cyrilzakka/clinical-trials huggingface dataset:
A Study of PRO95780 in Combination With Rituximab in Patients With Non-Hodgkin's Lymphoma That Has Progressed Following Previous Rituximab Therapy (APM4083g)

This Phase II, single-arm, open-label, multicenter trial is designed to evaluate the safety, efficacy, and pharmacokinetics of PRO95780 when combined with rituximab in patients with follicular, CD20-positive B-cell NHL that has progressed following previous rituximab therapy.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent Form
* Age ≥ 18 years
* Diagnosis of follicular, CD20-positive B-cell NHL
* Progression of disease after an objective response or stable disease lasting \> 6 months following completion of the most recent rituximab-containing regimen
* Measurable disease
* Life expectancy of \> 3 months

Exclusion Criteria:

* Grade 3b follicular lymphoma (according to the WHO classification) or histologic transformation from follicular lymphoma to aggressive lymphoma
* Prior radiotherapy to a lesion(s) that will be used to assess response unless that lesion(s) shows clear evidence of lymphoma progression at baseline
* Radiotherapy to a peripheral lesion within 14 days prior to Cycle 1, Day 1 or radiotherapy to a thoracic, abdominal, or pelvic field within 28 days prior to Cycle 1, Day 1
* Concurrent systemic corticosteroid therapy
* Other invasive malignancies within 3 years prior to first study drug administration except for adequately treated basal or squamous cell skin cancer, in situ carcinoma of the cervix, in situ breast cancer, in situ prostate cancer, limited-stage bladder cancer, or other cancers from which the patient has been disease-free for at least 3 years.
* History or evidence on physical examination of central nervous system (CNS) disease
* Prior treatment with agonistic DR4 or DR5 antibodies or Apo2L/TRAIL
Main Postoperative Complications After COVID-19

To explore the relationship between SARS-CoV-2 infection in different time before operation and postoperative main complications (mortality, main pulmonary and cardiovascular complications) 30 days after operation; To determine the best timing of surgery after SARS-CoV-2 infection.


Eligibility Criteria:
Inclusion Criteria:

* Age≥18 years;
* Patients undergoing any type of elective or confine surgery in operating room;
* Informed consent.

Exclusion Criteria:

* Surgery under local anesthesia (without participation of anesthetist)
* Surgery outside the operating room, such as gastrointestinal endoscopy, puncture biopsy, etc
* Patients who cannot determine whether they have had SARS CoV-2 infection before surgery
* Participating in conflicting clinical study
Pharmacokinetics and Drug Interaction Study Between Rosuvastatin and Fenofibric Acid in Healthy Male Volunteers

The purpose of this study is to evaluate the pharmacokinetics profile and drug-drug interaction between rosuvastatin and fenofibric acid in healthy adult subjects


Eligibility Criteria:
Inclusion Criteria:

1. Healthy adult male volunteers aged 19 to 45 years
2. A sybject who has judged to be healthy by the investigator to participate in this study based on screening result
3. A subject who provided written informed consent to participate in this study and cooperative with regared to compliance with study related constraints

Exclusion Criteria:

1. A subject with sign or symptoms or previously diagnosed disease of liver, digestive system, cardiovascular, kidney, respiratory, endocrinology, neurology, immune system, hematology, and psychology function or other significant disease and history.
2. A subject who shows the following result in clinical laboratory test

   * AST, ALT \> 1.25 times of the upper limit of normal range
   * PR ≥ 210 msec
   * QRS ≥ 120 msec
   * QT ≥ 500 msec
   * QTcF ≥ 500 msec
3. Subject who has taken other clinical medication from another clinical trial within 60-day period prior to the first administration of the study medication
Bone Density in Patients With Schizophrenia

People with chronic mental disorder such as schizophrenia and alcohol abuse are high risk groups for developing osteoporosis.

To evaluate the prevalence of bone mineral density in men patients with schizophrenia with alcohol abuse, the investigators will compare bone mineral density between patient with schizophrenia with and without alcohol abuse.

People with schizophrenia has been known as a high risk groups for developing osteoporosis, because of lack of exercise, poor nutrition and high rate of smoking. Those with alcohol abuse may be higher risk group than one with schizophrenia without alcohol abuse, because they frequently have several medical problems such as liver dysfunction, Vitamin D deficiency, hyperparathyroidism and those medical condition increase risk for developing osteoporosis. Also alcohol itself can increase bone loss too by disturbing bone remodeling and enhancing bone fragility. To compare the prevalence of bone mineral density in patients with schizophrenia with alcohol abuse to those without alcohol problem, we will investigate BMD in large population of Korean patients with those illnesses.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis of schizophrenia
* Onset of illness more than 5 years.

Exclusion Criteria:

* No severe Medical and endocrinological disorder
Remote Ischemic Preconditioning as a New Method of Nephroprotection

Remote ischemic preconditioning (RIPC), elicited by brief episodes of ischemia and reperfusion in distant tissue, offers a protection against acute kidney injury (AKI) in patients after cardiac surgery. Investigators conducted a prospective, randomized, controlled clinical trial to assess whether RIPC reduces the incidence of AKI measured by standard way using serum creatinine concentration (SCr) and with use of serum level of neutrophil gelatinase-associated lipocalin (NGAL) as a new potential biomarker of a kidney injury. Moreover the aim of investigation was to analyse the safety and clinical outcomes of RIPC after elective, isolated, primary off-pump coronary artery bypass graft surgery (OPCAB).

Cardiac surgery patients have a high risk of AKI. The development of AKI is associated with higher mortality and a higher risk for complications in patients undergoing cardiac surgery. However, there are no effective clinical strategies for preventing prevalence of AKI. RIPC as a simple, inexpensive way of protecting tissues against ischemic damage, may also reduce kidney injury. That makes RIPC under the area of interests of many researches which apply this method to prevent AKI. Investigators conducted a single-center, double-blind trial involving patients at high risk of postoperative AKI, in which want to check wether RIPC reduce the prevalence of AKI, according Kidney Disease: Improving Global Outcomes (KDIGO) definition, by increase in SCr. Furthermore researchers want to investigate a benefit from RIPC in reduction of level of SCr and higher glomerular filtration rate (GFR) 72 hours after off-pump coronary artery bypass as well as reduction of postoperative expression of NGAL an early biomarker of AKI.

Eligibility Criteria:
Inclusion Criteria:

* Human patients with coronary artery disease.

Exclusion Criteria:

* history of cardiac surgery,
* acute myocardial infarction up to 7 days before surgery,
* chronic kidney disease in 4th or 5th stadium (eGFR\<30 ml/min/1,73m2),
* peripheral vascular disease affecting upper limbs,
* history of severe injuries and surgeries in 2 months before cardiac surgery,
* history of cancer, acute inflammation during hospitalization,
* chronic autoimmunology diseases,
* dialysis patients.
Safety and Performance of the Cardiovalve TR Replacement System

The objective of this study is to evaluate the safety and performance of Cardiovalve TR system

The study is a multi-center, prospective, single arm study designed to evaluate the safety and performance of the Cardiovalve Tricuspid Valve Replacement System

Eligibility Criteria:
Inclusion Criteria:

* Functional TR ≥3+
* Symptomatic, NYHA Class II-IVa
* Patient approved by the Subject Screening Committee

Exclusion Criteria:

* Cardiac anatomy deemed not suitable for the Cardiovalve TR system
* Hemodynamic instability
* Severe right ventricular failure
* Refractory heart failure requiring advanced intervention
Chinese Cohort Study of Coronary Heart Disease

Construction of coronary heart disease cohort of more than 10000 patients in China. Investigation on current situation of secondary prevention of CHD will be carried out and the effect of physician training and patient education will be evaluated.

More than 40 hospitals of 16 provinces will enroll patients for this study. The study will include patients with diagnosed coronary heart disease. Investigators and all the physicians who will involve in daily care of CHD patients will have a brief training on guideline of secondary prevention in CHD and take a test on that. Questionnaires are used to evaluate patient's cognition of their diseases and knowledge on coronary heart disease. Patient education will be carried out during a 2 years follow up of all the patient enrolled before they are required to fill out another questionnaire. Physicians will also take a second test on secondary prevention of CHD at that time. Patients will take blood lipids and glucose test according to their physician's requirement.The effect of physician training and patient education will be evaluated by comparing the results of questionnaires and tests at the beginning of the study and in the end of the 2 years follow up.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed coronary heart disease
* Confirmed by coronary angiography;
* Diagnosed myocardial infarction;
* Typical symptom of ischemic chest pain with positive stress test;
* Willing to sign an inform consent.

Exclusion Criteria

* Patients won't sign an inform consent or will not comply with the follow up.
A Clinical Study to Assess the Effect of Enlicitide on How the Body Processes Digoxin in Healthy Adult Participants (MK-0616-031)

Researchers have designed a new study medicine called enlicitide decanoate as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood. Enlicitide decanoate will be called "enlicitide" from this point forward.

The purpose of this study is to learn the effect of this new study medicine enlicitide on digoxin (medicine used in heart disease) over time (a pharmacokinetic or PK study). Researchers will compare what happens to digoxin in the body over time when it is given with this new study medicine enlicitide in healthy adult participants.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Is in good health before randomization
* Has a body mass index (BMI) ≥18 and ≤32 kg/m\^2, inclusive

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of clinically significant psychiatric, immunological, gastrointestinal, cardiovascular abnormalities or diseases.
* Has a history of cancer.
* Has positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at the screening visit.
Classic vs. High-Fat Intermittent Fasting Effects

Poor eating habits contribute to weight gain and obesity, leading to numerous metabolic issues such as diabetes and cardiovascular diseases. The treatment of obesity involves lifestyle interventions that include dietary and nutritional modifications, physical activity, and behavioral therapy. Literature supports both carbohydrate and fat restriction in the treatment of obesity. In low-carbohydrate diets, less than 40% of energy is sourced from carbohydrates.Besides the dietary model, individual eating behavior can also influence the diet's outcomes. There is a significant relationship between eating behavior and food choices. Given that food choices can impact diet satisfaction, evaluating eating behavior is important when assessing dietary compliance.The literature includes studies demonstrating the effects of a classic intermittent fasting diet. However, no studies have compared the potential effects of intermittent fasting models based on the macronutrient distribution within their content. Therefore, this study aims to evaluate the effects of high-fat, low-carbohydrate intermittent fasting versus classical intermittent fasting on body composition, eating behavior, and diet satisfaction.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* no chronic disease
* female
* volunteering

Exclusion Criteria:

* hypoglycemia
* eating disorders
* pregnant and lactating women
The Effect of Aerobic Exercise on Lower Urinary System Symptoms in Women With Diabetes Mellitus

The goal of this clinical trial is to investigate the effect of aerobic exercise (AE) on bladder functions and urinary system symptoms in women diagnosed with Diabetes Mellitus (DM) and suffered from Lower Urinary Tract Symptoms (LUTS). In the study, 44 individuals (35-55 age) were divided into two groups: Aerobic Exercise (AE) (n=22) and Control Group (n=22) by simple random method.

The main questions it aims to answer are:

* Is aerobic exercise effective on bladder functions in women diagnosed with Diabetes Mellitus and suffered from Lower Urinary Tract Symptoms?
* Is aerobic exercise effective on urinary tract symptoms in women diagnosed with Diabetes Mellitus and suffered from Lower Urinary Tract Symptoms?
* Is aerobic exercise effective on quality of life in women diagnosed with Diabetes Mellitus and suffered from Lower Urinary Tract Symptoms?

Intervention/treatment

* Control group individuals will be given a behavioral treatment program.
* Submaximal aerobic exercise training will be given to the AE group in addition to the behavioral treatment program.

The goal of this clinical trial is to investigate the effect of aerobic exercise (AE) on bladder functions and urinary system symptoms in women diagnosed with Diabetes Mellitus (DM) and suffered from Lower Urinary Tract Symptoms (LUTS). In the study, 44 individuals (35-55 age) were divided into two groups: Aerobic Exercise (AE) (n=22) and Control Group (n=22) by simple random method. Bladder sensation (first sensation) and compliance from urodynamic evaluations will be taken as reference as the primary outcome measurement in treatment effectiveness.

* Control group individuals will be given a behavioral treatment program.
* Submaximal aerobic exercise training will be given to the AE group in addition to the behavioral treatment program.

AE training was provided three days a week, 45 minutes a day, for 12 weeks. The behavioral treatment protocol was completed with an initial training period of 40 minutes, and subsequent control interviews of 20 minutes at four-week intervals.

Eligibility Criteria:
Inclusion Criteria:

* Women between the ages of 35-55,
* Individuals who volunteer to participate in the study,
* Those diagnosed with Type II diabetes for 5 years or more and those diagnosed with LUTS

Exclusion Criteria:

* Stage 2 and more advanced pelvic organ prolapse,
* Urinary tract infection,
* Has had previous surgery for urinary incontinence and pelvic organ prolapse,
* Diagnosis of Cerebro Vascular Event (CVE) and dementia,
* Using A-blockers, antimuscarinics, antidepressants, diuretics and antihistamines,
* Individuals in menopause.
Communicating About Choices in Transplantation

The purpose of this study is to test the impact of a newly developed educational program on kidney transplant candidates' communication about living and deceased donor kidney transplantation.

The Communicating about Choices (COACH) in Transplantation program educates patients with end stage renal disease, who are waitlisted for kidney transplantation, about kidney disease and the risks, benefits and processes for both living and deceased donor transplantation. The program also teaches key communication skills needed to effectively initiate and manage conversations about transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Wait listed for kidney transplantation in active status
* Adult (at least 18 years of age)
* English speaking
* Capable of making medical decisions (i.e., not cognitively impaired)
* Non-institutionalized

Exclusion Criteria:

* Not listed for kidney transplantation
The Efficacy of Diclofenac Gel for Breakthrough Pain and the Neuropathic Components of Pain in Knee Osteoarthritis

The purpose of this proposed study is to conduct a trial with knee osteoarthritis (OA) patients using the diclofenac gel.

The purpose of this proposed study is to conduct a trial with knee OA patients using the diclofenac gel. The effectiveness of diclofenac gel in managing breakthrough pain or the neuropathic components of pain (e.g., the burning, soft tissue joint sensitivity, or allodynic components) in knee OA is unknown. It is likely that patients will use the gel in a as needed (prn) fashion, on top of other analgesics prescribed for their pain. The neuropathic components of a generally nociceptive or inflammatory condition, such as knee OA, are underappreciated, and typically not tracked in OA analgesic studies. Yet, evidence across a variety of chronic painful conditions suggests that these components are quite disabling. The results of this study would show whether diclofenac gel as a prn medication is beneficial to patients suffering from knee OA pain.

Eligibility Criteria:
Inclusion Criteria:

* Ages 20-75
* Unilateral or bilateral knee osteoarthritis (OA), confirmed radiographically.
* Patients taking oral non-steroidal anti-inflammatory drugs (NSAIDs) in the amount and schedule prior to the breakthrough period will be permitted.

Exclusion Criteria:

* Patients with clinical history of anterior cruciate ligament (ACL) involvement.
* Patients on tricyclic antidepressants or anticonvulsants (neuropathic medications)
* History of ulcers or gastrointestinal (GI) bleeding
* Coagulation disorders
* Hypersensitivity to Aspirin or NSAIDS
* Congestive Heart Failure and Edema
* Advanced renal disease
* Aspirin triad
* Pregnant women
Sunitinib Plus Prednisone In Patients With Metastatic Castration-Resistant Prostate Cancer After Failure Of Docetaxel Chemotherapy

This study will compare the safety and efficacy of sunitinib in combination with prednisone versus placebo and prednisone in patients that have metastatic castration-resistant prostate cancer that has progressed after treatment with a docetaxel-containing chemotherapy regimen. This is a second-line study.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate.
* Progressive, metastatic castration-resistant prostate cancer after failure of docetaxel chemotherapy (resistant or intolerant).
* Progressive disease based on PSA progression, RECIST, or positive bone scan.
* ECOG 0 or 1.

Exclusion Criteria:

* Prior treatment with sunitinib and/or more than 1 prior chemotherapy regimen in the metastatic disease setting.
* Chemotherapy within 3 weeks.
* Impending complications from bone metastases.
* Ongoing urinary obstruction.
* Cardiac dysfunction, QTc \>470 msec.
* CNS involvement.
Study to Validate a Computerized Neuropsychological Test Battery

This study is comparing a new computer-based method of administering neuropsychological tests to the standard method of verbal and paper/pencil tests administered in person by an examiner. The purpose of the research is to determine if the computerized and standard testing methods are equivalent.

Cognitive decline is one of the primary symptom triad of Normal Pressure Hydrocephalus (NPH). Neuropsychological measures have been demonstrated as being effective in the diagnosis of NPH, and in assessing the efficacy of treatment intervention. Hence, neuropsychological assessment is a critical component in the assessment for the presence of NPH. Specifically, measures of attention/concentration, fine motor skills, executive functioning abilities, speed of processing and memory have been found to be useful in the assessment of NPH and treatments thereof.

Neuropsychologists are typically found in large hospitals, academic centers and in urban locations. Neuropsychologists are under represented in rural or low population centers. At the present time, cognitive assessment is frequently limited to a Mini Mental Status Examination. Furthermore, neuropsychological testing can be very expensive for patients, given insurance constraints. Finally, there is no standardized test battery that is used in different centers treating this patient population. The creation of a standard battery that could be used in other NPH centers would promote research collaboration.

A computerized neuropsychological test battery was developed in Umea, Sweden with the specific goal of using tests that are considered to be sensitive to the cognitive profile observed in NPH. The battery was developed in JAVA and Adobe Flash making it platform independent (Runs on Mac, Windows and Linux). The test battery is administered on a touch screen display, where the tests are presented through animations with audio instructions. Before the real test trails are administered, subjects are given practice trials with auditory and visual feedback. For the American version of the test, the auditory stimuli have been translated and recorded in English.

Eligibility Criteria:
Inclusion Criteria:

* Age 60-80

Exclusion Criteria:

* Neurological disorder that results in motor or cognitive dysfunction
* Perceptual or motor difficulties that would prevent subjects from taking the assessment
* MMSE score \<20
* MoCA score \<26
* MAS score \>9
* Significant abnormal neurologic examination findings
Timing of Corticosteroids in COVID-19, II. Post COVID-19 Follow-up

Timing of of corticosteroids administration is very important in COVID19 cases for the recovery and decrease the mortality.

The sickest patients with COVID-19 suffer a hyperinflammatory state-a cytokine storm-that has features in common with a rare haematological condition called haemophagocytic lymphohistiocytosis. Immune suppression should help such patients. By contrast, immune suppression during the early phase of the viral infection might allow increased viral replication and aggravate the disease.

The 3C-like proteinase on SARS-CoV-2 (nsp5) inhibits HDAC2 transport into the nucleus, and so impairs the way in which it mediates inflammation and cytokine responses, so activation of histone deacetylase by dexamethasone may directly oppose the action of SARS-CoV-2.

Timing of of corticosteroids administration is very important in COVID19 cases for the recovery and decrease the mortality.

Eligibility Criteria:
Inclusion Criteria:

* any case with COVID-19 more than or equal to 18 years
* mild and moderate severity

Exclusion Criteria:

* Severe to critical COVID-19
* Any contra-indication for the interventional drug
* Mentally disabled cases
EMBRACE1: Prostate Biorepository

The objective of this multi-center prospective observational clinical study is to evaluate the clinical performance of the Carisome Prostate assay as an aid in the diagnosis of prostate cancer in men that have been scheduled for a prostate biopsy. Primarily, results of the Carisome Prostate assay will be compared with pathology results of prostate biopsy procedures. Secondarily, the performance of the Carisome Prostate test will be compared to the current standard of care for the detection of prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Men scheduled for a routine prostate biopsy expected to produce a pathology evaluation and report
* Blood draw within 7 days prior to scheduled prostate biopsy procedure
* Blood draw on the day of but prior to biopsy

Exclusion Criteria:

* Any previous diagnosis of cancer with the exception of non-melanoma skin cancer
* Any prior or ongoing treatment for prostate cancer including prostatectomy or hormone therapy
* Prostate biopsy within one month of blood draw
* Previous enrollment in the Caris Life Sciences Biorepository