cyrilzakka/clinical-trials huggingface dataset:
Effect of Bariatric Surgery on Mechanisms of Type 2 Diabetes

The purpose of this study is to determine the effects of bariatric surgery on blood sugar control and underlying mechanisms that contribute to type 2 diabetes in men and women with a BMI between 27 and 42. Sixty subjects will be randomized to either undergo the roux-en-y gastric bypass operation or intensive medical, dietary and exercise management.

Obesity and type 2 diabetes mellitus (T2DM) are two of the greatest public health problems of the 21st century. Lifestyle changes and pharmacotherapy, which are mainstay treatments for T2DM have had limited success. More intensive lifestyle weight management such as in the Look AHEAD trial reported an 8.6% weight loss after 1 year, while the Diabetes Prevention Program reported a 7% weight loss after 2 years, and a 58% decrease in the risk of developing T2DM. In contrast,we have observed a 31% weight loss together with 83% remission of T2DM in severely obese patients after Roux-en-Y gastric bypass (RYGB) surgery. However, direct evidence of the glycemic benefits of bariatric surgery from randomized control trials is lacking; there is no clear consensus that RYGB surgery is a good treatment option for moderately obese T2DM patients; and the mechanisms responsible for reversing T2DM after surgery remain unclear but may involve pancreatic insulin secretion and skeletal muscle and hepatic insulin resistance.

The objective of this application is to evaluate the effects of RYGB surgery on glycemic control and underlying mechanisms that contribute to T2DM in obese subjects (BMI: 30-40 kg/m2). Our central hypothesis is that RYGB surgery will reduce hyperglycemia via reversal of beta-cell dysfunction and decrease hepatic and peripheral insulin resistance. The approach requires a 12-month randomized controlled trial. The rationale is based on data showing that RYGB lowers fasting and postprandial glucose, and increases the GLP-1 response to a meal. However, the therapeutic efficacy of RYGB surgery in obesity-related T2DM needs to be demonstrated in a randomized trial.

Eligibility Criteria:
Inclusion Criteria:

* candidate for general surgery
* 18 to 60 years old
* BMI 27-43
* type 2 diabetes
* willing to participate in either study arm
* understand and comply with requirements of each arm
* not pregnant
* willing to use reliable birth control for duration of study

Exclusion Criteria:

* prior bariatric surgery of any type
* prior complex abdominal surgery
* abdominal, thoracic, pelvic, obstetrical surgery within last 6 months
* significant cardiovascular disease
* kidney disease with a creatinine greater than or equal to 1.8 mg/dl
* chronic liver disease except for NAFLD/NASH
* celiac, malabsorptive, inflammatory bowel disorders
* psychiatric disorders requiring 3 or more medications
* pregnancy
* cancer except squamous or basal cell skin cancer or cancer in remission
* anticoagulation therapy that can't be stopped for surgery
* clotting disorders
* severe pulmonary disease
Julina Post-marketing Surveillance for Postmenopausal Osteoporosis in Japan

This study is a regulatory post-marketing surveillance in Japan, and it is a local prospective and observational study of patients who have received Julina for postmenopausal osteoporosis. The objective of this study is to assess safety and efficacy of using Julina in clinical practice. A total 100 patients will be recruited and followed 3 years since starting Julina administration.


Eligibility Criteria:
Inclusion Criteria:

* Patients who received Julina for postmenopausal osteoporosis

Exclusion Criteria:

* Patients who are contraindicated based on the product label
Prospective Clinical Trial - Obturator Reflex Predictors and Blockage

The aim of this study is to estimate the incidence rate of obturator nerve reflex and leg jerking during Transurethral Resections of Bladder Tumors (TURBTs), evaluate the efficacy of obturator nerve block in the prevention of inadvertent muscle spasm, and to identify predictors for both the jerking reflex and successful nerve block.

Study design: A single center single arm prospective study aiming to estimate the incidence rate of obturator nerve reflex and leg jerking during TURBTs, evaluate the efficacy of obturator nerve block (ONB) in the prevention of inadvertent muscle spasm, and identify predictors for both the jerking reflex and successful nerve block.

Study population: patients who are scheduled for TUR for bladder tumor, as standard care, who are willing and able to participate in the study

Intervention: a uni-lateral ONB (using Lidocaine 2%)

Study outline: Once in the operating room patients will be monitored by continuous electrocardiography, non-invasive arterial blood pressure measurement, and pulse oximetry in the usual manner. They will then undergo general or spinal anesthesia according to their preference and at the discretion of the treating anesthesiologist, without the use of muscle relaxants. As part of the study, a uni-lateral ONB will be performed under ultrasound guidance- using 2% lidocaine for obtaining a short term block, for the duration of the procedure itself. The non-blocked nerve will be used as control. The surgeon will be blinded as to the side in which the ONB has been performed. A catheter will be used to fill the bladder with saline to its full capacity. The inner wall of the bladder will then be stimulated to test for an obturator nerve reflex and leg jerking. Stimulation will be done using a trans-resectoscope and a single-twitch electrical current generated by a neuromuscular monitoring device, as previously described by Mihara et al. Four different bladder volumes will be tested. For each bladder volume, a reflex response on both sides will be documented and graded. The investigators will then proceed with a TUR in the usual manner.

Primary endpoints: frequency of obturator jerk reflex and efficacy of obturator nerve block

Eligibility Criteria:
Inclusion Criteria:

* Adult patient, older than 18 yo, scheduled for TUR for bladder tumor.
* The subject is willing and able to read, understand and sign the study specific informed consent form.

Exclusion Criteria:

* Patients with known coagulopathy, including patients receiving antithrombotic or thrombolytic therapy not in compliance with standard precautions.
* Patients with a known allergy to anesthetics.
* Patients who underwent partial cystectomy.
* Patients with tumors involving bladder diverticula.
* Patients with pre-existing obturator nerve injury or pre-existing neurologic deficits.
* Patients with neuromuscular disease.
* Patients with local infection above planned ONB site.
* Patients in whom the use of muscle relaxants is deemed necessary by the anesthesiologist.
* Patients with inguinal lymphadenopathy.
* Patients unable to sign an informed consent form.
A Study of Hookah Café Customers in the Atlanta Area

The purpose of the study is to assess the effectiveness of health warnings on waterpipe smoking behavior in a real-world setting. The primary hypothesis is that hookah café customers who are in the intervention (warning) arm will smoke less than customers who are in the control (no warning) arm, determined by differences in the boost in expired carbon monoxide from café entry to after café exit.

Expired carbon monoxide is an objective biological marker of combustible tobacco smoking and is strongly correlated with the amount of smoke inhaled. In the intervention arm, warning messages will be displayed at various agreed-upon locations in the café, such as on hookah pipes, tables, countertops, walls, and menus. The goal is to maximize the potential for customers to be exposed to warnings. Participants will be patrons of the café and will be recruited before entering the café. Participants will complete a brief survey and provide a breath sample to measure expired carbon monoxide. When leaving the café, they will complete another survey and provide a second breath sample.

Eligibility Criteria:
Inclusion Criteria:

* Planning to enter the hookah café where study is being conducted
* Age 18 or older
* English speaking
* Planning to smoke hookah inside
* Not planning to smoke cigarettes, cigars, cigarillos or marijuana while at the hookah café
* Had not previously entered the café earlier in the day on the same day/night as data collection
* Has not been approached to participate in the study at another café or another day/night at the current café
* Are not employees of the business
* Have capacity to participate as determined by the staff member conducting eligibility screening

Exclusion Criteria:

* Not planning to enter the hookah café where the study is being conducted
* Age 17 and under
* Non-English speaking
* Not planning to smoke hookah in the café
* Planning to smoke cigarettes, cigars, or marijuana while at the hookah café
* Are employees of the business
* Had previously entered the café on the same day/night as data collection
* Has not been approached to participate in the study previously
* Does not have capacity to participate as determined by the staff member conducting eligibility screening
Mobile-enhanced Group CBT for Adolescents at Risk Severe Mood Disorders

Although cognitive-behavioral therapy (CBT) has shown efficacy in reducing symptoms and rates of mood relapse in adolescents at high risk for severe mood disorders (SMD; i.e., bipolar I/II disorder and recurrent or unremitting major depression), a significant limitation to the CBT's efficacy is the low rate of participant adherence to the prescribed between-session homework tasks. Mobile health applications have the potential to improve adherence to and acceptance of treatment through embedded treatment content, skill-practice, thought and symptom monitoring, all of which are facilitated by reward contingencies and notifications. This study examines whether a mobile application-enhanced CBT can improve participant adherence and treatment acceptance for adolescents at high risk for SMD.


Eligibility Criteria:
Inclusion Criteria:

1. Meet DSM-5 criteria for at least one past major depressive disorder, persistent depressive disorder, or unspecified bipolar disorder
2. Be 13-17 years old
3. English speaking and able to complete written questionnaires
4. Ability to attend pre-determined group session time(s)
5. Access to a smartphone to engage with the study app
6. Medication usage is acceptable, but not required

Exclusion Criteria:

1. Regular use or current abuse of a psychoactive drug
2. Evidence of behavioral problems that are thought to interfere with group treatment
3. Suicidality that requires more intensive treatment
4. Meeting DSM 5 criteria for bipolar I or II disorder, a psychotic disorder, or significant psychiatric symptoms (e.g., self-injurious behavior) that require more intensive treatment
5. Concurrent participation in cognitive-behavioral therapy
6. Inability to travel to study sessions and assessments
Characteristics and Evolution of Hospitalized Patients in Post-Resuscitation Rehabilitation Care Units (SRPR)

Non-interventional cohort study (on data), prospective national multicenter. Inclusion of patients as they enter in a post-intensive care rehabilitation unit (SRPR) .

Collection of data after inclusion, from patients' records during their stay (weekly follow-up) to the SRPR and at their discharge, to D28, D90 and at 1 year after their hospitalization from hospital reports or call of the attending physician.

For one year, all patients, adults and children hospitalized in a post-intensive care rehabilitation unit (SRPR) of Ile de France and Rouen will be offered to participate in the SRPR Cohort in order to have a completeness of data on a new practice.

The study of these data will make it possible to know the future of the patients and to establish criteria prior to the admission in the SRPR which could make it possible to predict this future and to select the patients as well as possible. It will also make it possible to know the impact of care on the outcome of patients at discharge, at 28 days, 90 days and 1 year of their admission to SRPR to improve practices.

This research will focus on the collection of data from patients' medical records. General information about their stay in the intensive care unit - including the patient's ventilatory status - will be collected upon arrival at the SRPR units, during their stay (weekly follow-up), at the exit of the SRPR, at D28, and in the longer term. (J90 and J365 of the entry into the SRPR unit) where will be listed more comprehensive data with, in addition to general information, data on nutritional, neurological, neuromuscular, respiratory and biological hemodynamic assessments will be collected.

In addition to the common data base, each type of SRPR (respiratory and pediatric neurology) will collect data that is specific to its specialty.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalization in a Post-Resuscitation Rehabilitation Care Units (SRPR) of Ile de France and Rouen

Exclusion Criteria:

* Refusal of access to the data by the patient or the designated trusted person or the holder (s) of parental authority (pediatric population)
Production of Clinical-grade Anti-CD19 Chimeric Antigen Receptor T Cells for Refractory B-cell Malignancies

Immunotherapy is a promising therapeutic approach for patients with cancers. Patients with acute lymphoblastic leukemia (ALL) experiencing early relapse less than 18 months from diagnosis had very poor prognosis with 5-year survival rate of 21% (1). Recent clinical trials demonstrated that infusions of autologous T cell modified with chimeric antigen receptors (CARs) induced durable complete remissions in patients with relapse or refractory B-cell ALL (2-4). The editors of Science Journal announced cancer immunotherapy as the breakthrough of the year for 2013 (5). On Jan 30, 2015, Dr. Steven M. Altschuler, chief executive officer of the Children's Hospital of Philadelphia and 9-year-old ALL patient Emily Whitehead with 3-year leukemia free after CAR-T cell infusion were invited to White House for President Barack Obama's announcement of the Precision Medicine Initiative. The MIT Technology Review announced that the top one breakthrough technology in 2016 is genetically engineered immune cells saving the lives of cancer patients. This project will focus on the manufacturing of clinical-grade anti-CD19 CARs for B-cell malignancies in the future clinical trials.


Eligibility Criteria:
1. At least 14 years of age (underage patients under the age of 20 only collect peripheral venous blood, do not perform double-lumen venous catheter and white blood cell separation).
2. There are no known serious systems or diseases with systemic immunodeficiency, but blood-related cancers are not.
3. Systemic chemotherapy and target treatment were not received within 14 days.
4. The subject consent form has been signed prior to the program-related procedures.
RibFix Advantage™ Post-Market Follow-Up

To confirm safety, performance, and clinical benefits for the use of RibFix Advantage™ in the fixation, stabilization, and fusion of rib fractures and osteotomies of normal and osteoporotic bone

Retrospective review of subject demographic and hospital data with a prospective follow-up component evaluating clinical outcomes and quality of life for patients receiving RibFix Advantage for surgical stabilization of rib fractures from 2019 to 2021

Eligibility Criteria:
Inclusion Criteria:

* 18-80 years of age, male or female
* Underwent reconstruction of the chest wall between February 2019 and September 2021 with RibFix Advantage™ for the fixation, stabilization, or fusion of rib fractures
* Minimum amount of follow-up data available, including one visit post-surgery
* Willing and able to sign an Informed Consent for research
* Willing and able to and complete a post-operative follow-up survey at least 3 months post-surgery

Exclusion Criteria:

* Latent or active infection with positive culture at the time of implantation
* Documented history of metal sensitivity
* Documented psychiatric condition preventing the patient from following post-op care instructions
* Fixation of the first and/or second (true) vertebrosternal rib
* Bilateral rib fractures
* Concurrent surgical procedures (i.e. splenectomy, aortic disruption repair, diaphragm injury repair, etc.) performed during the same hospitalization
* Lung injury (open pneumothorax, tension pneumothorax, hemothorax \> 1L, pulmonary contusion requiring mechanical ventilation)
Glue Application in the Treatment of Low-Output Fistulas

Adjuvant use of fibrin glue (FG) in the fistula tract has been shown to promote closure of low-output enterocutaneous fistulas (ECFs). The primary objectives of this study are to compare the clinical efficacy, safety of autologous platelet-rich fibrin glue (PRFG), commercial fibrin glue, and control therapy in the management of patients with low-output volume ECFs.

* This is a prospective, randomized, multi-centered study clinical, safety and economic outcome of ECFs patients.
* Subjects are randomized to one of 3 groups:

  * Group 1: Autologous PRFG-treatment \[PRFG + Standard of care (SOC)\]
  * Group 2: Commercial FG-treatment \[FG + Standard of care (SOC)\]
  * Group 3: Control (SOC only)
* Study will include three phases:

  * Phase 1: Screening, consent and enrollment
  * Phase 2: Patients will receive either PRFG, commercial FG, or SOC only for 14 days
  * Phase 3: Follow up: for patients with closed fistula within 14 days, we will follow up them for 6 months. For patients whose fistulas were still open will be treated with other therapeutic option and follow up for 6 months after closure.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a single tubular ECF
* Low output volume (\<200 ml/24h)
* Tract length \>2cm
* Tract diameter \< 1cm

Exclusion Criteria:

* Cancer-infiltrated fistula
* Abscess
* Foreign bodies
* Distal bowel obstruction
* Inflammatory Bowel Disease
A Chart Review to Evaluate the Safety and Efficacy of Phrenic Nerve Reconstruction for the Treatment of Diaphragmatic Paralysis

A retrospective chart review to evaluate the safety and efficacy of phrenic nerve reconstruction for diaphragmatic paralysis.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent phrenic nerve reconstructive surgery for the treatment of Diaphragmatic Paralysis.

Exclusion Criteria:

* Age 18 and below.
Radial or Focus Extracorporeal Shock Wave Therapy in Epin Calcanei

Objective: The aim of the study was to investigate the effectiveness of radial and focused ESWT treatment on pain, function, and size of the calcaneal spur in patients with a clinical and radiological diagnosis of epin calcanei.

Methods: A total of 112 patients aged between 18 and 95 years were randomly divided into two groups: group 1 received rESWT (2.4 bar 12 hz 2000 beats), and group 2 received fESWT (0.14 bar 14 hz 1000 beats) three times a week for three weeks. All patients were evaluated using the Visual Analog Scale (VAS)-pain and Foot Function Index (FFI) before and after the treatment, at 4 weeks and 12 weeks. Epin size was measured radiographically in the patients before and after the treatment at the 12-week follow-up.


Eligibility Criteria:
Inclusion Criteria;

* Presence of heel pain for at least four weeks,
* Receiving no medical treatment, injection, physical or surgical treatment for the last four weeks and
* Agreed to participate in the study.

Exclusion Criteria:

* History of fracture or surgery,
* Polyneuropathy,
* Rheumatological diseases,
* Coagulation disorders,
* Tumor,
* Thrombosis,
* Soft tissue or bone infection,
* Pregnancy and lactation,
* Epilepsy,
* Presence of a pacemaker.
Omega-3 Fatty Acid Administration in Dialysis Patients

The overall goal of this study is to examine the role of fish oil supplementation in ameliorating the inflammatory state of uremia and the related muscle protein catabolism associated with this disease state. We hypothesize that if administered for a period of 3 months, fish oil will improve the chronic uremic inflammation. We further hypothesize that fish oil administration will improve the muscle protein breakdown associated with uremia and inflammation.


Eligibility Criteria:
Inclusion Criteria:

* Patients on CHD for more than 6 months;
* Ability to read and sign the consent form;
* Have acceptable dialysis adequacy (Kt/V \> 1.2);
* Use biocompatible hemodialysis membrane;
* Have a patent, well functioning, arteriovenous dialysis access or permanent dialysis catheter (no other option for arteriovenous access);
* Signs of chronic inflammation (average CRP of ≥ 5 mg/L for 3 consecutive measurements)

Exclusion Criteria:

* Pregnancy;
* Intolerance to the study medication;
* Severe, unstable, active, or chronic inflammatory disease (active infection, active connective tissue disorder, active cancer, HIV, liver disease);
* Diabetes mellitus on insulin therapy;
* Hospitalization within 1 month prior to the study;
* Malfunctioning arterial-venous vascular access (recirculation and/or blood flow \< 500 ml/min);
* Patients receiving steroids (\> 5 mg/day) and/or other immunosuppressive agents;
* Life-expectancy less than 6 months;
* Age less than 18 years old;
* Atrial fibrillation (only for those undergoing the optional Pulse Wave Velocity);
* Hypersensitivity to organic nitrates, isosorbide, or nitroglycerin (only for those undergoing the optional brachial artery Doppler).
Comminuted Fractures of the Midshaft of the Tibia; (Interlocking Nail +/- Blocking Screws or Locked Plating With Predicted Distribution of Locking Screws) Choice Based on Finite Element Analysis Correlated With Clinical Outcome and Union.

study is to assess the clinical and radiological results of Comminuted fractures of the midshaft of the tibia; treated with interlocking nail +/- blocking screws or locked plating with predicted distribution of locking screws, choice based on finite element analysis correlated with clinical outcome and union.

FE analyses will be performed using the finite element code COSMOS/M. The three-dimensional "lower leg" FE model (LL FE model) will be used included the tibia and the fibula. The bony structures will be generated by segmentation of a data set of computed tomographies from the Visible Human Project.

Analysis of data regarding clinical outcomes and radiological assessment of healing rate and union

Eligibility Criteria:
Inclusion Criteria:

1. patients with closed comminuted fractures of the midshaft of the tibia
2. patients with age ranging from 25 to 45 years old

Exclusion Criteria:

* 1- Simple fractures of the midshaft of the tibia. 2- patients with open comminuted fractures of the midshaft of the tibia. 3- critical and ICU patients. 4- patients with ipsilateral lower limb fractures.
IMPROVE Stroke Care- Developing and Optimizing Regional Systems of Stroke Care

The purpose of this program is to develop a regional integrated stroke system that identifies, classifies, and treats patients with acute ischemic stroke more rapidly and effectively with reperfusion therapy.

The design is based upon the implementation of best practice, that is, based on a comprehensive review of AHA guidelines regarding treatment of acute stroke, ICH (intracranial hemorrhage) and SAH(sub arachnoid hemorrhage). In the second phase, the project will be doing national and international surveys of best practices among comprehensive stroke centers and then combine evidence based guidelines and recommendation as well as expert consensus and guidelines when high level evidence is not available from the published literature. The aim to improve public stroke awareness, stroke symptom recognition within the time benefit window for treatment and calling 9-1-1, EMS transportation, and the proportion and speed of reperfusion therapy (fibrinolytic and in appropriate patients- endovascular treatment) in eligible patients. These improvements in acute stroke care delivery are expected to result in lower mortality, fewer recurrent strokes, and improved long term functional outcomes that we will measure.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients \> 18 years of age who undergo the local acute code stroke process

Exclusion Criteria:

* In house patients with stroke are not included in this data set.