cyrilzakka/clinical-trials huggingface dataset:
Slow Yogic-Derived Breathing and Respiration and Cardiovascular Variability in Spinal Cord Injury Patients

This research will aid in understanding of slow-breathing and its effect on heart rate and blood pressure in people with a spinal cord injury (SCI). This research will investigate if traditional 'yogic' breathing exercises can be performed by subjects with SCI and its influence on the cardiovascular system.

The relationship between respiratory patterns and cardiovascular variability in healthy persons has been previously studied. However, the impact of SCI on the interrelationships between the respiratory and cardiovascular systems remains relatively unstudied. The loss of autonomic control in SCI may mean that slow breathing has profound effects on cardiovascular variability. Hence, those with SCI may represent a population that could benefit from the potential physiologic effects of numerous yogic-based breathing patterns that can be applied anywhere any time. Hence, it is important to determine if slower breathing patterns can shift the cardiovascular control pattern to-wards important healthful effects. This physiological study will compare the effects of uncontrolled breathing and traditional yogic slow-breathing practices on cardiovascular variability in SCI patients.

Eligibility Criteria:
Inclusion Criteria:

1. Age: 18-60 years old
2. Wheelchair user
3. Medically stable \& able to follow directions
4. Body mass index (18.5 - 35 kg/m2)

Exclusion Criteria:

1. BP \>140/90 mmHg
2. Current use of cardioactive medications (except medication to support blood pressure)
3. Current tobacco use
4. Significant arrhythmia
5. Coronary artery disease
6. Diabetes
7. Renal Disease
8. Cancer
9. Epilepsy or other neurological diseases
NB-UVB and PUVA Vitiligo Study

To evaluate if the combination of psoralen plus ultraviolet A and narrowband ultraviolet B is more effective than narrowband ultraviolet B alone in the treatment of vitiligo.


Eligibility Criteria:
Inclusion Criteria:

* Vitiligo affecting more than 15% body surface area.
Identification of Autoantibodies and Autoantigens in the Cerebrospinal Fluid of Patients With Spinal Cord Trauma

The purpose of the study is to detect the presence of autoantibodies and autoantigens in cerebrospinal fluid early (\<48 hours) following spinal cord trauma.

The study also aims to define the central or peripheral origin of autoantibodies by looking for their simultaneous presence at the blood level and to evaluate the prognostic value of the presence of autoantibodies within the cerebrospinal fluid, as well as on the initial clinical severity than on the recovery potential.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with spinal cord injury dating back less than 48 hours
2. Men or women over 18 years of age
3. Patients benefiting from social protection
4. Surgery performed within 48 hours of the trauma
5. Informed and signed consent by the patient or trusted person

Exclusion Criteria:

1. Contra-indication to ensure surgical decompression within the first 48 hours following the trauma
2. Coagulation disorders or any condition that may make the lumbar puncture risky (eg, history of lumbar surgery)
3. Severe cranial trauma associated
4. History of autoimmune pathology
5. Immunosuppressive therapy or long-term corticosteroid therapy
6. Patients unable to comply with protocol requirements
7. Person benefiting from legal protection (guardianship / curator)
8. Person deprived of liberty
9. Patient unable to express consent
10. Pregnant women
Encouraging Healthy Food Shopping and Eating Behaviors by Price Reduction: A Community Supermarket Study

The investigators plan to test the effect of price reduction of fruits and vegetables and non-caloric beverages on food purchasing, food intake, body weight, and body composition of primarily single adult shoppers. One hundred subjects will be randomized to an experimental or control group for a 4 month period. In the experimental group, there will be an automated 50% reduction in fruits vegetables and non-caloric beverages during the middle 2-month period. The investigators expect to observe significant changes in food shopping and eating behavior during this period, which should lead to body weight and fat loss. Some of these new shopping patterns should persist in the last month of the study even though prices revert.


Eligibility Criteria:
Inclusion Criteria:

* regularly buy 50% of groceries at designated supermarket
* primary food shopper for household, shopping for up to one other person, not counting children ≤ 6 years old

Exclusion Criteria:

* significant medical or psychiatric conditions
* participation in a weight loss program or a related study
Prevalence of Hepatitis C Virus Infection in HIV-Infected Children

The purpose of this study is to find out how many children who are infected with HIV are also infected with hepatitis C virus (HCV).

HCV infection is a major health concern. HIV-infected adults who are co-infected with HCV appear to have more rapid HIV disease progression. There is little data on how widespread HCV is among children who are HIV-infected. Information from this study will help determine the need for future HCV studies. This study also will obtain blood samples for future testing for other hepatitis viruses such as hepatitis G virus (HGV or GB virus C).

HCV infection is a major public health concern with worldwide seroprevalence estimated at 1 percent. HIV-infected adults co-infected with HCV appear to have accelerated HIV disease progression. There is little data on HCV prevalence in the pediatric HIV-infected population. This substudy will provide estimates of HCV prevalence among HIV-infected children and determine the need for future HCV natural history and treatment protocols. In addition, this substudy will archive samples from patients for future testing for other hepatitis viruses such as hepatitis G virus (HGV or GB virus C).

Patients participating in PACTG 219C are selected randomly to enroll into PACTG P1028S. Patients who agree to participate have a single blood draw for HCV antibody (Enzyme Immunoassay-EIA) testing and HCV RNA (Polymerase Chain Reaction-PCR) testing. An additional blood draw is necessary in the case of discordant results between the HCV EIA and HCV PCR. HCV-negative patients have 1 study visit. Patients with positive HCV test results have 2 visits. Patients with discordant HCV test results have 2 or 3 visits.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this substudy if they:

* Are between 1 year and 20 years of age.
* Were infected with HIV from the mother at or around the time of birth.
* Are enrolled in PACTG 219C.
* Children known to be HCV-infected will be permitted to enter the substudy.

Exclusion Criteria

Patients may not be eligible for this substudy if they:

* Have hemophilia.
* Contracted HIV through a route other than from the mother around the time of birth.
Humeral Resurfacing Hemiarthroplasty

The primary objective of this study is to examine quality of life outcomes in patients who have undergone a humeral surface replacement hemiarthroplasty.

Resurfacing arthroplasty is gaining popularity for the reconstruction of advanced shoulder arthritis. New generation re-surfacing prostheses are engineered to anatomically restore a smooth articulating surface to the humeral head, while preserving bone stock, and potentially minimizing the risk for diaphyseal fracture. The results for shoulder resurfacing prostheses have largely been reported in retrospective reviews and have been very favorable. The purpose of this multi-centered, prospective study will be to determine the extent to which patient self-assessed outcomes (American Shoulder and Elbow Society (ASES) Score) following humeral resurfacing improve compared to pre-operative ASES scores.

Eligibility Criteria:
Pre-Operative Inclusion Criteria:

* Failed standard non-surgical management (analgesics, nsaids, physiotherapy, activity modification)
* Persistent pain and disability for at least 6 months
* Imaging demonstrates advanced humeral head cartilage loss

Pre-Operative Exclusion Criteria:

* Active or systemic joint infection
* Significant muscle paralysis of shoulder girdle
* Charcot's Arthropathy
* Major medical illness (life expectancy \<2years)
* Unable to speak and read English/French
* Psychiatric illness that precludes informed consent
* Unwilling/unable to remain in study for one year

Intra-Operative Inclusion Criteria:

Advanced humeral head cartilage loss AND ONE of:

* minimal/no glenoid cartilage loss
* complete glenoid cartilage loss and no bony erosion
* complete glenoid cartilage loss and concentric bony erosion with no humeral anterior/posterior subluxation

Intra-Operative Exclusion Criteria:

* Eccentric glenoid erosion with biconcavity of glenoid and subluxation of humeral head
* Inability of humeral head to support the CAP surface replacement
The POUR (Postoperative Urinary Retention) Study

The primary aim of this study will be to compare the rate of postoperative urinary retention between patients receiving Sugammadex and those receiving traditional reversal agents

Postoperative urinary retention following laparoscopic inguinal hernia repair occurs in approximately one out of ten patients. The more rapid reversal of neuromuscular blockade with Sugammadex has empirically been associated with low rates of postoperative urinary retention. In this study, patients will receive Sugammadex following laparoscopic inguinal hernia repair and then be retrospectively matched against a group of patients who did not receive Sugammadex. The primary aim of this study will be to compare the rate of postoperative urinary retention between patients receiving Sugammadex and those receiving traditional reversal agents (e.g. neostigmine which has a retention rate of 5-11%). We will also examine difference in cost and quality of life between the two groups. Our hypothesis is that the use of Sugammadex will decrease rate of postoperative urinary retention, decrease associated cost, such as need for admission, and not negatively impact quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18
* Undergoing laparoscopic inguinal hernia repair at Carolinas Medical Center by attending surgeons within the Division of Gastrointestinal and Minimally Invasive Surgery
* Unilateral or bilateral inguinal hernia repair; may have concurrent umbilical hernia repair performed
* Agreeable to participation in the study

Exclusion Criteria:

* Patients who are having concurrent ventral or flank hernias repaired at time of operation or are having an inguinal hernia repair along with another operation (e.g.

laparoscopic cholecystectomy)

* End-stage renal disease (Creatinine clearance less than 30)
* Neuromuscular disease
* Prior adverse reactions to Sugammadex
* Patients who do not provide consent for the study
Artificial Intelligence to Measure Adherence to Oral Medication

The aims of this project is to use an artificial intelligence (AI) smartphone app to provide support for medication adherence by patients with first episode psychosis.

The challenge of oral medication adherence in first-episode psychosis (as in any potentially chronic illness) is enormous, and numerous studies have linked non-adherence to increased rates of relapse/ hospitalization. Determining whether a patient is adhering to medication is a challenge. Pill counts, pharmacy records, technology-assisted monitoring, biological assays, and a range of self-report and interviewer-rated scales have been employed. In other areas of medicine such as antiretroviral treatment Direct Observation of Treatment (DOT) has been employed with excellent success both in monitoring and demonstrated improvement of important clinical outcomes. DOT is clearly not feasible in community settings. An artificial Intelligence (AI) platform that can be downloaded as an application onto a smart phone app represents a novel approach to offering DOT to support participant oral medication adherence and thereby improve outcomes. Aims of the project are: 1) to document acceptability to patients of the AI smartphone app based upon participation in the study and 2) to compare rates of hospitalization and emergency room visits between participants who receive the AI smartphone app with participants who receive standard care.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in a CSC program
* Prescribed an oral antipsychotic

Exclusion Criteria:

* none
The Effectiveness of Mindfulness-based Intervention as a Workplace Health Promotion Program on Weight Loss

The present study will carry out a workplace health promotion via MBI with lessons of dietary behavior to help overweight or obese workers to loss weight.

The study will adopt a longitudinal research design with randomized quasi- experimental trial. The workers with overweight or obesity (BMI≧24) provided by the company will be randomly assigned to Group A (four lessons of dietary behavior and six lessons of MBI) or Group B (four lessons of dietary behavior and six lessons of mental health). There will be 100 participants in each group. Data will be collected five times. The research questionnaire includes basic information (including BMI, waist circumference, etc), Perceived Stress Scale, The Five Facet Mindfulness Questionnaire, Food Cravings Questionnaire, the scale of physical activity and information regarding dietary behavior.

Eligibility Criteria:
Inclusion Criteria:

1. adults aged 20 to 65 years old;
2. full-time workers with BMI ≧ 24;
3. motivated to participate in the study;

Exclusion Criteria:

1. suffering from mental illness or in an acute episode;
2. suffering from life threatening or other major physical illness;
3. no motivation to participate in the study.
The Effect of Patient Counseling on Adolescent Hemophilia Patient Compliance With Bleeding Logs

The study will see if counselling adolescents with severe or moderate Hemophilia A or B results in increased compliance in the maintenance of bleeding logs.

The study will see if counselling adolescents with severe or moderate Hemophilia A or B results in increased compliance in the maintenance of bleeding logs.To do this subjects will be randomized into a control group and a group who will receive consistent counselling by a pharmacist about their bleeding logs.

The aims of the study are:

* To provide a new method of bleeding and treatment documentation in the home setting (logs) to adolescent subjects with Hemophilia A or B
* To counsel these subjects about adherence to their treatment regimen prescribed by physician and the importance of keeping accurate documentation of each bleeding episode and its treatment.
* To improve maintenance of logs, to allow for 1) assessment of bleeding frequency and treatment efficacy and 2) early detection of target joint bleeding and the potential need for prophylactic factor replacement.

Eligibility Criteria:
Inclusion Criteria:

* Ages 12 through 20
* Severe or moderate Hemophilia A or B
* Self-infusing or transitioning to self infusion in the home setting
* Already assigned responsibility of monitoring bleeding logs

Exclusion Criteria:

* Not meeting inclusion criteria
Contribution of Hypnosis in Guided Hepatic Biopsy (Ap-Hy-PBH)

The purpose of this study is to evaluate the contribution of hypnosis on the level of pain felt by the patient during ultrasound-guided hepatic biopsy, by comparing an intervention group (hypnosis) to a control group (routine and benevolent care).

Single-center randomized controlled trial.

Hepatic Biopsy Puncture (HBP) is a very useful procedure for the assessment of chronic liver disease as well as in certain acute situations, and is also essential in oncology for the histological diagnosis of primary and secondary focal lesions. A study on the prevalence and characteristics of induced pain shows that it is a pain-generating procedure for 84% of patients and that the combination of anxiolytics and local anesthesia is insufficient. The effect of relaxing therapies was evaluated during percutaneous interventional radiology procedures. Anxiety and pain measured with visual analogue scales were significantly reduced in the group receiving support from sophrology and hypnosis . The mean evaluation of anxiety per procedure was 2.07 (95% CI, 1.48-2.82) in the group receiving relaxation therapy compared with 5.94 (95% CI, 4.62-7.22) in the other group. The mean level of pain felt was 1.83 (95% CI, 1.23-2.78) for the accompanied procedures versus 4.16 (95% CI, 2.53-6.04) without accompaniment. However, this study did not specifically look at percutaneous liver biopsy, and moreover the relaxation technique used was based on sophrology and not on an Ericksonian hypnosis approach.

Data concerning the use of hypnosis during percutaneous liver biopsies are limited to clinical cases, which report an absence of pain felt, including an observation in a patient who did not receive local anesthesia because of a history of allergy to Lidocaine.

Training in attentive and benevolent patient care already allows this type of procedure to be performed under good conditions in our department. This training of about one hour, carried out internally, does not require specific means. It would therefore seem useful to see what the impact is of using Ericksonian hypnosis, a recognized and risk-free technique which would require longer specific training for the staff and would represent a cost.

Eligibility Criteria:
Inclusion Criteria:

* Patients with an indication for ultrasound-guided hepatic biopsy
* Over 18 years of age
* Affiliated to a social security system

Exclusion Criteria

* History of psychiatric pathology, psychotropic or anxiolytic treatments
* Refusal to participate.
* People who do not understand and/or speak French.
* People who are deaf
* Patients with impaired cognitive abilities, evaluated by the prescribing service
* Disorders of hemostasis against percutaneous approach
* Allergy to Lidocaine
* Patient under National Health Aids
Infections in Hospitalized Cirrhotic Patients

Hospitalized cirrhotic patients are at high risk of complications and adverse outcomes. This study aims to determine the current practice and outcomes in these following areas:

1. Community-acquired infections
2. Nosocomial infections
3. Development of second infections
4. Factors predicting ICU care, organ failure, death, and disability
5. Patterns and adequacy of albumin use in infected and non-infected patients
6. Per and post-liver transplant outcomes
7. Quality-assurance and adequacy of management of complications of cirrhosis such as hepatic encephalopathy, variceal bleeding, hyponatremia, and hypernatremia
8. Regional variations in outcomes and therapeutic strategies


Eligibility Criteria:
Inclusion Criteria:

* Male and Female over 18 years of age
* Cirrhosis as diagnosed by either liver histology or a combination of clinical biochemical (low platelets, elevated bilirubin, and/or INR, low albumin) radiologic (nodular liver on ultrasound) and endoscopic (esophageal varices) criteria
* Subject must be able to understand and provide informed consent
* Evaluated in the ER or admitted to the hospital for non-elective reasons

Exclusion Criteria:

* admitted for elective purpose
Pharmacoscintigraphic Investigation of NN9924 in Healthy Male Subjects

This trial is conducted in Europe. The aim of this trial is to investigate whether the volume of water administered with NN9924 affects the anatomical location (stomach or proximal small bowel) of tablet erosion.


Eligibility Criteria:
Inclusion Criteria:

* Good general health
* Body mass index (BMI) of 18.5-30.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Males who are not willing to use two acceptable forms of highly effective contraception
* Participation in another clinical trial within 90 days
* Any chronic disorder or severe disease
* Use of GLP-1 (glucagon-like peptide-1) agonists within 3 months preceding dosing
* Subjects who are smokers
* Subjects who have donated any blood or plasma in the past month or in excess of 500 mL within the 12 weeks preceding screening
Study of Dengue in Patients With Autoimmune Diseases During the Epidemics of 2020 and 2021 in Reunion Island

It is not known whether there is a different clinical profile of dengue in patients with immune system dysfunction. Preliminary data and previous literature suggest that autoimmune diseases, and in particular their treatment, may favour the evolution to severe forms of dengue.

Our research hypothesis is that the clinico-biological presentation of dengue might be different in case of autoimmune disease, either on the side of overactivation (autoimmune and auto inflammatory diseases without treatment) or immunodepression (autoimmune and auto inflammatory diseases under immunosuppressive treatment).


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Patient with autoimmune or autoinflammatory disease
* Confirmed diagnosis of dengue (in 2020 or 2021): serological test, antigenic test or PCR test to confirm the diagnosis according to current criteria

Exclusion Criteria:

* minor
* opposition to the re-use of data
* patient not followed in Reunion
* protected adult (guardianship or curatorship) or under legal protection
Regulation of Vitamin D Metabolism by Washed Microbiota Transplantation in Patients With IBD

WMT could effectively induce clinical response and maintain remission in patients with Inflammatory bowel disease (IBD). VD maintains gut microbiota and gut microbiota alter intestinal vitamin D metabolism (VDM),The aim of this study was to evaluate the effect of WMT on VD metabolism by measuring the level of serum 25(OH)D in IBD patients before and after treatment

Inflammatory bowel disease (IBD) is a chronic, relapsing disorder that is represented by Crohn's disease (CD) and Ulcerative colitis (UC), the pathogenesis of IBD is not completely understood, but it is now acknowledged that it is related to intestinal microbiota. The gut microbiota is a central regulator of host metabolism, More and more evidences show that the gut microbiota plays an important physiological role in the pathogenesis of a variety of human metabolic, immune and neurological diseases, including IBD. Fecal microbiota transplantation (FMT) transplants the gut microbiota of healthy donors into the patients' intestines, This is an effective strategy to restore the intestinal microbiota and it is also a hot research topic in recent years. Our previous studies and other studies have proved that FMT could effectively induce clinical response and maintain remission in patients with IBD. Washed microbiota transplantation (WMT) is a fecal bacteria transplantation based on Intelligent fecal bacteria separation system and strict quality control of washing process, It is a new stage of FMT development, our group have proved that WMT is safer, more precise and more quality-controllable than the crude FMT by manual.

Vitamin D(VD) has been shown to have multifaced effects on the skeletal environment,immune system and infection. A number of diseases, including tumors, Type I diabetes, IBD and autoimmune diseases are associated with VD deficiency, VD could have an important role in the prevention and possible treatment of these conditions. Several studies have shown that intestinal microbiota is closely related to VD，VD maintains gut microbiota and gut microbiota alter intestinal vitamin D metabolism (VDM). A clinical trial shows that probiotics supplementation can change the level of 25 hydroxyvitaminD(25(OH)D). Serum 25(OH)D correlates with overall storage of VD, which is the preferred clinical measure to assess VD sufficiency. The aim of this study was to evaluate the effect of WMT on VD metabolism by measuring the level of serum 25(OH)D in IBD patients before and after treatment

Eligibility Criteria:
Inclusion Criteria:

* IBD patients aged 16-65years

Exclusion Criteria:

* previous history of partial small bowel resection;
* Abnormal thyroid and parathyroid function;
* Complicated with complicated intestinal fistula and severe infection and treated with antibiotics
* Women during pregnancy, lactation and oral contraceptives.