cyrilzakka/clinical-trials huggingface dataset:
Therapeutic Play in Children With Mild Intellectual Disability

The aim of this study is to determine the effectiveness of a designed therapeutic play activities program on improving motor adaptive behavior in a sample of Egyptian children with mild intellectual disabilities. The main question it aims to answer is:

What is the effect of therapeutic play activities in improving adaptive motor skills (fine-gap) of children with mild intellectual disability? A quasi-experimental design will be used as researchers will compare therapeutic play exercise program to standard treatment to find its effect on motor adaptive behavior in the selected sample of children with mild intellectual disability

Participants will:

Take play-based activity program for 24 sessions in 2 months Have a pre- and post-intervention evaluation of motor adaptive behavior by Vineleand Adaptive Behavior Scale II

The research sample consists of twenty children whose ages range between 5 and 9 years of children with mild intellectual disabilities, with intelligence coefficients ranging between 50 and 70 on the Stanford Binet Scale, 5th edition (SB-5). The sample will be divided into two groups: 10 children in the control group and 10 children in the experimental group.

Methods For Intervention Experimental group Therapeutic Play Activities program for children with mild intellectual disability The validation of the current research hypotheses required the preparation and design of a program of therapeutic play activities aimed at improving the adaptive motor skills of children with intellectual disabilities. The program consists of 24 sessions of play-based activities that will be applied in 2 months on a day-by-day basis. Therapeutic Play programs include activities that address core strength, bilateral coordination, motor skills, visual skills, body awareness, outdoor sensory activities, vestibular, and balance skills. Activities will be simulated for the child by the therapist to ensure the child understands them. All children will be evaluated by VABSII before and after implementation of the program.

Eligibility Criteria:
Inclusion Criteria:

The child should be between 5 and 9 years of age of both sexes

- The child should be of mild intellectual disabilities according to Stanford Binet scale 5th edition The child should not be suffering from any apparent physical deformity in upper limbs, lower limbs or spine The child should not suffer from any visual or auditory disorder

Exclusion Criteria:

Children out of age range Children with moderate or severe intellectual disabilities Children with physical deformities in upper limb, lower limb or spine Children suffering from visual or auditory disorders
A Human Trial to Evaluate the Efficacy and Safety of Fermented Turmeric in Subjects Showing Mild Hepatic Injury

The investigators performed a double-blind parallel study in a group of showing mild hepatic injury subjects who were given Fermented turmeric over a period of 12 weeks. The investigators measured liver function parameters , including ALT(Alanine Transaminase), AST(Aspartate Transaminase), ALP(Alkaline Phosphatase), γ-GT(Gamma-Glutamyl Transferase), and serum bilirubin, and monitored their blood pressure.


Eligibility Criteria:
Inclusion Criteria:

* Males and females 19-70 years old
* Mild hepatic injury as indicated by ALT(Alanine Transaminase) level ≥ 40
* Able to give informed consent

Exclusion Criteria:

* Allergy or hypersensitivity to any of the ingredients in the test products
* History of reaction to any of the experimental products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery
* Carriers of viral hepatitis (type B and C)
* History of underlying Esophageal varices, hepatic encephalopathy, ascites(past 12 months)
* Participation in other clinical trials within the past 2 months
* Patients with acute hepatitis (type B and C)
* History of underlying cirrhosis and liver cancer
* History of underlying biliary diseases such as jaundice or gallstones
* History of underlying kidney disease such as Chronic renal failure or nephrotic syndrome
* Pregnant, planning to become pregnant, or breast-feeding
* Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study
Neuroinflammation in FTLD

The goal of this observational study is to investigate the role of neuroinflammation in frontotemporal lobar degeneration (FTLD). The main aims of this study are:

1. To elucidate the role and timing of neuroinflammation in FTLD by using a combination of clinical measures, 7T MRI, and CSF biomarkers;
2. To differentiate FTLD-TDP and FTLD-tau during life using biomarkers for neuroinflammation;
3. To identify biomarkers to predict and monitor disease progression in FTLD;

Secondary aim:

1. To explore the role of brain clearance in the disease process of FTLD.

Participants will undergo 7T MRI scans, blood and CSF collection, clinical, neurological, and neuropsychological evaluation.

At baseline, the study will involve the following procedures: clinical assessment including neurological and neuropsychological investigation, blood sampling, and a voluntarily lumbar puncture on the first day at the Erasmus MC University Medical Center, (EMC) and two sessions of 7T MRI scanning on the second day at the Leiden University Medical Center (LUMC). After one year, clinical assessment and blood analyses will be repeated in the EMC to assess disease progression. The aim is to include 25 patients with probable or definite FTLD-tau, 25 patients with probable or definite FTLD-TDP, 50 healthy individuals with 50% risk to carry a mutation in MAPT or GRN, or the C9orf72 HRE. If necessary for age matching, 10 additional healthy subjects without increased risk of FTLD will be included.

Eligibility Criteria:
Inclusion Criteria:

* Ability to undergo MRI scanning
* For probable FTLD-tau: a clinical diagnosis of PSP, CBS or nfvPPA, or any clinical FTLD spectrum diagnosis with a proven MAPT mutation
* For probable FTLD-TDP: a clinical diagnosis of svPPA or any clinical FTLD spectrum diagnosis with a proven GRN mutation or C9orf72 repeat expansion
* For presymptomatic mutation carriers: a MAPT mutation, GRN mutation or a C9orf72 mutation without clinical sign of a FTLD spectrum phenotype (CDR 0) For control subjects: no known neurological or psychiatric disorder
* For controls: no known neurological or psychiatric disorder

Exclusion Criteria:

* Other neurological or psychiatric disorder that may affect cognitive functions, such as a brain tumour, multiple sclerosis or drug or alcohol abuse or use of psycho-active medications
* CSF profile (β-amyloid, p-tau, t-tau) suggestive of AD pathology
* Clinical dementia Rating Scale (CDR) score \>1
* Contra-indication to undergo MRI
* Contra-indication to undergo lumbar puncture
Visualization of the Papilla Through Use of the NuView Device in Patients With FAP

The goal of this observational study is to test the NuView device in participants with familial adenomatous polyposis (FAP). The main question it aims to answer is:

* can the papilla be visualized using a forward-facing endoscope outfitted with the NuView device. Participants will undergo standard of care esophagogastroduodenoscopy with an additional endoscopic exam using NuView device, for which participant have given prior consent.

The clinical practice at Vanderbilt University Medical Center will first perform the routine upper endoscopic exam with a forward-viewing gastroscope to evaluate the patient's esophagus, stomach, and duodenum. After this has been completed, the forward-viewing endoscope will be removed from the patient and outfitted with the EndoTheia NuView. The endoscope with NuView will then be inserted transorally down the esophagus, traverse the stomach, and be passed into the duodenum for visualization of the papilla. After the papilla is visualized, the endoscope with NuView will be removed from the patient. As per standard of care, the conventional side-viewing endoscope will then be inserted transorally down the esophagus, traverse the stomach, and be passed into the duodenum for visualization of the papilla. The side-viewing endoscope will then be removed from the patient. The Investigators plan to enroll 3 FAP patients who are already scheduled to undergo their standard of care endoscopic exam. The primary endpoint of the study is successful visualization of the papilla with the NuView platform.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 18 to 70 years of age.
* Able to provide written informed consent.
* Have FAP

Exclusion Criteria:

* Females who are pregnant. As part of routine pre-operative care, all females of childbearing potential will undergo either urine or blood pregnancy testing.
* Cancer positive subjects or any patients currently undergoing any treatment or therapy to treat, cure, or mitigate cancer.
* Patients who do not meet inclusion criteria
* Patients who are unable or unwilling to provide informed consent
Clinical Study of Umbilical Cord Tissue Mesenchymal Stem Cells (UC-MSC) for Treatment of Osteoarthritis

Allogeneic human umbilical cord tissue-derived stem cells injected intravenously (IV) once per day for 3 days or once intra-articularly are a safe and will induce a therapeutic effect in osteoarthritis (OA) patients.

The proposed study will assess primarily safety and secondary efficacy endpoints of allogeneic umbilical cord mesenchymal stem cells (UC-MSC) administered to 40 patients with OA. Arm 1 will receive one intra-articular injection of UC-MSC into the knee and Arm 2 will receive IV UC-MSC once per day for 3 consecutive days.

The primary objective of the trial is freedom from treatment associated adverse events at 3 and 12 months post treatment. Secondary objective will be efficacy as assessed at baseline, and 3 and 12 months post treatment and will be quantified based on the Western Ontario and McMaster osteoarthritis index (WOMAC).

Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent by the subject.
* Age greater than or equal to 18 years
* Ability to understand the planned treatment.
* Idiopathic or secondary osteoarthritis of the knee with grade 2, 3, or 4 radiographic severity, as defined by the modified Kellgren-Lawrence classification

Exclusion Criteria:

* Pregnant or lactating women
* Women of childbearing potential unwilling to use two forms of contraception
* Cognitively impaired adults.
* Presence of large meniscal tears ("bucket handle" tears), as detected by clinical examination or by magnetic resonance imaging.
* Inflammatory or postinfectious arthritis.
* More than 5 degrees of varus or valgus deformity.
* Kellgren Lawrence grade 4 osteoarthritis in two compartments (the medial or lateral compartments of the tibiofemoral joint or the patellofemoral compartment) in persons over 60 years of age.
* Intraarticular corticosteroid injection within the previous 3 months.
* A major neurologic deficit.
* Serious medical illness with a life expectancy of less than 1 year.
* Prior admission for substance abuse
* Body Mass Index (BMI) of 40 kg/m2 or greater
* Patient receiving experimental medication or participating in another clinical study within 30 days of signing the informed consent
* In the opinion of the investigator or the sponsor the patient is unsuitable for cellular therapy
Efficacy of Extended Release Tramadol for Treating Prescription Opioid Withdrawal

Prescription opioid addiction is a growing public health problem and more pharmacologic treatments are needed because current approved medications have had limited patient acceptance (naltrexone), limited availability (methadone), and concerns about misuse and diversion (methadone and buprenorphine). Tramadol is a currently approved medication used to treat moderate-severe pain, and initial studies demonstrate that it may be useful for treatment of the uncomfortable syndrome of opioid withdrawal without producing euphoric effects. This study will determine whether two different doses of extended release tramadol can treat opioid withdrawal and whether tramadol itself produces withdrawal after it is no longer taken.


Eligibility Criteria:
Inclusion Criteria:

* Addicted to opioids

Exclusion Criteria:

* Any major medical or psychiatric disorder that would be contraindicated for participation
An Exploratory Investigation of Dietary Supplementation and the Effect on Common Symptoms of Perimenopause and Menopause

A combination of synergistic dietary supplements is hypothesized to significantly improve self-reported measures of menopausal symptoms when compared with a baseline without the intervention.


Eligibility Criteria:
Inclusion Criteria:

* Ability to take oral medication and be willing to adhere to the dietary supplement regimen (1 capsule per day)
* Moderate self-reported discomfort related to perimenopause or menopause. Participants will complete the menopause well-being survey and must answer an average of "moderate" or higher.

Exclusion Criteria:

* Current use of medication for high blood pressure or for blood thinning
* Currently undergoing chemotherapy or has previously been treated for cancer
* Pregnancy, breastfeeding, or attempting to become pregnant during the study
* Known allergic reactions to components of the dietary supplement (red clover extract, olive extract, bergamot extract )
Influence of Socioeconomic and Environmental Factors on the Natural History of Idiopathic Pulmonary Fibrosis

Idiopathic Pulmonary Fibrosis(IPF) is the most common idiopathic interstitial lung disease whose cause is unknown. With age and gender, socio-economic factors are the most influential indicators of health. At present there is very little data on socio-economic factors in the IPF. The investigators hypothesize that a lower socio-economic level and / or exposure to various air pollutants may influence the IPF's natural history, including the severity of diagnosis and prognosis of the IPF. The investigators also hypothesize that the deleterious effect of air pollutants is modulated by individual susceptibility (shorter telomeres) and that this effect is related to oxidative stress and shortening of telomeres.

Idiopathic Pulmonary Fibrosis is the most common idiopathic interstitial lung disease whose cause is unknown. However, it remains a rare disease, there is an incidence of approximately 4400 new patients per year in France. It is a serious disease with few therapeutic options and a median survival after diagnosis around 36 months. It is also responsible for high morbidity, with a marked deterioration in quality of life (dyspnea, cough, fatigue and anxiodepressive disorders) and significant functional impairment (respiratory failure) With age and gender, socio-economic factors are the most influential indicators of health. At present there is very little data on socio-economic factors in the IPF. The investigators hypothesize that a lower socio-economic level and / or exposure to various air pollutants may influence the IPF's natural history, including the severity of diagnosis and prognosis of the IPF. The investigators also hypothesize that the deleterious effect of air pollutants is modulated by individual susceptibility (shorter telomeres) and that this effect is related to oxidative stress and shortening of telomeres.

Eligibility Criteria:
Inclusion Criteria:

* Man woman over 18 years old
* Certain or probable Idiopathic Pulmonary Fibrosis determined by a multi-disciplinary discussion ("ATS / ERS / JRS / ALAT" 2018 criteria)
* Idiopathic Pulmonary Fibrosis with a diagnosis of less than 12 months
* Signed informed consent
* Patient affiliated to a social security scheme or universal health coverage or benefiting from state medical aid

Exclusion Criteria:

* Known cause of Diffuse Interstitial Lung Disease (including connectivity, Hypersensitivity pneumonitis or pneumoconiosis authenticated)
* Patient unable to answer questionnaires
* Pregnant or lactating woman
* Persons under guardianship
Role of ASpirin in Placental and Maternal Endothelial Cell Regulation IN Pre-eclampsia

Endothelial dysfunction and defective placental vascularization are hypothesized to be significant causes of preeclampsia. In preeclampsia, due to vascular endothelial dysfunction, vasoconstriction and platelet activation can result in severe features which alter pregnancy outcomes. However, studies have shown that acetylsalicylic acid (Aspirin) can decrease endothelial dysfunction leading to decreased platelet aggregation which reduces adverse outcomes. The objective of our study is to determine if Aspirin has a dose-dependent response for modifying biomarkers reflective of maternal endothelial dysfunction when indicated for preeclampsia prevention in a cohort of women identified at risk for developing preeclampsia.

Pregnant women who are at risk for preeclampsia will be randomized to receive either 81mg Aspirin or 162mg Aspirin daily starting from 11-16 weeks of gestation until 36 weeks of gestation. A third, control group of women at low risk for preeclampsia will not receive aspirin. All women will be assessed with uterine artery Doppler studies and mean arterial blood pressures at three time points during pregnancy. Blood, urine, and cord blood samples will also be collected.

Eligible women will be identified in the late first or early second trimesters. Once recruited, women will be randomly assigned to either 81 mg or 162 mg per day dosing schedules. The randomization scheme will vary based on the body mass index (BMI) with separate schemes for women \<=30 kg/m2 versus \>30 kg/m2. Ultrasonographic assessment of biophysical biomarkers will be obtained at 11-16 weeks, 18-22 weeks, and 28-32 weeks gestation. Biologic samples of serum and urine will be obtained at the 11-16 week and 28-32 week visit. Upon delivery, cord blood and a placental specimen will also be obtained. Medication treatment will continue until 36 weeks gestation. Pregnancy and neonatal outcome data will be recorded.

Eligibility Criteria:
Inclusion Criteria (control)

• No risk factors for preeclampsia

Inclusion Criteria (pre-eclampsia)

* History of preterm preeclampsia
* Chronic hypertension
* Type 1 and Type 2 diabetes
* Renal diseases
* Autoimmune disease

Exclusion Criteria

* Pregnant women younger than 18 years or older than 45 years
* Multiple gestations
* History of allergy (urticaria or anaphylaxis) to aspirin or aspirin-related products asthma that worsens after aspirin use
* Patients with gastrointestinal or genitourinary bleeding
* Patients with peptic ulcer disease
* Patients with severe liver dysfunction
* Patients who have undergone bypass surgery
* Patients on anticoagulant medication(s)
* Women with anomalous fetus
Neurodynamic Sliding Verses Static Stretching

Hamstring muscle are more likely to shorten among all biarticular muscles of human body. One of the many factors of hamstring tightness is increased tension in the neural structure. Apart from routine stretching techniques, mobilization of nervous system proves to be more effective. There are lot of stretching techniques available but they are more effective after multiple sessions. This study aims to cater the problem of hamstring tightness by neural sliding and static stretching in minimum sessions and compare which technique is more effective in resolving the issue.

Randomized Controlled Trials was used to collect data. Total patients were selected in two group with each 31 subjects. Purposive sampling technique was used. Experimental group will receive routine physical therapy along with TENS, Hot pack and Neurodynamic Stretching. (For 30 seconds, 3 times per session for 3 alternative days a week \& duration of 4 weeks). Outcome measure will be the hamstring tightness value angle in degrees, which will be obtained with the help of goniometer after performing active knee extension test and active straight leg raise test

Eligibility Criteria:
Inclusion Criteria:

* People with age ranging between 25 and 35 years.
* Hamstring tightness of twenty degrees
* Incapability to reach seventy degree hip flexion in SLR.

Exclusion Criteria:

* Neurological or orthopedic diseases
* Chronic or acute low back pain, Hamstring injury.
* During last three month, involved in any lower extremity exercise programs.
Incidence and Nature of Heparin-induced Skin Lesions in Medical Patients

An increased number of patients with heparin-induced skin lesions is reported in the literature. Heparin-induced skin lesions may result from either occlusion of cutaneous vessels in patients suffering from autoimmune HIT or from a type IV allergic reaction (delayed type hypersensitivity (DTH) response). However, the incidence and nature of heparin-induced skin lesions has not been determined in a prospective investigation.

To address this open issue is the goal of this ongoing, so far monocenter, clinical investigation.


Eligibility Criteria:
Inclusion Criteria:

* age \> 18 Y.
* s.c. anticoagulant therapy \>6 days

Exclusion Criteria:

* history of HIT
* history of DTH to heparin
Virtual Reality in Patients With Knee Osteoarthritis

One of the main challenges facing the therapist in the treatment of adhesive capsulitis is to motivate the patient throughout conventional therapy. As noted in a recent review, individuals are more interested in leisure activities rather than performing repetitive tasks during therapy. Virtual reality (VR) is a three-dimensional computer-aided programme built with a system that creates virtual reality movements and generates a high amount of visual and sensory feedback during exercise. As a result, virtual reality (VR) has been used in many medical indications and has been shown to promote adherence to treatment by increasing patient motivation.

Different VR systems have been shown to be effective in individuals with kinesiophobia as well as stroke patients. Virtual reality guided exercise is a proven method already used in stroke, Parkinson's, cerebral palsy rehabilitation, vestibular rehabilitation and orthopaedic rehabilitation. However, there is limited data on its effectiveness in patients with adhesive capsulitis. This randomized controlled study will contribute to the literature by investigating the effects of VR based exercises in individuals with AC

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of chronic (\>3 months) knee osteoarthritis between the ages of 40-85
* Kellgren and Lawrence Score ≥ 2 on knee radiograph
* Visual Analogue scale result VAS 4-8

Exclusion Criteria:

* Orthopedic surgery performed on the lower extremity
* Cognitive dysfunction (Mini Mental Test Score \<23)
* Having received any treatment for knee osteoarthritis in the last 6 months
* Following any ongoing exercise program (tai chi, pilates, yoga, fitness)
* History of ligament and ligament injury around the knee
The Accuracy of Automated Audiometry Application on Smart Phone to Screen Hearing Loss

The purpose of study is to determine the diagnostic value of Hearing test program on smart phone for detected patients who has hearing loss.


Eligibility Criteria:
Inclusion Criteria:

* Patient who underwent hearing test in our otologic clinic

Exclusion Criteria:

* Age below 15 year
* Patients who cannot following command
Endoscopic Injection Sclerotherapy Versus N-butyl-2-cyanoacrylate Injection

Endoscopic Injection Sclerotherapy vs N-butyl-2-cyanoacrylate Injection

Endoscopic Injection Sclerotherapy versus N-butyl-2-cyanoacrylate Injection in the Management of Actively Bleeding Esophageal Varices

Eligibility Criteria:
Inclusion Criteria:

* cirrhotic patients presented with actively bleeding

Exclusion Criteria:

* other sources of UGIB than esophageal varices, hepatic encephalopathy or hepatocellular carcinoma (HCC)