cyrilzakka/clinical-trials huggingface dataset:
Genetic Determinant of Blood Pressure Sensitivity to Salt Intake

Nedd4.2 is a regulator of ENac, a transporter of sodium involved in the regulation of salt retention by the kidney. The study address the consequence of a frequent genetic variation leading expected to impact the function of Nedd4 and in turn, the ability of kidneys to excrete salt intake. Our hypothesis is that the genetic variants of Nedd4.2 could constitute a genetic predisposition to (or protection against) salt-sensitive hypertension.

Subjects were submitted one week to a low sodium-high potassium diet, and then switch to a high sodium,-low potassium diet for two weeks. the last week, subject were taken a 20 MG daily dose of amiloride, a potassium sparing diuretic.

Eligibility Criteria:
Inclusion Criteria:

* healthy volunteers
* between 18 and 35 years odl
* BMI between 18 and 28 Kg per m2
* non smokers
* no active disease
* no alcool or drug abuse
Effects of Short Term, High Dose Atorvastatin Therapy on Periprocedural Myonecrosis and Platelet Inhibition After Percutaneous Coronary Intervention (PCI)

This research study plans to evaluate the use of atorvastatin in patients with coronary artery disease given immediately before PCI and whether it will decrease the amount of heart damage after PCI.


Eligibility Criteria:
Inclusion Criteria:

* patients undergoing revascularization for significant coronary artery disease
* age range 21-85 years

Exclusion Criteria:

* non-STEMI, STEMI
* cancer
* renal failure with creatinine\>3.0mg/dl
* liver cirrhosis
* lymphoproliferative disorder
* pregnancy
* thrombocytopenia\<150'000
* coagulopathy (INR\>1.5)
* abnormal liver function tests
* illicit drug use
* history of statin intolerance
* history of rhabdomyolysis
* planned use of Glycoprotein IIb/IIIa inhibitors during PCI
* current therapy with atorvastatin, pravastatin, lovastatin, fluvastatin, or rosuvastatin
Staple Line Inversion vs Buttressing on Postoperative Vomits After LSG

Patients undergoing laparoscopic sleeve gastrectomy will be randomized into 2 groups. In one group, a staple line inversion with a running suture of Polypropylene will be performed. In the second group, the gastric section will be performed with a stapler with preloaded buttress material

Postoperative nausea and vomits during the first 24 hours will be investigated.

Patients undergoing laparoscopic sleeve gastrectomy as bariatric procedure will be randomized into 2 groups. In one group after the stapling and section of the stomach with stapling devices (EndoGIA, Covidien, USA), a staple line inversion with hemostatic and aims will be performed. Staple line inversion will be performed with a running suture of Polypropylene 2/0. In the second group, the gastric section will be performed with a stapler with preloaded buttress material (EndoGIA with reinforced reload, Covidien, USA).

Postoperative nausea and vomits during the first 24 hours after surgery will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>40
* BMI\>35 with obesity-related comorbidities

Exclusion Criteria:

* Patients undergoing other bariatric techniques than sleeve gastrectomy
* Laparotomic approach
Effect of Hydrotherapy Versus Aerobic Exercise on Pulmonary Function on Hemiplegic Cerebral Palsied Children

Cerebral palsy (CP) is the most common motor disability in childhood. Respiratory muscle weakness and a low upper to lower chest diameter ratio are common respiratory dysfunction manifestations in those children which negatively affect their quality of life..

Objective: To compare the effectiveness of hydrotherapy versus aerobic exercise on pulmonary function in hemiplegic children with cerebral palsy. Methods: Sixty hemiplegic children (both genders) took part in this research, they were between the ages of 8 to 16, moreover, they were split equally between three groups (A, B and C). The three groups participated in the same conventional physical therapy, group (A) received conventional physical therapy only, group (B) received hydrotherapy, while group (C) received aerobic exercise. Pulmonary function tests are measured by Six-minute walk test (6-MWT) and Spirometer to measure Forced vital capacity (FVC), Forced expiratory volume in the first second (FEV1) as well as FEV1/FVC ratio for all children before the beginning and after the end of this study, the treatment program was applied three sessions per week for 12 consecutive weeks.

Eligibility Criteria:
Inclusion Criteria:

* Ages ranged from 8 to 16 years.
* Belonged to levels I to II of the Gross Motor Function Classification System (GMFCS).
* Spasticity ranged from grade 1 to grade 1+ according to Modified Ashwarth Scale. - Able to walk, no impairment of sensation or other neurological or psychological problems.
* Clinically and medically stable and able to understand and follow the instructions

Exclusion Criteria:

i) Visual and/or auditory defects. ii) Significant shortening and/or deformity of lower extremities. iii) Other neurological problems that affect balance or mentality (e.g. epilepsy) iv) Advanced radiographic alterations comprise (bone destruction, bony ankylosis, knee joint sublaxation as well as epiphysial fracture).

v) Lower extremity skeletal abnormalities (whether congenital or acquired). vi) Cardiopulmonary dysfunction.
Study of an Investigational Glucose Meter System

The purpose of this study is to demonstrate that untrained subjects who have diabetes or pre-diabetes can operate the investigational Blood Glucose Monitoring System (BGMS) and obtain valid glucose results.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of diabetes or pre-diabetes.
* Be 18 years of age or older
* Be able to speak, read and understand English and understand the Informed Consent document.
* Be willing to complete study procedures

Exclusion Criteria:

* Pregnancy
* Infections or skin disorders at the site of the venipuncture (at the discretion of the phlebotomist).
* Hemophilia, bleeding disorder, or clotting problems. Persons taking aspirin (81 mg or 325 mg) daily or Plavix® are not reason for exclusion.
* Physical (dexterity), visual, or neurological impairments that would make the person unable to perform testing with the BGM (at the discretion of the site professional staff).
* A condition, in the opinion of the Investigator, would put the subject at risk or influence the conduct of the study or interpretation of the results. The reason for exclusion will be documented by the professional staff.
* Previously participated in a blood glucose monitoring study using a similar device or use a similar device for personal use when monitoring blood glucose.
* Working for a competitive medical device company or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company
* Working for a medical laboratory, hospital or other clinical setting that involves training on and clinical use of blood glucose monitors
A Switch Study From High-Sodium Oxybate to XYWAV to Evaluate Changes in Blood Pressure in Participants With Narcolepsy

The aim of this study is to quantify the change in blood pressure when participants with narcolepsy treated with high-sodium oxybate are transitioned to XYWAV, a low-sodium oxybate. The results of this study may provide health care providers (HCPs), patients, and payers with important new information regarding BP changes related to differences in sodium content between available oxybates for the treatment of narcolepsy.


Eligibility Criteria:
Key Inclusion Criteria:

* Participants must be 18 to 70 years of age inclusive, at the time of signing the informed consent.
* Participants have a documented diagnosis of Type 1 or Type 2 narcolepsy that meets International Classification of Sleep Disorders (ICSD)-3 or Diagnostic and Statistical Manual of Mental Disorders (DSM)-5 criteria.
* Participants must have been receiving a total dose of high-sodium oxybate (eg, XYREM) of 6 to 9 g/night (inclusive) with twice-nightly dosing for a minimum of 6 consecutive weeks prior to screening.
* If currently treated with stimulants and/or alerting agents or other medications known to affect BP, participant must have been taking the same dosing regimen for at least 2 months prior to screening and agree to take the same dose throughout the study.
* If currently taking stable doses of antihypertensive therapies, participant must maintain these treatments at the same dose throughout the study unless otherwise advised by their medical care
* Participant is male or female. A female participant is eligible to participate if she is not pregnant or breastfeeding, if she is a woman of nonchildbearing potential or is a woman of childbearing potential and using a contraceptive method that is highly effective.

Key Exclusion Criteria:

* History or presence of any acutely unstable medical condition, behavioral or psychiatric disorder (including active suicidal ideation), or surgical history that could affect the safety of the participant or interfere with study assessments or the ability of the participant to complete the study based on the judgment of the investigator.
* Presence of significant cardiovascular disease or cardiovascular condition that in the investigator's opinion may jeopardize participant safety in the study, including screening ECG results.
* Presence of atrial fibrillation detected on screening electrocardiogram (ECG).
* Presence of resistant hypertension.
Manhattan HIV/Hepatology Brain Bank

Description: The Manhattan HIV/Hepatology Brain Bank (MHBB) was established in 1998 as a resource for the AIDS research community. The MHBB was created to act as a center for the provision of pre- and post-mortem tissues and body fluids from HIV infected persons. It has recently expanded its goals to assist in the elucidation of liver disease-induced nervous system disorders.

The MHBB is dedicated to improving the understanding of HIV and Hepatitis C and thereby, improving the lives of patients living with HIV and/or Hepatitis C.

Participation is voluntary and can be stopped at any time.

Benefits: This is an observational study; no experimental procedures, devices or drugs are used. All enrolled patients undergo regular examinations by physicians, nurses, and neuropsychologists who specialize in the problems that HIV and HCV can cause.

Taking part in this study may result in the detection of brain, muscle, or spinal cord disease for which treatments may be available. Participants may receive no direct benefit from this study. However, knowledge gained from this research may, in the future, help others who suffer from HIV/AIDS and/or liver disease.

Participants agree to autopsy and organ donation upon demise by signing an Anatomical Gift Consent document.


Eligibility Criteria:
Inclusion Criteria:

CD4 \< 50 on two occasions \>12 weeks apart. Hemoglobin \<10 G/dL. Albumin \<3.2 G/dL.

CMV end-organ disease Disseminated MAC PML AIDS Dementia Complex Wasting (\>30% of lean body mass)

Visceral Kaposi's sarcoma Lymphoma-systemic of CNS

CHF Major systemic illness with poor prognosis (as determined by primary physician).

Exclusion Criteria:

- \<18 years old Not willing to sign an Anatomical Gift Consent for autopsy and organ donation upon demise.
Exercise Therapy for People With a Diabetic Foot Ulcer - a Feasibility Study

The aim of this feasibility study is to evaluate a 12-week exercise intervention in people with an active diabetic foot ulcer through pre-defined research progression criteria (participant recruitment and retention, duration of the collection of outcome measures, adherence to the exercise programme, and adverse events), besides participant and physiotherapist feedback, self-reported outcomes and objective measurements in preparation for a potential future RCT.

The primary study hypothesis is that exercise therapy for people with an active diabetic foot ulcer will have high participant recruitment and adherence to treatment and that it does not affect wound healing negatively.


Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or above
* Diabetes mellitus
* Non-surgical ulcer located distal to the malleoli
* Willingness to participate in a 12-week supervised exercise therapy intervention twice a week
* Prescribed with a therapeutic shoe, orthopaedic specialist shoe from the outpatient clinic or a specialized podiatrist.

Exclusion Criteria:

* Dementia or other reasons that cause inability to give informed consent
* People that are wheelchair-bound
* People with a prescribed cast or walker boot
* Unable to understand Danish.
* Diagnosed with or awaiting evaluation of suspected acute phase Charcot arthropathy or osteomyelitis
Sonographic Prediction of Preterm Delivery Between 24-34 Weeks of Gestation

to evaluate if sonographic measure of short uterin cervix, sludge in amniotic fluid and abnormal doppler of the uterin artery can predict preterm labor


Eligibility Criteria:
Inclusion Criteria:

* pregnancy between 24-34 wees of gestation

Exclusion Criteria:

* lack prenatal care
* fetal malformations stractural or genetical
* plcenta previa
* cerclage
* women who underwent conization of cervix
* polyhydramnious
* premature rupture of membranes
* induction of labor d/t medical condition preterm
* women with hypertension, diabetis or preeclampsia
* susp IUGR
* women with a chronic illness that may interupt pregnancy
Discovering Factors in Head and Neck Cancer Patients' Clinical Study Experiences

Enrollment in clinical trials usually favors a particular demographic group. But there is limited research available to explain what study attributes affect the completion of these specific demographic groups.

This trial will evaluate the safety and efficacy of head and neck cancer treatments. The focus will be on tracking the rates of completion and withdrawal among these individuals.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future head and neck cancer studies.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years of age
* Patient is able and willing to comply with the treatment/follow-up schedule and requirements
* Patient must provide written informed consent

Exclusion Criteria:

* Participants who are vulnerable to any intervention
* Women who are pregnant, intend to become pregnant, or are lactating
* Inability to perform regular electronic reporting
Treatment of Depression Following Multiple Brain Tests

The main purpose of this study is to correlate brain testing with treatment outcome.

40 medication-free Depressed Patients will receive a battery of neuropsychologic tests, standard dichotic listening tests, EEG, ERP and an f-MRI while performing a neuropsychologic test, the Simon. Once testing is completed, patients will be treated in an open treatment trial of SSRI. Non-responders will then receive Bupropion followed by Tricyclic Antidepressant if still depressed. While our main purpose is to correlate imaging testing with other measures of brain functioning, we also intend to see whether f-MRI findings demonstrate specific brain areas which differ between responders and non-responders. At the end of SSRI treatment, patients will have a second f-MRI scan to investigate any changes treatment and/or response may have caused.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV Major Depression or Dysthymia
* Age 18-65
* Physically healthy
* Normal hearing
* Drug-free (two weeks for most antidepressants, four weeks for Fluoxetine)

Exclusion Criteria:

* Hearing deficit in one or both ears
* Body metal (e.g., wire stitches, screws in bones, stainless steel hips)
* History of Psychosis or Epilepsy
* Current (past six months) Substance Use Disorder (illicit drugs and/or alcohol)
* Unstable medical problem
* Insufficient English for neuropsychological and dichotic testing
* Bipolar I
* Need for wash-out from effective treatment in order to participate
* Pregnant
* High suicide risk
* Currently taking (within 2 weeks; 4 weeks for Fluoxetine) antidepressants
Nurse Practitioner Hospice Program for Patients With Terminal Metastatic Cancer and Their Families or Caregivers

RATIONALE: Gathering information about patients with terminal metastatic cancer may help doctors learn more about the effectiveness of a nurse practitioner hospice program. It is not yet known whether a nurse practitioner program helps increase patients' length of stay in hospice.

PURPOSE: This randomized research study is evaluating a nurse practitioner hospice program for patients with terminal metastatic cancer and their families or caregivers.

OBJECTIVES:

Primary

* To assess the effect of the palliative advanced registered nurse practitioner liaison program (PAL) on length of patient's enrollment in hospice care.

Secondary

* To evaluate the impact of the PAL program on patient's knowledge about hospice services.
* To evaluate the impact of the PAL program on patient and family or caregiver's psychological stress during palliative treatments.

OUTLINE: Patients are randomized to 1 of 2 arms.

* Arm I (advanced registered nurse practitioner \[ARNP\] intervention): Patients and their families or caregiver receive information from an ARNP about terminal cancer, resources available for supportive care, and the benefits of palliative care. After transition to hospice, patients receive pain and palliative medicine, psychology, social services, chaplaincy, and patient support group intervention arranged by the ARNP. Patients complete the Patient Questionnaire about overall quality of life and mental, emotional, and physical well being at baseline and at 3 weeks after intervention or at time of enrollment in hospice. Patients and their families or caregivers are contacted by the ARNP weekly.
* Arm II (no ARNP intervention): Patients and their families or caregivers complete the same Patient Questionnaire, administered by a clinical research assistant (CRA), as in Arm I. Patients and their families or caregivers receive no ARNP intervention. After transition to hospice, patients receive routine hospice care.

Patients participate in this study for a duration of 21 days while in hospice care. At the completion of the study, patients in both arms complete questionnaires about pain management, social, emotional, and spiritual and mental well-being. Patients' families or caregivers complete the Caregiver Questionnaire and the Hospice Family Satisfaction Survey 3 weeks after patient's death.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of terminal metastatic cancer
* Patient at Mayo Clinic in Jacksonville, Florida
* Strong candidate for hospice care
* Entering or planning to enter Community Hospice of Northeast Florida

  * Willing to undergo visits by an Advanced Registered Nurse Practitioner (ARNP) after hospice enrollment

PATIENT CHARACTERISTICS:

* Willing to participate in 2 palliative care consultations with an ARNP prior to hospice enrollment
* Life expectancy \< 12 months
* Able to complete questionnaires with or without assistance
* Has a primary caregiver with an identified relationship to the patient

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Mobile HIV Prevention App for Black Women

Black women have a significantly higher risk of acquiring HIV compared to their non-Black counterparts.

The purpose of this study is to refine and test a mobile HIV Prevention and Reproductive Health app developed specifically for Black women.

The overall goal in implementing this study will be to assess the feasibility, acceptability, and usability of the in-the-kNOW mobile app. The app will be refined using preliminary data obtained through prior research with Black women in which their perspectives towards the use of an HIV and sexual health mobile app were ascertained.

Preliminary data obtained from a Community Advisory Board (CAB), which will consist predominately of Black women will guide refinement of the content and features included within the mobile app, whilst ensuring that the app is tailored towards the needs and perspectives of Black women.

This will be a randomized study with quantitative data collected through surveys, and qualitative data collected through in-depth interviews.

Eligibility Criteria:
Inclusion Criteria:

* 18-44 years of age
* Self-identify as Black
* Assigned female at birth and identify as female;
* Individuals who qualify for Pre-Exposure Prophylaxis (PrEP) based on the Centers for Disease Control (CDC) criteria (for residence in high HIV incident areas-reside in Fulton, Cobb, Gwinnett, or Dekalb counties)
* Sexually active within the last 6 months
* HIV-negative
* Owner of an Android or IOS smartphone

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Pregnant women
* Prisoners
* Cognitively impaired or Individuals with Impaired Decision-Making Capacity
* Individuals who are not able to clearly understand English
Evaluation of the Efficacy of the Two-point Method in Percutaneous Transhepatic Choledoscopy and the Influence of the Long-term Recurrence of Hepatolithiasis

The goal of this clinical trial is to evaluate the efficacy and safety of the two-point approach in patients with intrahepatic bile duct stones。The main questions it aims to answer are:

① By comparing the technical success rate and clinical success rate of the two-point method and the non-two-point method, the clinical effect of the two methods was judged.

② To analyze the probability of short-term complications of the two-point method during the operation and to judge its safety.

③ Patients were followed up after the two-point method to determine the recurrence rate of stones and the probability of long-term complications.

The researchers will compare the two-point method with conventional PTCS to evaluate its effectiveness.


Eligibility Criteria:
Inclusion Criteria:

* ≥18 years of age
* PTCS were only used for the treatment of hepatolithiasis
* patients receiving PTCS for the first time.

Exclusion Criteria:

* PTCD failure and withdrawal from treatment due to patients' subjective wishes were excluded.
Real World Effectiveness of Natalizumab Extended Interval Dosing in a French Cohort

Natalizumab (NTZ) use in Multiple Sclerosis (MS) in highly active patients has been largely established during the last Rationale 10 years in both clinical trials and real-world practice. Along with its efficacy, NTZ use has been limited by potential risk of progressive multifocal leukoencephalopathy (PML). Thus, several studies have tried to assess how to minimize this risk.

One suggested approach is to move from the standard interval dose (SID) of 4 weeks to an extended interval dose (EID) of 5 weeks or longer. Extending the dosing interval of NTZ has been practiced by some physicians with the intention of improving the benefit/risk of the treatment by reducing the exposure-dependent risk of progressive multifocal leukoencephalopathy (PML) while maintaining efficacy. We propose to retrospectively analyze data from clinical records coming from RRMS patients treated in France at 5 different centers; Caen, Nice, Bobigny and Toulouse hospitals as well as Percy Military Hospital, to evaluate the effectiveness of natalizumab EID in subjects who have previously been treated with natalizumab SID for 12 months, in relation to continued SID treatment. In the clinical practice of these centers, patients are shifted after minimum 12 months under SID to an EID of 6 weeks regardless antibody JC serum status. Clinical, magnetic resonance imaging (MRI) and serum anti-JCV antibody status data are collected when available.

The objective of this study is to assess the efficacy in term of ARR and safety.


Eligibility Criteria:
Inclusion Criteria:

* Patients receiving at least 11 infusions of natalizumab as disease-modifying monotherapy for RRMS that is consistent with the approved dosing

Exclusion Criteria:

* Patients for whom the NTZ infusion history and/or MRI and clinical history is not available.
* Patients with dosing gap defined as \>=12 weeks between any two doses.
* Patients with over dose defined as \<3 weeks between any two doses.
* Pregnancy during the follow-up period