cyrilzakka/clinical-trials huggingface dataset:
Correlation of Children's Electronic Screen Time Exposure and Dental Anxiety and Behavior

This study aims to detect the correlation between children's electronic screen time exposure and dental anxiety and behavior in a group of Egyptian children


Eligibility Criteria:
Inclusion Criteria:

* Healthy children aged 6-to-8-years old
* First dental visit
* Both genders

Exclusion Criteria:

* Children with Mental or neurological disorders.
* Children with Systemic disorders.
* Children who use medications that could interfere with the central nervous system
* Children with previous hospitalization
Skin Fluorescent Imaging (SFI) System in Patients With Nevi

The Sponsor has developed the Skin Fluorescent Imaging (SFI) system, an in vivo imaging modality, for the purpose of providing physicians with insight into the biological changes occurring during tissue remodeling in a nevus.

The SFI system, a non-invasive point-of-care imaging system, is able to detect markers associated with tissue remodeling and thus provide real-time information about biological and structural changes occurring in nevi indicative of dysplastic transition.

Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study a subject must meet all of the following criteria:

* Provide a signed and dated informed consent form
* Age ≥ 18 years old
* Subjects must present with suspicious atypical nevi scheduled for a biopsy\*
* Nevi with at least 1 cm of skin surrounding the mole
* Nevi must be accessible to the SFI imaging device
* Excisional or a tangential excision with a dept of 1 to 2 mm biopsy will be performed for the mole tested within 21 days of testing.
* Nevi with clinically atypical features

Only 1 mole per eligible subject will be SFI tested in this study. \*NOTE: a subset of patients (\~10%) with benign nevi (by clinical observation) who wish to have nevi removed for cosmetic reasons will be enrolled as negative controls.

Exclusion Criteria:

An individual who meets any of the following criteria will be excluded from participation in this study:

* Subjects who are younger than 18 years old
* Lesions that are consistent with

  - Features of Keratosis and keratin plugs
  * Basal Cell Carcinoma
  * Squamous Cell Carcinoma
  * Challenging anatomical location (e.g., body cervices)
* Subjects with nevi that fit the inclusion criteria but are:

  * Less than 1 cm from the eyes
  * On the palms of the hands or soles of the feet
  * Associated with scar tissue
  * Mucosal lesions
  * Ulcerated lesions / breached skin
  * Lesions with some clinical certainty of being melanomas (large, dark, etc.)
  * Any nevi with ink marking including tattoos, on or adjacent to the nevi
  * Lesions treated with local anesthesia such as lidocaine prior to enrollment
  * Lesions larger than 20 mm or too large to allow imaging
  * Subject is known to be pregnant
  * Subject who is mentally or physically unable to comply with all aspects of the study
  * Subject who is undergoing systemic cancer treatment within 6 months of SFI testing
  * Subject with hypersensitivity to any of the SFI reagents
  * Subjects with known sensitivity to fluorescent dyes
  * Any subject who has previously participated (testing to biopsy) in SFI 003
Efficacy and Safety of LGX818 in Patients With Advanced or Metastatic BRAF V600 Mutant NSCLC

This is an open-label, multi-center, single arm phase II study to evaluate the efficacy and safety of novel BRAF (B-raf murine sarcoma viral oncogene homolog B1) inhibitor encorafenib (LGX818) when used as single agent in patients with advanced or metastatic (stage IIIB or IV) BRAF V600 mutant NSCLC. Patients must have progressed on or after at least one previous systemic, anti-cancer therapy for locally advanced or metastatic NSCLC.


Eligibility Criteria:
Inclusion Criteria:

* Presence of BRAF V600E mutation in tumor tissue
* Histologically or cytologically confirmed diagnosis of Stage IIIB or IV NSCLC
* At least one measurable lesion as defined by RECIST v1.1
* Patients must have progressed during or after at least one previous systemic, anti-cancer treatment for locally advanced or metastatic NSCLC.
* Eastern Cooperative Oncology Group (ECOG)/World Health Organization (WHO) performance status 0-2

Exclusion Criteria:

* Patients with symptomatic Central Nervous System (CNS) metastases
* History of leptomeningeal metastases
* Prior therapy with a BRAF inhibitor
* Patients taking prohibited medication listed in the protocol
* Presence or history of a malignant disease other than NSCLC that has been diagnosed and/or required therapy within the past 3 years.
* Impaired cardiovascular function or clinically significant cardiovascular diseases
* Pregnant or lactating women or woman of childbearing potential
Concordance of Three Imaging Methods by Dynamic CT, Contrast Ultrasound and CT Angiography in the Characterization of Endoleaks in Patients With an Aortic Endoprosthesis

Among patients who have undergone EVAR, there is a significant risk of 20-50% endoleak. These endoleaks often require secondary interventions to reduce the risk of expansion or rupture. Currently, three-phase CT angiography and CEUS ultrasound are recommended in the post-operative monitoring of EVAR but these remain limited in characterizing the type and source of endoleak. In this study the investigators will study the interest of d-CTA for a better detection and characterization of endoleaks.


Eligibility Criteria:
Inclusion Criteria:

* Patients 18 years of age and older,
* Patients who have received EVAR ,
* Detection of endoleak and/or with an aneurysmal sac enlargement greater than or equal to 5 mm over 6 months.

Exclusion Criteria:

* Minor patients,
* absence of endoleak and growth of the aneurysmal sac (greater than or equal to 5 mm over 6 months),
* patient under guardianship, curators, safeguard of justice,
* patient deprived of liberty,
* pregnant woman
* Patient who does not benefit from a social security scheme
Influence of Didgeridoo Practice on UA Obstruction Levels in Moderate OSA

Didgeridoo practice has been shown to improve OSA severity. The aim of our study is to assess the changes in upper airways obstruction levels before and after Didgeridoo practice in moderate OSA patients.

Didgeridoo practice has been shown to improve Obstructive Sleep Apnea (OSA) severity. The aim of our study is to assess the changes in upper airways obstruction levels, evaluated by sleep endoscopy, before and after 3 months of Didgeridoo practice in moderate non obese OSA patients. Severity of OSA will also be documented by polysomnography.

Eligibility Criteria:
Inclusion Criteria:

* moderate OSA, non obese

Exclusion Criteria:

* not willing play didgeridoo age\<18 significant lung, cardiac disease neuromuscular disease psychiatric disorders drugs with influence on respiratory drive
The Impact of Post-operative Voiding Trial on Length of Stay Following Laparoscopic Hysterectomy: A Prospective, Randomized Control Trial

The aim of this study is to investigate the impact of an active voiding trial compared to a passive voiding trial on time to discharge following a planned same day discharge laparoscopic hysterectomy. The investigators hypothesize that performing an active voiding trial will assess urinary function and lead to a reduction in length of stay.

Following laparoscopic surgery with hysterectomy, there is no standard method for assuring urinary function prior to discharge. Total laparoscopic hysterectomy (TLH) has been demonstrated to be safe with a reduction in post-operative morbidity and length of hospital stay with no difference in cancer related outcomes in endometrial cancer. Furthermore, the investigators have demonstrated that following the adoption of same day discharge, there was no difference in composite complication rates or readmissions. Awaiting a passive void trial may impact time to discharge as well as same day discharge; however, this has not been clearly studied in this patient population. The aim of this study is to determine the difference in time to discharge following an active voiding trial with bladder backfill in the post-operative recovery unit compared to a passive voiding trial with removal of the Foley catheter in the operating room at the end of the procedure. Secondary outcomes include time to void, catheter replacement, discomfort with the voiding trial, and overnight admission.

Eligibility Criteria:
Inclusion Criteria:

* Patients scheduled to undergo a total laparoscopic hysterectomy by a gynecologic oncology surgeon for either benign or malignant disease
* planned same day discharge surgery

Exclusion Criteria:

* history of significant urinary dysfunction (such as home catheterization) or neurologic dysfunction precluding spontaneous voiding
* bilateral radical pelvic dissection (defined as bilateral ureterolysis or removal of bilateral parametria)
* surgical cases converted to laparotomy or open surgery
* Surgical or medical contra-indications (based on the surgeons or anesthesiologists' recommendations) to same day discharge requiring inpatient admission
An Effectiveness and Safety Study of IDEA-033 in Comparison to Oral Naproxen and Placebo for the Treatment of Osteoarthritis of the Knee

The purpose of this study is to identify the dose(s) of IDEA-033 that will provide a meaningful effect for treating osteoarthritis of the knee.

The objective of this double-blind, placebo-controlled, randomized study is to evaluate the safety of and to identify the dose(s) of IDEA-033 that will provide a minimum clinically meaningful effect for treating the signs and symptoms of osteoarthritis of the knee. This study will also compare the safety profile of the three doses of IDEA-033 in treating the signs and symptoms associated with osteoarthritis for 12 weeks. The primary hypothesis is that at least one of the three doses of IDEA-033 is superior to placebo with respect to three primary efficacy endpoints of WOMAC Pain, WOMAC Physical Function, and Subject Global Assessment of Response to Therapy. A second hypothesis is that there is an increase in efficacy with increasing doses of IDEA-033.

Patients will receive one of five treatments for 12 weeks:Three doses of IDEA-033, or naproxen 1 g over-encapsulated tablet + placebo or placebo

Eligibility Criteria:
Inclusion Criteria:

* Osteoarthritis of both knees for minimum of six months
* Moderate pain in the most involved knee when not taking NSAIDs
* Must have used an oral NSAID on at least three days per week for last three months or 25 of 30 days before screening
* Demonstrate x-ray evidence of osteoarthritis in the most involved knee during the last six months

Exclusion Criteria:

* Grade 1 or Grade 4 severity of the most involved knee based on x-ray criteria
* Intra-articular injections or arthroscopy of the most involved knee during three months before Screening visit
* Inflammation of the most involved knee that could be related to gout or pseudogout-induced synovitis or infection
* A large bulging effusion
* History of gout or pseudo-gout induced synovitis or infection of the more severe knee
* History of partial or total knee replacement in either knee
Mass Balance Study of [14C]JAB-21822

Mass Balance Study of \[14C\]JAB-21822 in China Healthy Subjects

A phase I study to quantify the total mass balance in healthy subjects after a single dose of \[14C\]JAB-21822

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male subjects between the ages of 18 and 45 years (inclusive).
2. Subjects weighing ≥ 50 kg and Body Mass Index of 19.0 to 26.0 kg/m2.
3. Subjects who have voluntarily participated in the study and signed the informed consent form with good compliance.

Exclusion Criteria:

1. With abnormal and clinically significant comprehensive physical examinations, vital signs, or laboratory examinations.
2. Has a positive test for HBV, HCV, HIV, or syphilis.
3. Known medical history judged by the investigator as not suitable for the study.
4. Known history of drug or food allergy.
5. Has drug or alcohol abuse history or positive drug or alcohol abuse test results.
6. Heavy smokers or caffeine addicts.
7. Has diseases or other conditions affecting the absorption, distribution, metabolism, and excretion of oral drugs.
8. Disagree to strict contraception within one year after the trial
9. Has any other conditions judged by the investigator as not suitable for the study.
Screening Hepatitis Positive Women for Congenital Anomalies

Hepatitis C virus is one of the virulent viruses

Hepatitius positive women should be screened for congenital anomalies

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with hepatitis C virus received treatment during first trimester

Exclusion Criteria:

* pregnant women with hepatitis C virus who didnot receive treatment during first trimester
A Master Protocol for Orforglipron (LY3502970) in Participants With Hypertension and Obesity or Overweight: (ATTAIN-Hypertension Screening)

The GZPL master protocol will support 2 independent studies, J2A-MC-GZL1 (GZL1) and J2A-MC-GZL2 (GZL2). The purpose of this study is to create a framework to evaluate the safety and efficacy of orforglipron for the treatment of hypertension in participants with obesity or overweight.


Eligibility Criteria:
Inclusion Criteria:

* Has systolic blood pressure (SBP) ≥ 140 mmHg and/or diastolic blood pressure (DBP) ≥ 90 mmHg (if DBP criteria alone is met, SBP must be ≥130 mmHg) at screening (Visit 1).
* Has SBP ≥ 140 mmHg and/or DBP ≥ 90 mmHg (if DBP criteria alone is met, SBP must be ≥130 mmHg) at week 0 (Visit 3).
* Untreated for hypertension, or on stable antihypertensive medications ≥ 30 days prior to Visit 1.
* Have a body mass index (BMI) ≥ 25 kg/m².

Exclusion Criteria:

* Has SBP ≥170 mmHg and/or DBP ≥110 mmHg at Visit 1 or at Visit 3.
* Has known secondary causes of hypertension
* Have heart failure with reduced ejection fraction (HFrEF) diagnosis
* Have had any of the following conditions within 90 days prior to screening.

  * hospitalization for hypertension or for congestive heart failure
  * acute coronary syndrome or acute myocardial infarction, or
  * cerebrovascular accident (stroke).
* Have type 1 diabetes (T1D)
* Have acute or chronic hepatitis, including a history of autoimmune hepatitis
Risperidone-controlled,Multicentre Clinical Trial of Iloperidone in Patients With Schizophrenia

This research is a Randomized, double-blind, risperidone-controlled, multicenter clinical study. Chinese subjects with Ischemic Schizophrenia.

Subjects will randomly enter into one of two groups,the period of treatment is 8 weeks.

Eligibility Criteria:
Inclusion Criteria:

* men and women aged 18 to 65 years with schizophrenia;
* PANSS total score of at least 70 at screening and baseline;
* at least 2 more than 4 points in 7 of PANSS-P;
* informed consent.

Exclusion Criteria:

* allergy with iloperidone or risperidone;
* psychotic symptoms failing to improve after sufficient exposure to 2 antipsychotic treatment;
* any other primary Axis 1 psychiatric diagnosis;
* a history of alcohol or drug dependence in recent 1 year;
* at imminent risk of harm to self or others;
* systolic blood pressure≤90mmHg。
A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

The purpose of the study is to evaluate the safety and effectiveness of an investigational glaucoma therapy in patients with open-angle glaucoma or ocular hypertension.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older.
* Diagnosis of open-angle glaucoma (with or without pseudoexfoliation or pigment dispersion component) or ocular hypertension.
* Mean intraocular pressure (IOP) in at least one eye greater than 21 mmHg and less than or equal to 36 mmHg at screening visit.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Pregnant
* History of chronic or recurrent severe inflammatory eye disease.
* History of ocular infection or ocular inflammation within the past three months in either eye.
* Other protocol-defined exclusion criteria may apply.
Rapamycin Versus Mycophenolate Mofetil in Kidney-Pancreas Recipients

This study was designed to determine which maintenance immunosuppressive agent, rapamycin or mycophenalate mofetil, resulted in better outcome in patients with type 1 diabetes and renal failure, who presented for a kidney-pancreas transplant.

This is a randomized, prospective single center study evaluating the two maintenance drugs above.

Eligibility Criteria:
Inclusion Criteria:

* Patient with Type 1 diabetes and end stage renal disease.
* Women of childbearing potential must have had a negative pregnancy test (serum or urine).
* Patient agrees to participate in the study and sign an informed consent.
* Patient has no known contraindication to the administration of rapamycin or mycophenolate mofetil.
* Patient has no history of hypersensitivity to rapamycin or mycophenolate mofetil.

Exclusion Criteria:

* Patient has history of a malignancy within two years, with the exception of adequately treated localized squamous or basal cell carcinoma of the skin without evidence of recurrence.
* Patient is currently abusing drugs or alcohol.
* Patient is known or suspected to have an active infection or be seropositive for hepatitis B surface antigen (HBsAg), hepatitis C (HCV) or human immunodeficiency virus (HIV).
High Intensity Functional Training for Individuals With Neurologic Diagnoses and Their Care Partners

Individuals with and without neurologic diagnoses greatly benefit from participation in regular exercise but the majority are physically inactive. This is an issue for both them and their care partners as their health is often linked. This study aims to examine the long-term physical and psychosocial effects of structured, group-based, high intensity functional training (HIFT) exercise for people with neurologic diagnoses and their care partners.

Over the course of two years, this study will provide no-cost, twice weekly, group-based, HIFT exercise for people with neurologic diagnoses and their care partners. All participants will be required to have physician or advanced practice provider clearance to exercise. All participants will be evaluated by a physical therapist at no-cost prior to beginning the intervention to assess eligibility for the study. All eligible participants will complete a demographics questionnaire, questionnaires regarding physical and psychosocial health, and a battery of physical tests assessing mobility, strength, endurance, and balance. Participants' physical activity levels will also be monitored throughout the study through accelerometers.

Participants will participate in a maximum of twice weekly HIFT exercise for up to 2 years. All exercise programming will be led by licensed physical therapists with assistance from Doctor of Physical Therapy students. All exercise staff will be Cardiopulmonary resuscitation/basic life support certified and an automated external defibrillator will be available onsite. Exercise classes will utilize HIFT, which includes various exercises that are functional and to be performed at a high intensity. Exercises will include aerobic, resistance, and/or balance training and align with the 2018 Physical Activity Guidelines for Americans.

Eligibility Criteria:
Inclusion Criteria:

* Participants must be at least 18 years of age
* Participants must be able to communicate and read in English
* Participants must have physician and/or advanced practice provider clearance to exercise
* Participants must have a neurologic diagnosis (e.g., spinal cord injury, Parkinson's, brain injury, stroke, poliomyelitis, multiple sclerosis, spina bifida, etc.) OR participants must be care partner of a person with neurologic diagnosis.
* Participants must possess at least 4/5 elbow flexion strength bilaterally
* Participants must be able to locomote independently (i.e., ambulate or propel a manual or power wheelchair independently).
* Participants must provide their own transportation to/from the research study

Exclusion Criteria:

* Participants will be excluded if they fail to meet any of the inclusion requirements
Prehospital High-Flow Nasal Oxygen Therapy

The purpose of the present project is to compare High-Flow Nasal Oxygen therapy with Standard Oxygen therapy, initiated in the prehospital setting in patients with acute hypoxemia respiratory failure, in terms of oxygenation at arrival to the hospital and need of mechanical ventilation during the subsequent 28 days

Patients with respiratory distress and an SpO2 below 90% in the prehospital setting will be randomized to receive either high-flow nasal oxygen therapy through a dedicated device or standard oxygen therapy through standard devices such as nasal cannula or face mask. Need of mechanical ventilation either invasive or noninvasive from enrollment to day 28 and time course of oxygenation between first SpO2 measured on scene and arrival to the hospital will be the main outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* First SpO2 on scene \<90%
* At least one other sign of respiratory distress defined by (a) respiratory distress with a respiratory rate ≥ 25/min; (b) laboured breathing
* No advance directives or known decisions of Do Not intubate or Do Not Ventilate order.

Exclusion Criteria:

* Known COPD or other hypercapnic chronic respiratory failure
* age \<18 years
* Pregnancy or breastfeeding
* Anatomical factors precluding the use of a nasal cannula
* Emergency intubation required
* Patients with tracheostomy
* Patient transported to a hospital not involved in the study