cyrilzakka/clinical-trials huggingface dataset:
The Impact of Aquatic Therapy on Walking, Balance Functions, and Quality of Life in Children With Cerebral Palsy

The purpose of the study is to contribute to the rehabilitation program by comparing the effects of traditional rehabilitation methods and aquatherapy given in addition to these methods in patients with cerebral palsy. If the superiority of the rehabilitation program including aquatherapy is demonstrated, evidence will be provided for its more widespread use.

The participants will be divided into two groups as the study group and the control group. The study group will receive an aquatherapy rehabilitation program in addition to the conventional rehabilitation program, while the control group will only receive the conventional rehabilitation program.

Eligibility Criteria:
Inclusion Criteria:

1. Having a diagnosis of Hemiplegic Type or Diplegic Type Cerebral Palsy
2. Being between the ages of 3 and 16
3. Being at GMFCS levels I, II, and III
4. Having sufficient cognitive abilities such as understanding simple instructions, following them, and performing requested tasks
5. Parents and patients aged ≥ 9 agreeing to participate in the research

Exclusion Criteria:

1. Experiencing uncontrolled seizures
2. Having serious learning difficulties, behavioral problems, skin lesions, visual and/or hearing impairments that could affect function and participation
3. Active infection
4. Incontinence
Impact of Vaccination in Acute COVID-19

The aim of this study was to evaluate the association between vaccination with one of the four SARS-CoV-2 vaccines authorized for use in the European Union-BNT162b2, ChAdOx-1S, mRNA-1273 or Ad.26.COV2.S-and progression to critically severe disease among adult patients with PCR-confirmed acute COVID-19.


Eligibility Criteria:
Inclusion Criteria:

* age 18 yers or more
* hospitalized for acute COVID-19
* PCR confirmed infection with SARS-CoV-2

Exclusion Criteria:

* hospitalized for other conditions
Urodynamics and Music

Today music acts as an analgesic and anxiolytic in a safe, cheap and simple way. Several trials have confirmed its potential administration and benefits in urology practice. We aimed to assess the influence of music therapy on perceived anxiety and pain during outpatient urodynamic study (UDS) using the Visual Analog Scale (VAS) and the State-Trait Anxiety Inventory (STAI) in a prospective, randomized fashion

Urodynamic study (UDS) is often used to help urologists to evaluate the functions of bladder and urethra in outpatient clinic.1 Although a UDS is a reliable tool for accurate diagnosis, the process itself can be accompanied by discomfort and pain as it includes the positioning the catheters urethral and rectally, and the bladder filling. Reports of having such invasive outpatient process whilst awake may demonstrate pain and disquiet that result in incomplete examinations and patient noncompliance2,3.

Various pharmacologic options including lidocaine gel and catheter tip lubrication for urethral catheterization were used to relieve pain and anxiety during UDS. Besides, there are some non-pharmalogical methods such as patient education, heating pad, music, distraction and relaxation4-6.

Music has been considered complementary treatment modality as cheap, safe and effective. In various urological procedures including cystoscopy, transrectal prostate biopsy and extracorporeal shock wave lithotripsy (ESWL) music has been proven helpful on pain and anxiety levels 7-10. However, current literature presents limited and controversial data evaluating the influence of music on pain and anxiety perspective of the patient during UDS. We, therefore, aimed to assess the effect of music on patient satisfaction in a analgesic and anxiolytic way during UDS.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

Exclusion criteria included paraplegia, hearing impairment, taking any analgesic or anxiolytic drug to suppress the symptoms of anxiety until 24 hours prior to UDS, inability to understand or fulfill commands during UDS.
Impact of Meal Fatty Acids on Postprandial Vascular Reactivity

Cardiovascular disease (CVD) is the leading cause of death in women. Premenopausal women have a lower risk of CVD compared with men of a similar age. However, the incidence of CVD increases greatly after the menopause. The risk of heart disease is strongly associated with the health of an individual's blood vessels. It is thought that changes to the type of fat the investigators eat in their diet may affect the normal functioning and elasticity of the blood vessels, as well as affect cholesterol levels in the blood. Types of fat in the diet include monounsaturated fats (found mainly in olive oil), n-6 polyunsaturated fats (found mainly in sunflower oil) and saturated fats (found mainly in dairy products, such as butter and cheese). Since the investigators are in the fed (or postprandial) state for up to 18 hours of the day, it is important to see how these different fats affect the investigators blood vessels and blood fats over the course of the day after eating a meal. The aim of this study is to determine how consuming meals rich in saturated fats, n-6 polyunsaturated fats or monounsaturated fats influence the normal functioning and elasticity of the blood vessels throughout the day in postmenopausal women. A secondary aim is to determine the effects of these different dietary fats on a range of accepted heart disease risk markers including circulating levels of fats (lipids) and glucose in the blood.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal (not menstruated for at least 1 year)
* Plasma triacylglycerol (TAG) between 0.8 and 4.0 mmol/l
* Body mass index (BMI) between 18-35 kg/m2
* Total cholesterol (TC): \<8 mmol/l
* Systolic blood pressure \<160 mmHg and diastolic blood pressure \<100 mmHg
* Non-smoker

Exclusion Criteria:

* Having suffered a myocardial infarction/stroke in the past 12 months
* Diabetic (diagnosed as fasting blood glucose \>7 mmol/l) or suffering from other endocrine disorders
* Suffering from renal or bowel disease or have a history of cholestatic liver or pancreatitis
* On drug treatment for hyperlipidaemia, hypertension, inflammation or hypercoagulation
* History of alcohol abuse
* On hormone replacement therapy (HRT)
* Planning or on a weight reducing regime
* Taking nutritional supplements (e.g. fish oil, calcium)
* Anaemic: haemoglobin \<11.5 g/dl
Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer

The primary objective of this study is to assess and compare the efficacy and safety of sacituzumab govitecan-hzi versus treatment of physician's choice (TPC) in participants with hormonal receptor-positive (HR+) human epidermal growth factor receptor 2 (HER2-) negative metastatic breast cancer (MBC).


Eligibility Criteria:
Key Inclusion Criteria:

* Documented evidence of hormone receptor-positive human epidermal growth factor receptor 2 negative (HER2-negative) (hormonal receptor-positive (HR+)/HER2-) metastatic breast cancer (MBC) confirmed.
* Refractory to or relapsed after at least 2, and no more than 4, prior systemic chemotherapy regimens for metastatic disease:

  * At least 1 taxane in any setting.
  * At least 1 prior anticancer hormonal treatment in any setting.
  * At least 1 cyclin-dependent kinase inhibitor 4/6 in any setting.
* Eligible for one of the chemotherapy options listed in the TPC arm.
* Documented disease progression after the most recent therapy.
* Adequate bone marrow function (hemoglobin ≥ 9 g/dL, absolute neutrophil count (ANC) ≥ 1,500 per mm\^3, platelets ≥ 100,000 per mm\^3).
* Adequate renal function: calculated creatinine clearance ≥ 30 mL/minute according to the Cockcroft and Gault formula .
* Adequate liver function (bilirubin ≤ 1.5 institutional upper limit of normal (IULN), or ≤ 3 IULN for individuals with documented Gilbert's syndrome, aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤ 2.5 x IULN (in the case of liver metastases ≤ 5.0 x IULN)).
* Females must not be lactating or pregnant at Screening or Baseline (as documented by a negative beta human chorionic gonadotropin (ß-hCG)).

Key Exclusion Criteria:

* Previous treatment with topoisomerase 1 Inhibitors as a free form or as other formulations.
* History of significant cardiovascular disease or clinically significant electrocardiogram (ECG) abnormality.
* Active serious infection requiring antibiotics.
* Any medical or other condition which, in the opinion of the Investigator, causes the individual to be medically unfit to receive sacituzumab govitecan or unsuitable for any reason.
* Locally advanced MBC (stage IIIc) in individuals who are candidates for curative intent therapy at the time of study enrollment.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Implementation of Home Monitoring in Patients with Pulmonary Fibrosis

The objective of this study is to evaluate the impact of structurally replacing half of the outpatient clinic visits for patients with pulmonary fibrosis by home monitoring and video consultations on patient self-management and health(care) outcomes.

Patients will be randomly assigned to receive either hospital-based care or a home monitoring program integrated into hospital-based care. Hospital-based care involves outpatient clinic visits every three months including lung function testing. Home monitoring involves weekly measurements of both physiological- and patient reported outcomes (PROs) in a mobile health care application with half of the outpatient clinic visits alternately being replaced by remote video consultations. The home monitoring program includes home spirometry, pulse-oximetry, PROs, video consultations, a medication coach, and an infotheque showing disease-specific information. Questionnaires will be filled out by both study groups at set time points. The total study duration for individual patients will be 12 months.

Eligibility Criteria:
Inclusion Criteria:

* A multidisciplinary ILD team diagnosis of pulmonary fibrosis according to ATS/ERS/JRS/ALAT guidelines;
* Adults (=/\>18 years).

Exclusion Criteria:

* Patients who are not able to speak, read and/or write in Dutch;
* Patients with no access to the internet;
* Patients with a life expectancy of less than 1 year as determined by the treating healthcare provider;
* Patients who are or have been using a home monitoring program for PF.
Mediterranean Style Diet and Low Glycemic Responses

the aim of this study is to evaluate whether a Mediterranean diet rich in pasta and other starchy foods with a (Low-GI), as compared with a similar Mediterranean diet containing very little pasta and based on starchy foods with a (Hi-GI) is able to reduce insulin and glucose concentrations during a prolonged test study meal.

The overall aim of this study is to evaluate whether a Mediterranean diet rich in pasta and other starchy foods with a low glycemic response (Low-GI), as compared with a similar Mediterranean diet containing very little pasta and based on starchy foods with a high glycemic response (Hi-GI) is able to reduce insulin and glucose concentrations during a prolonged test study meal.

Eligibility Criteria:
Inclusion Criteria:

* • BMI 25-37 kg/m2 with a waist circumference \> 102 cm (males) or \> 88 cm (females) and one additional feature of Metabolic Syndrome according to ATPIII \[1\], including blood pressure \> 130/85 or treatment, fasting plasma glucose \>100mg/dL, fasting triglycerides \>150 mg/dL, HDL cholesterol \< 40 mg/dL (males) or 50 mg/dL (females),

  * weight stable (± 3 kg in previous 3 mo);
  * no acute illness; and non-diabetic.

Exclusion Criteria:

* age \<30 and \>69years;
* fasting triglycerides ≥400 mg/dL;
* fasting cholesterol \>240 mg/dL or low-density lipoprotein cholesterol\>160 mg/dL
* fasting glucose \>126 mg/dL,
* systolic blood pressure \>160 mmHg, diastolic blood pressure \>100 mmHg
* a BMI \>37 kg/m2, weight changes during the previous 3 months (greater than ± 3 kg),
* stable intensive physical activity regimen during the previous 3 months (\>3 h/wk of moderate or high intensity exercise, resistance or aerobic training).
* cardiovascular events (myocardial infarction or stroke) during the 6 months prior to the study;
* renal and liver failure (creatinine \>1.7 mg/dl and ALT/AST \>2 times than normal values, respectively);
* anaemia (Hb \<12 g/dL);
* diabetes mellitus.
* If you are pregnant
Addressing Body Image Issues While Teaching Academic Course: The Group- Theory and Practice

MSc. course addressing the issue of body image among nutrition students while delivering the course "The group- theory and practice". A non-randomized controlled trial was conducted between 2014 and 2016 with 135 dietetics' students in Tel Hai Academic College, Israel. Changes in body image and eating disorders features were assessed between course conclusion and baseline among participants within controlled efficacy study.

An innovative MSc. course addressing the issue of body image among nutrition students while delivering the course "The group- theory and practice". A non-randomized controlled trial was conducted between 2014 and 2016 with 135 dietetics' students in Tel Hai Academic College, Israel. All stages of the project were compliant with the Declaration of Helsinki. Informed written consent was obtained from all participants in the study. Changes in body image and eating disorders features were assessed between course conclusion and baseline among participants within controlled efficacy study.

The primary task of the described course is four folded:

1. Explore the theory and practice of key dimensions of groups and group facilitation.
2. Active participation in body image group
3. Develop deep understanding of the dynamics and processes through participants' own experience and behavior as it occurs in real time.
4. Develop ideas about how and what have been learned, that can be applied to their role as nutritionists and group facilitators.

The described course provides an alternative to the traditional psycho-education approach using an experiential and analogize approach during the course sessions. The three parts session starts with 45 minutes of frontal lecture focused on group theories. In the next 45 minutes, half of the students participate in a body image group while the other half serve as outside observers using structured forms. All participants filled the day before structured exercise, which expose them to the main issues that will be discussed and practiced in the group session. In the last 45 minutes, the observers report about their observation and the whole class discuss the group dynamics observed. The course includes 42 hours, 3 hours in each of the 14 sessions.

This model of learning emphasize deep learning of the "participant role" as well as the "facilitator role".

Eligibility Criteria:
Inclusion Criteria:

* Must be student enrolled at Tel-Hai Academic College.
* Must be among first 20 students to sign up for the course.

Exclusion Criteria:

* Non-students.
* Not among first 20 students to sign up for the course.
Cartilage Injury and Remodeling After ACL Rupture and Reconstruction: Functional Imaging and Biomarkers

The proposed study will establish novel relationships between intra-articular MSC recruitment, synovial inflammation, biomarkers of cartilage degeneration and joint inflammation, clinical patient factors, and downstream alterations in cartilage composition and morphology to provide novel insights into the pathoetiology of PTOA after ACL injury and reconstruction.

In efforts to study the pathoetiology of post-traumatic osteoarthritis (PTOA), we propose a collaborative, prospective cohort study of 38 patients undergoing primary anterior cruciate ligament (ACL) reconstruction after ACL rupture. We will assess the longitudinal progression of patient-reported outcomes, knee laxity, MRI-based articular cartilage morphology and composition, and serum-borne biomarkers of cartilage degeneration up to 1 year of follow-up. Furthermore, stem cell mobilization, chemokine and pro-inflammatory cytokine concentrations, and inflammatory cell recruitment into synovial tissue will be measured from intraoperatively-collected samples. We will perform mixed multivariate linear regression modeling to elucidate potentially novel relationships between patient demographics, anatomy, biological factors, and downstream alterations in articular cartilage morphology and composition. We request $200,000 in funding over a two-year duration.

Eligibility Criteria:
Inclusion Criteria:

* - Males and females, aged 18 - 30 years
* Isolated, traumatic primary anterior cruciate ligament rupture requiring surgical reconstruction
* Surgical reconstruction performed using a single-bundle technique utilizing an autograft
* No history of ipsilateral traumatic knee injury or fracture
* No evidence of PCL injury or more than grade 1 injury to the MCL or LCL

Exclusion Criteria:

* - BMI \< 18.5 or \>35 kg/m2
* Injury occurred longer than 4 weeks before enrollment
* Intra-articular steroid injection within 3 months of injury
* Chondral defects greater than 3 cm2 or Outerbridge grade II or higher lesions
Endoscopic Treatment for Zenker's Diverticulum

Zenker's diverticulum (ZD) is a rare benign condition, due to an acquired sac-like outpouching of the mucosa and submucosa layers originating from the pharyngoesophageal junction. Endoscopic techniques like flexible endoscopic septum division (FESD) or per-oral endoscopic septotomy (POES), represent a minimally invasive alternative to surgery or to rigid endoscopic procedure to treat ZD. The goal of the research will be to evaluate the safety of the procedures and to measure Zenker-symptom severity in all patients treated by endoscopic procedures.


Eligibility Criteria:
Inclusion Criteria:

* patients with symptomatic ZD treated by endoscopic procedures

Exclusion Criteria:

* pregnancy and breastfeeding
TaiChi-DTx for Treating Long Covid Symptoms

The randomized controlled trial will be conducted to evaluate the effectiveness of a Multi-domain Tai Chi Digital Therapy for treating the individuals suffering from the long term COVID-19 syndrome (Long COVID).

The randomized controlled trial will be conducted to evaluate the effectiveness of a Multi-domain Tai Chi Digital Therapy for treating the individuals suffering from the long term COVID-19 syndrome (Long COVID).

This intervention will comprise of traditional Tai Chi physical therapy with background music entraining 40 Hz sound wave and respiratory control training. The Multi-domain Tai Chi Digital Therapy will be delivered via a tablet or smart phone to participants for a 4-week therapeutic cycle. Clinical standardized physical tests and self-scored questionnaires will be collected to understand the change in symptoms, including fatigue, dyspnea, and brain fog, as well as absenteeism.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis with SARS-CoV2 infection via PCR during the past 3 to 6 months
2. Must be Grade 2 and Grade 3 assessed by the Post-COVID-19 Functional Status (PCFS) Scale

Exclusion Criteria:

1. Admitted in the Intensive Care Unit due to SARS-COV2 infection or any other serve illness
2. Psychiatric diseases and somatic co-morbidities
3. COVID-19 infections or co-morbidities started or exacerbated during the same time
Impact of a Health Intervention on Some Indicators in the Care of Chronic Complex Patient (CCP).

The aim of this study is to assess the effectiveness of proactive and integrated healthcare program for chronic complex patients (CCP). This program are based in coordination the primary level of attention with and speciality level. The objective is reducing hospital readmissions and know the benefit in total cost of care in 4 month before and 4 after intervention.

Quasi-experimental study with single-arm (pre-post study design without control group). The investigators checking pre and post intervention the effectiveness of a healthcare program for CCP. The interventions consist:

1. - Help the nurse in the hospital to carry out the care plans and the continuity care report.
2. - Refer patients to the social workers.
3. - Collaborate with the social worker to refer to centers of media, long stay and reference hospital.
4. - Ensure the follow-up appointments for the CCP.
5. - Make proactive calls to the CCP and/or their caregiver after discharge
6. - Plan the hospital discharge 48 hours in advance, so that the family and the patient can be organized.

The investigator analysed if with this program, the CCP reducing hospital readmission and reducing the Hospital expenditure.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 75 years.
* Having attended 5 or more emergency visits or having had more than 3 hospital admissions in the last 12 months.
* Identified with social risk alert.

Exclusion Criteria:

* Participate in other health programs (AHT, diabetes mellitus,...).
* Terminal patient.
A Study of C-CAR039 (Prizloncabtagene Autoleucel) in Patients with Relapsed/Refractory Large B-Cell Lymphoma

This is a multicenter, single arm, open-label study. The purpose of the study is to evaluate safety of Prizloncabtagene Autoleucel (Prizlon-cel) and establish the recommended Phase 2 dose (RP2D) (Phase 1b) and to evaluate the efficacy of Prizlon-cel (Phase 2) in patients with relapsed or refractory large b-cell lymphoma (LBCL).

The purpose of the study is to evaluate the safety and efficacy of Prizlon-cel. It includes two phases, Phase 1b and Phase 2. In Phase 1b study, RP2D will be determined. The selected dose will be further evaluated in the Phase 2 study. The study includes the following sequential procedures: Screening, Apheresis and CAR-T manufacturing, Baseline, Lymphodepletion, CAR-T infusion, DLT period (Phase 1b) and Follow-up Visit. Subjects will be followed for at least 2 years after Prizlon-cel infusion, with up to 15 years long-term follow-up on a separate study.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Histologically confirmed CD19 or CD20 positive B-cell non-Hodgkin lymphoma, including the following neoplasms as defined by the 2016 WHO classification of lymphoid neoplasms:

  1. Diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS)
  2. Primary mediastinal large B-cell lymphoma (PMBCL)
  3. Transformed follicular lymphoma (tFL)
  4. High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements (HGBL-DH/TH)
  5. High-grade B-cell lymphoma, NOS (HGBL, NOS)
  6. Follicular lymphoma grade 3B (FL3B)
* Relapsed or refractory disease after ≥ 2 lines of standard therapy or relapsed after autologous stem cell transplantation (ASCT)
* At least one measurable lesion per the Lugano 2014 Classification
* Adequate organ and marrow function

Exclusion Criteria:

* Prior allogeneic hematopoietic stem cell transplantation (HSCT) at anytime, or ASCT within 12 weeks prior to apheresis
* Suspected or confirmed central nervous system involvement
* Stroke or convulsion history within 6 months of signing informed consent form (ICF)
* Autoimmune disease, immunodeficiency or diseases requiring immunosuppressants treatment
* Uncontrolled active infection
* Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive hepatitis C virus (HCV) antibody with positive HCV RNA in peripheral blood; positive human immunodeficiency virus (HIV) antibody; positive syphilis test
* Severe heart, liver, renal or metabolism disease
* Inadequate wash-out time for previous anti-tumor treatments prior to apheresis
* Prior CAR-T therapy