cyrilzakka/clinical-trials huggingface dataset:
The Immediate Effect of Applying Transcutaneous Electrical Nerve Stimulation (TENS) on Sympathetic Ganglion and Gastrocnemius for Popliteal Blood Flow

This study aims to evaluate the immediate hemodynamic effects of transcutaneous electrical nerve stimulation (TENS) on the popliteal artery and vein. Vascular issues like PAOD and DVT are common in patients with diabetes, obesity, or immobility due to increased resistance and reduced blood flow. Traditional treatments (medication or surgery) are not always feasible, prompting interest in TENS as an alternative. Although primarily used for pain relief, TENS may enhance blood flow. This research compares different stimulation frequencies (80 Hz vs. 4 Hz) and sites (gastrocnemius muscle vs. thoracolumbar sympathetic ganglia) to identify the most effective configuration.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy people
2. Age: 18 years and above (inclusive)
3. Body mass index (BMI) between 18.5 and 24

Exclusion Criteria:

1. Unable to complete two interventions within a week
2. Have contraindications to electrotherapy (for example: metal implants in the body, open wounds, pregnancy, sensory loss)
3. Obvious varicose veins 4. Unable to lie down for about 1 to 2 hours 5. Taking drugs or nutritional supplements that affect autonomic nervous activity or vasodilation (for example: Ginkgo biloba) 6. Smoking 7. Ankle and Ankle Index (ABI) less than 0.9 or greater than 1.3
The Potential Biochemical Diagnosis Criteria and Therapeutic Effect Indexes: Sex Hormone Binding Globulin Levels and Free Androgen Index in Blood of Patients With Polycystic Ovary Syndrome

To explore whether Free androgen index（FAI）can be regarded as biochemically diagnostic indexes of high androgen hormone in blood of patients with Polycentric ovary syndrome（PCOS）. Also to explore whether Sex hormone-binding globulin（SHBG） and FAI can be seen as therapeutic effect indicatrixes of women with PCOS.


Eligibility Criteria:
Inclusion Criteria:

* The clinical diagnosis criteria for PCOS by European Society of Human Reproduction and Embryology, and Rotterdam working group of American Society for Reproductive Medicine (ESHRE /ASRM )

Exclusion Criteria:

* hyperprolactinemia and other endocrine diseases such as high androgen hormone in blood, namely Cushing's syndrome, congenital adrenal hyperplasia ( CAH ), ovarian or adrenal tumor and so on
The Role of Antioxidant Supplementation in Keratoconus Patients

Keratoconus is the most common primary cornea ectasia, where the cornea undergoes structural changes, leading to loss of tissue integrity and vision loss. The prevalence of Keratoconus is 1:2000 in the general population. Oxidative stress has been thought to have a major effect in the disease pathogenesis of Keratoconus. In vitro studies have shown increase in metabolites related to oxidative stress in Keratoconus disease, and that Keratoconus cells undergo increased oxidative stress and tissue damage. Animal models have shown a therapeutic effect of Vitamin C (ascorbate) in corneal wound healing. Glutathione and Vitamins A, C, and E are important antioxidants in the human body. To this date, the role of systemic antioxidant supplementation in Keratoconus patients has yet to be studied. In addition, it has yet to be established as to whether there is a correlation between serum antioxidant levels, and the severity of disease in the Keratoconus patient. The investigators propose to investigate the plasma levels of antioxidants in relation to disease severity. The investigators will also investigate the role of antioxidant supplementation-consisting of parenteral Glutathione (GSH), and Vitamins A, C and E-in delaying the disease progression in Keratoconus.


Eligibility Criteria:
Inclusion Criteria:

* Participants would be without illness or condition that could make follow-up, or compliance with study medication difficult.
* Participants may have a prior diagnosis of Keratoconus, or may be diagnosed at the initial visit.
* Participants should not have an eye diagnosis, other than Keratoconus, that could adversely influence the visual acuity.
* These participants must not have had prior surgical procedure to treat Keratoconus, including collagen cross-linking, Intacs ring segments, or corneal transplantation.

Exclusion Criteria:

* would exclude smokers and former-smokers.
Multiple Islet Peptide Administration in Type 1 Diabetes (MultiPepT1De)

Type 1 diabetes is an autoimmune disease in which the insulin secreting βcells of the pancreas are destroyed such that the patient is reliant on injection of insulin to adequately control blood glucose levels for the remainder of his/her life. The autoimmune process targets proteins in beta-cells which are termed autoantigens. This is a Phase 1 study using a novel investigational medicinal product (IMP) known as MultiPepT1De in a study of safety and tolerability of administration in patients with recent onset Type 1 diabetes. MultiPepT1De is a mixture of peptides from islet auto antigens. The mixture has been designed to induce or restore immunological tolerance to the beta-cell and thus control or limit autoimmunity to protect beta-cells

Recent onset type 1 diabetes patients will be randomized into 4 groups of 6 subjects and each group will receive 6 injections of either placebo, low, medium or high dose of IMP; each injection is intradermal and spaced 1 month apart.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Type 1 diabetes
* Age 18-45 years
* Maximum of 4 years from diagnosis
* Evidence of ≥1 autoantibody against β-cell autoantigens
* Possession of the HLA-DR4 (DRB1\*0401) genotype
* Residual β-cell function (peak C-peptide \>200)

Exclusion Criteria:

* Females who are pregnant, breast-feeding or not using adequate forms of contraception.
* Use of β-cell stimulants, immunosuppressive or immunomodulatory therapies, including systemic steroids within 1 month prior to randomization, any monoclonal antibody therapy given for any indication and any antigen-specific
Surgical Application of Vac Dressings In Obese Patients to Reduce Wound Complications

The purpose of this study is to determine whether application of an incisional wound Prevena trademark (TM) dressing (applies negative pressure to wounds) in the obese (BMI ≥30) surgical patient will reduce surgical site infections (SSI) when compared to the standard of care dressing.

In an attempt to decrease wound infection incidence and improve healing time of open surgical wounds, vacuum assisted closure (VAC) was developed. This innovative technique provided contained controlled wound irrigation without bacterial aerosolization. A newer customizable subset of the Prevena incision Management System TM called Prevena Peel and Place TM has been released a few months ago. The new model can be cut to specific wound sizes and has a connector that can be attached to the already widely available VAC machines. The versatility and the comparability to older models of Prevena Peel and Place TM have not been tested to this date.

The investigators believe that a randomized clinical trial evaluating the use of the Prevena Incision Management System TM for homecare and the use of Prevena Peel and Place TM for inpatients in special populations is warranted. Obese patients (BMI≥30) undergoing open surgery will have decreased surgical site infection rates, improved healing time, better quality of life (QOL) and lower readmission rates with use of Prevena in the post-operative management of surgical incisions.

Eligibility Criteria:
Inclusion Criteria:

* Patient has been informed of the nature of the study, and has provided written informed consent, approved by the appropriate Institutional Review Board (IRB) / Medical Ethics Committee (MEC) of the respective clinical site.
* Patient meets the criteria for and is undergoing open surgery at Johns Hopkins Medical Institutes.
* Patient with BMI≥ 30 at the time of surgery
* Patient agrees to return for all required clinical follow up for the study.

Exclusion Criteria:

* Known allergic reaction to acrylic adhesives or silver.
* Known history of intolerance to any component of Prevena Incision Management System TM.
* Very fragile skin around incision site.
* Bleeding disorder or refuses blood transfusion.
* Malignancy or other condition limiting life expectancy to \<5 years.
* Pregnancy
Measurement of the Quality of Life in Patients Operated With a Total Knee Prosthesis (TKA) From the FHK® Range.

As part of Medical Devices CE marking regulatory process, an appropriate post-market clinical follow-up (PMCF) is required. This PMCF study is in the framework of CE mark renew of FHK® total knee prosthesis, it aims to answer specific questions related to safety and performance of the device, when used in accordance with the approved instructions for use.

This study is based on a quality of life self-assessment from the preoperative to postoperative phases and up to two years of follow-up.

The primary objective of this study is to evaluate the quality of life in patients operated with a FHK® total knee prosthesis up to 2 years of follow-up.

The secondary objectives are to evaluate the security and performance of the devices by gathering complications, revision rate of the devices (survival analysis) and functional score up to 2 years of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Subject implanted with FHK® prosthesis in one of the following indication according to the instructions for use: knee disorders; Aseptic condylar necrosis.
* Subject who received an information form and is willing to participate in the study.
* Adults subjects (≥18 years old).
* Access to an internet connection allowing to complete the questionnaires on the online platform

Exclusion Criteria:

* Contraindications described in the instructions for use
* Subject who is not able to express his/her non-opposition
Wellness Interventions After Transplant Study

The Wellness Interventions after Transplant (WIAT) Trial has reached its enrollment target. This trial is no longer recruiting new patients. Those currently enrolled will be followed for a year to evaluate trial outcomes.

The purpose of this trial is to determine if training in Mindfulness-Based Stress Reduction can reduce symptom distress and improve quality of life in solid organ transplant recipients. Primary study outcomes are depression, anxiety and insomnia symptoms, measured by well-validated self-report scales. The impact of this program on objectively measured sleep outcomes, use of health care resources and costs will also be evaluated.

Pharmacologic options for managing symptoms increase the risks of side effects and drug interactions, and may reduce adherence by complicating an already challenging medication regimen. In contrast, mind-body based complementary therapies may be ideal to treat distressing symptoms and negative emotions after transplantation. Our long-range objective is to develop evidence-based recommendations for non-pharmacologic strategies that provide symptom relief to transplant recipients, and are safe, practical and cost-effective.

Potential participants are recruited by mail, screening by clinic staff and provider referrals. Interested persons are screened by telephone and mailed informational study brochures. Informed consent is conducted by face-to-face interview, where a diagram of the study design is used to explain the 2-stage randomization and study requirements.

Eligibility Criteria:
Inclusion Criteria:

* kidney, kidney/pancreas, pancreas, lung, liver, heart or heart-lung recipients, with a functioning graft
* 18 years old or older
* English-speaking
* literate
* mentally intact
* reachable by telephone
* on immune suppressive medication
* receiving regular medical follow-up care
* interested in health promotion and mind-body interventions
* able to attend weekly classes in a Minnesota Metro area
* willing to complete the informed consent process

Exclusion Criteria:

* serious preexisting mental health issues such as suicide attempts or a psychosis
* medically unstable (a hospital admission for non-elective purposes in the last 3 months or major surgery planned in the next 3 months)
* on dialysis
* regularly practicing mindfulness meditation
Development and Application Study of ePRO Software for Managing Cancer Patients Throughout the Treatment Period

After receiving chemotherapy, targeted therapy, immunotherapy and other drug treatments, tumor patients often experience various adverse reactions such as bone marrow suppression, diarrhea, pneumonia, etc. However, due to the limited capacity of the hospital, if patients who are discharged home cannot timely detect and deal with severe drug adverse reactions, it will cause harm to their bodies and even threaten their life safety. With the rapid development of network communication, many foreign institutions have tried to develop ePRO software based on patient symptom reports. This type of software is used to monitor drug adverse reactions and provide timely feedback to the attending physician for medical intervention. Existing studies have shown that the application of this type of ePRO software significantly reduces the severity of drug adverse reactions on patients and significantly prolongs survival time.

In this study, the investigators plan to collaborate with Shenzhen 123 Digital Medical Group Co., Ltd. to design and develop a tumor ePRO software that allows outpatient treatment period patients who are discharged home to regularly self-assess the severity of drug adverse reactions and automatically feed back the scoring results to the department's monitoring center. Doctors will make timely diagnosis and treatment based on each patient's score results in order to maximize patient safety after treatment at home. The results of this study will provide better follow-up care for tumor patients who are discharged home after anti-tumor treatment by significantly improving the safety of outpatient treatment period patients with tumors and thereby improving patient survival time and quality.


Eligibility Criteria:
Inclusion Criteria:

1. Histopathology confirmed as malignant tumor;
2. ECOG (Eastern Cooperative Oncology Group) performance status score: 0-1;
3. The expected survival time was ≥6 months;
4. Intended to receive systemic antitumor therapy (Cisplatin/oxaliplatin regimen);
5. Proficient in using ePRO software after training;

Exclusion Criteria:

1. Patients who were unable to operate the ePRO system without compliance or after repeated training
2. The chemotherapy regimen did not contain cisplatin or oxaliplatin
3. According to the investigator's assessment, the subjects had other factors that might lead to their forced termination of the study, such as non-compliance with the protocol, other serious diseases requiring combined treatment, serious abnormal laboratory test values of clinical significance, family or social factors, and circumstances that may affect the safety of the subjects or the collection of trial data
Predictors of HFNC Failure in Patients With AHRF Using Diaphragm Ultrasound

Ultrasound of the diaphragm is an easily reproducible bedside tool that provides a non-invasive measurement of inspiratory muscle function and respiratory efficiency. The diaphragmatic thickness correlates with the strength and muscle shortening and is reflective of its contribution to the respiratory workload. Diaphragm thickening fraction (DTF) has been shown to be predictive of extubation failure in ventilated patients. However, whether measurements of DTF are predictive of high flow nasal cannula (HFNC) outcomes in patients with acute hypoxemic respiratory failure (AHRF) remains unknown. The objective of this study is to identify predictors of HFNC failure by diaphragm ultrasound and to compare its performance with the well-established ROX index.


Eligibility Criteria:
Inclusion Criteria:

* Age ≧ 18; AND
* Acute hypoxemic respiratory failure (AHRF), defined by respiratory rate of greater than 25 breaths per minute and a ratio of the PaO2 to the fraction of inspired oxygen (PaO2 / FiO2) of less than 300, and use of accessory muscles of respiration or paradoxical abdominal motion; AND
* Required ventilatory support with high-flow nasal cannula (HFNC)

Exclusion Criteria:

* Patients suffering from hypercapnic respiratory failure; OR
* AHRF secondary to conditions that are indicated for non-invasive ventilation (NIV) (e.g. acute exacerbation of COPD, cardiogenic pulmonary edema); OR
* Use of NIV or invasive mechanical ventilation (IMV) prior to HFNC initiation; OR
* Patients with imminent need for endotracheal intubation and invasive mechanical ventilation (IMV); OR
* Patients with known or suspected diaphragm paralysis; OR
* Pregnancy; OR
* Patients with abdominal compartment syndrome; OR
* Use of HFNC for more than 12 hours prior to ICU admission; OR
* Patients with suboptimal diaphragm ultrasound image quality for data processing; OR
Sensible Sleep: Measuring Alarm and Snooze Behavior in Teens Using Wearables and Smartphones

Pilot data suggests that working professionals and college students routinely use alarms and snooze. Alarm usage and snoozing is associated with several negative health biomarkers including lighter sleep, higher resting heart rate, and reduced sleep duration. It is unclear when this behavior is established, but it is likely in the teenage years when chronic sleep restriction begins to effect a large percentage of Americans. We will ask teens about psychological traits (e.g. personality) and snoozing behavior in a repeated measures design. In addition, we will implement a smartphone based intervention which notifies teens when they are awake past their minimum bedtime for adequate sleep. throughout the study, we will monitor sleep and heart-rate via wearable. From this data, we will establish the prevalence of alarm and snoozing behaviors in teens. We will determine what demographic, psychological, and behavioral traits predict snoozing, and if there are any differences in health biomarkers (e.g. sleep duration, resting heart rate)between snooze and/or alarm users. We will use data from the wearables and smartphones to generate features that can detect snoozing, and will validate them against self-report. Finally, we seek to determine if alarm and snoozing behavior can be reduced via a smartphone intervention aimed at increasing sleep duration.


Eligibility Criteria:
Inclusion Criteria:English as a primary language -

Exclusion Criteria:

-
OUTpatient Treatment of COVID-19 in Patients With Risk Factor for Poor Outcome

COVID-19 is a respiratory disease due to a novel coronavirus (SARS-CoV-2) that causes substantial morbidity and mortality. To date, no treatment has been proved to be effective in COVID-19. Elderly patients and patients with comorbidities have the worse prognosis with a higher risk of hospitalization, ICU admission and death. The efficacy of an early outpatient treatment could be suggested but need to be confirmed. This confirmation is mandatory to improve prognosis of COVID-19 but also to avoid unsuspected deleterious effect of drugs already used in clinical practice but not based on evidence.

The investigators make the hypothesis that an early outpatient treatment of COVID among patient with respiratory symptoms and risk factors for poor outcome can improve the prognosis of these patient and decrease the need for hospital admission.

Our study is an open label randomized clinical trial comparing 4 arms of treatment: Standards of Care (SoC) alone versus SoC + Azithromycine versus SoC + Hydroxychloroquine vs Soc + Lopinavir/Ritonavir.

Our involved population is patients more than 50 years of age with comorbidity or patients more than 70 years of age.

Our primary objective is to evaluate the efficacy of early outpatient treatment compared to standard of care in patients COVID-19 with risk factors for poor outcome. The criteria is hospital admission at Day 20 and the hospital admission rate will be compared between groups by a Chi² test or a Fisher's exact test.

Eligibility Criteria:
Inclusion Criteria:

1. Either patients over 50 years of age with at least one comorbidity (hypertension, diabetes, obesity, cancer, chronic renal disease, immunodeficiency) OR patients over 70 years of age with or without comorbidity
2. Laboratory (PCR-) proved infection by COVID-19 or radiological sign highly suggestive of COVID-19
3. Respiratory symptoms (cough, chest discomfort, dyspnea)
4. Affiliation to the social security network
5. Able to understand and sign a written informed consent form

Exclusion Criteria:

1. Need for hospitalization according to updated French guidelines (ministère de la santé_04/04/2020)
2. Patient in long-term care facility
3. Patient without concern confirmation of COVID-19 by laboratory (PCR swab) test or chest CT
4. Known hypersensitivity or contra-indication to the 3 experimental treatments (azithromycin, hydroxychloroquine, lopinavir/ritonavir).
5. Any reason making follow up of the patient impossible during the study period.
SECOND GENERATION COLON CAPSULE ENDOSCOPY (CCE-2) IN PEDIATRIC CROHN'S DISEASE (CD).

This prospective pilot study of 40 pediatric patients with Crohn's Disease, that are candidates for endoscopic and imaging re-evaluation, examines the Given Diagnostic System and the second generation of colon capsule in comparison second generation of colon capsule endoscopy (CCE-2) to magnetic resonance enterography (MRE), small intestine contrast ultrasonography (SICUS) and endoscopy (upper and lower).

This study aims

1. To evaluate and compare the accuracy of CCE-2 with MRE, SICUS and endoscopy in the evaluation of pediatric Crohn's disease.
2. To evaluate the safety of CCE-2 in pediatric CD.


Eligibility Criteria:
Ages Eligible for Study: 6-18 Years Genders Eligible for Study: Both Accepts Healthy Volunteers: No

Inclusion criteria:

Subjects must meet one the following inclusion criteria to be eligible for enrollment into this proposed study:

* diagnosis of Crohn's Disease made at least 3 months before the enrolment;
* subject was referred for endoscopic and imaging follow-up in Crohn's Disease
* signed informed consent.

Exclusion criteria

The presence of any of the following will exclude a subject from study enrollment:

* Subject has dysphagia
* Subject has renal insufficiency
* Subject is known structuring Crohn's Disease identified by magnetic resonance enterography (MRE) or small intestine contrast ultrasonography (SICUS).
* Subject has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the magnetic resonance enterography findings and clinical judgment of the investigator.
Comparison of Hyperemic Efficacy Between Nicorandil and Adenosine for Fractional Flow Reserve (FFR) Measurement

The purpose of this study is to evaluate the efficacy of nicorandil in the achievement of maximal coronary hyperemia compared with adenosine.


Eligibility Criteria:
Inclusion Criteria:

* non -infarct related, patients with moderate coronary artery stenosis
* normal left ventricular ejection fraction on echocardiogram

Exclusion Criteria:

* infarct-related arteries or clinically unstable state
* collateral blood flow to the target vessel is shown
* atrioventricular block on electrocardiogram
* reduced left ventricular ejection fraction (\<50%) or left ventricular hypertrophy on echocardiogram
* contraindication of adenosine
* bronchial asthma