cyrilzakka/clinical-trials huggingface dataset:
Gaze Modification Strategies for Toddlers With Autism Spectrum Disorder

This project seeks to understand how the gaze behavior of infants and children with or at high risk for autism spectrum disorder (ASD) may be manipulated in the contexts of dynamic social and non-social scenes. The study explores not only the methods which may be most effective in aligning and teaching normative patterns of scene exploration, but also seeks to establish what behavioral characteristics may be most predictive of atypical scanning and atypical learning.

This study initiates a highly novel line of research which uses adaptive, gaze-contingent, eye-tracking technology to help infants and children with or at high risk for ASD learn to direct their attention to people and their actions in a more typical fashion. This study will begin with a Normative Collection phase, and will conclude with a Gaze-Shaping phase. In the Normative Collection phase, the investigators will examine the gaze behavior of a group of typically developing infants and children with typical development (TD), in order to establish a normative gaze pattern. In the Gaze-Shaping phase, within the same videos shown in the Normative Collection phase, the investigators will highlight selectively targeted people, objects, and activities, in an attempt to shape participants' viewing patterns to match the normative gaze pattern.

Manual coding of live-action interaction probes will provide an additional evaluative measure, allowing the investigators to track real-world (live-action) correlates alongside video-eye-tracking behaviors. In addition, live-action probes may allow the investigators to check for generalization to live interaction with another person (as opposed to gaze behavior when watching videos). In live-action probes, one or two clinical research staff member(s) will interact with each participant (or with each other in front of the participant), in a manner analogous to the actions performed in the training videos.

Please note: The original estimated enrollment as specified to and funded by NIH was 98 participants, but was incorrectly listed on ClinicalTrials.gov as 220 participants reflecting maximal recruitment in this and other ongoing studies.

Eligibility Criteria:
Inclusion Criteria:

* Between the ages of 18 and 60 months
* Fulfill criteria for autistic disorder or PDD-NOS (Pervasive Developmental Disorder- Not Otherwise Specified) on the Autism Diagnostic Observation Schedule - Module 1
* A diagnosis of autism or PDD-NOS by experienced clinicians

Exclusion Criteria:

* Gestational age below 32 weeks
* Suspected or diagnosed hearing loss or visual impairment
* History of head trauma with loss of consciousness
* Non-febrile seizure disorders
* Diagnosed neurological abnormality significantly impacting on visual or auditory acuity.
Study Comparing 0.5mg of Ranibizumab and Higher Doses in the Treatment of Clinically Significant Diabetic Macular Edema

The purpose of this study is to evaluate the safety and tolerability of Ranibizumab in patients with Clinically Significant Diabetic Macular Edema (CSDME). It will also compare treatment outcomes for patients receiving 0.5mg Ranibizumab and higher doses of 1.0mg and 2.0mg Ranibizumab.


Eligibility Criteria:
Inclusion Criteria:

* Type I or Type II diabetic subjects
* Vision between 20/20 and 20/400
* Presence of Clinically Significant Diabetic Macular Edema

Exclusion Criteria:

* Presence of any condition that would prevent clear visualization of the back of the eye
* Uncontrolled glaucoma
* Complications of glaucoma
* Inflammation inside the eye
* Certain prior eye surgeries, other than cataract surgery
* Other eye diseases that may compromise the vision in the study eye
* Certain prior eye treatments
* Pregnancy
* Uncontrolled health conditions
* History of heart attack
* History of stroke
* Current participation in another investigational trial
An Open Study of the Effect of Itraconazole Oral Solution for the Treatment of Fluconazole Refractory Oropharyngeal Candidiasis in HIV-Positive Subjects.

To assess the efficacy and safety of itraconazole oral solution in HIV-seropositive patients with oropharyngeal candidiasis that is refractory to fluconazole.

Patients receive itraconazole oral solution twice daily. Per 08/15/94 amendment, patients with complete resolution of oropharyngeal candidiasis lesions upon completion of treatment are eligible for maintenance treatment on protocol FDA 236C. Patients who decline maintenance are followed for 6 weeks. Patients who relapse during follow-up are re-treated for 14-28 days; if lesions clear, patients may enter the maintenance protocol.

Eligibility Criteria:
Inclusion Criteria

Patients must have:

* HIV antibody seropositivity or diagnosis of AIDS.
* Confirmed oropharyngeal candidiasis.
* Failed fluconazole treatment within the past 14 days.
* Life expectancy of at least 3 months.
* NO symptoms of esophageal candidiasis (e.g., dysphagia) unless endoscopic exam of esophagus was performed and fungal esophagitis was not present.
* NO prior disseminated candidiasis.

Exclusion Criteria

Co-existing Condition:

Patients with the following symptoms or conditions are excluded:

* Underlying clinical condition that precludes study completion or places the patient at significant risk.
* Considered unreliable about following physician's directives.

Concurrent Medication:

Excluded:

* Investigational drugs (approved expanded access drugs are permitted).
* Rifampin.
* Rifabutin.
* Phenobarbital.
* Phenytoin.
* Carbamazepine.
* Terfenadine.
* Astemizole.

Patients with the following prior conditions are excluded:

* History of hypersensitivity to imidazole or azole compounds.
* Clinical evidence of significant hepatic disease within the past 2 months.

Prior Medication:

Excluded:

* Investigational drugs within 1 month prior to study entry (approved expanded access drugs are permitted).
Study for Effectiveness Evaluation of Panax Ginseng, Vitamins and Minerals (Natugerin®) in Improvement of Stress and Fatigue

It is hoped that the group treated with Panax Ginseng, Vitamins and Minerals obtain significant reduction in levels of stress and fatigue and that the results are superior to the placebo group.


Eligibility Criteria:
Inclusion Criteria:

* Agree with all study procedures, signing the IC in two ways, by his own free will;
* Patients older than 18 years, male or female, regardless of ethnicity or social class;
* Presence of pictures of mild to moderate stress, confirmed with the aid of the Stress Symptom Inventory (ISS), which considers stress and mild to moderate classification Alert classification Resistance;
* Presence frame of fatigue with a score greater than 36 according to the Fatigue Severity Scale (FSS).

Exclusion Criteria:

* Participation in clinical trials in the 12 months preceding the survey;
* Current treatment with drugs that are stimulants or central nervous system depressants such as hypnotics, anxiolytics, antipsychotics, antidepressants, statins and muscle relaxants;
* Alternative Therapies that scientifically, or have no influence in the tables of stress or fatigue as acupuncture or relaxing massages;
* Treatment psychotherapeutic medication or not;
* Current treatment or prediction of treatment with oral anticoagulants (due to interaction with the tocopherol);
* Women who are pregnant or lactating;
* Patients with lactose intolerance;
* Patients allergic to soy or peanuts;
* chronic renal failure;
* Patients using other multivitamins or individual vitamins such as vitamin D and / or A.
* Chronic alcoholism;
* Patients with clinical diagnosis of diseases causing severe chronic pain or adversely affect the clinical interpretation as fibromyalgia, multiple sclerosis, neuropathies and myopathies;
* Patients with hypothyroidism or hyperthyreosis diagnosed clinically;
* Patient history and physical examination suggestive of severe hepatorenal failure;
* Patients with decompensated diabetes mellitus (fasting glucose above 180 mg / dL);
* Patients being treated for cancer;
* Amendment of the routine of life during the study as early vacation or suspected change in working hours;
* Patients with complaints of excessive sleepiness caused by organic source frameworks such as sleep apnea and morbid obesity (BMI above 35);
* History of hypersensitivity to any component of the product under investigation;
* Any finding of clinical observation (clinical history or physical examination) that is interpreted by the physician investigator as a risk to the patient's participation in the study.
Clinical Efficacy of Biomimetic Hydroxyapatite in the Treatment of Molar Incisor Hypomineralization.

The aim of the following study is to evaluate che clinical efficacy of a toothpaste with biomimetic hydroxyapatite for the management of Molar-Incisor Hypomineralization. Patients who agree to participate to the study will use Biorepair toothpaste for the first 7 days of the month for 3, 6 and 9 months. The following indices will be measured: BEWE, Bleeding Index, Gingival index, Plaque index and the dental sensitivity test. The contralateral tooth will be used as control if not affected by MIH; otherwise, adjacent teeth will be considered.

Informed consent will be signed by the parents of the patients underage; patients will be asked the approval for the attendance of the study.

Adult patients will sign the informed consent for the treatment and for processing personal data for research purpose, with their approval for the attendance of the study.

Patients will be given for free a toothpaste with biomimetic hydroxyapatite (Biorepair Enamel-Repair Shock Treatment) and the Investigator will explain the correct procedures for home oral care. The toothpaste will be applied the first 7 days of the month for 9 months with a specific tray.

Teeth will be randomly assigned to:

* Trial group: 1 tooth with MIH from 1 quadrant will be treated with the biomimetic hydroxyapatite toothpaste. The applications will be performed for the first 7 days of the month for 9 months (1 application per day that lasts 10 minutes).
* Control group: 1 contralateral tooth with MIH will not be treated with the biomimetic hydroxyapatite toothpaste Patients will be visited after 1, 2, 3, 6 and 9 months from the baseline. For each visit, BEWE index, Bleeding Index, Gingival index, Plaque index and Dental sensitivity test. Tooth with MIH will be assessed, together with its contralaterals as control. If the contralateral tooth should suffer from MIH too, measurements will be carried out on the adjacent tooth.

Eligibility Criteria:
Inclusion Criteria:

* presence of at least 2 enamel demineralizations of permanent molars and incisors (Molar-Incisor Hypomineralization - MIH) in contralateral quadrants
* good general health (absence of systemic diseases)

Exclusion Criteria:

* patients undergoing orthodontic therapy
* patients taking drugs
Vitamin A Equivalence of the Provitamin A in Biofortified Bananas

The objective will be to quantify the vitamin A equivalence of the provitamin A in transgenic biofortified bananas.


Eligibility Criteria:
Inclusion Criteria:

* General good health as determined by interview, blood biochemistry profile, and complete blood count
* Antecubital veins amenable to blood collection

Exclusion Criteria:

* Adverse reactions to blood sample collection
* History of anemia or excessive bleeding
* Cigarette smoking, frequent alcohol consumption
* Use of vitamin/mineral supplements
* Food allergies
* Lactose intolerance
* Abnormal thyroid status
* Chronic disease, lipid malabsorption or gastrointestinal disorders
* Hyper- or hypolipidemia
* Body mass index (BMI) \> 28
* History of eating disorder or restrained eating
* Current or planned pregnancy; menstrual cycle irregularities or abnormalities
* Use of hormonal contraceptives (affects chylomicron clearance); use of medications that may affect lipid absorption or transport
A Multicenter, Cross-sectional Study on the Quality of Life in Long-term Survival Esophageal Cancer Patients After Radical Radiochemotherapy/Radiotherapy

This study is a multicenter cross-sectional survey of esophageal cancer patients who underwent radical chemoradiotherapy/radiotherapy from July 2017 to July 2020 in various medical centers, and who survived without disease progression at the time of the survey. The purpose of this study is to evaluate the current quality of life, as well as the incidence of long-term toxic side effects, nutritional status, and psychological status of esophageal cancer patients cured by radiotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Voluntarily accept this survey and research;
* The age at the time of radiotherapy is between 18-75 years old, and the age at the time of investigation is\<80 years old;
* Histologically confirmed esophageal squamous cell carcinoma without undergoing surgical resection;
* Received radical chemoradiotherapy/radiotherapy from July 2017 to July 2020, currently alive and without disease progression;
* Radiotherapy dose ≥ 45Gy.

Exclusion Criteria:

* Patients who do not cooperate with this survey;
* Patients who have died at the time of investigation;
* Patients who experience tumor progression within the time frame from the end of radiotherapy to receiving this survey;
* Patients diagnosed with other malignant tumors within the time frame from the end of radiotherapy to receiving this survey;
* Patients with incorrect contact information and missing visits
Combined Suprascapular and Axillary Nerve Blocks for Arthroscopic Shoulder Surgery

Arthroscopic shoulder surgery is associated with severe pain postoperatively. Regional nerve block adding to general anesthesia might improve the quality of postoperative analgesia. The aim of the study is to compare the subacromial local anesthetic infiltration and the suprascapular-axillary nerve blocks combination for intraoperative sevoflurane consumption, postoperative analgesia and analgesic consumption.

After informed consent and with ethics approval, 60 ASA 2-3 patients scheduled for elective arthroscopic shoulder surgery will be included in this study. Patient will be divided to two groups by using computer -generated list for randomization. In group A, the surgeon will apply 20 ml of 0.250% bupivacaine to the subacromial region at the end of the procedure. In Group B, suprascapular (10 ml of 0.250% bupivacaine ) and axillary block (10 ml of 0.250% bupivacaine) will be performed with ultrasound and nerve stimulator guidance before induction of anesthesia. In all patients after standard and BIS (Bi spectral index) monitorization general anesthesia will be induced with remifentanil (10mcg iv), propofol (2.5 mg/kg iv) and rocuronium (0.5mg/kg iv). After intubation, anesthesia will be maintained with 50% O2 and N2O mixture. Hemodynamic parameters, BIS values, end-tidal sevoflurane consumption will be recorded by blind investigator. Postoperative visual analog scale (VAS) values, postoperative analgesic consumption (Tramadol, patient controlled analgesia), complications will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* American society of anesthesia physical status (ASA) 1,2 patients
* Elective arthroscopic shoulder surgery

Exclusion Criteria:

* ASA 3,4 patients
* Coagulation abnormality
* Body mass index \>30
* Preexisting neurological deficit Local anesthetic allergy history Diabetes
Tamoxifen Pharmacokinetics and CYP2D6 Polymorphisms in Asian Women With Hormone Receptor Positive Breast Cancer

We hypothesized that subjects with CYP2D6\*10 alleles may have a lower steady state levels of endoxifen due to reduced conversion of tamoxifen to endoxifen.

Primary objectives:

* To determine the steady state pharmacokinetics of tamoxifen and its metabolites
* To test the effects of genetic polymorphisms of CYP2D6 on plasma concentration of tamoxifen and its metabolites in hormone receptor positive women who are taking tamoxifen as adjuvant treatment for breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Signed informed consent.
* At least 18 years of age.
* On tamoxifen for at least 3 months for adjuvant therapy.
* On a stable diet for past 1 week before blood sampling.
* Compliant with tamoxifen medication.
* Completed adjuvant chemotherapy and/or adjuvant radiation therapy.

Exclusion Criteria:

• Patients should not be on the list of medications for the last 1 week before accrual to the study
Targeted Hypoglossal Neurostimulation Study #3

The purpose of this study is to evaluate the benefits and risks of hypoglossal nerve stimulation with the ImThera Medical aura6000 System as a potential therapeutic option for individuals with moderate to severe OSA that have failed or do not tolerate PAP.

The objectives of this study are to evaluate the safety and effectiveness of the aura6000 System for the treatment of moderate to severe obstructive sleep apnea (OSA) in individuals who have failed or do not tolerate positive airway pressure (PAP) therapy or have failed or are intolerant of or refuse indicated alternative OSA treatments (such as oral appliances, positional devices and conventional sleep surgeries). PAP failure is defined as an inability to eliminate OSA (AHI \> 20 despite PAP usage) and PAP intolerance is defined as: 1) inability to use PAP (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night); or 2) unwillingness to use PAP (for example, a patient returns the PAP system after attempting to use it). The results of this study are anticipated to provide reasonable assurance of the safety and effectiveness of the aura6000 System when used as intended and to support the application for FDA Premarket Approval of the system.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years
* Individual has failed or does not tolerate PAP therapy
* Has failed or refuses alternative OSA treatments (e.g.surgery, oral appliances, and behavioral treatments)
* AHI ≥ 20 (Moderate to severe OSA)

Exclusion Critera:

* Implanted with another active implantable device
* Body mass index (BMI) ≥ 35 kg/m²
Development and Validation of the Patient-completed Caprini Risk Score

The investigators aimed to test the reliability and validity of the Chinese version of patient-completed CRS in hospitalized patients and to evaluate whether this form can be widely used in clinical practice instead of only health care workers' evaluation.


Eligibility Criteria:
Inclusion Criteria:

* patients older than 18 years
* patients with first admission to the medical and surgical units within 24 hours
* willingness to participate in the study

Exclusion Criteria:

* patients with a diagnosis of PTE or DVT on admission
* patients with cognitive impairment
* inability to read or write
* patients with mental diseases
* patients with visual impairment
* refusal to cooperate
School-Based Intervention Program to Promote Healthy Eating and Physical Activity

The purpose of this research is to develop, apply, and evaluate a school-based intervention program in East Jerusalem schools, designed to increase knowledge and to improve the attitudes and healthy behavior of schoolchildren, their teachers and their mothers' with regard to healthy eating and physical activity habits. The study tested the hypothesis that the impact of the entire school intervention program on students' lifestyles is mediated by their teachers' engagement in health promotion and by their mothers' involvement in school activity.

A randomized controlled intervention program trial was carried out in 14 females' schools in East Jerusalem, selected randomly by a stratified sampling of four groups of schools. The primary target population was the students, while the secondary target populations were the mothers and the teachers at these schools. From the schools operating in East Jerusalem (Palestinian Authority, Jerusalem Municipality, private, and United Nations Relief and Works Agency) grades 4 and 5 were considered eligible to participate in the pre- and post-intervention studies.

The study process was designed, using the ecological model, in three stages; Stage one: Need assessment stage (pre-intervention, March-Jun 2011): A semi-structured interview was used with all 14 school principals, and a structured self-administered questionnaire was used with all teachers. A random sample of a 4th and 5th grade classes was selected, in which all mothers and their daughters were eligible to answer a self-administered questionnaire. The height and weight of the children were measured during this stage. These measurements were the baseline for assessing the current situation. In addition to school inspection tours was done to assess the school's health environment.

Stage two: Action stage (intervention, September 2011-June 2013): A random allocation of schools into intervention and control groups was done, followed by participatory planning and administration of the intervention in each of the 7 schools based on their needs assessments and assets. The program was implemented and administered by a steering committee in each of the schools, consisting of teachers, mothers, and children. Teachers underwent trainings in nutrition and physical activity. The program activities were monitored by regular visits twice a month. The implementation team met every four to six weeks to review the progress.

Stage three: Evaluation (post intervention, February-April 2013): Evaluation of the program was done after eighteen months of intervention using the same assessment questionnaires for both intervention and control schools among a different sample of children from grades 4 and 5, their mothers, and all of the teachers.

Eligibility Criteria:
Inclusion Criteria:

* East Jerusalem Female Schoolchildren

Exclusion Criteria:

* None
Role of Indocyanine Green (ICG) for Detection of Sentinel Nodes in Breast Cancer

This is a single-center prospective study evaluating the diagnostic performance and safety of Infracyanine in women with early breast cancer whose the research of sentinel node(s) combines isotopes and Infracyanine.

Visits:

Screening:

Complete physical and gynecological examination by surgical oncologist Informed and signed consent form. The intervention will be planned within one month.

Intervention:

In the beginning of the intervention, a periareolar injection of the Infracyanine will be carried out (Infracyanine®, 2ml to 2.5mg/ml whether 3.2nM).

The search or sentinel node will be made using a infrared camera for transcutaneous visualization Secondly, data lymphoscintigraphy may be communicated to the surgeon. The nodes are identified as SN fluorescent nodes and / or radioactive nodes.

* All radioactive nodes and / or fluorescent will be deleted
* Reports of anatomy fluorescent SN and / or hot

Next visit:

The patient will be reviewed in consultation in the months following the itervention for a clinical examination, the collection of adverse events.

Eligibility Criteria:
Inclusion Criteria:

1. Female age \> 18 years
2. Invasive breast cancer ≤ 5 cm, unifocal bifocal or multifocal
3. Diagnosis confirmed by biopsy
4. Breast cancer extended in situ
5. First surgical treatment

Exclusion Criteria:

1. Neoadjuvant chemotherapy or hormone therapy.
2. Multicentric tumor
3. Pregnant patient
4. Ongoing participation in another clinical trial with an investigational drug