cyrilzakka/clinical-trials huggingface dataset:
HSV-2 Suppression to Reduce Maternal HIV-1 RNA Levels During Pregnancy and Breastfeeding

In this study, we will determine whether treating pregnant and breastfeeding women co-infected with human immunodeficiency virus type 1 (HIV-1) and herpes simplex virus type 2 (HSV-2) with daily valacyclovir will reduce HIV-1 levels in plasma, genital, and breast milk and will decrease the risk of mother-to-child HIV-1 transmission (MTCT).

Each year over 500,000 children become HIV-1-infected in sub-Saharan Africa after exposure to maternal virus in blood, genital secretions, and breast milk. Identifying feasible, safe, and affordable interventions that prevent mother-to-child transmission remains a priority for HIV-1 prevention research. Interventions to reduce breast milk HIV-1 transmission are lacking and most urgently needed.

We propose a randomized clinical trial to determine whether incorporating HSV-2 suppression with valacyclovir into standard prevention of mother-to-child HIV-1 transmission regimens will reduce plasma, cervical, and breast milk HIV-1 RNA levels and risk of transmission among HIV-1-infected and HSV-2-seropositive women. We plan to enroll a total of 148 HIV-1 and HSV-2 co-infected pregnant women with CD4\>200 cells/μl who seek antenatal care prior to 32 weeks gestation at a clinic in Nairobi, Kenya. Women will be randomized to receive either valacyclovir suppressive therapy or placebo at 34 weeks gestation and mother-infant pairs will be followed for 12 months postpartum. Follow-up visits will be scheduled at 38 weeks gestation; birth; 2, 6, 10 and 14 weeks; and 6, 9, and 12 months postpartum. Maternal blood, genital, and breast milk specimens obtained at follow-up visits will be used to determine the effect of valacyclovir suppressive therapy on plasma and breast milk HIV-1 RNA levels. Infant filter paper specimens for HIV-1 DNA assays will be collected at birth; 2, 6, 10 and 14 weeks; and 6, 9, and 12 months in order to compare the proportion of infants acquiring HIV-1 by 12 months in the two study arms and determine the timing of HIV-1 infection. In addition, we will monitor maternal and infant renal function in preparation for a larger randomized clinical trial in Africa. The results of this study will help guide the design of a multi-site clinical trial with adequate power to determine the effect of HSV-2 suppression on vertical (MTCT) transmission of HIV-1 infection.

Eligibility Criteria:
Inclusion Criteria:

* HIV-1 seropositive
* HSV-2 seropositive
* Plans to deliver in Nairobi
* Resides and plans to remain in Nairobi for 12 months postpartum
* 18 years of age or older
* CD4 count\>250 cells/μl

Exclusion Criteria:

* indication for highly active antiretroviral therapy (e.g., WHO stage III or IV)
* hypersensitivity to valacyclovir or acyclovir
COVID-19 and ICU-acquired MDR Bacteria

This multicenter before-after study aimed to determine the impact of infection related to SARS-CoV-2 on the incidence of ICU-acquired multidrug resistant (MDR) bacteria.

Multicenter observational before-after study, aiming to determine the impact of infection related to SARS-CoV-2 on the incidence of ICU-acquired colonization and infection related to MDR bacteria.

Eligibility Criteria:
Inclusion Criteria:

* Expected ICU stay \> 48 hours
* Rectal and nasal BMR screening performed \< 48 hours after admission to ICU

Exclusion Criteria:

* Patients aged \< 18 years Refusal to take part in the study ICU-stay \< 48 hours At least a second rectal and nasal BMR screening was not performed prior to ICU discharge (a posteriori exclusion criterion).
Sample Collection Study in Patients With Suspected Melanoma Utilizing DermTech's Non-invasive Adhesive Patch Biopsy Kits

A multi-center sample collection study in patients presenting with pigmented lesion(s) suspicious for melanoma. All suspicious lesions should meet at least one of the "ABCDE" criteria.

A multi-center sample collection study in patients presenting with pigmented lesion(s) suspicious for melanoma. All suspicious lesions should meet at least one of the "ABCDE" (asymmetry, border, color, diameter, evolving) criteria. Patients will be consented for the study and screened against the inclusion and exclusion criteria. Once the patient is determined to be acceptable for the study they will be assigned a unique patient number and tissue collection will begin. Tissue from the lesion will be collected using DermTech's non-invasive adhesive patch kit according to the instructions for use followed by surgical biopsy. Digital dermoscopy of the lesion is preferred but not required.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females at least 21 years of age
2. Have a pigmented lesion suspicious for melanoma the pigmented lesion meets at least one of the "ABCDE" criteria
3. The pigmented lesion mst be at least 3mm and not more than 16mm in diameter
4. Patient is willing to follow the start of care to test and treat the pigmented lesion as determined by the treating physician
5. Willing to have DermTech adhesive patch biopsies performed
6. Must be able to complete study procedures as required by the protocol
7. Willing to provide informed consent to participate in this trial

Exclusion Criteria:

1. Require a surgical biopsy or excision of the lesion of interest prior to the DermTech non-invasive patch biopsy(ies)
2. Has an ulcerated or bleeding lesion that could confound the biopsy results
3. Has a suspicious lesion(s) in an area that was previously surgically biopsied
4. Has a lesion that is classified as "clinically" evident melanoma appropriate for excision
5. The lesion to be sampled is on the mucosal surface, palmoplantar surface or other area where adhesive patch biopsies cannot be performed
6. Has a known sensitivity to adhesive patches
7. Any significant medical condition that would indicate an unreasonable risk to the patient or potential interference with the study
8. Lesion is in a location were sufficient removal of non-vellus hair cannot be achieved (e.g., scalp)
9. Suspected non-melanoma skin cancer
10. Patients with contraindication(s) to surgical biopsy -
Initial Safety Assessment of SNS-595 for the Treatment of Solid Tumors.

The purpose of this study is to determine whether SNS-595 given intravenously once every 3 weeks is safe.

Other objectives of this study include measuring pharmacokinetics (how long the drug can be measured in the blood) and determining the dose and dose schedule for the next phase of studies with SNS-595.

Eligibility Criteria:
Inclusion Criteria:

* Must give written informed consent
* 18 years of age
* Advanced solid malignant tumors
* Tumor can be measured and evaluated
* Blood tests are within standard limits
* Normal blood coagulation
* ECOG Performance Status equal to 0 or 1

Exclusion Criteria:

* Pregnant or breastfeeding.
* Women of childbearing potential unwilling to use an approved, effective means of contraception according to the institution's standards.
* Heart attack, stroke/TIA or other blood clotting event (deep vein thrombosis or pulmonary embolus) within 6 months before the screen visit.
* Requires kidney dialysis (hemodialysis or peritoneal).
* Known bleeding disorder (ie, hemophilia, von Willebrand Disease, coagulopathy, etc.).
* Received an investigational agent or prior chemotherapy or immunotherapy within 28 days before first dose of SNS-595
* Receiving therapeutic anticoagulation therapy (coumadin, heparin, etc.).
* Currently receiving corticosteroids (inhaled steroids for breathing diseases are allowed) or seizure medications.
* Any medical, psychological, or social condition that, in the opinion of the Principal Investigator, would contraindicate the patient's participation in the clinical trial due to safety and or compliance with study procedures.
Chylothorax Following Heart Surgery

The purpose of this study is to determine at risk populations for certain congenital heart defects or certain operative procedures and to define the associated morbidity secondary to chylothorax - prolonged chest tube drainage, prolonged hospital stay, need for central access and hyperalimentation, subsequent infection.

Chylothorax is not uncommon following congenital heart surgery. It often results in prolonged chest tube drainage and hospital stays. Due to the feeding difficulties, it often results in malnutrition and the need for central hyperalimentation. In addition, it results in a depressed immune system with the possibility of subsequent infection. Chylothorax can be a significant contributor to post-operative morbidity and mortality.

The primary aims are to determine at risk populations - certain congenital heart defects or certain operative procedures, to define the associated morbidity secondary to chylothorax - prolonged chest tube drainage, prolonged hospital stay, need for central access and hyperalimentation, subsequent infection and to review our current treatment methods - change formulas, hyperalimentation, somatostatin. The secondary aims are to determine ways to prevent chylothorax, determine the most successful treatment method, and to discover better treatment methods. This study will be conducted through a retrospective chart review.

Eligibility Criteria:
Inclusion Criteria:

* Patients in the congenital surgery database
* patients have developed post-operative chylous effusions

Exclusion Criteria:

-
Use of a Portion Control Food Tool to Induce Weight Loss in Obese Type 2 Diabetics.

The purpose of this study was to determine whether a food portion control tool would be effective to result in weight loss in a group of overweight type 2 diabetics. We hypothesized that this tool would be effective to induce weight loss in these patients. We also hypothesized that diabetic control would be improved in patients using these plates.

The prevalence of obesity is increasing worldwide. Portion size is known to be an important determinant of energy intake. However, to our knowledge, no clinical trials have previously been conducted which examine the efficacy of a food portion control tool to control caloric intake and thereby induce weight loss.

Most cases of type 2 diabetes can be attributed directly to obesity. Dietary caloric restriction has been shown to improve glycemic control by virtue of weight loss, with an additional benefit independent of weight loss.

Comparison: daily use of a food portion control tool plus usual care at a diabetes care center, compared to usual care alone.

Eligibility Criteria:
Inclusion Criteria:

* age 18 or older
* diagnosis of type 2 diabetes mellitus
* body mass index of 30 or greater
* a member of the Diabetes Education Center in Calgary, AB, Canada, for at least 6 months prior to study enrollment

Exclusion Criteria:

* taking a weight loss medication (sibutramine or orlistat)
* weight loss \>10 lbs in 2 months preceding study enrolment
* consumption of dinner at restaurants more than twice weekly
* current diagnosis of cancer
* psychiatric illness under care of a psychiatrist
* surgery in the 3 months prior to the study, or expected during the study period
* history of bulimia or anorexia nervosa
Tumor Tissue, Blood Samples, and Family History in Predicting Tumor Development and Response to Treatment in Young Patients With Low-Grade Glioma

RATIONALE: Studying samples of tumor tissue and blood in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors understand why low-grade gliomas develop in young patients and predict how they will respond to treatment.

PURPOSE: This clinical trial is studying tumor tissue, blood samples, and family history in predicting tumor development and response to treatment in young patients with low-grade glioma.

OBJECTIVES:

* To develop a better understanding of why low-grade glioma tumors develop in children and adolescents.
* To study genetic profiles that may predict response to treatment and provide clues to how these tumors developed initially using tumor and blood samples from these patients.

OUTLINE: This is a multicenter study.

* Retrospective data collection (for participants recruited from study SIOP-LGG1): During a follow-up appointment for study SIOP-LGG1, both biological parents\* are asked to complete a questionnaire about their family's cancer history. They may complete the questionnaire either in the clinic or in their home. Participants may complete and return the questionnaires at any time throughout the study.
* Prospective data collection (for participants recruited from study SIOP-LGG-2004): Both biological parents\* are asked to complete a family history questionnaire and provide information about their family's cancer history. Participants may complete and return the questionnaires at any time throughout the study.

NOTE: \*In circumstances where either or both biological parents are unable to complete the questionnaire, it may be completed by the patient diagnosed with low grade glioma (if they are over 16 years old) or adoptive parents or guardians, if they feel they have the knowledge to complete the questionnaire.

Tumor tissue and blood samples collected on SIOP-LGG1 or SIOP-LGG-2004 are analyzed for genetic profiles predictive of response to treatment and for different patterns of tumor development, natural tumor behavior, and tumor sensitivity to cancer therapies. Collected family data are anonymised and linked to the biological sample collected. Samples are then stored for future molecular genetic studies.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Biological parents of a child or adolescent patient diagnosed with low grade glioma (LGG)

  * LGG patients participating in 1 of the following clinical trials:

    * On active follow up for study SIOP-LGG1 at a Children's Cancer and Leukemia Group center
    * On study SIOP-LGG-2004
  * Adoptive parents or guardians allowed if they feel they have the knowledge to complete the study questionnaire, provided either or both biological parents are unable to complete the questionnaire

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Myocardial Injury and Major Adverse Outcomes in Patients With COVID-19

The study will analyze the incidence, clinical outcomes and predictors of myocardial injury in a large patient population with COVID-19 treated in Mount Sinai Hospital (MSH) system. In addition, the study team will explore the association between high-sensitivity troponin I (TnI) levels and clinical characteristics, biomarkers, cardiac tests data and treatment approaches to uncover the potential mechanisms responsible for COVID-19 induced myocardial injury.

The study team's understanding of diagnosis, treatment and outcomes of coronavirus disease 2019 (COVID-19) is rapidly evolving. First reports from China clearly indicate that older patients with underlying cardiovascular disease and/or cardiac risk factors demonstrate higher mortality rates. Most recent reports provided novel insights into the incidence of myocardial injury in COVID-19 patients and its association with adverse outcomes. In both studies, patients with myocardial injury manifested by elevated high-sensitivity troponin I (TnI) levels had significantly higher in-hospital mortality rates compared with those without myocardial injury, (59.6 and 8.9% (3) and 51 vs 4.5 %). Among patients with myocardial injury, higher levels of TnI were associated with higher mortality rates. While the highest mortality rates were observed in patients with elevated TnI and underlying cardiovascular disease (CVD), mortality rates were also considerable in patients with elevated TnI and without prior CVD. In contrast, patients with known cardiovascular disease without TnI elevation had more favorable outcomes. Cardiac injury was independently associated with an increased risk of mortality in patients with COVID-19. The arming reports clearly indicate that the data from larger populations from multiple centers are needed to further characterize and better understand the association between myocardial injury and adverse outcomes in COVID-19 patients.

II. STUDY AIM The aim of the proposed study is to analyze the incidence, clinical outcomes and predictors of myocardial injury in a large patient population with COVID-19 treated in Mount Sinai Hospital (MSH) system. In addition, the study team will explore the association between TnI levels and clinical characteristics, biomarkers, cardiac tests data and treatment approaches to uncover the potential mechanisms responsible for COVID-19 induced myocardial injury.

III. STUDY POPULATION By October 2020, there have been 4,695 COVID-19 positive patients treated in the Mount Sinai Hospital (MSH) and more than 1,1000 patients with COVID-19 had been healed and discharged. All consecutive patients admitted to the MSH system from February 2020 to October 2020 with laboratory-confirmed COVID-19 will be included in the retrospective study.

Eligibility Criteria:
Inclusion Criteria:

* Laboratory confirmed COVID-19

Exclusion Criteria:

* None
the Effects of Epidural Fentanyl on Vaginal Delivery

The study hypothesis was that epidural fentanyl may accelerate the dilation of the cervix and possibly result in a shorter duration of vaginal delivery.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anaesthesiologists physical status I or II
* nulliparous
* normal singleton uncomplicated pregnancies of more than 38 weeks
* cephalic presentation of the fetus
* anticipated vaginal delivery
* active stage of labour
* cervical dilatation between 3-5 cm
* regular uterine contractions
* normal cardiotocographic recordings.

Exclusion Criteria:

* medical problems during pregnancy
* BMI≥40 kg m-2
* opioid allergy
* prior administration of opioids or other analgesics
Dexmedetomidine Neuroprotection in Pediatric Cardiac Surgery

Neurodevelopmental disability is the most significant complication for survivors of infant surgery for congenital heart disease. In this study we sought to determine if intraoperative continuous infusion of dexmedetomidine are associated with neurodevelopmental outcomes at 12 months.


Eligibility Criteria:
Inclusion Criteria:

* Neonates undergoing cardiac surgery
* Infants undergoing cardiac surgery with cardiopulmonary bypass (atrial septal defect repair, ventricular septal defect repair, or tetralogy of fallot repair)

Exclusion Criteria:

* History of hypersensitivity of any drug
* Presence of hypotension or bradycardia considering age Bradycardia (heart rate \< 80 beats/min) or hypotension (systolic blood pressure \< 70mmHg for infants, \< 60mmHg for neonates)
* Elevated liver enzyme levels (aspartate transaminase \>100unit/L, alanine aminostrasferase \> 50 unit/L)
* surgery with deep hypothermic circulatory arrest
* Presence of complex cardiac defect
* single ventricular physiology
* plan of additional operation within a year
* preoperative use of beta-agonists
* presence of history of any neurological disorder
Noninvasive Cardiac Output Monitoring in Pulmonary Hypertension

Comparison of Ultrasonic Cardiac Output Monitor (USCOM) system with Fick and thermodilution methods during right heart catheterization in patients with pulmonary hypertension.


Eligibility Criteria:
Inclusion criteria:

* Age \> 18 years
* Diagnosis of Group 1 or Group 4 PAH based on PAPm \> 25 mmHg, PAWP \<15 mmHg, PVR \>3 WU and consistent clinical history. Note: for logistical reasons, patients at high suspicion for Group 1 or Group 4 PAH will sign informed consent to have the USCOM system applied during right heart catheterization before the procedure; if it is found that the patient does not meet the definition of Group 1 or Group 4 PAH during right heart catheterization, he/she will be excluded.
* Willingness and ability to comply with study procedures.
* No known hypersensitivity to the components of USCOM electrodes

Exclusion criteria:

* Unwillingness to sign informed consent or inability or unwillingness to comply with study procedures
* Evidence of postcapillary pulmonary hypertension on right heart catheterization
Memantine Monotherapy for Executive Dysfunction and ADHD

This is a 12-week clinical trial evaluating the efficacy and safety of memantine hydrochloride (Memantine HC1, brand name Namenda) in the treatment of executive function deficits (EFDs) in adults with Attention Deficit Hyperactivity Disorder (ADHD). After screening procedures, memantine is prescribed in randomized, double-blind fashion (equal chance of medication or placebo) for 12 weeks.

The investigators hypothesize that memantine hydrochloride will prove to be an effective, safe, and well-tolerated agent for the treatment of EFDs in individuals with ADHD interested in non-stimulant medications.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female adults ages 18-45 years;
2. a diagnosis of DSM-IV \[78\] ADHD-combined type
3. a score of at least 20 on the AISRS (a score of 20 in the AISRS identifies subjects with at least moderate severity of symptoms);
4. a BRIEF-A Global Executive Composite T-score of \>6; and
5. proficiency in English. -

Exclusion Criteria:

1) Pregnant or nursing females; 2) investigator and his/her immediate family (spouse, parent, child, grandparent, or grandchild); 3) any serious, unstable medical illness including hepatic, renal, gastroenterological, respiratory, cardiovascular (including ischemic heart disease and hypertension), endocrinologic, neurologic, immunologic, or hematologic disease; 4) hypersensitivity to memantine; 5) multiple adverse drug reactions; 6) current or past history of seizures; 7) any history of a major psychiatric disorder including schizophrenia, psychosis, bipolar disorder (BPD), or autism spectrum disorder (ASD); 8) meets DSM-IV criteria in the last month for major depression or any major anxiety disorder or has a Hamilton Rating Scale for Anxiety (HAM-A) or Hamilton Rating Scale for Depression (HAM-D) score greater than 14; 9) meets DSM-IV criteria for substance abuse or dependence in the last month or has a positive drug urine screen; 10) judged to be at serious suicidal risk; 11) use of any other concomitant medication with primarily central nervous system activity; or 12) IQ \< 80.

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LTR for Treatment of Obstructive Sleep Apnea

Study of tongue implant for treatment of obstructive sleep apnea

Subjects with obstructive sleep apnea will be treated with a tongue based suspension implant technique to keep airway open while sleeping. Subjects will be followed a year with primary endpoint of AHI results through Polysomnography readings (PSG) testing in an overnight sleep lab.

Eligibility Criteria:
Inclusion Criteria:

* AHI\>10
* 18 years of age

Exclusion Criteria:

* Subjects with \>20% of their AHI accounted for from central apnea.
* Mallampanti score of 4
* Tonsillar hypertrophy (4+)
* Prior uvulopalatopharyngoplasty (UPPP) procedure
* Narrowing of hypopharynx airspace more than velopharyngeal airspace as seen on examination or x-ray
* Tongue thickness \<40 mm measured on lateral cephalogram x-ray from the frenulum to linea terminalis
* More than 10% of sleep time with blood O2 desaturation below 70%
* Unable and/or unwilling to comply with study requirements
* Females of child bearing age who are pregnant or intending to become pregnant
* Allergy to silicone
* History of radiation therapy to neck or upper respiratory tract
* Subjects with bleeding disorders, impaired immunity for any reason, or heart attack within the last six months