cyrilzakka/clinical-trials huggingface dataset:
Efficacy and Safety of HSK3486 Compared to Propofol in Induction of General Anesthesia in Adults Having Elective Surgery

This is a multicenter, randomized, double-blinded, propofol-controlled, Phase 3 clinical study to evaluate the efficacy and safety of HSK3486 for induction of general anesthesia in adults undergoing elective surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects undergoing elective surgery (nonemergency, noncardiothoracic, and nonintracranial surgery anticipated to last at least 1 hour ).
* Males or females, aged ≥18 years old, with American Society of Anesthesiologists Physical Status (ASA PS) I to IV.
* Body mass index (BMI) ≥18 kg/m2.
* For all females of childbearing potential, negative pregnancy test at screening and baseline. Additionally, females of childbearing potential must agree to use birth control (such as condom, intrauterine device \[IUD\], abstinence) from the time of consent until 30 days post study drug administration.
* Capable of understanding the procedures and methods of this study, willing to sign an Informed Consent Form, and to complete this study in strict compliance with the study protocol.

Exclusion Criteria:

* Contraindications to deep sedation/general anesthesia or a history of adverse reaction to sedation/general anesthesia.
* Known to be allergic to eggs, soy products, opioids and their antidotes, or propofol; subject having contraindications to propofol, opioids, and their antidotes.
* Medical condition or evidence of increased sedation/general anesthesia risk.
* Management risks of respiratory tract and judged by the investigator to be unsuitable for inclusion in the study.
* Any medication that has the potential to interact synergistically with propofol or HSK3486, including but not limited to all sedatives and hypnotics.
* Laboratory parameters significantly out of range at screening.
* Female subjects with a positive pregnancy test (serum or urine) at screening or baseline; lactating subjects; any subject planning to get pregnant within 1 month after the study (including the male subject's partner).
* Judged by the investigator to have any other factors that make the subject unsuitable for participation in the study.
Less Bleeding by Omitting Aspirin in Non-ST-segment Elevation Acute Coronary Syndrome Patients

Rationale: Dual antiplatelet therapy, consisting of aspirin and a P2Y12-inhibitor, reduces the risk of stent thrombosis, myocardial infarction and stroke after coronary stent implantation. Inevitably, it is also associated with a higher risk of (major) bleeding. Given the advances in stent properties, stenting implantation technique and pharmacology, it may be possible to treat patients with a single antiplatelet strategy by completely omitting aspirin.

Objective: This study will assess whether omitting aspirin reduces the rate of major or minor bleeding while remaining non-inferior to the current standard of care with regards to ischemic events in patients with non-ST segment elevation acute coronary syndrome.

Study design: Open-label, multicentre randomized controlled trial.

Study population: Adult patients presenting with non-ST segment elevation acute coronary syndrome undergoing percutaneous coronary intervention.

Intervention: In the intervention group aspirin will be completely omitted from the antiplatelet regimen in the 12 months following PCI.

Main study endpoints: The primary bleeding endpoint is major or minor bleeding defined as Bleeding Academic Research Consortium type 2, 3 or 5 bleeding at 12 months. The primary ischemic endpoint is ischemic events defined as the composite of all-cause death, myocardial infarction and stroke at 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of NSTE-ACS (i.e. NSTEMI or unstable angina)
* Successful PCI (according to the treating physician)

Exclusion Criteria:

* Known allergy or contraindication for aspirin or all commercially available P2Y12-inhibitors (i.e. ticagrelor, prasugrel and clopidogrel)
* Concurrent use of oral anticoagulants (e.g. because of atrial fibrillation)
* Ongoing indication for DAPT at admission (e.g. due to recent PCI or ACS)
* Planned surgical intervention within 12 months of PCI
* Pregnant or breastfeeding women at time of enrolment
* Participation in another trial with an investigational drug or device
Zambia Infant Cohort Study - Brains Optimized for Surviving and Thriving

Children exposed to HIV in-utero but uninfected (CHEUs) number 14.8 million globally. In Zambia, an estimated 56,000 CHEUs are born annually, a staggering fraction of the national birth cohort. Multiple studies establish that CHEUs are more neurodevelopmentally vulnerable than HIV-unexposed peers. In Zambia, there are existing effective early childhood developmental (ECD) interventions that target other vulnerable populations, but never trialed specifically for CHEUs. Scaling up ECD is now a priority of Zambia's national strategy, but CHEUs are not currently targeted.

There is a need to better understand the scope and mechanism of CHEU-related neurodevelopmental differences and what interventions are most effective. This randomized clinical trial (RCT) is a true effectiveness trial as the intervention will deploy a home-based adaptation of the same curriculum that is currently used elsewhere in the country, named Scaling Up Early Childhood Development In Zambia (SUPERCDZ). The effectiveness of a scalable early childhood development (ECD) intervention for CHEUs will be evaluated using normalized Z-scores of neurodevelopmental testing at age 24 months.

In this RCT the investigators will test the following hypotheses:

Hypothesis 1: An ECD intervention delivered by community health workers via bi-weekly home visits will improve neurodevelopmental outcomes in CHEUs.

Hypothesis 2: CHEUs have significantly worse neurodevelopmental outcomes than unexposed peers at 24 months, mediated by preterm birth, disease stage or antiretroviral (ARV) exposure.

This RCT will build on an existent, actively recruiting cohort of 1500 pregnant women-infant dyads in a peri-urban hospital in Zambia, the Zambian Infant Cohort Study (ZICS), by extending the follow-up of a subsample of infants from 6 months to 2 years amongst the last 525 children enrolled (ZICS-BOOST- Brains Optimized to Survive and Thrive). The study will have three arms: Arm 1) CHEU + ECD intervention (n=175); Arm 2) CHEU without ECD intervention (n=175); Arm 3) HUU without intervention (n=175).


Eligibility Criteria:
Inclusion Criteria:

* Zambia Infant Cohort Study (ZICS) cohort participants who are \>18 years old AND are still pregnant OR whose infants are less than 9 months of age by February 2022.
* ZICS inclusion criteria were pregnant women (1:1, HIV+:HIV-) presenting for antenatal care at Chawama First Level Hospital and intending to deliver at Chawama First Level Hospital and less than 26 weeks gestation by ultrasound

Exclusion Criteria:

* Mother-infant dyads not enrolled in ZICS
* Mother-infant dyads where mother is \<18 years of age
Extended Wear of a Steel and a Teflon Insulin Infusion Set

This is a cross-over study to evaluate if insulin infusion sets can be used up to 7 days.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of type 1 diabetes for at least 12 months
* Using an insulin pump for at least 12 months
* Age ≥18 years
* Hemoglobin A1c level less than or equal to 8.5%
* Willing to use mylife™ YpsoPump® system while they are participating in the study
* Willing to use NovoRapid® insulin while they are participating in the study
* An understanding of and willingness to follow the protocol and sign the informed consent

Exclusion Criteria:

* Diabetic ketoacidosis in the past 3 months prior to enrollment
* Severe hypoglycemia resulting in seizure or loss of consciousness in the 3 months prior to enrollment
* Urea, Creatinine, ALT more than three times the upper limit of normal, or thrombocytopenia (\<150 G/l)
* Female subjects: pregnancy, lactation period, lack of a negative pregnancy test (except in case of menopause, sterilization or hysterectomy), or unwilling to use an acceptable form of contraception during the study (for sexually active subjects of childbearing potential)
* Known severe tape reactions or allergies
* Known severe nickel allergies
* History of frequent catheter abscesses associated with pump therapy
* Serious acute or chronic disease besides diabetes mellitus or an anamnesis which might, in the opinion of the investigator, pose a risk to the subject, e.g. seizure disorder, adrenal disorder, dialysis for renal failure, cystic fibrosis, active infection
* Any incapacity or general condition that, in the opinion of the investigator, prevents adequate compliance with the study procedures, e.g. mental or visual incapacity, language barriers, alcohol or drug misuse
* Dependency from the sponsor or the clinical investigator
CONDOR Study of Osteonecrosis of the Jaws (TMJ)

The purpose of this study was to examine risk factors for osteonecrosis of the jaw (ONJ), including the possible association with bisphosphonates (BPs). This study used the research infrastructure from the three NIDCR-funded dental practice-based research networks (DPBRN, PEARL, PRECEDENT). De-identified data from the DPBRN were merged with comparable de-identified data from PEARL and PRECEDENT to form a single trans-PBRN data set used for analysis.

The aims of this study were to (1) test the hypothesis that (BP) treatment is a risk factor for (ONJ); (2) to test the hypothesis that dental diseases (particularly periodontal disease), and invasive dental procedures such as dental extractions are true risk factors for (ONJ).

Eligibility Criteria:
Inclusion Criteria:

* participants directly involved in this study were patients of dentists from the dental practice based research networks (DPBRN, PEARL, PRECEDENT).

Exclusion Criteria:

* participants with a history of sickle cell anemia
* participants with a history of external severe trauma to the jaws
A Phase I Study of an HIV Vaccine in Healthy, HIV Uninfected Adults

The purpose of this study is to assess the safety and tolerability of Modified Vaccinia Ankara (MVA) Mosaic vaccine in healthy adult participants.

This is a Phase I, placebo-controlled (the use of an inactive substance identical in appearance to the active vaccine), double-blind (neither the participant or study personnel will know the identity of the treatment administered) study where participants will be randomized (treatment type assigned by chance) to receive a Modified Vaccinia Ankara (MVA) Mosaic vaccine (at 1x10E8 pfu) or placebo. This design is intended to reduce the likelihood of observer and selection bias, provide control for confounding variables, and aid an unbiased analysis of the study results. The study will include 4 groups of participants, 2 groups having previously been vaccinated with Ad26.ENVA.01 (A recombinant adenovirus \[rAd\] vaccine for HIV-1) and 2 groups not previously vaccinated with Ad26.ENVA.01. Participants will be randomized in a 4:1 ratio to receive either a MVA Mosaic vaccine or placebo. The trial comprises a 4-week screening period, a 12-week vaccination period during which participants will be vaccinated at baseline (Day 1) and Week 12 (Day 84), and a 40-week follow-up period to the final visit at Week 52.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adults (determined by medical history, physical examination, and clinical judgment)
* HIV uninfected
* Female participants of child bearing potential must have a negative serum β-human chorionic gonadotrophin pregnancy test at the screening visit and immediately prior to each vaccine/placebo administration, practice adequate birth control measures from 28 days prior to the first vaccine/placebo administration through to at least 3 months after the final vaccine/placebo administration
* Male participants who are sexually active with a woman of childbearing potential and has not had a vasectomy must agree to use a double barrier method of birth control, e.g. either condom with spermicidal foam/gel/film/cream/suppository or partner with occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository

Exclusion Criteria:

* Confirmed HIV-1/-2 infection
* Chronic active hepatitis B or hepatitis C or active syphilis infection. Active syphilis documented by exam or serology unless positive serology is due to past treated infection
* Within the 12 months prior to enrollment: a history of newly acquired syphilis, gonorrhea, non-gonococcal urethritis, herpes simplex virus type 2 (HSV2), Chlamydia, pelvic inflammatory disease (PID), trichomonas, mucopurulent cervicitis, epididymitis, proctitis, lymphogranulomavenereum, chancroid, or hepatitis B
* A woman who is breastfeeding
* Any clinically significant acute or chronic medical condition that, in the opinion of the investigator, would preclude participation
* Major surgery within the 4 weeks prior to study entry or planned major surgery through the course of the study
Facilitating Improvements in Kidney Health Using a Smartphone App Counseling Program in Patients With Diabetes

This pilot study tests the feasibility of dietary app-supported tele-counseling in the treatment of patients with stage 1-3a chronic kidney disease (CKD) and diabetes.

Patients with diabetes and stage 1-3a CKD receive instructions on downloading and using MyFitnessPal on their smartphone or computer to log meal data daily, weekly website educational materials, and weekly telephone visits with a dietician for 8 weeks. Patients receive a follow-up phone call from the dietitian and 5 and 11 months for further support and counseling, and are also invited to attend a local dietitian-led grocery tour. This pilot study examines the feasibility of dietary app-supported tele-counseling in the treatment of patients with stage 1-3a chronic kidney disease (CKD) and diabetes.

Main outcomes include sodium intake assessed by 24 hour urine collection as well as other dietary measures related to kidney disease (sodium/potassium ratio, Healthy Eating Index score, 24-hour urine phosphorus, estimated net endogenous acid production) and health measures (24-hour ambulatory blood pressure, weight, albumin/creatinine ratio)

Eligibility Criteria:
Inclusion Criteria:

* Age \> 21 years
* Diabetes diagnosis (Type I or Type II)
* Last urine albumin/creatinine ratio (ACR) within the past two years \> 30 mg/g
* Last outpatient estimated glomerular filtration rate (eGFR) within the past year \> 45 ml/min/1.73m2
* Last outpatient systolic blood pressure (SBP) within the past year \< 160 mmHg
* Last outpatient diastolic blood pressure (DBP) within the past year \<100 mmHg
* Preceding eGFR decline rate less than -2 ml/min/1.73m2/y
* At least 2 outpatient eGFR measurements in electronic health record, separated by at least 2 years
* Agreeable to change diet (decrease sodium and red/processed meat intake, increase fruit and vegetable intake)
* Access to smartphone or computer

Exclusion Criteria:

* Inability to understand English
* Myocardial infarction, stroke, or atherosclerotic cardiovascular disease procedure within 6 months.
* Current treatment for malignancy
* Planned bariatric surgery
* Pregnancy or planning to become pregnant within next 2 years
* Self-reported average consumption of \> 14 alcoholic beverages per week
* Psychiatric hospitalization in past year
* Unstable angina
* Urine ACR \> 2500 mg/g
* Last potassium \> 5.0 mg/dL
* Hypoglycemia episode in past 1 month (glucose \< 70 mg/dL)
* Principal investigator discretion (i.e. concerns about safety, compliance)
Safety and Efficacy of Oxcarbazepine Monotherapy in Adults With Partial Seizures

This study is aimed to evaluate the efficacy, safety and tolerability of oxcarbazepine monotherapy in adults with partial seizures.


Eligibility Criteria:
Inclusion Criteria:

* males and females, 18 - 70 years of age;
* diagnosis of epilepsy, partial seizures;
* ineffective or intolerable present therapy with 1 antiepileptic drug, or none of previous therapy with antiepileptic drugs

Exclusion Criteria:

* progressive lesion of brain revealed by CT/MRI that performed no earlier than 2 years prior to screening;
* non-epileptic seizures;
* drug or alcohol dependence during a year prior to screening;

Other protocol-defined inclusion/exclusion criteria may apply.
Antiglucocorticoid Therapy for Cognitive Impairment in Late-life Anxiety Disorders

This study seeks to develop and test a novel, mechanistic treatment for mitigating cognitive impairment in older adults with anxiety disorders. Anxiety disorders are common, severe, and disabling in older adults. One particularly impairing aspect of late-life anxiety disorders is cognitive impairment: impairments in memory and executive function cause disability, impede treatment response to psychotherapy, may lead to dementia, and are not corrected by standard anti-anxiety treatments.

This pilot study will test the glucocorticoid antagonist, mifepristone, for cognitive impairment in late-life anxiety disorders. Mifepristone blocks the effects of elevated cortisol levels on glucocorticoid receptors in the brain; it has been studied preliminarily in various neuropsychiatric disorders, such as psychotic depression and bipolar disorder, with well-documented safety and tolerability.

Currently, no treatment exists to address cognitive impairment in late-life anxiety disorders. In this study, fifteen patients aged 60+ with an anxiety disorder (current or in partial remission) and subjective and/or objective evidence of cognitive impairment will receive treatment with mifepristone. At the baseline visit participants will be randomized to receive either mifepristone 300mg or a placebo daily for 7 days. Participants will be reassessed after 7 days (week 1 visit) of receiving study medication (mifepristone or placebo). At that time all participants will be provided mifepristone 300mg daily for the remaining 3 weeks of study treatment. The primary outcome measure will be neurocognition, as assessed by a battery of neuropsychological measures focusing on immediate and delayed memory and executive function (administered at baseline, week 1, week 4, and week 12). Saliva samples for cortisol measurement will be collected immediately following the baseline visit and week 4 visit. Secondary outcomes will be self-reported anxiety and depressive symptoms.

Eligibility Criteria:
Inclusion Criteria:

* Age 65 and older
* Non-demented by clinical evaluation
* Current or partially remitted generalized anxiety disorder or panic disorder
* Currently taking antidepressant treatment with stable dose for at least 8 weeks
* Memory impairment

Exclusion Criteria:

* Mild to severe dementia
* Diabetes
* Current alcohol or substance abuse
* Current or lifetime psychotic symptoms, bipolar disorder, or eating disorder
* Untreated endocrinologic disease
* Lifetime Cushing's or Addison's disease
* Current cancer
* History of metastatic cancer
* Current use of systemic corticosteroids
Gain-framed Messages and NRT for Lung Cancer Screening Patients

This research is a randomized smoking cessation trial conducted within and specifically personalized for lung cancer screening patients presenting to a lung screening clinic. Novel tobacco treatments for this population are critically needed, given the growing population of lung screening patients, which will grow dramatically now that lung screening is an approved CMS benefit. In the proposed study, we will test a gain-framed messaging intervention specifically designed for lung screening patients (vs. unframed messaging), as well as evaluating NRT sampling (vs. no medication) at 2 study sites. Our project is designed to be translational (in that it can be transferable from our controlled efficacy study to other lung screening programs).


Eligibility Criteria:
Inclusion Criteria:

1. 50 years or older
2. at least a 20-pack year history of smoking
3. current smoker (defined as any smoking in the past 30 days)
4. willing to be randomized
5. English speaking

Exclusion Criteria:

1. unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia,
2. known allergy to adhesives
3. being in the immediate (within 2 weeks) post myocardial infarction period
4. serious arrhythmias
5. unstable angina pectoris
6. hemodynamically or electrically unstable.
7. current participation in another tobacco treatment program (e.g., using medication from a primary care doctor, Quitline, etc.)
Impact of an E-Learning Coaching for Parents of Young Children With Autism

The goal of this study is to evaluate the impact of a parental coaching based on E-Learning (EL), intended for parents of children with autism spectrum disorder (ASD). Population: parents of young children (2 to 4 years old) with an ASD diagnosis.

The main questions that our study will answer are:

* Has parental coaching via E-Learning a significant impact compared to no coaching?
* If so, is that impact comparable to standard parental coaching such as PACT?

The impact will be evaluated in three domains:

* Child development: behavior, sleep, eating behavior
* Parental competences: stress, coping, feeling of parental competencies
* Parent-child interaction: communication, visual attention

The investigators will compare 3 groups:

1. ASD children whose parents will follow a parental coaching via E-learning,
2. ASD children whose parents will follow a standard parental coaching (PACT)
3. ASD children whose parents will not follow any specific coaching program


Eligibility Criteria:
Inclusion Criteria:

* Children with ASD
* Age 2 years to 4 years and 6 months
* Family speaking french
* Parent who signed the consent form

Exclusion Criteria:

* children with known genetic syndrome
* children with visual or auditive deficit
* children with epilepsy
* no internet access
* no french speaking