cyrilzakka/clinical-trials huggingface dataset:
Obesity Management for Kidney TRANSPLANTation: OK-TRANSPLANT 2

OK-TRANSPLANT 2 is a vanguard study for a large randomized, pragmatic, open-label trial.

We will randomize participants with obesity, high-risk CKD/dialysis who are hoping for lose weight for the purpose of kidney transplant. Subjects will either be enrolled on a virtual weight management program or continue their usual care.

Obesity is well-recognized as an independent risk factor for chronic kidney disease (CKD) including end-staged kidney disease (ESKD). In people with ESKD, obesity can preclude access to lifesaving kidney transplantation. Of solid organ transplant programs in Canada, 80% exclude people with obesity (based upon body mass index or BMI), due to a potential risk of perioperative complications and post-transplant mortality.

Losing weight for kidney transplantation can, however, be extremely difficult. Medications that can promote weight loss in other populations including glucagon-like peptide 1 receptor agonists (GLP-1RA; liraglutide, semaglutide, and dulaglutide) and glucose-dependent insulinotropic polypeptide (GIP-1RA)/GLP-1RAs (tirzepatide), have not been studied in devoted trials of advanced CKD participants, and their efficacy and safety remain unclear.

Nutritional advice is often very difficult to follow when trying to balance kidney and diabetes diets (e.g. potassium), and if diets are too restrictive, there may be protein-energy wasting which could be detrimental to patients. People with high-risk CKD frequently live with functional impairment which can limit exercise. Weight loss programs can be cost prohibitive to those who are already socioeconomically disadvantaged.

A vanguard is needed before a large, multicentered RCT: A feasibility study will allow us to ensure that we can recruit a sufficient sample of participants into our trial, that our trial processes are inclusive, and that they are acceptable to patients. In the vanguard phase of our trial, we will answer the following questions:

1. Is participant recruitment into a large multi-centered trial feasible?
2. Will participants remain adherent to their assigned treatment arm over 26 weeks of study?
3. Will participants find our program acceptable?
4. Will safety events preclude us from testing our intervention in a larger RCT?

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18 years or older
* BMI \&gt; 35 kg/m\^2
* \&gt;10% risk of ESKD requiring renal replacement therapy over 2 years or receiving dialysis

Exclusion Criteria:

* Known contraindication to a GLP-1RA
* Type 1 diabetes
* Current use of more than the starting dose of semaglutide, liraglutide, or dulaglutide
* No access to semaglutide via drug coverage
* Absolute contraindication to kidney transplant
* Pregnant, breastfeeding or planning to become pregnant
Prognostic Value of Right Ventricular-pulmonary Arterial Coupling Assessed by Echocardiography in Septic Patients

Sepsis and septic shock are common clinical conditions, representing a significant healthcare challenge due to their high mortality rates and increasing incidence. Sepsis-induced cardiomyopathy is a frequent complication, occurring in up to 44% of septic patients. This condition is associated with a two- to three-fold increase in mortality. Although sepsis-induced cardiomyopathy is typically diagnosed via echocardiography to assess left ventricular systolic function, both ventricles may be affected. Several studies have demonstrated that right ventricular dysfunction (RVD)/ right ventricular failure (RVF) was prevalent in sepsis and septic shock, with significant implications for prognosis and mortality.

The right ventricle (RV) has a distinct anatomical structure and function compared to the left ventricle, characterized by its high sensitivity to afterload variations. Even minor increases in afterload can severely impair RV contractile function. Meanwhile, septic patients often experience hypoxemic respiratory failure and require mechanical ventilation. This condition generates hypoxia-induced pulmonary vasoconstriction, which, combined with positive pressure ventilation, leads to increased pulmonary vascular resistance and elevated pulmonary arterial pressure. Additionally, systemic vasodilation reduces RV preload, while septic shock and vasopressor use further compromise right coronary perfusion, exacerbating RV contractile dysfunction. Consequently, simultaneous assessment of RV contractility and its afterload is crucial in septic patients.

Tricuspid annular plane systolic excursion (TAPSE) is a widely used echocardiographic parameter for evaluating RV systolic function. Pulmonary artery systolic pressure (sPAP) reflects RV afterload and can be estimated in the presence of tricuspid regurgitation. Recently, the TAPSE/sPAP ratio has been proposed as a clinical tool to assess right ventricle-pulmonary artery (RV-PA) coupling. This index has been shown to be associated with mortality in patients with pulmonary hypertension and heart failure. Several studies have been conducted to evaluate RV-PA coupling in sepsis and septic shocks, but these studies have limitations in terms of study design and patient selection.

In Vietnam, the issues of RVD/RVF in sepsis/septic shock have not been thoroughly investigated. Le Minh Khoi and colleagues reported that the incidence of reduced RV strain in septic patients was as high as 55.1%. Currently, no studies have specifically evaluated RV function, nor have any studies assessed RV-PA coupling in septic patients.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with sepsis,
* Received treatment in the Intensive Care Unit (ICU) at the University Medical Center at Ho Chi Minh City during the study period.

Exclusion Criteria:

* Pregnancy,
* History of right ventricular myocardial infarction,
* Acute coronary syndrome within the past 1 week,
* Valvular heart diseases or a history of valve replacement surgery,
* Congenital heart diseases or conditions involving intracardiac shunts.
Hemostasis in COVID-19: an Adaptive Clinical Trial

Hypercoagulability has been demonstrated in COVID-19, leading to respiratory distress and increased mortality. This is an adaptive clinical trial to compare the efficacy and safety of two experimental strategies in patients with COVID-19: ASA or inhaled UFH associated with standard VTE prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* Adult ≥18 years of age at time of enrollment
* Subjects with a positive COVID-19 diagnosis by RT-PCR or serologic testing
* Subject (or legally authorized representative) must be willing, understanding and able to provide written informed consent.
* Only at phase 2:

  * onset of symptoms must not exceed 4 weeks
  * ICU patients
  * PaO2 to FiO2 ratio \< 200

Exclusion Criteria:

1. General

   * Indications for therapeutic anticoagulation
   * History of chronic lung disease oxygen dependent
   * Pregnancy
   * Death considered imminent and inevitable within 24 hours
   * Patients under exclusive palliative care
   * Participation in another trial of investigational drug
   * Body weight \< 40 Kg
   * Total bilirubin \> 20 mg/dL
   * Severe active bleeding
   * Persistent GI bleeding
   * Known allergy to UFH or LMWH
   * History of heparin-induced thrombocytopenia (HIT) within the past 6 months
2. Exclusion criteria at phase 1

   * Platelet count \< 25,000/mm3
   * Bacterial endocarditis
3. Exclusion criteria at phase 2

   * Platelet count \< 50,000/mm3
   * History of surgery in the last 30 days
   * Intervention A: allergy to ASA and long-term use of antiplatelet drug
   * Intervention B: inhaled nitric oxide use
ELEVATE, a Registry of Patients With Acute Hepatic Porphyria (AHP)

This global patient registry is being conducted to characterize the natural history and real-world clinical management of patients with AHP, and to further characterize the real-world safety and effectiveness of givosiran and other approved AHP therapies.


Eligibility Criteria:
Inclusion Criteria:

* Documented diagnosis of AHP, per physician's determination

Exclusion Criteria:

* Currently enrolled in a clinical trial for any investigational agent
A Single-Center, Prospective, Pilot Study to Compare the Effect of Diet in Overweight or Obese Patients With Psoriasis on Light Therapy

Weight loss may help psoriasis. Phototherapy helps psoriasis. Combining the two treatments may help even more. Determining if a high protein diet vs a low protein diet results in improving psoriais may help lead to future dietary effects on psoriasis therapy


Eligibility Criteria:
Inclusion Criteria:

* PSA greater 10
* BMI greater than 30

Exclusion Criteria:

* PSA less than 10
* less than 18 years old
Antibody and Delayed Cyclosporine Versus Initial Cyclosporine Alone in Patients Receiving Kidney Transplants

The purpose of this study is to see if kidney function can be improved during transplants by giving the drug Thymoglobulin with delayed cyclosporine treatment instead of initial cyclosporine treatment.

There have been improvements for patients receiving kidney transplants, yet acute rejection is still a problem. This can lead to kidney failure over time. Patients whose graft fails to function properly in the first week after transplant do not do as well after 5 years as compared to patients without early problems. This study will see if Thymoglobulin, a drug that suppresses the immune system, will improve early graft function.

While graft survival of post renal transplant has improved over the last decades, acute rejection remains a problem that clinical research has sought to minimize through improved strategies. Graft survival prognosis is significantly worsened in patients whose allografts exhibit delayed function and patients may require early dialysis. Data shows that cadaveric organ recipients requiring dialysis use in the first transplant week have a 5-year post-graft survival rate of 51 percent compared to 70 percent for those free of this complication. A recent evaluation of Thymoglobulin (a rabbit-derived polyclonal antibody; an immunosuppressant) suggests it is an effective agent worthy of further evaluation as induction therapy. This trial evaluates whether a decreased DGF is seen with an improved Day 90 graft function.

Recipients of a first or second cadaver kidney transplant are randomized pre-transplant to 1 of 2 treatment groups. One group receives antibody therapy (Thymoglobulin) at the time of transplant and delayed cyclosporine therapy. The other group starts cyclosporine therapy at the time of transplant without Thymoglobulin. DGF is diagnosed by a less than 20 percent decrease in the serum creatinine levels in the first 24 hours post-transplant and/or the need for dialysis. Patients on the antibody arm receive additional antibody if they experience DGF. Biopsies are performed in all cases of suspected rejection and any patient with biopsy-confirmed acute cellular rejection receives treatment. Patients have regular examinations including blood tests and are evaluated for kidney function and incidence of complications for 24 months after the transplant. The trial endpoint of graft function encompasses graft survival and graft function as calculated by creatinine clearance.

Eligibility Criteria:
Inclusion Criteria

Patients may be eligible for this study if they:

* Are receiving a first or second kidney transplant.
* Are at least 21 years old.
* Understand the purposes and risks of the study and have given consent.
* Agree to use an acceptable form of birth control for a year following transplant.

Exclusion Criteria

Patients will not be eligible for this study if they:

* Have received a kidney transplant from a living donor.
* Have had multiple organ transplants.
* Are allergic to Thymoglobulin (contains a rabbit protein).
* Are pregnant.
Efficacy and Safety of Gefapixant (MK-7264) in Women With Chronic Cough and Stress Urinary Incontinence (MK-7264-042)

The purpose of this study is to evaluate the efficacy and safety of gefapixant, in improving symptoms of cough-induced stress urinary incontinence (SUI) in adult female participants with refractory or unexplained chronic cough. The primary hypothesis is that gefapixant is superior to placebo in reducing the frequency of cough-induced SUI episodes over 12 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Has a chest radiograph or computed tomography scan of the thorax (within 5 years of Screening and after the onset of chronic cough) not demonstrating any abnormality considered to be significantly contributing to the chronic cough or any other lung disease
* Has chronic cough (defined as duration of \>8 weeks after onset of cough symptoms) for ≥12 months
* Has a diagnosis of refractory chronic cough or unexplained chronic cough
* Has symptoms of SUI, defined as involuntary loss of urine on effort, physical exertion, or on sneezing or coughing, for ≥3 months
* Is a female who is not pregnant, not breastfeeding, not of childbearing potential, or agrees to follow contraceptive guidance

Exclusion Criteria:

* Is a current smoker
* Has given up smoking within 12 months of screening
* Is a former smoker with a smoking history greater than 20 pack-years (1 pack of 20 cigarettes per day for 20 years)
* Has a history of respiratory tract infection or recent change in pulmonary status within 4 weeks of screening
* Has a history of chronic bronchitis
* Has a history of surgery to treat SUI within 1 year of screening
* Has a history of other specialized treatments for SUI, including intravesical balloon or urethral bulking agent therapy
* Has other external incontinence device currently or within 1 month of screening
* Has a history of Grade 3 or higher pelvic organ prolapse previously documented or diagnosed on screening
* Has a neurogenic bladder
* Has a history of adult nocturnal incontinence
* Has a history of continuous urine leakage within 1 month of screening
* Has a history of interstitial cystitis
* Has a history of neurological disease or injury
* Has active or recurrent urinary tract infection
* Has a history of having a permanent urinary catheter or any urinary catheterization within 3 months of screening
* Has a history of malignancy ≤5 years prior to signing informed consent
* Is a user of recreational or illicit drugs or a recent history (within the last year) of drug or alcohol abuse
* Has a known allergy to gefapixant or its excipients
* Has donated or lost ≥1 unit (\~300 mL) of blood within 8 weeks prior to first dose of gefapixant
* Requires certain medications and/or other therapies that may impact their cough or bladder function
* Has previously received gefapixant
* Is currently participating or has participated in an interventional clinical study within 30 days of participating in this current study
SLSMDS Natural History Study

The Single Large-Scale mtDNA Deletion Sydrome: Natural History Study (PS-NHS) aims to collect data on standardized clinical outcomes, store data on the Champ Foundation Registry (CFR) and make this data available to researchers, clinicians, and industry partners who are studying SLSMDS to answer questions regarding the disease, including its causes, potential treatments, and other topics. A secondary aim is to analyze the data to understand research questions relating to the natural history of SLSMDS.

This study is a prospective, observational, and longitudinal study intended to track the course of Pearson syndrome and single large scale mitochondrial DNA deletion syndromes (SLSMDS) to identify demographic, genetic, environmental, and other variables that correlate with the diseases development and outcomes. If available, retrospective clinical data may be accessed and used in analyses as well.

The PS-NHS will be conducted at two Center of Excellence sites: the Cleveland Clinic and Children's Hospital of Philadelphia (CHOP).

All PS-NHS data will be entered and stored on the CFR. The CFR exists entirely online.

Eligibility Criteria:
Inclusion Criteria:

* Have an active account on the Champ Foundation Registry (CFR) or be willing to create an account on the CFR.
* Must have a genetic diagnosis of a single large-scale mitochondrial DNA deletion and must upload their genetic report to the CFR.
* Have a clinical diagnosis or history of Pearson syndrome OR have symptom onset prior to five years of age and a genetic diagnosis of a single large-scale mitochondrial DNA deletion OR in the opinion of the principal investigator the participant is suitable for participating in this study based on clinical presentation.

Participants may be of any age or gender, and originate from any country.
Study to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers

The purpose of this study is to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers.

This study was a randomized, double-blind, placebo- and active-controlled, crossover study that evaluated the potential of Abametapir to prolong cardiac repolarization in healthy adult subjects (total of 57 subjects).

Eligibility Criteria:
Inclusion Criteria:

* healthy male or female subject, 18 to 50 years of age, inclusive, at least 45 kg and has a body mass index (BMI) of 18 to 33 kg/m2,
* Female subjects of childbearing potential must not be pregnant and not lactating or prepared to practice highly effective birth control methods
* The subject has normal 12-lead ECG results or, if abnormal, the abnormality is not clinically significant (as determined by the investigator).

Exclusion Criteria:

* has evidence of cardiac conduction abnormalities
* history of unexplained syncope, cardiac arrest, unexplained cardiac arrhythmia or torsade de pointes, structural heart disease, or family history of Long QT syndrome (suggested by sudden death of a close relative due to cardiac causes at a young age
* potassium, calcium, or magnesium levels that are below the clinical laboratory's lower limit of normal
* laboratory test results at Screening are \>2 x the upper limit of normal (ULN) for alanine aminotransferase (ALT) or aspartate aminotransferase (AST), \>1.5 x ULN for bilirubin, or \>1.5 x ULN for creatinine
* history or evidence of any clinically significant (as determined by the investigator) cardiovascular, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, neurologic, dermatologic, psychiatric, renal, and/or other major disease or malignancy (excluding non-melanoma skin cancer)
* febrile illness or symptomatic viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week before clinic admission
* supine mean systolic blood pressure \<90 or \>140 mmHg and a mean diastolic blood pressure \<50 or \>90 mmHg
* positive for HIV or hepatitis C antibody or hepatitis B antigen (HBsAg)
The Effect and Safety of Hemodialysis and Hemoperfusion on Severe Renal Osteopathy and Itching in Uremia Patients

A prospective, randomized, controlled open clinic trial to evaluate the effect and safety of combination of conventional hemodialysis(HD) and hemoperfusion(HP) on middle molecules removal and complications improvement in long-term maintenance hemodialysis (MHD) patients.

There are two phases of study for each subject. Phase 1 (screening phase). During this phase, each potential subject will be evaluated to determine if he/she is eligible for the study.

Phase 2 (intervention phase). Each subject will be randomly allocated to HD+HP(HA130 once per week) group ,HD+HP(HA330 once per week) group and HD group. The follow-up duration was 3 months.

All patients recruited from these centers who met the inclusion criteria were randomly allocated to HD+HP(HA130 once per week) group ,HD+HP(HA330 once per week) group and HD group. The follow-up duration was 3 months.

Hemoperfusion is performed by HA130 or HA330 resin adsorbents. Blood flow is 200ml/min，dialysate flow is 500ml/min， hemodialysis and hemoperfusion last for 2.5h，continue HD after removing the adsorbent to complete 4 hours'treatment.Heparin for anticoagulation ：first pulse 0.5-1mg/kg ，appending 8-10mg/h. Primary endpoint is the improvement of the clinic symptoms, meanwhile secondary endpoint is serum β2MG、iPTH、CRP、ADMA、BMP2 decrease compared with the baseline, life quality, nutrition condition, and cardiovascular (CVD) incidence.

Eligibility Criteria:
Inclusion Criteria:

* Willingness to sign an informed consent
* Stable haemodialysis treatment for more than 3 months, undergoing 2 to 3 times haemodialysis a week for 4 to 5 hours per session
* middle or large molecules retention defined as immunoreactive parathyroid hormone (iPTH) \> 400 pg/mL, β2MG\>5000 pg/ml、CRP\>10mg/l.
* Refractory pruritus, carpal tunnel syndrome, restless leg syndrome, hyperparathyroidism or other refratory complications.

Exclusion Criteria:

* Incapable or reluctant to sign the informed consent or comply the schedule.
* platelet (PLT) count\<60×109/L or disturbance in coagulation, tendency of severe bleeding or acute bleeding.
* Severe hypotension and heart or lung insufficiency
* Known hypersensitive or contradiction or intolerance to dialyzer or adsorbents
* Attend to other clinic trial now or in recent 30 days
Objective Assessment for Cleft Lip Nasal Deformity Correction

Rhinoplasty remains one of the most challenging procedures in plastic surgery, and patients with cleft lip nasal deformity pose an even greater challenge, in which biggest issue is to achieve caudal nose harmony and creation of symmetrical nostrils with patent normal nasal function

Cleft lip and palate represent the most common birth defects affecting the head and neck region. It has been estimated, based on global birth rates that a child born with a cleft every 2.5 minutes .which is associated with varying degrees of nasal deformity grading from mild to severe inadequate function, shape and appearance of the nose. Functional impairment of the nose has been reported in 70% of cases with cleft lip. It negatively affects patients' personal and professional lives, physical activity, well-being and general quality of life.

However, historical interest in cleft lip and palate was traced to pre-Columbian artisan; the interest in the associated nasal deformities only began with rhinoplasty techniques introduced in the 19th century. That's why despite the great improvement achieved in primary repair of cleft lip and nasal deformity, the secondary cleft and nasal deformity still occur in significant number of patients, and the surgical management of the nasal deformity remains a functional and aesthetic dilemma for patients, their families and for reconstructive surgeons.

Lake of objective assessment of the initial severity and the changes introduced by growth and by surgical treatment lead to inability to optimize a treatment of cleft lip nasal deformity, hence there is no perfect surgical technique exists and surgeons must tailor approaches to individuals and evolve techniques to best serve each patient.

Although surgery can give dramatic effect, the lack of objective assessment of different surgical procedures results in decision that is based on the experience of the surgeon.

Secondary rhinoplasty is done after facial growth is completed. This is around 14 to 16 years old in female patients and 16 to 18 years old in male patients. Surgical techniques rely on well-accepted open rhinoplasty principles and are applied for unilateral or bilateral cleft nasal deformities.

Careful complete analysis followed by logical plan for each case is the key stone for success.

Multislice CT Flesh mode will be used for measuring some angles and ratios of the nose and its relation to the face. The results will be recorded at the spread sheet and the preoperative and post operative results will be compared. Other parameters can also be measured, as long as user records the measurements manually.

Eligibility Criteria:
Inclusion Criteria:

1. Age group: \> 14-16 years old females and \>16-18 years old male patients.
2. Patients with unilateral or bilateral cleft lip nasal deformity that isn't previously operated.

Exclusion Criteria:

1. Previous rhinoplasty operated CLND cases.
2. Patients who need skeletal base reconstruction.
3. Syndromic cases.
4. Post traumatic nasal deformity.
5. Female patients less than 14 years' old and male patients less than 16 years old.