cyrilzakka/clinical-trials huggingface dataset:
Pilot Study of Loop Diuretics Among Individuals Receiving Hemodialysis

Individuals with kidney failure receiving maintenance hemodialysis (HD) have high mortality rates, driven largely by cardiovascular causes. Volume-related factors are critical, modifiable contributors to cardiovascular complications. Reversing volume overload has been shown to improve blood pressure and cardiac remodeling. Use of loop diuretics may represent a pragmatic, low-cost, and low-burden strategy to improve outcomes in people receiving HD. Lack of data on optimal furosemide dosing, safety, and acceptability are barriers to expanded use. This study investigates whether oral furosemide is safe and effective at increasing urine volume in HD patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient self-report of at least 1 cup urine/24-hours
* Age ≥18 years
* Receipt of thrice weekly in-center HD at a participating clinic (UNC-associated Carolina Dialysis- Carrboro, Siler City, Pittsboro, Sanford, and Lee County)
* ≥60 days receiving in-center HD
* Willingness to take study medication and undergo study testing
* Ability to provide informed consent

Exclusion Criteria:

* Known allergy to loop diuretic
* History of poor adherence to HD or medical regimen per nephrologist
* \>1 hospitalization in prior 30-days
* Frequent hypotension (systolic BP \<80 mmHg at \>30% of HD treatments in prior 30-days)
* Cirrhosis per nephrologist
* Hearing disorder per nephrologist
* Serum potassium \<3.5 mEq/L, magnesium \<1 mg/dL, or corrected calcium \<8 mg/dL in prior 30-days
* Taking a non-loop diuretic (e.g. spironolactone, eplerenone, ethacrynic acid, thiazides)
* Taking an aminoglycoside, cisplatin, methotrexate, cyclosporine, adrenocorticotropic hormone (ACTH), lithium, phenytoin, or oral/intravenous steroid
* Natural licorice consumption
* Prisoners, patients with significant mental illness
* Pregnant patients and nursing mothers
Testing the Neuroscience of Guided Learning in Depression

Major depression is a prevalent and impairing illness. To better understand the basic science and treatment of depression, the investigators study the behavioral and brain processes associated with learning in depression and how potential disruptions in learning may be repaired. Understanding different methods that change learning may lead to novel treatments that contribute to recovery in people with depression.

Major depressive disorder ranks among the most significant causes of mortality and disability in the world. Recent data from the investigators and others highlight that impairments in reward and loss learning are central to depression, have distinct neural substrates, and improve with successful treatment. Together, these findings suggest an urgent need to delineate the relationships among neural and behavioral learning impairments and depression. Equally important, these insights suggest new targets for treatment such that manipulating the neural and behavioral substrates of learning may facilitate symptom change in depression.

To address these issues, the investigators use functional neuroimaging and a computational psychiatry framework to i) systematically characterize the neural and behavioral substrates that attend reward- and loss- learning in depression and ii) assess the degree to which learning in depression responds to two behavioral methods that target learning in different ways. The investigators test the broad hypotheses that i) that depression may be characterized by distinct neural and behavioral disruptions of learning, and ii) these disruptions and associated symptoms may be ameliorated through different methods of guiding learning. Recent advances in computational psychiatry provide a mechanism-based framework within which to understand the nature and trajectory of potential learning impairments in depression and suggest new ways that disrupted learning and associated symptoms may be improved in depression

Eligibility Criteria:
Inclusion Criteria:

* males and females of all ethnicities
* meet diagnostic criteria for major depression or non-depressed control (assessed by study staff)
* ages 18-55
* fluent in English
* able to see computer display clearly
* able to provide informed consent
* able to follow verbal or written instructions
* for participants who are referred by a clinician, a letter from that clinician indicating that participation in the study does not constitute an elevated medical or behavioral risk to the participant will be requested.

Exclusion Criteria:

* current pregnancy or menopause
* claustrophobia
* MRI contraindications
* psychotic or bipolar disorder
Latent Viral Infection of Lymphoid Cells in Idiopathic Nephrotic Syndrome

The primary purpose of the study is to evaluate the association of a latent infection of lymphoid cells during the first manifestation of steroid sensitive nephrite syndrome. The thirty nine units of general pediatrics and pediatric nephrite covering the parisian area will participate to the study. We speculate that hybridization of the genome, or a part of the genome, of a virus in lymphoid cells is responsible specific changes of genes expression, leading to the development of the disease.

An additional blood volume will be sampled in patients and controls during a scheduled biological check-up for the initial disease and viral genome of EBV, CMV, HHV6, HHV7 as well as adenovirus will be searched for using PCR reaction in total blood DNA extract. The frequency of a latent hybridization of virus genome within human genome will be compared between patients with steroid sensitive nephrotic syndrome and controls matched for age and sex. Secondary studies will include a comparison of steroid dependency in nephrotic patients according to the occurence of a latent viral hybridization, the epidemiology of idiopathic nephrotic syndrome in the Parisian area and a pharmacogenetic analysis of steroid sensitivity and dependency. If necessary, the chromosomal localization of viral hybridization will be studied with fluorescence in situ hybridization using specific probes.

Eligibility Criteria:
Inclusion Criteria:

* proteinuria over 0.25 g/mmol of creatinine with hypoalbuminemia below 30g/L for the case
* No history of renal disease
* Normal C3 and negativity for hepatitis B and C

Exclusion Criteria:

* no medical insurance
* inclusion in another study
Evaluation of PROCHYMAL® for Treatment-refractory Moderate-to-severe Crohn's Disease

To provide open-label re-treatment with PROCHYMAL to subjects enrolled in companion Protocol 603 to evaluate the safety in subjects with active Crohn's disease who are resistant to standard Crohn's disease therapies.

Subjects will receive infusions of PROCHYMAL on Day 42, Day 84, and Day 126 after initial infusion of PROCHYMAL in Protocol 603. Each infusion will contain 200 million cells. As subjects will be required to be in Protocol 603 during the entire duration of their participation in Protocol 611, all concomitant medication and safety information will be monitored by Protocol 603 and the combination of data from the two protocols

Eligibility Criteria:
Inclusion Criteria:

* Subject must have qualified for, enrolled in, and provided written informed consent form (ICF) and authorization for use and disclosure of protected health information (PHI) for Protocol 603 after the August 3, 2010.
* Subject successfully completed all screening assessments in Protocol 603 as required by Protocol 603.
* Subject successfully completed the full course of each of the four infusions of investigational agent on Days 0, 3, 7, and 14 of Protocol 603 after August 3, 2010.
* Subject must enroll in Protocol 611 on or before the 45th day after first infusion in Protocol 603.
* Subject must provide written ICF and authorization for use and disclosure of PHI for Protocol 611.

Exclusion Criteria:

* Subject is unwilling or unable to adhere to requirements of Protocol 611.
* Subject had confirmed respiratory distress during a PROCHYMAL infusion in any prior PROCHYMAL study.
* Subject had a serious adverse event in any previous PROCHYMAL study that was deemed by the principal investigator of that study to be possibly or probably related to PROCHYMAL and also that was within 48 h after a PROCHYMAL infusion.
Echo-guided Hemodynamic Management Strategy in Elderly Patients Undergoing Noncardiac Surgery

Elderly patients are the fastest growing surgical population and have an increased risk of postoperative cardiac problems. Diastolic dysfunction, or the reduced ability of the heart' s ventricles to fill completely, is common in the elderly population and increases the risk of major adverse cardiac events after surgery. This study will measure diastolic filling and implement fluid and drug management during surgery to determine whether this reduces serious cardiac events related to diastolic dysfunction after surgery in this high-risk population.

Elderly patients are the fastest growing surgical population and present with increased risk of postoperative cardiac problems, especially congestive heart failure. Diastolic dysfunction is common in the elderly population and increases the risk of major adverse cardiac events after surgery. This project will use dynamic measurements of diastolic filling pressures by echocardiography for goal-directed fluid and drug management during surgery to determine whether this reduces serious cardiac events related to diastolic dysfunction after surgery in this high-risk population.

Eligibility Criteria:
Inclusion Criteria:

* Age 70 years and older
* Echocardiographic Evidence of Grade I, II or III LVDD on Preoperative Transthoracic Echocardiography (TTE) examination
* Undergoing Vascular Surgery including but not limited to : Lower extremity bypass,Open abdominal aortic aneurysm repair

Exclusion Criteria:

* Patients with expected hospital stay \< 24 hours
* Inability to undergo TEE and Transesophageal Echocardiography(TTE)
* Clinical evidence/suspicion of elevated Intercranial Pressure (ICP)
* Preoperative shock or systemic sepsis
* Emergency operation
* American Society of Anesthesiologists Status V
* Participation in another clinical trial
* General Anesthesia not planned for procedure
An Extension Study of TS-152 in Subjects with Rheumatoid Arthritis

To evaluate the long-term safety and efficacy of TS-152 in subjects with Rheumatoid Arthritis who have completed the previous study (TS152-3000-JA study or TS152-3001-JA study).


Eligibility Criteria:
Inclusion Criteria:

1. At visit1(-4 weeks), Subject must be fully informed about the study and must obtain written informed consent from the subject himself.
2. At Visit2(0 week), Subjects must have completed the previous study (TS152-3000-JA or TS152-3001-JA) ,and must have completed all evaluations required at the follow-up visit.

etc.

Exclusion Criteria:

1. Subjects who had serious adverse drug reactions in the previous study.
2. At Visit1(-4 weeks) or Visit2 (0 week), Subjects who have not recovered from clinically important adverse events.

etc.
Symptom Control 1-year After Circular Stapler Anopexy or Diathermy Excision for Prolapsed Haemorhoids

Background: In an international randomised controlled trial we studied how patient self-reported symptoms improved after either a stapled anopexy operation or a diathermy excision of the haemorrhoids.

Methods: The study involved 18 hospitals in Sweden, Denmark and the UK. Two hundred and seven patients were randomised. After exclusion of 27 patients, 90 in both groups were operated and followed one year. Patients provided self-reported symptoms before surgery and after 1 year. A patient diary obtained daily self-reported postoperative pain scores (VAS). Surgeons evaluated the anal anatomy before surgery and after 1 year.


Eligibility Criteria:
Inclusion Criteria:

* Grades III and IV haemorrhoids

Exclusion Criteria:

* Previous operation for high anal fistula or injury to the anal sphincteres
Video Double-Lumen Tube Prospective Randomized Study

The goal of this clinical research study is to learn how often a fiberoptic bronchoscopy (FOB -- also known as a fiberoptic scope procedure) needs to be used with a video double lumen tube (VDLT) during surgeries that require lung isolation. On this study, you will have one of 2 types of commonly-used breathing tubes used, either a VDLT or a non-video double lumen tube (called a non-video DLT). An FOB may or may not be performed, as described below.

The level of effectiveness of the VDLT and non-video DLT will be compared.

The difference between the 2 types of breathing tubes is that the VDLT has a built-in camera that is designed to allow the doctor to see the airways continuously.

A fiberoptic scope is a thin device that may be placed into the breathing tube in order to check that the tube is in the correct place.

Study Groups:

If you agree to take part in this study, you will be randomly assigned (as in the flip of a coin) to 1 of 2 study groups. This is done because no one knows if one study group is better, the same, or worse than the other group. You will have an equal chance of being assigned to either group.

If you are in Group 1, you will receive a non-video DLT for lung isolation before surgery. Once the doctor thinks the non-video DLT is in the correct place, its final position before surgery will be checked with an FOB.

If you are in Group 2, you will receive a VDLT for lung isolation before surgery. Once the doctor thinks the VDLT is in the correct place, its final position before surgery will be checked with the camera inside the tube. However, if the doctor thinks it is needed, an FOB may also be used to confirm that the VDLT is in the correct place.

You will sign a separate consent form that describes the risks of surgery.

Procedures:

Once the doctor thinks the VDLT or non-video DLT is in the correct place and your lung(s) can be isolated, you will have surgery as planned. At the end of surgery, the breathing tube will be removed.

If the breathing tube cannot be placed, you will not have the surgery at that time.

Length of Study:

After the surgery, your study participation will be over.

This is an investigational study. The VDLT and non-video DLT are FDA approved and commercially available. Comparing them is investigational. The study doctor can explain how the study devices are designed to work.

Up to 80 participants will be enrolled in this study. All will take part at MD Anderson.

Eligibility Criteria:
Inclusion Criteria:

1. Patients need lung isolation for purposed surgery
2. 18 years or older
3. All patients to give written informed consent to participate

Exclusion Criteria:

1. Patient with known tracheobronchial anatomical anomalies
2. Patient requiring emergency operations
3. Patients with known difficult airways
4. Patients where other lung isolation devices may be warranted (tracheostomy, nasal intubation)
5. Patient requiring sizes not available in DLT or VDLT
6. Patients requiring a right sided VDLT or DLT
Virtual Health Focused Acceptance-Based Program for Parents and Youth

The main purpose of vHAPPY is to pilot test a new type of virtual family-based healthy lifestyle program for children aged 8-14 with obesity and their caregivers. vHAPPY aims to (1) Transition a previously developed acceptance-based behavioral treatment to web-based platform, utilizing qualitative and quantitative program evaluation data from past participants. (2) Determine the feasibility, acceptability, and preliminary outcomes of the adapted web-based treatment. (3) Evaluate whether the adapted web-based treatment (self-guided treatment + brief coaching) is similar to the traditional treatment (interventionist-guided treatment) in terms of feasibility, acceptability, and preliminary outcomes utilizing a non-randomized sequential arm design.

Caregiver and child pairs will complete a 14 week virtual, self-guided healthy lifestyle program including education on health and wellness topics such as food groups, physical activity and stress management. Special skill builders for managing the thoughts, feelings and emotions associated with changing health behaviors will also be included. Pairs will have biweekly 15 minute coaching sessions to check in on progress in the past week, set goals and problem solve. Optional group sessions will be offered for peer support. In order to assess progress, pairs will also complete assessment visits before and after the program. These visits include one virtual assessment via Zoom and one in-person assessment at the University of Alabama at Birmingham. Caregivers and children will complete questionnaires and measures such has height, weight, blood pressure and a finger prick.

Eligibility Criteria:
Inclusion Criteria:

Children who:

1. have a BMI ≥ 85th percentile;
2. are 8 and 14 years old at the beginning of treatment;
3. can read, write, and speak English, along with their caregiver;
4. plan to stay living in the local area during the study period;
5. have a consenting caregiver who can commit to all study procedures.

Exclusion Criteria:

Children who:

1. have been diagnosed with a medical condition and/or are taking medication known to affect appetite/weight, physical activity level or executive function;
2. are currently participating in a formal weight management program beyond usual medical care or have a caregiver participating in a formal weight management program.
Observational, Prospective, Cohort Study of Mpox Infection in Brazil (NETPOX)

The study is a prospective cohort that evaluates the clinical and immune-metabolic variables that may be linked to the risk and severity of the infection or even hospitalization or death in patients infected with the Mpox virus in Brazil. The expectation is to include at least 80 patients over six months, with a follow-up of 90 days from inclusion, through contact via decentralized visits.


Eligibility Criteria:
Inclusion Criteria:

* Men and women aged ≥ 18 years with confirmed MPOX infection.

(laboratory-confirmed monkeypox infection is defined as determined by PCR, culture, or antigen test obtained from a sample collected from blood, oropharynx, anal or skin lesion within 4 days of randomization)

Exclusion Criteria:

* Inability to provide informed consent;
* Patient who, judging by the study team, does not have a condition for decentralized follow-up
Statin for Preventing Hepatocellular Carcinoma Recurrence After Curative Treatment

The purpose of this study is to evaluate whether statin could prevent recurrence of hepatocellular carcinoma after curative treatment

This is a multi-center double-blind randomized placebo-controlled trial. A total of 240 patients with HCC at BCLC stage 0 or A will be enrolled from 8 hospitals in Taiwan. After complete ablation or hepatic resection of the tumor(s), participants are randomized 1:1 to receive either atorvastatin 10mg once daily (intervention group) or matched placebo (control group) for 3 years. During the 3-year period, patients are monitored for recurrence of HCC by dynamic computed tomography (or magnetic resonance image) every 4 months. They will be followed up until death, withdrawal from participation, study termination, or 3 years after the ablative treatment. The primary endpoint is to compare the 3-year cumulative incidence of recurrent HCC between the intervention group and control counterpart. Secondary endpoints are occurrence of clinical complications related to hepatic decompensation (including gastroesophageal variceal bleeding, spontaneous peritonitis, hepatic encephalopathy, hepatorenal syndrome, and hepatopulmonary syndrome), liver-related mortality, and all-cause mortality.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with HCC BCLC stage 0 or A who received curative radiofrequency ablation or hepatic resection could be eligible.
* Individuals who had single HCC (size \> 5.0 cm) received hepatic resection would be eligible
* Individuals with prior history of HCC who had ever received curative ablation or hepatic resection without any recurrence for more than 2 years could be eligible if they had a new episode of recurrent HCC which could meet either of the former two criteria.
* After 12+/-1 weeks of curative treatment, eligible patients who have no evidence of local residual or recurrent tumors according to the dynamic CT or MRI could be enrolled
* The diagnosis of fresh HCC should be compatible with either pathological report or meet the criteria of AASLD guidelines

Exclusion Criteria:

* Undetermined nature of hepatic tumor
* HCC with extrahepatic metastasis or major vascular invasion
* With other malignant disease
* Child Pugh score \>7
* Previous history of CAD event (angina, unstable angina, acute myocardial infarction) or ischemic stroke
* Hyperlipidemia or other indication for statin (according to Taiwan NHI guideline)
* Advanced CKD (eGFR\<30) or ESRD
* Severe comorbidity with life expectancy \< 2 years
* Allergy to statin
Effect of Laparoscopic Cholecystectomy on Risk of Metabolic Syndrome

Prospective cohort study. POPULATION: patients with gallstone disease qualified for laparoscopic cholecystectomy INTERVENTION: patients undergoing cholecystectomy for gallstones COMPARISON: gallstone disease without surgery in an observation period OUTCOME: metabolic syndrome symptoms evaluated in 3 months period The main inclusion criteria is cholelithiasis confirmed by ultrasound examination in patients between 18-75 years old. The main exclusion criteria are metabolic syndrome, diabetes, thyroid diseases, pancreatic diseases, serious abdominal surgeries in the past, pregnancy, and lactation. Participants who qualified for laparoscopic cholecystectomy in 3 months are included in the investigation group. Those not having cholecystectomy planned in the upcoming three months for any reason (no consent for surgery, long term) are included in the control group. The intervention is to assess all metabolic syndrome criteria (blood pressure, glucose tolerance, dyslipidemia, abdominal obesity) before and three months after surgery. The endpoint is to evaluate if the risk of metabolic syndrome after cholecystectomy is higher than in patients with gallstones.

Laparoscopic cholecystectomy is well known as a gold standard of treatment for gallstone disease. Gallbladder removal is one of the most common procedures in the United States, with more than 1.2 million cholecystectomies per year, and 92% of the procedures are performed laparoscopically. In 2011 Amigo et al. reported increased triglyceride levels in mice after cholecystectomy. According to Ruhl et al. (2013), cholecystectomy is associated with an increased risk of non-alcoholic fatty liver disease that is considered a liver manifestation of metabolic syndrome. In 2014, Shen et al. published a retrospective study enrolling 5672 participants that demonstrated an increased risk of metabolic syndrome after cholecystectomy compared with gallstone disease alone. Metabolic syndrome (MS) is a disease of civilization. It is a group of disorders containing impaired glucose intolerance, hypertension, abdominal obesity, and dyslipidemia. According to meta-analysis, individuals reaching the criteria of metabolic syndrome have a twice higher risk of myocardial infarction or stroke and a 1,5-times higher risk of death for any reason. The study aims to assess the risk of metabolic syndrome after laparoscopic cholecystectomy prospectively.

Eligibility Criteria:
Inclusion Criteria:

* cholelithiasis

Exclusion Criteria:

* metabolic syndrome
* obesity
* diabetes
* thyroid disease
* pancreatic disease
* serious abdominal surgeries in the past
* pregnancy, lactation