cyrilzakka/clinical-trials huggingface dataset:
SREBF1 Polymorphism and Egg Yolk on Cardiovascular Disease Risk in Healthy Young Adults: a Randomised, Two-period, Single Blinded, Crossover Trial

Our previous analysis showed that sterol regulatory element binding protein gene (SREBF1) rs2236513/rs2297508/rs4925119 polymorphism modulated the relation between dietary cholesterol and serum low density lipoprotein cholesterol /serum total cholesterol. This study aims to confirm and extend this finding by characterizing the effects of cholesterol from egg yolks on lipid profiles in healthy young adults with different SREBF1 genetic makeup. 32 SREBF1 C/G/G minor allele carriers at rs2236513/rs2297508/rs4925119 and 32 SREBF1 AA/CC/AA major homozygotes at rs2236513/rs2297508/rs4925119 were enrolled to test their response to egg yolks.


Eligibility Criteria:
Inclusion Criteria:

* SREBF1 C/G/G minor allele carriers and AA/CC/AA major homozygotes at rs2236513/rs2297508/rs4925119, age 18-25 years, body mass index (BMI) 18\~23.9 kg/m2 , blood pressure within normal ranges (Systolic blood pressure \< 140mmHg, diastolic blood pressure \< 90mmHg), lipid profiles within normal ranges according to test kit instructions (fasting serum triglycerides \< 1.7mmol/L, fasting serum total cholesterol \< 5.2 mmol/L, fasting serum low density lipoprotein cholesterol (LDL-C) \< 3.12 mmol/L, fasting serum high density lipoprotein cholesterol (HDL-C) \>1.04 mmol/L ), liver and kidney functions within normal ranges according to test kit instructions (alanine aminotransferase (ALT) 9\~50 U/L for male, 7\~40 U/L for female; aspartate transaminase (AST) 15\~40 U/L for male, 13\~35 U/L for female; creatinine 62\~115 μmol/L for male, 53\~97 μmol/L for female; blood urea nitrogen (BUN), 1.43\~7.14 mmol/L), both parents are Chinese Han nationality, willing to eat two or more eggs, and willing to maintain "Three Low Diet" except when they were given egg yolks during the study.

Exclusion Criteria:

* History of diabetes, cancer, stroke, heart disease or any other known diseases, allergic to eggs, or having habits such as drinking or smoking.
Trial of Lenalidomide in Patients With Lymphoma of the Mucosa Associated Lymphoid Tissue (MALT) Type

The activity of monotherapy with Lenalidomide will be evaluated in patients with lymphoma of the mucosa associated lymphoid tissue (MALT).

The primary objective of the study is to evaluate the clinical potential of Lenalidomide to induce objective/histologic responses in patients with MALT lymphoma.

The secondary objectives are to evaluate the safety of Lenalidomide in this patient population and to evaluate the impact of Lenalidomide on progression free survival.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed MALT lymphoma with measurable disease (stage I - IV)
* With first or greater relapse after HP-eradication, radiation or chemotherapy in case of gastric lymphoma
* Age \> 18 years
* Must be able to tolerate therapy, and have adequate cardiac, renal, and hepatic function, ECOG status of 0 - 2
* Must be capable of understanding the purpose of the study and have given written informed consent

Exclusion Criteria:

* Lymphoma histology other than MALT lymphoma or MALT lymphoma with a diffuse large cell lymphoma ("high grade lymphoma") - component
* Use of any investigational agent within 28 days prior to initiation of treatment with lenalidomide
* History of malignancy other than squamous cell carcinoma, basal cell carcinoma of the skin or carcinoma in situ of the cervix within the last 5 years
* Major surgery, other than diagnostic surgery, within the last 4 weeks
* Evidence of CNS involvement
* A history of uncontrolled seizures, central nervous system disorders or psychiatric disability judged by the investigator to be clinically significant and adversely affecting compliance to study drugs
* Severe peripheral polyneuropathy
* Clinically significant cardiac disease (e.g., congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias not well controlled with medication) or myocardial infarction within the last 6 months
* Inadequate hematological status at baseline prior to study entry: Dependency on red blood cell and/or platelet transfusions, ANC (absolute neutrophil count (segmented + bands)) \< 1.0 x 109/L
* Patients with active opportunistic infections
* Pregnancy
* Uncontrolled diabetes mellitus
* Preexisting thromboembolic events at start of study
Efficacy and Safety of Intravenous Phenobarbital in Neonatal Seizures

This is a randomized, double-blind, parallel-group, Phase 3 study to evaluate the efficacy of the administration of phenobarbital sodium injection in neonates who have suffered from electrographic or electroclinical seizure. As neonatal seizures can have long-term adverse effects, including death, placebo-controlled studies are not appropriate for this population. This study is designed to show intravenous phenobarbital is effective at preventing subsequent seizures by demonstrating greater efficacy at a higher dose compared to a lower dose.


Eligibility Criteria:
Inclusion Criteria:

* Male or female neonates with a gestational age of ≥ 34 - ≤44 weeks admitted into the NICU with a high probability of developing seizures (e.g., HIE, stroke, intracerebral hemorrhage, central nervous system infection)
* Parental informed consent (in-person or remote consent)
* Undergoing continuous video electroencephalogram (cvEEG) monitoring
* Has evidence of electrographic seizure burden of at least 30 seconds/h

Exclusion Criteria:

* Received anticonvulsant treatment, including phenobarbital, prior to randomization (with exception of lorazepam administered for sedation \> 24 hours before enrollment)
* Strong suspicion or confirmed diagnosis of brain malformation, inborn error of metabolism genetic syndrome, or major congenial malformation prior to randomization
* Seizures responding to correction of hypoglycemia, hypocalcemia or any other metabolic disorder
* Death appears to be imminent as assessed by the NICU attending physician
* Is currently enrolled in another study assessing the same and/or similar primary/secondary endpoints with/without drug treatment.
New Castle Disease Virus (NDV) in Glioblastoma Multiforme (GBM), Sarcoma and Neuroblastoma

Patients with specific metastatic cancers who failed prior therapeutic regimes will be treated with NDV for at least a year or until disease progression. The study will measure progression-free disease and posits that it will be extended.

Present therapeutic regimes have not much improved the survival of patients with metastatic cancer. Therapeutic cancer vaccines are a form of immunotherapy designed to educate the immune system to recognise tumor cells as foreign rather than self. New Castle Virus (NDV) has a long history as a broad system oncolytic that can destroy tumor cells and stimulate the immune system. Up to 30 patients suffering from recurrent, refractory Glioblastoma Multiforme, soft an bone sarcomas and disseminated neuroblastoma will be enrolled in this trial and receive daily doses of NDV at least 5 days a week for a minimum of a year or until disease progression.

Eligibility Criteria:
Inclusion Criteria:

* Evidence of progressive disease in the above categories evaluated by standard tumor staging.
* Histologically confirmed diagnosis.
* Failure of conventional anti- cancer modalities.despite optimal application of all relevant available anti- cancer modalities.
* Age between 3 and 75 years old.
* Liver function tests less than twice the normal, renal function no more than 20% reduction and white cell and platelets count no more than 30% reduction.
* Karnofsky performance status of 50% or greater
* A written informed consent understood and signed by the patient and by a spouse, parent or guardian. In patients with GBM two signs will be required due to possible alterations of psych and understanding.

Exclusion Criteria:

* Not fulfilling any of the above criteria
* Moribund patients or patients with life- expectancy \< 3 months
* Karnofksy performance status \< 50%
* Pregnant or lactating women
* Active local or systemic infections requiring treatment
* Patients receiving other investigational agents
* History of allergy to egg ova-albumin.
* Co-morbidity or life- threatening clinical condition other than the basic cancer
The Effect of Bowel Preparation Training Given to Patients Undergoing Colonoscopy

This study was planned to examine the effect of bowel preparation training and monitoring given to patients planned to undergo colonoscopy on the level of anxiety, compliance with bowel preparation and bowel cleansing. The research sample was collected at the Sultan II. University of Health Sciences affiliated to the Istanbul Provincial Health Directorate between December 2022 and August 2023. 34 intervention and 34 control groups will be randomly selected from outpatients who apply to the Colonoscopy Unit of Abdülhamid Han Training and Research Hospital and meet the inclusion criteria.

In this study, it is aimed to increase the effect of bowel preparation training, supported by nurses in the clinic and via instant messaging/calling or communication application, on patients' anxiety level, level of compliance with bowel preparation, and bowel cleansing in patients scheduled for colonoscopy.


Eligibility Criteria:
Inclusion Criteria:

* Colonoscopy is planned
* Understands Turkish, can read and write,
* Patients who volunteer to participate in the research.

Exclusion Criteria:

* Patients who do not attend planned training and do not receive telephone counseling
The Türkiye Heart Failure Registry

A comprehensive understanding of the socio-demographic, clinical, and biological characteristics of patients with heart failure is essential to develop novel strategies for improving outcomes. The identification of the barriers to guideline-directed medical therapy implementation in a real-world setting is critical to decreasing the risk of heart failure hospitalization and mortality. A comprehensive and well-designed heart failure registry can determine the clinical characteristics of patients with heart failure, identify patient, physician, and healthcare system-related factors for the non-use of evidence-based therapies, and improve the implementation of guideline-directed medical therapy. It should be noted that the number of heart failure registries that enroll patients with de novo heart failure, chronic heart failure (outpatients), and worsening of heart failure (hospitalized or treated in the emergency department), with all three relevant ejection fraction categories (heart failure with reduced ejection fraction, heart failure with mildly-reduced ejection fraction, and heart failure with preserved ejection fraction), is limited. Furthermore, only a few registries assess detailed aspects of guideline adherence, treatment decisions, and both in-hospital and long-term outcomes. Therefore, the Türkiye Heart Failure (TURK-HF) registry has been designed to address this gap in knowledge about the identification, management, and long-term prognosis of patients with heart failure in a real-world setting.


Eligibility Criteria:
Inclusion Criteria: Presence of heart failure -

Exclusion Criteria: Age \<18 years

-
Single-Incision Laparoscopic Cholecystectomy Versus Traditional Laparoscopic Cholecystectomy

This study will compare Single Incision Laparoscopic Surgery (SILS) cholecystectomy to traditional laparoscopic cholecystectomy (LC), focusing on patient-reported outcomes and cost.

Single-Incision Laparoscopic Surgery (SILS) is accepted as a form of surgical treatment. Traditional laparoscopic cholecystectomy (TLC) is well tolerated, with a low complication risk and high patient satisfaction; thus a SILS procedure needs to be at least equivalent to be a justifiable replacement, and should not result in higher costs.

Eligibility Criteria:
Inclusion Criteria:

* Patient recommended to undergo cholecystectomy
* Patient age 18-80
* Patient competent to give his/her own informed consent
* Patient speaks English without the need for an interpreter

Exclusion Criteria:

* Additional procedures planned during same surgery
* Patient deemed inappropriate for TLC or SILS cholecystectomy
Prospective Study of Belated Pulmonary Complications Occurring in Children Treated With Allogeneic Hematopoietic Stem Cells.

Hematopoietic stem cell transplantation (HSCT) is used to treat an expanding array of malignant and non-malignant disorders. This is a prospective multicenter study, in pediatric allo-BMT recipients to analyze the spectrum of noninfectious pulmonary complications (PC), to evaluate the prevalence and course of PFT abnormalities before and after transplant, and to detect risk factor for PC.

It's a multicenter prospective study in France. All children under 18 years are included, just before the HSCT. The functional test before the HSCT at 6, 12, 18, 24, 30 and 36 months will be collected and a cardiopulmonary exercise test is done one and three years after the HSCT. Thoracic tomodensitometry is done before the HCT and after at 6, 12, 24 and 36 months.

All data will be collected upon the HSCT, the infections before and after the HSCT, the respiratory symptoms, and the treatment. Bronchia alveolar lavage and serum will be collected and frozen during the study.

The inclusion will be done during two years and children will be following during three years.

The purpose is to evaluate the prevalence, the course of PFT abnormalities before and after transplant, and to detect risk factor for PC.

Eligibility Criteria:
Inclusion Criteria:

* Age: from birth to 18 years
* Patient to be treated by allogeneic hematopoietic stem cell - Parents who have given their signed consent for the study
* Affiliation to a social security scheme

Exclusion Criteria:

* non exclusion criteria
Evaluation of Conventional and Long Pulse Widths During a Temporary Spinal Cord Stimulation Trial

The purpose of this study is to evaluate the effect of pulse widths \<500 µS and \>1000 µS on clinical outcomes during a temporary SCS trial.

The proposed study is a prospective, single-center, two arm, randomized, crossover design to be conducted at The Ohio Pain Clinic. The study will enroll up to 15 subjects in order to include up to 10 subjects in the study. Subjects selected to participate in the trial have back and/or leg pain, have been evaluated as a candidate for SCS and have agreed to undergo a temporary SCS trial using the Algostim system with percutaneous leads. Each subject will be followed during the trial period of approximately 7 days.

The study will end when the last subject has completed the trial period. exited. The expected enrollment period for this study is approximately three months. After exit from the clinical study, subjects will continue to be followed by their physician per usual care. All device and procedure-related AEs will be collected and reported per the study protocol.

Eligibility Criteria:
Inclusion Criteria:

* Subject is eligible for SCS therapy according to the Algovita SCS system Indications for Use statement
* Study candidate is undergoing a SCS trial using Nuvectra Algostim system
* Subject signed a valid, Institutional Review Board (IRB)-approved informed consent form.
* Subject is 18 years of age or older when written informed consent is obtained

Exclusion Criteria:

* Subject is contraindicated for an Algovita SCS system
* Subject has a cognitive impairment or exhibits any characteristic, that would limit the study candidate's ability to assess pain relief or complete study assessments
* Subject has a life expectancy of less than 2 years
* Subject is participating in another clinical study that would confound data analysis
* Subject has a coexisting pain condition that might confound pain ratings
* Subject has a significant psychiatric disorder
A Phase I, Open-label Study of Absorption, Metabolism, and Excretion of Defactinib (VS-6063) in Healthy Male Subjects

This study assesses the mass balance recovery, pharmacokinetics, metabolite profile and metabolite identification of defactinib.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) 18.0 to 35.0 kg/m2
* History (Hx) regular bowel movements
* Creatinine clearance \>80 mL/min

Exclusion Criteria:

* Hx alcohol abuse in past 2 yrs
* Current smoker
* Systolic blood pressure (S) or diastolic blood pressure (DBP) above upper limit of reference range (age 40-44 \>90/140; age 45-65 \>90/150)
Contrast-Enhanced Ultrasound and Shear Wave Elastography for the Treatment of Lymphedema

The purpose of this research is to determine the preferred microbubble agent (Lumason®, Optison®, and Definity®) for lymphatic channel visualization by ultrasound. This research will also evaluate the utility of preoperative high-frequency B-mode ultrasound with contrast-enhanced ultrasound for presurgical planning, and ultrasound shear wave elastography for assessing treatment response at 6-month follow up.

Part 1 - Evaluate the uptake of microbubble agent (Lumason®, Optison®, and Definity®) for lymphatic visualization by ultrasound.

Part 2 - Combine preoperative high-frequency B-mode ultrasound with contrast-enhanced ultrasound to identify patent lymphatic channels for lymphaticovenous anastomosis presurgical planning. Evaluate the utility of ultrasound shear wave elastography for assessing treatment response at 6-month follow up.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral lymphedema in the upper extremity (ISL stage 2 or 3) secondary to breast cancer or breast cancer treatment.
* Patient qualifies for LVA surgery as determined by the plastic surgeons performing the surgery (Dr. Bill Tran or Dr. Vahe Fahradyan), and the patient consents to surgery.
* Patient must be able to come to the 6-month clinical follow-up appointment (Part 2 only).
* Patients must be able to understand the study procedures and comply with them for the entire length of the study.
* No contraception is necessary or required.

Exclusion Criteria:

* Pregnant or nursing women.
* Known or suspected hypersensitivity to microbubble contrast agent, perflutren, blood products, albumin, polyethylene glycol (PEG), or egg.31.
* Known or suspected cardiac shunts.
* Prior lymphedema surgery in the upper extremity.
* Tattoo or scar on either upper extremity.
* Current drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
* Inability or unwillingness of individual or legal guardian/representative to give written informed consent..
* Current or past participation within a specified timeframe in another clinical trial, as warranted by the administration of this intervention.
Safety, Tolerability and Pharmacodynamics of BIIX 1 XX in Healthy Young Male Volunteers

The objective of the present study is to obtain information about the safety and tolerability of BIIX 1 XX, to determine the pharmacologically active dose (range) by performing a methacholine challenge test and to obtain preliminary pharmacokinetic data


Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteers who have Broca-Indices within +-20%
* Participants in the age range between 21 to 50 years
* Following the methacholine challenge the airway resistance (Raw) shows an increase of at least 130%
* In accordance with Good Clinical Practice (GCP) and local legislation each volunteer is supposed to give his written informed consent prior to admission to the study
* As part of the screening (within 14 days before drug administration), each subject was to receive a complete medical examination (including blood pressure, pulse rate, medical history, documentation of demographics, inclusion/exclusion criteria and concomitant therapy) as well as a 12-lead Electrocardiogram (ECG)
* Haematopoietic, hepatic and renal function test will be carried out in the laboratory
* The subjects will fast for 12 hours before collection of specimens for all laboratory evaluations. The above mentioned examinations will be performed within 14 days before the first administration of the test substance

Exclusion Criteria:

* Volunteers will be excluded from the study if the results of the medical examination or laboratory tests are judged by the clinical investigator to differ significantly from normal clinical values
* Volunteers with known gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Volunteers with diseases of the central nervous system (such as epilepsy) or with psychiatric disorders
* History of orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of allergy/hypersensitivity (including drug allergy) which is deemed relevant to the trial as judged by the investigator
* Intake of a drug with a long half-life (\>= 24 hours) within one month before enrolment in the study
* Use of any drugs which might influence the results of the trial the week previous to the start of the study
* Participation in another study with an investigational drug within the last two months preceding this study
* Smoker (\> 10 cigarettes or 3 cigars or 3 pipes/day)
* Inability to refrain from smoking on study days
* Alcohol abuse (\> 60g/day)
* Drug abuse
* Blood donation within the last 4 weeks
* Excessive physical activities within the last week before the study
Role of Allopurinol on Oxidative Stress and Mitochondrial Alterations in Skeletal Muscle of Diabetic Patients

Our recent data in mice have demonstrated a key role of xanthine oxidase in hyperglycemia-induced by Reactive oxygen species production, and a preventive role of allopurinol (inhibitor of xanthine oxidase) on the keeping of mitochondria number and structure, in skeletal muscle of diabetic mice. The investigators want to initiate a clinical trial in order to evaluate the efficacy of allopurinol on the improvement of mitochondrial alterations, oxidative capacities and insulin sensitivity, in skeletal muscle of type 2 diabetic patients.


Eligibility Criteria:
Inclusion Criteria:

* BMI from 25 to 40 kg/m²
* Type 2 diabetes known for over one year but less than 10 years, treated with Oral anti-diabetic drugs or a Glucagon-like peptide-1 (GLP1-analog)
* well controlled hypertension (untreated or currently treated) with a systolic blood pressure of 95 to 140 mmHg and diastolic blood pressure of 45 to 90 mmHg and heart frequency of 40 to 100 per minute
* Recent HbA1c \< 9 %
* Uricemia \> 300 µmol/l
* For women : Menopausal or contraception
* Renal function as defined by glomerular filtration rate (GFR) ≥ 80 mL/min/1.73 m2

Exclusion Criteria:

* Tobacco ( more than 5 cigarettes)
* Excessive drinking
* Known pathology
* Hypersensitivity to allopurinol
* Treatment by anticoagulants, allopurinol, regular steroids or Nonsteroidal anti-inflammatory drug (NSAID), fibrate or insulin