cyrilzakka/clinical-trials huggingface dataset:
Eye Rubbing and Transient Change in Corneal Parameters

This study addresses the research question:

How does eye rubbing affect corneal (clear part of eye) parameters in healthy volunteers

The study objectives are:

1. To determine the corneal changes following eye rubbing
2. To assess tear film changes following eye rubbing
3. To investigate if there is an association between eye rubbing and axial length of the eye.

Background

A human eye has a front clear window called cornea. This cornea should ideally be spherical but in some subjects, this cornea gets deformed to a cone shape. This cone shaped cornea is called keratoconus. This keratoconus will cause blurring of vision which may require the use of a rigid contact lens or surgical intervention to improve vision. One of the etiological factors for keratoconus is eye rubbing. Eye rubbing is very common in subjects with eczema and other chronic allergic conditions. It is believed that constant eye rubbing every few minutes over years may lead to permanent changes to corneal curvature leading to formation of keratoconus.

It is known from previous studies that eye rubbing causes transient changes in the shape of the clear window of the eye, these changes are returned to baseline at 5 minutes following 1 minute of eye rubbing.

Although clinicians routinely advise such subject to refrain from eye rubbing and prescribe them long term anti allergic medication, there is paucity of scientific evidence on this.

With the knowledge of rubbing induced changes to the clear part of the eye in relation to the axial length we will have a further understanding of those subjects who are more susceptible to moulding and mechanical injury of the clear part of the eye. If we can identify a relationship between eye rubbing and eye length then those subjects with a chronic stimulus to eye-rubbing, such as allergy etc, efforts can be made to protect the eye from rubbing induced changes to prevent disease progression (Keratoconus).

The aim of this study is to assess transient changes (if any) in corneal and surface tear film parameters in healthy volunteers after rubbing of the right eye for 2 minutes. The volunteers will undergo a tear film assessment and a corneal scan before and after eye rubbing on both eyes. In addition to these, the volunteers will also undergo a simple scan (IOLMaster scan) to assess the overall dimension of their eyeballs before eye rubbing. The data from both eyes will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* aged 18 years or above healthy

Exclusion Criteria:

* aged less than 18 years
* subjects with: terminal illness, poor English language skills or a confused state history of previous ocular problems or surgeries history of contact lens wear not will to undergo simple \& quick scans and eye examinations
A Community-based Depression Screening Intervention for Middle-aged Suicide

The purpose of this study is to examine the effectiveness of a community-based depression-screening program for suicide prevention among middle-aged adults, the investigators conducted a quasi-experimental intervention study, using a parallel cluster design with communities at municipal level as the unit of allocation and individuals as the unit of analysis.

Suicide is a major cause of premature death, particularly among middle-aged adults, in the majority of Western and Asian countries. A strong association of suicide and depression often indicates the necessity of a high-risk approach for suicide prevention. Improvements in identification and treatment can lead to better depression outcomes and suicide prevention. The investigators hypothesize that a 4-year community-based intervention, consisting of universal depression screening and subsequent care support in the target areas and health education programs, would result in reduced suicide rates among the middle-aged adult population in areas with a high suicide rate.

Eligibility Criteria:
Inclusion Criteria:

* A municipal area located in the following 4 Aomori Second Medical Zones: Hachinohe, Kamitosan, Aomori, and Tsugaru.
* A municipal area with the higher suicide rate than the prefectural average.
* A municipal area having the sufficient and coverable size to serve the intervention (population 10,000-99,999).

Exclusion Criteria:

* A municipal area receiving further intervention including a depression screening for middle-aged adults.
Once-daily Fluorometholone Vs Twice-daily Cyclosporine in Dry Eye Disease

This study compares the therapeutic effects of once-daily fluorometholone 0.1% versus twice-daily cyclosporine 0.05% after short-term fluorometholone induction treatment in dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

1. participants aged 18 years or older
2. complaint of dry eye symptoms for 6 months or longer at screening
3. ocular surface disease index (OSDI) score of 33 or higher
4. tear film breakup time of 7 seconds or less

Exclusion Criteria:

1. abnormal lid anatomy or active blepharitis
2. severe systemic autoimmune diseases
3. received permanent lacrimal plug within 3 months
4. DED secondary to alkali burns, cicatricial pemphigoid, or Stevens-Johnson syndrome
5. ocular/periocular malignancy
6. active ocular allergies or allergy to the study drug or its components
7. active infection
8. intraocular surgery or ocular laser surgery within 6 months
9. uncontrolled systemic disease or history of herpetic keratitis
10. contact lens user
11. intraocular pressure \>25mmHg
12. pregnancy or current breast-feeding.
Balneotherapy in Primary Fibromyalgia

Balneotherapy (BT) is recommended as non-pharmacological treatment for Fibromyalgia Syndrome (FS). BT efficacy is based on beneficial properties of both mud bath and stay in a spa environment. The main aim of this multicentric prospective longitudinal cohort study is to evaluate BT effectiveness in patients withFS. All FS patients with a stable treatment in the past month and a Fibromyalgia Impact Questionnaire (FIQ) score ≥39 will be enrolled after providing written informed consent. Patients will be divided into two groups based on whether or not BT is added to usual therapy: BT Group and Control Group. Each patients will be assessed at baseline, after 15 and 45 days in BT Group and at baseline and after 15 days in Control group with an assessment of pain by Visual Analogue Scale, FIQ, Short-Form Health Survey, State-Trait Anxiety Inventory (STAI) and Center for Epidemiologic Studies Depression Scale (CES-D). Collected data will provide a new insight of BT role and the removal of daily stress in FS management


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of primary FS according to the 2010 American College of Rheumatology (ACR) criteria;
* Pharmacological and non pharmacological treatment stable for at least 3 months;
* FIQ-Total score ≥ 39

Exclusion Criteria:

* Secondary FS;
* Primary FS patients actually enrolled in other clinical trials;
* Patients who had receveid a cycle of BT or of mud-bath in the previous 6 months;
* Patients treated with intra-articular steroid injections of any joints in the previous 3 months;
* Pregnancy or breastfeeding;
* Cognitive or psychiatric disorders and history of substance abuse;
* Absolute and relative contraindications to BT
Safety, Biomarker Study of RL-007 in Subjects With Schizophrenia

The purpose of this study is to assess the safety and effects on electrical activity in the brain of an investigational drug (RL-007) for improving cognition in patients with schizophrenia

Potential participants will first be given an Informed Consent document and have the study explained to them. All patients who provide written informed consent will undergo screening to determine eligibility for the study. Patients who meet all eligibility criteria will be admitted to the clinic for 5 days / 4 nights as an in-patient. During this time, participants will be assigned to a specific dose cohort and will receive sequence that includes both placebo and RL-007. Brain activity and cognitive performance will be assessed on study days 2 and 4.

Eligibility Criteria:
Key Inclusion Criteria:

* Provide a written informed consent
* Diagnosis of schizophrenia, as defined by DSM-5 and evaluated with the MINI Plus interview
* Positive and Negative Symptoms Severity Score (PANSS) of 40 - 80 (inclusive), and a score of 4 or less on the following PANSS items: P2, P3, P5, P6, G6.
* Currently being treated with a single protocol-allowed antipsychotic at a stable dose and clinically stable for at least 8 weeks before admission (note: allowed meds = aripiprazole, brexipiprazole, paliperidone, risperidone)
* Modified Simpson-Angus Scale total score \<= 4
* At least 1 standard deviation below normative value of total number of words recalled on the Hopkins Verbal Learning Test
* BMI \<= 38

Key Exclusion Criteria:

* History of hospitalization for medical indication within 4 weeks prior to screening or psychiatric hospitalization within 3 months prior to screening
* Use of any other psychoactive medication known to interfere with the EEG/ERP assessments within 1 week prior to screening or during the study period.
* Subjects who present a serious risk of suicide
* Any history of GI surgery, or other condition, that may affect GI absorption or any history of GI bleeding or peptic ulcer.
* Evidence or history of significant cognitive impairment, other than associated with schizophrenia, that in the judgement of the Investigator would confound secondary or exploratory assessments or prevent safe and satisfactory completion of the study protocol.
* Moderate to severe alcohol use disorder, per DSM-5 within 3 months of admission visit.
* Positive alcohol breath test or urine test for drugs of abuse at either screening or admission visit.
* Currently smoking more than 1 pack of cigarettes a day and unable or unwilling to maintain smoking to less than 1 pack a day during in-patient portion of study.
* Positive test result for SARS-CoV2 prior to admission per site standards.
* Positive test for hepatitis B, hepatitis C or HIV
* Subjects whose hair type or style is likely to interfere with successful application of scalp electrodes.
* Subjects with needle phobia or in whom venous access is technically difficult.
* Other unspecified reasons that, in the opinion of the PI or sponsor, make the subject unsuitable for enrollment.
A Comparative Study of Azithromycin and S-P as Prophylaxis in Pregnant HIV+ Patients

Randomized controlled single blind prospective comparative study

This study is intended to be a randomized controlled single blind prospective comparative study conducted to compare the efficacy of three monthly doses of sulphadoxine-pyrimethamine as intermittent preventive therapy for malaria with azithromycin in HIV positive pregnant women

Eligibility Criteria:
Inclusion Criteria:

* Pregnant HIV positive patients,
* Gestational age 16 weeks and above,
* No history of azithromycin or sulphadoxine-pyrimethamine use four weeks prior to recruitment

Exclusion Criteria:

* Anaemia packed cell volume less than 30%,
* pre-existing medical conditions- diabetes mellitus,
* hypertension,
* allergy to sulphadoxine-pyrimethamine or azithromycin
Evaluation of the Washington Intensive Supervision Program

This study entails an evaluation of the Washington Intensive Supervision Program (WISP). The purpose of the evaluation is to test whether subjects assigned to WISP perform better than those assigned to parole-as-usual (PAU).

This study entails an evaluation of the Washington Intensive Supervision Program (WISP). WISP is a program targeting high-risk parolees in Seattle, and is modeled after the HOPE program in Hawaii. The purpose of the evaluation is to test whether subjects assigned to WISP perform better than those assigned to parole-as-usual (PAU) on a number of outcomes, including drug use, missed appointments, recidivism, prison and jail stays, and parole revocations. WISP uses regular random drug testing and close community supervision, paired with swift and certain, but modest sanctions for every detected violation.

Eligibility Criteria:
Inclusion Criteria:

* Inmates released by DOC to community corrections supervision
* Supervised out of the Seattle CJC (Community Justice Center) to include field offices and offenders from the downtown "Metro" unit, Southeast Seattle unit, Northgate (north Seattle) and West Seattle.
* Have a parole supervision discharge date at least one year from the date of release from entry into WISP

Exclusion Criteria:

* Level III Sex Offenders
* Existing assignment to supervision that precludes WISP. These include: Drug Offender Sentencing Alternative (DOSA)and Special Sex Offender Sentencing Alternative (SSOSA).
* Dangerously Mentally Ill (DMIO)
Sorafenib Drug Drug Interaction Study in Healthy Male Subjects

To evaluate the effect of levothyroxine on the absorption, distribution, metabolization and elimination of sorafenib and safety in healthy male subjects


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects between the ages of 18 (inclusive) and 45 years (inclusive) at the first screening visit.
* Body mass index (BMI) between 18.5 (inclusive) to 30.0 kg / m² (inclusive) with body weight ≥ 65kg.
* Normal thyroid function indicated by thyroid examination to include total and free T3 (Triiodothyronine) , T4 (total and free Thyroxine, levothyroxine), TSH (Thyroid stimulating hormone), anti-TSH-receptor (anti-TSHR) antibody, anti-thyroperoxidase (anti-TPO) antibody, anti-thyroglobulin antibody (anti-ATA) as well as thyroid ultrasound.

Exclusion Criteria:

* History of clinically significant metabolic, renal, hepatic, or central nervous system disorder such as seizure, psychosis and sleep disorders.
* History of cardiovascular diseases including arrhythmia, hypertension, ischemia, etc.
* Known or suspected cardiovascular disease including potential risk of atrioventricular (AV) block, arrhythmia, etc. with or without a formal cardiologist consultation.
* Subjects who had received iodine containing contrast medium within 2 months before first study drug administration.
* Use of systemic or topical medicines or substances which might affect the study drug(s) must be avoided
Hydrocortisone in Patients of Out-of-hospital Cardiac Arrest

Out-of-hospital cardiac arrest (OHCA) is an important issue for the emergency physicians and co-workers. How to improve the return of spontaneous circulation (ROSC) rate and prognosis of these patients challenges the emergency team. When encounters stress, the hypothalamus of human releases corticotropin releasing hormone, which in turn stimulates the pituitary gland to release ACTH. Then ACTH acts on the adrenal gland to release glucocorticoid to against stress. Foley PJ et al found the dogs with bilateral adrenalectomy had lower ROSC rate during resuscitation than those without surgery\[1\]. Karl H. Linder et al showed OHCA patients had high serum vasopressin and ACTH level but low serum cortisol level. Besides, the serum cortisol level had a negative correlation with collapse duration (no CPR duration)\[2\]. Studies also revealed the successfully resuscitated patients had higher serum ACTH and cortisol level than non-resuscitated ones\[2,3\]. In addition, the serum cortisol level was found to be correlated with short term survival rate and hemodynamic status in resuscitated OHCA patients\[3\]. Animal study also showed mice receiving higher dosage of hydrocortisone had higher ROSC rate and lower epinephrine requirement than those receiving lower dosage of hydrocortisone or normal saline.

\<Reference\>

1. Foley PJ, Tacker WA, Wortsman J, Frank S, Cryer PE.;" Plasma catecholamine and serum cortisol responses to experimental cardiac arrest in dogs."Am J Physiol 1987;253:E283-9
2. Lindner KH, Strohmenger HU, Ensinger H, Hetzel WD, Ahnefeld FW, Georgieff M.;" Stress hormone response during and after cardiopulmonary resuscitation."Anesthesiology 1992;77:662-8
3. Schultz CH, Rivers EP, Feldkamp CS, Goad EG, Smithline HA, Martin GB, Fath JJ, Wortsman J, Nowak RM.;"A characterization of hypothalamic-pituitary-adrenal axis function during and after human cardiac arrest."Crit Care Med 1993;21:1339-47
4. Smithline H, Rivers E, Appleton T, Nowak R.;"Corticosteroid supplementation during cardiac arrest in rats."Resuscitation 1993;25:257-64


Eligibility Criteria:
Inclusion Criteria:

* Out-of-hospital cardiac arrest

Exclusion Criteria:

* pregnancy
* younger than 18 years old
* trauma
* concurrent steroid use
* ECMO use in resuscitation
* allergy to steroid
Educational Intervention for Optimizing Adolescent Mental Health Screening and Treatment in Pediatric Residency

The purpose of this study is: 1) to assess pediatric resident knowledge of adolescent mental health; 2) to assess pediatric resident comfort level for screening, assessing, and treating mental health disorders in adolescents, and; 3) to evaluate pediatric resident current practices for adolescent mental health screening, assessment, and treatment.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric Residents
* Adolescent Rotation

Exclusion Criteria:

* None
Expanded Access of Omidubicel, for Allogeneic Transplantation in Patients With Hematological Malignancies

Omidubicel is an investigational therapy for patients with high-risk hematologic malignancies.

Successful blood and marrow transplantation (BMT) requires the infusion of a sufficient number of hematopoietic stem/progenitor cells (HSPCs), capable of both homing to the bone marrow and regenerating a full array of hematopoietic cell lineages with early and late repopulating ability in a timely fashion.

Omidubicel is a stem/progenitor cell-based product composed of ex vivo expanded allogeneic cells from one entire unit of umbilical cord blood. Omidubicel utilizes the small molecule nicotinamide (NAM), as an epigenetic approach to inhibit differentiation and to increase the migration, bone marrow (BM) homing and engraftment efficiency of hematopoietic progenitor cells (HPC) expanded in ex vivo cultures.

The overall study objectives are to provide access to omidubicel for transplantation in patients with hematological malignancies and to collect additional safety and efficacy data.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be at least 12 years of age
* Applicable disease criteria
* Patients must have one or two partially HLA-matched CBUs
* Back-up stem cell source
* Sufficient physiological reserves
* Females of childbearing potential agree to use appropriate method of contraception
* Signed written informed consent

Exclusion Criteria:

* Extensive bone marrow fibrosis
* Donor specific anti-HLA antibodies
* Pregnancy
* Medically unsuitable for transplant
School Support as Structural HIV Prevention for Adolescent Orphans in Kenya

The purpose of this study is to test whether school support can keep adolescent Kenyan orphans in school, reduce sexual risk behaviors, and prevent HIV /HSV-2 infection.

This study examines the impact of school support as a structural intervention, tested among adolescent orphans in Siaya District, Nyanza Province, Kenya.

Aims for the proposed study are: 1) To experimentally test whether providing comprehensive school support to Kenyan orphaned boys and girls will reduce school dropout, reduce sexual risk behaviors, and prevent HIV/HSV-2 infection; 2) To conduct a process evaluation of the implementation of the program; and 3) To conduct comparative cost effectiveness analyses, specifying the intervention's cost and return on investment as evidenced by cost per unit improvement in the primary outcomes of school enrollment, delay of sexual debut and prevention of risk behaviors and HIV/HSV-2 infection, as well as by gains in health-related quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Orphan (one or both parents deceased)
* In Grade 7 or 8 in a primary school participating in the study
University of Michigan / Wayne State Chronic Pain Study

This study is designed to determine if a brief educational program can alter the attitudes and knowledge of individuals with chronic back pain, which is likely to be non-structural in nature.

Individuals will be randomly assigned to an experimental condition (performs written educational and emotional awareness exercises) or a control condition (completes a general health activities questionnaire). Comparisons will be made to assess the degree of centralized pain features and functional improvements at 1-month follow-up. A 10-month follow-up as a secondary endpoint is also planned.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking adults ages 18 years or older with internet access who are referred to the University of Michigan Health Service Physical Medicine and Rehabilitation Spine Program identified the physician with chronic nonspecific back pain (longer than 3 months) or fibromyalgia. Degenerative changes seen on imaging are considered nonspecific. Alternatively, enrolled in the University of Michigan Health Research Volunteer Pool with a profile that includes chronic low back pain or fibromyalgia.

Exclusion Criteria:

* Any signs of a serious underlying condition (cancer, infection, cauda equine), spinal stenosis or radiculopathy, or other specific spinal cause (vertebral compression fracture or ankylosing spondylitis). Those patients who are being considered for an interventional spine procedures or surgical consults would not be included in this study.
* Individuals receiving or applying for compensation or disability, the inability to provide written informed consent, severe physical impairment (e.g. blindness, deafness), co-morbid medical condition limiting function (e.g. malignant cancer), the use of illicit drug use, or a psychiatric condition that would limit judgment.
Differences Between Long Distance Road Runners and Treadmill Runners in Achilles Tendon Structure

this study will investigate the structure of the Achilles tendon and functional tests in road runners compared to treadmill runners.

Healthy runners (road and treadmill runners) who run regularly at least twice a week for half an hour, over 80% of the training on the treadmill or road, will be recruited for the study.

All subjects will fill out a demographic questionnaire for personal details (age, sex, height, weight, past injuries, training). Each participant will undergo functional tests in random order: 1. Examination of the morphology of the Achilles tendon - will be examined by ultrasound tissue characterized (UTC) 2. Balance test - Y Balance Test 3. Proprioception test - AMEDA device 4. Muscle strength test - manual dynamometer for testing gastrocnemius muscle strength. 5. Gastrocnemius muscle endurance test - single leg heel raise test until fatigue.

A comparison will be made between the two study groups.

Eligibility Criteria:
Inclusion Criteria:

* run regularly at least twice a week for half an hour,
* over 80% of the training on a treadmill or road

Exclusion Criteria:

* pain or injury to Achilles tendon during the 6 months, preventing running for at least 3 days.
* past Achilles tendon surgeries,
* sprained ankle in the last six months,
* lower limb and back pain while running
* participants who report running with minimalist shoes.
Efficacy and Safety of Paliperidone ER in First Episode Psychosis

The aim of the study is to investigate the efficacy and safety of Paliperidone ER in patients with first episode psychosis.


Eligibility Criteria:
Inclusion Criteria:

* Aged 18-59 years and meet DSM-IV diagnostic criteria for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version.

Exclusion Criteria:

* Meeting DSM-IV criteria for another axis I diagnosis, including substance abuse or dependence
* Needing another nonantipsychotic psychotropic medication at enrollment
* Having a serious or unstable medical illness.
* Pregnant or lactating women or women without adequate contraception will be also excluded.