cyrilzakka/clinical-trials huggingface dataset:
Cognoa ASD Diagnostic Device - Data Collection Study

The primary objective of this study is to collect data to ascertain the PPV and NPV of the current version of the Cognoa diagnostic device. A secondary objective is to collect data, in the form of additional questions, in order to train new algorithms related to children's developmental and behavioral conditions.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 months of age and \< 72 months of age
* Functional English capability in the home environment
* Documented parental and/or clinician concern for developmental delay
* Participants must have a smartphone capable of downloading the Cognoa App (Cognoa supports iOS 10.0 and up, Android 6.0 and up)

Exclusion Criteria:

* Children with suspected auditory or visual hallucinations or with prior diagnosis of childhood onset schizophrenia.
* Children with known sensory impairment such as deafness or blindness
* Children with known physical impairment affecting their ability to use their hands
* Children with major dysmorphic features or prenatal exposure to teratogens (such as fetal alcohol syndrome)
* Children with history or diagnosis of genetic conditions (such as Rett's syndrome or fragile X)
* Children with microcephaly
* Children with history or prior diagnosis of epilepsy or seizures
* Children with history of or suspected neglect
* Children with history of brain defect, injury or insult requiring interventions such as surgery or chronic medication
* Children whose age on the date of enrollment is outside the target age range
* Children who have been previously enrolled in any Cognoa clinical study or survey
* Children whose medical records had been included in any internal Cognoa training or validation sets
BIOmarkers of Dyspnea IN Emergency Room

The purpose of this study is to evaluate the capacity of some novels biomarkers Procalcitonin (PCT), Midregional Proadrenomedullin (MR pro ADM), Midregional pro-atrial natriuretic peptide (MR pro ANP), Copeptin (CT pro arginine vasopressin), Pro endothelin to stratify the risk in severe dyspnea.

In emergency department shortness of breath (SOB)is a common symptom and its cause is not easy to be identified. The risk stratifying remains a challenge, Prognostic value of biomarkers might be helpful.

Eligibility Criteria:
Inclusion Criteria:

* tachypnea \> 25 /min or Pa02 \< 70 mmHg or SpO2 \< 93%
* diagnosis suspected: CAP, PE,EACOPD, AHF

Exclusion Criteria:

* other cause of dyspnea,
* unreachable on Day 30
Methylphenidate for Treating Children With ADHD and Tourette Syndrome

This study will evaluate the safety and effectiveness of methylphenidate in treating attention deficit hyperactivity disorder in children with both attention deficit hyperactivity disorder and Tourette syndrome.

Tourette syndrome is a neurological disorder that is characterized by repetitive, involuntary movements and vocalizations called tics. Many children with Tourette syndrome also have attention deficit hyperactivity disorder (ADHD), which is one of the most common childhood mental disorders. Symptoms of ADHD usually include impulsiveness, inattention, and hyperactivity. ADHD is commonly treated with a stimulant medication, such as methylphenidate. It is under debate, however, whether using stimulants in children with Tourette syndrome exacerbates tics associated with the disorder. This study will evaluate the safety and effectiveness of methylphenidate in treating ADHD in children who have both ADHD and Tourette syndrome.

Participants in this 6-week, double blind study will receive three doses of methylphenidate over the course of the study. Each dose will be taken twice daily, approximately 3.5 hours apart, for 2 weeks. Medication will be dispensed at study visits, which will occur once every 2 weeks. At each study visit, participants will take a dose of the medication. About an hour after ingesting the medication, they will be observed in a classroom setting by study physicians. Participants will then complete a Continuous Performance Test, which will measure their voluntary attention levels. The following will be assessed at study visits: ADHD symptoms; oppositional and aggressive behavior; frequency and severity of tics and obsessive compulsive disorder symptoms; rebound tic exacerbation; effects of methylphenidate on tic-related problems with self-esteem, family life, academic and social performance, and overall tic severity; anxiety and mood symptoms; and adverse drug reactions. Parents and teachers will also complete assessments of participants' behavior on 2 days of each week for the duration of the study.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of ADHD or ADHD plus Tourette syndrome

Exclusion Criteria:

* Determined to be dangerous to self or others
* Scores less than 70 on an IQ test
* Any seizure disorder, major organic brain dysfunction, major medical illness, major mood disorder, psychosis, pervasive developmental disorder, or peripheral sensory loss
* Any condition that may make use of methylphenidate unsafe
Study Comparing Standard Dose and High-dose Imatinib Mesylate in Patients With Chronic Phase Philadelphia Chromosome Positive (Ph+) Chronic Myelogenous Leukemia (CML)

The study will assess the role of high-dose imatinib mesylate, in patients who have taken imatinib mesylate for at least 1 year at the standard dose, in achieving a major molecular response (a measure of the level of chronic myelogenous leukemia) versus the standard dose.


Eligibility Criteria:
Inclusion Criteria:

* Chronic myelogenous leukemia with Philadelphia chromosome
* 18 years and older
* Patients must have been taking imatinib mesylate standard dose for at least 12 months and have achieved a complete cytogenetic response but not a major molecular response.

Exclusion Criteria:

* Patients with cardiac problems such as congestive heart failure, or myocardial infarction within the last 6 months
* Patients with an uncontrolled medical disease such as uncontrolled diabetes, chronic renal (kidney) disease or active uncontrolled infection.
* Patients with other current primary malignancy or malignancy requiring active intervention

Other protocol defined inclusion/exclusion criteria may apply.
A Phase 1b Study Assessing GS-7340 in Treatment-Naive Adults With Chronic Hepatitis B

This is an open-label study evaluating multiple doses of GS-7340 versus Tenofovir disoproxil fumarate (TDF).

This is a randomized, open-label, active-controlled study whose primary objective is to evaluate the safety and efficacy of several doses of GS-7340. This study will evaluate the safety, viral kinetics, and antiviral activity of 4 different doses of GS-7340 over 28 days of therapy. In addition, the study will evaluate the antiviral activity of an optimal dose of GS-7340 versus 300mg Tenofovir disoproxil fumarate (TDF) over 28 days of therapy.

Eligibility Criteria:
Inclusion Criteria:

* Must be between 18 and 65 years of age
* Must have Screening plasma HBV DNA ≥ 2x10\^3 IU/mL
* Must have chronic HBV infection for at least 6 months
* Must have estimated creatinine clearance (CLCr) ≥ 70 mL/min
* Not pregnant or nursing
* Women must be of non-childbearing potential OR of childbearing potential with confirmed negative pregnancy tests
* Consistent and correct use of recommended methods of birth control for men and women

Exclusion Criteria:

* Pregnant or lactating subjects
* Receipt of anti-HBV nucleoside/nucleotide therapy. Subjects who have failed prior Interferon treatment, greater than 6 months prior to screening, are permitted to participate in the study screening
* Known co-infection with HIV, hepatitis C virus (HCV) or hepatitis D virus (HDV)
* Presence of autoimmune disorders
* History of liver disease other than Hepatitis B
* History of Gilbert's Disease
* Any sign of decompensated liver disease
* Known or suspected cirrhosis
* Evidence of hepatocellular carcinoma
* Presence or history of cardiovascular disease, cardiomyopathy, and/or cardiac conduction abnormalities
* Electrolyte abnormalities
* History of treatment that permanently alters the gastric condition
* Alcohol or substance abuse
* History of bleeding diathesis
* Significant bone disease
Accuracy of the Pima™ CD4 Test for Enumeration of CD4+ T-Cell Counts

This is a multi-center study designed to assess the accuracy of Pima™ CD4 Test to enumerate CD4+ T-cells in whole blood over the measurement range expected for the intended population. The Pima CD4 Test consists of the Pima™ CD4 cartridge and Pima™ Analyzer to identify and determine the absolute counts of mature helper (CD3+/CD4+) T-lymphocytes in whole blood.

Blood samples will be collected from HIV infected adolescents and adult men and women presenting to a physician's office or outpatient clinic. Capillary whole blood samples will be obtained by fingerstick in duplicate from all Subjects in the study for immediate measurement of CD4+ T-cell count on the Pima CD4 Test by a trained healthcare professional. Venous whole blood samples from all Subjects in the study will also be collected and transported to the clinical laboratory of each study site for concurrent testing on the reference method by a trained laboratory professional. Venous samples from all Subjects in the study will also be measured on the Pima CD4 Test at the study site. Hematocrit will also be measured for all Subjects.

Eligibility Criteria:
Inclusion Criteria:

1. 12 years of age or older
2. Confirmed HIV infection, HIV-1 or HIV-2 according to medical history (this inclusion will be waived for healthy non-HIV infected individuals who may need to be enrolled in order to fill the high end of the CD4+ T-cell measurement range of the Pima CD4 Test.
3. Subject agrees to complete all aspects of the study

Exclusion Criteria:

1. Subject has already participated in this study at a previous date
2. Subject is enrolled in a study to evaluate a new drug
3. Patient unable or unwilling to provide informed consent
4. Vulnerable populations as deemed inappropriate for study by site principal investigator.
Stylet Shape in Simulated Endotracheal Intubation by Medical Students

Endotracheal intubation is a life saving procedure where a tube is placed into a person's windpipe to help them to breathe. This is a study of which shape of tube would lead to improved success in this procedure.

Endotracheal intubation (ETI) is a lifesaving procedure. It involves placing a tube in the patient's airway to maintain ventilation and oxygenation.

Simulation has been shown to be effective for medical procedural skills training. Medical simulation literature now focuses on instructional design (ID) features that improve learning.

There are multiple aspects of ETI technique and ID that can be modified to improve successful ETI. Patient positioning, mastery learning, and dyad rather than solo practice are examples for which evidence exists to guide instructors. Despite this, ETI complication rates are substantial.

Thus, areas for continued improvement in ETI ID should be explored. One area is the optimal endotracheal tube (ETT) shape, achieved using a stylet, for novices learning ETI, for which there is limited evidence.

The straight to cuff (STC) shape has been postulated to optimise views of the airway compared to an arcuate shape. These shapes have only been directly compared as subgroups among multiple other comparisons in ETI technique in difficult intubations in one study. This does not generalise well to educating novices such as medical students, where intubations at normal difficulty are within the learner's zone of proximal development, and findings from subgroup comparisons are hypothesis generating rather than definitive evidence

This study will compare which shape is most likely to lead to successful endotracheal intubation, when performed by novices (medical students) learning this procedure on mannequins.

Eligibility Criteria:
Inclusion Criteria:

* Final year medical students in the Yong Loo Lin School of Medicine, National University of Singapore, undergoing their simulation posting. Endotracheal intubation is a procedure that is taught during this posting.

Exclusion Criteria:

* Injuries precluding performance of endotracheal intubation. Non exhaustive examples include arm injuries.
The Lived Experience of Participants in an African Randomised Trial

There has been no previous qualitative study conducted in a low-income setting which has aimed to explore the experience of individuals who enrol into a clinical trial for the management of a life-threatening illness. The investigators plan to collect data from trial participants, their next-of-kin, and researchers working on a multi-site randomised controlled trial for the treatment of HIV-associated cryptococcal meningitis.

Individuals recruited into clinical trials for life-threatening illnesses are particularly vulnerable and this is especially true in low-income settings. The decision to enrol may be influenced by existing inequalities, a poor healthcare infrastructure and the fear of death. Where patients are confused or unconscious the responsibility for this decision falls on the relatives. The objectives of this study are to learn from the experience of participants, relatives and researchers involved in a randomised controlled trial, AMBITION (ISRCTN 72509687), which is testing a novel treatment approach for HIV-associated cryptococcal meningitis and is recruiting participants from multiple sites across sub-Saharan Africa.

The investigators will collect data from trial participants and their relatives who provided consent on their behalf in Gaborone, Botswana; Kampala, Uganda and Harare, Zimbabwe. Interviews will follow a narrative approach and encourage the drawing of timelines. This will be supplemented by direct observation of the research process at each of the three recruiting hospitals. In addition, interviews will take place with researchers from the African and European institutions that form the partnership through which the trial is administered. Findings from the interviews will be prospectively fed back to the individual sites and Trial Management Group to improve the ongoing trial.

Eligibility Criteria:
AMBITION Trial Participants

Inclusion Criteria:

* Enrolled onto the AMBITION trial and has completed at least six weeks of follow-up
* Not currently confused
* Willing and able to consent to the study

Exclusion Criteria:

* Nil

The next-of-kin of AMBITION Trial Participants

Inclusion Criteria:

* Provided surrogate consent for an individual who was enrolled into the AMBITION trial
* Willing and able to consent to the study

Exclusion Criteria:

* Nil

AMBITION Researchers

Inclusion Criteria:

* Currently or previously employed on the AMBITION trial
* Willing and able to consent to the study

Exclusion Criteria:

* Nil
To Study the Efficacy of Therapeutic Pulsed Ultrasound in the Treatment of Vitiligo: a Randomized, Intra-individual, Left-right Comparison Study

In this study, the investigators demonstrated that in vivo THG microscopy can differentiate vitiligo lesions and normal skin based the optical nature of melanin. This THG-based procedure provides a valuable tool for noninvasive determination of third-order nonlinear susceptibility of melanin within the skin. It can also provide real-time histopathology information for treatment follow-up, without performing invasive skin biopsy.

The investigators initiate this open, randomized, left-right comparative study to evaluate the efficacy of pulsed ultrasound in the treatment of vitiligo on the face or trunk. Face is included in this study because vitiliginous lesions on the face has a better treatment response and causes more psychological distress on the patients than vitiligo affecting other body areas. Thirty adult subjects with vitiligo affecting the face or trunk symmetrically will be recruited. After randomization, subjects will be administrated their ulrasound treatment twice a week for 24 weeks. Their original topical treatment and/or phototherapy will be continued. During follow-up visits, digital photographs will be taken for evaluating the extent of residual depigmentation. In vivo harmonic microscopy and three skin biopsy specimens will be performed at the indicated time points on the depigmented, repigmented areas and surrounding normal skin.

Eligibility Criteria:
Inclusion Criteria:

1. 20-75 years old
2. With skin type Ⅲ or Ⅳ
3. With Vitiligo
4. Can read the informed consent form
5. Can continue the original treatments

Exclusion Criteria:

1. With segmental vitiligo.
2. Have joined other clinical trials
A Comparison of Beverages Consumed Within a Meal to Satiation on Meal-time Food Intake and Post-meal Appetite and Glycemic Response in Healthy Young Adults

The objective of the current study is to determine the effects of an ad libitum intake of 1% milk, fruit juice, regular cola, diet cola and water, as part of a pizza meal, on meal food intake, appetite and postprandial blood glucose in healthy men and women. We hypothesize that 1% milk will reduce food intake and result in better post-meal glycemic response compared to the other beverages.


Eligibility Criteria:
Inclusion Criteria:

* healthy men and women
* age 20-30 years
* BMI between 20-24.9 kg/m\^2

Exclusion Criteria:

* breakfast skippers
* diabetes or any metabolic diseases
* lactose intolerance or allergies to milk
* taking medications
A Study to Evaluate the Effects of Phenytoin and Itraconazole on Sonrotoclax (BGB-11417) in Healthy Volunteers

This is a single-center, open-label, parallel group study designed to investigate the effect of CYP3A induction and inhibition following multiple doses of phenytoin (Part A) and itraconazole (Part B), respectively, on the pharmacokinetics of sonrotoclax in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand and sign a written informed consent
* Able and willing to comply with all study requirements
* Healthy males or healthy females of non-childbearing potential
* Agrees to use an adequate method of contraception
* Body mass index (BMI) of 18.0 to 32.0 kg/m\^2 as measured at screening or, if outside the range, considered not clinically significant by the investigator.

Exclusion Criteria:

* Positive hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency (HIV) antibody results
* Prior treatment with sonrotoclax
* Evidence of renal impairment at screening
* Any contraindication to the use of phenytoin (Part A) or itraconazole (Part B)
* Current smokers and those who have smoked within the last 12 months
* Current users of e-cigarettes and nicotine replacement products and those who have used these products within the last 12 months
* History of any drug or alcohol abuse in the past 2 years
* Serious adverse reaction or serious hypersensitivity to any drug or formulation excipients
* History of clinically significant disorders as judged by the investigator

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
A Phase 1 Study Testing CP-675,206 In Combination With Gemcitabine In Patients With Previously Untreated, Advanced Pancreatic Cancer

The purpose of this study is to determine the safety and tolerability of different doses of CP-675,206 in combination with gemcitabine and to determine the maximum dose of CP-675,206 that is well tolerated when given in combination with gemcitabine to patients with advanced pancreatic cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patients with metastatic pancreatic cancer
* Patient must have adequate bone marrow, liver and kidney function
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
* Chemotherapy naive
* Inoperable pancreatic cancer

Exclusion Criteria:

* Patient must not have received prior systemic therapy for pancreatic cancer
* Patient must not have previously received anti-CTLA4 therapy
* History of chronic inflammatory or autoimmune disease
Effect of High Flow Nasal Cannula vs. Standard Care on Respiratory Stability in Pediatric Procedural Sedation

Procedural sedation is an established and safe intervention and is widely used in diagnostic and therapeutic procedures for pediatric patients. Nonetheless, problems of the respiratory system such as upper airway obstruction, hypoventilation and apnea are frequent adverse events. We postulate that respiratory instability is less frequent in patients high flow nasal cannula vs. standard care on respiratory stability, i.e. low flow nasal cannula, in pediatric procedural sedation. The purpose of this pilot study is to estimate the effect of HFNC (high flow nasal cannula) on the respiratory instability in children undergoing upper gastrointestinal endoscopy under pediatric procedural sedation (PPS).


Eligibility Criteria:
Inclusion Criteria:

1. Age 6 years - 18 years
2. Undergoing pediatric non-emergency upper gastrointestinal endoscopy under sedation
3. Informed consent/assent for enrollment by parents/legal guardians/patient

Exclusion Criteria:

1. Congenital or acquired malformations involving the airways
2. Patients with the history of spontaneous pneumothorax or connectives tissue diseases (Marfan syndrome, Ehlers-Danlos-Syndrome)
3. Patients with a history of traumatic/iatrogenic air leak within the last 3 months before enrollment
Surgical and Patient Reported Outcomes in Robotic Mastectomy

Conventional nipple and/or skin-sparing mastectomy (NSM/SSM) with or without immediate reconstruction is becoming one of the mainstream surgical treatment for breast cancer and risk reducing mastectomy in recent years. While this technique provides satisfactory oncologic and aesthetic outcomes, its disadvantages include skin flap and/or nipple-areolar complex (NAC) necrosis, NAC malposition/distortion as well as visible scar(s) on the breast.

In terms of technical aspects, NSM/SSM has its inherent challenges in view of limited incisions and thereby difficulties in dissection. Since 2015, a number of institutions worldwide had adopted a new technique of NSM/SSM using robotic surgical system. Institutional experiences worldwide demonstrated feasibility and safety of this technique coupled with improved patients' satisfactions.

To date, there is no center in Singapore or the region offering Robotic NSM/SSM (R-NSM/R-SSM). The authors believe that robotic mastectomy is a feasible and safe technique that can be utilized in our institution and it provides superior aesthetic outcomes with less morbidity and higher patient satisfaction if compared to conventional NSM/SSM.

The aim of this study is to conduct a single-arm prospective pilot study to investigate the safety and feasibility as well as learning curve of R-NSM/R-SSM.


Eligibility Criteria:
Inclusion Criteria:

* Women aged 21-70, with invasive breast cancer, ductal carcinoma in situ (DCIS), Breast Cancer (BRCA) gene or other breast cancer genetic mutation carriers or high risk female patients who are otherwise candidates for conventional NSM/SSM will be eligible for the study. All suitable patients will be offered the option of R-NSM/ R-SSM.

For patients with breast cancer (invasive or DCIS), selection criteria include but not limited to:

1. Early breast cancer
2. Tumor size less than 5 cm
3. No evidence of lymph node metastases
4. No evidence of skin or chest wall invasion.

Exclusion Criteria:

1. Extensive axillary lymph node metastasis (Stage 3B or later)
2. Heavy smokers (\>20 cigarettes a day)
3. High risk patient with severe and poorly controlled co-morbid conditions (include but not limited to diabetes, heart disease, renal failure or liver dysfunction)
4. Poor performance status or high risk for anaesthesia (ASA 3 and above)
5. Inflammatory or Locally Advanced Breast Cancer (with or without chest wall or skin invasion)