cyrilzakka/clinical-trials huggingface dataset:
Exercise Study in Subjects With NAFLD

Non-Alcoholic Fatty Liver Disease is the most common cause of chronic liver diseases. The benign non-alcoholic fatty liver, characterized by excessive fat accumulation, can evolve into non-alcoholic steatohepatitis and liver cancer.

The recommendation nowadays is a lifestyle change with physical exercise and diet to reduce liver fat and improve inflammation. Besides this, a leaky gut and dysbiosis have an impact on the liver, and exercise ameliorates the diversity of gut microbiota and permeability of the intestine.

The aim of this study is to find out a link between exercise and the gut-liver axis regarding the stage of liver adiposity and define exercise-responsive gut microbiome in NAFLD patients

For this 12-week randomised controlled intervention 60 subjects between 18 and 70 years old, diagnosed with NAFLD and body mass index under 35 kg/m2 will be recruited. They will be randomly assigned in a high-intensity aerobic interval training (n=30) and a control group with a sedentary lifestyle (n=30). The intervention group follows a supervised high-intensity aerobic interval training two times per week and additionally, an individualised home workout program to have 3 hours of aerobic training per week. Blood samples, adipose tissue biopsy, 24h-urine and faecal samples will be collected at the baseline, midway (only stool) and at the end of the study. Dietary intake will be analysed at weeks 0, 6, 12.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed NAFLD
* BMI:25 - 35 kg/m\^2

Exclusion Criteria:

* acute illness or current evidence of acute or chronic inflammatory or infective diseases
* liver disease (e.g. Wilsons disease/alpha-1-antitrypsin deficiency, Hepatitis B and C, hemochromatosis)
* bleeding disorder, anticoagulation medication
* subjects with diagnosed type 1 diabetes or diagnosed type 2 diabetes with insulin or Glucagon-like peptide-1 agonist treatment
* diagnosed depression and mental illness
* any condition preventing physical activity
* smokers
* alcohol abuse (daily consumption ≥ 30 g for men and ≥ 20 g for women)
A Randomised Open-label Phase III Trial of REduced Frequency Pembrolizumab immuNothErapy for First-line Treatment of Patients With Advanced Non-small Cell Lung Cancer (NSCLC)

REFINE-lung will test whether reduced pembrolizumab dose frequency after 6 months of standard treatment is safe and effective. Patients treated with 1st line pembrolizumab who are progression free and otherwise planning to continue therapy at 6 months will be initially randomised to control 6 weekly versus interventional 12 weekly therapy. If an interim analysis shows that the 12 weekly treatment is no less effective, subsequent patients will also be randomised to 9, 15 and 18 weekly treatment frequency arms. Patients who progress on a reduced frequency arm will be offered re-escalation to standard 6 weekly therapy.

Immunotherapy with pembrolizumab targeting the T cell inhibitory PD-1 receptor has significantly improved outcomes in advanced non-small cell lung cancer (NSCLC). Approximately 3600 new patients are treated in the 1st line setting per year in England alone and up to 25% remain on 6 weekly pembrolizumab for 2 years. However, pharmacological and clinical trial data suggest current frequent dosing for 2 years result in overtreatment. Indeed, pembrolizumab remains bound to its target receptor for up to 100 days following a single dose and studies in multiple tumour types have found no relationship between dose and patient outcome. Moreover, anti-PD1 treated patients who respond but discontinue therapy either as planned after 2 years, or earlier because of toxicity, can either remain in remission and/or be sensitive to re-challenge with pembrolizumab.

REFINE-lung will test whether reduced pembrolizumab dose frequency (9, 12, 15, 18 weeks) after 6 months of standard treatment is safe and effective.

This UK study represents a unique opportunity to determine whether pembrolizumab dose frequency can be safely reduced in NSCLC, resulting in significant cost benefits to the NHS and globally, in addition to enhanced patient QoL associated with fewer hospital attendances and reduced toxicity.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent prior to initiation of any study procedures and willingness and ability to comply with the study schedule
* Any patient ≥18yrs who has received 6 months of pembrolizumab treatment with or without chemotherapy for advanced Non small cell lung cancer who is planned to continue immunotherapy treatment because of continued benefit.

Exclusion Criteria:

* Disease progression or not tolerating treatment at 6 months into therapy
* Clinician does not intend to continue immunotherapy
* Any patient with a synchronous primary cancer. This includes any new cancer diagnoses or relapse of previously treated cancer since starting pembrolizumab treatment.
* Any patient currently receiving an investigational agent and/or using an investigational device or has participated in a study of an investigational agent and/or used an investigational device within 28 days of randomisation.
Alfacalcidol Supplementation on Levator Ani Muscle Strength of Menopausal Pelvic Organ Prolapse Patients

This is a study performed to evaluate the role of vitamin D supplementation on the strength of levator ani muscle in menopausal women with pelvic organ prolapse

Forty eight POP women were divided into experimental and control groups in this quasi-experimental study. The experimental group was given 0.5 mcg alfacalcidol orally for three months. We measured levator ani muscle strength, serum 25-hydroxy-vitamin D3 levels, and serum Vitamin D Receptor (VDR) levels at zero months and three months preoperative. Enzyme-linked immunosorbent assay (ELISA) assessed VDR and myoblast determination protein 1 (MyoD) protein expressions in levator ani muscle surgical biopsies.

Eligibility Criteria:
Inclusion Criteria:

* patients with pelvic organ prolapse stages III and IV who underwent surgery at menopausal age
* normal BMI
* initial serum vitamin D levels \<30 ng/mL

Exclusion Criteria:

* comorbidities (chronic cough, conspitation)
* vitamin D metabolism or immune system interfering diseases or drugs specific routine medications such as anticonvulsants, statin, fibrate or orlistat
* history of vitamin D supplementation within the last month
Evaluate Mesothelin as a Biomarker for the Clinical Management of Esophageal Adenocarcinoma (EAC)

The purpose of this study is to find out whether a protein, called mesothelin, found in the blood and tissue can be used as "marker" for esophageal cancer. Doctors at Memorial Sloan-Kettering Cancer Center would like to compare levels of this protein in patients with abnormal cells or tissue of the esophageal to the levels of this protein in patients being treated for cancer for the esophagus.


Eligibility Criteria:
Inclusion Criteria:

* Patients with T1 adenocarcinoma or suspected adenocarcinoma who are scheduled for a biopsy and mucosal resection (Group 1)
* Patients with a T1-2N0 adenocarcinoma or suspected adenocarcinoma who are scheduled to undergo and esophagectomy (Group 2)
* Patients with T2N1 and T3N0-1 adenocarcinoma or suspected adenocarcinoma who are scheduled to undergo endoscopy and biopsy and/or endoscopic ultrasound and biopsy prior to pre-operative chemo-radiotherapy and have baseline and surgical tissue available for staining (Group 3)

Exclusion Criteria:

* Patients \<18 years of age
* Patients unfit medically for endoscopy surveillance and therapy
* Patients unfit medically for esophagectomy
* Patients with stage IV esophageal adenocarcinoma
* Patients previously treated with chemo-radiotherapy for their esophageal cancer
* Patients with squamous cell carcinoma of the esophagus
* Patients who have a history of cancer within 3 years or have a concurrent cancer.
Efficacy of Cognitive Bias Modification in Residential Treatment for Addiction

The purpose of this study is to determine whether computer bias modification for interpretation bias (CBM-I) is effective in the reduction of suicidal ideation in substance use disorders.

Eighty-eight adult inpatients completing residential treatment in the Addictions Services at the Centre for Addiction and Mental Health (CAMH) will be randomized to receive CBM-I daily for one week, adjunct to the residential psychosocial treatment or to an assessment-only control condition. Participants will complete clinical measures consisting of interviews and questionnaires measuring suicidal ideation, hopelessness, depression, negative affect, and interpretation biases before, during and after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Exhibit moderate suicide risk or greater
* Be enrolled in the Addictions Services inpatient program
* Fluent in reading English
* Capacity to give informed consent

Exclusion Criteria:

* A lifetime diagnosis of a psychotic or bipolar disorder
* Significant neurological disorder or psychical illness likely to interfere with participation
* Psychotropic medication changes within the past two weeks
PMMA vs Polysulfone in SARS-CoV-2 Infection Hemodialysis Patients

Controlled, prospective, open-label trial with a total duration of 2 weeks to assess the clearance of inflammatory interleukins by different membranes in haemodialysis patients with COVID-19.

Controlled, prospective, open-label trial with a total duration of 2 weeks to assess the clearance of inflammatory interleukins by different membranes in haemodialysis patients with COVID-19.

Patients will be dialysed according to the usual dialysis schedule of three weekly sessions. The study has a duration of 8 days in order to include 4 haemodialysis sessions. The first and third haemodialysis sessions will be dialysed with PS membrane and the second and fourth sessions with PMMA membrane, both dialysers with a surface area of 1.8 m2.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years .
* Patient on chronic haemodialysis admitted to the hospital with a diagnosis of infection by COVID-19.
* Signature of informed consent or legal representative.
* Estimated duration of admission greater than 8 days (4 haemodialysis sessions).
* Patient with haemodynamic stability, understood as systolic blood pressure ≥ 100 mmHg.

Exclusion Criteria:

* Refusal to sign the consent form.
* Patients who for clinical reasons are unable to follow a regular dialysis schedule of three sessions per week.
* Allergy (documented or suspected) to either of the two membranes involved in the study.
* Patient with haemodynamic instability (Mean arterial pressure \< 100 mmHg).
The Effect Of Smartphone Addiction On Trunk Muscles Performance In Adolescents

Statement of the problem:

Does overuse of the smartphones affect trunk muscles performance in normal adolescents it will be assumed that There will be no affection of smartphone addiction on trunk muscles performance in normal adolescents

* Subjects:

  - Sixty - six normal healthy adolescent from both genders will be recruited for the study from high school students and first year university students, they will be divided according to their smart phone addiction scale short version (SAS-SV) scores into two groups: Group (A): smartphone addicts (consists of 33 participants) Group (B): smartphone non- addicts (consists of 33 participants)
* Inclusion criteria

  * Age ranges from 14 to 18 years
  * Have Body Mass Index (BMI) = 5th percentile to less than the 85th percentile 2. Exclusion criteria

Subjects will be excluded from the study if he/she has:

* visual or hearing defects
* overweight or obese
* neurological disorder
* marked musculoskeletal problem

Eligibility Criteria:
Inclusion Criteria:

* Age ranges from 14 to 18 years
* Have Body Mass Index (BMI) = 5th percentile to less than the 85th percentile

Exclusion Criteria:

* Subjects will be excluded from the study if he/she has:
* visual or hearing defects
* overweight or obese
* neurological disorder
* marked musculoskeletal problem
Improving Blood Lipid Management in Symptomatic Intracranial Atherosclerotic Stenosis on Clinical Outcome

sICASBLM is a prospective controlled trial, to asses the impact of improving blood lipid management on clinical outcome of moderate to severe symptomatic intracranial atherosclerotic stenosis patients (LDL-C\>1.8mmol/L) without endovascular therapy.

sICASBLM aims to determine the effectiveness of conventional lipid management combined with PCSK9 inhibitors compared to conventional lipid management (atorvastatin 20-40mg or rosuvastatin 10-20mg or simvastatin 20-40mg) in reducing the incidence of recurrent stroke in patients with moderate to severe symptomatic intracranial atherosclerotic stenosis (LDL-C\>1.8mmol/L) without endovascular therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Symptomatic intracranial atherosclerotic stenosis of moderate to severe, did not receive intravenous thrombolysis, thrombectomy, stent implantation and other intravascular treatment
3. low density lipoprotein cholesterol \> 70mg/dl (1.8mmol/L)
4. Receive 3T magnetic resonance angiography or multi-mode MR (high resolution is required), angiography can be included, and images for analysis can be obtained.
5. Lipid-lowering indications of statins
6. Signed an approved informed consents

Exclusion Criteria:

1. Contraindications to statins
2. There are contraindications to MRI examination or cannot accept MRI examination
3. Stenosis caused by vasculitis, arterial dissection and moyamoya disease
4. Patients with active bleeding or obvious bleeding tendency
5. Severe heart, lung, renal insufficiency, malignant tumor or other malignant diseases, and death is highly likely within 7 days; pregnancy or women who are lactating
6. Uncontrolled severe diabetes and hypertension
7. Other conditions inappropriate for inclusion judged by investigators
Lentiviral-mediated Gene Therapy of Fanconi Anemia Patients Subtype A

This is an open, Phase I / II clinical trial to evaluate the safety and efficacy of a hematopoietic gene therapy procedure with an orphan drug consisting of a lentiviral vector carrying the FANCA gene for patients with Fanconi Anemia of Subtype A .

CD34 + cells derived from bone marrow and / or mobilized peripheral blood (fresh and / or cryopreserved) from patients with Fanconi subtype A (FA-A), will be transduced ex vivo with a lentiviral vector carrying the gene FANCA (orphan drug) . After transduction the cells will be inoculated in patients in order to restore their hematopoiesis with genetically corrected stem cells.

The main objective of this open-label Phase I / II clinical trial is to evaluate the safety and therapeutic efficacy of a hematopoietic gene therapy procedure with an orphan drug consisting of a lentiviral vector carrying the FANCA gene for patients with Fanconi's Anemia Subtype A.

The drug to be administered to the patients consists of the cellular product resulting from the transduction of autologous CD34 + cells with the therapeutic lentiviral vector PGK-FANCA.Wpre \*.

The dose of cells to infuse in the patients will be that obtained from the transduction process of between 3x10\^5 and 4x10\^6 CD34 + cells / kg of patient body weight.

The cells will be infused intravenously in a single dose, after complete the transduction process.

Follow-up period: 3 years after infusion of transduced cells. However, patients will be monitored outside the clinical trial over a 10-year period.

Follow-up of the grafted transduced cells will be performed on peripheral blood and bone marrow samples.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Fanconi Anemia complementation group A (FA-A)
* Minimum age 1 year
* Maximum age 21 years
* Lansky Index\> 60%.
* Informed consent in accordance with current legal regulations.
* Number of cells to be transduced: At least 3x10\^5 purified CD34+ / kg body weight.
* Negative result in the urine pregnancy test at the baseline visit for women of childbearing age, who should be committed to using an effective contraceptive method during the period of study participation.

Exclusion Criteria:

* Patients with an human leukocyte antigen (HLA) identical family donor.
* Evidence of myelodysplastic syndrome or leukemia, or cytogenetic abnormalities predicting the same in bone marrow aspirates. In this case, the studies carried out two months in advance of the patient's entry into the clinical trial will be considered valid.
* Evidence that the patient to be infused has signs of somatic mosaicism, with hematologic improvement.
* Any illness or concomitant process that in the opinion of the investigator incapacitates the subject for their participation in the study.
* Pre-existing sensory or motor impairment\> = grade 2 according to the National Cancer Institute (NCl) criteria.
* Pregnant or lactating women.
Comparative Bioavailability Study of Eplerenone 50 mg Tablets Under Fed Conditions

The purpose of this study is to demonstrate the relative bioequivalence of Eplerenone 50 mg Tablets Under Fed Conditions.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening.

Exclusion Criteria:

* Positive test results for HIV or hepatitis B or C.
* Treatment for drug or alcohol dependence.
Marginal Periosteal Pedicle Flap - Platelet Rich Fibrin Barriers in Treating Periodontal Intrabony Defects

The use of autogenous graft materials has been recorded to be a gold standard in regenerative therapy. This study directed toward evaluation of two autogenous regenerative materials, marginal periosteal pedicle graft (MPP) and platelet rich fibrin (PRF) as membrane barriers for treating intrabony defects. In spite of its reported significant clinical outcomes, the limited availability of the periosteum makes it necessary to evaluate other autogenous alternatives such as PRF that could offer predictable outcomes.

Material and methods: 10 patients with sever chronic periodontitis and at least single ≥4 mm intrabony defect had participated in this randomized clinical study. Subjects were randomly divided into2 groups, Group 1(MPP) defect coverage with xenograft defect fill(10 patients),Group 2(PRF) defect coverage with xenograft defect fill(10 patients).Clinical and radiographic measurements were carried out at 3,6 and 9 months postoperatively.

Eligibility Criteria:
Inclusion Criteria:

* No systemic diseases that could influence the outcome of therapy
* Good compliance for plaque control instructions after initial therapy
* Vital teeth
* Had contralateral matched pair of 2- or 3-walled intrabony interproximal defects in premolar or molar teeth
* Probing pocket depth (PPD)≥6 mm and clinical attachment level (CAL) ≥4mm 6) selected 2- or 3-wall intrabony defect depth ≥ 3 mm as detected in diagnostic periapical radiographs,

Exclusion Criteria:

* Pregnant females and patients presented with opened interproximal contact
The Individual and Family Self Management Theory Based Epilepsy Education Program's Effectiveness

The aim of the study; to determine the effect of education program given to adolescents diagnosed with epilepsy and their parents based on Ryan and Sawin's individual and family self-management theory, on adolescents 'attitudes towards disease, self-efficacy, quality of life and parents' nurse-parent support levels.

In addition to the expected effects of epilepsy on children, the course of the disease and the course of the child's life will change as the duration of life with the disease increases. In epilepsy, it is necessary to develop self-management behaviors in order to facilitate adaptation to the disease, to encourage seizure control and to increase the quality of life. Regular repetition of the trainings created within the framework of a certain plan to improve self-management behaviors is one of the recommended steps to strengthen the individual with chronic disease in the disease process. This randomized controlled study including aged 12-18 adolescents with a diagnosis of epilepsy, monotherapy, mental retardation without cerebral palsy, and no secondary disease and their parents. However, there isn't enough published research examining the effect of education program given to adolescents diagnosed with epilepsy and their parents based on Ryan and Sawin's individual and family self-management theory, on adolescents 'attitudes towards disease, self-efficacy, quality of life and parents' nurse-parent support levels.

Eligibility Criteria:
Inclusion Criteria:

* Having a diagnosis of epilepsy for at least 6 months,
* Being in the age range of 12-18 years,
* Cerebral palsy, attention deficit, lack of mental retardation, except for a different physical or epilepsy,
* Receiving monotherapy treatment for epilepsy
* To be able to communicate in Turkish

Exclusion Criteria:

* Cerebral palsy, attention deficit, mental retardation other than epilepsy,
* Patients who are over the age of 18 or who switch to an adult care program,
* Not being open to communication and cooperation, not taking polytherapy
* Adolescents not continuing the monitoring phase or wanting to stop working at any stage,
* Prior history of seizures due to screen exposure
Efficacy of Anisodamine Hydrobromide Combined With Low-molecular-weight Heparin in the Treatment of Patients With Sepsis

The study aimed to investigate the effectiveness of anisodamine hydrobromide combined with heparin in the treatment of patients with critical infection, in the hope that the therapy will provide alternatives to the treatment of patients with critical infection.

Objective: The study aimed to investigate the effectiveness of anisodamine hydrobromide combined with heparin in the treatment of patients with critical infection, in the hope that the therapy will provide alternatives to the treatment of patients with critical infection.

Methods: The study is a multi-center randomized controlled clinical trial. Study population will include critically infected patients requiring vasopressor use. The critically infected patients will be randomly assigned to four groups in a ratio of 1:1. The groups will consist of the conventional treatment group and the anisodamine hydrobromide combined with heparin treatment group.

Interim analysis will be performed. The primary study end point is 28-day mortality, and other secondary study endpoint is lactate clearance rate. The investigators will appropriately use chi-square test, student t test or rank sum test to compare the differences between the experimental groups and the control group.

Discussion: The treatment of anisodamine hydrobromide combined with heparin will be better than the conventional treatment. The study will provide new insight into the treatment of patients with critical infection and can help to reduce mortality rate of critically infected patients.

Eligibility Criteria:
Inclusion criteria:

1. Age greater than 18 years;
2. Meets the diagnostic criteria for sepsis according to the "Sepsis-3" ;
3. Patient or their legal representative consents to treatment and signs an informed consent form.

Exclusion criteria:

1. Patients expected to die within 24 hours after enrollment;
2. Contraindications to low molecular weight heparin and scopolamine butylbromide drugs;
3. Patients with thrombotic diseases requiring treatment with low molecular weight heparin;
4. Patients with terminal-stage malignancies, severe immunodeficiency, immunosuppression, severe liver or kidney dysfunction (defined as liver or kidney SOFA score ≥ 3 points), etc.;
5. Pregnant and lactating women;
6. Patients participating in other clinical trials.