cyrilzakka/clinical-trials huggingface dataset:
Using a Transcutaneous Electrical Auricular Stimulator to Harness the Cholinergic Anti-Inflammatory Pathway

Persistent chronic inflammation is an important underlying event in multiple diseases including rheumatoid arthritis, inflammatory bowel diseases and type 2 diabetes. These disorders are characterized as inflammatory in part because of the important mediating role of pro-inflammatory cytokines in their pathogenesis. This study will investigate whether transcutaneous auricular electrical stimulation of the vagus nerve will affect and decrease the inflammatory cytokine response in healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

1. Age between 18-60 years,
2. Currently healthy with no medical problems
3. Able and willing to give written informed consent and comply with the requirements of the study protocol.

Exclusion Criteria:

1. History of any of the following: cardiac arrhythmia, coronary artery disease, autoimmune disease, chronic inflammatory disease, anemia, malignancy, depression, neurologic disease, diabetes mellitus, renal disease, malignancy, dementia, psychiatric illness including active psychosis, or any other chronic medical condition.
2. Family history of inflammatory disease
3. Treatment with an anti-cholinergic medication, including over the counter medications,
4. Implantable electronic devices such as pacemakers, defibrillators, hearing aids, cochlear implants or deep brain stimulators.
5. Current tobacco or nicotine user (to limit potential confounding effects of exposure to nicotine),
6. Chronic inflammatory disorders
7. Investigational drug and/or treatment during the 28 days or seven half-lives of the investigational drug prior to the start of study drug dosing (Day 0), whichever is the greater length of time,
8. Any condition which, in the opinion of the investigator, would jeopardize the subject's safety following exposure to a study intervention,
9. Pregnancy or lactation (Pregnancy status \& lactation will be determined via self-report),
10. Implanted vagus nerve stimulator
11. Inability to comply with study procedures
12. Ear infection (otitis media or externa)
Improving Diabetes Through Lifestyle and Surgery

Weight loss is effective in reducing many complications of obesity, with the majority of patients who undergo bariatric surgery having substantial improvements in their weight-related illnesses. The investigators propose a pilot study in 45 subjects with mild to moderate obesity to compare how losing 10% of initial body weight via one of three common weight loss strategies (medical weight loss with a low calorie diet, Roux-en-Y gastric bypass surgery, and adjustable gastric banding) affects diabetes. While the investigators do not expect this pilot study to provide definitive answers, it will provide valuable information to design a larger trial which will help guide therapy for people with mild-moderate obesity and substantial comorbidities.


Eligibility Criteria:
Inclusion Criteria:

* BMI 30-40 kg/m2 at screening visit 1
* Age 21-64 years
* Insured by collaborating insurance plan (Employee Health Plan)
* Type 2 Diabetes
* Medically safe to undergo surgery and approved by a psychologist
* Able to exercise at a moderate level
* Able to give informed consent
* Willing to accept randomization to each group
* Able to communicate (both written and oral) in English
* Willing to use reliable method of birth control during study and ≥18 months postop (if applicable)

Exclusion Criteria:

* Prior bariatric surgery
* Prior gastric, small or large bowel, spleen, pancreas, kidney, or liver surgery, including large ventral hernia or previous large ventral hernia repair.
* Weight loss of ≥ 5% of body weight in the past 6 months
* Uncontrolled diabetes (HbA1c\>8.5%)
* Untreated severe diabetic retinopathy
* Use of thiazolidinediones or insulin currently or within the past 3 months
* Uncontrolled blood pressure (\>160/100 -may be rescreened)
* Estimated glomerular filtration rate (GFR)\<30
* Malignancy (except squamous or basal cell of the skin) in the past 5 years
* MI, stroke or cardiovascular procedure within 12 months
* Known HIV positive or use of anti-HIV therapy (HAART)
* Unstable angina
* Significant pulmonary disease with oxygen dependency
* Chronic use (including in the past 6 months) of medications likely to cause weight gain or prevent weight loss (e.g. corticosteroids, lithium)
* Use of prescription weight loss medication or over-the-counter orlistat in the past 6 months
* Other serious medical condition likely to hinder accurate measurement of weight, or for which weight loss is contraindicated, or which would cause weight loss
* History of severe depression requiring hospitalization in the past 12 months
* Severe mental illness including bipolar disorder, schizophrenia or other psychotic disorders
* Current bulimia nervosa
* Unable or unwilling to use meal replacement products
* Consumption of \>14 alcoholic drinks/week or \> 5 drinks on more than 2 occasions in the past 12 months
* Use of illicit substances in the past 12 months
* Cigarette or cigar smoking in the past 2 months
* Pregnant or nursing within past 6 months
* Plans to become pregnant within 2 years
* Plans to relocate from the area within 1 year
* Another member of household is a study participant or staff in the trial
VELCADE in Subjects With Relapsed or Refractory Mantle Cell Lymphoma

The purpose of this study is to find out whether treatment with VELCADE will increase the time it takes for lymphoma to get worse.

VELCADE is approved in multiple myeloma for patients who have received two prior therapies and their disease came back or got worse while on their second therapy. VELCADE is currently being studied in other types of cancers.

Eligibility Criteria:
Inclusion Criteria

* 18 years of age or older
* Confirmed diagnosis of mantle cell lymphoma
* Documented relapse or progressive disease following 1 or 2 prior lines of anti-cancer therapy. At least one of those regimens must have included an anthracycline or mitoxantrone. Relapsed or progressive disease, since last therapy must be documented by new lesions or objective evidence of the progression of existing lesions.
* At least 1 measurable or evaluable site of disease
* Voluntary consent

Exclusion Criteria

* Previous treatment with VELCADE
* Any experimental or anti-cancer therapy within 3 weeks before the first dose of study drug
* Radiation therapy within 3 weeks before the first dose of study drug
* Major surgery with 2 weeks before the first dose of study drug
* Rituximab, Campath, or other unconjugated therapeutic antibody within 4 weeks before the first dose of study drug
* Radioimmunotherapy or other toxin immunoconjugates such as Zevalin or Bexxar within 10 weeks before the first dose of study drug
* History of allergic reactions to boron or mannitol compounds
* Diagnosed or treated for another malignancy other than mantle cell lymphoma with 5 years before the first dose of study drug
* Active systemic infection requiring treatment
* Women patients must not be pregnant or breast-feeding, confirmed through pregnancy test obtained during screening (this test is not required for women who are post-menopausal or surgically sterile)
* Serious medical or psychiatric illness likely to interfere with participation in this clinical study
* Concurrent treatment with another investigational drug or participation in non-treatment studies is not allowed if it interferes with participation in this clinical study
Pneumonia in Tetanus Study

This is a randomised controlled trial of the incidence of nosocomial pneumonia in patients with severe tetanus admitted to the intensive care ward nursed in a supine or semi-recumbent position.

Background: Hospital-acquired pneumonia remains a common and important cause of morbidity and mortality in patients with severe tetanus who require a tracheostomy whether or not they are mechanically ventilated. We propose to investigate if the incidence of hospital-acquired pneumonia can be reduced by nursing tetanus patients semi-recumbent at 30o rather than supine as is the current practice.

The aim of this study will be to assess the frequency of clinically suspected and microbiologically confirmed hospital acquired pneumonia in patients nursed in a semi-recumbent or supine body position. A secondary end-point will be the mortality in each group. Patients at risk of developing hospital acquired pneumonia (in hospital without developing pneumonia for more than two days) will be evaluated

Eligibility Criteria:
Inclusion Criteria:

1. Consecutive patients will be entered into the study as they are admitted to the intensive care ward with a clinical diagnosis of tetanus.
2. Informed consent will be obtained from the patient or next-of-kin before randomisation.
3. An envelope for the next study number will be opened in which patients will be randomly allocated to either semi-recumbent (300) or supine (00) body position. The randomisation will be created by a computer generated list.
4. All health care personnel will be instructed not to change the position, unless for medical requirements.
5. The correctness of the position will be checked twice daily.
6. Surveillance for clinical detection of pneumonia or other infection will be done daily. If infection is suspected relevant microbiological samples will be taken.
7. The study period will end 72 hours after the patient has left the intensive care ward, or if there is a permanent change in body position for more than 1 hour or death.

Exclusion Criteria:

1. Recent abdominal surgery (\<7 days)
2. Shock refractory to vasoactive drugs or volume therapy
3. Recent intensive care (\<30 days)
4. Neonates
5. Pneumonia at the time of admission to intensive care.
Congenital Heart Disease: Impact on Learning and Development in Down Syndrome (CHILD-DS)

The study objective is to compare neurodevelopmental (ND) and behavioral outcomes between children with Down syndrome (DS) who had complete atrioventricular septal defect (CAVSD) repair and children from the same clinical sites with DS without major congenital heart disease (CHD) requiring previous or planned CHD surgery.

We are conducting a multicenter cohort study, ancillary to the Pediatric Heart Network (PHN) Residual Lesion Score (RLS) study, to investigate determinants of ND and behavioral outcomes in children with DS, focusing on the role of CHD surgery. We are including children with DS who had CAVSD repair, as this group comprises 91% of all children with DS in the RLS Study, with similar underlying congenital cardiac defect and surgical repair complexity, allowing our children with DS and CHD to be a homogeneous group. Moreover, one in five individuals with DS is born with an AVSD, a 2000 times higher incidence than in those with normal chromosomes. In addition to recruiting children with DS who had CAVSD repair, we will recruit similarly-aged children with DS who do not have documented major CHD (i.e., CHD requiring previous or planned CHD surgery) to come into the same PHN site for a single study visit consisting of detailed phenotyping by completion of a Health \& Developmental History Intake form, ND and behavioral assessments, and optional collection and storage of saliva specimens in the PHN Biorepository. By building our sample from RLS Study participants and recruiting additional children who had infant CAVSD repair and meet study eligibility criteria, as well as a comparison group from the same PHN sites, we are leveraging rich prospective data in a group of DS children with CAVSD repair from a nationally representative sample, and the expertise of the PHN and Boston Children's Hospital (BCH).

Eligibility Criteria:
Inclusion Criteria:

Down Syndrome CAVSD Repair Group:

* Trisomy 21
* Male or Female, ages 5 years through 12 years
* Had CAVSD repair within the first year of life
* Parent or guardian and patient willing to comply with protocol and complete all study assessments; parent or guardian willing to provide written informed consent
* Child able to speak and understand English

Down Syndrome Comparison Group

* Trisomy 21
* Male or Female, age 5 years through 12 years
* No major CHD, defined as CHD requiring previous or planned CHD surgery
* Parent or guardian and patient willing to comply with protocol and complete all study assessments; parent or guardian willing to provide written informed consent
* Child able to speak and understand English

Exclusion Criteria:

Both Groups

- Mosaic DS

Down Syndrome CAVSD Repair Group only - Did not have CAVSD repair in the first year of life

Down Syndrome Comparison Group only

- Major CHD requiring previous or planned CHD surgery - i.e., CHD surgery occurring (a) in the period between birth and time of recruitment into the CHILD-DS Study, or (b) planned for a future date.
Postoperative Restrictions for Patients Undergoing Minimally Invasive Gynecologic Procedures

The goal of this randomized controlled trial is to assess recovery in patients undergoing benign laparoscopic gynecologic surgery. The main question it aims to answer is: do liberalized postoperative restrictions improve patient recovery after laparoscopic gynecologic surgery?

Researchers will compare postoperative recovery surveys from the control group (patients given standard postoperative restrictions limiting activity for 2 weeks) to the research group (patients given liberalized postoperative instructions allowing them to engage in their normal activities of daily life at their own discretion without prescribed activity restrictions) to see if liberalized postoperative restrictions improve the recovery experience.

Participants will be asked to fill out a brief questionnaire at two time intervals, 1 week after surgery and 2 weeks after surgery.

The questionnaire will consist of the Recovery Index-10 (RI-10), a short recovery-specific instrument to assess subjective postoperative recovery that is specifically validated for gynecologic surgery. It is graded on a 5-point numerical Likert scale ranging from "full disagreement" to "full agreement." The questionnaire asks questions regarding pain, stamina/ability to complete daily chores, energy, and sleep.

In addition to the RI-10 survey, a few additional questions will be asked to assess whether the patient has dependents they are responsible for, if they have returned to work, and if they have resumed driving.

Eligibility Criteria:
Inclusion Criteria:

* Greater than or equal to 18 years of age
* English speaking (Spanish speaking to be added once appropriate forms are professionally translated and approved)
* 5-8 mm port sites used during the surgery

Exclusion Criteria:

* Less than 18 years of age
* Primary language other than English (or Spanish once forms are professionally translated and approved)
* Use of port size \>8mm
A Brief Laboratory-Based Hypnosis Session for Pain in Sickle Cell Disease

This pilot study will assess the effects of a brief laboratory-based guided imagery procedure on responses to pain in patients with sickle cell disease (SCD) and healthy controls.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy control or with a diagnosis of sickle cell disease
2. Age 13 or older
3. African-American
4. Subject is able to provide informed signed consent
5. Subject is able to follow instructions

Exclusion Criteria:

1. Any known acute or chronic illness that in the judgment of the investigator, may compromise subject safety or data integrity
2. Neurologic disorders affecting sensation
3. Skin abnormality/abrasion over sites of stimulus
4. Under 13 years of age
5. Unable to follow instructions
Effect of the Autonomic Nervous System on the Outcomes of PULSEd Field Ablation to Treat Atrial Fibrillation

Pulmonary vein (PV) isolation is considered the therapeutic strategy of choice to maintain sinus rhythm (SR) in symptomatic patients with atrial fibrillation (AF). The most commonly used energy modality is radiofrequency (RF). However, this type of energy presents notable challenges, such as its lack of selectivity for myocardial tissue, which increases the risk of serious complications such as atrioesophageal fistula, PV stenosis, and vagus nerve injuries. In this context, PV isolation using pulsed field ablation (PFA) emerges as a promising alternative due to its greater myocardial selectivity. However, this selectivity presents additional challenges. Preliminary studies indicate that PFA may not damage the autonomic nervous system (ANS) involved in the initiation and maintenance of AF in certain patients, although stronger evidence is needed to support this claim.

The investigators propose to carry out a single-center clinical trial, although with the possibility in the future of including other centers. Patients will be randomized to three research groups: PV isolation with RF, PV isolation with PFA, and PV isolation combining PFA and RF (using RF on the anterior wall and PFA on the posterior wall). This assignment will be open to the operator who performs the procedure, but blind for the researcher responsible for monitoring and for the data analyst. The objective is to compare the impact of different energy sources during PV isolation on the ability to produce a permanent alteration in the ANS. The hypothesis is that combined PF isolation will be capable of producing a permanent alteration of autonomic function parameters superior to ablation using exclusive PFA.


Eligibility Criteria:
Inclusion Criteria:

- Patients with a diagnosis of paroxysmal atrial fibrillation, referred to our center for pulmonary vein isolation, who are willing and able to sign the informed consent.

Exclusion Criteria:

* Patients with permanent atrial fibrillation.
* Patients with previous pulmonary vein isolation procedure.
* Patients with pacemakers, or with a diagnosis of atrioventricular block or sinus dysfunction.
* Patients who show their refusal to participate in the registry, or are unable to understand the informed consent.
* Patients under 18 years of age.
* Pregnant.
Clinical Trials to Compare the Effects of Pioglitazone and Evogliptin on Hepatic Fibrosis in Patients With Chronic Hepatitis B With Significant Hepatic Fibrosis With Type 2 Diabetes

The clinical study determines the effect of Evogliptin in patients with type 2 diabetes mellitus and chronic hepatitis B to confirm the improvement of hepatic fibrosis.


Eligibility Criteria:
Inclusion Criteria:

* Adultes between 20 and 80 years of age
* Patients who satisfy the following conditions among chronic hepatitis B patients diagnosed with type 2 diabetes

  1. Patients who are newly diagnosed as type 2 diabetes : 6.5% ≤ HbA1c \< 10.0%
  2. Patients who are already diagnosed as type 2 diabetes: HbA1c \< 10.0%
* Patients who have significant liver fibrosis of at least 7 kPa in a hepaticity test using fibroscan
* Patients who voluntarily signed the consent form after informed on the object, method, benefits and risks of the clinical study

Exclusion Criteria:

* Patients who were taking Pioglitazone or Evoglipitin medication or who took diabetes medication within 4 weeks at the time
* Patients who meet the standard of alcoholic fatty liver (in excess of 210g per week for men and 140g per week for women over the last two years)
* Liver cirrhosis patients with impaired liver function (CTP class B and C)
* Patients who took drugs that can cause fatty liver (amiodarone, methotrexate, tamoxifen, valproate, corticosteroids, etc.)
* Patients with acute or chronic metabolic acidosis with or without coma and history of ketonic acid (within 24 weeks)
* Allergic or hypersensitive to the target drug or its composition;
* Patients treated with oral or non - oral corticosteroid treatment for chronic (more than 14 consecutive days) within 8 weeks prior to screening.
* Poor nutrition, starvation, and debilitating conditions (including severe infections and severe injury patients before and after surgery)
* Patients who are receiving radiation and chemotherapy for malignant tumors or patients who have been on chemotherapy or radiation treatment for less than two years.
* Patients with heart failure in 24 weeks (class III to IV in NYHA classification) or unregulated arrhythmia.
* Patients with acute cardiovascular disease in 12 weeks or less (e.g. unstable angina, myocardial infarction, routine ischemic seizures, cerebrovascular disease, coronary bypass surgery, or coronary artery interventions).
* Patients with renal failure, chronic neuropathy (estimated glomerular filtration rate \<60 mL/min/1.73 m2) or dialysis
* Anemia patients whose Hb levels are less than 10.5g/dl
* Women who are pregnant or breastfeeding
* Patients who do not agree to use proper contraception during clinical trials only for women or men.
* Patients who took medicines for clinical trials in other clinical trials within four weeks of document consent
* Patients who are unable to participate in clinical trials on the judgment of other researchers
* Patients who cannot read the consent form (e.g. illiteracy, foreigners, etc.)
Can Parathyroid Hormone Injections Reverse Glucocorticoid-induced Osteoporosis

Glucocorticoids are potent anti-inflammatory and immunosuppressive agents. However, prolonged use of these potent agents results in severe bone loss and osteoporotic fractures. Parathyroid hormone (1-34), when given as a daily injection has been found to dramatically increase bone mass in osteoporotic animals and postmenopausal women. The purpose of this study is to determine whether 2 years of daily PTH (1-34) injections will increase bone mass and reduce the development of new fractures. In addition, we will follow the study subjects for 2 more years to determine which type of anti-resorptive agent is required to maintain the newly formed bone.

We are enrolling postmenopausal women that are on chronic corticosteroid therapy (prednisone etc.) and have bone loss (osteopenia by DXA) to be a part of this four-year-long study. The patients will receive two-year therapy with either PTH (1-34) or placebo, and for the second part of the study subjects receive either estrogen and placebo or alendronate and placebo. We will measure bone gain by standard bone densitometry, special x-rays of the spine and hip, and serum and urine bone markers.


Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women on glucocorticoids (prednisone 5mg/d or greater
* Osteopenia by T score of hip or lumbar spine of -2.0
* All study subjects must be on a stable dose of estrogen/progesterone or raloxifene
* Ambulatory and able to come to the clinical center 9 times over 2 years
* Willing to sign an informed consent

Exclusion Criteria:

* Generalized disease of the bone (other than glucocorticoid-induced osteoporosis), including hyperparathyroidism, hyperthyroidism, Paget's disease)
* Diseases that affect bone metabolism (e.g. alcoholism, inflammatory bowel disease, malabsorption, renal disease (Cr2) or liver disease (transaminase level 2 times limit of normal)
* Within the past 1 year, regular use of medications that are known to affect bone metabolism (e.g. anabolic steroids, anticoagulants, anticonvulsants, pharmacologic doses of vitamin D and vitamin A supplements).
* History of drug abuse
* Senile dementia, paraplegia and/or quadriplegia
* Unstable rheumatic disease with clinically significant renal or central nervous system involvement.
Prospective Procedural Data Collection for Continuous Improvement of the KODEX - EPD™ System Performance.

The purpose of the KODEX EPD Field study is to evaluate the performance of the KODEX-EPD system and collect procedural data and medical images for Philips' internal research and development activities (R\&D) related to the KODEX-EPD system, as well as for marketing and publication purposes. The KODEX-EPD system is an imaging system that will allow for real time visualization of the catheters in your heart during your procedure, as well as display cardiac images of your heart in several different formats.


Eligibility Criteria:
Inclusion Criteria:

* Cardiac Ablation

Exclusion Criteria:

* There is no exclusion criteria