cyrilzakka/clinical-trials huggingface dataset:
HEALTHY (Health Education Adolescent Leadership Training to Help Youth) Leaders

This project will measure baseline stress among a group of youth in foster and kinship care. The investigators will implement a pilot program to target stress reduction by using an evidence-based group therapy technique teaching mindfulness skills. The investigators hypothesize that the mindfulness skills will help youth to reduce stress, which will be measured using psychological and physiological techniques.


Eligibility Criteria:
Inclusion Criteria:

* ages 14-21 years at time of intervention being offered, offered to youth in out of home care (e.g. foster and kinship care)

Exclusion Criteria:

* severe developmental delay
* non English speaking, not in age range
Sequential Intravesical Gemcitabine and Docetaxel for Rescue Therapy in BCG Unresponsive Non-muscle Invasive Bladder Cancer Patients

Studies in the literature are limited both throughout Turkey and in general. For this reason, as a result of the study that we will create, it will provide us with information for bladder protective treatments in patients who do not respond to BCG therapy in bladder cancer patients.


Eligibility Criteria:
Inclusion Criteria:

- BCG refractory/relapsed/unresponsive or intolerant Who do not want or are not suitable for radical cystectomy

Exclusion Criteria:

- BCG naive A history of multiple cancers Having a radical cystectomy plan
Uganda Sickle Surveillance Study (US-3)

It is estimated that over 250,000 babies are born with sickle cell disease (SCD) annually in sub-Saharan Africa, and only 10% - 50% of them survive beyond five years of age. Data describing the magnitude of the sickle cell problem are lacking in most African countries. The available data on prevalence were mainly from older studies and small numbers of hospitalized patients. In Uganda, approximately 25,000 children are born with SCD but 70-80% die before their 5th birthday. Lehmann and Raper found 'sicklaemia' prevalence of 0.8% and 45% in the Sebei and Bambaa ethnic groups, respectively. A recent study found a SCT and SCD prevalence of 3% - 19% and 0% - 3%, respectively but this study addressed only 5 of Uganda's 111 districts and used a small convenience sample of children aged 6 - 60 months. The objective of this study is to determine the prevalence and map out the burden of SCT and SCD in Uganda.

The investigators propose a cross-sectional study of sickle cell trait (SCT) and disease in all districts of Uganda using dried blood spots (DBS) collected from HIV exposed babies over a 12-month period. About 90,000 DBS samples collected from HIV exposed children from all districts of Uganda from February 2014 to March 2015 will be analyzed. Follow-up analysis will occur on up to 1,000,000 samples collected during 2015 - 2030 based on surveillance findings and secondary objectives. The study will be conducted at the Central Public Health (CPHL) in Kampala where the samples from across the country are collected for PCR testing. The investigators will perform hemoglobin analysis using isoelectric focusing (IEF). The overall prevalence and the prevalence by district of SCT and SCD will be determined. Geospatial mapping will be performed using a specialized software program to produce a map illustrating the prevalence of SCT and SCD throughout the country and allow associations between sickle cell trait/disease with either malaria prevalence or HIV co-morbidity. Further analysis of sickle cell disease or hemoglobin variants will be conducted using HPLC and DNA-based techniques.

Eligibility Criteria:
Inclusion Criteria:

* Up to 1,000,000 samples may be collected during 2015 - 2030 following primary analysis based on surveillance findings.

Exclusion Criteria:

* Repeat samples on the same individuals during the study period will be excluded.
ELEVATE (Evaluation of Left Ventricular Autothreshold) 3.0

This 3rd phase of the ELEVATE study. The study is collecting data from an implanted CRT-D device to evaluate a new feature for future heart failure devices.

ELEVATE 3.0 is an acute, prospective, multicenter feasibility study which is randomized within a patient test sequence and pulse width. The study is designed to characterize the performance of LVAT (Left Ventricular Authothreshold) feature.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are age 18 or above, or of legal age to give informed consent specific to state and national law
* Patients who have a COGNIS CRT-D device implanted for at least 24 hours, with or without an active right atrial lead
* Patients who have an active LV bipolar or unipolar lead
* Patients who have an active RV defibrillation lead
* Patients who are willing and capable of participating in all testing associated with this Clinical Investigation

Exclusion Criteria:

* Patients who have a COGNIS CRT-D that has less than or equal to one year of battery life remaining
* Patients who are pacemaker-dependent as defined as VVI 40 without intrinsic atrial or ventricular activity
* Patients who will not tolerate a pacing pause of up to 6 seconds
* Patients with a pre-existing unipolar pacemaker
* Patients who are unable or unwilling to maintain a supine or sitting position for 20-50 minutes
* Patients enrolled in any concurrent study, without Boston Scientific CRM written approval
* Women who are pregnant;women of childbearing potential must have a negative pregnancy test within 7 days prior to enrollment.
The Effects of Nutritional Supplementation on Occupational Performance in Firefighters

The purpose of this study was to assess the usefulness of protein and carbohydrate supplementation, with and without creatine, on occupational performance in firefighters. Research has examined the effects of adding creatine to whey protein and carbohydrates on training adaptations in resistance-trained individuals with mixed finding.

Furthermore, the ergogenic benefit of protein and carbohydrate supplementation, with or without creatine, in firefighters is largely unknown. Therefore, the primary aim of the current study was to examine the effects of protein and carbohydrate supplementation, with or without creatine, on occupational performance in firefighters.


Eligibility Criteria:
Inclusion Criteria:

* Being a firefighter between the ages of 18-55 years of age, and medically cleared for field duty.

Exclusion Criteria:

* Any current musculoskeletal or neurological condition that would prohibit the completion of performance testing.
Effect of Preventional Drug Therapy on Pain Regulation Mechanisms Among SCI

Central neuropathic pain (CNP) is defined as chronic pain due to injury or disease in the central nervous system. This pain is most common among people with a spinal cord injuries (SCI), with a prevalence of about 50%. The central pain usually develops within a few months of spinal cord injury - and this period is significance in terms of this research work. This pain is one of the most complex and challenging pain syndromes. One of the reasons for this stems from its adherence to most treatments. Another reason is that there is partial information about the mechanism responsible for its development. Animal studies suggest that it is possible to prevent and / or reduce its development or reduce its strength by preventive treatment (given immediately after the injury). Currently, the treatments found to prevent or reduce central pain in animals are anti Inflammation and neuronal excitability suppressors such as interleukin 10.

The purpose of this study,is to explore whether pre-treatment with pregabalin prior to the development of the central pain will prevent the incidence of pain or reduce its intensity by improving pain regulation and reducing hypersensitivity.

The goal of the pharmacotherapy is to reduce the hypersensitivity- lyrica is used to reduce chronic neuropathic pain by reducing the degree of hypersensitivity in the pain system.

the objectives of this study are to examine whether early treatment of central pain can prevent or reduce the incidence of pain by improving pain regulation and reducing hypersensitivity. That is, whether there will be a difference between those who take Lyrica-Pregabalin (a drug that reduces hypersensitivity of pain) compared to placebo.

Methods: A randomized, double-blind, placebo-controlled study in which people with a fresh SCI will receive lyrica or placebo as soon as possible from their arrival at the rehabilitation hospital for 2-3 months during which pain system characteristics will be measured and monitored for central pain development.


Eligibility Criteria:
Inclusion Criteria:

* People with a Spinal injury below C3 2-3 weeks after the injury
* Cognitive, mental, and verbal state (understanding and speech) that allows for voluntary cooperation in research and compliance with instructions

Exclusion Criteria:

* Pregnant women
* Other neurological diseases (such as head trauma)
* Other systemic diseases that affect the sensation (such as uncontrolled diabetes).
Spinal Manipulative Therapy: Dual-Task Performance

The purposes of this study is to determined the effects of instrument applied spinal manipulative therapy upon dual-task performance involving complex postural and cognitive task.

This study sought to determine whether a 2-week regimen of spinal manipulative therapy could improve postural control under 2 conditions. Condition one was a complex postural task which consisted of a shoulder width stance on a compliant surface with eyes closed to remove visual input. Condition 2 was as above with the addition of visio-spatial cognitive task (serial 7s subtraction). These tasks were performed on a force-place designed to capture center of pressure data. Data was captured prior to the onset of therapy and then again after 6 treatment sessions (2-week period). Data was also collected 1 week post treatment to note any lasting effects following therapy. This pilot study utilized a repeated measures designed with no control group.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants

Exclusion Criteria:

* No injuries
* No surgeries
* No visual, vestibular, or somatosensory disorders capable of affecting balance
Effectiveness of the Collaborative Community Clinic for Persons With Spinal Cord Injury and Disease

The investigator is evaluating data stored on the Collaborative Community Clinic data repository (IRB #201811032). Researchers seek to evaluate the effectiveness of the Collaborative Community Clinic (CCC), an occupational therapy student experiential learning clinic for uninsured or under-insured people with spinal cord injury and disease (SCI/D), using participants' initial and follow-up assessment batteries.

All data reviewed will be pulled from the Collaborative Community Clinic (CCC) data repository according to the data manual and procedures. A separate IRB was approved to review outcomes from participants in the CCC to evaluate the effectiveness of the clinic. All participants participated in an informed consent process to provide the option to have their data stored in a data repository for aggregate review. If any participate chooses not to have their data stored, it will not be stored or outcomes reviewed. However, participants are still provided services through the CCC. Researchers anticipate up to 200 participants participating in the registry over five years. All data will be data checked by a member of the research team to limit errors and identification of missing data recorded. Statistical analysis methods are to be determined upon completion of the study.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age; diagnosis of spinal cord injury or disease, un-insured or under-insured for occupational therapy services

Exclusion Criteria:

* under 18 years of age, lack of SCI/D diagnosis, full insurance coverage for OT services (ie. Medicare or Private Insurance)
Acupuncture for Dry Eye Syndrome

This study is about the effectiveness of acupuncture treatment on dry eye syndrome. Study hypothesis is that a standardized acupuncture would be more effective than a sham acupuncture in dry eye syndrome patients. This is a randomized, patients-assessor blinded, sham acupuncture controlled study. Additionally, the investigators will assess the safety of acupuncture treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have had dry eye syndromes in single eye or in both eyes e.g. Other disorders of lacrimal gland: Dry eye syndrome (ICD-10: H04.1). He or she must have both of the conditions below:

  1. Patients who have had such symptoms like ocular itching, ocular foreign body sensation, ocular burning, ocular pain, ocular dryness, blurred vision, sensation of photophobia, ocular redness, sensation of tearing
  2. Patient whose tear film break-up time (BUT) is below 10 seconds and measured tear amount is below 10mm/5sec by Schirmer 1 test

Exclusion Criteria:

* Those who have defects of eyelid or eyelashes
* Those who have acute infection of eyelid, eyeball or accessories of eye
* Those who have Stevens-Johnson syndromes or Pemphigoids
* Those who have Vitamin A deficiency
* Those who have any defects of eye or accessories of eye by external injuries
* Those who have undergone any surgical operation for eye during last 3 months
* Those who are using contact lens
* Those who have any difficulties about eye opening or eye closing due to facial palsy
* Those who have undergone punctual occlusion surgery
* Those who have used any kinds of anti-inflammatory eyedrops for recent 2 weeks (steroids, cyclosporin or autologous serum eyedrops)
* Those who have systemic immune therapy
* Those who are pregnant or have any plan for pregnancy
* Those who are not appropriate to this study by investigators decision
Effect of Anterioposterior Weight Shifting Training With Visual Biofeedback in Subacute Stroke

Asymmetric gait patterns of stroke is one of the most important functional activities to enable community participation, it is major goal for stroke patients. Reported that the stroke patients had asymmetry at stance time, single stance, double support time, and swing time compared to normal people, and claimed that the most important factor was step length. According to Albert et al., patients with an asymmetric gait pattern have a long double support phase and a healthy side single support phase, and less weight shift to the affected side. Recent studies have shown that visual feedback for weight shift may be helpful to obtain a symmetrical posture after stroke. However, no study has been conducted on the therapeutic effect on gait asymmetry and patterns. We aimed to investigate the effect of Anterioposterior Weight Shifting Training with Visual Biofeedback in subacute post-stroke patients on gait asymmetry and pattern.

40 subacute post-stroke patients with Step Length Asymmetry were enrolled in this study. The subjects were randomly assigned into two groups. The training group received an additional anterioposterior weight shifting training with visual Biofeedback 5 times per week for 4weeks. The control group received the usual gait training. The spatiotemporal and kinematic data were obtained during walking through 3D motion analysis. Functional Ambulation Category, Self-selected walking speed, Maximum safe walking speed, Berg balance Test (BBT), Fugl-Meyer Assessment (FMA), Medical Research Council Score (MRC), Functional Independent Measure-mobility, Timed Up and Go test (TUG) were assessed at pre, during, post- training, and 4week follow-up. Those were compared between two groups by repeated measures ANOVA.


Eligibility Criteria:
Inclusion Criteria:

1. less than 6 months after onset of the stroke
2. can stand and walk independently 10m
3. K-MMSE score of at least 15
4. have asymmetrical gait pattern with Step length asymmetric ratio greater than 1.1
5. over 20 years of age.

Exclusion Criteria:

1. quadriplegia
2. past history of stroke
3. past history of Musculoskeletal disease or history of Neurological diseases
A Brief Intervention for Chronic Pain in Primary Care

The purpose of this research study is to investigate potential benefits of a behavioral intervention for co-occurring chronic pain and distress that is delivered in a primary care clinic.


Eligibility Criteria:
Inclusion Criteria:

* Chronic pain condition
* A current patient within the Henry Ford Health System Academic Internal Medicine Clinic in Detroit
* Has been within the Henry Ford Health System for at least 6 months

Exclusion Criteria:

* Current behavioral health treatment
Natural History in Children Up to 16 Years with Mild to Profound Hearing Loss Due to Mutations in GJB2 / OTOF Genes

The purpose of this study is to follow the natural history of non-syndromic hearing loss caused by mutations in two genes (GJB2 or OTOF) in children up to 16 years of age.

The study aims to:

* better describe the prevalence of cases of DFNB1A and DFNB9, including the type of mutations, and to assess the clinical course of the disease in children up to 16 years of age who have a mild to profound deafness.
* better understand the audiological and genetic characteristics of the participants with congenital versus evolutive DFNB1A and DFNB9 deafness.

Eligibility Criteria:
Main Inclusion Criteria:

Participants meeting all the following main inclusion criteria will be eligible to participate in the study:

* Aged ≤ 16 years on the date of signed informed consent for cohort 1 and ≤ 10 years for cohort 2;
* With a diagnosis of non-syndromic, bilateral, mild to profound, sensorineural hearing loss (according to the American Speech Language-Hearing Association);
* With documented genotyping results showing mutation(s) in GJB2 or OTOF genes;
* Written informed consent as required by local regulations.
* Either without Cochlear Implant, or with unilateral or bilateral Cochlear Implant(s)

Exclusion Criteria:

Participants presenting with any of the following main exclusion criteria will not be included in the study

* Other type of deafness, such as unilateral deafness, persistent conductive deafness, malformation syndrome, syndromic deafness, known familial deafness linked to mutations in other genes than OTOF or GJB2;
* Documented genotyping results showing pathogenic mutation(s) in other gene(s) than GJB2 or OTOF genes in the tested panel;
* Unable and/or unwilling to comply with all the protocol requirements and/or study procedures.
Clinical Outcomes of Knee Replacement

The objective of this study is to document the demographic and clinical characteristics and the long-term clinical outcomes of patients who require a robot assisted knee arthroplasty.

The hypothesis is that MAKO® robot assisted surgery replacing one or two compartments of the knee joint has 10 year implant survival and clinical outcomes that are equivalent to other knee replacement systems.


Eligibility Criteria:
Inclusion Criteria:

* requires either primary or revision knee replacement surgery because of pain and joint stiffness that interferes with performance of normal daily activities
* has failed non-operative management of their joint disease

Exclusion Criteria:

* cognitively unable to complete study health-related quality of life forms
* pregnant women
Sensory Stimulation During Simulated Driving

The purpose of this study is to examine the effect of three specific odors on simulated driving performance. It is hypothesized that the presence of peppermint, rosemary, and zest/pulp will increase memory recall for navigation and improve reaction times for braking, compared to performance during unscented conditions

This study will examine the effect of scented odors on the attention and behavioral performance of healthy young adult and older adult drivers. Past research indicates that specific scented odors (i.e., peppermint and cinnamon) enhance motivation, performance and alertness, decrease fatigue and stimulate the central nervous system in a variety of contexts. The current study will examine the effect of three different odors on simulated driving as participants perform navigation and braking scenarios. This study will be the first of its kind to elucidate the association between specific scents and performance gains in simulated driving. The data will serve as proof-of-concept for eventual patient focused interventions relative to sensory stimulation and driving.

Eligibility Criteria:
Inclusion Criteria:

* valid drivers license
* normal or corrected to normal vision

Exclusion Criteria:

* no drivers license
* hyperopic vision without contact lenses
* history of congenital or acquired cognitive, ophthalmologic, or neurological disorders including developmental delay, brain tumor, stroke, or known peripheral or central vestibular disorders
* participants who have been diagnosed with Attention Deficit Hyperactivity Disorder (ADHD) will be excluded
* Participants will also be excluded if they have: (a) a history of skin irritation or sensitivity to scented products or cosmetics, (b) known skin allergies, sensitive skin or allergies to fragrance, (c) suffers from a cold, allergy, sinus condition or any other condition that might interfere with their sense of smell and (d) is pregnant or nursing.
* Participants will also be excluded if they smoke or use tobacco related products
* participants will be excluded if they commonly experience motion sickness