telerehabilitation: Telehealth is emerging as a key method for delivering essential healthcare. Primary care research suggests that telehealth is acceptable and has potential to overcome geographical barriers for individuals needing many times rehabilitation by eliminating the need for extensive and costly travel
3. Diet approach: A customized low-carbohydrate high-fat (LCHF) restricted caloric diet in women with lipedema will be used for 12 weeks. The LCHF diet may be a valuable nutritional strategy for lipedema and overweight/obese women, reducing inflammatory status with a beneficial effect on weight, glucose profile the concentration of triglycerides and HDL


Eligibility Criteria:
Inclusion Criteria:

1. Sixty female patients diagnosed with lipedema.
2. Their ages will range from 35-45 years old.
3. Patients diagnosed with lipedema ≥ 5 years.
4. Patients with grade 2 and 3 lipedema.
5. Patients with type 2 and 3 lipedema.
6. Patients with BMI ≥ 25 kg/m2
7. All patients will be clinically stable.

Exclusion Criteria:

Patient with any of the following will be excluded from the study:

1. Patients with lower limb edematous diseases such as lymphedema or chronic venous insufficiency.
2. Patients with history of previous liposuction.
3. Patients with asymmetrical lower limbs.
4. Patients with history of bariatric surgeries.
5. Patients on weight loss medications.
6. Patients any medical condition prohibiting exercise (cardiac pacemakers, diabetes mellitus, uncontrolled hypertension, and congestive heart failure)
7. Pregnant females.
8. Patients with BMI ≥ 40 kg/m2 (morbid obese).
9. Cancer patients (patients on chemotherapy, immunotherapy radiopathy).
10. Infectious diseases (HIV/AIDS, HCV, and Tuberculosis).
11. Chronic inflammatory autoimmune disease such as Sjogren's syndrome
12. Patients with neurological disorders: stroke and epilepsy.
An Observational Study to Learn About the Interferon-beta Exposure of Pregnant Women During the Second and Third Trimester in Finland and Sweden

Observational data have suggested no increased risk of adverse pregnancy outcomes associated with exposure to interferon-beta (IFNB) before or during pregnancy. After the emergence of these data, the European Medicines Agency approved a label change for IFNB in September 2019, stating that use of IFNB during pregnancy may be considered, if clinically needed. However, limited data on pregnancies exposed in the 2nd and 3rd trimesters were observed.

INFORM is a secondary use of data drug utilisation study (DUS) to determine late pregnancy exposure (i.e. during the 2nd and 3rd trimester) to IFNB in Finland and Sweden, which will inform whether the number of exposed pregnancies is adequate to conduct a cohort study on adverse pregnancy outcomes, with a focus on late pregnancy exposure.

The number of pregnancies will be initially reported three years after the revised label implementation (September 2019) and will include data on pregnancies from 1996 in Finland and from 2005 in Sweden up through 31 December 2022. If the number of pregnancies is deemed adequate for conducting the cohort study on adverse pregnancy outcomes, this DUS will be finalised with the drug utilisation data accrued up through 31 December 2022. If the number of pregnancies until 31 December 2022 is deemed inadequate, this study may be continued and the primary and secondary objectives may be examined five years after the revised label implementation, including pregnancies until 31 December 2024.


Eligibility Criteria:
Inclusion Criteria:

* Women with a diagnosis of MS disease, regardless of MS clinical type, recorded at least once during the full study period.
* Women with at least one recorded pregnancy after the MS diagnosis (including pregnancies ending in live birth, stillbirth, spontaneous abortion, ectopic pregnancy, or elective termination)

Exclusion Criteria:

- None.
Comparison of Explicit, Implicit and no Values Clarification Decision Aids for Men Considering Prostate Cancer Screening

The investigators aim at comparing the perceived clarity of personal values in men considering PSA screening using decision aids with no VCM versus an implicit VCM versus an explicit VCM. This study will add to the body of evidence on the role of decision aids to support health preference-sensitive choices and provide further insight on the impact of different methods for eliciting people's values embedded within a decision aid.

PSA test to screen for prostate cancer is considered a preference sensitive decision, meaning it does not only depend on what is best from a medical point of view, but also on patient values. Decision aids are evidence-based tools which showed to help people feel clearer about their values, therefore it has been advocated that decision aids should contain a specific values clarification method (VCM). VCM may be either implicit or explicit but the evidence concerning the best method is scarce. We aim at comparing the perceived clarity of personal values in men considering PSA screening using decision aids with no VCM versus an implicit VCM versus an explicit VCM.

Eligibility Criteria:
Inclusion Criteria:

* adult men (50 - 69 years);
* men with average risk for prostate cancer;
* willing and able to provide written informed consent.

Exclusion Criteria:

* unable to understand written Portuguese.
Analysis of Patients With Post-traumatic Vertebral Fracture and Accompanying Rib Fracture

The present study investigates the trauma mechanisms, the type and level of vertebral fractures, the number of accompanying rib fractures and thoracic pathologies, the surgical procedures employed and the development of complications in a sample of patients who presented with vertebral fractures and concurrent rib fractures after sustaining trauma.

The study aimed to analyze the mechanisms of trauma, type and level of vertebral fractures, number of accompanying rib fractures and thoracic pathologies, necessity of surgery and development of complications in patients who developed vertebral fractures and rib fractures after trauma. Patients were divided into 3 groups: upper cervical , lower cervical and thoracolumbar. They were compared with each other in terms of trauma mechanisms, rib fracture numbers, accompanying thoracic pathologies, complication developments and need for surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients who had vertebral and rib fractures due to trauma

Exclusion Criteria:

* Patients whose electronic patient records and radiological imaging findings cannot be accessed
* Patients whose development of complications could not be evaluated due to not coming to post-discharge check-ups
Safety and Efficacy of Multiple EPO Injections in Children With Cerebral Palsy

This study is a retrospective review on the safety and efficacy of repetitive erythropoietin injection in children with cerebral palsy

Cerebral palsy is mostly caused by hypoxic-ischemic encephalopathy from preterm birth, involving inflammatory and apoptotic cellular response. Erythropoietin (EPO) has shown neuroprotective effects via activation of anti-inflammatory, angiogenic, and anti-apoptotic pathways. The safety and feasibility of EPO in children were proven in previous clinical trials. In addition, the efficacy of EPO is actively being investigated and some reports have shown potential benefits in cerebral palsy. To confirm the safety and efficacy of multiple injections with expected effect, retrospective review on medical records was performed.

Eligibility Criteria:
Inclusion Criteria:

* confirmed clinical diagnosis of cerebral palsy based on neuromotor findings,
* less than 18 years of age,
* received recombinant human erythropoietin (rhEPO) more than once.

Exclusion Criteria:

* not responding to phone interview or
* no functional assessments available.
Evaluation of Evodial Hemodialyzer Selectivity Modifications (Evodial +)

Evodial +hemodialyzer consists of an evolution of the existing CE marked Evodial device, with respect to the hemodialyzer membrane removal characteristics. Different membrane prototypes configurations are proposed (3 versions in total), with the objective to modulate the hemodialyzer removal capacities (convective and adsorptive capacities).

Materials(including heparin grafted specifications) as well as the sterilization process are identical to the Evodial hemodialyzer. Based on available preclinical data , a clinical study is requested to document in vivo the different prototypes removal capacities with respect to middle Molecular Weight (MW) reference toxins such as b2 Microglobulin and collect data with regards to protein loss.


Eligibility Criteria:
Inclusion Criteria:

1. Anuric patient (diuresis\<300ml) ,
2. ESRD patient treated for at least 3 months,
3. Patient treated in HDF post-dilution,
4. Vascular access functioning properly (Qb \> 250 ml/min),
5. Patient aged 18 years or more,
6. Written consent to participate in the study (informed consent).

Exclusion Criteria:

1. Patient with pre-dialytic albuminemia \<3.3 g/dl(Nephelometry assay)
2. Patient with known allergy to heparin or type II heparininduced thrombocytopenia (HIT type II);
3. Patient under guardianship;
4. Women pregnant or breast feeding;
5. Patient included in other studies that could interfere with the goals of the current study.
6. Patient that are not affiliated to the health system(beneficiary or dependent).
7. Patient with positive serology (HIV, Hepatitis).
A 12-Week Study Comparing Pitavastatin 4 mg vs. Pravastatin 40 mg in HIV-Infected Subjects

A 12-Week, Randomized, Double-Blind, Active-Controlled, Parallel-Group Study.


Eligibility Criteria:
Inclusion Criteria:

* Males and females (non-pregnant, non-lactating females) 18-70 years of age, inclusive, at time of consent.
* Both men and women of child bearing potential (i.e., not surgically sterile or post-menopausal defined as age \>40 years without menses for ≥2 years) must agree to use at least 2 reliable forms of contraception
* Documented HIV infection.

Exclusion Criteria:

* Homozygous familial hypercholesterolemia
* Any conditions that may cause secondary dyslipidemia
* History of coronary artery disease (CAD) or CAD equivalent
A Research Study of the Effect of Etavopivat on Other Drugs in Healthy Participants

The study aims to test if a new medicine called etavopivat potentially affects other medicines in healthy participants. The purpose of the study is to investigate whether the use of etavopivat affects the breakdown and metabolism of commonly used medicines in the body. During the study, participants will receive etavopivat and five different medicines that are already approved and available on the market, and which can be prescribed by doctors. These marketed medicines are called substrate drugs and they are: digoxin, pitavastatin, metformin, midazolam, and rosuvastatin. During a period of the study, participants will take 2 tablets of etavopivat daily for 10 consecutive days. The study will last for about 34 to 64 days.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) between 18.5 and 29.9 kilograms per square meter (kg/m\^2) (both inclusive) at screening.
* Body weight greater than (\>) 50.0 kg at screening.
* Considered to be generally healthy based on the medical history, physical examination, and the results of vital signs, electrocardiogram and clinical laboratory tests performed during the screening visit, as judged by the investigator.

Exclusion Criteria:

* Known or suspected hypersensitivity to study interventions or related products.
* Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using adequate contraceptive method.
* Exposure to an investigational medicinal product within 30 days or 5 half-lives of the investigational medicinal product (if known), whichever is longer, before screening.
* Participant is unable to refrain from or anticipates the use of any drug known to be a moderate or strong inhibitor or inducer of uridine 5'-diphospho-glucuronosyltransferase (UGT) enzymes, CYP3A4, CYP2C9, MATE1, OATP1B1/1B3, BCRP, OCT2, or P-gp, including St. John's Wort for 28 days prior to dosing and throughout the study.
* Use of any medication with unknown or unspecified content within 90 days before screening.
* Use of or intent to use prescription medicinal products or non-prescription drugs (including vitamins and herbal supplements) within 14 days prior to dosing and throughout the study, as declared by the participant, except for:
* Adequate contraceptive methods.
* Hormone replacement therapy (HRT) (for menopausal females).
* Over-the-counter topical medications known to not reach systemic circulation.
* Occasional use of acetaminophen up to 2 grams (g) (4 x 0.5 g) daily.
* Not able or not willing to adhere to study procedures, including:
* Eating the food provided in the study.
* Refraining from ingesting food or drinks that are not allowed during the study.
* Swallowing tablets.
* Abstaining from concomitant medication not allowed during the study.
Predictive Value of Combining AccuIMR and AccuFFR in Patients With STEMI

Patients with acute myocardial infarction were enrolled retrospectively. The fractional flow reserve (AccuFFR) and microcirculatory resistance index (AccuIMR) based on coronary angiography were analyzed, and the relationship between FFR and IMR and the prognosis of patients with acute myocardial infarction was analyzed

We retrospectively enrolled STEMI patients who underwent PCI in Peking University Third Hospital. The fractional flow reserve (AccuFFR) and microcirculatory resistance index (AccuIMR) based on coronary angiography were obtained by analyzing the coronary angiography images. The prognosis of patients was obtained by searching inpatient and outpatient systems and telephone follow-up. The relationship between AccuFFR, AccuIMR and prognosis was statistically analyzed

Eligibility Criteria:
Inclusion Criteria:

* Age of \>18 years;
* Onset-to-treatment time of ≤12 h, meeting the diagnostic criteria for STEMI;
* underwent primary PCI within 12 h of symptom onset and achieved successful PCI in the culprit vessel;
* Availability of complete clinical data

Exclusion Criteria:

* severe tortuosity and overlap of the target vessel;
* poor-quality coronary angiography images;
* missing two coronary angiography images \>25° apart
Recovery Sleepers: A Pilot Study of a Sleep Health Intervention for College Students in Recovery

The purpose of this research study is to examine how to improve sleep in college students in recovery from substance use disorder(s). This study is a pilot test of an experimental program called Recovery Sleepers (RS) to explore its feasibility and how well it works to improve sleep, wellbeing, and cravings.


Eligibility Criteria:
Inclusion Criteria:

* More than 18 years of age
* Enrolled (full- or part-time) at a college or university
* Have struggled with substance addiction in the past
* More than 3 months of self-reported continuous abstinence from alcohol and all illegal drugs
* Have an Internet-enabled device with audio capabilities.

Exclusion Criteria:

* Younger than 18 years of age
* Not enrolled at VCU
* Have not struggled with substance addiction in the past
* Have not had at least 3 months of self-reported continuous abstinence from alcohol and all
* illegal drugs
* In active treatment for a sleep disorder (seen a health provider specifically regarding sleep within the last 6 months)
* Unable to communicate in English both orally and in writing
* Do not have an Internet-enabled device with audio capabilities.
Establishment and Characterization of Patient-Derived Non-Small Cell Lung Cancer Xenografts and Cell Cultures

Xenografts and cell cultures provide sufficient material for analyses at the protein, RNA and DNA level. Patient derived NSCLC xenografts and cell lines are available but none however are Asian in origin. Given the emerging evidence to suggest inter-ethnic differences in NSCLC biology, new models of preclinical drug evaluation should be designed and validated using Asian tumors. Furthermore, such models will allow studies of biological mechanisms of sensitivity and/or resistance and also the study of dynamic regulations under standardized conditions in the Asian context.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 21 years and above.
* Undergoing a surgical resection of tumor as part of clinical management

Exclusion Criteria:

* Patient or legally acceptable representative unable to provide consent patient in the judgement of the study investigator, is medically unsuitable for this study
Effects of Exercise and Back Counselling for Nurses

Low back pain (LBP) is most common occupational health problem among nurses. Therefore, how to prevent and reduce low back pain have been the important issue for nurses. A Quasi-Experimental design is used in this study to compare the effectiveness of 12-week exercise and counselling program to reduce low back pain in nursing personnel compared with counselling alone.

A Quasi-Experimental design is used in this study. Purposive sampling is used to recruit participants from medical center in Central Taiwan. Participants will be randomly assigned to two groups: (1) exercise and back counselling, and (2) back counselling only. The results of this study will provide a guideline for nurses to prevent and to improve low back pain.

Eligibility Criteria:
Inclusion Criteria:

1. Has worked at current job for at least 12 months;
2. Intensity of low back pain on Visual Analogue Scale (scale 0-10) at least two during the past 3 months.

Exclusion Criteria:

1. Serious former back injury (fracture, surgery, disc protrusion);
2. Pregnant;
3. Other serious disease or symptoms that limit participation exercise defined by a physician.
Prehospital Analgesia in Adults Using Inhaled Methoxyflurane : A Feasibility Study

Pain is common and can contribute to both psychological and physiological effects if not treated. Currently primary care paramedics have limited selections within their pain management tool box. This contributes to inadequate pain management. Methoxyflurane is a safe, easy and effective choice in prehospital management of pain. The impact of this feasibility trial, will hope to inform the larger multi-centred trial and then support the implementation of out-of-hospital Canadian National Guidelines for prehospital pain control, enabling paramedics to provide rapid, effective prehospital pain relief to patients.

This will be a single-centred prehospital prospective observational feasibility study to evaluate the ability to perform a multicentred step wedge design trial. The feasibility outcomes will provide evidence for the development of the multicentred study and will capture clinical metrics to inform this larger study. A waver of consent will be sought from the ethics board with participation consent for paramedics understanding the risk of using a gas for analgesia. Patient \>= 18 years of age with traumatic pain with a verbal score \>= to 4 will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* \>=18 years of age
* Acute pain from traumatic injury
* numeric pain score \>=4

Exclusion Criteria:

* Allergy or sensitivity to methoxyflurane
* History or family history of malignant hyperthermia
* Pregnant or breast-feeding patients
* Known renal impairment
* Known liver disease
* Methoxyflurane use within previous 3 months
Fentanyl Test in Children's Adenotonsillectomy

The purpose of this study is to discuss the relationship between the result of fentanyl test and required dosage of morphine for children with OSAS after adenotonsillectomy；and to evaluate the ability of predicting requested dosage of morphine postoperatively.

All the patients were intubated. Sevoflurane was used for maintenance without any opioids. Before the end of the procedure, spontaneous respiratory was recovered. All the patients were given 1 mcg/kg fentanyl i.v. after the end of the procedure. The positive result was defined as spontaneous respiratory rate decreased more than 50%, the others were defined as negative result. All the patients were given morphine for pain relief according to our protocol after extubation.

Eligibility Criteria:
Inclusion Criteria:meet all of the following

1. the American society of anesthesiologists (ASA) class Ⅰ \~ Ⅱ
2. the age of 3 \~ 7 years old
3. children who underwent selective adenotonsillectomy.

Exclusion Criteria:meet anyone of the following

1. craniofacial malformations
2. mental retardation
3. BMI \> 22 kg/m2
4. a history of bronchial asthma
5. a recent history of opioid use.
Alpha-lipoic Acid in Diabetic Patients With Ischemic Cardiomyopathy

The aim of this study is to investigate the effect of alpha-lipoic acid on inflammatory markers and cardiac fibrosis markers in diabetic patients with Ischemic Cardiomyopathy.

* A 3-month, prospective double blind interventional study, which will include 60 patients with type II Diabetes Mellitus with Ischemic Cardiomyopathy on optimal standard medical therapy, who will be consecutively randomized into two groups, group on ALA 600 mg once daily and the second group on placebo once daily.
* Approval will be obtained from Research and Ethics Committee of Faculty of Pharmacy, Damanhour University. A written informed consent will be obtained from patients before begining of the study.
* All patients will undergo complete physical examination at baseline and after 3 months of treatment.
* Patients will be assessed using Echocardiography before and after the study focusing on:

Left atrial diameter (LAD), basic left ventricular dimensions (EDD and ESD) and both systolic and diastolic function.

-Measurements of inflammatory markers such as \[C-reactive protein (CRP), Tumor necrosis factor alpha (TNFα)\] and fibrosis markers such as \[Transforming growth factor beta (TGFβ), Matrix metalloproteinase 2 (MMP-2)\] at the beginning of the study and after 3 months of the study.

Study Outcomes: all patients will be followed up for 3 months for:

* 1ry outcomes: Change in inflammatory and fibrosis markers levels. LV Echocardiography improvements of any of basic Echo parameters.
* 2ry outcomes: Major Adverse Cardiovascular Events (MACE) such as MI, stroke or death. any side effects of the drug. Results The results of the study will be tabulated and statistical tests appropriate to the study will be conducted to evaluate significance of results.

conclusion Conclusion, and recommendations will be given.

Eligibility Criteria:
Inclusion criteria:

* Type 2 diabetes with a history of CAD.
* LV ejection fraction (LVEF) ≤40%.
* Ischemic heart failure patients with NYHA grade II-IV.

Exclusion criteria:

* Type 1 diabetes.
* Severe CKD with GFR ≤ 15 ml/min/1.73m\^2.
* Severe liver disease.
* Thyroid disorders.
* Acute febrile illness.
* Autoimmune disorders or connective tissue disorders.