cyrilzakka/clinical-trials huggingface dataset:
Exercise Effects on Adipose Tissue Structure and Function

Participants will be randomized into one of two different experimental groups: 1) Exercise group and 2) No exercise (control group). Subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending on group randomization). After completing this weight loss portion of the study, participants will then be required to adhere to a high calorie diet program to regain half of the weight the participant lost - followed by the same series of metabolic tests.

Exercise is among the first line treatments for obesity and obesity-related diseases, yet it is shocking how little is known about how exercise works to improve health. Expanding the knowledge about novel exercise-induced adaptations in fat tissue of obese individuals and furthering the understanding about mechanisms underlying these adaptations could lead to innovative approaches for preventing and treating insulin resistance and obesity-related diseases.

Overall, the researchers believe that exercise training modifies key processes in subcutaneous fat tissue that may contribute to an increase body fat storage capacity (without increasing fat mass). The research team anticipates that exercise will evoke an even more potent adaptive response when fat tissue is dynamically changing in response to alterations in nutritional status (i.e., weight loss and weight regain).

Participants will be randomized into one of two different experimental groups: 1) Exercise group and 2) No exercise (control group). Subject participation in the study will involve a series of metabolic tests before and after participants undergo a 10% weight loss program (with or without exercise training depending on group randomization). After completing this weight loss portion of the study, participants will then be required to adhere to a high calorie diet program to regain half of the weight the participant lost - followed by the same series of metabolic tests. After the participant completes the study, the study team will help the participant to lose more weight. Total involvement in the study for each participant will likely be about 8-10 months.

Eligibility Criteria:
Inclusion Criteria:

* Age: 18-40
* Body Mass Index: 27-45 kg/m2
* No regularly planned exercise/physical activity for at least 6 months
* Women must have regularly occurring menses and must be premenopausal

Exclusion Criteria:

* Evidence/history of cardiovascular or metabolic disease
* Medications known to affect lipid or glucose metabolism, or inflammation
* Weight instability ≥ ± 6 pounds in the last 3 months
* Tobacco or e-cigarette users
* Women must not be pregnant or actively lactating
Nutritional Status in Patients With Chronic Kidney Disease

The goal of this observational study is to investigate how the GLIM criteria\* for the diagnosis of malnutrition should be operationalized in patients with chronic kidney disease (CKD) treated with hemodialysis. The main questions it aims to answer are:

* How can malnutrition be defined when applying different combinations and operationalization strategies of the GLIM criteria?
* How can information from other nutrition assessment tools be used in the operationalization of GLIM?
* Which combinations and operationalization strategies of the GLIM criteria can best predict deterioration in quality of life, muscle strength, and increased mortality? An observational study on patients with CKD in hemodialysis will be performed. Variables will be extracted from the Swedish renal registry, SNR and medical records at two hemodialysis units at one university hospital in Sweden. With start in the fall of 2024, data will be collected during two timepoints (baseline and follow-up) when wanted variables for this study are routinely measured at the units.

  * The Global Leadership Initiative on Malnutrition (GLIM) criteria to diagnose malnutrition in adults


Eligibility Criteria:
Inclusion Criteria:

* age ≥18 years
* dialysis duration \&amp;gt;3 months prior to recruitment

Exclusion Criteria:

* patients who only have a dialysis frequency of once a week
* patients treated with a combination of peritoneal dialysis and hemodialysis or treated at home
* patients were written consent cannot be obtained due to medical or mental illness or weakened state of health
Effect of Proactive Management of Side Effects on Treatment Compliance in Malignant Melanoma Patients on High-dose Intron A Therapy (Study P04600)

Patients with malignant melanoma who had undergone surgery will receive adjuvant treatment with high-dose Intron A for one year. The objective of this study is to maximize treatment compliance by proactive management of side effects in a day-to-day healthcare setting.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent
* Age \> 18 years
* Confirmed melanoma
* Patient has been prescribed Intron A therapy for High-Risk Stage II \& III Melanoma
* Intron A therapy started within 70 days of surgery (additional 15 days may be granted by the sponsor upon written approval)
* Proper contraception in both male and female subjects and the female partner(s) of male study subjects

Exclusion Criteria:

* Metastatic disease at the time of diagnosis
* Other malignancies
* History of non compliance to other therapies
* Pregnancy or breast feeding
* Previous Intron A therapy
NEAT!2 Sedentary Behavior Reduction for Individuals With Past or Present Knee Symptoms, Injuries, or Surgeries

This study will evaluate the effectiveness of an mHealth sedentary reduction program over a 6-month period of time in adults with past or present knee symptoms, injuries, or surgeries.

Sedentary behavior, in excess, is associated with numerous health consequences including poor physical function. Older adults with symptomatic knee pain spend the majority of their waking hours engaging in sedentary behaviors. To reduce the risk of disability, improve quality of life, and prevent deterioration in physical function, it is imperative the investigators develop ways to reduce sedentary time. Smartphone ownership among older adults is increasing and may provide a scalable opportunity to disseminate a sedentary reduction intervention. Therefore, this study aims to evaluate and compare changes in sedentary behavior and physical function between an mHealth sedentary reduction, mHealth intervention plus coaching, and delayed mHealth group. Sedentary behavior and physical function will be assessed at baseline, 1 month, 3 months, and 6 months after randomization.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 40 years of age
* Own an Android or Apple smartphone
* Have their smartphone near them (in their pocket, in their hand, or within 10 feet of them) for \>50% of their waking day
* Be willing to download the study application and be compatible on their smartphone
* Spend at least 7 hours/day sitting
* Have at least 4 days of valid accelerometer data at baseline
* Have knee pain (at least one knee with pain, aching, or stiffness on most days for one month of the last 12 months), knee injury, or knee replacement within the last 5 years
* Read, speak, and understand English

Exclusion Criteria:

* Have any contraindications to activity
* Have a mobility limiting comorbidity
* Have a scheduled surgery within the next 6 months
Bendamustine Hydrochloride in Treating Patients With Previously Treated Multiple Myeloma

This phase I trial studies the side effects and best dose of bendamustine hydrochloride in treating patients with previously treated multiple myeloma. Drugs used in chemotherapy, such as bendamustine hydrochloride, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

PRIMARY OBJECTIVES:

I. To identify a maximum tolerated dose of bendamustine (bendamustine hydrochloride) in patients with multiple myeloma.

SECONDARY OBJECTIVES:

I. To evaluate the safety of escalating doses of bendamustine in patients with multiple myeloma.

II. To describe the response after bendamustine

OUTLINE: This is a dose-escalation study.

Patients receive bendamustine hydrochloride intravenously (IV) over 60-180 minutes on days 1 and 2.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with multiple myeloma who have not achieved a CR following at least 4 cycles of induction therapy
2. Age up to 80 years
3. ECOG Performance Status of 0 or 1
4. Left ventricular ejection fraction =/\> 40%. No uncontrolled arrhythmias or symptomatic cardiac disease
5. FEV1, FVC and DLCO =/\> 40%. No symptomatic pulmonary disease.
6. Serum bilirubin \<2 x upper limit of normal, alkaline phosphatase \<3 x upper limit of normal. No evidence of chronic active hepatitis or cirrhosis. No effusion or ascites \> 1 L prior to drainage.
7. HIV negative
8. Negative beta HCG test in woman with child bearing potential, defined as not post-menopausal for 12 months or no previous sterilization
9. Patients or guardian able to sign informed consent
10. Availability of previously collected autologous stem cells (at least 3.0 x 106 CD34 cells/kg)
11. Calculated GFR \> 50 ml/minute

Exclusion Criteria:

1. Patients with uncontrolled hypertension (systolic \> 140, diastolic \> 90 despite antihypertensive therapy
2. Patients with uncontrolled bacteria, viral or fungal infections (currently taking medication and progression of clinical symptoms)
3. New York Heart Association (NYHA) Class III or IV heart failure, uncontrolled angina, severe uncontrolled ventricular arrhythmias, or electrocardiographic evidence of acute ischemia or active conduction system abnormalities
4. Relapsed/refractory myeloma
Study of Human Papillomavirus (HPV) 16 Vaccine in the Prevention of HPV 16 Infection in 16- to 23-Year-Old Females (V501-005)

Subjects received HPV 16 L1 VLP vaccine or placebo (1:1 ratio). Endpoints included efficacy, immunogenicity, and safety.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, unmarried females age 16 to 23 years with intact uteri
* Not pregnant at enrollment
* Agreed to use effective contraception through Month 7 of the study
* A lifetime history of 0 to 5 male partners with whom the subjects engaged in at least one episode of insertive intercourse

Exclusion Criteria:

* No prior history of Human Papillomavirus (HPV) vaccination
* No receipt of any other vaccination within 1 month prior to enrollment or plans to receive any other vaccination within 1 month prior to or after any dose of study vaccine
* No prior history of an abnormal Papanicolaou (Pap) test showing Squamous intraepithelial lesion (SIL) or biopsy showing Cervical intraepithelial neoplasia (CIN)
Study of TGF-β Receptor Inhibitor Galunisertib (LY2157299) and Enzalutamide in Metastatic Castration-resistant Prostate Cancer

The primary objective of this study is to compare the progression free survival (PFS) of patients with metastatic castration-resistant prostate cancer treated with enzalutamide in combination with LY2157299 (Arm 1) versus enzalutamide alone (Arm 2).


Eligibility Criteria:
Inclusion Criteria:

* Have metastatic castration-resistant prostate cancer
* Must have had prior abiraterone treatment
* Life expectancy of greater than 3 months
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 2
* Age ≥18 years
* Have measurable disease
* Patients acceptance to have a tumor biopsy of an accessible lesion at baseline and on treatment if the lesion can be biopsied with acceptable clinical risk (as judged by the investigator).
* Ability to take oral medication
* Patients must have adequate organ and marrow function defined by study-specified laboratory tests
* Must use acceptable form of birth control while on study
* Ability to understand and willingness to sign a written informed consent document

Exclusion Criteria:

* Known history or evidence of brain metastases
* Prior chemotherapy for metastatic disease in castration-resistant prostate cancer
* Had surgery within 4 weeks prior to the first dose of study drug
* Had radiation, biological, or other investigational cancer therapy within 2 weeks prior to the first dose of study drug
* Had second-line hormonal therapy within 2 weeks prior to the first dose of study drug
* Systemic steroids within 1 weeks prior to the first dose of study drug
* Had prior enzalutamide, ARN-509, or galeterone therapy
* Have moderate or severe cardiovascular disease
* Have a history of a seizure
* Have uncontrolled intercurrent illness, including but not limited to ongoing or active infection, systematic congestive heart failure, unstable angina pectoris, cardiac arrhythmia or psychiatric condition that would limit compliance with study requirements
* Have a history of any autoimmune disease:inflammatory bowel disease, (including ulcerative colitis and Crohn's Disease), rheumatoid arthritis, systemic progressive sclerosis (scleroderma), systemic lupus erythmatosus (SLE) autoimmune vasculitis (e.g., Wegener's Granulomatosis), central nervous system (CNS) or motor neuropathy considered to be of autoimmune origin (e.g., Guillian-Barre Syndrome, Myasthenia Gravis, Multiple Sclerosis)
* Have known history of infection with HIV, hepatitis B, or hepatitis C
Prognostic Determinants in Patients With Diabetic Foot Ulcer.

The worse prognosis observed in patients with Diabetic Foot Ulcer (DFU) has not been fully understood. Poor prognosis may be related to other conditions (inflammation, infectious disease, cancers) further to cardiovascular disease.

The aim of the study is to conduct the first prospective, observational and multi-centre cohort of patients with DFU in France, in order to evaluate the 5-years mortality rate, its causes and relevant prognostic determinants.

Diabetic foot ulcer (DFU) is one of the major complications frequently observed in patients with diabetes. DFU is the leading cause of non-traumatic lower-limb amputation (LLA), and it is associated with cognitive decline, worsening quality of life and substantial economic impact on French healthcare system. DFU is also associated with excess risk of premature death with significant decrease in life expectancy despite major improvement in medical care during last decades. The hypothesis of the study is that this worse prognosis seen in DFU patients may not be fully explained by a high cardiovascular risk, but mainly linked to different causes, including inflammatory, infectious and malignant conditions.

In addition, to conduct the first prospective, observational and multi-centre cohort of patients with DFU in France to evaluate the 5-years mortality rate, its causes and relevant prognostic determinants, the investigators will also assess all changes in health-related quality of life (HRQoL), and the economic impact related to DFU (cost of illness study) for the French healthcare system, using SNDS claims databases. A 3-year inclusion period will start during 2020, and each participant will be followed for 5 years or until death.

Eligibility Criteria:
Inclusion Criteria:

Adults with diabetes and DFU, defined as a foot skin ulceration or open LLA wound, measuring at least 5 mm of diameter, located below the malleolus, and induced by diabetic complications. In the case of an amputation before inclusion, the amputation stump will be considered as the main wound and not the wound that led to the amputation.

Exclusion Criteria:

* Acute or chronic lower-limb ischemia without open skin wound,
* Foot infection without open skin wound,
* Intercurrent disease prohibiting participation in an observational study,
* Pregnancy or breastfeeding
* Curatorship or guardianship
* Prisoners -- Patient currently participating to more than one other clinical study (interventional or observational, 2 study maximum including PDF) or currently participating to another study interfering with standard care of diabetic foot
Evaluation of Neoplasia with Artificial Intelligence in Gastrointestinal Endoscopy

This study aims to validate and evaluate AI algorithms for detection and characterization of early GI neoplasia.

This is an investigator initiated; multi-centre study and will be conducted in two phases. Validation \& Optimization phase, where routinely collected and anonymized endoscopic images and videos from the departmental teaching and training library will be used to validate, and if needed fine-tune and improve, the accuracy of an AI algorithm. Testing phase, where the evaluation of AI algorithms performance will be conducted on a prospective basis. The ground truth (standard) will be expert assessment and histological diagnosis.

This study has no direct impact on patient's clinical care, and collection of all endoscopic data will take place during standard endoscopy procedures done for purely clinical indications. No additional procedures, biopsies or interventions will be performed as a part of this study.

Eligibility Criteria:
Inclusion Criteria:

-The participant must meet ALL of the following criteria to be considered eligible for the study:

* Male or Female, aged 18 years or above.
* Requiring gastroscopy and/or colonoscopy to investigate gastrointestinal symptoms, or as part of screening or ongoing surveillance of GI neoplasia.
* Participant is willing and able to give informed consent for participation in the study.

Exclusion Criteria

The participant may not enter the study if ANY of the following apply:

* Patients with endoscopically active severe oesophagitis
* Poor bowel preparation
Colchicine in Moderate Symptomatic COVID-19 Patients

This is a prospective, double blind, randomized, placebo controlled clinical trial. The participants will be randomized into two groups (group A and group B). Patients of group-A are the treatment group. They will be treated with optimal treatment based on the algorithm proposed in National Guidelines on Clinical Management of Coronavirus Disease 2019 (Covid-19) Version 7.0, 28 May 2020, along with Colchicine for 14 days. The patients in group-B will be controlled group. They will be treated with optimal treatment based on the algorithm proposed in National Guideline along with a placebo.


Eligibility Criteria:
Inclusion criteria:

* Males and females of least 18 years of age and can swallow tablets
* Competent and willing to provide informed consent
* Patient must have received a diagnosis of COVID-19 infection with positive RT-PCR for SARS CoV-2 within the last 3 days
* Patients with moderate symptoms (According to National Guidelines on Clinical Management of Coronavirus Disease 2019 (COVID- 19).Version 7.0 .2020, DGHS, MOHFW, Government of the People's Republic of Bangladesh). Following features of moderate covid-19 must be present-

  1. Fever or history of fever
  2. Cough and /or Shortness of breath
  3. Oxygen saturation 94% or more
  4. Pneumonia -pulmonary consolidations on chest imaging (chest x ray or CT scan of chest) involving less than 50%of lungs
  5. CRB 65 score 0

Exclusion criteria:

* Pregnancy and breast-feeding
* Known hypersensitivity to colchicine
* Known chronic illness e.g hepatic failure, chronic kidney disease (eGFR\<30ml/min), decompensated heart failure, long QT syndrome (QTc \>450 msec.)
* Patient with inflammatory bowel disease (Crohn's disease or ulcerative colitis), chronic diarrhea or malabsorption
* Patient currently taking colchicine for other indications (mainly chronic indications represented by Familial Mediterranean Fever or gout)
* Patient undergoing chemotherapy for cancer
* Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma

With the development of endoscopic technology, endoscopic retrograde cholangiopancreatography (ERCP) has been widely used in the diagnosis and treatment of extrahepatic cholangiocarcinoma.In patients with extrahepatic cholangiocarcinoma, cytological brushing performed concurrently with ERCP had a lower pathologically positive rate and increased the times of ERCPs, increased the risk of postoperative complications at the same time.The present study aims to compare the efficacy and safety outcomes of Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma.

Endoscopic retrograde cholangiopancreatography (ERCP) has been used as the primary method for the diagnosis of biliary strictures and the treatment of extrahepatic cholangiocarcinoma. However, the accurate visual diagnosis of malignant biliary strictures and assessment of the extent of a lesion are not possible by ERCP, and treatment of extrahepatic cholangiocarcinoma by ERCP procedures is sometimes difficult. In patients with extrahepatic cholangiocarcinoma, cytological brushing performed concurrently with ERCP had a lower pathologically positive rate and increased the times of ERCPs, increased the risk of postoperative complications at the same time. Spyglass enables direct visualization of the biliary tract and the sampling of suspicious lesions, together with radiofrequency ablation.Endoscopic radiofrequency ablation (RFA) is an emerging technique for the palliation of inoperable malignant biliary strictures (MBSs). In a dozen published studies, this novel approach has shown better safety and feasibility, as well as improvement in overall survival (OS). The present study aims to compare the efficacy and safety outcomes of Spyglass+RFA Versus Cytobrush+RFA for Extrahepatic Cholangiocarcinoma.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years ;
* Patients with high suspicion of extrahepatic cholangiocarcinoma such as unexplained bile duct stenosis or elevated CA19-9 were found according to relevant imaging studies or symptoms;
* Willing to abide by the research procedures and sign the informed consent.

Exclusion Criteria:

* Myocardial infarction within 3 months;
* Renal insufficiency (Scr\>177 umol/L);
* Serious cardiovascular and cerebrovascular or respiratory diseases before surgery;
* Preoperative shock manifestations, such as hypotension ( Systolic blood pressure \<90mmHg) or increased heart rate (\>120 beats/min);
* Pregnancy and lactation;
* Allergic to NSAIDs; Other clinical observation trials or those who have participated in other clinical trials within 60 days;
* Cases deemed inappropriate by the investigator (such as those with clear contraindications to ERCP).
Pan-European Survey on the Under Treatment of Hypercholesterolemia

The survey try to establish the proportion of patients on lipid-lowering pharmacological treatment reaching the LDL-C goals according to the Third Joint European Task Force guidelines, overall and by country.·


Eligibility Criteria:
Inclusion Criteria:

* Patients had to be on a lipid-lowering drug treatment for at least 3 months, with no dose change for a minimum of 6 weeks.
EEG Monitoring in Children With Moyamoya Disease

EEG in moyamoya disease in children preoperatively

EEG monitoring in children with moyamoy disease preoperatively for 10 minutes

Eligibility Criteria:
Inclusion Criteria:

* moyamoya disease

Exclusion Criteria:

* refusal
Focused Assessment With Sonography in Trauma

The study evaluates the knowledge and attitude about Focused Assessment with Sonography in Trauma examination among medical students and medical staff in Poland.


Eligibility Criteria:
Inclusion Criteria:

* Give voluntary consent to participate in the study

Exclusion Criteria:

* not meet the above criteria