cyrilzakka/clinical-trials huggingface dataset:
The Effect of Remote Ischemic Preconditioning on Kidney Function in Patients Undergoing Partial Nephrectomy

This study is intended to evaluate the renal protective effect of Remote Ischemic Preconditioning (RIPC) in patients undergoing partial nephrectomy. Half of the enrolled subjects will receive 4 cycles of brief ischemia on the upper arm after anesthesia induction and prior to the surgery, while the other half will not receive this treatment as a control group.

Remote Ischemic Preconditioning (RIPC) is the concept of mitigating ischemia-reperfusion injury to target organs by a brief episode of ischemia-reperfusion of the limb. The protective effect of RIPC on major organs has been demonstrated in an animal study, but its clinical efficacy has not yet been established.

The kidney is a typical organ vulnerable to ischemic injury, and the renal protective effect of RIPC can be expected. There have been many reports of renal protective effects of RIPC in cardiac and vascular surgery. On the other hand, few studies have investigated the effect of RIPC during partial nephrectomy in which ischemia-reperfusion injury can occur during the surgery.

In this study, the investigators will evaluate the effect of RIPC in patients undergoing partial nephrectomy to prevent renal impairment and improve the prognosis after the surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled to undergo open, laparoscopic, or robot-assisted laparoscopic partial nephrectomy
* Normal contralateral renal function was defined as split renal function of \>40% as determined by preoperative Tc-99m DiethyleneTriamine Pentaacetic Acid (DTPA) kidney scan
* Written informed consent

Exclusion Criteria:

* Peripheral vascular disease involving upper extremities or lower extremities
* Severe cardiopulmonary diseases (valvular or ischemic heart disease, heart failure, chronic obstructive pulmonary disease)
* Hepatic failure, renal failure
Comparison of Subjective Balance Tests

There is many subjective balance tests to evaluate static and dynamic balance. But, there is no sufficient information about which balance test is the most sensitive test to evaluate balance. Therefore, the aim of this study is to compare of sensitivity of the subjective balance tests with an objective system.

In the clinical setting, many balance tests are used for evaluating balance in individuals. These tests are utilized to assess both static and dynamic balance. However, sufficient research has not been conducted to decide which subjective balance test is more sensitive than the other tests. Therefore, the aim of this study is to compare of sensitivity of the subjective balance tests with an objective system.

Eligibility Criteria:
Inclusion Criteria:

* at least 18 years,
* To be a volunteer to participate

Exclusion Criteria:

* orthopedic problems affecting gait and stance
* visual, auditory, orientational problems that could affect study results,
* Walking with assist device
* Having a neurological disorders
A Study to Evaluate the Pharmacokinetics and Safety of HIP1701 in Healthy Subjects

An open-label, randomized, single-dose crossover study to evaluate the pharmacokinetics and safety of HIP1701 in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

1. Age 19\~55 years in healthy volunteers
2. BMI is more than 18.5 kg/m\^2 , no more than 24.9 kg/m\^2
3. Subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing

Exclusion Criteria:

1. Presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in digestive system, neuropsychiatric system, endocrine system, liver, cardiovascular system
2. Subjects who judged ineligible by the investigator
A Study on the Effects of Soy Protein on Blood Lipids in Men and Women With Mild to Moderate Hypercholesterolemia

The objectives of the trial are to determine whether a non-commercial soy protein product, consumed as part of a low-saturated fat diet, reduces low-density lipoprotein cholesterol (LDL-C) concentrations in men and women with mild to moderate hypercholesterolemia, and affects other aspects related biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 18-79 years of age
* Fasting LDL-Cholesterol level borderline to high range taking no cholesterol lowering medications
* otherwise judged to be in good health, willing to maintain a stable body weight and follow the TLC diet throughout the trial.

Exclusion Criteria:

* CHD or CHD risk equivalent
* Pregnancy
* Food allergy or sensitivity to soy or milk protein
* Certain muscle, liver, kidney, lung or gastrointestinal conditions and medications
* Poorly controlled hypertension
* Cancer treated within prior 2 years
Biomarkers for the Activity of Immune Checkpoint Inhibitor Therapy in Patients With Advanced Melanoma

1. Screen and recruitment: patients will be screened based on their prior history and intention to initiate treatment with an immune checkpoint inhibitor.
2. Study phase:

   * Collection of baseline demographic data, prior disease history, nature of ICI therapy, outcome data of ICI therapy (treatment disposition, toxicity, tumor response and survival).
   * Collection of blood samples will be performed every 3 to 4 weeks for the first year on ICI therapy and every 6 to 12 weeks thereafter until the end of ICI therapy, disease progression, death or loss to follow-up. Collection of blood samples will be aligned with the visits necessary for the administration of the ICI therapy.
   * Collection of archival melanoma metastasis tissues will be performed on a continuous basis and be triggered by availability of such tissue following therapeutic resections of melanoma metastases.
3. Follow-up phase

1. Screen and recruitment: patients will be screened based on their prior history and intention to initiate treatment with an immune checkpoint inhibitor. This screening of candidate patients by the investigators will be non-interventional. Patients that are considered eligible candidates will be invited to participate in this study and to Page 3/18 provide written informed consent.
2. Study phase:

   * Collection of baseline demographic data, prior disease history, nature of ICI therapy, outcome data of ICI therapy (treatment disposition, toxicity, tumor response and survival).
   * Collection of blood samples will be performed every 3 to 4 weeks for the first year on ICI therapy and every 6 to 12 weeks thereafter until the end of ICI therapy, disease progression, death or loss to follow-up. Collection of blood samples will be aligned with the visits necessary for the administration of the ICI therapy.
   * Collection of archival melanoma metastasis tissues will be performed on a continuous basis and be triggered by availability of such tissue following therapeutic resections of melanoma metastases.
3. Follow-up phase: patients who stop treatment with the immune checkpoint inhibitor will be followed-up for

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed malignant melanoma;
2. AJCC Stage IIIC or IV melanoma with evaluable disease;
3. Treatment with an immune checkpoint inhibitor;
4. Willing and able to give written informed consent;
5. Accessible for treatment and follow-up;

Exclusion Criteria:

* non
Direct Comparison of 2D Cardiac PET With 3D Cardiac PET

Lowering the per-infusion dose of Rb-82 offers advantages of lessening radiation exposure and extending useable generator life. Prior studies have not shown equivalence of 3D vs 2D Rb-82 PET. The investigators therefore compare 3D PET after a lower Rb-82 dose (\~20 mCi) processed using a Monte-Carlo driven scatter correction algorithm against conventional higher dosage (\~50 mCi) 2D Rb-82 PET MPI.

This study re-examines 2D an 3D myocardial perfusion PET data from 19 subjects, mean age 65 years, mean BMI 30 kg/m2, 79% male. Rest and stress scans were acquired on a Siemens Accel™ PET scanner in 2D (septa extended) and 3D (septa retracted) modes. Rb-82 doses were rest 53+/-5 mCi and stress 53+/-6 mCi. Imaging times were 2D emission scan for 3 mins (90 sec delay post Rb-82 infusion), followed by a 3 minute, 3D gated emission scan (180 sec delay). Decay and shorter acquisition times led to a 62% reduction in the effective dosage 2D vs 3D datasets. 3D images were first pre-processed using a Monte-Carlo scatter and prompt gamma correction algorithm (Imagen3D™) then reconstructed using ImagenProTM (CVIT, Kansas City, MO). Reconstructed images were evaluated using relative, 17 segment raw scores (Cedars QPET). Studies were read by consensus of 2-blinded readers for: image quality (1-4, poor-excellent), interpretive certainty (1-3, low-high) and rest perfusion using a 17 segment model (0=normal; 1-3 = mild, moderate, or severe perfusion defects). Stress segmental scores were not evaluated due to differences in imaging start time post dipyridamole infusion.

Eligibility Criteria:
Inclusion Criteria:

* \>18 Years of Age
* Have ability to provide informed consent
* Have a technically adequate rest/stress Rb-82 perfsion PET study within the past 60 days

Exclusion Criteria:

* Pregnant or nursing feamle
* Weight \> 275 lbs
* Have contraindications to adenosine stress testing
* Unstable cardiac rhythm (atrial fibrillation, frequent PVCs
* PTCA or CABG within the last 60 days
Reverse Shoulder Replacement: Age 60 or Younger Outcomes

The purpose of this study is to assess the early outcomes following Reverse Shoulder Arthroplasty (RSA) in patients sixty years or younger for the purpose of characterizing these patients, evaluating their clinical outcomes and radiographic appearance.The investigators would like to know how quickly they are healing and returning to their baseline activities of daily living and ability to work. This will help when counseling patients prior to surgery as it will give us a better defined and study supported understanding of the post-operative recovery timeline in the younger population.

This study is looking at patients who are sixty years or younger at the time of they undergo a reverse total shoulder replacement. This is an important population to look at their functional and clinical outcomes as they are often still employed and have more physical demands upon their shoulder in everyday life than the older replacement population for which there are more outcome data available. The investigators would like to determine how the younger population is healing and returning to their baseline activities of daily living and ability to work. This will help when counseling patients prior to surgery as it will give us a study supported understanding of the post-operative recovery timeline in the younger population. The investigators will review x-rays to evaluate healing at two years. Functional surveys are given pre and post operatively (1 \& 2 years) and these will be reviewed as well. A physical exam is also performed to determine range of motion pre and post operatively (1 \& 2 years).

Eligibility Criteria:
Inclusion Criteria:

* 60 years old or younger at the time of surgery
* reverse shoulder arthroplasty with a single implant system by one of our four surgeons

Exclusion Criteria:

* minors
* unable to complete imaging portion of the two-year follow-up due to health safety/exposure concerns
* unwilling/unable to return for follow up
* Revision procedure
Dexmedetomidine Versus Midazolam for Intensive Care Sedation of Children

Dexmedetomidine will be tested against midazolam in a prospective, randomized, double-blind study of intensive care children, age 2-17 years.

The investigators' primary hypothesis is that time from end of medication to extubation will be shorter with dexmedetomidine sedation.


Eligibility Criteria:
Inclusion Criteria:

* informed consent from parents
* age between 2 and 18 years
* anticipated need of respirator treatment for more than 24 hrs
* included in study within 48 hrs of admission to intensive care unit (ICU)

Exclusion Criteria:

* severe, unstable circulatory failure
* severe intracranial or spinal trauma with circulatory instability
* sever bradycardia or atrioventricular (A-V) block
* liver failure
* less than 50% chance of anticipated survival
* known allergy to study drugs
Trajectories of Cardiac Allograft Vasculopathy After Heart Transplantation

This project aims: i) to identify Cardiac Allograft Vasculopathy (CAV) trajectories after heat transplantation using latent class mixed modeling, ii) to characterize the global and specific determinants of different trajectories and iii) to provide an easily accessible tool to project individual probability of CAV trajectory belonging.

Background:

Cardiac Allograft Vasculopathy (CAV) is the third cause of late mortality and the leading cause of late allograft dysfunction. The field of heart transplantation currently lacks longitudinal description of CAV profiles. Identifying relevant CAV trajectories, or evolution profiles, and their respective determinants is an unmet clinical need. CAV trajectories requires an additional level of understanding and characterization over the current paradigm. Understanding the mechanisms and clinical factors involved in the development of CAV will be useful to provide a more nuanced picture of disease progression, which may ultimately contribute to risk stratification and ultimately guiding the care of HTx patients.

Main Outcome(s) and Measure(s):

* Identification of CAV trajectories after transplantation using an unsupervised latent class mixed modeling. CAV angiograms were recorded per center protocol for all patients after transplantation. CAV was graded according to the current ISHLT classification as CAV 0 (not significant), 1 (mild), 2 (moderate) and 3 (severe).
* Determination of clinical, functional, structural, immunological factors associated with the trajectories. In the derivation cohort, the associations between CAV trajectories and clinical, histological, functional, and immunological parameters at the time of transplantation, during the first year and at one-year post-transplant were assessed using multinomial logistic regression.

Eligibility Criteria:
Inclusion Criteria:

* Heart recipient with at least two coronary angiograms after heart transplantation,
* Heart recipient over 18 years of age.

Exclusion Criteria:

* Patient with \< 2 coronary angiograms during follow-up
A Phase 2 Randomized, Double-blind Trial Evaluating the Effects of Chloroquine in Breast Cancer

Chloroquine (CQ) is a well known, well tolerated medication that has been used for many years traditionally for arthritis, lupus, and malaria. It has anti-inflammatory properties but is often the drug of choice for arthritis and malaria due to its few side effects. Recently, laboratory investigations have proven that CQ may potentially have anti-cancer properties, by inhibiting a process which allows cancers such as breast cancer to continue to grow (a process known as "autophagy"). Therefore, this study will look at how well CQ can inhibit the growth of breast cancers in patients while waiting for surgery.

Patients diagnosed with breast cancer can sometimes wait up to 6 weeks for their surgery. The wait leading up to surgery is a potentially long and anxious time. Since no treatment is happening during this period anyway, this study will allow patients to receive CQ during this waiting period. This study will compare CQ treatment before surgery with the standard approach during this time, which is no treatment.

Although CQ is widely used for the treatment of arthritis and malaria, CQ is considered investigational for use in breast cancer.

The study will NOT interfere with the routine assessments as part of the pre-operative care, NOR will it delay the date of surgery.

This study compares the effects of the CQ to placebo. Participants will be randomized 1:1 and be provided with the blinded placebo or QC (500mg daily) during the wait time. Biomarker testing will be performed on the initial biopsy tissue and at the time of surgery as well as blood work. There is also an opportunity for participants to enrol in the optional sample collection for future research.

Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed histologically confirmed primary invasive breast cancer who is currently not undergoing any treatment while awaiting surgery in the next 2-6 weeks
* tumour ≥ 1.5 cm by palpation or imaging
* ECOG performance status 0-2
* written informed consent for the study

Exclusion Criteria:

* Known Metastatic breast cancer
* history of pre-existing known retinal or ocular pathology patient has only one functioning eye
* abnormal hepatic function (serum AST or ALT \>3x upper limit of normal)
* currently on CQ or HCQ or has been on the drug within the past 3 months for other conditions
* known history of psoriasis
* known history of epilepsy or seizures
* electrocardiogram showing QT prolongation based on QTc interval \>450 ms
* inability to comply with a study protocol (abuse of alcohol, drugs or psychotic states)
* current known pregnancy or actively nursing
* allergic reactions to quinolones or CQ
* inability to consent.
Clonal Hematopoiesis of Immunological Significance

Ambispective, national, multicenter observational cohort study aimed at characterizing the satellite dysimmune manifestations of clonal hematopoiesis, including Vexas (Vacuoles, E1 enzyme, X-linked, Autoinflammatory and Somatic) syndrome.

The clinical spectrum of dysimmune manifestations associated with blood diseases is wide. The pathophysiology of these manifestations is not well understood and their management is poorly codified. This observational cohort aims to list the different clinical pictures, the therapeutic management and the prognosis of patients according to the type of dysimmune manifestations and the type of hemopathy. We wish to have an inventory of the demographic, genetic, clinical and evolutionary data of patients with an inflammatory manifestation associated or not with a myeloid or lymphoid hemopathy. This will make it possible to establish quantitative data on the morbidity and mortality of these rare diseases and to propose therapeutic trials for the most serious patients.

Eligibility Criteria:
Inclusion Criteria:

* Age \>=18 years old
* Confirmed dysimmune manifestations: clinical or biological abnormality or systemic disease
* Presence or absence of myeloid or lymphoid blood disease according to World Health Organization (WHO) classification

Exclusion Criteria:

* Persons benefiting from special protection: adults under guardianship and curatorship; people hospitalized without their consent and not protected by law; persons deprived of liberty.
* Persons not affiliated to the social security system
Subject Reported Outcomes With Use of Adapalene 0.3% - Benzoyl Peroxide (BPO) 2.5% in Dark Skin Acne

This is a multicenter open-label, prospective study in subjects with dark skin from one of the 3 ethnic/race backgrounds: Asian, Latin American and Black/African-American and with moderate to severe acne vulgaris on the face.

All eligible subjects will receive Adapalene 0.3% - BPO 2.5% gel (Epiduo Forte/TactuPump Forte) once daily on whole face.

The purpose of this trial is to evaluate subject reported outcomes with the combination of Adapalene 0.3% - BPO 2.5%, Epiduo Forte / TactuPump Forte gel, after 16 weeks of treatment of moderate to severe acne in dark skin phototypes (IV to VI).


Eligibility Criteria:
Inclusion Criteria:

* Subject with clinical diagnosis of moderate to severe facial acne vulgaris, defined by:

  1. Investigator's Global Assessment (IGA) score of 3 (Moderate) OR 4 (Severe ); and
  2. A minimum of 25-100 inflammatory lesions (papules and pustules); and
  3. A minimum of 30-150 non-inflammatory lesions (open and closed comedones) in total (excluding the nose); and
  4. No more than two acne nodules (≥ 1 cm),
* Subject with skin phototype IV to VI on Fitzpatrick skin phototype scale,
* Subjects from one of the 3 ethnic/race backgrounds: Asian, Latin American and Black/African-American,

Exclusion Criteria:

* Subject with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), nodulo cystic acne, acne requiring systemic treatment,
* Subject with history of lupus, atopic dermatitis, perioral dermatitis, dermatomyositis, rosacea
* Female subject who is pregnant, lactating or planning a pregnancy during the trial,
* Subjects having received at least one of the following topical treatments on the treated area: Corticosteroids, antibiotics, benzoyl peroxide, azelaic acid, dapsone, hydroxyacids, Zinc containing treatments, antiseptics, other anti-inflammatory products or other acne treatments (2 weeks); Retinoids (4 weeks); Cosmetic/aesthetic procedures on the face (1 week); Wax epilation (2 weeks); Photodynamic therapy (6 weeks); Laser therapy, microdermabrasion, deep chemical peel, plastic surgery for acne (3 months).
* Subjects having received at least one of the following systemic treatments: Corticosteroids, tetracyclines, other antibiotics (except penicillin) (1 month); Oral retinoids/isotretinoin/ anti-androgens / Cyproterone acetate / Chlormadinone acetate (6 months); Spironolactone/ Drospirenone (3 months); Immunomodulators (3 months) and Oral contraceptives/ oral dapsone for acne(1 month).
Propositive (Protecting Positive People From Meningococcal Infection) Follow-up Study

The need for and timing of booster doses of meningococcal vaccines in People Living with HIV (PLWHIV) is currently unknown. As such it is impossible for clinicians to recommend booster doses or to know if and when these might be necessary.We propose to follow up a group of participants from the Propositive study who received two doses of both MenB (Bexsero) and MenACWY (Menveo). This was a group of PLWHIV between the ages 18-45 years. We propose following up these participants at 18 and 30 months post completion of two doses of vaccine and investigating their immunological response.


Eligibility Criteria:
Inclusion Criteria:

* Received vaccination with Bexsero and Menveo during Propositive study
* Able to sign fully informed consent
* Able to comply with study requirements

Exclusion Criteria:

• Unwilling or unable to comply with study requirements