cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Ex-situ Normothermic Perfusion Versus Cold Storage in the Transplant With Steatotic Liver Graft.

Prospective, randomized, controlled clinical trial to determine the overall efficacy of normothermic machine perfusion (NMP) for steatotic liver preservation versus traditional static cold storage (SCS), in 50 liver transplant recipients with 1-year follow-up.

This is a prospective, randomized, controlled clinical trial comparing static cold storage (SCS) versus normothermic machine perfusion (NMP) for organ preservation before liver transplantation with steatotic livers (between 30 % and 60% of histologic macrovesicular steatosis), in order to:

Main Objective:

To compare the effect of NMP versus SCS in preventing preservation injury and graft dysfunction, as measured by highest transaminase levels during the first week after liver transplantation.

Secondary Objectives:

* To compare graft and patient survival between the NMP and SCS steatotic livers.
* To compare the liver biochemical function between the NMP and SCS steatotic livers.
* To compare the physiological response to the reperfusion between the NMP and SCS steatotic livers.
* To compare the evidence of reperfusion injury between the NMP and SCS steatotic livers.
* To compare the evidence of ischemic cholangiopathy between the NMP and SCS steatotic livers.

Eligibility Criteria:
Inclusion Criteria:

LIVER DONOR:

* Donors older than 16 years
* Liver donation grafts due to brain death
* Steatosis confirmed by histological study (between 30% and 60% of macrovesicular steatosis)

LIVER RECIPIENT:

* Adult patients (18 years or older)
* Active liver transplant waiting list candidate
* Able to give informed consent

Exclusion Criteria:

LIVER DONOR:

* Living donors
* Liver destined to the transplant "split"
* Donor age \<16 years
* Donation after death due to asystole.
* When the biopsy establishes a steatosis ≥ 50%, patients who fulfill at least 3 of the following 5 risk factors will be excluded: Transaminases (AST and ALT) ≥ 200 U / L; Age ≥ 55 years; Hypernatremia ≥ 155 mEq / L; Cardiovascular risk factors, at least 2 of the following 5: DM, HTA, IMC ≥ 35, Active smoking, ischemic stroke; Days of stay in ICU ≥ 4 days with vasoactive drugs (noradrenaline or dobutamine at any dose)

LIVER RECIPIENT:

* Age under 18
* Acute/fulminant hepatic failure
* Transplant of more than one organ (for example, liver and kidney)
* Rejection of informed consent
* Unable to give informed consent
Mirror Therapy and Treadmill Training for Patients With Chronic Stroke

This is a pilot randomised controlled trial investigating a combination of mirror therapy and treadmill training for the rehabilitation of lower limb impairment following a stroke. This study has been conducted as part of a PhD qualification at the Institute of Technology Sligo in Ireland with all therapy sessions taking place at the institute. The study was conducted in conjunction with Sligo University Hospital and it attained ethical approval through the relevant University Hospital Ethics Committee.

The study necessitated patients with chronic stroke to walk on a treadmill while viewing a reflection of their non-affected limb in a mirror. There was also a placebo group and these patients walked on the treadmill and viewed a mirror in an altered position. Patients were referred through Hospital Health Professionals. Prior to trial commencement all participants were given comprehensive trial information and provided signed written informed consent. A total of 30 participants were recruited. Patients attended the study for 30 minutes per day, three days per week, for four weeks. Patients received outcome assessment prior to the beginning of the intervention, directly after it and at three month followup assessment. All assessments were carried out by a Chartered Physiotherapist specialising in stroke rehabilitation. Patients were assessed using established outcome measures for lower limb motor function, muscle tone, walking speed and endurance.

Eligibility Criteria:
Inclusion Criteria:

* Chronic stroke (greater than or equal to 6 months post stroke) with lower limb heimiparesis.
* Ambulatory with/without walking aid.
* Discharged from formal rehabilitation.
* A Mini Mental State Examination \>/= 24.

Exclusion Criteria:

* Younger than 18 years
* Any additional illness that may prevent treadmill walking
* A Mini Mental State Examination \< 24.
Erector Spinae Plane Block vs. PECS I-II Blocks After Breast-conserving Surgery

The goal of this study is to compare the analgesic effects of ESPB and PECS II blocks in patients undergoing BCS. The main question it aims to answer is:

* Whether these two different block procedures will create a difference in postoperative pain scores.
* Comparison of total opioid consumption during the 24-hour postoperative period.

Our study included patients who were female, who were going to undergo elective breast-conserving surgery between March 2022 and August 2022.

The patients to be included in our study were divided into two groups as ESPB group or PECS II group by an anesthesia assistant independent of the study using a computer-based randomization program one day before the operation. All patients were informed about the block in the preoperative period, the use of the patient-controlled analgesia device to be used after the operation, and Visual Analog Scale (VAS) assessment. (Patients were asked to indicate their pain on a scale where 0 represented "no pain" and 10 represented "unbearable pain.)

On the day of the operation, group envelopes were placed in the patient files to indicate the groups in sealed envelopes. The appropriate anesthesia method was applied to the patient according to the group written on the patient's envelope by the relevant anesthesiologist on duty in the study. Our study was conducted as a randomized controlled and prospective study.

VAS scores at 0, 15, 30, 60 minutes postoperatively recorded for the primer output of the study. For the secondary outputs the total amount of analgesic used was recorded from the records of the PCA device. All patients' demographic data, intraoperative hemodynamic data, anesthesia duration, surgical duration and hospital stay, VAS at 4, 6, 12, 24 hours in the service follow-up, rescue analgesic requirements and numbers, nausea-vomiting and developing complications were evaluated and recorded. The evaluations were made by the anesthesiologist who was blind to the groups.

Eligibility Criteria:
Inclusion Criteria:

* female
* age between 18-70
* underwent breast conserving surgery

Exclusion Criteria:

* patients with coagulopathy
* known local anesthetic allergy
* abnormal liver function tests
* infection at the planned injection site
* chronic usage of analgesics
* under the age of 18
* over the age of 70
* ASA (American Society of Anesthesiologists) IV and higher risk classes
* limited cooperation for Visual Analog Scale (VAS) follow-ups
Catalytic Antibodies to Predict Uninvasively Late Transplant Failure

Chronic Allograft Nephropathy (CAN), a major cause of late allograft failure, is characterized by a progressive decline in graft function correlating with tissue destruction. Recent data suggest that it may be possible to delay graft destruction if adequate management is initiated early (ie, at the stage of subclinical CAN). It is therefore essential to design new tests allowing physicians to predict transplant recipients prone to develop CAN

Superantibodies are multifunctional antibodies combining the classical antigen-binding function with nonclassical biological activities, such as protease-like activity. In the past few years the role of proteolytic SuperAntibody (pSAb) has been evidenced in many biological processes in which their role may be either deleterious (autoimmune disease, alloimmune response against) or beneficial (sepsis).

Nothing is known so far regarding the role of pSAb in the setting of solid organ transplantation.

Preliminary data

The investigator has obtained preliminary results from a retrospective case control study indicating that an elevated serine protease activity of circulating IgG (measured by the hydrolysis of a synthetic fluorescent substrate: Proline-Phenylalanine-Arginine-Methylcoumarinamide (PFR-MCA)), correlates with the absence of CAN on protocol biopsy performed 2 years post-transplantation. Interestingly, low level of proteolysis IgG, measured 3 months post-transplantation, were also predictive of CAN at 2 years down the lane.

Aim of the Research project:

The aim is to validate in a prospective study, the potential of pSAb as predictive marker for CAN

100 recipients of a renal graft have to be enrolled and followed for 2 years.

The level of PFR-MCA hydrolysis by circulating Immunoglobulin G (IgG) will be measured before the transplantation and every 3 months up to one year and every 6 months thereafter until 2 year post-transplantation. The development of CAN will be assessed by estimated glomerular filtration rate (Modification of the Diet in Renal Disease (MDRD) formula), the proteinuria and the histological examination of the graft (screening biopsy at 3 months and 1 year will be analysed using a computerized color image analysis to quantify interstitial fibrosis).

The capacity of the pSAb test to predict CAN will be validated and the sensibility and specificity of this test will be calculated. The optimal cut-off value will be determined from the Receiver Operating Characteristic (ROC) analysis. The accuracy of the test will be evaluated in subgroups displaying various risk factors for CAN.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 the day of transplantation
* Recipient of a renal graft
* Informed consent to participate to the study
* Patient transplanted and followed 2 years in one of the 3 transplantation centers of the study (Hospital Edouard Herriot or Centre Hospitalier Lyon Sud)

Exclusion Criteria:

* Multiorgan transplantation
* Previous transplantation
* ABO incompatible renal transplantation
* Patient \> 18 years old but under guardianship
Safety Study of Subclavian and Internal Jugular Venous Catheterization

There is no randomized controlled trial to compare the rates of complications associated with internal jugular and subclavian venous catheterization. The aim of this study is to compare mechanical, infectious, and thrombotic complications of internal jugular and subclavian venous catheterization. An improved understanding of CVC-related risks might help clinicians to choose one approach over the other in specific clinical settings.

Central venous catheterization is often necessary to treat critically ill patients hospitalized in intensive care units (ICUs). However, this procedure may lead to serious and sometimes life-threatening complications, including mechanical, infectious, or thrombotic complications. The choice of insertion site can influence the incidence and type of such complications. The most frequently used sites for CVC insertion are the internal jugular and the subclavian vein. However, in an individual patient, criteria for choosing one approach over the other remain unclear.

Eligibility Criteria:
Inclusion Criteria:

* admission to ICU
* requiring central venous catheterization
* without contraindications to attempt both jugular and internal jugular access

Exclusion Criteria:

* the presence of a central venous catheter at admission
* central venous catheterization within 2 weeks prior to admission
* emergency catheterization for a life-threatening situation
* major blood coagulation disorders
* anatomic defect precluding catheterization at either site
* skin lesions or recent surgery at either site
A Study to Evaluate the Efficacy of IBI939 in Combination With Sintilimab in Patients With Advanced NSCLC

This study is an open-label, phase I clinical study to evaluate the efficacy, tolerability and safety of recombinant fully human anti-TIGIT antibody (IBI939) in combination with recombinant fully human anti-programmed cell death receptor 1 (PD-1) antibody (sintilimab) in subjects with advanced lung cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Signed the Informed Consent Form;
2. Male or female ≥ 18 and≤75 years of age;
3. Life expectancy ≥ 12 weeks;
4. Eastern Cooperative Oncology Group Performance Status (ECOG PS) score is 0 or 1
5. Have at least 1 lesion (not previously irradiated) with an accurately measured longest diameter ≥ 10 mm by computed tomography (CT) or magnetic resonance imaging (MRI) (intravenous contrast agent is preferred) at baseline (except lymph nodes which must have short axis ≥ 15 mm) according to RECIST V1.1 and lesions amenable to repeated accurate measurements.
6. Histologically or cytologically confirmednon-small cell lung cancer

Exclusion Criteria:

1. Previous exposure to immune-mediated therapy; previous use of antitumor vaccine;
2. Received the last anti-tumor therapy within 4 weeks prior to the first dose of study drug;
3. Received any investigational agent within 4 weeks prior to the first dose of study drug;
4. Received systemic treatment with Chinese herbal medicine indicated for cancer or drugs used for immunoregulation (including thymosin, interferon, interleukin, except for local use for pleural effusion) within 2 weeks before the first dose;
5. Are participating in another interventional clinical study, or observational (non-interventional) clinical study or in the follow-up phase of an interventional study;
Blue Light Phototherapy

This study will use Blue-light Photo-therapy to treat patients with psoriasis vulgaris and Grover's Disease.


Eligibility Criteria:
Inclusion Criteria:

1. Patient's aged 18-89 at time of enrollment
2. Previous diagnosis of psoriasis vulgaris or Grover's disease

Exclusion Criteria:

1. All Groups: Subjects who are younger than 18 years of age or older than 90 years of age
2. Patients who have received topical or systemic treatment within the prior 2 weeks of planned phototherapy
3. Patients prescribed any of the following drugs for issues not related to their psoriasis or Grover's disease

   * topical steroids
   * calcineurin inhibitors
   * methotrexate
   * retinoids
   * biologic agents
4. Unable to schedule phototherapy sessions
5. We will not recruit the following populations: adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners and other vulnerable populations.
Turkish Version of Evaluation of the Ability to Sing Easily (EASE-TR)

The aim of the study is to translate and culturally adapt the Turkish version of the EASE (EASE-TR) scale and investigate its validity and reliability.

The study consists of two phases. In the first phase of the study, the scale will be translated and culturally adapted into Turkish. The second phase involves assessing participants and validating the translated scale. In this phase, participants will complete the EASE-TR and the severity part of the Vocal Tract Discomfort Scale (VTDS) before and after a 1-hour performance. One hundred choir member between the ages of 18 and 65 will be included in the study.

Both construct and criterion validity procedures will be used.Within the scope of construct validity, the "Known Groups Validity" method will be used based on variables such as experience duration, vocal training status, and the presence or absence of current vocal complaints. A comparison of pre- and post-performance EASE-TR scores will be conducted. Regarding criterion validity, the correlation between EASE scores and the severity part of the VTDS will be examined. For reliability, Cronbach's alpha and test-retest reliability will be calculated. The questionnaire will be administered a second time to 30 participants after 14 days in order to measure test-retest reliability.

Eligibility Criteria:
Inclusion Criteria:

* Having Turkish as mother tongue
* Singing in choir at least 6 months
* Performing at least for an hour

Exclusion Criteria:

* Having previously received voice therapy or undergone voice surgery
* Having a systematic/or neurological disorder that may affect voice quality
A-SPIRE Heart Failure: Utilizing Health Tags to Identify Patients at Risk for Hospital Readmissions

To evaluate the use of the Spire Health Tags in heart failure patients to determine the feasibility of capturing signals of respiration, pulse rate, activity, sleep patterns, and stress levels following HF hospitalization.

Over 5 million Americans suffer from heart failure (HF), and treating HF as a chronic condition is associated with significant costs. In addition, about 24% of the patients discharged with a primary diagnosis of HF are readmitted to the hospital within 30 days, representing a significant public health burden. While there have been efforts to predict and reduce 30-day hospital readmission initiated by the Centers for Medicare and Medicaid Services (CMS), no studies utilized daily physiologic data from wearables to identify at-risk patients.

The overall goal of this proposed pilot feasibility study is to utilize the Spire Health Tags in a heart failure patient population to ascertain the feasibility of capturing appropriate signals of respiration, pulse rate, activity, sleep patterns, and stress levels (calm/focused/tense during the day) for \> 80% of the time in patients following HF hospitalization for a 30-day period. The investigators will do exploratory analysis of the changes in these physiologic variables during a 30-day period following HF hospitalization to identify risk markers that could predict 30-day readmission.

Eligibility Criteria:
Inclusion Criteria:

* Men and women 18 years of age or older;
* Admitted for acute heart failure;
* Expected to be discharged from hospitalization;
* Able to give consent;
* Willing to use the Spire Health Tags for 30 days continuously.

Exclusion Criteria:

* Unable or unwilling to participate in the study.
Serum Copeptin in Cirrhotic Patients With Spontaneous Bacterial Peritonitis

Current reports have demonstrated that copeptin predicts disease progression and prognosis in cirrhotic patients, independent of liver-specific scoring systems. To the best of our knowledge, few studies have addressed the association between copeptin and sepsis in cirrhotic patients, however, they were performed on different types of infections. Therefore, we will conduct this study with a focus on it is possible role in patients with SBP.


Eligibility Criteria:
Inclusion Criteria:

* The diagnosis of liver cirrhosis will be based on clinical data and findings on abdominal ultrasound. The diagnosis of SBP will be based on the presence of at least 250 cells/ml PMNLs in the ascitic fluid, with or without positive ascitic fluid culture in the absence of hemorrhagic ascites and secondary peritonitis

Exclusion Criteria:

* Patients with heart failure, coronary insufficiency, advanced chronic respiratory disease, polyuria-polydipsia syndrome and hypotension or shock.

  * Patients with chronic kidney disease treated with hemodialysis before admission.
  * Patients with previous liver or kidney transplantation.
  * Patients with intraabdominal malignancy.
  * Patients with severe infection other than SBP.
  * Patients who had received antibiotics before hospital admission.
Clinical Trial of 4% Niacinamide Versus 0.05% Desonide for the Treatment of Axillar Hyperpigmentation

Axillary hyperpigmentation is a frequent consultation in dark skin populations although its exact prevalency is unknown. Currently, there are not studies about physiopathology and treatment for this entity. The objective is to evaluate the depigmenting effect of topical 4% niacinamide versus 0.05% desonide in axillary hyperpigmentation.

At least 30 axillas with hyperpigmentation in individuals of phototype III-V, aged 18-50 years are going to be randomly assigned to receive niacinamide, desonide or placebo daily. No hygienic habits will not be modified. Volunteers will be evaluated at baseline and for 9 weeks, by means of histological, histochemical and immunohistochemistry analysis, as well as Transepidermal Water Loss (TEWL), colorimetry, clinically and by photography control.

Axillary hyperpigmentation is frequent in dark skin population, is possible a type of postinflammatory hyperpigmentation present in phototypes IV to VI. Previous reports have described increased intensity of Masson-Fontana, anti-tyrosinase and/or anti-TRP1 staining, indicative of melanocyte stimulation and increased melanin production, but the exact mechanism is unknown. The hair plucking, the rubbing of clothes on skin and physical stimulation from washing and drying the underarm are factors implicated. The objective of our study is evaluate the depigmenting effect of topical niacinamide versus desonide in axillary hyperpigmentation through the histochemistry and immunohistochemistry staining.

The study population will include at least 30 axillas with hyperpigmentation in a population with phototype III-V and aged 18-50 years old. Informed consent will be obtained from the patients, under approval by the local ethical committee (Institutional Review Board). The patients are going to be randomly assigned to receive 4% niacinamide, 0.05% desonide or placebo daily once at night. None hygienic habit is going to be modified. Volunteers will be evaluated at baseline and 9 weeks later, with histochemical and immunohistochemical analysis (biopsies), colorimetric value axis L\*, a\*, b\* (Chromameter CR-300, Minolta, Osaka, Japan), Transepidermal Water Loss (TEWL) by means of an evaporimeter (Dermalab, Cortex Technology, Denmark), clinical assessment and photography control.

Statistical analysis was performed using t student, the level of significance was set at 5%. And clinical evaluation will be analysed by means of chi square test.

Eligibility Criteria:
Inclusion Criteria:

* Women over 18 years old
* Healthy
* Clinical diagnosis of axillar hyperpigmentation

Exclusion Criteria:

* Pregnancy or lactation
* Obesity
* Endocrinological diseases
* Mental diseases
* Treatment for axillar hyperpigmentation in the last 2 months
Cleave-stage Transfer on Day 3 Versus Day 5 Transfer When Only One Embryo Available

When only one embryo is available after in vitro fertilization, the option is to transfer either day 3 or day 5. There is no randomized trial compared the day 3 to day 5 for this subgroup.

Recruitment is very slow. The TSC will discuss termination next meeting with the DMC.

Eligibility Criteria:
Inclusion Criteria:

* Infertile couple with only one embryo available for transfer

Exclusion Criteria:

* ineligible for study
AnalyST Treadmill Study

The objective of the study is to collect information on the naturally occurring variations in ST deviations at different heart rates, as detected by the AnalyST and AnalyST Accel Implantable Cardioverter Defibrillators (ICD).


Eligibility Criteria:
Inclusion Criteria:

* Patient has received or is scheduled to receive a St Jude Medical AnalyST or AnalyST Accel ICD;
* Patient has documented ischemic heart disease.

Exclusion Criteria:

* Patient has an indication for ventricular pacing;
* Patient has chronotropic incompetence or insufficiency;
* Patient has a contraindication to stress testing;
* Patient is physically unable to complete the stress test protocol;
* The patient has persistent or permanent atrial fibrillation (AF);
* Patient is unable to comply with the protocol and follow-up schedule based on geographic location or for any reason;
* Patient is pregnant;
* Patient is minor (\< 18 years old).