cyrilzakka/clinical-trials huggingface dataset:
A Study to Investigate the Disposition of Radio-labeled AVE8062 Compound Administered as a 30-minute IV Infusion to Patients With Advanced Solid Tumor

Primary Objectives:

* To determine the excretion balance and systemic exposure of radioactivity after intravenous infusion of \[14C\]-AVE8062 to humans
* To determine the pharmacokinetics of AVE8062 and RPR258063 and their contribution to overall exposure
* To collect samples to determine the metabolic pathways of AVE8062 and identify the chemical structures of the main metabolites

Secondary Objective:

* To assess the safety profile of the drug

The duration of the study for each patient will include approximately 4 weeks of a screening phase prior to first infusion of study drug, 21-day study treatment cycles and end of treatment visit. The patient can continue treatment until disease progression, unacceptable toxicity, or the patient's refusal of further treatment.

Eligibility Criteria:
Inclusion criteria:

* Patients with advanced neoplastic disease that has become refractory to conventional treatment or for which no standard therapy exists.
* Age = or \> 18 years
* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
* Adequate hematological, hepatic and renal functions

Exclusion criteria:

* Poor metabolizers for CYP2C19, CYP2C9, CYP2D6 and polymorphic UGTs will be excluded from the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Genetic Variants Affecting the Clinical Severity of Beta Thalassemia

β-thalassemia is one of the most common single gene disorder in Southern China. The phenotypic severity of beta thalassemia widely varies from mild to severe forms. Patients with the same beta thalassemia genotype show wide phenotypic variability that ranges from moderate to severe disease due to various genetic modifiers of disease severity. The aim of this study is to looking for the genetic factors which could affect the severity of beta thalassemia.

The understanding of the genotype-phenotype correlation is a very important issue to the precise diagnosis of beta thalassemia. However, the genotype-phenotype correlation of Beta thalassemia is so complex that the pathogenesis of some patients remains uncertain and cannot be explained by known mechanisms. The study of the role of the genetic variants in modulating beta thalassemia phenotype could brought us considerable novel and interesting information in this area. We will collecting more than 1000 beta thalassemia patients , analyzing their clinical data and genome data, and association study will be conducted to screen the positive genetic variants which exert a significant effect on both the HbF levels and onset ages of beta thalassemia patients.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with β-thalassemia

Exclusion Criteria:

* Iron Deficiency Anemia
Consensus Statements on Definition, Components and Grading of Postoperative Pulmonary Complications

An international team of experts is working on a project called PrECiSIOn to develop a clear, consistent definition of PPCs. The goals of this study are to:

* Define postoperative pulmonary complications in a way that makes sense for patients, families, and healthcare providers.
* Rank complications by severity so doctors can focus on the most serious ones first.
* Decide how and when to monitor patients after surgery to catch problems early.

Postoperative pulmonary complications (PPCs) are associated with prolonged hospital stays, increased mortality, and significant clinical and economic burdens. Despite their importance, the definition of PPCs varies across studies, leading to inconsistencies in reported incidence rates and research outcomes. Existing definitions, such as the EPCO criteria, have been developed based on expert opinion but lack systematic consensus-building methods.

To address these limitations, the StEP collaboration conducted a systematic review and Delphi process to refine PPC classifications. However, challenges remain, including the lack of universal definitions, hierarchical ranking of complications, and representation from diverse healthcare settings. Composite outcome measures improve statistical power but may obscure differences in severity and clinical significance among PPC subtypes.

The PrECiSIOn Delphi initiative aims to develop an expert consensus on defining PPCs, grading their severity, and determining standardized monitoring methods. The goal is to create a valid, reliable, and universally accepted patient-centered definition of PPCs that enhances comparability across studies and informs clinical decision-making.

Eligibility Criteria:
Inclusion Criteria: Panellists will be identified based on either of the following criteria

* At least 10 years of clinical experience as a staff member in Anesthesiology, Surgery or Intensive Care Medicine with involvement in care of patients with postoperative complications
* Author of at least three publications (observational studies or randomised controlled trials) using postoperative pulmonary complications as a primary or secondary outcome

Exclusion Criteria

- None
Research Study of Nutritional Methods to Reduce Body Fat Percentages in Overweight and Obese Populations

The purpose of this study is to compare the use of personalized low-fat meal plans vs. non-personalized low-fat meal plans and the results in body fat reduction in overweight and obese subjects 25 to 45 years of age.

Compensation to Eligible Participants:

1. FREE Nutritional Services will be provided to eligible participants, which normally have a business value of between $165.00 and $195.00.
2. Each eligible participant will receive compensation for mileage directly related to this study up to 35 miles at the 2007 IRS Business Mileage Reimbursement Rate for medical purposes of $0.20 per mile. This compensation will be provided to each eligible participant in the form of a complimentary Wal-mart Gift Card in the amount of $7.00, contingent upon his or her completion in the study.

Study Rationale: This experiment on the effect that the use of personalized low-fat meal plans has on body fat reduction is important for several reasons. First, the details of this research study may equip the public with knowledge to select quality nutrition programs for weight loss responsibly. Second, it may encourage the wellness and fitness community to reconsider the practice of providing clientele with non-personalized meal plans for weight loss, which are not usually designed by accredited dietetic professionals. Third, this study may benefit dietetic professionals by opening the lines of communication between the wellness community and the dietetic community regarding standards of care, and protecting the public by dispelling harmful and erroneous nutrition advice.

Eligibility Criteria:
Inclusion Criteria:

* Between 25 to 45 years of age
* Classified as overweight or obese with body mass index (BMI) measurement between 25 and 50
* Limited to minor chronic health

Exclusion Criteria:

* Individuals with the following health conditions:
* Food allergies
* Food intolerances
* Cancer
* Debilitating joint conditions such as Degenerative Joint Disease (DJD) and Degenerative Disk Disease (DDD)
* Diabetes Mellitus receiving insulin therapy
* Kidney problems
* Menopause
* Polycystic ovarian syndrome (PCOS)
* Currently pregnant or breast feeding
* Using diuretics, chromium, and/or diet pills
* Participants must:
* Live in the following Oklahoma Counties:
* Canadian, Cleveland, Logan, Lincoln, Oklahoma, and Pottawatomie
* Will to travel to Edmond and Oklahoma City, Oklahoma
Comparison Between the Use of Phentolamine Versus Glyceryl Trinitrate for Their Effect on Renal Function in Pre-eclampsia Patients in ICU

Severe pre-eclamptic toxemia has a high incidence of renal complications. Rapid diagnosis and termination of pregnancy are still the gold standard main treatment for pre-eclampsia. Rapid control of blood pressure showed to provide protection against many adverse effects of preeclampsia as intracranial hemorrhage, subcapsular hepatic hematoma and acute kidney injury (AKI).

In Assiut university hospital ICU regimen, glyceryl trinitrate (GTN) was used primarily for this purpose. But it was accused in many cases as a cause for AKI without any other organ damage along with the severe preeclampsia disease. Some previous studies supported this assumption as , Ying-Hsuan .T. et.,al during their study of GTN on renal outcome during cardiopulmonary bypass in cardiac surgery. Phentolamine infusion is a new rising alternative for an old drug with a high safety profile.

In this research protocol the researchers will study comparative effect of glyceryl trinitrate (GTN) versus phentolamine on renal outcome in severe pre-eclampsia patients during their stay in obstetric ICU.


Eligibility Criteria:
Inclusion Criteria:

* Severe preeclampsia defined by presentation of 2 or more of the following criteria:

  1. Blood pressure more than 160/100
  2. Proteinuria
  3. Pitting edema
  4. With or without organ dysfunctions

Exclusion Criteria:

1. Patient relatives' refusal
2. Recent active internal hemorrhage
3. Chronic renal impairment or failure on dialysis for any other etiology
Treatment With Acetyl-Choline Esterase Inhibitors in Children With Autism Spectrum Disorders

We propose a study which will combine multiple modalities in evaluating the treatment response of children with autism spectrum disorders (ASD) to acetyl-choline esterase (AChE) inhibitors and choline supplements. The primary objective of the study is to examine the efficacy of this treatment in improving core autistic symptoms. The Secondary objective of the study is to evaluate the safety and tolerability of the treatment protocol in ASD children. Exploratory objectives include evaluation of the influence of the treatment on linguistic performance, comorbid behaviors, adaptive functioning and executive functions.

Autism Spectrum Disorders (ASD) are a group of developmental disorders of brain function resulting in a distinct phenotype, most probably related to many specific causes. Individuals with a disorder in the autism spectrum are a heterogeneous group of patients with early childhood onset of deficits in social interaction, communication and language, and repetitive and stereotypic behaviors. ASD has become increasingly prevalent during the last few decades (Wiznitzer, 2005).

The neuro-anatomical substrate of ASD has been the subject of intense investigation, but current findings are inconclusive, limited and sometimes even contradictory.

Medical treatment of autism is still a matter of dispute. Medications used are mainly aimed to treat the comorbid symptoms, such as epilepsy, tics, obsessive-compulsive or hyperactive behaviors (Wiznitzer, 2005). Although many efforts were invested in establishing a model of autistic pathophysiology, no such model is currently accepted, and there is no evidence for an efficient treatment of the core autistic symptoms (Wiznitzer, 2005).

Previous studies indicate that many brain systems are involved in the expression of autism. Specifically, it has been suggested that autism involves neurotransmitter dysregulations (Lam et al, 2006). A recent investigation of the cholinergic system in autism, detailed below, has provided promising findings. Our study aims to assess the clinical outcomes associated with cholinergic manipulations using pharmacological agents and nutritional supplements. The study approved by the Helsinki committee for clinical research.

Eligibility Criteria:
Inclusion criteria:

* A formal diagnosis of Autism or Pervasive Developmental Disorder not otherwise specified (PDD-NOS), given by a child neurologist.
* Age: 10-18 years.
* A signed parental consent form.

Exclusion criteria:

* Evidence for one of the following conditions:

  * an underlying infectious disease
  * chromosomal abnormality
  * metabolic disorder
  * specific brain related disorder (such as tuberous sclerosis)
  * history of fetal cytomegalovirus infection
  * birth asphyxia
  * a history of major head injury
  * a chronic use of non-steroidal anti-inflammatory drugs, (NSAID)
  * known brain damage
* Epilepsy
* Abnormal Electro-cardiogram (ECG)
* Epileptiform EEG
* Use of psychostimulants, anti-depressants, neuroleptics or anti-convulsive agents within the past month.
* Lack of cooperation in the screening phase
DEB-TACE+RALOX-HAIC vs DEB-TACE for Large HCC

This study is conducted to evaluate the efficacy and safety of transarterial chemoembolization with drug-eluting beads (DEB-TACE) combined with hepatic artery infusion chemotherapy (HAIC) with oxaliplatin and raltitrexed (RALOX-HAIC) versus DEB-TACE alone for unresectable large hepatocellular carcinoma (HCC).

This is a multicenter randomized study to evaluate the efficacy and safety of DEB-TACE plus RALOX-HAIC (DEB-TACE+HAIC) compared with DEB-TACE alone for unresectable large HCC (\>7cm).

130 patients with unresectable large HCC (\> 7cm) will be enrolled in this study. The patients will receive either DEB-TACE+HAIC or DEB-TACE using an 1:1 randomization scheme. In the DEB-TACE+HAIC arm, the microcatheter will be reserved at the main hepatic tumor-feeding artery and chemotherapy drugs (RALOX-based regimen) will be intra-arterially administered though the microcatheter. In the DEB-TACE arm, patients will be treated with DEB-TACE alone. The treatments can be repeated on demand (at a 4-week interval usually) based on the evaluation of follow-up laboratory and imaging examination by the multidisciplinary team. During follow-up, the potential resectability of the tumor will be assessed by the multidisciplinary team (MDT). Once the tumors become resectable, curative surgical resection will be recommended for the patients.

The primary end point of this study is progression-free survival (PFS). The secondary endpoints are tumor response (objective response rate and disease control rate), overall survival (OS) , and adverse events (AEs).

Eligibility Criteria:
Inclusion Criteria:

* HCC confirmed by histology/cytology or diagnosed clinically.
* At least one measurable intrahepatic target lesion.
* The largest tumor size \> 7 cm.
* Tumor recurrence after curative treatment (hepatectomy or ablation) is eligible for enrollment.
* Child-Pugh score 5-7.
* ECOG performance status ≤ 1.
* Adequate organ and hematologic function with platelet count ≥75×10\^9/L, leukocyte \>3.0×10\^9/L, Neutrophil count ≥1.5×10\^9/L, ASL and AST≤5×ULN, creatinine clearance≤1.5×ULN, and prolongation of prothrombin time ≤4 seconds.

Exclusion Criteria:

* Macrovascular invasion or extrahepatic metastasis.
* Diffuse HCC.
* Decompensated liver function, including: ascites, bleeding from gastroesophageal varices, and hepatic encephalopathy.
* Previous palliative treatments, including TACE, transcatheter arterial embolization, HAIC, radiation therapy, systemic therapy.
* Organ (heart and kidneys) dysfunction, unable to tolerate TACE or HAIC treatment.
* History of other malignancies.
* Uncontrollable infection.
* History of HIV.
* Gastrointestinal bleeding within 30 days, or other bleeding\> CTCAE grade 3.
* History of organ or cells transplantation.
* Pregnant or lactating patients.
Comparison of Thoracolumbar Interfascial Plane Block (TLIP-block) and Local Anesthetic (LA) Infiltration in Minimally Invasive Spine Surgery: A Randomized Controlled Trial

The goal of this clinical trial is to compare the effectiveness of the thoracolumbar interfascial plane block (TLIP block) versus local anesthetic (LA) infiltration in managing postoperative pain in minimally invasive surgery (MIS) for spine surgery.

The primary outcome was total morphine consumption. Secondary outcomes included pain scores using the the numerical verbal scale (NRS), opioid-related side effects, time of the first request for rescue analgesia, time to ambulation and hospital length of stay.

A single-center, prospective, double-blind, randomized controlled trial at Queen Savang Vadhana Memorial Hospital.

All 40 enrolled patients were randomized to receive the assigned intervention, Thoracolumbar interfascial plane group (TLIP group) and local anesthetic (LA) infiltration group (LA group).

* For TLIP group, patients will receive ultrasound-guild bilateral TLIP block with a total of 40 ml of 0.25% Bupivacaine.
* For LA group, patients will receive local anesthetic infiltration with a same drug by orthopedic surgeon.

At the end of surgery, patients were extubated and transferred to the PACU before being shifted to the orthopedic ward.

Postoperative assessments began upon admission to the PACU, designated as time zero, and continued at regular intervals in the orthopedic ward (6-, 8-, 12- and 24-hours post-surgery).

Eligibility Criteria:
Inclusion Criteria:

* Older than 18 years
* American Society of Anesthesiologists classes I-III
* Able to use a patient-controlled analgesia (PCA) device
* Able to rate their pain using a numerical verbal scale (NRS)

Exclusion Criteria:

* Declined to participate
* Uncooperative or unable to complete study assessments
* Had contraindications to the medications used in the study protocol and regional anesthesia.
* History of alcohol or substance abuse within two years prior to surgery,
* Allergies to medication used in the study protocol
* Pregnancy.
Flecainide for Catecholaminergic Polymorphic Ventricular Tachycardia

The purpose of this study is to test whether the addition of oral flecainide to standard therapy will reduce ventricular ectopy on exercise test compared to placebo plus standard therapy in patients with Catecholaminergic Polymorphic Ventricular Tachycardia.

Catecholaminergic Polymorphic Ventricular Tachycardia (CPVT) is a genetic arrhythmia syndrome characterized by frequent ventricular ectopy and polymorphic, classically bidirectional ventricular tachycardia with physical or emotional stress, which also carries a risk of ventricular fibrillation and sudden death, despite no structural heart abnormality. Treatment consists of beta-blockers and/or calcium channel blockers, but up to 30% of patients require implantable cardioverter-defibrillators (ICDs) due to recurrent symptoms on medical therapy. In an animal model, flecainide was found to directly target the molecular defect in CPVT. In a retrospective clinical study in patients with CPVT we have seen improvement of ventricular ectopy on exercise tests when flecainide is added to standard therapy. We propose a prospective trial of flecainide added to standard therapy in CPVT patients to test the hypothesis that flecainide will reduce ventricular ectopy on exercise testing compared to placebo plus standard therapy.

This will be a single-blind (blinded subjects) randomized cross-over study, in which each patient will receive treatment A (flecainide or placebo) for at least 3 months and, after a 1 week wash-out, treatment B (placebo or flecainide) for at least 3 months.

Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of CPVT, based on:

   A. reproducible polymorphic or bidirectional ventricular tachycardia with exercise OR B. Ventricular ectopy on exercise test with RYR2 or CASQ2 mutation
2. Functioning ICD in place
3. On stable dose of standard therapy defined as the maximal tolerated dose of beta-blocker and may include a calcium channel blocker

Patients on flecainide or mexiletine are also eligible for enrollment after a 1 week "washout" period during which flecainide or mexiletine is discontinued, and standard therapy alone is used.

Exclusion Criteria:

1. Females who are pregnant or plan to be pregnant during the study period
2. Children \< 5 years of age
3. Patients unable to perform treadmill exercise
4. Patients with significant structural heart disease
5. Patients with features consistent with Andersen-Tawil syndrome A. Periodic paralysis or unexplained weakness B. Dysmorphic facies C. Known KCNJ2 mutation
6. Patients with known hypersensitivity to flecainide
7. Patients on amiodarone
8. Patients not expected to comply with follow-up
Kinesiotaping Applied to the Thumb in Rheumatoid Hand

Objective: It was aimed to evaluate the acute effect of Kinesiotape taping on pain, function, range of motion and grip strength parameters in patients with rheumatoid arthritis and hand involvement.

Material and Methods: A total of 34 patients, 27 women and 7 men, diagnosed with RA according to the American Rheumatism Association (ACR) criteria were included in our study. All patients were divided into two groups as Kinesiotape and Control groups, each consisting of 17 patients. Subjective pain intensity was evaluated with the Visual Analog Scale, range of motion was evaluated with a goniometer, functional evaluation was evaluated with the Grip Skill Test, hand grip strength was evaluated with a dynamometer, and finger grip strength was evaluated with a pinchmeter. Evaluation parameters were evaluated before and 1 hour after the application, and the acute effect was examined. The patients in the kinesiotape group were taped with the mechanical correction method and the patients in the Control group were taped with tensionless gluing of the I tape. Applications were made on both dominant and nondominant hands.

This study is a double-blind, randomized clinical trial conducted by the Non-Interventional Ethics Committee from April 2018 to October 2018 in the Rheumatology unit of a university hospital in Turkey. The patients were divided in two groups using simple randomization method. There are 17 patients in groups. As the evaluation content; Socio-demographic information was recorded. Pain assessment was done by participants' subjective pain intensity Visual Analogue scale, mobility assessment was made by evaluating the range of motion with a goniometer, functional assessment was by grasping skill test, hand grip strength was measured by dynamometer, and finger grip strength was measured by pinchmeter. In our study, the mechanical correction method of taping to the Kinesiotape group was used. In rheumatoid hand patients, due to the presence of a deformity called hitchhiker's finger, the thumb is taped with 50-75% tension to create a pulling force in the direction of flexion and abduction. Sham application was applied to both dominant and nondominant hands in Control Group patients. Sham taping is the bonding of I tape to the 1st finger without tension and does not contain any features. Both the dominant and nondominant hands of the patients were taped and the differences between the two hands were also examined.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed as Level 2-3 Rheumatoid Arthritis
* no change in pharmacological treatment until 1 month before the study

Exclusion Criteria:

* Presence of acute disease
* Diagnosis of Level 4 Rheumatoid Arthritis
* Intra-articular or intramuscular injection application in the previous months
* Presence of hand-wrist surgery history in the last 6 months
* Non-rheumatoid hand deformity