cyrilzakka/clinical-trials huggingface dataset:
HFIT Versus TENS Study for Chronic Low Back and Knee Pain

A high-frequency impulse therapy (HFIT) device (Enso, San Francisco, CA) is a portable device for the treatment of musculoskeletal pain. This three-arm randomized controlled trial study compares a HFIT group to a standard transcutaneous electrical nerve stimulator (TENS) group and a control group.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or over and under age 65
* Baseline pain is 40 or more out of 100 on a NPRS
* Member of digital MSK program's chronic back or knee pain program, after January 1, 2023
* Member engaged in the most recent 3 weeks
* Experiencing chronic pain for at least 3 months
* Subject able to understand and provide informed consent
* Has an email account

Exclusion Criteria:

* Diagnosis of cancer/malignant tumors in the last 5 years
* Back or knee surgery in the last 6 months
* Has a cardiac pacemaker, implanted defibrillator, spinal cord stimulator, pain pump, insulin pump, or any other implanted electronic device
* Patients with history of opioid, alcohol, or drug abuse in the last 1 year
* Cognitive, behavioral, neurologic, or psychiatric disorder (e.g., dementia, Parkinson's, schizophrenia, stroke) that may interfere with the study or prevent the subject from complying with the requirements of the protocol
* Pregnant or plan on becoming pregnant in the next year
* Have epilepsy
* Have cardiovascular disease
* Current pain (in the past 24 hours) is less than 40 out of 100 on a NPRS
Post-Marketing Surveillance for Crohn's Disease Participants Treated With Stelara (Ustekinumab)

The purpose of post-marketing surveillance (PMS) is to assess the safety and effectiveness of ustekinumab (Stelara) for Crohn's disease participants under real world clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Participants who are administered with Stelara for the first time for the indication of Crohn's disease in accordance with the label
* Participants must sign a participation agreement/informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements

Exclusion Criteria:

- Have contraindication to Stelara in accordance to the label
Pre- Vs. Postoperative Thromboprophylaxis in Pancreatic Surgery

Thromboprophylaxis for pancreatic surgery can be commenced either preoperatively or postoperatively. Despite a clear trade-off between thrombosis and bleeding in pancreatic surgery patients, there is no international consensus when thrombosis prophylaxis should be commenced in patients undergoing pancreatic surgery. There are no prospective randomized trials in this field, and current guidelines are unfortunately based on very low quality evidence, that is, a few retrospective studies and expert opinion. Both American and European thromboprophylaxis guidelines for abdominal cancer surgery support the preoperative initiation of thromboprophylaxis, but these guidelines do not specifically address the increased bleeding risk associated with pancreatic surgery. On the contrary, Dutch guidelines recommend postoperative thromboprophylaxis only, because of lack of evidence for preoperative thromboprophylaxis. Enhanced Recovery After Surgery (ERAS) Society Guidelines recommend preoperative thromboprophylaxis in pancreatic surgery, but the guidelines provide no supporting evidence for this recommendation. Overall, the amount of evidence is scarce and somewhat contradictory in this clinically relevant field of thromboprophylaxis in pancreatic surgery. The aim of this study is to compare pre- and postoperatively initiated thromboprophylaxis regimens in pancreatic surgery in a randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

All patients undergoing either

1. pancreaticoduodenectomy or total pancreatectomy (for any indication) or
2. distal pancreatectomy for suspicion of cancer

Exclusion Criteria:

1. Patient on anticoagulative medication (heparin, low-molecular weight heparin, warfarin, direct oral anticoagulants) during the month (30 days) preceding surgery
2. Emergency operation (e.g. for trauma, infection or pancreatitis)
3. Age \< 18 years
4. Allergy or other contraindication to planned low-molecular weight heparin
5. Inability to give written informed consent
6. Pancreatic resection not performed (removed from analyses after randomization)
Retrograde Femoral Nail-Advanced Outcomes for Fixation of Distal Femur and Femoral Shaft Fractures

This project consists of a prospective and retrospective case series design. Study candidates will include all patients 18 years or older, who were evaluated at UCSD and found to have a distal femur or femoral shaft fracture requiring surgical fixation. Patients who consent to study participation will recieve the RFN-advanced Retrograde Femoral Nailing System implant for fracture fixation. Data on functional status, healing rates, complication rates, and pain levels will be collected for each participant. After 3 years of data collection, investigators will analyze this data to provide further insight on the utility of this new design of retrograde femoral nails. Given the relatively high rate of complications, such as malalignment, with current femoral nail designs, it is imperative to evaluate novel systems to appropriately manage distal femur or femoral shaft fractures.


Eligibility Criteria:
Inclusion Criteria:

* Distal femur or femoral shaft fracture requiring surgery
* Evaluation and treatment at UCSD
* Age 18 years or older
* Ability to understand the content of the patient information/Informed Consent Form
* Signed and dated IRB-approved written informed consent

Exclusion Criteria:

* Any not medically managed severe systemic disease
* their doctor has decided that it is in the patient's best interest to receive a different method of fixation
* Their doctor has determined that the patient has a condition that would make them unsuitable for participation in the study
* Pregnancy or women planning to conceive within the subject participation period (1 year) note: pregnancy will be self-reported and no test will be performed to test for it
* Prisoner
* Participation in any other pharmacologic or medicinal product study within the previous month that could influence the results of this study
Optimising Management of Patients With Heart Failure With Preserved Ejection Fraction in Primary Care

Heart failure (HF) accounts for 2% of National Health Service (NHS) expenditure, and 5% of emergency hospitalisations. Patients with HF with preserved ejection fraction (HFpEF) are older, have more comorbidities, have similarly poor or worse outcomes compared to patients with reduced ejection fraction (HFrEF), and currently lack an evidence base for treatment. The investigators hypothesise that outcomes of patients with HFpEF can be improved through optimised management and self-management of comorbidities, fluid status and lifestyle delivered in primary care in collaboration with specialists. The primary aim is to develop a programme of optimised management by improving understanding of needs and experiences of patients with HFpEF, clinical decision-making and management in primary care, and integrating research findings with patient and clinical expertise. The main objective for this work package is to identify patients with HFpEF in primary care and assess comorbidities and other factors, management, morbidity and mortality at one year. The methodology employed will be a longitudinal cohort study of 270 patients with HFpEF in primary care followed for 12 months.

This work package of the study will use phenotyping and one-year follow-up of a community recruited cohort of patients with HFpEF or probable HFpEF to understand the characteristics and needs of this patient group. It involves a longitudinal cohort study conducted to identify patients with HFpEF in primary care and assess comorbidities, lifestyle factors, frailty, self-management, symptoms, quality of life, cognitive function, types of care received, management of risk factors and comorbidities, and one year morbidity and mortality. This will inform particular areas for assessment and management/self-management in the optimised programme. The investigators will also apply to NHS Digital who are the data controllers of Hospital Episode Statistics to check if participants have had any hospitals visits throughout the duration of the study.

Eligibility Criteria:
Inclusion Criteria:

Adult patients with diagnosed or suspected HFpEF (defined as: patients diagnosed with non-valvular HF that are i) not diagnosed with left ventricular systolic dysfunction or have a documented ejection fraction \< 50%; or ii) do have a reported 'normal' or preserved EF, documented EF \> 50%, or reported diastolic dysfunction without moderate to severe systolic dysfunction) who:

* Have stable Class I - III New York Heart Association (NYHA) classification for chronic heart failure
* Have not been hospitalised for an exacerbation of their heart failure in the 6 weeks prior to screening
* Are able to communicate in English (both verbally and in writing)

Exclusion Criteria:

Any patients who have:

* Any severe neuro-psychological or neuro-cognitive conditions that would confound outcome assessment
* NYHA Class IV classification for chronic heart failure receiving end of life care, or other life-threatening condition
Renin-Angiotensin Aldosterone System and Fibrinolysis Interaction in Humans-Specific Aim 3

The purpose of the study is to determine if giving isosorbide,a drug that is used to treat chest pain, affects blood vessel release of an anti-clotting factor.

To test the hypothesis that the administration of the NO donor isosorbide dinitrate,but not the phosphodiesterase inhibitor sildenafil, will attenuate stimulated vascular t-PA release whereas both agents will improve glucose uptake.

Eligibility Criteria:
Inclusion Criteria:

* 18-70 years of age
* Male and female subjects
* Surgical sterilization
* Childbearing potential: beta HCG on study day
* Subjects with a body mass index of 25 or greater

Exclusion Criteria:

* Diabetes type 1 to type 2 as defined by a fasting glucose of 126 mg/dl or greater or the use of anti-diabetic medication
* Use of hormone replacement therapy
* Statin therapy
* In hypertensive subjects, a seated systolic blood pressure greater than 179 mmHg or a seated diastolic blood pressure greater than 110 mmHg or taking hypertensives
* Pregnancy/Breast Feeding
* Cardiovascular disease such as myocardial infarction with 6 months prior to enrollment, presence of angina pectoris, significant arrhythmia, congestive heart failure (LV hypertrophy acceptable) deep vein thrombosis, pulmonary embolism, second or three degree heart block, mitral valve stenosis, aortic stenosis, or hypertrophic cardiomyopathy
* Treatment with anticoagulants
* History of serious neurologic disease such as cerebral hemorrhage, stroke or transient ischemic attack
* Diagnosis of asthma
* Clinically significant gastrointestinal impairment that could interfere with drug absorption
* Hematocrit \<35%
* Hyperlipidemic fasting Total Cholesterol \>220mg/dl
* Impaired renal function (Serum creatinine \>1.5 mg/dl)
* History or presence of immunological or hematological disorders
* Any underlying or acute disease requiring regular medication which could possible pose a threat to the subject or make implementation of the protocol or interpretation of the study results difficult
* Impaired hepatic function (Serum glutamic oxaloacetic transaminase, serum glutamate pyruvate transaminase \> 60)
* Treatment with chronic systemic glucocorticoid therapy (more than 7 days in 1 month)
* Treatment with lithium salts
* History of Alcohol or drug abuse
* Treatment with any investigational drug 1 month preceding study
* Mental conditions rendering the subject unable to understand the nature, scope and possible consequences of the study
* Inability to comply with the protocol
E-mental Health Support for Rural Areas

In the treatment of depression, primary care team play an important role, but they are most effective when inserted into a collaborative model of disease management.

Hypotheses:Depressed patients treated in rural primary care clinics participating in a e-mental heath collaborative programme to manage depression achieve at least 20% better recovery rates in comparison with the control group three months after the baseline assessment.

Goal: to compare the effectiveness of a e-mental health collaborative programme with usual care in rural primary-care clinics.

Methodology: a clinical trial with two arms will be conducted in 13 community rural hospitals in Chile. The active group will participate in a collaborative programme between primary care teams and specialized teams, with support from an electronic platform and a call center.The control group will receive usual care, according to the Ministry of Health's Guidelines to Depression.To evaluate inclusion criteria -depressive patients aged between 18 and 70 years- and exclusion criteria -current in treatment for depression- an interview will be used that will include the Mini-International Neuropsychiatric Interview (MINI) to evaluate depression .The principal outcome will be depressive symptoms measured with the Beck Depression Inventory (BDI-I), and secondary outcome quality of life measured with the Health Survey (SF-36) at three and six months after baseline assessment.To detect a difference of 20%, in a one-sided model, with an alpha of 5% and power of 80%, would require 152 depressed persons (76 to intervention and 76 to control group).A design effect of 1.35 based on an Intraclass Coefficient Correlation (ICC) of 0,03839 and 13 clinics were considered. After applying the design effect the sample needed increased to 206 depressed persons. Considering a retention rate of approximately 85% 237 depressed cases will be needed.

A program of this kind may be useful to assist primary care teams in remote areas of the country, in order to improve treatment outcomes for depression that is currently addressed at the primary care level.


Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 18 or more with a current major depressive episode according to Diagnostic and Statistical Manual of Mental Disorders IV criteria (DSM-IV)

Exclusion Criteria:

* Depressive treatment currently in process.
Prediction of the Recovery of Neuromuscular Transmission After Curarization

The vast majority of patients receive neuromuscular blockers during surgical procedures, either as a single injection to facilitate intubation or as repeated injections to induce muscle relaxation necessary for surgery. The action of neuromuscular blockers is monitored by measuring the contraction force of the adductor of the thumb after stimulation of the ulnar nerve.Different types of stimulation, such as train-of-four (TOF), post- Tetanus count (PTC), double-burst stimulation (DBS) measure different degrees of curarization.The duration of action of neuromuscular blockers has significant interindividual variability. If the investigators know how to measure the degree of curarization of a patient at a given time, it is difficult to know how long it will take to recover neuromuscular function.

The purpose of this study is to determine if the individual recovery of a patient can be predicted form data obtained at the beginning of his/her recovery curve. The investigators propose to record all neuromuscular transmission monitoring data in 100 patients. From these data, the investigators will try to develop an algorithm that would extrapolate the recovery curve of an isolated patient from the fist neuromuscular monitoring data.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing a surgical intervention with rocuronium
* Patients covered by the Belgian social security system

Exclusion Criteria:

* Allergy towards rocuronium
* 20\< Body Mass Index \<30
* Hepatocellular insufficiency, either clinical or abnormal liver tests
* Renal insufficiency, defined as Modification of diet in renal disease (MDRD) \<40ml / min or Cockgroft \<50ml / min
* Need to antagonize the curare
Comparison of the Effects of Home Exercise and Isokinetic Exercise Program in Subacromial Impingement Syndrome Patients

The aim of this study is to evaluate and compare the effects of home exercise program and isokinetic exercise program on pain, muscle strength, functionality, proprioception sensation and quality of life in patients with subacromial impingement syndrome.

The study was designed prospectively. A total of 50 patients with subacromial impingement syndrome according to clinical and MRI findings with shoulder pain for at least 3 months were included in the study. Patients were randomly divided into two groups. The first group (isokinetic exercise group, n = 25) was given isokinetic exercise. The second group(home exercise group, n=25) was given home exercise program. Patients were evaluated before and after treatment and 3 months after the end of treatment. In the evaluation, VAS, Shoulder Pain and Disability Index, Constant Murley Scoring, Shoulder Disability Questionnaire, Health Assessment Questionnaire, Pittsburgh Sleep Quality Index, Humic Norm II isokinetic device were used. At statistically evaluation of data Student T Test and Mann Whitney U tests were used. In qualitative datas comparison Ki-Kare Test was used. Significance was evaluated at the level of p\&lt; 0.05.

Eligibility Criteria:
Inclusion Criteria:

* Shoulder pain and functional disability at least 6 months

Exclusion Criteria:

* Instability of shoulder, Stage 2-3 adhesive capsulitis, tendinitis or bursitis, cervical radiculopathy, underwent surgery, norological diseases
Efficacy of ISST in Schizophrenia

The ISST study investigates whether integrated social cognitive remediation and social behavioral skills therapy is more efficacious in improving functional outcome and treatment adherence than an active control treatment comprising drill-and-practice oriented neurocognitive remediation.

Deficits in social functioning are a defining, very burdening feature of schizophrenia precluding patients from participating in a satisfying life. Traditional drug and psychosocial therapy and available specific treatment strategies that directly target single key determinants of functional outcome like neurocognition, social cognition, and social behavioral skills have produced only moderate effects leaving an urgent need for further optimization. The present trial aims to more efficaciously improve functional outcome by integrating social behavioral and social cognitive treatment strategies. Six months of "Integrated Social Cognitive and Behavioral Skills Therapy (ISST)" will be compared with "Neurocognitive Remediation Therapy (NCRT)" as active control condition in a randomized multicenter clinical trial using a two group pre-post design with 2x90 patients in the remitted early phase of schizophrenia. Beyond "all-cause-discontinuation" as common primary outcome of all clinical trials of the ESPRIT-consortium, measures of functional outcome and subjective quality of life, patient experience as well as neurocognitive, social-cognitive and social behavioral measures will be assessed at baseline (V0), after completion of treatment (V6), and after 6 months follow-up (V12). ISST is expected to reduce the one-year discontinuation rate by 20% compared with NCRT, and to be superior in functional outcome measures by an effect size of at least d=0.42.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* DSM-IV-TR diagnosis of schizophrenia (295.10-30, 295.90)
* PANSS at baseline: total score ≤ 75
* Proficiency in German language.

Exclusion Criteria:

* Lack of accountability
* Positive urine drug-screening for illicit drugs at screening (except cannabinoids and benzodiazepines)
* Serious suicidal risk at screening visit
* Other relevant axis 1-diagnoses according to diagnostic interview (MINI);
* Other relevant neurological or somatic disorders
* Verbal IQ\<80 (MWT-B)
Clinical Trial to Evaluate the Efficacy and Safety in Nasolabial Fold After Rhytidectomy Using Non-absorbable Mesh

The aim of this study is to evaluate the efficacy and safety of the investigational device, RPM,non-absorbable polypropylene mesh made by D Med, in correction of Nasolabial fold.

Study hypothesis

* level of significance: alpha=0.05( two-side)
* power of test: (power= 1-beta),power=0.08
* H0: P equals P0
* H1: P unequals P0
* The difference between the changes in the WSRS(Wrinkle Severity Rating Scale) of the pre and post rhytidectomy from baseline at 7week after administration is 0.237( P-P0= 0.237)

1. Benefits

* enhancing self-satisfaction and quality of life by improving skin elasticity and correcting folds in the nasolabial fold area 2. Risks
* erythema, swelling, pain and redness in the facial area generally resolve in 1 week 3.Duration of study
* entire duration: approximate 36weeks
* Follow-up period: 7 weeks
* Enrollment period: 12 weeks 4. study design
* 2 step operation process

  * First step- insert polypropylene mesh under the skin
  * Second step- pull the polypropylene mesh 3 weeks later

Eligibility Criteria:
Inclusion Criteria:

* Subjects who had soft tissue sagging around nasolabial fold
* Female aged between 30 and 65, having grade 3 or 4 of nasolabial fold as Wrinkle severity Rating Scale(WSRS)
* Subjects who voluntary decided to participate in the study and signed the informed consent

Exclusion Criteria:

* Subjects who have a skin disease on the face
* Subjects who have severe facial skin disease
* Subjects who are constantly taking anti-coagulants including aspirin
* Subjects who have too thin or thick skin
* Subjects who have a systemic disease such as uncontrolled high blood pressure, diabetes, heart disease
* Subjects who had an allergy to non-absorbable material.
* Subjects who are taking immune suppressants
* General weakness status
* Pregnant or lactating women
* Subjects who have an asthma, cancer, AIDS, Cystic fibrosis, Immobility cilia syndrome, leukopenia, Immunoglobulin deficiency, active infectious disease, serious liver or renal disease,
* Subjects who had a history of dermal augmentation surgery with permanent implants(e.g. silicone, Softform®)on the face
* Subjects who participated in other clinical trial within 30 days from screening
Evaluation of Vildagliptin (Galvus®) as add-on to Insulin in New-onset Type 1 Diabetes Mellitus

The primary objective of this study is to evaluate the action of DPP-IV inhibitors in the prevention of progressive beta cell dysfunction in patients with type 1 diabetes mellitus newly diagnosis ( less than 6 months).

The secondary objectives are:

1. To define the immune and inflammatory profile
2. To define the secretion of glucagon and GLP-1
3. To assess the glycemic variability

Clinical and autopsy studies show that up to 30% of patients with type 1 diabetes mellitus show a detectable β-cell function at clinical diabetes. The preservation of this endogenous insulin production, even if it is small, can have a great impact on the evolution of long-term disease through improving glycemic control, reducing chronic diabetes complications and hypoglycemia. Strategies for preventing the loss of beta cell are based on stopping the autoimmune process and also in the preservation and regeneration of beta cells. Currently have been questioned the potential use of GLP-1 for new-onset type 1 diabetes. The justification for this issue is based on the fact that this class of drugs, besides acting on insulin secretion and glucose regulation, may be effective to preserve and expand beta cell mass, which has been shown in animals. Ideal candidates for this treatment are newly diagnosed patients who still have significant viable beta cell mass.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 to 35 years
* Up to 6 months of clinical diagnosis
* Fasting C-peptide ≥ 0.25 ng / ml
* HbA1C \<9.0%
* Positive autoantibodies (anti-GAD, Anti-Insulin and Anti-IA2)
* Without chronic complications

Exclusion Criteria:

* Hepatic, cardiac, pulmonary and hematologic disease