cyrilzakka/clinical-trials huggingface dataset:
Effect of Spectacle Distribution to Myopic Secondary School Students in Rural Communities of Liaoning Province on Communities Academic High School Enrolment

To determine whether provision of free spectacles to rural-dwelling Chinese secondary school students with visually-significant refractive error, together with a teacher-based incentive to promote their use, increases the proportion of children going on to academic high school, as opposed to dropping out or pursuing a vocational track.

The investigators propose in the current trial to significantly expand the evidence base for spectacle distribution as the most-effective health intervention to improve educational opportunities for China's under-served rural children and adolescents by assessing impact on school attainment.

Eligibility Criteria:
Inclusion Criteria:

* Year 1 students (about 12-15 years old) from schools in county-level cities and below in Liaoning Province
* Uncorrected (self-glasses) visual acuity of ≤6/12 in both eyes
* Refractive error meets cut-offs shown to be associated with significantly greater improvement in visual acuity when corrected7 (myopia ≤-0.75 diopters (D, or astigmatism (non-spherical refractive error) ≥1.00 D
* Best corrected visual acuity ≥6/7.5 in either eye

Exclusion Criteria:

* Hyperopia ≥2.00 D
* Presence of visually-significant ocular condition besides refractive error
Dinoprostone Induction vs. Expectant Management After PROM at Term

Prelabour rupture of membranes (PROM) is associated with intrauterine infection and maternal and neonatal consequences. This risk increases with the length of time from PROM to delivery. Induction of labor has been shown to reduce the rates of those complications, however the optimal time interval has not yet been determined.

The main purpose of this single-center randomized prospective study is to assess the differences between two approaches of managing PROM at term-expectant management and induction with a dinoprostone vaginal delivery system.

Women with singleton pregnancy in cephalic presentation at term (37-41 6/7 weeks gestational age) will be randomised 4 to 12 hours after PROM when a sterile vaginal exam will be completed to assign Bishop score. When Bishop score at presentation will be ≤5, the study will be presented to the patient. Once the patient will be consented and randomized, women will receive dinoprostone vaginal delivery system (for up to 24 hours after randomisation) or will be managed expectantly (for up to 24 hours after randomisation).

Patients randomized to the expectant management group will be admitted to the maternity ward, where they will wait up to a maximum of 24 hours for labor to start spontaneously.

Patients in the induction group will also be admitted to the maternity ward and induced with a dinoprostone vaginal delivery system. If not removed sooner, the vaginal delivery system will be removed after 24h.

If patients in both groups will not be in active labor 24 hours after randomisation they will be admitted to the delivery room and health care providers will manage active labor per usual practice. The need for cesarean section or operative delivery or will be at the discretion of the healthcare provider.

In the days following birth, woman in both groups, will be asked to fill in a questionnaire about their satisfaction with the labour experience.

Eligibility Criteria:
Inclusion Criteria:

* 4 to12 hours after prelabour rupture of membranes
* 18-50 years of age
* Parity 0 to 2
* Singleton pregnancy
* Cephalic presentation
* Term (37-41 6/7 weeks gestational age)
* Bishop score ≤5
* Reassuring fetal status

Exclusion Criteria:

* Uterine contractions
* Signs of infection
* Signs of non-reassuring fetal status
* Meconium-stained amniotic fluid
* Group B Streptococcus colonization
* Fetal demise or major congenital anomaly
* Intrauterine growth restriction (estimated fetal weight ≤ 3 percentile)
* Contraindications for vaginal birth or use of prostaglandins for labor induction
First in Man Study With SLV342

First in man study with single and multiple rising doses with SLV342


Eligibility Criteria:
Inclusion Criteria

* Healthy

Exclusion Criteria

* Not healthy
Comprehensive Assessment of Nutrition and Dietary Intervention in Hypermobile Ehlers Danlos Syndrome

This study involves a comprehensive nutritional assessment of hEDS participants who have functional gastrointestinal disorders and dietary intervention to broaden their food choices and nutritional intake.

The impact of diet on symptoms in patients with Hypermobile Ehlers Danlos Syndrome (hEDS/HSD) is widely recognised yet poorly understood. The investigators aim is to assess existing dietary patterns and nutritional status in hEDS/HSD as well as pilot a personalised dietary strategy to optimise nutrition. Participants recruited from EDS UK and a tertiary Neurogastroenterology clinic at the Royal London Hospital will undergo comprehensive nutritional assessment and blood tests. The investigators will then undertake a feasibility study of personalised dietary intervention in select cohort of patients.

Eligibility Criteria:
Inclusion Criteria:

* Have completed Phase I of the CANDI-hEDS study
* Diagnosis of hEDS / HSD according to physical examination and history taking
* Diagnosis of Functional Dyspepsia and / or Irritable Bowel Syndrome according to Rome IV criteria
* Able and willing to give informed consent
* Access to video conferencing and a smart phone device
* Able to travel to the Wingate Institute

Exclusion Criteria:

* Dependent upon artificial feeding (parenteral and enteral)
* Structural gastrointestinal disease
* Any chronic health condition which already requires a restricted diet e.g. diabetes mellitus
* Functional vomiting disorder with associated weight loss
* Multiple Type I hypersensitivity reactions to food groups (i.e. anaphylaxis, urticaria, respiratory symptoms or positive RAST tests).
* Previous or current severe mental health disorder (e.g. severe depression with suicidal ideation)
* Previous or current eating disorder
* Positive screen for avoidant restrictive food intake disorder (ARFID)
Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Delicata Pocket BR

The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Delicata Pocket.


Eligibility Criteria:
Inclusion Criteria:

* Integral skin test in the region;

Exclusion Criteria:

* Lactation or gestational risk or gestation;
* Use of Anti-inflammatory or immunosuppression drugs 1 month before the study;
* Topical medication use at the region to be treated;
* Cutaneous disease or active gynecological disease which may interfere in study results;
* Personal history of allergic disease at the area to be treated;
* Allergic or atopic history;

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Role of Oxytocin in Telling and Detecting Lies

The investigators are interested in the impact of intranasal oxytocin in unethical behavior.

The objective of this project is to further explore the role of oxytocin in moral judgment and ethical behavior. Oxytocin is a peptide hormone produced in a variety of hypothalamic neurons. It is released into the brain or brought into general circulation through sensory stimuli in a pulsatile fashion. In social psychology research, oxytocin is hypothesized to coordinate both the causes and effects of positive social interactions in a biofeedback loop.

Eligibility Criteria:
Inclusion Criteria:

* Male

Exclusion Criteria:

* _____ _____BP \> 130/85, HRT \> 95 (can be included at discretion of study physician/designee)

  * _____History of seizures
  * _____Neurological Disorder
  * _____Current psychiatric disorder
  * _____Previous psychiatric disorder (can be included at discretion of PI)
  * Date last episode (if \> 1 year, include; if \<1 year, at discretion of PI)
  * _____Current use of psychoactive drugs
  * _____Previous use of psychoactive drugs (can be included at discretion of PI) _____Date last medicated_____ _____Type of medication___________________________________
  * _____Current use of anticoagulants
  * _____Current use of corticosteroids
  * _____Previous head trauma (can be included at discretion of PI)
  * _____Alcoholism or substance abuse
  * _____Carcinoma of the breast or prostate
  * _____Renal or Hepatic diseases
  * _____Chronic lung diseases
  * _____Cancer
  * _____Liver problems
  * _____Hypertension/Cardiac diseases
  * _____Cardiovascular Disease
  * _____Nephritis
  * _____Diabetes (use of insulin) /Obesity
  * _____Endocrine disease or malignancy
  * _____Asthma (can be included as discretion of study physician/designee, if episodes are infrequent, nonmedicated, and no active problems at time of study)
  * Medication
  * Frequency of episodes____ _____Date of last episode_____
  * _____Migraines(can be included as discretion of study physician/designee, if episodes are infrequent, nonmedicated, and no active problems at time of study)
  * Medication _____Frequency of migraines_____ _____Date of last migraine_____
  * _____High levels of physical contact with women or children
Infliximab and Methotrexate in Ankylosing Spondylitis

There is a great individual variability of pharmacokinetic of infliximab in patients treated for ankylosing spondylitis (AS). Moreover, some patients have a treatment with methotrexate (MTX), others have not.

Thus, the aim of this study is to assess the effect of MTX on the pharmacokinetic properties of infliximab in 30 patients treated for AS, 15 with MTX, 15 without.


Eligibility Criteria:
Inclusion Criteria:

* Ankylosing spondylitis
* Needing anti-TNF drugs

Exclusion Criteria:

* Contra-indications to anti-TNF drugs
Pinch Grafting Versus Second Intention Wound Healing for Mohs Micrographic Surgery Defects on the Scalp

Oftentimes, following surgery on the scalp, wounds are left to heal by themselves. This is called "second intention." Open wounds left to heal on the scalp often take 8 weeks or more to completely heal. The investigators are investigating how second intention closure compares to another established reconstruction technique, called "pinch graft." In the pinch graft technique, a dermatological surgeon numbs and then shaves off a thin piece of skin (usually from the groin area) and places it in the wound bed it (also known as "grafting"), to encourage growth of new healthy skin. This study will compare time-to-healing in the second intention method versus the pinch graft method.

Pinch graft methodology was first developed in 1976 as a treatment to accelerate healing of lower leg ulcerations, particularly venous or gravitational ulcerations (1, 2). It was later adapted as a tool to hasten healing in surgical wounds, such as surgical closure of diabetic foot wounds (3). It has also been used in the healing of patients with wounds related to dystrophic epidermolysis bullosa (4). More recently, pinch grafts have been investigated as a reconstruction option for Mohs micrographic surgery defects (5). In this study, patients with below the knee Mohs surgical defects were randomized to receive either PG reconstruction or SIH reconstruction. Patients with PG reconstruction healed 20 days sooner (i.e., faster time to reepithelialization) than those who underwent SIH. Complication rates, including infection and reported pain, were also lower in the PG cohort compared to the SIH cohort. SIH is often recommended as a reconstruction technique for surgical wounds without adjacent skin laxity to support primary closure, such as the anterior lower extremity and scalp. There is no study to date examining the use of pinch grafts in scalp wounds. In our study, the investigators explore whether PG is a viable and useful reconstruction method for wounds on the scalp that otherwise would be left to close via SIH. Specifically, in our study, the investigators examine the comparative time to healing and complication rates between PG and SIH in Mohs surgical defects of the scalp.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Able to give informed consent themselves
* Patient scheduled for cutaneous surgical procedure on the scalp with predicted second intention closure
* Willing to return for follow up visit
* Active user of MyChart
* Willing to send weekly messages until wound is healed

Exclusion Criteria:

* Incarceration
* Under 18 years of age
* Pregnant women
* Unable to understand written and oral English
* Scalp wounds with planned primary repair reconstruction
* Surgical defects with bone exposure
* No MyChart access or use
The Effect of Tablet Size on Cognitive Performance Caffeine

This study aims to assess if tablet size, due to placebo effect, alters participants' performance on cognitive tests after consuming caffeine. Participants will be randomly assigned to one of four groups: 1) 90 mg caffeine with a 1 mm diameter sucrose pillule; 2) no caffeine with the small sucrose pillule; 3) 90 mg caffeine with a 5 mm sucrose pillule; 4) no caffeine with the large sucrose pillule.

Background: A capsule's physical design (e.g. shape, size, and color) affects individuals' perception of drug efficacy; that is, how well a drug is likely to work. The goal of this study is to assess the effects tablet size may have on participant's performance on cognitive testing since research has found differences between preparation methods. Method: 120 participants will be randomly assigned to one of four groups: 1) 90 mg caffeine with a 1 mm diameter sucrose pillule; 2) no caffeine with the small sucrose pillule; 3) 90 mg caffeine with a 5 mm sucrose pillule; 4) no caffeine with the large sucrose pillule. Participants will consume the designated placebo tablet with water (caffeinated or non-caffeinated); then, participants will provide weekly caffeine intake and complete the neutral portion of Velten's Mood Induction Procedure until 30 minutes have passed to allow for caffeine activation. Participants will complete the Stroop test, Trial Making Tests A and B, and the Rey Auditory Verbal Learning Test. Previous literature, as far as the author knows, relied on evaluating drug efficacy based on appearance alone. This study aims to assess if tablet size, due to placebo effect, alters participants' performance on cognitive tests after consuming caffeine.

Eligibility Criteria:
Inclusion Criteria:

* Fluent in written and spoken English
* Ability to see color
* No uncontrolled high blood pressure
* No allergies to caffeine or sucrose
* No history of heart disease
* No untreated anxiety or depression
* Non-pregnant
* No caffeine consumed the day of participation

Exclusion Criteria:

* Not fluent in written and/or spoken English
* Uncontrolled high blood pressure
* Color-blindness
* Allergies to caffeine and/or sucrose
* History of heart disease
* Untreated anxiety or depression
* Pregnant
* Consumed caffeine on the day of participation
Open-Label Extension Study for the Long-Term Efficacy and Safety of Roxadustat in Participants With Dialysis and Non-Dialysis Chronic Kidney Disease

The purpose of this open-label extension study is to evaluate long-term efficacy and safety of roxadustat in maintaining hemoglobin (Hb) in participants with dialysis and non-dialysis chronic kidney disease (CKD) who have completed the Treatment Period of a roxadustat FibroGen-sponsored anemia study.

This is an open-label, long-term maintenance study of roxadustat anemia therapy in participants with dialysis and non-dialysis CKD who have completed the Treatment Period of a roxadustat FibroGen-sponsored anemia study. Participants assigned to roxadustat in the previous study will continue to receive the same roxadustat dose and dosing frequency, unless a dose adjustment is required.

Eligibility Criteria:
Inclusion Criteria:

1. Minimum age 18 years
2. Completed the Treatment Period of an ongoing roxadustat FibroGen-sponsored anemia study in the United States.

Exclusion Criteria

1. Participants assigned to epoetin alfa in a previous ongoing roxadustat anemia study
2. Pregnant or breastfeeding females
3. Females of childbearing potential, unless using adequate contraception; male participants with sexual partners of childbearing potential who are not on birth control unless the male participant agrees to use adequate contraception
4. Participants who received roxadustat in a previous study that did not demonstrate adequate hemoglobin response per the investigator's clinical judgment
5. Any medical condition that in the opinion of the investigator may pose a safety risk to a participant in this study or which may interfere with study participation
Optical Biopsy of Human Skin in Conjunction With Laser Treatment

This study is to compare the ability of optical biopsy. Research can use light enters the skin, collected, analyzed by the computer, and a picture created for the pathologist to conventional histologic examination compare with the pathologist looking at the piece of tissue through a microscope makes the diagnosis.

The Optical measurements provide quantitative optical property values that reflect changes in tissue perfusion, oxygen consumption, and cell/matrix development. Each measurement requires less than 5 minutes to execute. The measurements will be taken before and after skin treatment.This non-invasive, non-contact technique has great potential as a means to diagnose different skin problems without the need to obtain a piece of tissue from the skin.

Eligibility Criteria:
Inclusion Criteria:

* Male or female age \> 18 years

Exclusion Criteria:

* current participation in any other investigational drug evaluation
* inability to understand and carry out instructions
Preoperative Chemoradiation Versus Short Term Radiation Alone With Delayed Surgery for Stage II and III Resectable Rectal Cancer

Trial compares two preoperative stage II and III rectal cancer treatment strategies: short term radiotherapy 5x5 Gy and delayed surgery after 6 weeks versus conventional chemoradiotherapy 50 Gy + 5Fu/Lv and surgery also after 6 weeks.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed stage II and III rectal cancer less than 15 cm from anal verge
* less than 80 years old
* no other cancer during 5 years period
* compensate cardiovascular, pulmonary, hepatic and renal functions.

Exclusion Criteria:

* stage I or IV rectal cancer
* other cancer in 5 years period
* radiotherapy or chemotherapy in anamnesis
* not compensate cardiovascular, pulmonary, hepatic or renal functions, neurological, psychiatric disease, sepsis, etc.
* pregnancy or baby feeding
Pre-hospital Rule-out of Acute Coronary Syndrome

Patients with chest pain suspected for non ST-segment elevation acute coronary syndrome (NSTE-ACS) are routinely transferred to the emergency department (ED). A point-of-care (POC) troponin measurement might enable ambulance paramedics to identify low-risk patients in whom ED evaluation is not necessary. The ARTICA trial aims to assess the healthcare cost reduction and safety of a pre-hospital rule-out strategy using a single POC troponin measurement.

Patients with chest pain suspected of a NSTE-ACS are screened by ambulance paramedics. The HEAR score (HEART score without the Troponin component) is assessed and patients with a HEAR score of ≤3 are included. The patients are randomised to 1) pre-hospital rule-out with POC troponin measurement (intervention group) and 2) direct transfer to the ED (standard care group). Primary outcome is healthcare costs after 30 days.

Eligibility Criteria:
Inclusion criteria:

* Age at least 18 years; male ánd female
* All out-of-hospital patients with chest pain or symptoms suggestive of ACS initially visited by an ambulance with an indication for transfer to a hospital to evaluate and rule out ACS
* Symptom duration for at least two hours
* Modified HEAR(T) score less or equal than 3
* A point of care troponin below the upper reference limit (for patients stratified to pre-hospital management by the general practitioner)
* The patient has been informed of the nature of the study, agrees to its provisions and has provided written informed consent.

Exclusion criteria:

* Electrocardiographic ST-segment elevation
* Patients presenting an obvious non-cardiac cause for the chest complaints who need evaluation at an emergency department, e.g. trauma, pneumothorax, sepsis, etc.
* Patients in comatose state, defined as an Glascgow coma scale (GCS) \<8
* Patients with known cognitive impairment
* Pregnancy or intention to become pregnant during the course of the study
* Patients presenting cardiogenic shock, defined as: systolic blood pressure \<90 mmHg and heart rate \>100 beats per minute and peripheral oxygen saturation \<90% (without oxygen administration)
* Patients presenting with syncope
* Patients presenting with signs of heart failure
* Patients presenting with heart rhythm disorders and second or third degree atrioventricular block
* Patients with known end-stage renal disease (dialysis and/or glomular filtration rate (GFR) \< 30 ml/min)
* Patients without a pre-hospital 12-lead ECG performed or available
* Patients suspicious of aortic dissection or pulmonary embolism
* Patients with confirmed acute myocardial infarction, percutaneous coronary intervention or coronary artery bypass grafting \<30 days prior to inclusion
* Communication issues with patient/language barrier
* Decision of a present general practitioner to evaluate the patient at the emergency department (ED)
* Decision of the consultant cardiologist to evaluate patient at the ER irrespective of HEART score
* Any significant medical or mental condition, which in the Investigators opinion may interfere with the patients optimal participation in the study
VEGF Gene Association With Response to Neovascular Age-related Macular Degeneration With Anti-VEGF Agents

The main purpose of this study is to investigate the association between VEGF gene polymorphism and the response to intravitreal drugs in neovascular age-related macular degeneration. This is a retrospective review of patients treated between 2008 and 2012 at the Institute of Vision, in Belo Horizonte, Brazil.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of neovascular age-related macular degeneration
* Visual acuity better than 20/400
* Loading dose with three intravitreal injections of anti-VEGF agents, administred one per month over three months
* Follow-up period of at least six months

Exclusion Criteria:

* Choroidal neovascularization secondary to any other cause than age-related macular degeneration
* Eyes with polypoidal choroidal vasculopathy
* Eyes previously submitted to posterior vitrectomy
* Other diseases that could affect visual acuity