cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Two Daily Disposable Contact Lenses.

The objective of this clinical study is to evaluate the product performance of SofLens daily disposable contact lenses packaged in the investigational Test solution versus SofLens daily disposable contact lenses packaged in Control, solution as it relates to comfort when used by subjects who use technology devices (eg, Personal Digital Assistants \[PDAs\], computers, electronic game consoles, hand-held electronic devices, electronic book readers, etc) on an average of 4 hours per day over a week's time for a minimum of 4 days each week.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
* Subjects must be free of any anterior segment disorders.
* Subjects must be adapted soft contact lens wearers and wear a lens in each eye and each lens must be of the same manufacture and brand.
* Subjects must be myopic and require contact lens correction from -0.50 D to -6.00 D in each eye.
* Subjects must be willing and able to wear the study lenses for at least 8 hours (12 hours or more is recommended) each day throughout the duration of the study.
* Subjects must use a technologic device for an average of 4 hours per day over a week's time and at a minimum of 4 days per week.

Exclusion Criteria:

* Subjects who have worn gas permeable (GP) contact lenses within the last 30 days or who have worn polymethylmethacrylate (PMMA) lenses within the last three months.
* Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an effect on ocular health during the course of the study.
* Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Subjects with an active ocular disease or who are using any ocular medication.
* Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
* Subjects with any "Present" finding during the slit lamp examination that, in the Investigator's judgment, interferes with contact lens wear.
* Subjects with any scar or neovascularization within the central 4 mm of the cornea.
* Subjects who have had any corneal surgery (eg, refractive surgery).
* Subjects who are allergic to any component in the study care products.
* Subjects may not use their habitual rewetting drops while participating in this study.
Amodiaquine-Artesunate & Artemether-Lumefantrine Efficacy in Burkina Faso

This is a two-arm study aiming at recruiting 150 patients to assess the efficacy of Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL) in patients with a microscopy positive diagnosis of malaria in Nanoro, Burkina Faso and assess the performance of the Rapid Diagnosis Tests (RDTs) compared to the microscopy.

Study background and purpose

* Resistance to usual drugs was widespread and has required a change of the malaria treatment by several countries
* Several countries have changed their first-line treatments to ACTs; mainly AL and ASAQ. \& have adopted the use of RDTs prior to treatment
* Indeed, this contributes to decrease the number of unnecessary treatments and thus improve the management of malaria cases.
* In February 2005, Burkina Faso changed its national drug policy from Chloroquine to Amodiaquine-Artesunate (ASAQ) and Artemether-Lumefantrine (AL)
* the country has also implemented the strategy of using the Rapid Diagnosis Tests (RDTs) for the diagnosis of malaria prior to treatment
* Though endemic countries are being encouraged to implement RDTs, choosing a particular RDT is not easy as several brands are available on the market.
* In addition, little information on the performance of RDTs in Africa is available and recently quality problems have been reported with some RDTs.
* In this context, it is important to locally assess the performance of RDTs compared with the microscopy, which is the gold standard for the malaria diagnosis and to assess the efficacy of the new drugs used for malaria treatment

This is a phase IV two-arm randomized open-label study aiming at recruiting 150 patients to assess the efficacy of ASAQ and AL in patients with a microscopy positive diagnosis of malaria in Nanoro, Burkina Faso and assess the performance of the RDT compared to the microscopy

Eligibility Criteria:
Inclusion Criteria:

* Age above 6 months,
* eight above 5 kg;
* Positive blood slide (parasitaemia ≥ 2,000/μL to 200,000/μL) with Plasmodium falciparum monospecific infection ;
* Fever (axillary temperature above 37.5 °C) or history of fever in the preceding 24 hours;
* Haemoglobin value above or equal 5.0 g/dL
* Signed informed consent;
* Willingness and ability to comply with the study protocol for the duration of the trial.

Exclusion Criteria:

* Participation in any other investigational drug study (antimalarial or others) during the previous 30 days
* Known hypersensitivity to the study drugs
* Severe malaria
* Danger signs: not able to drink or breast-feed, vomiting (\> twice in 24hours), recent history of convulsions (more than 1 in 24h), unconscious state, unable to sit or stand;
* Known intercurrent illness or any condition (cardiac, renal, hepatic diseases) which would place the subject at undue risk or interfere with the results of the study.
* Severe malnutrition (defined as weight for height less than 70% of the median NCHS/WHO reference)
* Known pregnancy
Improving Academic and Social Functioning in Middle-Schoolers With Autism

The goal of this study is to test how well two group interventions work for middle-school children with Autism Spectrum Disorder (ASD). One of the interventions focuses on teaching parents and adolescent skills to help improve their social functioning and the other focuses on teaching parents and adolescents skills to improve organization, planning, and study skills. Eligible participants will be randomly (like a coin flip) assigned to attend one of the two interventions.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of autism
* No intellectual disability
* Problems with organization, materials management, and planning and prioritization
* Problems with social skills
* Fully included in middle school
* Stable medication and behavioral treatment regime

Exclusion Criteria:

* Home schooled
* Severe co-occurring psychopathology (e.g., aggression, suicidal)
* Non English-speaking
Safety and Efficacy of TSHA-102 in Adolescent and Adult Females with Rett Syndrome (REVEAL Adult Study)

The REVEAL Adult Study is a multi-center, Phase 1/2 open-label, dose-escalation study of TSHA-102, an investigational gene therapy, in adult females with Rett syndrome. The safety, tolerability, and preliminary efficacy of two dose levels will be evaluated.

The study duration is estimated to be up to 63 months.


Eligibility Criteria:
Inclusion Criteria:

* Participant has a clinical diagnosis of classical/typical Rett syndrome with a documented pathogenic mutation of the methyl-CpG-binding protein 2 (MECP2) gene that results in loss of function.
* Participants must be willing to receive blood or blood products for the treatment of an AE if medically needed.

Exclusion Criteria:

* Participant has another neurodevelopmental disorder independent of the MECP2 loss-of-function mutation, or any other genetic syndrome with a progressive course.
* Participant has a history of brain injury that causes neurological problems.
* Participant had grossly abnormal psychomotor development in the first 6 months of life.
* Participant has a diagnosis of atypical Rett syndrome.
* Participant has a MECP2 mutation that does not cause Rett syndrome.
* Participant requires invasive ventilatory support.
* Participant has contraindications for IT administration of TSHA-102 or lumbar puncture procedure, or other medical conditions, or contraindications to any medications required for IT administration.
* Participant has uncontrolled seizures or a history of status epilepticus within the 3 months prior to enrollment.
Radiologist Diagnostic Performance Versus Artificial Intelligence (AI)

In France, femoral neck fracture is mainly detected with interpretation of pelvis/hip X-ray imaging (French Health Authority recommandation).

However, up to 10% of fractures are not identified or misdiagnosed, especially in patients admitted to the emergency department.

Indeed, radiologists may be subject to excessive work, wich cause the risk of inaccurate on X-rays diagnosis.

The Artificial intelligence (AI) begins study the detection of fratures on medical imaging.

In this retropective study, this technology developed by GLEAMER company is tested to evaluate the detection rate of hip fracture and specifically femoral neck fracture, compared to the radiologist diagnostic, in eldery patients admitted in emergency department.

AI could optimize the diagnostic performance of radiologists (increase of confidence level) and improve the efficiency of suspected fractures sorting from emergency department.


Eligibility Criteria:
Inclusion criteria:

* Patients aged 60 and older
* Minor trauma
* Admitted in emergency department for painful hip/fonctional impotence after minor trauma
* Takes at least a hip radiography

Exclusion criteria:

* Painful before the minor trauma
* Important trauma
Improving Sleep With the Far-infrared Emitting Pyjamas

The aim of this study is to explore the effects of a far-infrared emitting pyjamas on improving sleep in adults with poor sleep.

Objectives: To explore the effects of a far-infrared emitting pyjamas on improving sleep in adults with poor sleep.

Hypothesis: Subjects who wear the far-infrared emitting pyjamas (FIR pyjamas) will have greater improvement in sleep quality than the subjects in sham pyjamas control group (sham-pyjamas) at 2, 4 and 6 weeks.

Design and subjects: A pilot randomized sham-controlled trial. Subjects with subjective sleep complaints will be recruited from the community. 40 subjects will be randomized to far-infrared emitting pyjamas and sham-pyjamas groups in a 1: 1 ratio. Study instrument: Pittsburgh Sleep Quality Index (PSQI) will be used as an overall evaluation of sleep quality.

Interventions: Subjects in the FIR pyjamas group will received pyjamas with far-infrared emitting features and will wear it every night for 6 weeks; subjects in the sham-pyjamas group will receive pyjamas in identical appearance without far-infrared emitting features.

Outcome measures: The primary outcome measure is the PSQI score. Other measures include insomnia severity index (ISI), sleep parameters derived from 7-day sleep diary, Hospital Anxiety and Depression Scale (HADS), Epworth Sleepiness Scale (ESS) and Satisfaction With Life Scale (SWLS) at 2, 4 and 6 weeks. Acceptability of the far-infrared emitting pyjamas will also be evaluated.

Data Analysis: Differences in the questionnaire scores, subjective sleep parameters will be examined using a mixed-effects model. Clinical significance of sleep improvement between two groups will be compared with chi-squared test.

Eligibility Criteria:
Inclusion Criteria:

* Chinese Hong Kong residents who are able to read Chinese;
* Aged 18 - 65 years;
* Subjective sleep complaints of having difficulties in falling asleep, difficulties in staying asleep, or early morning awakening with consequences for daily life for at least 3 months.
* Pittsburgh Sleep Quality Index total score of at least 5 indicating sleep disturbance with 89.6% sensitivity and 86.5% specificity; and
* Willing to give informed consent and comply with the trial protocol.

Exclusion Criteria:

* Currently receiving psychotherapy or participating in other clinical trials for insomnia;
* Pregnancy;
* Shift workers;
* At significant suicidal risk as rated by the Hamilton Depression Rating Scale item on suicide (score ≥ 3);
* No comorbid sleep disorders primarily requiring other treatment, such as sleep apnea or narcolepsy; and
* Taking herbal remedies, over-the-counter medication, or psychotropic drugs that target insomnia within the 2 weeks prior to baseline.
Bi-PAP vs Sham Bi-PAP on Pulmonary Function in Morbidly Obese Patients After Bariatric Surgery

The effect of biphasic positive airway pressure (Bi-PAP) at individualized pressures on the postoperative pulmonary recovery of morbidly obese patients (MOP) undergoing open bariatric surgery (OBS) and possible placebo device-related effects (sham-Bi-PAP) were investigated.

In the present study the effect of Bi-PAP on the postoperative respiratory function and related complications of MOP undergoing OBS through a randomized sham-controlled design was investigated. Bi-PAP was applied at individualized pressures in order to optimize respiratory support and sham Bi-PAP was also used in order to neutralize possible placebo device related effect and researcher related bias.

The investigators hypothesized that the use of Bi-PAP at individualized pressures in MOP undergoing OBS, ameliorates postoperative respiratory function as well as diminishes related pulmonary complications, postoperative pain and duration of hospitalization. Primary endpoints were the difference in pre- and postoperative measurements of certain pulmonary function parameters (forced expiratory volume at one second (FEV1), forced vital capacity (FVC), peak expiratory flow rate (PEFR) and oxygen saturation by pulse oximetry (SpO2) and the incidence of certain pulmonary complications postoperatively (hypoxemia, atelectasis, lower respiratory tract infections). Secondary endpoints were postoperative pain and days of hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* All patients have been Morbidly Obese (BMI\> 40kg/m2) for at least 10 years
* All patients had unsuccessfully tried to lose weight by other non-invasive means.
* All patients enrolled were continuous positive airway pressure (CPAP) and Bi-PAP naïve and had no knowledge about the Bi-PAP apparatus prior to enrollment
* All patients underwent OBS (gastroplasty by Mason or gastric bypass) by the same operating team
* All patients were treated with the same standard anesthetic protocol

Exclusion Criteria:

* Cardiovascular and pulmonary disease not related to obesity status
* Chronic renal disease
* Patients who were initially enrolled but did not use the allocated device (Bi-PAP or Sham Bi-PAP) for at least 12 h daily were also excluded at a later point.
An Bioequivalence Study Of Xanax Extended Release Tablets From Two Different Manufacturing Sites

Study to evaluate if Xanax sustained release tablets manufactured at two different sites provide similar drug levels in the blood.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects between the ages of 20 and 55 years, inclusive.
* An informed consent document signed and dated by the subject.

Exclusion Criteria:

* Evidence or history of clinically significant abnormality.
* A positive urine drug screen.
* Subjects who are hypersensitive to alprazolam or related compounds.
VARA (Virtual and Augmented Reality Applications in Rehabilitation): Motor Rehabilitation Protocol With GRAIL for Patients Affected by Hemiparesis

The main goal of the study is to verify the efficacy of the GRAIL system in respect to the walking pattern improvement in a population of hemiparetic subjects.

In particular, the specific goals will be:

* increase in walking symmetry and a better distribution among the time of stance and swing.
* Kinematics and Kinetics correction, with incentive of more corrected activation timing.
* Recruitment of the muscles most involved by the paresis, with the help of visual feedback.
* walking speed increase (but with the priority of the walking pattern)
* increase in the resistance
* Stregthening of the support reaction


Eligibility Criteria:
Inclusion Criteria:

* hemiparetic patients as a consequence of acquired brain injury

Exclusion Criteria:

* excessive muscular spasticity or contractures.
* recent (under 6 months) lower limbs surgery
* cognitive or emotional/relational obstacles to the therapy
Family Risk Analysis of Substance Use in Attention Deficit Hyperactivity Disorder (ADHD) Youth Treated With Concerta

The researchers will study 100 families over three years, each with a child (proband) between the ages of 12-17, with the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of ADHD. The researchers hypothesize smoking will be familial and ADHD probands with a family history of tobacco use will be at increased risk for early initiation and persistence of smoking, compared to ADHD probands with no family history of tobacco use.

As Attention Deficit Hyperactivity Disorder (ADHD) is a documented risk factor for smoking in adolescents, and as theoretical considerations suggest that ADHD and tobacco use may share common underlying mechanisms, the proposed study looks to examine the association between smoking and ADHD. Since both ADHD and smoking are known to be familial disorders, one approach to examine the nature of the association between the two disorders is to conduct a familial risk analysis comparing ADHD youth who smoke and ADHD youth who don't smoke. Another approach is to conduct a genetic study, to identify candidate genes associated with nicotine abuse and dependence in ADHD youth and relatives.

This study includes:

1. assessment of psychopathology and substance use/dependence,
2. assessment of the family environment, and
3. assessment of molecular genetics in 100 families with at least one child (proband) between the ages of 12-17 with a DSM-IV diagnosis of ADHD.

Eligibility Criteria:
Inclusion Criteria:

* First-degree relative between the ages of 6-55 years of a family member (proband) between the ages of 12-17 with the DSM-IV diagnosis of ADHD
Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis

This post-market study aims to compare health outcomes for Chronic Rhinosinusitis (CRS) patients treated with balloon sinus dilation (BSD) versus continued medical management.


Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 19 or greater
* Diagnosis of Chronic Rhinosinusitis (CRS)
* Failure of appropriate medical management
* Radiographic evidence of inflammation of the paranasal sinuses
* Surgical candidate
* Willing and able to read and sign the Informed Consent Form and remain compliant with the protocol and study procedures
* Able to read and understand English

Exclusion Criteria:

* Not suitable for balloon dilation for all peripheral sinuses that require treatment
* Clinically significant illness that may interfere with the evaluation of the study
* Patients involved in other clinical studies 30 days prior to study
* Pregnant or lactating females
* Patients unable to adhere to follow-up schedule or protocol requirements
Brain and Muscle Plasticity During Immobilization

Patients in rehabilitation may undergo periods of prolonged limb immobilization in response to injury, surgery, or illness. Due to disuse, the size and strength of muscles controlling the affected limb can decrease significantly, possibly resulting in physical impairment or lower quality of life during the recovery phase. Prior immobilization studies have shown that the rate and degree of decline in muscle strength exceeds that of muscle size, indicating that determinants of muscle strength unrelated to muscle size may further contribute to functional changes during immobilization.

The purpose of this study is to describe the changes in muscle strength, muscle size, corticospinal excitability, voluntary activation, M1 cortical thickness, and resting state functional connectivity following a 2-week limb immobilization period in young women.


Eligibility Criteria:
Inclusion Criteria:

* Biologically female
* Right-hand dominant
* Body mass index between 18.5-30 kg/m\^2 (inclusive)
* Regular menstrual cycle
* Be able to maintain a habitual diet throughout the duration of the study

Exclusion Criteria:

* Use of tobacco
* Pregnancy
* A history of brain trauma
* Suffers from a neurological disease or movement disorder
* Peripheral nerve damage
* Use of medications known to affect protein metabolism (i.e., corticosteroids, non-steroidal anti-inflammatory drugs, or prescription strength acne medications)
* Diagnosed with or suspects having a psychiatric illness
* Use of dietary supplements known to affect muscle size (i.e., creatine, fish oil)
* Past or present diagnosis of an eating disorder by a physician or registered dietician
* Possesses any metal implants (e.g. artificial joints, pacemakers, stents) or non-removeable medical devices that are contraindicative for magnetic resonance imaging (e.g. insulin pumps)
Smoking and Alcohol Initiation

This study evaluates multi-attribute utility, a modification of subjective expected utility, as a descriptive model of the adolescent's decision to initiate smoking or alcohol use. According to the model, the young decision maker envisions a set of consequences that will follow the two decision options, either to continue as a non-user or to initiate usage. Each consequence has three components. The components are the worth of the consequence, which may be positive or negative, the judged likelihood that the consequence will happen, and the importance of the consequence. Within an individual, importances will change with mood or circumstance, which is how the model accounts for impulsive decisions that may occur in social settings.

The model will be tested by eliciting components of ten independent consequences from a large group of students early in the seventh-grade year. Current usage will also be examined; extant data suggest that most students will be non-users at that time. It is known that a fair amount of initiation takes place during the seventh and eighth grade years. The hypothesis is that those non-users whose model scores are high will be more likely to initiate usage than those whose scores are low. The same students will be queried regarding usage eighteen months later to evaluate the hypothesis.

It is now well known that differential knowledge regarding the harmful effects of drug use does not distinguish adolescent users from non-users. The model approach quantifies the idea that anticipated positive consequences play a prominent role in the decision of those who choose to initiate. An important implication is that prevention campaigns might profit by addressing positive as well as negative consequences of usage.

A book entitled "A science of decision making: the legacy of Ward Edwards" and 4 chapters were published (Oxford University Press, 2008) with the support of this funding.

Eligibility Criteria:
Inclusion Criteria:

* enrolled middle school students

Exclusion Criteria:

* N/A
Vitamin D Deficiency and Asthma Exacerbation

The study aim is in two phases. First phase: to evaluate the influence of vitamin D deficiency on asthma severity, degree of airway obstruction and frequency of asthma exacerbations. Second phase: to evaluate if in patients with vitamin D deficiency (25-OH vitamin D levels below 20 ng/ml), vitamin D supplementation decreases the number of disease exacerbations.

The first phase of the study consisted of a cross-sectional examination of a cohort of 119 asthmatic patients, who had at least one year regular follow-up in our respiratory clinic, and were not receiving any vitamin D supplementation.

In the second phase patients with vitamin D deficiency (25-OH D values below 20 ng/ml), were recruited in a one year longitudinal study, during which they received vitamin D supplementation. The study started and ended in late autumn-winter season when, at our latitude, sun exposure is lowest. Symptoms, spirometry and number of exacerbations were recorded during both study phases.

Eligibility Criteria:
Inclusion Criteria:

* All the consecutive patients with bronchial asthma of any severity, who presented for a scheduled visit at our Respiratory Clinic during the period October 2012-March 2013 and who had at least one year regular follow-up every three months

Exclusion Criteria:

* Acute exacerbation in the last month and treatment with vitamins and dietary supplements in the last year.