linjc16/ctgov huggingface dataset:
Open Label, Dose Escalation Phase I Study of AZD2281

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the safety and tolerability of AZD2281 following single and multiple oral doses in patients in Japan with advanced solid malignancies

Official Title
-----------------
A Phase I, Open-label, Dose Escalation Study to Assess the Safety and Tolerability of AZD2281 Following Single and Multiple Oral Doses in Patients in Japan With Advanced Solid Malignancies

Conditions
-----------------
Advanced Solid Malignancies

Intervention / Treatment
-----------------
* Drug: KU-0059436 (AZD2281)(PARP inhibitor)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed malignant solid tumour and refractory to standard therapy or for which no suitable effective standard therapy exists. Exclusion Criteria: Patients undergone, within 4 weeks prior to trial entry, an anti-cancer therapy which includes chemotherapy (or a longer period depending on the defined characteristics of the drugs used eg,. 6 weeks for mitomycin C or nitrosourea.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: KU-0059436 (AZD2281)(PARP inhibitor)|oral|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this study is to determine the safety and tolerability of AZD2281. |  | assessed after each visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary objectives of the study are to determine MTD and pharmacokinetic profile of oral AZD2281. |  | assessed after each visit | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cancer, Advanced solid malignancies
The Population Pharmacokinetics of Montelukast in Infants and Children

Study Overview
=================
Brief Summary
-----------------
The investigators' aim was to evaluate the population pharmacokinetics of montelukast in infants and children and define the appropriate dose in order to optimize Montelukast treatment in this vulnerable population.

Official Title
-----------------
Population Pharmacokinetics of Montelukast in Infants and Children

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Montelukast Chewable Tablet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients have been diagnosed with asthma; age range: 1 month to 12 years old; montelukast used as part of regular treatment. Exclusion Criteria: expected survival time less than the treatment cycle; patients with other factors that researcher considers unsuitable for inclusion.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Montelukast Chewable Tablet|Montelukast treatment was used at a dosage of 5mg/day once daily|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma concentration | To detect the plasma concentrations of montelukast at 3(2-4) h, 8(6-10) h, 22 (20-24) h after oral administration. | 3(2-4) h, 8(6-10) h, 22 (20-24) h after oral administration | 
| bronchoalveolar lavage fluid(BALF) | To detect the concentrations of montelukast in bronchoalveolar lavage fluid | Procedure (When the patient underwent fiberoptic bronchoscopy) |
Melatonin Degradation Rate in Human Milk

Study Overview
=================
Brief Summary
-----------------
Our long term hypothesis is that giving premature infants breast milk that was pumped during the night and has high concentration of melatonin will improve outcome of several clinical conditions related to premature infants. Prior to testing this, we need to learn the pharmacokinetics of melatonin in vitro. In this preliminary research we would like to check the levels of melatonin in breast milk pumped during the night, and evaluate the rate of degradation of the melatonin to determine the half life of melatonin in pumped breast milk (in vitro).

Detailed Description
-----------------
The study includes 10 nursing women. Each woman will bring a frozen 5 ml sample of breast milk that was pumped at 03:00 AM. The samples will be collected at the NICU department of Carmel Medical Center and will be stored at deep freeze (-20°C). The samples will be numerically coded and will be kept anonimously. After defrosting the samples, melatonin concentration will be checked in the hospital laboratory every hour, for 4 hours. If meltonin levels will be detectable after 4 hours, continous measurements will be done at 8 hours and at 12 hours after defrosting. The samples will be tested with IBL Melatonin ELISA kit. For control we will use breast milk that was pumped at 10:00 am (when melatonin excretion is minimal). At the end of the analysis the samples will be thrown away.

Official Title
-----------------
Melatonin Degradation Rate in Human Milk

Conditions
-----------------
Preterm Infant, Lactation

Intervention / Treatment
-----------------
* Diagnostic Test: melatonin level in pumped breast milk


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women that are breast feeding and will pump and freeze a milk sample at 03:00 AM Women at least one week after delivery Exclusion Criteria: A sample that will not be freezed right after the pump Women that are taking hypnotic drugs Women that are taking melatonin

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| nursing women<br>women who gave birth and are breast feeding their baby- melatonin level in pumped breast milk have been checked | Diagnostic Test: melatonin level in pumped breast milk<br>* diagnostic test of melatonin level in pumped breast milk<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| melatonin stability in human milk | melatonin levels in human milk samples are checked every hour after defrost | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
melatonin, breast milk
A Randomized Controlled Trial Evaluating Sildenafil Citrate in Relieving Ureteral Stent Related Symptoms

Study Overview
=================
Brief Summary
-----------------
Despite its beneficial effect, ureteral stents may produce symptoms (such as hematuria, dysuria, frequency, urgency, urge incontinence and suprapubic or flank pain) that affect the quality of life in 70-80%. This study will be conducted to evaluate the role of Phosphodiestrase 5 inhibitor (Sildenafil Citrate) in relieving these symptoms.

Detailed Description
-----------------
Adult patient (>18 years) who will undergo ureteral stent fixation after endoscopic procedures will be randomized between the study arms. Exclusion criteria: Patients who had lower urinary tract symptoms before stent fixation. Ureteral stent fixation after open surgery. Known contraindications to Sildenafil Citrate

Official Title
-----------------
A Randomized Controlled Trial Evaluating Sildenafil Citrate in Relieving Ureteral Stent Related Symptoms

Conditions
-----------------
Quality of Life

Intervention / Treatment
-----------------
* Drug: Sildenafil
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Patient aged >18 years Exclusion Criteria: Patients who had LUTS before DJ stent fixation DJ stent fixation after open surgery Contraindication to Sildenafil citrate

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sildenafil<br>Patient in this arm will receive sildenafil citrate 50 mg tablet once daily after ureteral stent fixation. | Drug: Sildenafil<br> <br> * Other names: Viagra;|
| Placebo Comparator: Placebo<br>Patient in this arm will receive placebo daily after ureteral stent fixation. | Drug: Placebo<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ureteral Stent Symptoms Questionnaire (USSQ) Score | Comparison of total USSQ scores between study arms. | 2-4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events | Analyzing frequency and severity of side effects of Sildenafil | 2-4 weeks |
Taste Properties of HIV Inhibitor

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the taste properties of HIV inhibitor

Official Title
-----------------
An Open-Label Taste Assessment of BMS-955176 in Healthy Subjects

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: BMS-955176


Participation Criteria
=================
Eligibility Criteria
-----------------
For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com Inclusion Criteria: Men and women of non-childbearing potential professional sensory panelists Aged between 25 and 80 years Exclusion Criteria: History of relevant drug or food allergies, cardiovascular or Central nervous system (CNS) disease, clinically significant pathology, history of mental illness Positive HIV test

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: BMS-955176<br>BMS-955176 specified dose on specified days | Drug: BMS-955176<br> <br> * Other names: HIV Maturation Inhibitor;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Taste properties of HIV Inhibitor will be measured using the Flavor Profile of the Flavor Leadership Criteria |  | Up to 2 years |
Children's Activity and Nutrition III

Study Overview
=================
Brief Summary
-----------------
To track blood pressure from childhood through adolescence.

Detailed Description
-----------------
BACKGROUND: Children's Activity and Nutrition III was originally part of the Institute-initiated Studies of Children's Activity and Nutrition (SCAN), first funded in 1985. Children's Activity and Nutrition III was renewed in 1992 as a stand-alone project with a focus on assessment of the development of hemodynamic mechanisms responsible for blood pressure (BP) control within the context of ethnicity and family history of early myocardial infarction (MI), defined as having a parent or grandparent with an MI at less than 55 years of age and a family history. Blacks have a higher mortality rate through middle adulthood than whites from coronary heart disease (CHD), the leading causes of death in the United States. Blacks have been found to exhibit greater cardiovascular (CV) response to stress (i.e., reactivity), a potential risk factor for CHD, as have individuals with a family history. . Although CHD has its pathobiologic origins in childhood, little longitudinal reactivity research has been conducted in youth, especially from childhood through late adolescence. DESIGN NARRATIVE: The study followed a multiethnic sample of 250 13 to 14 year olds for an additional 5 years to determine: 1) whether blood pressure (BP) reactivity during childhood predicted changes in resting BP, left ventricular mass and concentric remodeling, carotid artery wall elasticity and endothelial dependent arterial dilation up to 11 years later after controlling for other expected predictors (i.e., age, gender, ethnicity, resting BP, adiposity, ambulatory BP); 2) the influence of ethnicity, family history and a select group of moderator variables (i.e., environmental stress, anger and John Henryism coping styles, aerobic fitness on youth's cardiovascular (CV) reactivity; and 3) the stability of CV reactivity and a 24- hour ambulatory BP from childhood through late adolescence. The long- term objectives were to provide a better understanding of the development of CV reactivity in youth and its influence upon early pathobiologic markers of coronary heart disease prior to overt manifestation of disease.

Conditions
-----------------
Cardiovascular Diseases, Hypertension, Coronary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Neural Correlates of Real World Spatial Navigation in Humans

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand the neural mechanisms that support real world spatial navigation in humans using deep brain recordings and stimulation during virtual reality (VR), augmented reality, and real world memory tasks. We will determine the cognitive (i.e., memory) and behavioral (i.e., body, head, eye position and movement) factors that modulate deep brain activity and the consequent effects of memory-enhancing deep brain stimulation.

Official Title
-----------------
Neural Correlates of Real World Spatial Navigation in Humans

Conditions
-----------------
Memory, Delayed

Intervention / Treatment
-----------------
* Device: Deep Brain Stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older and has undergone RNS system placement Willing to provide informed consent and participate the study Ability to read and write English fluently Exclusion Criteria: Unwilling to provide informed consent Not a native English Speaker

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Deep Brain Stimulation|Deep brain stimulation will be used|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spatial memory | Spatial memory will be measured using virtual, augmented and real-world spatial navigation tasks where participants will be asked to navigate a previously learned rout as well as if they recognize objects (i.e. landmarks) that appeared along the route (photos of seen landmarks vs unseen landmarks). | Throughout study completion, an average of 2-4 days per year | 
| Memory performance change | Memory performance will be measured using excess path length, latency, and accuracy rate. | Throughout study completion, an average of 2-4 days per year | 
| Oscillatory activity change | Changes in theta, gamma, and theta-gamma coupling will be measured both in relation to changes in memory performance on trials with and without deep brain stimulation as well as in relation to body, head, and eye position in a virtual, augmented, or real-world environment. | Throughout study completion, an average of 2-4 days per year |
Preventing Bacterial and Viral Infections Among Injection Drug Users

Study Overview
=================
Brief Summary
-----------------
We propose a randomized controlled trial (RCT) of the Skin intervention, compared to an assessment-only condition (both groups receive rapid HIV testing, a review of testing results, and brief HIV prevention counseling) among 350 injection drug users recruited during an acute medical hospitalization at Boston Medical Center. In the general hospital setting, injection drug users who otherwise might not seek care are accessible and teachable, and the presence of a drug-related illness can set the stage for patients to be more receptive to interventions2. We hypothesize that the Skin intervention will produce better outcomes at 1-, 3-, 6-, 9-, and 12-month(s) post-intervention.

Official Title
-----------------
Preventing Bacterial and Viral Infections Among Injection Drug Users

Conditions
-----------------
HIV, Bacterial Infection

Intervention / Treatment
-----------------
* Behavioral: SKIN Intervention
* Other: Treatment as Usual


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older report injection of heroin, cocaine, or methamphetamine (meth) on at least three different days in the week prior to admission have injected heroin, cocaine, or meth for at least three months positive urine screen for heroin, cocaine, or meth Exclusion Criteria: currently psychotic (e.g., responding to internal stimuli through observed hallucinations or delusions), homicidal or suicidal cannot provide informed consent not able to complete interviews in English (expected to exclude <5% of IDUs) in police custody, expecting incarceration unable to provide names and contact information for at least two verifiable locator persons who will know where to find them for retention/follow-up purposes plan to move out of the Boston area in the next 12 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SKIN Intervention<br>Participants will receive the SKIN intervention at Baseline and 1-mo interviews. | Behavioral: SKIN Intervention<br> <br> |
| Placebo Comparator: Assessment-Only<br>Participants in this arm will receive treatment-as-usual | Other: Treatment as Usual<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bacterial infections |  | one year | 
| high-risk behavior |  | one year | 
| health service use |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
injection drug use
Autonomic Modulation in Takotsubo Syndrome

Study Overview
=================
Brief Summary
-----------------
This is a minimal risk case-controlled single arm intervention study, including 10 patients with a prior history of takotsubo and 10-age and sex matched healthy controls. Subjects will undergo in laboratory testing to measure autonomic function. They will then undergo a 15-week program of device-guided breathing with remote measures of autonomic function obtained at home. Analysis will determine the reproducibility of home autonomic measures and the provide preliminary data to determine the efficacy of device-guided breathing on autonomic measures and quality of life in patients with takotsubo.

Official Title
-----------------
Autonomic Modulation in Takotsubo Syndrome

Conditions
-----------------
Takotsubo Syndrome

Intervention / Treatment
-----------------
* Device: Tako Breath


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed history of takotsubo syndrome Healthy person with no significant past history of cardiovascular or neurological disease such as heart failure or heart attack; people with cardiovascular risk factors such as hypertension will be permitted to participate Exclusion Criteria: Pacemaker or defibrillator implanted Evidence of autonomic neuropathy, alcohol or drug abuse or exposure to neurotoxins (chemotherapy). Diabetes

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Participants in the NYU takotsubo registry<br>10 patients with a confirmed history of takotsubo syndrome 10 age- and sex-matched healthy controls with no significant history of cardiac or neurological illness | Device: Tako Breath<br>* Device guided breathing. A medical device with a computerized control unit, a breathing sensor and a set of earphones with audio-prompts to guide breathing at a slow rate (<10 breaths/min) with prolonged exhalation.<br>* Other names: RESPeRATE;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate variability | Remote heart rate monitoring with an adhesive chest telemetry patch and biosensor wrist watch | 10 Weeks |