cyrilzakka/clinical-trials huggingface dataset:
Comparing ASHC and CDSMP Outcomes In Arthritis

The arthritis-specific Arthritis Self Help Course (ASHC) and the more generic Chronic Disease Self Management Program (CDSMP) teach generalizable skills for managing arthritis and other chronic diseases. In some locations it may be more feasible to combine efforts and offer the generic course rather than the arthritis-specific program. However anecdotal evidence has questioned whether people with arthritis obtain as much benefit from the more generic course as they do the arthritis-specific course. The primary purpose of this research studies is to compare health outcomes among people with arthritis who participate in either ASHC or the CDSMP. The North Carolina project is focusing primarily on African Americans from 6 rural counties in North Carolina. The results of this research will be used to guide Arthritis program recommendations on the use of ASHC and CDSMP to improve the quality of life for people with arthritis.


Eligibility Criteria:
Inclusion Criteria:

African american adults with arthritis Caucasian adults with arthritis

Exclusion Criteria:

-
Etanercept in New Onset Type 1 Diabetes

The investigators hypothesized that the administration of Etanercept to children newly diagnosed with T1DM may be able to interdict the progression of T1DM. The aim of this study is to evaluate the feasibility and safety of Etanercept administration to pediatric patients recently diagnosed with type 1 DM.

This is a double-blind randomized 24-week placebo-controlled feasibility and safety study. Subjects received study drug for a 24- week period, followed by 4 and 12-week wash out periods.

Eligibility Criteria:
Inclusion Criteria:

* Males and females subjects with T1DM aged 3-18 years
* Positive GAD 65 and/or islet cell antibody
* HbA1c at diagnosis above 6%
* Insulin regimen with 3 injection of insulin daily (as described below)
* White blood count between 3,000-10,000 and platelets \> 100,000
* Normal ALT and AST, creatinine \< 1.8 mg/dl
* T1DM duration equal or less than 4 weeks

Exclusion Criteria:

* Infection requiring IV antibiotics at diagnosis or within past 14 days from study entry
* BMI over 85th percentile for age and gender
* Unstable household
* Unable to provide compliance with study drug, insulin and study visits,
* Evidence of psychiatric disease in the potential study subject and/or primary care taker
* And chronic diseases, including additional autoimmune disorders with the exception of euthyroid autoimmune thyroiditis
Effects of Breathing Patterns on Post-prandial Vascular Function

The purpose of this study is investigate the effects of two different breathing styles on postprandial vascular function and oxidative stress markers. Participants will complete 2 breathing conditions in random order.


Eligibility Criteria:
Inclusion Criteria:

• Male participants ages 18-35 years

Exclusion Criteria:

* Infection within the previous 4 weeks
* Renal disorders
* Any cardiovascular disorders such as prior myocardial infarction, known coronary artery disease, personal history of stroke, heart failure, cardiac arrhythmias
* Chronic obstructive pulmonary disease
* Diabetes
* Inflammatory bowel disease
* HIV, rheumatoid arthritis, chronic or other inflammatory conditions
* Currently taking steroids or other anti-inflammatory medications
* Current use of nonsteroidal anti-inflammatory drugs
* Smoking
* Stage 2 hypertension or higher (systolic BP of 140 mm Hg or higher and/or diastolic BP of 90 mm Hg or higher)
* Lactose intolerance
Genetic Analysis of Congenital Diaphragmatic Disorders

The purpose of this study is to understand the genetic causes of congenital diaphragmatic disorders (CDD), namely congenital diaphragmatic hernia (CDH), eventration and hiatal hernia.

Specifically, the investigators plan to:

1. Ascertain informative families and sporadic cases with congenital diaphragmatic disorders and obtain appropriate phenotypic data and genetic material (peripheral blood and/or diaphragm tissue sample).
2. Localize the gene(s) for CDD to specific chromosomal segments using linkage analysis, and determine the role of somatic mutations in CDD.
3. Isolate and characterize genes involved in the pathogenesis of CDD.
4. Develop molecular markers that will facilitate accurate diagnosis (including prenatal diagnosis) and permit correlation of phenotypic variation with specific mutations.
5. Compare RNA-sequencing from tissue samples of children without CDH to those children with CDH.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with a congenital diaphragmatic disorder

Exclusion Criteria:

* none
Videolaryngoscopy During CPR for Trauma Patients

This is a clinical study based on collected video-clip data of cardiopulmonary resuscitation for patients with suspected neck injury in multiple trauma between 2011 and 2015. The study aimed to compare all possible factors relating to ETI performance during CPR for truma patients between experienced video-laryngoscopy and direct- laryngoscopy users.

Endotracheal intubation (ETI) is considered to be the best method of airway management during cardiopulmonary resuscitation (CPR). However ETI during CPR is a highly skill-dependent procedure, then it should be attempted only highly trained physicians. Especially, cervical immobilization by neck collar in truamatic patients is a great obstacle to successful ETI during CPR.

Because of technical difficulty in using direct laryngoscopy (DL), various types of videolaryngoscopy (VL) devices have been developed to overcome the problems of DL. VL may be more useful to perform ETI during CPR for trauma patients with cervical immobilization.

This study tried to compare the success rate of endotracheal intubation (ETI), speed of ETI, incidence of complications, and chest compression interruptions during cardiopulmonary resuscitation for trauma patients with suspected neck injury between intubators using the DL and the VL in a real clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* Multiple trauma patients with suspected neck injuries
* Arrest Patients

Exclusion Criteria:

* Case of requesting the do-not attempt resuscitation before ETI
* already intubated case before arrival to hospital
* Cardiac arrest from non-traumatic causes
Safety and Efficacy Trial of HP802-247 in the Treatment of Chronic Venous Leg Ulcers

This study is being done to find out if an investigational product called HP802-247 can help people with venous leg ulcers. Investigational means that HP802-247 has not been approved by the U.S. Food and Drug Administration (FDA).

This research is being done to compare the efficacy of HP802-247 plus compression therapy against Vehicle plus compression therapy in achieving complete wound closure over the 12-week treatment period. Vehicle looks the same as HP802-247 but contains no cells.

At least 440 subjects will participate. The study is going to be conducted in approximately 5 countries at approximately 50 sites across the European Union.

See Brief Summary

Eligibility Criteria:
Inclusion Criteria:

* Provide informed consent.
* Age ≥ 18 years and of either sex.
* Willing to comply with protocol instructions, including allowing all study assessments.
* Have a venous leg ulcer (VLU) between the knee and ankle (at or above the malleolus), with a surface area ≥ 2.0 cm2 and ≤ 12.0 cm2
* Venous insufficiency confirmed by duplex Doppler ultrasound examination for valvular or venous incompetence.
* Arterial supply adequacy confirmed
* Target ulcer involves a full thickness skin loss, but WITHOUT exposure of tendon, muscle, or bone.
* Target ulcer duration ≥ 6 weeks but ≤ 104 weeks (24 months).
* Acceptable state of health and nutrition

Exclusion Criteria:

* History of anaphylaxis, serum sickness, or erythema multiforme reaction to aprotinin, bovine serum albumin or bovine serum proteins, penicillin, streptomycin, amphotericin B.
* Prior diagnosis of Systemic Lupus Erythematosus with elevated anti-DNA antibody titers, Buerger's disease (thromboangiitis obliterans), current diagnosis of vasculitis, or current diagnosis of claudication.
* Therapy with another investigational agent within thirty (30) days of Screening, or during the study.
* A target ulcer of non-venous etiologies (e.g., sickle cell anemia, necrobiosis lipoidica diabeticorum, pyoderma gangrenosum, vasculopathic or vasculitic).
* Documented history of osteomyelitis at the target wound location within 6 months preceding the Screening Visit.
* Refusal of or inability to tolerate compression therapy.
* Therapy of the target ulcer with autologous skin graft, Apligraf™, or Dermagraft™ within 30 days preceding the Screening Visit.
* History of cancer in the preceding 5 years (other than carcinoma in situ of the cervix or adequately treated non-melanoma skin cancers).
* Any prior exposure to HP802-247 or its vehicle.
A Study to Evaluate the Safety and Tolerability of Trivalent Influenza Virus Vaccine in Children Aged 5 Years to < 9 Years

This is a study to assess the safety of a bioCSL split virion, inactivated Trivalent Influenza Virus vaccine containing the 2014/2015 Northern Hemisphere strains of vaccine in children aged 5 years to less than 9 years. Comparison will be made to a licensed Quadrivalent Influenza Virus vaccine that complies with the FDA recommendations for the 2014/2015 influenza season in the US.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged 5 to less than 9 years at the time of first study vaccination.
* The subject's parent or guardian to provide written informed consent and be willing and able to adhere to all protocol requirements.
* In good health, as determined by medical history and a targeted physical examination (if warranted).

Exclusion Criteria:

* Known hypersensitivity to a previous dose of Influenza Virus Vaccine or allergy to eggs or any components of the study vaccines.
* Clinical signs of significant active infection or an elevated oral temperature at study entry.
* A clinically significant medical or psychiatric condition.
* A history of seizures or febrile convulsions or Guillain-Barré syndrome.
* Vaccination with a seasonal or experimental influenza virus vaccine in the 6 months preceding study entry.
* Vaccination with a licensed vaccine within 14 days preceding study entry, or planning to be vaccinated with another licensed vaccine before the study exit evaluation.
* Currently receiving systemic glucocorticoid therapy (excluding intra-articular, topical or inhaled preparations) or have received such therapy within the 3 months preceding study entry.
* Currently receiving immunoglobulins and/or any blood products or have received such treatment within the 3 months preceding the administration of the study vaccine.
* Currently receiving treatment with warfarin or other anticoagulants.
Metabolism, Exercise and Nutrition at UCSD (MENU Study)

The purpose of the MENU Study is to examine whether there is a differential weight loss response to different dietary macronutrient composition (higher carbohydrate and lower fat versus lower carbohydrate and higher monounsaturated fat \[MUFA\] or lower carbohydrate and walnut-rich higher fat diets) in a weight loss intervention in healthy obese women, depending on insulin resistance status. Blood samples will be collected to enable analysis of potential mechanisms and differential response across subgroups.


Eligibility Criteria:
Inclusion Criteria:

* Aged 21 years and older
* Have BMI \>30.0 kg/m2 and \<40 kg/m2
* Willing and able to participate in clinic visits, group sessions, and telephone and Internet communications at specified intervals
* Able to provide data through questionnaires and by telephone
* Willing to maintain contact with the investigators for 12 months
* Willing to allow blood collections
* No known allergy to tree nuts
* Able to be physically active

Exclusion Criteria:

* Diabetic
* Inability to be moderately physically active
* A history or presence of a comorbid diseases for which diet modification and increased physical activity may be contraindicated
* Currently pregnant/breastfeeding
* Planning to become pregnant within the next year
* Currently enrolled in a weight loss program or diet intervention study
* Current use of weight loss medication or supplements
* Planned surgical procedure that can impact the conduct of the study
* Have plans to relocate from area within the next year
* 6+ months use of meds likely to cause weight gain or prevent weight loss
* Any condition which in the opinion of the investigator makes the subject unsuitable for inclusion in this study
Bilateral Allotransplantation of Upper Limbs

The aim of the study is to realize a bilateral transplantation of upper limbs. The first objective is functional but there are aesthetic and psychologic imperatives too. This open and descriptive study needs compatible donor and recipient. The sample should be realized simultaneously and the transplantation should be made by two coordinated teams according to this sequence : osteosynthesis, vascular anastomosis, sutures of tendons and nervous sutures. An immunosuppressant treatment should be initialized from the beginning of the intervention and continued for life. Rejections should be screened by regular clinical and histological examinations.


Eligibility Criteria:
Inclusion Criteria:

Donor:

* State of brain death
* Compatibility with recipient about sex, size, age and color
* Blood compatibility; integrity of upper limbs

Recipient:

* Double amputation of hands or forearms with traumatic origin
* Personal motivation
* Good health condition
* Delay from 2 months to 34 years between amputation and transplantation

Exclusion Criteria:

Donor:

* Uncompatibility with sample
* Lesion on upper limbs
* Neoplasia
* Hepatitis B or C
* Positive CMV serology

Recipient:

* Uncompatibility with immunosuppressant treatment
* Psychosis
* Carcinosis
* Cardiovascular diseases
* Addiction to alcohol or smoking
* Pregnancy
* Feeding
Music-listening During Deep Brain Stimulation to Relieve Anxiety

This study aims to demonstrate that music listening in patients undergoing awake deep brain stimulation reduces subjective and objective measures of anxiety. Furthermore, the investigators aim to demonstrate that music may alter neuronal firing patterns based on the type of music played and the location in the brain.

While conscious neurosurgical interventions are generally well-tolerated, they often cause some measure of pain and anxiety. Patients have been reported to suffer from recurring distressing recollections of, or dreams about, the surgery and other post-operative, Post-Traumatic Stress Disorder-like sequelae. High anxiety during surgery correlates with post-operative psychological disturbances. Notably, listening to music reduces anxiety in patients undergoing awake surgical procedures. Nonetheless, DBS is typically performed without music because ambient noise typically interferes with interpretation of neuronal recordings. Recording objective and subjective measures of stress during DBS provides a unique opportunity to determine the effect of music on intra-operative patient anxiety levels in patients listening to music compared to non-music listening control patients. The investigators hypothesize that playing music will improve intra-operative anxiety as measured by objective and subjective measures of stress, including blood pressure, heart rate, cortisol levels and anxiety questionnaires. Additionally, previous data in the investigator's lab has demonstrated that the subthalamic nucleus (STN) responds to melodic music by decreasing the average frequency of neuronal firing. The investigator's pilot study also suggests that STN and thalamic neurons respond differently to melodic music; the neurons in the STN increase synchrony of firing, while neurons in the thalamus decrease synchrony of firing over the course of the music clip. The investigators, therefore, aim to characterize the neuronal firing pattern changes in patients undergoing awake DBS procedures in greater detail, drawing from a larger sample size.

Eligibility Criteria:
Inclusion Criteria:

* STN or VIM targeted DBS surgery, awake DBS surgery

Exclusion Criteria:

* No previous DBS surgeries, no history of deafness
A Trial to Evaluate the Efficacy and Safety of YH12852 in Patients With Functional Dyspepsia

This is a multicenter, randomized, double-blind, placebo-controlled dose-finding phase 2 trial to evaluate the efficacy and safety of YH12852 in patients with functional dyspepsia.

Eligible subjects will be randomized into one of 4 groups; YH12852 0.1 mg, 0.25 mg, 0.5 mg, or placebo at the same ratio and will be administered investigational products orally, twice daily for 4 weeks and followed up for 2 weeks.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be willing and able to provide written informed consent.
2. BMI of \< 35 kg/m2
3. Patients experiencing one or more of functional dyspepsia symptoms beginning at least 6 months prior according to Rome III criteria, with the symptom(s) evident over the last 3 months at the time of screening
4. Patients with no evidence of organic lesions based on upper GI endoscopy, which could be the cause of dyspeptic symptoms
5. Women of childbearing potential (WOCBP) must have a negative pregnancy test result at the screening visit and use an adequate method of contraception to avoid pregnancy throughout the study

Exclusion Criteria:

1. Women who are pregnant or breastfeeding.
2. Women with a positive pregnancy test result on enrollment or prior to investigational product administration.
3. Subjects with a history of surgery that could affect gastrointestinal motility
4. Subjects with inflammatory bowel disease
5. Clinically significant chronic infection (eg. AIDS, etc), or significant medical or psychiatric illness.
6. Serious cardiovascular disease (including QT prolongation defined as QTc interval ≥ 450msec) or respiratory disease
7. History of alcohol or drug abuse within the previous one year.
8. Subjects with mental illness (e.g. schizophrenia, dementia etc) that may render the inability to complete the study
9. Physical and Laboratory Test Findings
10. Administration of any other investigational product or participation in other clinical trials within 3 months prior to randomization.
Rapid Postoperative Recovery Pathway in Adolescent Idiopathic Scoliosis.

the study will evaluate the clinical outcomes of an intra- and postoperative fast-track protocol in patients undergoing instrumented posterior arthrodesis surgery for adolescent idiopathic scoliosis.


Eligibility Criteria:
Inclusion Criteria:

* Ages 14-18 years
* iagnosis of adolescent idiopathic scoliosis requiring an instrumented posterior arthrodesis surgical procedure
* Males and females.

Exclusion Criteria:

* spinal infection
* neoplastic diseases
* heart disease
* hypersensitivity to tranexamic acid
* history of coagulopathy and/or previous thromboembolic events
* severe renal failure
Laparoscopic Sleeve Gastrectomy vs Laparoscopic Roux-en-Y Gastric Bypass

This is a retrospective work on 200 morbid obese patients randomized and categorized into 2 groups according to the treatment method: the laparoscopic sleeve gastrectomy (LSG) and LRYGB groups, within the period from 2014 to 2019 and matched weight dissipation, complications, life quality, and negative events


Eligibility Criteria:
Inclusion Criteria:

* All patients of (Body Mass Index) more than 40, with at least 1 comorbidity

Exclusion Criteria:

* All patients of (Body Mass Index) less than 40,
* No comorbidities
* Patients who refused the surgical procedures.
Pilot Study on Immunotherapy for the Treatment of Persistant Peanut Allergy

The purpose of this trial is to assess the safety and efficacy of peanut immunotherapy in children and adults with peanut allergy. Participants will receive immunotherapy with peanut every 2 weeks for a period of 3 months.


Eligibility Criteria:
Inclusion Criteria:

1. Informed Consent as documented by signature.
2. Male or female subjects 12 to 45 years old at screening visit.
3. Patients with convincing history of IgE-mediated systemic allergic reaction after consumption of peanut, and specific IgE above 95% positive predictive value:

   a. Peanut ≥ 15kU/L or Ara h 2 ≥ 5U/L
4. Patients without a convincing history of IgE-mediated systemic allergic reaction (for example only oral symptoms) after consumption of peanuts but with clear evidence of sensitization (SPT \> 3 mm and/or positive specific IgE (\> 0.1kU/l) and a positive standardized food challenge to peanut between V0 and V1.

Exclusion Criteria:

1. Subjects with a history of severe anaphylaxis to the incriminated food with the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence).
2. Subjects with a history of systemic reaction to peanutskin prick test with commercial extract.
3. Uncontrolled asthma (Forced expiratory volume at one second (FEV1) \<70% of predicted value), active eosinophilic oesophagitis or any condition deemed incompatible by the investigator.
4. Known or suspected systemic mastocytosis.
5. Subject currently under allergen immunotherapy.
6. Subject/parent with excessive anxiety unlikely to cope with study conditions as per investigator's opinion.
7. Participation in a clinical study with a new investigational drug within the last 3 months or for a biological within the last 6 months prior to or during the study.
8. Use of immunosuppression or immunomodulatory drug (including anti-IgE or anti-Tumor necrosis factor (TNF)) within 1 year prior to inclusion in study.
9. Relative counter-indication or inability to use epinephrine auto-injector.
10. Subjects receiving beta-blockers or angiotensin converting-enzyme (ACE) inhibitors.
11. Women who are pregnant or breast feeding.
12. Intention to become pregnant during the course of the study, or inadequate contraceptive measures for women of child-bearing age (contraceptive measures considered adequate are: intrauterine devices, hormonal contraceptives, such as contraceptive pills, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release).
13. Other clinically significant concomitant disease states (e.g., renal failure, hepatic dysfunction, cardiovascular disease, etc.).
14. Diseases with a contraindication for the use of adrenalin (e.g. hyperthyroidism, glaucoma).
15. Known or suspected non-compliance, drug or alcohol abuse.
16. Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant.
17. Patients who are employees of the sponsor, institution or 1st grade relatives or partners of the investigators