cyrilzakka/clinical-trials huggingface dataset:
Effect of Mediterranean Diet in Obese Adolescents With Nonalcoholic Fatty Liver Disease

The aim of this study was to evaluate the effects of mediterranean and low-fat diet on hepatic fat, inflammation markers and oxidative stress in adolescents with nonalcoholic fatty liver disease. This randomized, single-blind controlled study conducted with obese adolescents aged 11-18 years who were admitted to Tepecik Training and Research Hospital Pediatric Gastroenterology Outpatient Clinic with the diagnosis of nonalcoholic fatty liver disease. Participants were randomly assigned to the Mediterranean diet or low-fat diet group.

This study was conducted to evaluate the effect of Mediterranean and low-fat diet on hepatic fat, inflammation and oxidative stress in obese adolescents with nonalcoholic fatty liver disease (NAFLD). The study, which was designed as a single blind randomized control, was completed with 44 obese adolescents diagnosed with NAFLD between the ages of 11-18. Adolescents were randomized to either a Mediterranean diet (n = 22) or a low-fat diet (control diet) (n = 22) for 12 weeks. At the beginning of the study and at the 12th week, adolescents' blood samples, physical activity and food consumption records were taken, anthropometric measurements and body composition analyzes were made, and antioxidant food consumption frequency and Mediterranean diet quality index questionnaire were applied to adolescents. In the controls performed at the 2th, 4th, 6th, 8th, and 10th weeks, the physical activity and food consumption records of the adolescents were repeated and anthropometric measurements and body composition analyzes were made again.

Eligibility Criteria:
Inclusion Criteria:

* Being between the ages of 11-18
* Being obese (BMI ≥95.persentil)
* Getting a diagnosis of Grade≥1 NAFLD

Exclusion Criteria:

* Existence of liver disease (wilson,hepatitis etc.) other than NAFLD
* Drinking alcohol
* Having a history of type 1 and type 2 diabetes
* Using drugs that can cause steatosis
* Using lipid-lowering drugs
* Using weight loss medications
* Having applied dietary therapy for any disease and weight loss
* Existence of a chronic inflammatory disease
* Existence of cancer
* Thyroid dysfunction (hyperthyroid and hypothyroidism)
* Existence of a history of hepatic virus infection
* Having a history of parenteral nutrition
* Being pregnant and breastfeeding
* Receiving antibiotic treatment within 3 months prior to the study
* Regularly consuming foods containing probiotic and prebiotic properties and / or using nutritional supplements
Effectiveness of Video Based Games on Upper Extremity Functions in Mild Mental Retardation Diagnosed Cases

With Leap Motion Controller, virtual reality exercises have been implemented more often since 2014, and this technology has benefited more from upper extremity rehabilitation In literature, there are no publications investigating the effectiveness of virtual reality applications on upper extremity functions in cases of mental retardation with Leap Motion.

We think that virtual reality applications with Leap Motion are effective in fine motor skills and grip strength in cases of mental retardation.

The purpose of our work; To Investigation of the Effectiveness of Video Based Games on Upper Extremity Functions in Mild Mental Retardation Diagnosed Cases

For the study group, in addition to fine motor skills activities, 20 min. Leap-Motion virtual reality games, and for the control group only fine motor skill activities will be applied. The study will last 8 weeks, 2 times a week for a total of 16 sessions.The games that Fizyosoft has built on Leap Motion equipment will be played individually and will focus on running hand, wrist and grip movements to improve hand and grip activities of the events. Each game is designed to develop a different hand movement. In this study, CatchaPet and LeapBall of Fizyosoft HandRom products will be used.

"LeapBall," aiming at throwing the ball in the same color as the ball, and Leap Motion sensor games, "CatchaPet," aimed at touching the rabbits out of the holes with repeated wrist flexion / extensional movements, will be preferred by grasping a virtual ball with the fingers of all fingers.

The demographic characteristics of all the cases participating in the study will be recorded.

JEBSON hand function test, Manual Ability Classification System (MACS), 9 Hole Peg Test to measure fine hand skill. JAMAR Hand Dynamometer to measure Hand Grip Force, Pinchmeter to measure finger grip strength. The evaluation will be repeated before and after the treatment.

Eligibility Criteria:
Inclusion Criteria:

* He / she has been diagnosed with mild mental retardation Being between 5 and 18 years of age Ability to adapt to exercises No epileptic epilepsy no cardiac or orthopedic disturbance

Exclusion Criteria:

* Being healthy Not be between 5-18 years
Prehabilitation in Esophageal Cancer Care

Prehabilitation utilizes the preoperative period to prevent or attenuate the treatment-related functional decline and its consequences. This project aims at testing feasibility and effectiveness of multimodal prehabilitation in esophageal cancer care.

While evidence on prehabilitation is mounting, upper gastrointestinal surgery still remains under-investigated. This trial aims to explore the effect of prehabilitation over the whole perioperative trajectory, including neo-adjuvant treatment (NAT).

Multimodal prehabilitation includes exercise, nutrition therapy, and mental distress coping strategies. In the context of a multimodal approach, the two groups follow different exercise prescriptions: high-intensity interval supervised training prescribed accordingly cardiopulmonary exercise testing (CPET)-derived variables, versus a home-based program. For both groups, multimodal prehabilitation is prescribed over the whole preoperative period, including during NAT.

Eligibility Criteria:
Inclusion Criteria:

* Patients with non-metastatic esophageal cancer undergoing neo-adjuvant chemotherapy and surgery.

Exclusion Criteria:

* co-morbid medical, physical and mental conditions that contraindicate exercise or oral nutrition
Effects of Bladder Voiding on Sleep Architecture in Infants

Sleep changes rapidly during the first year of life. Brain maturation is accompanied by sleep consolidation in several episode during day and night (daytime naps and night sleep) and progressive organization during the 24h period (more wake during day et more sleep during night). In the first months of life, sleep episodes are frequently interrupted by wake, possibly induced by multiple external and internal stimuli. One of this stimulus could be bladder voiding that is particularly frequent in babies. Only one team worked on the link between sleep and bladder voiding and reported that bladder voiding was associated with cortical arousal during a daytime nap in a little group of babies.

In this study, investigators propose to study the relationship between sleep and bladder voiding in a bigger group of infant and during daytime but also nighttime sleep.


Eligibility Criteria:
Inclusion Criteria:

* Infants of both sex
* Age ≥1 month and ≤ 12 months
* Referred to the sleep unit for sleep trouble screening following ALTE (Apparent Life Threatening Event).
* Patients should benefit from appropriate insurance system
* Parents who have expressed a willingness to participate in the study, who have signed and dated the informed consent.

Exclusion Criteria:

* Neurological, endocrinal or syndromic diseases :

  * Head and neck congenital malformations
  * Pierre Robin Syndrome
  * Trisomy
  * Achondroplasia
  * Prader Willy syndrome
  * Ondine syndrome
  * Cardiac diseases and malformations
* Weight \<2.5 kg
* Preterm babies (under 37 weeks of gestational age)
A Randomized Controlled Study of Medical-education-community Collaborated Intervention in Children With ADHD

This study is designed to test if the medical-education-community collaborated intervention can reduce the symptoms of children with Attention deficit hyperactivity disorder (ADHD) compared to routine clinical care. Investigators will also evaluate if the intervention will positively affect organizational skills and academic achievement compared to controls.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with ADHD
* Doctor rated SNAP-IV Inattention of Hyperactivity/Impulsivity score\>12
* Full-Scale Intelligence Quotient\>=80 (Wechsler intelligence scale for children-IV)

Exclusion Criteria:

* Accepting any type of psychological treatment during the intervention
* Comorbid with epileptic disorder or other existing physical disorder, Tourette syndrome, Autism Spectrum Disorder, learning disorder, mood disorder, psychiatric disorder, or under suicidal risk
* Attending any other clinical research at the same time
Comparison of the Effectiveness of Spinal Stabilization Exercises and Chiropractic Spinal Manipulation

It is the study of the effectiveness of spinal stabilization exercises and chiropractic spinal manipulation in healthy individuals.

In addition, it was planned to investigate the effects of spinal stabilization exercises and manipulation on muscle strength, muscular endurance, balance and proprioception, depression and quality of life.

It is the study of the effectiveness of spinal stabilization exercises and chiropractic spinal manipulation in healthy individuals.

In addition, it was planned to investigate the effects of spinal stabilization exercises and manipulation on muscle strength, muscular endurance, balance and proprioception, depression and quality of life.

Eighty healthy individuals between the ages of 18-45 who voluntarily participated in the study from students or academic/administrative staff at Gümüşhane University were included in the study. The study program was explained to the participants in line with the Informed Consent Form. It was included in the study after the relevant form was signed by the participant.

Healthy individuals to participate in the study will be randomly divided into 4 groups; randomization will be done by "Research Randomizer" computer program. Group 1 Stabilization group (n = 20), Group 2 Manipulation group (n = 20), Group 3 Stabilization and Manipulation group (n = 20), Group 4 Control group (n = 20). Group 1 will be given stabilization exercises for a total of 18 sessions, 3 times a week for 6 weeks, each session for 45 minutes. Group 2 will be applied high-speed low-amplitude (HVLA) chiropractic manipulation for a total of 6 sessions, once a week for 6 weeks. Group 3 will be given both stabilization exercises and manipulation exercises. The fourth group will be followed as a control group and no application will be made. Prone plunk, side plunk and sorenson tests for muscular endurance in the individuals participating in the study; Quadriceps muscle strength for muscle strength assessment; Joint position sense for propioception; Y balance test for balance; Short Form-36 (SF-36) for quality of life; Beck Depression Inventory was planned to be evaluated before, after and 1 months for psychosomatic evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer individuals (Female and Male),
* Between the ages of 18-45,
* No pain, trauma or surgery history in the last 6 months,
* Without any chronic disease (Obesity, Diabetes, Hypertension, Osteoporosis),
* Individuals who had not received any treatment for spinal problems before were included in the study.

Exclusion Criteria:

* Conditions where chiropractic spinal manipulation is contraindicated (Inflammation, infection, malignancy, blood coagulation disorder, etc.)
* Any injury during the working process,
* Individuals who did not attend the work program regularly were not included in the study.
Comparing the Effect of Vaginal Misoprostol With Dinoprostone in Term Pregnancies

Hypothesis (H0): Labor duration and obstetric complications are not significantly different in the three groups (misoprostol-dinoprostone-oxytocin).


Eligibility Criteria:
Inclusion Criteria:

* Term pregnancy
* Singleton
* Vertex
* Bishop score below 6

Exclusion Criteria:

* History of drug reaction
* Medical disease
* IUGR
* Oligohydramnios
* Vaginal bleeding
* Fetal anomaly
* Uterine scar
Adjuvant Hyperthermic Intraperitoneal Chemotherapy (HIPEC) Versus no HIPEC in Locally Advanced Colorectal Cancer (APEC Study)

This study is designed to evaluate the efficacy and safety of adjuvant hyperthermic intraperitoneal chemotherapy (HIPEC) with raltitrexed or oxaliplatin versus no HIPEC in locally advanced colorectal cancer

Peritoneum is one of the common sites of metastasis in advanced stage colorectal cancer patients, resulting in a poor prognosis. Hyperthermic intraperitoneal chemotherapy (HIPEC) is effective to colorectal peritoneal metastasis and may play a significant role in reducing the risk of metachronous peritoneal metastasis among patients with locally advanced colorectal cancer. Oxaliplatin is routinely used for HIPEC in the Europe and Raltitrexed may be another ideal drug for HIPEC. The present phase II multicenter, randomized controlled trial is designed to evaluate the efficacy and safety of adjuvant HIPEC with raltitrexed or oxaliplatin versus no HIPEC in locally advanced colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Joined the study voluntarily and signed informed consent form
* Eastern Cooperative Oncology Group performance status of 0 to 1
* Life expectancy of more than 5 years
* Colorectal adenocarcinoma / mucinous adenocarcinoma / signet ring cell cancer confirmed by histopathology
* Stage T4NanyM0 cancer; or stage T3NanyM0 mucinous adenocarcinoma / signet ring cell cancer / adenocarcinoma with partly mucinous adenocarcinoma or signet ring cell cancer
* R0 resection of colorectal cancer
* Neutrophils (ANC) ≥ 1.5×10\^9/L, Platelet count (Pt) ≥ 100× 10\^9/L, Hemoglobin (Hb) ≥ 80 g/L, Hepatic function: ALT and AST ≤ 2.5 times upper limit of normal (ULN) and TBIL ≤ 1.5 times ULN, Renal function: creatinine ≤ 1.5 times ULN
* Use of an effective contraceptive for adults to prevent pregnancy

Exclusion Criteria:

* Rectal cancer below peritoneal reflection (≤ 8cm above the anal verge)
* Other malignant tumors within the past 5 years, except for skin basal cell carcinoma, or cervical carcinoma in situ, who survived from radical treatment
* Severe adhesion of peritoneal cavity impossible to separate
* Abdominal infection
* Allergic to raltitrexed, 5-FU, and oxaliplatin; Dihydropyrimidine dehydrogenase (DPD) enzyme deficiency
* Uncontrolled seizures or psychiatric diseases, loss of control over their own behavior
* Drug addiction, Alcoholism or AIDS
* Impossible to tolerate the operation due to severe cardiac, lung, and vascular diseases
* Pregnant or breast-feeding women or people during the birth-period who refused to take contraceptives
Glue Embolization vs Conservative Treatment for Pelvic Congestion Syndrome

The aim of this study is to compare glue embolization and conservative treatment for pelvic congestion syndrome regarding safety and efficacy.

Pelvic congestion syndrome (PCS) is a common cause of chronic lower abdominal/pelvic pain, estimated to affect about 40 % of women, predominantly between the ages of 30 and 45.The treatment of PCS depends mainly on the severity of the pain. Non-steroid anti-inflammatory drugs are often used, and contraceptives have a role in cases of pain associated predominantly with menstruation.

Traditionally, conservative approaches, such as pharmacotherapy with venoactive drugs like micronized purified flavonoid fraction (Daflon), have been utilized to address the symptoms of PCS. Daflon has been used to treat venous insufficiency and has demonstrated efficacy in reducing symptoms and improving the quality of life in patients with PCS. Its mechanism of action includes improving venous tone, reducing venous stasis, and exerting anti-inflammatory effects. Endovascular treatment of PCS is challenging and requires occlusion of incompetent pelvic veins.

Eligibility Criteria:
Inclusion Criteria:

* Women aged from 30 to 50 years.
* Complaining from pelvic congestion syndrome.

Exclusion Criteria:

* Pregnant women at any gestational age, women who gave birth less than 12 months ago, and breastfeeding mothers.
* Patients who are treated with opiates to reduce pelvic pain in the period before the study.
* Patient with history of contrast allergy
* Patient with renal impairment
* Patient has alternative gynecological cause of chronic pelvic pain as pelvic inflammatory disease (PID), endometriosis, fibroid, adenomyosis, ovarian cyst
* Patient underwent any previous intervention for pelvic congestion syndrome as laparoscopy or surgery.
Retrospective Study of Radio-induced Toxicities in the Treatment of Lung Cancer With Tomotherapy

Lung cancers treated by Tomotherapy represent between 60 and 100 patients per year at the CHR of Metz-Thionville. Some patients were observed to present acute toxicities during treatment such as dysphagia or esophagitis of CTCAE grade \> 2. Beyond well known therapeutic and comorbidities factors, the pathophysiology of these events is largely ruled by a constitutional factor - the enzymatic equipment allowing more or less good repair of the DNA lesions induced by radiotherapy (RT). This equipment is characteristic of each individual, hence the term individual radiosensitivity (IR).The scientific literature is rather poor in data describing the frequency of these toxicities in patients receiving RT for lung cancer.

The objective of this study is to describe the frequency of acute and late toxicities after normofractionated radiotherapy of 66 Gy in 33 fractions in patients with small cell or non-small cell lung cancer, stage 2 or 3.


Eligibility Criteria:
Inclusion Criteria:

* stage II-III non-small cell or small cell lung cancer treated with normo-fractionated radiotherapy of 66Gy in 33 fractions using Tomotherapy

Exclusion Criteria:

* patient who refused to be included in the study.
Pain Expression in the Perioperative Period of Cataract Surgery

Patients having cataract extraction in the second eye under topical anesthesia with monitored anesthesia care often report increased pain and awareness relative to the first surgery in the fellow eye, despite similar operative and anesthetic conditions. The purpose of this study is to investigate the pathogenesis of this phenomenon.


Eligibility Criteria:
Inclusion Criteria:

* Age-related cataract patients aged 50 years or older able to give informed consent undergoing cataract surgery;
* Pupil dilation ≧7 mm after mydrisis;
* VA prognosis ≧6/12

Exclusion Criteria:

* Unable to give informed consent;
* Patients with history of ocular pathology or diabetic retinopathy;
* Patients with traumatic, subluxated and posterior polar cataract;
* Patients had other ocular surgery (not cataract surgery) in the past 6 months;
* Patients with significant intra-operative complications
Immune Response followingTdap Vaccine in Pregnancy

Pregnancy involves changes in immune response. The investigators aim to evaluate the immune response to Tdap in pregnancy in comparison to non pregnant women usig proteomics and gene sequencing.

Many vaccine-preventable diseases, like influenza, pertussis, and tetanus cause substantial morbidity and mortality in pregnant women, newborns and infants. Immunization during pregnancy has the potential to provide protection to the newborn and infant by the transplacental transfer of vaccine-specific maternal antibodies. However, the immunobiology underlying immunization during pregnancy, that leads to the protection of the newborn are not understood. Current vaccine formulations were designed for and tested in non-pregnant populations; yet substantial immune modulations take place during different stages of pregnancy and potentially can impact the humoral response following maternal immunization. The investigators thus have insufficient data on quantity and quality of the immune response during pregnancy and how this relates to immunity provided from the mother to the newborn. First, The investigators hypothesize that the nature and breadth of the humoral immune response following vaccination differs in pregnant and non-pregnant vaccinees. Next, The investigators hypothesize that the vaccine-specific antibodies that cross the placenta, comprise distinct repertoire features thus, the placenta functions as a differential barrier for antibody transfer. To test these hypotheses, The investigators will use proteomic and genomic/transcriptomic measurements of antibody repertoires in the maternal and cord blood compartments. The measurements will be based on antibody clonal diversity/frequency, V(D)J germline usage and SHM, where we expect to find changes in i) vaccine-specific B cell frequency, antibody clonal diversity, germline usage and SHM in pregnant women and ii) distinct repertoire features in the transplacental vaccine-specific antibody compartment compared the maternal compartment. The investigators will utilize deep sequencing and proteomic technologies to provide, for the first time, insight into the immunobiology of a promising intervention aimed to prevent early life infectious morbidity and mortality and establish new research avenues for vaccine research in vulnerable populations.

Eligibility Criteria:
Inclusion Criteria for pregnant women (cohort 1):

* age between 18-45 years
* pregnant women who expected to have Tdap vaccine
* Informed Consent Form signature

Inclusion Criteria for non pregnant women (cohort 2):

* age between 18-45 years
* non pregnant women who expected to have Tdap vaccine
* Informed Consent Form signature

Exclusion Criteria (cohort 1 and 2):

* any background immune diseases- autoimmune conditions or cancer.
* women who take immunosuppressive/ immunomodulatory medications
* a patient has received Tdap vaccine in 6 months prior to study entry.
* no will to signed the Informed Consent Form.
Preoperative Pain Neuroscience Education in Patients With Carpal Tunnel Syndrome

Study Design: A double-blind randomized controlled study.

Background: Patients operated on for carpal tunnel release surgery may persist with pain after surgery, which could be modulated by psychosocial factors such as depression, catastrophic thinking and kinesiophobia.

Objectives: To evaluate the efficacy of a preoperative session in pain neuroscience education combined with postoperative therapeutic exercise in the perception of pain, functionality and psychosocial variables in patients following carpal tunnel release.

Methods: Thirty participants were randomly assigned to the pain neuroscience education group combined with postoperative therapeutic exercise (n = 15) or to the control group with preoperative usual care combined with postoperative therapeutic exercise (n = 15). Evaluations included the Visual Analogue Scale (VAS), Disability of Arm, Shoulder, and Hand Questionnaire (QuickDASH), pain Catastrophizing Scale (PCS), Tampa scale of kinesiophobia (TSK-11) and Hospital Anxiety and Depression Scale (HADS) . A basal, fourth and twelfth week measurement was made.


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years of age
* Medical diagnosis of Carpal Tunnel Syndrome waiting for surgery
* Agree to participate in the study.

Exclusion Criteria:

* Inability to understand instructions,
* Illiteracy,
* Previous participation in educational programs regarding pain,
* Pathology of uncontrolled mental health,
* Cognitive problems,
* Previous surgeries in the operated extremity.