cyrilzakka/clinical-trials huggingface dataset:
Behaviour After Exercise of Biological, Clinical and Metabolic Variables as From Different Temperatures and Times of Immersion Cold Water Application

Introduction: immersion cold water is a recuperative strategy commonly used, however, are not yet fully understood the real effects of this technique on specific conditions. Objective: To analyze and to compare the effects of the immersion cold water during the intense post-exercise recovery, using different times and temperatures on biological, clinical and metabolic variables. Method: 105 male subjects were divided into five groups: one control group (CG) and four recoveries (G1: 5' at 9±1 degrees Celsius; G2: 5' at 14±1 degrees Celsius; G3: 15' at 9±1 degrees Celsius; G4: 15' at 14±1 degrees Celsius). The volunteers were submitted an exhaustion protocol that consisted of a program of jumps and the Wingate test. Immediately after the exhaustion protocol, volunteers were directed to a tank with water and ice, which were immersed up to the height of the anterior superior iliac spine to the recovery procedure, during which blood samples were collected for later analysis lactate and creatine kinase (CK). Variables were collected prior to the exercise, 24, 48, 72 and 96 hours after the end of it. Furthermore, the perception of pain and recovery of the lower limbs were also collected at specific moments by means respectively of the Likert scale of perceived effort and visual analogue scale pain. Appropriate statistical analysis was used to compare the groups and the moments, considering the 5% level of significance.


Eligibility Criteria:
Inclusion Criteria:

* Male sex
* Healthy
* Aged between 18 and 30 years
* Classified as physically active through the International Physical Activity Questionnaire

Exclusion Criteria:

* Anemia
* Inflammation
* Diabetes
* Cardiovascular disease
* Liver problems
* Alcoholics
* Smokers
* Illicit drug users
* Chronic users of anti-inflammatory drugs
* Episode of musculotendinous or osteoarticular injury in the lower and/or column members during the last six months.
Digital Diabetes Self Management Education and Support for Patients With Type 2 Diabetes

The purpose of this study is to test the effect of using a digital diabetes self management education and support system compared with standard care for patients with type 2 diabetes in primary health care.

After being informed verbally and in text participants will sign a consent to participate. The participant will then be randomized to either use a digital diabetes self management education and support system for 10 weeks together with a diabetes nurse, or to continue with the regular care. The effects will be evaluated after 6, 12 and 36 months from randomization with emphasis on cardiovascular risk factors, life-style, diabetes knowledge and health economics.

Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetes mellitus diagnosed according to WHO criteria \< 5 years from randomization:
* Fasting plasma glucose \> 7 mmol/L at two timepoints. OR
* HbA1c ≥ 48 mmol/mol twice or in combination with fasting plasma glucose \> 7 mmo/L once. OR
* Non-fasting plasma glucose ≥ 11.1 mmol/L at one timepoint in combination with symptoms of hyperglycemia.
* Access to a digital ID-card to access the digital system
* Access to a computer, tablet or smart phone
* Sufficient knowledge of written and spoken Swedish to understand the information given in the digital system.

Exclusion Criteria:

* Treatment with Insulin
* Other co-morbidities limiting the use of the digital system according to the diabetes nurse judgement. E.g. dementia or severe psychiatric disease.
* Other forms of diabetes mellitus than type 2 diabetes.
Development of a Collapsible Folding Manual Wheelchair

The purpose of this research study is to evaluate the Endeavor, a compact, forward-folding, ultralight manual wheelchair that incorporates small "swing-down" wheels for navigation in confined areas. This enables access to narrow environments such as those encountered in offices, restrooms, and transportation settings. When using the small access wheels, the wheelchair also fits down the aisle of airplanes and collapses to be stowed in the overhead compartment. It is anticipated that the Endeavor will maximize mobility; increase access to confined areas; and ease the demands of travel for people with disabilities.

The purpose of this research study is to evaluate the Endeavor, a compact, forward-folding, ultralight manual wheelchair that incorporates small "swing-down" wheels for navigation in confined areas. This enables access to narrow environments such as those encountered in offices, restrooms, and transportation settings. When using the small access wheels, the wheelchair also fits down the aisle of airplanes and collapses to be stowed in the overhead compartment. It is anticipated that the Endeavor will maximize mobility; increase access to confined areas; and ease the demands of travel for people with disabilities.

There are two stages to this research project: an Activities of Daily Living Course and an In-Home trial. The activities of daily living course is located at the Human Engineering Research Laboratories and simulates daily barriers encountered by wheelchair users. Subjects will be asked to complete the course in their personal wheelchair and in the Endeavor three times each. Testing will be completed during a one-day visit that will not exceed 2 1/2 hours.

For the in-home trial, subjects will be asked to use the Endeavor as their primary means of mobility for two weeks, which will be compared to using their own wheelchair for two weeks. During this four-week period a datalogger will be mounted to the subject's wheelchair(s), which will give information about distance traveled, average speed, and time used. In addition to the data-logger, subjects will also be asked to keep a brief, daily, written log of the activities they performed while in the chair. At the end of the Endeavor trial-use period, subjects will be asked to complete a questionnaire. There is an 8-week follow-up period where subjects will be allowed to keep the Endeavor. We will make three calls during this period to conduct interviews on usage of the Endeavor.

Eligibility Criteria:
Inclusion Criteria:

1. Use a manual wheelchair as a primary means of mobility.
2. Male and females over the age of 18.
3. The ability to adequately fit in a wheelchair with a 16" seat width.
4. A minimum of 6 months experience using a manual wheelchair as primary means of mobility.
5. Able to transfer independently.
6. Drive own vehicle from vehicle seat.

Exclusion Criteria:

1. Active pressure sores as reported by subject.
2. History of traumatic upper extremity injury that would prevent you from folding, lifting and storing a manual wheelchair.
Ultrasound Elastography Assessment of Spleen and Liver Stiffness Before and After Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedure

The primary purpose of this project is to determine if acute monitoring of shunt patency via ultrasound elastography measurements of splenic stiffness before and after TIPS placement results in reduced morbidity and mortality from shunt failure.

Portal hypertension is a condition that is caused by various disorders of the liver, including cirrhosis, hepatitis, portal vein thrombosis, or Budd-Chiari Disease. Portal hypertension can lead to the accumulation of fluid in the abdomen, called ascites, or put patients at risk for bleeding of the esophagus, stomach, and bowel. In certain patients, portal hypertension is treated by placement of a Transjugular Intrahepatic Portosystemic Shunt (TIPS).

Elastography is a newer exam which measures the consistency, or softness/stiffness, of various organs in the body. It is performed with ultrasound by sliding a transducer across the abdomen. Elastography is most commonly used to evaluate the liver, as disorders that cause damage to the liver result in stiffer liver tissue. The spleen has also been shown to get stiffer in the setting of portal hypertension.

Eligibility Criteria:
Inclusion Criteria:

* All patients who undergo TIPS placement at the University of Kansas Medical Center (KUMC) are eligible for participation in this study

Exclusion Criteria:

* Patients under 18 years of age
* Patients with prior splenectomy
A Study in Adults With Advanced Classical Hodgkin's Lymphoma (cHL) in Brazil Treated With Brentuximab Vedotin Together With Chemotherapy Compared to Chemotherapy Alone

The main aim of this study conducted in Brazil is to understand if there is a difference in the length of time that Classical Hodgkin's Lymphoma (cHL) does not grow or spread further (also called progression free survival or PFS), and in the length of time that participants live with cHL if they are treated with Brentuximab Vedotin in combination with chemotherapy (A+AVD) or chemotherapy alone (ABVD).

A+AVD includes Brentuximab Vedotin + Doxorubicin + Vinblastine + Dacarbazine; ABVD includes Doxorubicin + Bleomycin + Vinblastine + Dacarbazine.

The study will be conducted by reviewing and collecting already existing medical records.

This is an observational, multicenter and retrospective study to evaluate the effectiveness of A+AVD regimen compared to ABVD regimen as first-line therapy for the treatment of Brazilian participants with advanced cHL diagnosis.

The study will enroll approximately 200 participants who were treated with A+AVD or ABVD as first line therapy for at least one full cycle of 28 days, from July 1st, 2017, to December 31st, 2020. Participants will be identified from medical charts and will be assigned into following treatment groups:

* ABVD: Doxorubicin 25 milligrams per square meter (mg/m\^2) + Bleomycin 15 milligram (mg) + Vinblastine 6 mg/m\^2 + Dacarbazine 375 mg/m\^2
* A+AVD: Brentuximab Vedotin 1.2 milligrams per kilogram (mg/kg) + Doxorubicin 25 mg/m\^2 + Vinblastine 6 mg/m\^2 + Dacarbazine 375 mg/m\^2

This multi-center trial will be conducted in Brazil. The duration of the study will be 12 months. Participants will be followed up for at least 2 years after the last therapy cycle (treatment window considered for the study from July 1st, 2017, to December 31st, 2020).

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of advanced cHL (International Classification of Diseases and Related Health Problems 10th Revision \[ICD-10\] code C81.X). The diagnosis of cHL will be confirmed according to World Health Organization (WHO) classification. Advanced disease is defined as having the diagnosis at stage IIB, III or IV, based on Ann Arbor classification.
* Who received at least one full cycle of A+AVD or ABVD regimen as first-line treatment (first systemic therapy for cHL management; systemic therapy naïve participants) from July, 1st 2017 to December, 31st 2020; and who completed the 6-cycle treatment until the end of December 2020.
* At least 2 years of retrospective information from the index date (treatment window) and at least 2 years of follow-up (after the end of treatment).

Exclusion Criteria:

* With previous or concurrent malignancies, except participants with completely excised carcinoma in situ of any type and basal or squamous cell carcinoma of the skin.
* Who are simultaneously participating in another study.
* Who participated in the ECHELON-1 Clinical Study.
Treatment of Systemic Sclerosis With Autologous Regulatory Т-cells

Treatment of patients with systemic sclerosis with autologous regulatory Т-cells

Considering the fact that a decrease in the content and functional activity of T-reg plays an important role in the immunopathogenesis of many systemic diseases of the connective tissue, the use of a large amount of T-reg can have a therapeutic effect.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Systemic Sclerosis
* The patient can read, understand, follow the examination procedures and complete, if necessary, the required documentation
* Written informed consent

Exclusion Criteria:

* The presence of any malignant tumor within the last 5 years
* Acute or chronic diseases in the stage of decompensation
* Chronic infectious diseases: HIV, viral hepatitis B, C, tuberculosis
* Patients who are pregnant, breastfeeding, or fertile patients who are not using adequate contraceptive methods
* Chronic and protracted mental disorders, all diseases with the presence of the syndrome of dependence on alcohol, drugs and psychoactive substances, any other condition that makes the patient unable to understand the nature, extent and possible consequences of the study or, in the opinion of the researcher, prevents the patient from observing and performing protocol
* Patients are unable or unwilling to give written informed consent and / or follow research procedures
* Any other medical condition that, in the opinion of the investigator, may be associated with an increased risk to the patient or may affect the outcome or evaluation of the study
A Prospective,Open-label Study of Anastrozole in Post-menopausal Women With Hormone Sensitive Advanced Breast Cancer

The overall objective of the clinical study is to assess the tolerability and clinical efficacy of anastrozole in post-menopausal women with hormone sensitive advanced breast cancer in India.


Eligibility Criteria:
Inclusion Criteria:

1. Patients must be adult (age ≥ 18 years age) post-menopausal\* women
2. Patients must be diagnosed with advanced breast cancer (histologically or cytological confirmation required) i.e. TNM stage III or IV disease (locally advanced or metastatic breast cancer) or locoregional recurrent disease, not suitable for treatment by local surgery or radiation therapy
3. Measurable or evaluable disease
4. Patients with ER/PR positive tumour or ER/PR unknown status
5. Patients must be suitable for endocrine treatment with anastrozole
6. Prior adjuvant chemotherapy or endocrine therapy for early breast cancer is allowed, provided such treatment was completed at least twelve months prior to study enrollment
7. Performance status 0-2 (As per WHO Classification)
8. Concurrent use of bisphosphonates is permitted.
9. Patients must give their written informed consent for participation in the study

Exclusion Criteria:

1. Patients with tumors known to be estrogen and progesterone receptor-negative.
2. Estrogen hormone replacement therapy, concurrently or within 6 weeks before randomization
3. Extensive visceral involvement (significant hepatic involvement, brain metastasis or pulmonary involvement \> 50% of the lungs); serum liver enzymes SGOT and SGPT should be no greater than five times the upper limit of the reference range
4. Patients received bone marrow transplantation before randomization
5. Any concurrent medical illness (uncontrolled cardiac disease or diabetes mellitus) or laboratory abnormalities that would compromise safety or prevent interpretation of results
6. An estimated survival of less than 3 months from the start of Study drug treatment based on clinical judgment.
7. Any systemic investigational drug within the thirty days of enrollment into study
Effect of BM-MSCs in DCD Kidney Transplantation

This study is designed to determine the efficacy and safety of allogeneic bone marrow-derived mesenchymal stem cells in kidney transplantation from Chinese donation after citizen's death (DCD). A pair uremia patients receiving kidney grafts from a same donor are randomized into two groups: MSCs group and control group. Besides routine induction therapy (ATG or Basiliximab) and maintenance immunosuppressive drugs (low-dose Tacrolimus + MPA + prednisone), patients in MSCs group are administered MSCs treatment (1\*10\^6/kg). Allogeneic bone marrow-derived MSCs (1\*10\^6/kg) are given intravenously at day 0 (post renal reperfusion during surgery), day 7, day 14 and day 21. The renal allograft function, rejection, patient/graft survival and severe adverse events within 12 months post-transplant are monitored.


Eligibility Criteria:
Inclusion Criteria:

1. Primary kidney transplantation
2. Receiving induction therapy and combined immunosuppressive regimens (CNIs + MPA + steroids)
3. Patient is willing and capable of giving written informed consent for study participation and able to participate in the study for 12 months

Exclusion Criteria:

1. Secondary kidney transplantation
2. Combined or multi-organ transplantation
3. Women who are pregnant, intend to become pregnant in the next 1 years, breastfeeding, or have a positive pregnancy test on enrollment or prior to study medication administration
4. Panel reactive antibody (PRA)\>20%
5. CDC crossmatch is positive
6. Donors or recipients are known hepatitis C antibody-positive or polymerase chain reaction (PCR) positive for hepatitis C
7. Donors or recipients are known hepatitis B surface antigen-positive or PCR positive for hepatitis B
8. Donors or recipients are known human immunodeficiency virus (HIV) infection
9. Patients with active infection
10. Recipients with a history of substance abuse (drugs or alcohol) within the past 6 months, or psychotic disorders that are not capable with adequate study follow-up.
11. Patients with severe cardiovascular dysfunction
12. WBC\<3\*10\^9/L or RBC \<5g/dL
13. Highly allergic constitution or having severe history of allergies.
14. Patients with active peptic ulcer disease, chronic diarrhea, or gastrointestinal problem affect absorption
15. Patients with a history of cancer within the last 5 years
16. Prisoner or patients compulsorily detained (involuntarily incarcerated) for treatment or either a psychiatric or physical (e.g. infectious disease) illness
Ocular Graft Versus Host Disease After Hematopoietic Stem Cell Transplantation in Adults

The purpose of this study is to evaluate the presence and manifestations of ocular graft versus host disease in adults that had hematopoietic stem cell transplantation in the past 3 years at the sheba medical center, Israel. As well as correlate the degree of the presentation to the therapeutic protocol (chemotherapy and irradiation).


Eligibility Criteria:
Inclusion Criteria:

* after hematopoietic stem cell transplantation done at sheba medical center Israel
* 3 month have past from transplantation but no more then 3 years

Exclusion Criteria:

* transplantation done in the last 3 month or more than 3 years have past since
Glaucoma Telemedicine Screening

The incidence of glaucoma is currently growing in the world's population, including the younger ones. However, the number of specialists who could perform examinations is unavailable in many areas of the Czech Republic outside large agglomerations. There is suitable alternative procedure that would make it possible to increase the intensity of screening, for example in general practitioners surgeries via application of teleophthalmology. Early detection is absolutely essential for the patient (and therefore the health care system) for his/her further successful treatment. At the same time, all the necessary technical prerequisites are well known and commercially available.

Detailed Description: The aim of this study is to increase the detection of patients suspected of having glaucoma. For this purpose, the use of a combination of a mobile fundus camera and a mobile intraocular tonometer is proposed. These devices are used within the general practitioners' surgeries in the rural parts of Olomouc and Jeseniky region. Their combination will allow a better stratification of patients suspected of glaucoma into the following groups:

* patients with ocular hypertension (higher intraocular pressure and normal optic disc)
* patients with normotensive glaucoma (normal intraocular pressure and suspected optic disc)
* glaucoma patients (higher intraocular pressure and suspected optic disc)

The advantage of involving a fundus camera is also in the possibility of the retinal pathologies detection such as diabetic retinopathy or age-related macular degeneration as a secondary outcome of the study.

However, the primary goal of the study is to detect glaucoma and ocular hypertension. This area is also supported by the Risk Factors Questionnaire and the Patient Education Questionnaire.

All patients will be evaluated by University hospital Olomouc (FNOL) ophthalmology specialists who will evaluate data coming through the specifically designed FNOL telemedicine webportal from intraocular tonometers and fundus cameras. Suspected patients will be invited to the FNOL Eye Clinic for follow-up assessment using other modalities - perimeter, OCT, stationary fundus camera, etc.

The secondary goal of the project is to create a database combining retinal images with intraocular pressure values, and data from other modalities in suspected patients who come to the FNOL for follow-up examinations. This goal will support the epidemiological study as well as it opens up the possibility of building a neural network over the database for easier classification of glaucoma patients in the future.

As cognitive impairments (for instance Alzheimer's disease) can also be inferred with the above-described equipment, patients are also presented with a questionnaire to examine their cognitive performance. Data collected with use of questionnaires will be also part of the database. Consequently, presenting the tertiary outcome of the described study.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Informed written and verbal consent

Exclusion Criteria:

• Absence of collaboration (informed consent)
Role of DbXell in the Treatment of Subjects With Mildly Uncontrolled Type 2 Diabetes Mellitus

This is a 2-arm, single-blind, crossover, placebo-controlled clinical study, with 24 weeks of therapy to evaluate the efficacy and safety of DbXell in improving metabolic control in patients with Type 2 Diabetes that is mildly uncontrolled, defined as HbA1c above target but less than 8.0% on their current conventional therapy.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects with age of 18-70 years Established type 2 diabetes mellitus as defined by the American Diabetes Association, but of duration less than 10 years.
* Suboptimal glycemic control as judged by HbA1c over target but not more than 8.0%.Current medication of not more than 2 oral hypoglycemic agents. No current or past insulin or GLP1 therapy.
* FPG ≤ 180 mg/dL
* Hemoglobin level of ≥ 10.0 g/dL
* Serum ALT ≤ 2.5 times upper limit of normal
* Serum creatinine \< 1.5 times upper limit of normal

Exclusion Criteria:

* Female of childbearing potential
* Subjects with symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or other symptomatic ischemic arterial diseases necessitating medical treatment
* Uncontrolled hypertension (SBP \> 160 mmHg and/or DBP \> 100 mmHg)
* History of renal and/or liver disease
* History of or the presence of any clinical evidence of malignancies
* Presence of exacerbation of chronic illnesses, severe and acute infections, complicated infections
* Current treatment with systemic corticosteroids or herbal (alternative) medicines
* Participation in any other intervention trial within 30 days prior to Screening