cyrilzakka/clinical-trials huggingface dataset:
Hazard Anticipation Program for Parents of Teen Drivers

This study will test an intervention that was developed to improve parents\&amp;#39; driving instruction of teens\&amp;#39; hazard anticipation skills when teens are in the learner phase of licensure. Half of the parents in the study will receive the intervention and half will not. Investigators will then compare driving instructions given by parents in the two groups by recording driving sessions that parents and teens have together in that real world and by recording a drive that parents and teens will complete in a driving simulator. The driving simulator allows us to expose teens and parents to hazards they may encounter on the roadway without putting them in harm\&amp;#39;s way.

The project seeks to test an intervention designed to improve parents' communication about roadway hazards by comparing parent instruction and teen driving outcomes between dyads whose parents were assigned to the intervention vs. the control condition. Participants will be 100 parent-teen dyads. Half of the parent-teen dyads will receive the intervention and half will not. Parents who receive the intervention will complete web-based program developed to help parents instruct teens on how to identify hazards on the roadway and respond appropriately before they pose a crash risk. Parents in the intervention arm of the study will be given 2 weeks to complete the training. Parents in the control arm of the study will not receive training. After the delivery period, parents and teens will be given two additional weeks to apply the training in their everyday driving instruction. During this period, parents in both groups will complete a minimum of 5 drives with their teen that will be recorded. Investigators will then have teens and parents complete a drive in a driving simulator. Teens will drive and parents will instruct from the passenger seat, just like they would in the real world. The drive will have 12 hazards. Compared to parents in the control group, investigators believe that parents in the intervention group will exhibit improved communication about potential hazard detection with their teens. Similarly, the investigators believe that teens of parents who received the training will be better at anticipating and reacting to potential hazards on the roadway when driving independently compared to teens whose parents did not engage in the program.

Eligibility Criteria:
Inclusion Criteria:

* Adolescents must be between the ages of 14 and 17 years. Additionally, they must be in the learner period of licensure.
* Parents must be the primary instructor of their teen's supervised driving.

Exclusion Criteria:

-
Vitamin D Effect on Calcium Absorption on Persons on Hemodialysis

The assumption has been that 1,25(OH)2D is solely responsible for calcium absorption. That has been one of the presumed causes of hyperparathyroidism in chronic kidney disease (CKD) (low 1,25(OH)2D leads to decreased calcium absorption, which increases parathyroid hormone release in compensation). Replacing 1,25 D directly has been the goal with using 1,25D or its analogues in CKD. There is very little data concerning use of native vitamin D or 25(OH)D in CKD, although autocrine functions in extrarenal tissues would use 25(OH)D. The latest KDIGO guidelines do recognize the autocrine role of vitamin D, but have no data on outcomes or doses or optimal levels to guide them and so have made a blanket recommendation to treat 25D levels in CKD by general healthy population guidelines.

1. This project focuses on an outcome (calcium absorption) that may be impacted by optimizing 25D status in renal patients. The investigators will assume for this project that a level of 25D \> 32 ng/ml is optimal in CKD patients as in a healthy population.
2. A secondary outcome is to quantify calcium absorption in CKD patients with and without vitamin D repletion and to quantify systemic 1,25D levels. This may clarify the roles 25D and 1,25D play in calcium absorption.


Eligibility Criteria:
Inclusion Criteria:

* on hemodialysis
* \> 19 years of age

Exclusion Criteria:

* Pregnancy or planned pregnancy
* Hypercalcemia (\> 10.2 mg/dl) at baseline
* Chronic GI disease
* Liver dysfunction
* Taking steroids
* Received any investigational drugs within 4 weeks
* Any allergy to vitamin D3
* Chronic vitamin D intake \> 1,000 IU daily
* Dialysate concentration (calcium 2.5mg/L) which is to remain constant during Rx
Chemotherapy/Radiotherapy Versus Concomitant Chemotherapy Followed by Radiotherapy in Stage IIIB Non-small Cell Lung Cancer

Randomized study in 2 arms, without any masking in patients with non small cell lung cancer, histologically or cytologically confirmed, not liable to surgery, stage IIIB or IIIA, according to the TNM classification of the American Joint Committee for cancer. In one arm will be administered concomitant radiotherapy and carboplatin-docetaxel-gemcitabine followed by docetaxel and, in the other arm will be administered docetaxel-gemcitabine followed by concurrent radiotherapy with carboplatin-docetaxel


Eligibility Criteria:
Inclusion Criteria:

* Unresectable stage IIIA or B NSCLC patients
* WHO PS 0 or 1
* Weight loss \< 5 % within the last 3 months
* At least one measurable lesion
* Planning CT scan previous to randomization
* Written informed consent

Exclusion Criteria:

* Malignant effusion, supraclavicular node or SVCS
* PTV \> 2000 cm3
* V20 \> 35%
* FEV1 and DLCO both \< 30% or 1 liter at study entry
The Use of Propranolol for the Prevention of Worsening of Esophageal Varices in Patients With Isolated Gastric Varices

Balloon-occluded retrograde transvenous obliteration (BRTO) has been effective method to manage gastric varices. However, more than one third of patients after BRTO treatment experienced worsening of esophageal varices. The present study was designed to evaluate the effect of post-BRTO propranolol adminstration on the change of esophageal varices.


Eligibility Criteria:
Inclusion Criteria:

1. Clinical diagnosis of liver cirrhosis
2. Clinical diagnosis of isolated gastric varices
3. The presenec of spontaneous portosystemic shunt

Exclusion Criteria:

1. Contradictions to Propranolol
2. Balloon occluded retrograde transvenous obliteration was failed
Implementing and Evaluating a Social-Emotional Learning Program for Refugee Children During the COVID-19 Pandemic

The overall goal of this overall goal is to pilot an adaptation of an established Social-Emotional Learning Program with novel wellness and COVID-19 safety components that are trauma-informed and culturally-specific in a resettled refugee community. In this pilot, "EMPOWER" (Emotions Program Outside the clinic and Wellness Education for Refugees), the study team will assess implementation outcomes (adoption, acceptability, and feasibility) of EMPOWER with refugee children and families during the COVID-19 pandemic through longitudinal evaluations and measurements of feasibility, acceptability, and attrition. The study team will also evaluate the impact of EMPOWER by assessing (a) children's social-emotional learning competence and (b) children's and family's COVID-19 knowledge.

The major question that guides this research is: can an adaptation of an established Social-Emotional Learning (SEL) curriculum effectively improve Social-Emotional wellness for refugee children and their families? The hypothesis is that participation in this program will (a) improve children's SEL competence and (b) lessen stress and improve quality of life for refugee families.

The overall objective of this study is to establish and evaluate the preliminary efficacy and implementation of an adapted social-emotional learning (SEL) and Wellness Program for refugees: EMPOWER (Emotions Program Outside the clinic with Wellness Education for Refugees). To achieve the two aims of this study, the study team will conduct a wait-list controlled pilot to establish and evaluate the preliminary efficacy of participation in EMPOWER by assessing (a) children's SEL competence and (b) measures of mental health, stress, quality of life and wellness before and after participation in the program (Aim 1). Then, the study team will assess the implementation of EMPOWER with refugee children by using mixed methods to perform a summative evaluation of implementation outcomes-including fidelity, sustainability, and reach-in the Afghan refugee community (Aim 2).

Eligibility Criteria:
Inclusion Criteria:

* at least 1 year of schooling in the United States
* must speak: Pashto, Dari or English
* connected with the community organization: Elena's Light

Exclusion Criteria:

* inability to meet any of the requirements of the inclusion criteria
Autologous Blood for Full-thickness Macular Hole

Autologous blood for primary and recurrent holes

Utilizing whole autologous blood for closing both primary and recurrent holes. Here, we apply a drop of the taken whole blood over the hole, and the access blood will be aspirated on the macula with a silicon-tipped active back-flash cannula, to abolish all the possibilities of the fibrinogenic behavior of the whole blood composition, which might cause traction and recurrent hole formation. Therefore, only the hole will be filled with blood. The blood will be taken under completely sterile and aseptic conditions.

The air infusion will be raised after the valve of one of the trocars will be removed, to allow the air current to dry the clot inside the hole rapidly. Then air gas exchange will be performed to allow the clot to remain away from intraocular fluids for one to two weeks and abolish the possibility of the clot being dissolved.

Eligibility Criteria:
Inclusion Criteria:

* Primary and recurrent holes

Exclusion Criteria:

* Lamellar and pseudoholes
Incidence and Prognostic Factors for Lower Extremities Injuries in Polish Youth Soccer Academy.

The aim of our study is to obtain data on the occurrence of injuries, their mechanisms and types among children and adolescents from a youth soccer club. In addition, in order to determine the potential risk of injury, the investigators will examine the prognostic factors on the basis of tests assessing the antropometric, anatomical, physical and fitness characteristics.

During the 2020/2023 seasons, participants will be obliged to report injuries to to sports physiotherapists.

Supervision and data collection on injuries will be documented by experienced sports physiotherapists. Using the Injury Record Form, a standardized definition and classification of injuries in line with the International Olympic Committee Consensus describing methods for recording and reporting epidemiological data on injuries and diseases in sport (Bahr et al. 2020). In addition, the data will also come from a physiotherapeutic examination, and in the case of severe injuries (requiring specialist consultation), a medical examination (orthopedic and / or neurological) and imaging tests.

Training and match exhibition (time spent by participants during training units and match games) will be recorded individually for each participant by the coaches of a given team (year). The given data (in minutes) will allow to determine the total time of sports exposure. The participant's missed training and / or competition due to an injury will also be analyzed.

Eligibility Criteria:
Inclusion Criteria:

* healthy, not reporting health problems on the day of the examination
* active participation in football competitions in the football club
* having a medical permit to participate in football games
* signed consent of the parent / guardian to participate in the study

Exclusion Criteria:

* unable to participate in the study
* restrictions related to full participation in football games and / or training
Quantitative Evaluation of Osteopathic Treatment in Temporomandibular Joint Disorders Using Magnetic Resonance Imaging

The aim of this study is to assess the impact of osteopathic manual treatment in patients with an anterior disc displacement over sleep and health quality, pain scores and the movement of the condyle and disc of the temporomandibular joint (TMJ) quantitatively.

Patients with TMD will involve to this study. After having the diagnose in Yeditepe U. Dental Hospital patients will be sent to the Radiology Department. MRI images will be gathered in sagittal, coronal and axial plane for each patient before and after treatment. Volunteers will be divided into two groups; (1) splint therapy for 6 weeks, (2) splint therapy + osteopathy 2 times a week for 6 weeks randomly. At the end of the treatment, patients will be sent to Radiology for the second images. Health Survey and pain scores, Disc condyle angle, disc and condyle displacements will be measured and compared inter and intra groups.

Eligibility Criteria:
Inclusion Criteria:

• Clinical diagnosis of TMD (anterior disc displacement)

Exclusion Criteria:

* Active orthodontic treatment
* Systemic diseases
* Oral or dental pathologies
* Dental implant placement
* Exodontia within 6 months
* Cranial and cervical trauma or surgery
* Taking antidepressant medication
* Contraindication of MRI scans
Effect of Multifunctional Nutrition Tube on Cerebral Small Vessel Disease Patients

Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia. Compared to NGT, IOE, as an enteral nutrition support mode, in CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, ADL, QOL, pneumonia, and adverse events, which should be considered as the preferred approach.

Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia.

This was a randomized controlled study with 60 CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy. Patients enrolled were randomly divided into the observation group (with IOE, n=30) and the control group (with NGT, n=30). At admission and after treatment, Video Fluoroscopic Swallowing Study (VFSS) and Functional Oral Intake Scale (FOIS), body mass index (BMI), serum albumin (Alb), and hemoglobin (Hb), Modified Barthel Index (MBI) and World Health Organization Quality of Life Assessment Instrument Brief Version (WHOQOL-BREF) were recruited to assess and compare dysphagia, nutritional status, activities of daily living (ADL) and quality of life (QOL). The incidence of pneumonia was recorded and compared.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of CSVD, confirmed by MRI;
* Must be able to cooperate with treatment and questionnaire investigation, (Generally with a Mini-Mental State Examination (MMSE) score ≥ 24) ;
* Clinical diagnosis of dysphagia through the Functional Oral Intake Scale (FOIS) and Video Fluoroscopic Swallowing Study (VFSS);
* Age between 40 and 70 years;
* Enteral nutrition support was required and feasible.
* No history of prior stroke.

Exclusion Criteria:

* Dysphagia related to other cerebrovascular diseases or caused by neurodegenerative diseases;
* Complicated with severe liver and kidney failure, tumors, or hematological disorders;
* Simultaneously need to undergo other therapy that might affect the outcomes of this study;
* Pregnant or nursing females.
Distant Healing for HIV/AIDS

The purpose of this study is to determine whether individuals praying at a distance (also known as "Distant Healing") can positively affect the health of people with HIV/AIDS.

Significant numbers of people with HIV/AIDS seek spiritual or "psychic" treatment. Distant healing could potentially be of benefit to large numbers of HIV/AIDS patients, as it is widely available and requires no travel or other activity on the part of the patient. However, the treatment can be costly and has not yet been proven effective in a controlled clinical trial. This study will evaluate the efficacy of distant healing in patients with HIV/AIDS.

Participants in this study will be randomly assigned to either the distant healing group or a control group. All participants will have hour-long study visits at entry and Months 6 and 12. At study visits, participants will complete a demographic questionnaire, self-report health and symptom inventory, quality of life assessment, and profile of mood states. Blood will be drawn at each study visit.

Eligibility Criteria:
Inclusion criteria

* HIV infection
* History of a CD4 cell count less than 200 cells/mm3
* Stable antiretroviral regimen
* English-speaking

Exclusion criteria

* Inability or unwillingness to fill out questionnaires
* History of non-HIV related life-threatening disease
Use of Biopsy Punch for Skin Biopsies for Fibroblasts Culturing

Fibroblasts can be cultured from human skin biopsies using fetal bovine serum and artificial growth medium. Fibroblasts cultured in this way retain the genetic characteristics of their donor but can be used for experiments where study conditions are much more precisely controlled than they can be in in vivo studies. We plan to culture fibroblasts from Pima Indians for two purposes. Firstly, to look for an in vitro system to measure insulin resistance, the underlying abnormality in Pima diabetics. Secondly, to look for biochemical markers of diabetes or obesity in Pimas employing two dimensional electrophoresis techniques.

Fibroblasts can be cultured from human skin biopsies using fetal bovine serum and artificial growth medium. Fibroblasts cultured in this way retain the genetic characteristics of their donor but can be used for experiments where study conditions are much more precisely controlled than they can be in in vivo studies. We plan to culture fibroblasts from Pima Indians for two purposes: 1) to look for an in vitro system to measure insulin resistance, the underlying abnormality in Pima diabetics; and 2) to look for biochemical markers of diabetes or obesity in Pimas employing two-dimensional electrophoresis techniques.

Eligibility Criteria:
* INCLUSION CRITERIA:

We will include Pima Indians who do not meet any of the exclusion criteria.

EXCLUSION CRITERIA:

We will exclude any seriously ill individuals, any known to have a bleeding diathesis or to be immunosuppressed or subjects who are carriers of HIV or HBV.

Children will be excluded, as the age range for this study's participants is 18-50.

Pregnant women will be excluded on the basis of a urinary pregnancy test.

All other subjects are potentially included.
Ireland Natalizumab (TYSABRI) Observational Program

The objectives of this study are to assess the long-term safety and impact on disease activity and progression of natalizumab (Tysabri) in participants with relapsing remitting multiple sclerosis (RRMS) in a clinical practice setting.

iTOP is a retrospective and prospective Irish observational study of participants receiving natalizumab, with each participant to be followed for 3 years. This study is designed to address the long-term safety profile and the long-term impact on disease activity and progression of natalizumab with marketed use. Collection of efficacy and safety data at 6- monthly intervals to coincide with regular clinic visits and routine clinical practice will therefore be undertaken during the iTOP observational period.

Eligibility Criteria:
Key Inclusion Criteria:

* Must give written informed consent and assent, as applicable.
* Decision to treat with natalizumab must precede enrollment.
* Patient characteristics and contraindications to treatment with natalizumab in accordance with prescribing information.
* Must be receiving natalizumab (Tysabri) for the treatment of RRMS in accordance with the natalizumab indication statement.
* Must have a documented diagnosis of Relapsing Remitting Multiple Sclerosis (RRMS).

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
Healthy Volunteer Positron Emission Tomography (PET) Brain Occupancy Study of a Phosphodiesterase 4 (PDE4) Inhibitor in Huntington's Disease

This study will investigate if a new experimental drug to treat Huntington's Disease gets into the brain. If it does get into the brain the study will explore the relationship between the amount of drug in the brain and the amount of drug in the blood. The study will involve healthy male volunteers.

This is an open label, non-randomized, adaptive design PET occupancy study in healthy adult males. The primary aim of this study is to describe the relationship between plasma concentrations and brain PDE4 occupancy of GSK356278 over time. Up to 24 healthy volunteers may be administered single doses of GSK356278 in order to obtain 12 evaluable complete data sets of occupancy estimates. This study will help to optimize the dose selection for future clinical studies with GSK356278.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male volunteer, aged 22-55 years.
* Normal blood pressure, laboratory values, and body mass index
* Willing to agree to study procedures \& contraception requirements
* Capable of giving written informed consent

Exclusion Criteria:

* Any evidence of disease that would preclude participation in the clinical study (includes sexually transmitted diseases, exessive alcohol consumption, and substance abuse).
* Previously involved in another clinical trial within 3 months prior to scheduled administration of study drug
* Smoker
* Suffers from claustrophobia
* Any contraindications for MRI scanning (e.g. pacemaker, metal implants or fillings)
Study of ALVR106 in Patients With Respiratory Viral Infections After Hematopoietic Cell and Solid Organ Transplant

A study to evaluate ALVR106; an allogeneic, off-the-shelf multi-virus specific T cell therapy that targets four community acquired respiratory viruses: respiratory syncytial virus (RSV), influenza, human metapneumovirus (hMPV), and/or parainfluenza virus (PIV) following hematopoietic cell transplant (HCT) and solid organ transplant (SOT).

The study hypothesis is that the administration of ALVR106, multi-virus specific T cells, plus standard of care, to post HCT or SOT patients suffering from infection with any of the four targeted viruses (RSV, influenza, hMPV, and/or PIV) will be safe and demonstrate shorter time to resolution of the respiratory viral infection (as measured by resolution of symptoms and viral load clearance in nasal swab) compared to patients treated with placebo.

This trial will consist of two parts: Part A is Dose Escalation and Part B is Cohort Expansion.

Eligibility Criteria:
Inclusion Criteria:

* Undergone hematopoietic cell transplantation (HCT) ≥21 days or solid organ transplantation (SOT) ≥28 days prior to study treatment administration
* Detection of at least 1 target virus of interest (ie, RSV, influenza, hMPV, and/or PIV)
* Diagnosis of Upper or mild Lower Respiratory Tract Infection

Exclusion Criteria:

* Ongoing therapy with high-dose systemic corticosteroids (ie, prednisone equivalent dose \>0.5 mg/kg/day)
* Infection by novel coronavirus disease 2019 (COVID-19)
* For HCT patients, evidence of Grade \>2 GVHD; and for SOT patients, any history or evidence of GVHD