bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetics of Tenofovir and Tenofovir-diphosphate, Emtricitabine and Emtricitabine-triphosphate, and Rilpivirine Once Daily Over 14 Days Following Drug Intake Cessation in Healthy Volunteers
Condition: HIV
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to look at the levels of three HIV medications: tenofovir,
      emtricitabine, and rilpivirine in blood after the drug intake has been stopped in order to
      understand how long these drugs persist in the blood. The study will specifically look at
      blood levels of these three drugs (taken as a 3-in-1 tablet) after taking them every day for
      14 days.

      The duration of the subjects involvement in the study will be up to 23 days plus a screening
      visit which will take place up to 4 weeks prior to the start of the study, and a follow up
      visit which takes place 16-22 days after the last dose of study medication.

      This study is not randomised which means that all participants will receive all study
      medications in the same order. The participant and the study doctor will know which study
      medications you are taking at all times during the study.
    


Intervention name(s): Eviplera®
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lowering Viral Load With Nucleos(T)Ide Analogues Prior to Peginterferon Treatment to Ncrease Sustained Response in CHB
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      Treatment with a nucleoside analogue and subsequent viral decline has shown to partially
      restore immune hyporesponsiveness in chronic hepatitis B patients. Recent pilot studies
      investigating whether the effect of lowering viral load with nucleoside analogue therapy
      prior to the initiation of peginterferon results in higher sustained off-treatment responses
      showed contradictory findings.

      The aim of this study is to investigate sustained off-treatment response to peginterferon
      alfa-2b in chronic HBeAg-positive hepatitis B patients who are pretreated with nucleos(t)ide
      analogues, thereby lowering viral load
    


Intervention name(s): PegIFN alfa-2b
Intervention type(s): Drug
Intervention description(s): Peginterferon alpha-2b 1.5 μg/kg per week s.c.for 48 weeks
Other intervention name(s): Pegintron
Intervention MeSH terms: Peginterferon alfa-2b
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis B; sustained response; peginterferon; nucleos(t)ide analogues
Safety and Immunogenicity of an Intramuscular A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine in Children
Condition: Influenza; Orthomyxoviridae Infections; Orthomyxovirus Infections
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Influenza in Birds; Orthomyxoviridae Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is part of an effort to develop an effective vaccination program in children in
      the event of a pandemic.

      Study objectives:

        -  To describe the safety profiles in the periods following each vaccination in subjects
           receiving different vaccination schedule.

        -  To describe the immune response after each vaccination in subjects receiving study
           vaccine.
    

Detailed description: 
      Study participants will receive two administrations of the investigational vaccine at one of
      3 vaccination schedules.
    

Intervention name(s): A/H5N1 Inactivated, Split Virion Pandemic Influenza Vaccine
Intervention type(s): Biological
Intervention description(s): 0.5 mL, Intramuscular
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza; Orthomyxoviruses; Split Virion Pandemic Influenza Vaccine; A/H5N1
Effect of Apidra Compared to Humalog in Decreasing Post-Prandial Hyperglycemia
Condition: Type 1 Diabetes
MeSH terms: Hyperglycemia
Study type: Interventional

Summary: 
      This study aims to compare the post-meal blood glucose values of two drugs in a "real-world"
      setting.
    

Detailed description: 
      This is a randomized, open-label trial that aims to compare the glycemic excursion following
      food intake following post-meal injection of Glulisine (Apidra) insulin and Lispro (Humalog)
      insulin in a real-world setting. Children participating in the Florida Camp for Children and
      Youth with Diabetes will be randomized to receive either Glulisine or Apidra to cover
      carbohydrates after meals. The difference in blood glucose values will be analyzed before and
      2 hours after meals to see if there is a difference in post-prandial hyperglycemia between
      groups.
    

Intervention name(s): Apidra; Humalog; Novolog
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.; Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.; Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
Other intervention name(s): Insulin glulisine; Insulin lispro; Insulin aspart
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin Lispro; Insulin glulisine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: post-prandial hyperglycemia
PEEP Test and Gas Exchange in ALI/ARDS Patients
Condition: Acute Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
Study type: Interventional

Summary: 
      The investigators aim to study the effect of different levels of PEEP in ALI/ARDS patients on
      gas exchange.
    

Detailed description: 
      In a population of ALI/ARDS patients during mechanical ventilation we will evaluate the
      effect of different levels of PEEP on gas exchange and dead space.
    

Intervention name(s): Mechanical ventilation
Intervention type(s): Procedure
Intervention description(s): measurement of gas exchange, dead space, respiratory mechanics 5, 15, 30, 60 minutes from PEEP change (5 and 15 cmH2O)
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: gas exchange; dead space; respiratory failure; ALI/ARDS patients
PheWAS of a Polygenic Predictor of Thyroid Function
Condition: Thyroid; Genetic Predisposition to Disease
MeSH terms: Thyroid Diseases; Genetic Predisposition to Disease
Study type: Observational

Summary: 
      Performing a phenome-wide association study (PheWAS) identifying clinical diagnoses
      associated with a polygenic predictor of Thyroid stimulating hormone (TSH) levels identified
      by a previously published genome-wide association study (GWAS). PheWAS will be applied in an
      electronic-health-record (EHR) cohort including North American (n: 37,154) and European
      participants using 1,318 phenotypes.
    

Detailed description: 
      Applying a genetic predictor of thyroid stimulating hormone levels to an
      electronic-health-record cohort to verify associations with thyroid disorders as positive
      controls, and identify new associations .
    

Intervention name(s): phenome-wide association study (PheWAS)
Intervention type(s): Genetic
Intervention description(s): Phenome-wide association study (PheWAS) identifying clinical diagnoses associated with a polygenic predictor of TSH levels identified by a previously published genome-wide association study (GWAS) which included North American and European participants. A phenome-wide scanning of 1,318 phenotypes will be performed, using a cohort of 37,154 North American individuals of European ancestry with electronic-health-record (EHR) data.
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A primary electronic health record population derived from the eMERGE Phase I & II Network
        (n=16,924), and from Vanderbilt University Medical Center's (VUMC) BioVU resource
        (n=20,230). All subjects born prior to 1990 and falling within 4 standard deviations for
        each of the first 2 principal components based on common single nucleotide variants (SNVs)
        for the subset of subjects self-identified as "White, non-Hispanic".

        Thyroid Stimulating Hormone(TSH)-Population subgroup: Subjects of European Ancestry in
        BioVU who did not have any ICD-9 or ICD-10 codes for thyroid diseases and who had thyroid
        stimulating hormone (TSH) measurements that fell within the clinically normal reference
        range.
Elderberries and Obesity
Condition: Fuel Management
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Previous studies in humans indicate that anthocyanin-rich berries can positively alter fat
      oxidation and insulin sensitivity. This study will determine if this is also true with
      elderberries, which are a more concentrated source of anthocyanins compared to other commonly
      consumed berries.
    


Intervention name(s): Elderberry juice; Placebo beverage
Intervention type(s): Other; Other
Intervention description(s): Participants will consume elderberry juice 1-week.; Participants will consume placebo for 1-week.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Cannabis Cigarettes Used for Doping: Delta-9-Tetrahydrocannabinol (THC) Urine Detection
Condition: Healthy
MeSH terms: Marijuana Abuse
Study type: Observational

Summary: 
      The purpose of this study on volunteers is whether THC and short-living metabolites are
      suited to detect recent Cannabis smoking within urine doping control.
    

Detailed description: 
      About half of all positive doping cases in Switzerland have been related to Cannabis
      consumption (mainly recreational smoking). So far, the target analyte in urine is
      11-nor-9-carboxy-THC (THC-COOH), the main metabolite of delta-9-tetrahydrocannabinol (THC),
      which is excreted up to several days after single use. However, the wide detection window of
      THC-COOH does not allow a conclusion concerning the impact on the physical performance.
      Therefore, the evaluation of other target analytes with shorter elimination half-lives is
      needed and the aim (primary endpoints) of the present study. This pharmacokinetic, open,
      1-session trial on 12 healthy, male, infrequently Cannabis smoking volunteers is focussed on
      the GC/MS profiling of THC and metabolites in urine and plasma after standardized smoking of
      a single 7% THC Cannabis cigarette of the Dutch Ministry of Health, Welfare & Sport, Office
      of Medicinal Cannabis. Pharmacodynamic measurements (secondary endpoints) include the
      side-effects monitoring by using Visual Analog Scales and checking vital functions.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy male subjects; light (max. 1/month), infrequent Cannabis smokers, medium (max.
        15/month) tobacco smokers experienced in the inhalation technique; age 20-30 years; body
        weight 75+/-15 kg, normal medical history physical examination, passed laboratory tests
        (safety lab), normal lung functions (spirometry).
      
Biospecimen description: 
      Plasma, urine
    
Keywords: Cannabis; doping; THC; GC/MS; Pharmacokinetics; Volunteers
NICUSeq: A Trial to Evaluate the Clinical Utility of Human Whole Genome Sequencing (WGS) Compared to Standard of Care in Acute Care Neonates and Infants
Condition: Rare Diseases
MeSH terms: Rare Diseases
Study type: Interventional

Summary: 
      Prospective, multi-site, study to evaluate the clinical utility of cWGS in a proband. One
      group will receive cWGS and a clinical report approximately 15 days after blood samples are
      received, while the other group will continue to receive standard of care until Day 60. The
      standard of care group will receive cWGS and a clinical report at Day 60 as part of secondary
      and tertiary analyses. Both groups will be followed for a total of 90 days.
    

Detailed description: 
      This is a prospective, multi-site, randomized study to evaluate the clinical utility of cWGS
      in each proband. Throughout this study, each proband will receive SOC testing as determined
      by the site clinical team. Upon enrollment in the study, each proband will be randomly
      assigned to the 15 day cWGS group or the SOC group. SOC is defined as the management of the
      proband's care under the same or similar conditions as if the proband was not enrolled in
      this study. A blood sample from each enrolled proband will be collected and shipped to the
      Illumina Clinical Services Laboratory ("ICSL"), which is Clinical Laboratory Improvement
      Amendments (CLIA)-certified and College of American Pathologists (CAP)-accredited. ICSL will
      conduct cWGS testing with the TruGenome Undiagnosed Disease Test ("TruGenome Test"). The
      TruGenome Test cWGS results will be provided to the Principal Investigator (PI) or designee
      who will evaluate each proband test outcome based on the aggregate medical information,
      informed by the cWGS or SOC results.
    

Intervention name(s): clinical whole genome sequencing (cWGS)
Intervention type(s): Other
Intervention description(s): Clinical Whole Genome Sequencing (cWGS) consists of the sequencing, analysis and interpretation of subjects samples and a return of the result to the ordering physician.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multi-cohort, time delay study receiving Clinical Whole Genome Sequencing (cWGS) at either 15 days or 60 days in an acutely ill newborn population
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: ICU; Intensive Care Unit
Gallbladder Functions & Serum Cholecystokinin Levels in Women Diagnosed With Hyperemesis Gravidarum
Condition: Hyperemesis Gravidarum; Pregnancy Related
MeSH terms: Hyperemesis Gravidarum
Study type: Observational

Summary: 
      This study evaluates the gallbladder functions and serum cholecystokinin levels in pregnant
      women diagnosed with hyperemesis gravidarum. Half of the participants are healthy pregnant
      women and half of the participants are pregnant women diagnosed with hyperemesis gravidarum.
      Two groups will be compared by means of gallbladder functions and serum cholecystokinin
      levels.
    

Detailed description: 
      Previously gallbladder functions have been observed in human with gallbladder disease.
      However it has never been evaluated whether there is any difference in gallbladder functions
      between healthy pregnant women and pregnant women diagnosed with hyperemesis gravidarum.
      Moreover correlation between hyperemesis gravidarum symptom scores and gallbladder functions
      has never been assessed. There is also few data comparing serum cholecystokinin levels
      between healthy pregnant women and those diagnosed with hyperemesis gravidarum. The
      investigators will measure serum cholecystokinin levels after a fatty meal (100 g chocolate)
      and compare two groups. In this study the investigators would like to evaluate gallbladder
      functions and serum cholecystokinin levels in women with hyperemesis gravidarum and compare
      these with healthy subjects.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        healthy pregnant women and pregnant women diagnosed with hyperemesis gravidarum before 14
        weeks of pregnancy
      
Biospecimen description: 
      Blood samples
    
Keywords: gallbladder functions; cholecystokinin; hyperemesis gravidarum
Conventional Ovarian Stimulation vs. Single Injection Stimulation of Corifollitropin Alfa in Oocyte Donor
Condition: Ovarian Stimulation
Study type: Interventional
Phase: Phase 4

Summary: 
      This study aims to study the efficiency of using a single injection of Corifollitropin alfa
      for ovarian stimulation by initiating administration late and without further administration
      of follicle-stimulating hormone after the 7th day of stimulation compared to conventional
      ovarian stimulation using Corifollitropin alfa (drug administration 5 days after cessation of
      hormonal contraceptive and supplementation with follicle-stimulating hormone daily
      administration from the 8th day of stimulation).

      This a controlled randomized clinical study and 180 patients will be recruited (90 per arm)
      and the primary study outcome is the number of obtained oocytes.
    


Intervention name(s): Time of administration of Corifollitropin Alfa
Intervention type(s): Drug
Intervention description(s): The used treatment will be identical in both arms. The difference between the groups will be the moment of beginning of the stimulation as well as the later administration of more FSH activity.
The control grup will receive the treatment on the 5th day after the cessation of hormonal contraceptive use. The used treatment will be identical in both arms. The difference between the groups will be the moment of beginning of the stimulation as well as the later administration of more FSH activity.
The intervention grup will receive the treatment on the 7th day after the cessation of hormonal contraceptive use.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Miltefosine (Long Course) for Bolivian Mucosal Leishmaniasis
Condition: Leishmaniasis
MeSH terms: Leishmaniasis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Miltefosine (longer course) will be used to try to improve the cure rate of mucosal
      leishmaniasis
    

Detailed description: 
      Miltefosine (42 days) will be used to try to improve upon the cure rate with 28 days of drug
      for bolivian mucosal leishmaniasisi
    

Intervention name(s): miltefosine: 2.5 mg/kg/day for 42 days
Intervention type(s): Drug
Intervention MeSH terms: Miltefosine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: mucosal; miltefosine
Atherosclerosis Monitoring and Atherogenicity Reduction Study
Condition: Carotid Atherosclerosis
MeSH terms: Carotid Artery Diseases; Atherosclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was designed to estimate the effect of two-year treatment with time-released
      garlic-based drug Allicor on the progression of carotid atherosclerosis in double-blinded
      placebo-controlled randomized clinical trial.
    


Intervention name(s): Allicor; Placebo
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Sugar pill manufactured to mimic Allicor 150 mg tablet
Other intervention name(s): time-released garlic powder tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: atherosclerosis; regression; Allicor; garlic; intima-media thickness
A Study to Estimate the Effect Sizes of HRCT Endpoints in Response to Glucocorticoid Induction Therapy in Subjects With Pulmonary Sarcoidosis
Condition: Sarcoidosis, Pulmonary
MeSH terms: Sarcoidosis, Pulmonary; Sarcoidosis
Study type: Interventional

Summary: 
      This is a multicenter, single-arm, unblinded/open-label study of the effect size of HRCT
      endpoints in response to glucocorticoid induction therapy in subjects with a diagnosis of
      pulmonary sarcoidosis who have not received glucocorticoid as initial sarcoidosis therapy (≥
      20 mg/day prednisone or prednisolone) or other sarcoidosis therapy for at least 3 months
      prior to enrollment. This study will enroll a total of approximately 24 subjects.
    

Detailed description: 
      Optimal development of novel treatments for sarcoidosis requires clinical study endpoints
      that efficiently reflect changes in disease activity over short treatment durations. Such
      endpoints enable preliminary assessment of candidate drug efficacy in small studies - prior
      to exposing large cohorts to experimental compounds in pursuit of registrational data.

      This study will accordingly investigate the ways that certain HRCT-based functional
      respiratory imaging (FRI) measures can serve as more quantitative and sensitive endpoints
      compared to pulmonary function tests to measure drug effect in a short duration small sample
      size study in patients with pulmonary sarcoidosis. The study is designed to minimize impact
      on sarcoid care that the patient would have otherwise received. Glucocorticoid (≥ 30 mg/day
      prednisone or prednisolone) as per local clinical practice of sarcoidosis initial induction
      therapy will be taken orally in this study. The glucocorticoid dose may be modified depending
      on ongoing assessment as a part of standard local clinical practice.
    

Intervention name(s): Glucocorticoid (prednisone or prednisolone)
Intervention type(s): Drug
Intervention description(s): ≥ 30 mg/day prednisone or prednisolone taken orally as per local clinical practice of sarcoidosis initial induction therapy
Other intervention name(s): prednisone or prednisolone
Intervention MeSH terms: Prednisone; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Glucocorticoids
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Pulmonary Sarcoidosis; HRCT; Glucocorticoid; Prednisone; FRI; Prednisolone
Efficacy Study of HoLEP and TURP on LUTS Secondary to BPH
Condition: Lower Urinary Tract Symptoms; Benign Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia; Lower Urinary Tract Symptoms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare of Efficacy and Safety Between Holmium Laser
      Enucleation of the Prostate (HoLEP) and Transurethral Resection of the Prostate (TURP) on the
      Lower Urinary Tract Symptoms (LUTS) Secondary to Benign Prostate Hyperplasia (BPH).
    


Intervention name(s): Transurethral resection of the prostate; Holmium Laser Enucleation of the Prostate
Intervention type(s): Procedure; Procedure
Intervention description(s): Standard transurethral resection of the prostate using electrocautery loop; HoLEP using 100W Ho:YAG laser
Other intervention name(s): TURP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment