bioihbjkbjnl/mcl2 huggingface dataset:
An Open-label, Phase I/II Study of the Pan-immunotherapy in Patients With Relapsed/Refractory Ovarian Cancer
Condition: Ovarian Cancer
MeSH terms: Ovarian Neoplasms; Carcinoma, Ovarian Epithelial
Study type: Interventional
Phase: Phase 2

Summary: 
      Ovarian cancer is the most lethal gynecological cancer and the 5th leading cause of cancer
      death in women. Platinum chemotherapy has been widely adopted as a standard treatment for
      advanced ovarian cancer, the response rates in patients with relapsed/refractory ovarian
      cancer is unacceptably low. PD-1 blockade has been developed to a new class of cancer
      immunotherapy that could restore an adequate immunosurveillance against the neoplasm and
      enhance T-cell-mediated anticancer immune responses. Manganese has been confirmed to activate
      antigen-presenting cells and function as mucosal immunoadjuvants in pre-clinical studies.
      This two-arm, phase I/II study is designed to assess the safety and efficacy of combined
      therapy of anti-PD-1 antibody and chemotherapy with or without Manganese priming.
    


Intervention name(s): Manganese Chloride; nab-paclitaxel; Platinum chemotherapy; Sintilimab
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered by inhalation at 0.4mg/kg twice per week in the first 3-week cycle, and then inhaled 0.4mg/kg twice in the first week of each 3-week cycle thereafter; Administered intravenously, 180-220mg/m2 on day 2 in a 3-week cycle (day 1 without Manganese priming); Administered intravenously, Cisplatin (60-80mg/m2) or Carboplatin (area under the curve [AUC] 4-6 mg/mL per min) on day 2 in a 3-week cycle (day 1 without Manganese priming); Administered intravenously, 200mg on day 3 in a 3-week cycle (day 2 without Manganese priming)
Other intervention name(s): Paclitaxel For Injection (Albumin Bound); anti-PD-1 antibody; PD-1 inhibitor
Intervention MeSH terms: Manganese; Paclitaxel; Albumin-Bound Paclitaxel; Immune Checkpoint Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: relapsed; refractory; anti-PD-1 antibody; Manganese; chemotherapy
Sleep Duration Required to Restore Performance During Chronic Sleep Restriction
Condition: Sleep; Sleep Deprivation; Insufficient Sleep Syndrome
MeSH terms: Sleep Deprivation
Study type: Interventional

Summary: 
      The purpose of this study is to test the hypothesis that sleep and performance depend on
      length of time awake, length of time asleep, the amount of sleep over several sleep episodes,
      and circadian phase.
    

Detailed description: 
      The purpose of this study is to test the hypothesis that sleep and performance depend on
      length of time awake, length of time asleep, the amount of sleep over several sleep episodes,
      and circadian phase. Inpatient sleep and performance data will be collected from healthy
      volunteers.
    

Intervention name(s): Sleep:wake 1; Sleep:wake 2
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Sleep and Wake durations for arm 1; Sleep and Wake durations for arm2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Inpatients; Health Normalcy; circadian rhythm
A Study Evaluating ABI-H0731 as Adjunctive Therapy in Participants With Chronic Hepatitis B Infection
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if ABI-H0731 given in combination with a standard
      of care (SOC) hepatitis B virus (HBV) nucleos(t)ide reverse transcriptase inhibitor (NUC)
      medication is safe and effective in participants with chronic hepatitis B virus infection
      (cHBV).
    

Detailed description: 
      This is a Phase 2a, Multi-center, Double-blind, Placebo-controlled Study Evaluating ABI-H0731
      as Adjunctive Therapy in Virally-suppressed Participants with cHBV.
    

Intervention name(s): ABI-H0731; SOC NUC; Placebo Oral Tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive ABI-H0731 300 mg tablets orally once daily (QD).; Participants will continue on their SOC NUC (ETV, TDF or TAF) tablet orally as per approved package insert.; Participants will receive placebo matching ABI-0731 tablets orally QD.
Other intervention name(s): Entecavir (ETV); Tenofovir disoproxil fumarate (TDF); Tenofovir alafenamide (TAF)
Intervention MeSH terms: Tenofovir; Entecavir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic hepatitis B; HBV; HBeAg-positive; hepatitis B; HBeAg-negative; vebicorvir; VBR
Non-Invasive Hemoglobin Monitoring in Patients With Hemorrhage
Condition: Hemorrhage
MeSH terms: Hemorrhage
Study type: Observational

Summary: 
      This study will evaluate the accuracy of two rapid methods of measuring hemoglobin in
      patients with suspected hemorrhage. These methods will be compared with standard laboratory
      measurements.
    

Detailed description: 
      Anemia and bleeding are major causes of morbidity and mortality in both surgical and
      nonsurgical patients. The current standard of care for monitoring patients at risk for
      bleeding is serial measurement of hemoglobin levels. At present, the photometric
      cyanmethemoglobin method is the most widely used technique for monitoring hemoglobin in the
      lab, and is currently the gold standard. However, this method has potential for delay before
      final results are obtained.

      Immediate hemoglobin measurements are available with portable point-of-care devices such as
      the iSTAT, which can produce a measurement of hemoglobin concentration in less than 1 minute.
      Unfortunately, the accuracy of this device has been reported to vary with hemoglobin level,
      and as such may not be as accurate in detecting blood loss when compared with the gold
      standard of laboratory analysis.

      Recently, a noninvasive, spectrophotometry-based monitoring technology has been developed.
      This novel technology measures the differential optical density of wavelengths of light
      passed through the finger in a method similar to conventional pulse oximetry. While some
      studies have reported that this device appears to be accurate in patients undergoing elective
      surgical procedures, more recent work suggests that this accuracy degrades with increased
      blood loss, lower oximeter signal quality and lower absolute Hgb values.

      We will evaluate the accuracy of point-of-care and non-invasive SpHb measurements and utility
      of continuous hemoglobin monitoring in an intensive care unit setting. If these methods of
      rapid hemoglobin measurement can be validated in patients at risk for ongoing hemorrhage, use
      of this technology may result in earlier detection of ongoing hemorrhage, expedite
      appropriate treatment, and improve patient outcomes.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted to the Surgical Intensive Care Unit of University Hospital, Cincinnati
        will be eligible for this study if they are at risk of ongoing bleeding and require serial
        CBC measurements. A patient will not be eligible if he or she is:(1) less than 18 years of
        age, (2) a prisoner, or if (3) clinicians are unable to take pulse oximetry readings due to
        injuries, burns, amputations, or related problems.
      
Keywords: Hemorrhage; Hemoglobin; Non-invasive monitoring; Medical device accuracy
Metronomic Oral Vinorelbine in Patients With Metastatic Tumors
Condition: Breast Cancer; Non Small Cell Lung Cancer; Prostate Cancer
MeSH terms: Prostatic Neoplasms; Carcinoma, Non-Small-Cell Lung; Neoplasm Metastasis
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with recurrent or metastatic solid tumors receive oral vinorelbine at one of three
      different doses (30 or 40 or 50 mg). Vinorelbine will be administered orally at a metronomic
      schedule three times a week: on Monday, Wednesday and Friday.
    

Detailed description: 
      The purpose of this study is to define the biologically optimal dose of vinorelbine when
      administered at a metronomic dosing schema. [Metronomic chemotherapy refers to the close,
      regular administration of minimally toxic doses of cytotoxic drugs, with minimal or no
      drug-free breaks, over prolonged periods]. Patients with recurrent or metastatic solid tumors
      are randomly assigned one of three different doses of oral vinorelbine (30 or 40 or 50 mg).
      Treatment is administered three times a week (Monday, Wednesday and Friday) continuously
      until disease progression or unacceptable toxicity or to a maximum of 24 months.
    

Intervention name(s): vinorelbine oral formulation
Intervention type(s): Drug
Intervention description(s): Patients will take three times a week [Monday, Wednesday and Friday] by mouth, a standard dose of soft capsules of vinorelbine given at dose ascribed by randomization procedure
Other intervention name(s): Navelbine
Intervention MeSH terms: Vinorelbine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metronomic-therapy; vinorelbine; Recurrent Breast Cancer; Recurrent Non Small Cell Lung Cancer; Metastatic prostate cancer
Efficacy of Inhaled Cannabis for Acute Migraine Treatment
Condition: Migraine; Cannabis; THC; CBD
MeSH terms: Migraine Disorders; Marijuana Abuse
Study type: Interventional
Phase: Phase 2

Summary: 
      This crossover study will evaluate 3 different treatments of vaporized cannabis (THC, THC/CBD
      mix, and CBD) and vaporized placebo cannabis for the acute treatment of migraine.
    

Detailed description: 
      In this double-blind, randomized, crossover trial, subjects will treat 4 separate migraine
      attacks with 4 different treatments. Inhaled cannabis will be administered using a portable
      vaporization system (Mighty Medic; Storz & Bickel) based on a validated Storz & Bickel system
      and using a standardized inhalation approach. Subjects will self-administer inhaled cannabis
      as early as possible in the course of a migraine (see Procedure), taking 4 puffs of 1) THC,
      2) THC/CBD mix, 3) CBD, or 4) placebo. Patients will treat each of the 4 distinct migraine
      attacks with a different cannabis sample. Outcomes measured will include pain freedom and
      pain relief as well as presence or absence of photophobia, phonophobia, and nausea at 1 hour,
      2 hours (primary outcome), 24 hours, and 48 hours.
    

Intervention name(s): THC ~5%; CBD ~12%; THC ~5% and CBD ~12%; Sham Cannabis
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 4 puffs of vaporized flower containing THC ~5%; 4 puffs of vaporized flower containing CBD ~12%; 4 puffs of vaporized flower containing THC ~5% and CBD ~12%; 4 puffs of vaporized flower from which the THC and CBD have been extracted
Other intervention name(s): THC; delta 9-tetrahydrocannabinol; marijuana; CBD; cannabidiol; hemp; THC; CBD; delta 9-tetrahydrocannabinol; cannabidiol; marijuana; hemp; Placebo; Sham
Intervention MeSH terms: Dronabinol; Cannabidiol
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Randomized, Double-blind, Placebo-controlled, Crossover Trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Migraine; Cannabis; THC; CBD
Safety and Pharmacokinetic Comparison of Co-administration and a Combination Drug of Rosuvastatin and Olmesartan in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study investigates safety and pharmacokinetic comparison of DWJ1276, a combination drug
      of Rosuvastatin and Olmesartan (test formulation), and co-administration of Rosuvastatin and
      Olmesartan (reference formulation) for single dose in healthy volunteers
    


Intervention name(s): Test formulation; Reference formulation
Intervention type(s): Drug; Drug
Intervention description(s): Single administration of a combination tablet of Rosuvastatin 20mg and Olmesartan 40mg; Co-administration of Rosuvastatin 20mg tablet and Olmesartan 40mg tablet
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics
High vs Standard Energy Children's Drink Study
Condition: Growth Failure
MeSH terms: Failure to Thrive
Study type: Interventional

Summary: 
      This study is a pilot trial investigating the effects of a high energy drink for children, in
      comparison to standard energy drink for children.
    

Detailed description: 
      A four week, multi-centre, randomised controlled trial investigating the effects of a high
      energy density, low volume oral nutritional supplement versus standard energy density oral
      nutritional supplements in children aged 1-12yrs old requiring nutritional support. Fifty
      eligible children will be recruited and randomised to receive either the high energy density
      oral nutritional supplement or the standard energy density oral nutritional supplement for
      four weeks. The primary outcome is nutrient intake, with secondary outcomes of compliance,
      tolerance, acceptability, anthropometry and safety.
    

Intervention name(s): HE ONS; SE ONS
Intervention type(s): Other; Other
Intervention description(s): High energy density, low volume oral nutritional supplement (HE ONS) in addition to appropriate nutritional management; Standard energy density oral nutritional supplement (SE ONS) in addition to appropriate nutritional management
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Positron Emission Tomography (PET) Study to Describe the Relationship Between Plasma Concentrations and Brain Gly-T1 Occupancy of GSK1018921 Over Time.
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      A PET study using [11c]GSK931145 to characterise the exposure-occupancy relationship over
      time for GSK1018921.
    

Detailed description: 
      This is an open-label, adaptive-design, single-dose, non randomized PET occupancy study.The
      primary aim of this study is to describe the relationship between plasma concentrations and
      brain occupancy of GSK1018921 over time. Up to 22 healthy volunteers will be administered
      single doses of GSK1018921 in order to obtain 12 evaluable complete data sets of occupancy
      estimates.
    

Intervention name(s): GSK1018921
Intervention type(s): Drug
Intervention description(s): GSK1018921 is a GT1 recepor antagonist
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glycine Tranporter; MRI; PET
Fetal Neurobehavior in Poly-drug Dependent Women
Condition: Poly Drug Exposed Pregnancies
Study type: Observational

Summary: 
      This project examines fetal neurobehavior and maternal physiology in poly-drug dependent
      women. This study also evaluates infant neonatal abstinence syndrome, infant neurobehavior
      and vagal tone in the post-partum period.
    

Detailed description: 
      Little is known about the link between maternal physiology, fetal neurobehavior and neonatal
      abstinence syndrome in multiply drug-dependent women. Previous research by this group of
      investigators has found that the severity of neonatal abstinence syndrome in methadone
      exposed infants is related to maternal vagal tone changes in response to methadone during
      pregnancy. While previous research has focused on drug abstinent, methadone maintained women,
      most drug dependent pregnant women are poly-substance abusers who also use prescription
      psychiatric medications, alcohol and nicotine. This protocol seeks to further our
      understanding of the effects of multiple drugs on the fetus, including the co-variate effects
      of maternal psychological status. Infant neurobehavior and vagal tone will also be evaluated.
      This research will extend our knowledge of fetal neurobehavioral development and neonatal
      abstinence syndrome in a realistic population of poly-drug dependent women, potentially
      altering the way in which these women are evaluated and their infants monitored and treated
      for neonatal abstinence syndrome.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Poly drug dependent pregnant women
      
Keywords: Substance abuse; fetal development; vagal tone
The Safety, Tolerability and Efficacy of Multiple Subcutaneous Injections of SHR-1209 in Subjects With Hyperlipidemia
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a randomized, double-blind, placebo- controlled phaseⅠb/Ⅱclinical study. Totally 108
      subjects are planned to enrolled with 36 subjects in three low-dose groups (group 1, group 2
      and group 3) and 72 subjects in three high-dose groups (group 4, group 5, and group 6).12
      subjects with hyperlipidemia who received statin stable treatment for more than 28 days are
      enrolled in each low-dose group, randomly given SHR-1209 or placebo treatment at a ratio of
      5:1. 24 subjects with hyperlipidemia who received statin stable treatment for more than 28
      days are enrolled in each high-dose group, randomly given SHR-1209 or placebo treatment at a
      ratio of 5:1. The primary objective of this study is to evaluate the safety, tolerability,
      and efficacy of multiple subcutaneous injections of SHR-1209 in hyperlipidemia subjects
      treated with stabilized dose of statin. Groups detail as follows:

        1. SHR-1209 dose 1 /placebo frequence 1

        2. SHR-1209 dose 2 /placebo frequence 2

        3. SHR-1209 dose 3 /placebo frequence 3

        4. SHR-1209 dose 4 /placebo frequence 1

        5. SHR-1209 dose 5 /placebo frequence 2

        6. SHR-1209 dose 6 /placebo frequence 3
    


Intervention name(s): SHR-1209; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form: lyophilized formulation
Route of administration: subcutaneous; Pharmaceutical form: lyophilized formulation
Route of administration: subcutaneous
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Human Papillomavirus Vaccine Safety & Immunogenicity Trial in Healthy Young Adult Women With HPV Vaccine (GSK1674330A)
Condition: Infections, Papillomavirus
Study type: Interventional
Phase: Phase 1

Summary: 
      Infection with human papillomavirus (HPV) has been clearly established as the central cause
      of cervical cancer. Indeed, certain oncogenic types of HPV can infect the cervix (part of the
      uterus or womb). This infection may go away by itself, but if it does not go away (this is
      called persistent infection), it can lead in women over a long period of time to cancer of
      the cervix. GlaxoSmithKline Biologicals has developed a HPV vaccine against the oncogenic
      types HPV-16 and HPV-18 formulated with the AS04 adjuvant (control vaccine) and is also
      evaluating novel HPV vaccines formulations. This study will evaluate a novel GSK Biologicals'
      HPV vaccine (GSK1674330A) in terms of safety and immunogenicity compared to the control
      vaccine. There will be different levels of blinding in the study.

      The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
      2007.
    


Intervention name(s): GSK Biologicals' HPV vaccine (GSK1674330A); Cervarix TM
Intervention type(s): Biological; Biological
Intervention description(s): Intramuscular administration, 5 different formulations; Intramuscular administration
Other intervention name(s): GSK Biologicals' HPV vaccine (580299)
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: HPV
Extended Safety Study of Montelukast in Infants and Young Children With Chronic Asthma (0476-232)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients were treated with either montelukast 4 mg oral granules or usual care. Patients who
      completed Protocol MK0476-176-01 (NCT00943683) had the option to enroll in this study.
      Additionally, patients with asthma who were 6 to 11 months of age and who had not
      participated in Protocol MK0476-176-01, could also enroll.
    


Intervention name(s): montelukast sodium; Comparator: Usual Care
Intervention type(s): Drug; Drug
Intervention description(s): Montelukast 4 mg oral granules mixed with 1 tablespoon soft food once daily at bedtime for 52 weeks; Usual care defined as inhaled/nebulized cromolyn or inhaled nedocromil or inhaled/nebulized corticosteroids, according to the investigator's usual clinical practice for 52 weeks
Other intervention name(s): Montelukast
Intervention MeSH terms: Montelukast
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Aripiprazole for the Augmentation of Antidepressant Therapy
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      The study aims to evaluate effectiveness and tolerability of aripiprazole augmentation in
      outpatients with major depressive disorder who have had inadequate response to
      antidepressants in Taiwan clinical practice.
    


Intervention name(s): Aripiprazole
Intervention type(s): Drug
Intervention description(s): starting aripiprazole dose from 2-5mg/day, dose adjustment by every week, and maximum dose can up to 15mg/day. The duration is 6 weeks.
Intervention MeSH terms: Aripiprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment