cyrilzakka/clinical-trials huggingface dataset:
Phenomenology of Anxiety in Preschool Children With ASD

This study investigates the prevalence, phenomenology, and correlates of anxiety in preschool children with autism spectrum disorder (ASD) across a two-year period. Attention bias to threat, a potential objective marker of anxiety, also is examined using eye tracking methods.

Anxiety disorders in children with autism spectrum disorders (ASD) are one of the most prevalent and impairing co-occurring conditions, affecting approximately 40% of the population and causing major disruptions in school and family life. Research in typically developing (TD) children suggests that anxiety usually emerges in the preschool years (3-5 years) and can result in future psychopathology. Early detection and treatment of childhood anxiety in children with ASD can lead to improved clinical outcomes.

This study assesses the prevalence and phenomenology of anxiety in preschool children with ASD utilizing an established and comprehensive measure of anxiety in children with ASD across three time points (baseline, one year post, two years post).It also investigates the association of child (e.g., ASD features) and parent (e.g., mental health, caregiver strain) characteristics with anxiety cross-sectionally and longitudinally, to determine if certain correlates predict or maintain future anxiety. Attention bias to threat stimuli and its physiological correlates are also examined as potential objective markers of anxiety using eye tracking and pupillometry methods.

Eligibility Criteria:
Inclusion Criteria:

* Age 3 years 0 months to 5 years 11 months;
* DSM-5 ASD diagnosis based on clinical impressions and results of the Autism Diagnostic Observation Schedule-2 (ADOS-2)
* Child resides with at least one biological parent
* Parents are English speaking

Exclusion Criteria:

* History of psychological trauma
* History of neurologic illness
* Parent substance abuse, bipolar disorder, psychosis
* Parents require support from a medical interpreter
* Child displays severe behavior challenges
* Severe eyesight or hearing impairments that may interfere with the protocols
Collecting Bone Graft During Spinal Decompression and Posterolateral Lumbar Fusion to Better Define Bone Making Cells

The purpose of this study is to improve fusion (bony healing) techniques and improve patient recovery by identifying cells in your body that make bone. Patients with spine problems often need surgeries that include fusion (bony healing) of vertebrae (bones in your back) together in order to hold the bones steady allowing them to heal together (fusion). If the vertebrae (back bones) fail to heal together, which occurs about 10-15% of the time, it can result in a slower recovery and may require revision (another) surgery. By using a small portion of the graft taken during surgery the investigators hope to define the cells that make bone most efficiently. This will help reduce the need for revision surgeries and improve patient recovery.

This study requests using your additional bone tissue (the extra tissue not needed after your back surgery is complete).

This tissue will be measured for total volume (amount), labeled with your age, gender, date and time the tissue was removed (date and time of surgery), and taken to a lab for analysis. You will not be billed for the collection of your additional tissue or the lab analysis. All routine procedures (surgery and all follow-up care relating to your back surgery) will still be paid for by you or your insurance.

Once your extra tissue sample has been collected, measured, labeled, and sent to the lab for testing, no further participation is required from you in this research study. The investigators will use your sample in our research to enhance bone healing.

Eligibility Criteria:
Inclusion Criteria:

* Patients electing to undergo spinal decompression with an instrumented posterolateral fusion

Exclusion Criteria:

* Patients not undergoing spinal decompression with an instrumented posterolateral fusion
REACH VET Implementation Program Evaluation

The VA's Office of Mental Health and Suicide Prevention implemented an new program to increase suicide prevention outreach for Veterans at highest risk for suicide. Using a statistical model, REACH VET, short for Recovery Engagement and Coordination for Health - Veterans Enhanced Treatment, uses information from Veterans' health records to identify those who are at a higher risk for suicide, hospitalization, illness, or other negative outcomes. Once a Veteran is identified, his or her VA mental health or primary care provider reaches out to check on the Veteran's well-being and review their treatment plan to determine if enhanced care is needed. The goal of the current study was to evaluate the implementation of this program. The objectives of this evaluation were to evaluate how well this program is put into place using an implementation strategy called virtual external facilitation, and to collect data about the cost of the program and the strategy.

The VA's Office of Mental Health and Suicide Prevention is implemented an innovative new program to increase suicide prevention outreach and target Veterans at highest risk for suicide. Using a new predictive model, REACH VET, short for Recovery Engagement and Coordination for Health - Veterans Enhanced Treatment, analyzes existing data from Veterans' health records to identify those who are at a statistically elevated risk for suicide, hospitalization, illness, or other adverse outcomes. Once a Veteran is identified, their VA mental health or primary care provider reaches out to check on the Veteran's well-being and review their condition(s) and treatment plans to determine if enhanced care is needed.

The goal of the proposed study is to evaluate the implementation of REACH VET. The objectives of this evaluation are to:

1. evaluate the implementation of REACH VET using virtual external facilitation, and
2. collect preliminary data about the cost and cost offsets.

The current evaluation will examine the impact of a virtual external facilitation strategy on the implementation of REACH VET in 28 medical facilities across 7 Veteran Integrated Service Networks (VISNs) in a stepped wedge design. Primary implementation outcomes include metrics of REACH VET implementation: coordinator assignment, provider assignment, care evaluation, and attempted outreach. Qualitative interviews will be conducted with implementation facilitators, Suicide Prevention Coordinator(s), clinical leadership, and providers to identify barriers and facilitators to implementation of REACH VET and the experience of facilitation. Secondary data will be collected on the cost of the intervention and the cost of implementation strategy.

Eligibility Criteria:
Inclusion Criteria:

* VA employee at a facility receiving virtual external facilitation
* Involved in REACH VET implementation

Exclusion Criteria:

* Not a VA employee
* Not employed at a facility receiving virtual external facilitation
* Not involved in REACH VET implementation
General Clinical Study of AJG555 in Pediatric Patients With Chronic Constipation

This baseline-controlled, open-label, multicenter study evaluates the efficacy and safety of AJG555 orally administered for 2 weeks in pediatric participants with chronic constipation. The safety and efficacy of 12 weeks of administration will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

Main Inclusion Criteria:

* Participants with chronic constipation
* Age: 2 years old or older and 14 years old or younger (at the time of the informed consent)
* Gender: N/A

Exclusion Criteria:

Main Exclusion Criteria:

* Participants with organic constipation or participants suspected of having organic constipation
* Participants with symptomatic constipation or participants suspected of having symptomatic constipation
* Participants with drug-induced constipation or participants suspected of having drug-induced constipation
Pilot Project of Health Promotion for People With Diabetes

Limited participation in health promotion activities is noted in people with diabetes, even though lifestyle changes have been found to be essential in decreasing the risk of complications of the disease. The purpose of this study is to gather preliminary data to assess the feasibility of an intense, customized health promotion program in people with diabetes, and to evaluate outcome measures following participation to determine effect size for future studies. Subjects with type 2 diabetes will participate in a 10-week health promotion program, at a frequency of 3-4 days per week. The intervention will include aerobic and strength training exercises with a schedule of progression, individual nutrition counseling, and diabetes health education sessions.


Eligibility Criteria:
Inclusion Criteria:

1. diabetes type II
2. age 40-70

Exclusion Criteria:

1. hospitalization for myocardial infarction, heart surgery, or congestive heart failure during the preceding 3 months
2. significant cardiac arrythmia, hypertrophic cardiomyopathy, severe aortic stenosis, or pulmonary embolus
3. recent symptoms of chest discomfort
4. currently smoking or significant pulmonary pathology
5. serious musculoskeletal problems that would limit ability to exercise
6. current active involvement in a regular exercise program (\> 3 times per week)
7. open wounds on the weight bearing surface of the feet
8. not able to ambulate independently
9. stroke or other central nervous system pathology
10. stage 2 hypertension (resting blood pressure \> 160 systolic or \> 100 diastolic)
Prevention and Treatment of CINV Caused by TC Regimen in Gynecological Malignant Tumor Patients

To determine the best method to prevent CINV caused by TC regimen in patients with gynecological malignant tumor.

The risk of vomiting caused by high-dose carboplatin is controversial, and there is currently no prevention of TC in patients with gynecological malignant tumors High-level evidence-based medical evidence for programme-induced CINV. Therefore, different guidelines recommend the best antiemetic regimen as well It's different. This study is intended to conduct a prospective, multicenter, randomized, double-blind, placebo-controlled, crossover study The designed Phase III clinical study provides important data and basis for clinical practice and guideline formulation.

Eligibility Criteria:
Inclusion Criteria:

1. Age 20-75 years old;
2. ECOG PS：0～2;
3. She was diagnosed as gynecological malignant tumor and was to receive TC chemotherapy;
4. Carboplatin AUC 5～6mg/ml/min；
5. Basically normal organ function (normal bilirubin level circumference, normal range of creatinine, ALT\&lt; 2 times the upper limit of normal, AST\&lt; 2 times the upper normal value)

Exclusion Criteria:

1. Patients with previous history of chemotherapy, radiotherapy or targeted therapy;
2. Malignant tumors with brain metastases;
3. History of gastrointestinal malignancy;
4. History of brain tumor;
5. Previous gastrointestinal surgery history, such as segmental resection, (partial) gastrectomy, except intestinal polyp resection and appendectomy;
6. (incomplete) intestinal obstruction;
7. Vestibular dysfunction;
8. Massive abdominal accumulation liquid (except for those who have undergone puncture drainage);
9. Opioid concomitant drug users;
10. Diabetic.
Gonadotropin-Releasing Hormone Agonist for the Preservation of Ovarian Function During Chemotherapy in Premenopausal Breast Cancer

The study is a prospective randomized control clinical trial which is sponsored by the researchers. The purpose of this study is to determine the effectiveness of Gonadotropin-Releasing hormone agonist on ovarian function for premenopausal breast cancer patients during chemotherapy. The premenopausal breast cancer patients will be randomly (1:1) enrolled to receive standard chemotherapy with the GnRH agonist goserelin (goserelin group) or standard chemotherapy without goserelin (chemotherapy alone group). All patients are stratified according to age (\<35years vs.36-44years), hormone receptor status (HR+ or ER+ vs.HR- and ER-), chemotherapy regimen(3-4 cycles vs.6-8 cycles, and cyclophosphamide-based vs.noncyclophosphamide).The follow-up time will be at least 2years. The ovarian failure, follicle-stimulating hormone, estradiol and anti-Mullerian hormone, pregnancy outcomes and disease-free and overall survival will be compared between two groups to evaluate the effectiveness of protect against ovarian failure.


Eligibility Criteria:
Inclusion Criteria:

* The patients signed the written informed consent.
* Histologically proven stage I, II, or III breast cancer
* Must be candidates for adjuvant or neoadjuvant chemotherapy,
* Must be premenopausal.
* Trastuzumab is permitted in patients with human epidermal growth factor receptor 2 (HER2) overexpressing tumors.

Exclusion Criteria:

* The patients were previous chemotherapy;
* Evidence of distant metastases;
* Other malignancies in the previous 5 years.
* The patients were using GnRHa, progesterone, stimulate ovulation drugs, oral contraceptives, aromatase inhibitors, intrauterine device with hormone, subcutaneous preparations contraceptive drugs such as hormone drugs and instruments during 3 month preceding the start of chemotherapy.
* Pregnancy or lactation.
Internal Monitoring of Eye Movement in Schizophrenia

Background:

* Researchers are studying how humans are able to move our eyes to a remembered region even when the target has disappeared. The ability to do this suggests that the brain can keep track of where the eyes have looked, without an external target for continued reference. This is called corollary discharge.
* Other research has indicated that patients with schizophrenia might have difficulty monitoring their eye movements. The corollary discharge process may be defective in patients with schizophrenia, and perhaps delayed in time. Researchers have developed a test to examine this possibility in the hope of learning more about schizophrenia and eye movement.

Objectives:

- To assess whether there is a defect in internal monitoring of eye movements in patients with schizophrenia.

Eligibility:

* Individuals over 18 years of age who are able to give informed consent and are able to concentrate on a 20-minute task that involves following projected targets and moving their eyes to remembered locations.
* Individuals with schizophrenia will be recruited from an ongoing NIH protocol studying schizophrenia.
* In addition healthy will be recruited for this protocol.

Design:

* Researchers will check participants' vision in each eye, and ask them to sit at a machine that measures eye movement in order to complete research tasks. Researchers will monitor participants ability to complete these tasks.
* The first task involves simply following a target that jumps to different parts of the screen.
* The second is a 2-step task, in which a participant is asked to look at two separate light targets and then look at the remembered target positions when the lights are off.
* This protocol does not provide treatment. Participants will remain under the care of their own physicians during participation in this protocol.

OBJECTIVE:

To study if there is a defect in internal monitoring of eye movements in patients with schizophrenia.

STUDY POPULATION:

Patients with schizophrenia and normal controls.

DESIGN:

Patients and controls will be asked to follow targets to remembered locations and their eye movements will be monitored.

OUTCOME MEASURES:

Eye movements will be examined for evidence of internal monitoring (corollary discharge) defects which would result in mislocalizing remembered targets.

Eligibility Criteria:
* INCLUSION CRITERIA:

  1. Adult subjects over 18 years of age who are able to give informed consent and are able to concentrate on a task for 20 minutes which involves following projected targets and moving their eyes to remembered locations.

EXCLUSION CRITERIA:\<TAB\>

1. Large refractive error requiring strong glasses. Glasses may interfere with the video eye movement recording system. However, participants may wear contact lenses. Subjects with a history of eye disease affecting vision or eye movements will also be excluded.
2. Participants with guardians will be excluded.
Metformin Glycinate, Treatment of Patients With COVID-19 and Severe Acute Respiratory Syndrome Secondary to SARS-CoV-2.

The purpose of this study is to evaluate the efficacy and safety of the metformin glycinate and standard treatment of the hospital in hospitalized patients with Severe Acute Respiratory Syndrome secondary to SARS-CoV2.

After being informed about the study and potential risks, all patients giving written informed consent will undergo a 1 day screening period to determine eligibility for study entry. At day 0, patients who meet the eligibility requirements will be randomized in a double blind manner (participant and investigator) in a 1:1 ratio to metformin glycinate (620 mg, taken orally, twice daily) plus standard treatment or placebo (taken orally, twice daily) plus standard treatment, both for 14 days.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years old
2. Ability to understand and the willingness to sign a written informed consent document before any study procedure
3. Coronavirus infection, severe acute respiratory syndrome (SARS-CoV)-2 confirmed by the polymerase chain reaction (PCR) test ≤ 4 days before randomization.
4. Hospitalized
5. Radiographic evidence of pulmonary infiltrates

Exclusion Criteria:

1. Participation in any other clinical trial of an experimental treatment for COVID-19
2. Evidence of multi-organ failure
3. Require mechanical ventilation before randomization
4. Pregnant patients
5. Patients with kidney failure, cancer and among other conditions that due to their treatment and / or baseline condition, affect the distribution, bioavailability and elimination of the studied drug
The Efficacy and Safety of Apatinib Monotherapy in Maintenance Treatment of Extensive-stage Small-cell Lung Cancer

52 patients with extensive-stage small-cell lung cancer and without progression after completing chemotherapy, will receive apatinib monotherapy as maintenance therapy.

52 patients with extensive-stage small-cell lung cancer, who had a best response of complete response (CR), partial response (PR), or stable disease (SD) after completing chemotherapy will receive apatinib monotherapy as maintenance therapy after chemotherapy to evaluate the efficacy and safety of maintenance apatinib after chemotherapy for small-cell lung cancer. At the same time, we will explore the correlation between efficacy and tumor stem cell markers expression by taking peripheral blood to detect tumor stem cell markers. The primary end point is progression-free survival (PFS). The secondary end point is overall survival (OS), toxicity, and the correlation between efficacy and tumor stem cell markers expression.

Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed small-cell lung cancer and extensive stage (extrathoracic metastatic disease, malignant pleural effusion, contralateral supraclavicular adenopathy, or contralateral hilar adenopathy)
* Having a best response of complete response (CR), partial response (PR), or stable disease (SD) after completing chemotherapy, or combining sequential radiotherapy
* Prior treatment without c-kit targeted drugs
* Life expectancy of more than 3 months
* Age ≥ 18 years
* Oncology Group performance status of 0 to 2
* Informed consent.

Exclusion Criteria:

* Mixed lung cancer or other types of lung cancer
* Have previously received c-kit targeted drugs
* Hemoglobin\<8.0 g/dL, white blood cell \<3 X 10\^9/L, platelet count \<75 X 10\^9/L, alanine aminotransferase, glutamic-oxalacetic transaminase, blood urine nitrogen and creatinine more than normal limits on 3.0 times
* Known or suspected allergy to the investigational agent or any agent given in association with this trial
* Patients had recent major surgery, significant hemoptysis ( 5 ml), open wounds, or brain metastases present on required pre-enrollment brain imaging or required full-dose anticoagulation
* Uncontrol hypertension, \>160/100 mmHg after treatment
* Pregnant or lactating patients
* Known history of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV) infection
* Patients who are suffering from serious autoimmune disease
* Patients who had active infection
* Patients who are suffering from serious organ dysfunction
* Patients who are suffering from other cancer
* Other situations that the researchers considered unsuitable for this study.
* Other concurrent uncontrolled illness
Preoperative Breast Magnetic Resonance Imaging for Patients Undergoing Mammoplasty

all female with operable breast cancer seeking health care at general surgery department Assiut university hospitals,and decision of therapeutic mammoplasty was taken depending on clinical examination, findings on mammography and sonography, will undergo MRI breast, and see if MRI finding will change decision of the surgery.

* Study Setting: Assiut university hospital, general surgery department (C unit )
* Study subjects: all female with operable breast cancer seeking health care at general surgery department and decision of therapeutic mammoplasty was taken depending on clinical examination, findings on mammography and sonography.

The size, number, and location of breast cancer lesions were identified on US and mammography.

Also size, number, location, pattern of enhancement and presence or absence of intraductal component will be evaluated by preoperative MRI.

The surgical plane will be decided based on US and mammography findings. The final decision will be based on MRI findings. When the initial surgical decision was the same as final decision the patient will be assigned to the unchanged group.

However, if the final decision differed from the initial surgical decision the patient will be assigned to the changed group.

Eligibility Criteria:
Inclusion Criteria:

* Female patient with operable breast cancer (stage 1 and 2 ) Patient meet the criteria of therapeutic mammoplasty

Exclusion Criteria:

* Inoperable breast cancer (stage 3 and 4) Breast cancer size \> 4 cm in diameter Previous radiotherapy Local recurrence after previous breast conservation surgery Male breast cancer