cyrilzakka/clinical-trials huggingface dataset:
FITBIT Study on Mobility and Readmissions After Radical Cystectomy

This is a two-arm randomized, controlled trial during the postoperative period after major abdominal surgery for cancer, including for example radical cystectomy, nephrectomy, colectomy, comparing a control group that uses a wearable device to track physical activity to an intervention group that uses the same wearable devices and receives a supportive social incentive-based gamification intervention to adhere to a step goal program.

We will conduct a two-arm randomized, controlled trial during the postoperative period after a radical cystectomy for bladder cancer, comparing a control group that uses a wearable device to track physical activity to an intervention group that uses the same wearable devices and receives a supportive social incentive-based gamification intervention to adhere to a step goal program. Patients will be enrolled after being diagnosed with bladder cancer and scheduled to undergo a radical cystectomy. The median length of stay after a radical cystectomy is 8 days, with 90% being discharged within two weeks. Postoperatively, the baseline step count will be averaged by taking the steps taken during the first two days outside of the intensive care unit. There will be two postoperative phases: Phase I will be while the patient is hospitalized postoperatively. Phase II will be when the patient is discharged for three months.

5.2 Study

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* diagnosis of cancer undergoing definitive surgical treatment

Exclusion Criteria:

* Inability to provide consent
* does not have daily access to a smartphone compatible with the wearable device and not willing to use a device that the investigators can provide them
* any other medical conditions that would prohibit participation in a physical activity program
Suicide Risk Scale and Distress Intervention for the Patients With Chronic Medical Illness or Physical Disabilities

The aims of this study are developments of distress intervention and a suicidal risk scale for the patients with chronic medical illness or physical disabilities. To do these things, four times of interview \& completion of self-report scale will be done, and newly developed distress intervention will be simulated to subject group and control group.

The aims of this study are developments of distress intervention and a suicidal risk scale for the patients with chronic medical illness or physical disabilities.

To achieve the aims, multidisciplinary team is organized such as doctors of internal medicine, rehabilitative medicine, psychiatrist specialized in psychosomatics, psychologist, nurse, social worker and researchers.

Before developing the intervention and scale, review of literature about intervention, suicide, management system of chronic illness, several scales and others are done. Also, qualitative interview and self report scale with those patients are done to figure out what bothers them most, how they feel, and what kind of help they need.

Based on collected data, means of intervention is carefully selected and further review of literature is proceeded. Also, questions which describe patients' feeling, discomfort, and need are made. Moreover, modified management system of chronic illness is planned to develop to link between those who need help among patients and multidisciplinary team members.

Once, the intervention is developed, subject group and control group are recruited in stroke patients, and the intervention is simulated. The change of distress is measured before and after the intervention, and 1 month later the intervention is finished with several tools such as WHOQOL-BREF, Perceived Stress Scale, Rosenberg Self-Esteem Scale, Acceptance of Disability Scale, Participation Scale, Pain Belief \& Perception Inventory, Insomnia Severity Index, FACIT-Fatigue, Hospital Anxiety and Depression Scale, digit span, trail making test, stroop test, verbal fluency test.

Also, newly developed questions and other scales are performed among patients to determine whether the newly developed questions are appropriate and how well they reflect their difficulties and feelings. After selecting the appropriate questions, the revised version will be tested by the patients twice in a different time frame.

If the revised version is appraised appropriate, it will be distributed as a cell phone application.

Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic illness or physical disabilities (Heart failure, Chronic kidney disease, Stroke patients)

Exclusion Criteria:

* Patients who have other severe illness such as cancer, severe memory impairment or intellectual disabilities and others
Exercise and Diet Intervention in Promoting Weight Loss in Obese Patients With Stage I Endometrial Cancer

This pilot clinical trial studies exercise and diet intervention in promoting weight loss in obese patients with stage I endometrial cancer. Exercise and diet may cause weight loss and minimize the risk of gynecologic surgery related to being overweight in patients with endometrial cancer.

PRIMARY OBJECTIVES:

I. To determine if participation in a 16-week exercise and diet intervention would elicit weight loss, assessed by a 10% decrease in fat mass, in endometrial cancer (EC) patients.

SECONDARY OBJECTIVES:

I. To determine if participation in a 16-week exercise and diet intervention would improve cardiorespiratory fitness (CRF) and muscular strength.

TERTIARY OBJECTIVES:

I. To determine if participation in a 16-week exercise and diet intervention could improve quality of life (QOL), fatigue, and depression.

II. To determine the effects of a 16-week exercise and diet intervention on cardiovascular (CV) health.

OUTLINE:

Patients undergo aerobic exercise thrice weekly over 95 minutes for up to 16 weeks. Patients also undergo multi-lifestyle interventions based on the dietary approaches to stop hypertension (DASH) diet once weekly over 1 hour for up to 16 weeks.

After completion of study, patients are followed up for 16 weeks.

After completion of study, patients are followed up for 16 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Clinical stage I EC
* Low grade disease positive for estrogen and progesterone receptors
* Body mass index (BMI) \>= 30 kg/m\^2
* No history of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
* Self ambulatory and without use of assistive walking devices
* Is not a candidate for immediate hysterectomy, following evaluation by a physician, due to desire to preserve fertility, due to degree of obesity, due to comorbidities, or due to patient refusal of hysterectomy
* Must agree to take progestin agents (i.e., oral agents or MIRENA intrauterine device \[IUD\] which are accepted treatments for low grade uterine malignancies to control their disease while the intervention is ongoing)

  * Note: potential participants WILL NOT be asked to delay surgery to participate in this pilot study

Exclusion Criteria:

* Patients with metastatic disease
* BMI =\< 29.9 kg/m\^2
* History of any musculoskeletal, cardiorespiratory or neurological diseases that preclude the participation in exercise
* Is not self ambulatory and relies on the use of assistive walking devices
* Is a candidate for immediate hysterectomy, following evaluation by a physician
* In judgement of a physician, is not a candidate for progestin agents
The Relationship Between Epicardial Fat Tissue and Cardiac Function in HFpEF Patients

Heart failure with preserved ejection fraction (HFpEF) refers to a group of symptoms and signs of heart failure, normal or near-normal left ventricular systolic function (EF\>50%), and ventricular muscle diastolic dysfunction and A clinical syndrome characterized by decreased compliance and increased stiffness. The pathogenesis of HFpEF is related to impaired lipid metabolism and inflammation. Epicardial adipose tissue (Epicardial Adipose tissue, EAT) is a kind of visceral adipose tissue. Related studies have shown that extracardiac Membrane fat is related to inflammation markers, cardiometabolic risk and cardiovascular disease.However, there is still no research investigating the the relationship between epicardial fat thickness and Cardiac Function in HFpEF patients.

Heart failure with preserved ejection fraction (HFpEF) refers to a group of symptoms and signs of heart failure, normal or near-normal left ventricular systolic function (EF\>50%), and ventricular muscle diastolic dysfunction and A clinical syndrome characterized by decreased compliance and increased stiffness. The pathogenesis of HFpEF is related to impaired lipid metabolism and inflammation. Epicardial adipose tissue (Epicardial Adipose tissue, EAT) is a kind of visceral adipose tissue, which is composed of adipose tissue deposited between the myocardium and the visceral layer of the pericardium. It is closely adjacent to the coronary arteries and myocardium. Related studies have shown that extracardiac Membrane fat is related to inflammation markers, cardiometabolic risk and cardiovascular disease.However, there is still no research investigating the the relationship between epicardial fat thickness and Cardiac Function in HFpEF patients. This study intends to observe the relationship between epicardial fat thickness and left and right functions in patients with HFpEF, and evaluate whether epicardial fat thickness can be used as an indicator of left and right dysfunction.

Eligibility Criteria:
Inclusion Criteria:

* Adult aged \>=18years old;
* Diagnosed with HFpEF.

Diagnostic criteria including:

1. left ventricular ejection fraction ≥50%；
2. with the symptoms and/or signs of heart failure；
3. BNP≥35 pg/mL and/or NTproBNP≥125 pg/mL；
4. at least one additional criterion: relevant structural heart disease(LVH and/or LAE) or diastolic dysfunction

Exclusion Criteria:

* LVEF less than 45% at any time;
* Severe liver failure;
* Primary pulmonary hypertension;
* Age \<18 years old.
A Clinical Trial to Evaluate the Safety and Pharmacokinetics of AJU-C52L in Healthy Volunteers

To evaluate the safety and pharmacokinetic characteristics of AJU-C52L in healthy adults

This study is to assess the safety and pharmacokinetic characteristics between co-administration of C52R1H with C52R2 and administration of AJU-C52L.

This is an open-label, randomized, single-dose, 2x2 crossover study in healthy subjects to assess the bioequivalence after taking the study drugs.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult volunteers aged ≥ 19-year-old
2. Weight ≥ 50kg (man) or 45kg (woman), with calculated body mass index(BMI) of 18 to 30 kg/m2
3. Those who are eligible for adequate blood pressure criteria during screening tests Systolic blood pressure: 90 to 139 mmHg Diastolic blood pressure: 60 to 89 mmHg
4. Those who have no congenital chronic disease or chronic disease requiring treatment and who have no pathological symptoms or findings
5. Those who are eligible for clinical trials based on laboratory (hematology, blood chemistry, serum, urine test) and 12-lead ECG results during screening tests
6. Those who agree to contraception during the participation of clinical trial
7. Those who voluntarily decide to participate and agree to comply with the cautions after hearing and fully understanding the detailed description of this clinical trial

Exclusion Criteria:

1. Those who received investigational product or bioequivalence test drug within 6 months before the first administration of clinical trial drug
2. Those who take barbiturate and related (causing induction or inhibition of metabolism) drug within 1 month before the first administration of clinical trial drug
3. Those who donated whole blood and apheresis within 8 weeks or received transfusion within 4 weeks
4. Those who has a history of gastrointestinal surgery
5. Those who exceeding an alcohol and smoke consumption criteria Alcohol: Men - 21 glass/week, Women - 14 glass/week (1 glass: Soju 50 mL, Beer 250mL, Wine 30 mL) Smoke: 20 cigarettes/day
6. Those who has a disease history of diabetic mellitus, nephropathy, biliary obstruction, dihydropyridine sensitivity, angioedema
7. Genetic problems such as galactose intolerance, Lapp lactose deficiency or glucose-galactose malabsorption
8. Those who are deemed unfit by the investigators to participate in the clinical trial for other reasons including the results of laboratory tests
9. Women who are pregnant or who may be pregnant and breastfeed
Procedural Outcomes in Endobronchial Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) With and Without Rapid On-Site Evaluation (ROSE)

The objective of this study is comparing the attributable procedural time of Endobronchial Ultrasound - Transbronchial Needle Aspiration (EBUS-TBNA) when sampling mediastinal and hilar lymph nodes with or without Rapid On-Site Evaluation (ROSE). The primary outcome will be the time elapsed from EBUS bronchoscope insertion to bronchoscope withdrawal. Secondary outcomes will include total number of sampled lymph nodes, average number of needle aspirations per lymph node sampled, overall diagnostic yield, and procedural time of the cytopathologist.


Eligibility Criteria:
Inclusion Criteria:

1. Subject provides informed consent
2. Subject is \>18 years of age
3. Subject is scheduled to undergo flexible bronchoscopy with EBUS-TBNA of suspected enlarged mediastinal or hilar lymph nodes as part of their standard medical care
4. A negative pregnancy test in women of child-bearing potential
5. Subject is mentally capable of following study directions

Exclusion Criteria:

1. Study subject has any disease or condition that interferes with safe completion of initial or follow-up assessments
2. Concurrent participation in another study involving investigational drugs or investigational medical devices
3. Inability to read and understand the necessary study documents
Dextenza vs Prednisolone Acetate After Cataract Surgery for Patients With Diabetes

This study aims to compare the effectiveness of Dextenza vs standard of care prednisolone taper after cataract surgery in diabetic patients with regards to controlling post-op inflammation at post-op days 7, 14, and 30.

The inflammation after cataract surgery is controlled at the investigators' institution by a taper of prednisolone acetate 1%, which consists of four drops daily for one week, followed by three drops daily for one week, then two drops daily for one week, then one drop daily for one week. Due to the frequency of drops needed after cataract surgery, compliance with the post-op regimen often wavers. This study aims to evaluate the efficacy of Dextenza, which has been shown to be better than placebo after cataract surgery (1), against prednisolone acetate taper. If shown to be as effective without compromising safety, it could be a very convenient alternative to prednisolone acetate taper. Furthermore, if Dextenza is shown to be as effective as prednisolone taper in diabetic patients, it could be logically generalized that it would be effective in patients without diabetes as well, as patients without diabetes (and with no confounding risk factors, such as a history of uveitis) are less prone to developing post-op macular edema. Risks are minimal for this FDA approved treatment and include iridocyclitis (10%); intraocular pressure increased (6%); visual acuity reduced (2%); cystoid macular edema (1%); corneal edema (1%); eye pain (1%) and conjunctival hyperemia (1%). These risks are comparable to prednisolone acetate.

Eligibility Criteria:
Inclusion Criteria:

* Patients with diagnosed diabetes
* Patients must be undergoing cataract surgery in each eye
* Patients must have no worse than moderate nonproliferative diabetic retinopathy

Exclusion Criteria:

* Patients must not have any history of documented macular edema on OCT
* Patients must not have any macular edema on pre-op OCT
* Patients must not have any history of uveitis
* Patients must not have severe nonproliferative or proliferative diabetic retinopathy
* Patients with operative complications will be excluded from this study
* Patients with any active corneal disease, infectious or rheumatologic, will be excluded
* Patients must not be pregnant
Obesity Surgery and Kidney Transplant for Patients with Obesity and Renal Failure

Gastric Bypass followed by renal transplantation is superior to medical management followed by renal transplant for patients with severe obesity and renal failure.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index 40-55 kg/m2
* Age less than 60 years
* Available support person
* Adequate insurance
* All other criteria required for renal transplantation

Exclusion Criteria:

* Schizophrenia
* Bipolar disorder
* Crohn's disease
* Human Immunodeficiency Virus
* Cirrhosis
* Prior weight loss surgery
* Prior mesh hernia repair
* Prior anti-reflux surgery
* Inability to walk 200 feet
* Significant coronary disease
* Significant lung disease - Fixed expiratory volume 1 less than 75% or on oxygen
* Addiction to alcohol or drugs
* Inability to quit smoking
* Jehovah's witness
* Non-compliance with dialysis regimen
* Previous renal transplant
* Non-English speaking
A Study of Tirzepatide at Different Injection Sites in Participants With Different Body Sizes

The purpose of this study is to compare the amount of tirzepatide that gets into the blood stream and how long it takes the body to get rid of it, when injected under the skin of the upper arm and thigh compared to the abdomen. The study will be conducted in healthy males and females with different body sizes. The tolerability of tirzepatide will be evaluated and information about any side effects experienced will be collected. For each participant, the study will last about 20 weeks, including screening.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or females of nonchildbearing potential as determined by medical history, physical examination, and other screening procedures
* Are between the body mass index (BMI) of 18.5 and 45.0 kilograms per meter squared (kg/m²), inclusive, at screening
* Are agreeable to receiving study treatment by injections under the skin

Exclusion Criteria:

* Have known allergies to tirzepatide or related compounds
* Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
* Have a history or presence of pancreatitis (history of chronic pancreatitis or idiopathic acute pancreatitis), elevation in serum amylase or lipase or gastrointestinal (GI) disorder (eg, relevant esophageal reflux or gall bladder disease) or any GI disease which impacts gastric emptying (eg, gastric bypass surgery, pyloric stenosis, with the exception of appendectomy) or could be aggravated by glucagon-like peptide-1 (GLP-1) analogs or dipeptidyl peptidase IV (DPP-IV) inhibitors
* Have a prior history of malignant disease(s) in the past 5 years prior to screening
* Smoke more than the equivalent of 10 cigarettes per day
* Is a known user of drugs of abuse
Pharmacogenetic Testing of Patients With Unwanted Adverse Drug Reactions or Therapy Failure

Genetic makeup of a patient influences the efficacy and safety profile of a drug. This study is to summarize individual cases, where Pharmacogenetics (PGx) has been applied during pharmaceutical care. The primary objective is the compilation of case reports, where pharmacogenetic testing is applied to determine the hereditable component of the patient's susceptibility to experience therapy failure and/or adverse drug reactions. The experience with the compiled cases will be basis for the development of a reliable standard of procedure for pharmacogenetic testing in the community pharmacy. The cases will be supplemented with information on additional Parameters reported in the literature to affect efficacy or safety of the respective drug.

Genetic makeup of a patient influences the efficacy and safety profile of a drug. This study is to summarize individual cases, where Pharmacogenetics (PGx) has been applied during pharmaceutical care. Health-related data of patients experiencing therapy failure (TF) or adverse drug reaction (ADR) is collected and will then be supplemented with pharmacogenetic testing during pharmaceutical care in a study pharmacy. The patient data (diagnoses, medications and results of pharmacogenetic testing) is harmonized in order to generate a compilation of case reports. The primary objective is the compilation of case reports, where pharmacogenetic testing is applied to determine the hereditable component of the patient's susceptibility to experience therapy failure and/or adverse drug reactions. The experience with the compiled cases will be basis for the development of a reliable standard of procedure for pharmacogenetic testing in the community pharmacy. The cases will be supplemented with information on additional Parameters reported in the literature to affect efficacy or safety of the respective drug.

Eligibility Criteria:
Inclusion Criteria:

* New medication with known PGx association (preemptive)
* Current medication with observation of adverse drug reactions probably linked to drugs with known PGx association (reactive)
* Current medication with observation of therapy failure probably linked to drugs with known PGx association (reactive)
* Current and/or new medication and a family history of adverse drug reactions/therapy failure probably linked to drugs with known PGx association
* Signed informed consent

Exclusion Criteria:

* Insufficient German knowledge
* Not able to personally visit to the study pharmacy
Melatonin for Patients with Chronic Low Back Pain

Low back pain is one of the conditions causing more disability worldwide. The use of pain medications is substantial in patients with chronic LBP. But the efficacy of commonly used analgesics is modest. More than half of patients with chronic LBP also has sleep problems. In recent years, some preliminary studies have shown a promising effect of melatonin for the treatment of pain.

The objective of this study is to investigate the efficacy of melatonin, relative to placebo, in patients with chronic LBP.


Eligibility Criteria:
Inclusion Criteria:

* age 18-65
* understand and write Dutch
* LBP for 3 months or longer
* LBP must be present on 'most days' or 'every day' within the past 3 months
* LBP must limit life or work activities on 'some days', 'most days', or 'every day' within the past 3 months
* average LBP intensity of ≥4 on a 0-10 NRS in the past 7 days

Exclusion Criteria:

* LBP resulting from a specific cause such as malignancy, fracture, lumbar radiculopathy and spinal stenosis
* Radiating pain into the leg that goes further (down) than the knee
* Inflammatory/autoimmune arthritis
* Severe physical or psychiatric co-morbidities
* Contraindications to melatonin