bioihbjkbjnl/mcl2 huggingface dataset:
A Phase 1, Randomized, Placebo-controlled, Single & Multiple Dose Escalation Study to Investigate Safety, Pharmacokinetics, and Pharmacodynamics of SHR0534 in Healthy Chinese Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, placebo-controlled, single & multiple dose escalation study to
      investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of SHR0534. The
      study will be conducted with starting dose of 5 mg followed by dose escalation groups up to
      100 mg. Healthy Chinese subjects will be randomized in each cohort to receive the study drug
      or placebo.
    


Intervention name(s): SHR0534; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluating a Pharmacokinetic Drug Interaction Between HGP0918 and HGP0816
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators investigate the potential pharmacokinetic drug-drug interaction between
      HGP0918 and HGP0816 in healthy adult subjects who receive HGP0918 alone, HGP0816 alone, and
      both together in a 3 period repeatedly
    


Intervention name(s): HGP0918; HGP0816; HGP0918 + HGP0816
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Consistency Study of Three Lots of Henogen's Adjuvanted Hepatitis B Vaccine When Given in 0, 1 Month Schedule
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The study vaccine has been developed for use in pre-dialysis/ haemodialysis patients and
      immuno-compromised individuals who could have or had a sub-optimal response following
      vaccination for hepatitis B with currently available commercial vaccines (target population).
      This study will aim to confirm in a clinical setting the consistency of production of three
      lots of the vaccine.
    

Detailed description: 
      Double-blind, randomised, single centre study with three groups receiving three different
      lots of Henogen's adjuvanted hepatitis B vaccine according to 0, 1 months schedule. Blood
      samples will be taken at Month 0, Months 1 and 2.
    

Intervention name(s): Adjuvanted Hepatitis B vaccine Lot 1; Adjuvanted Hepatitis B vaccine Lot 2; Adjuvanted Hep B vaccine Lot 3
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 20 µg, IM, month 0 and 1; 20µg, IM, month 0 and 1; 20µg, IM, month 0 and 1
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Consistency; Immunogenicity
Dose Finding and Pharmacokinetics/Pharmacodynamics Study of Apatinib in the Treatment of Advanced Colorectal Cancer
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE:

      Apatinib is a tyrosin-inhibitor agent targeting at vascular endothelial growth factor
      receptor (VEGFR), and it's anti-angiogenesis effect has been viewed in preclinical tests. The
      investigators' phase I study has shown that the drug's toxicity is manageable.

      PURPOSE:

        1. Studying how well Apatinib works in treating patients.

        2. Finding the efficacy and safety of 500 mg or 750mg Apatinib.

        3. Pharmacokinetics/Pharmacodynamics(PK/PD).

        4. Exploring new outcome measures of antiangiogenic drugs.
    


Intervention name(s): Apatinib; apatinib
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg,p.o.,qd, until disease progression or intolerable toxicity or patients withdrawal of consent.; 750 mg,p.o.,qd, until disease progression or intolerable toxicity or patients withdrawal of consent.
Intervention MeSH terms: Apatinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced Colorectal Cancer
Treatment for Anxiety in Children
Condition: Obsessive-Compulsive Disorder; Anxiety Disorders; Generalized Anxiety Disorder; Social Phobia; Separation Anxiety
MeSH terms: Anxiety Disorders; Obsessive-Compulsive Disorder; Phobia, Social; Anxiety, Separation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to see if it is effective to treat children with anxiety
      disorders with fluvoxamine.

      Fluvoxamine has been successfully used to treat obsessive-compulsive disorder (OCD) in adults
      and children. Anxiety disorders other than OCD, such as generalized anxiety disorder, social
      phobia, or separation anxiety, are very common in youth and are not always responsive to
      behavioral therapies alone. These disorders may respond to fluvoxamine.

      A child will be evaluated for 3 weeks before he/she is assigned randomly (like tossing a
      coin) to receive either fluvoxamine or an inactive placebo for 8 weeks. After this
      double-blind phase (neither the child/parents nor the doctor know which treatment is being
      given), the child will have the option of continuing treatment during a 4-month open-label
      extension period (both the child/parents and the doctor know which the child is receiving).

      A child may be eligible for this study if he/she:

      Is 6 to 17 years old and has been diagnosed with an anxiety disorder (i.e., generalized
      anxiety disorder, social phobia, or separation anxiety).
    

Detailed description: 
      To evaluate fluvoxamine in the treatment of children and adolescents with anxiety disorders.

      Fluvoxamine is a serotonin reuptake inhibitor that is FDA-approved for the treatment of
      obsessive-compulsive disorder (OCD) in adults and children. Anxiety disorders other than OCD
      are very common in youth and are not always responsive to psychosocial therapies. Fluvoxamine
      is an alternative treatment.

      After a 3-week period of evaluation, patients meeting study entry criteria are randomized to
      receive either fluvoxamine or placebo for 8 weeks. After this double-blind phase, patients
      can enter a 4-month open-label extension.
    

Intervention name(s): Fluvoxamine
Intervention type(s): Drug
Intervention MeSH terms: Fluvoxamine
Masking: Double
Primary purpose: Treatment
Keywords: Adolescence; Anxiety Disorders; Child; Female; Fluvoxamine; Human; Male; Serotonin Uptake Inhibitors; Anxiety Disorders -- *drug therapy; Fluvoxamine -- *therapeutic use; Serotonin Uptake Inhibitors -- *therapeutic use
Ovarian Reserve and Ankylosing Spondylitis
Condition: Ovarian Diseases; Ankylosing Spondylitis; Anti-Mullerian Hormone Deficiency
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing; Ovarian Diseases
Study type: Observational

Summary: 
      The aim of this study was to determine the status of ovarian reserve in patients with
      ankylosing spondylitis (AS) using anti-mullerian hormone (AMH) level and antral follicle
      count (AFC). Women with AS and women controls diagnosed according to the classification
      criteria proposed by the American-European Consensus Group will be included in the study.
      Ovarian reserve will be evaluated in terms of clinical findings, AFC and serum AMH and
      reproductive hormone levels.

      Researchers predict that the ovarian reserve may be reduced in patients with AS due to the
      autoimmune process and the pathophysiology of the disease. Serum AMH and ovarian AFC may be
      useful for assessing ovarian reserve. It is aimed to determine the course of ovarian reserve
      abnormalities and the best possible biomarkers of reduced ovarian reserve in patients with
      AS.
    


Intervention name(s): ovarian reserve for Ankylosing spondylitis and control groups
Intervention type(s): Other
Intervention description(s): Additional organ diseases due to the pathophysiology of the disease may be seen in women with ankylosing spondylitis. therefore, we established the first group of women with the diagnosis of ankylosing spondylitis.
Women Who Are Diagnosed With Ankylosing Spondylitis Will Form The Study Group. and health women will be control group.
Clinical And Laboratory Parameters Will Be Evaluated For Ovarian Capacity Of These Women.
Amh Will Be Looked For (Pmol / L). Antral Folukul Census In The Overin Folukular Stage Will Be Valued As Number. Fsh (Iu / L) And Estradiol (Pmol / L) Values Will Also Be Recorded.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women who are diagnosed with ankylosing spondylitis will form the study group.
      
Keywords: Ankylosing spondylitis; fertility; anti-müllerian hormone; ovarian reserve
A Study in Healthy Men to Test Whether Food Affects the Amount of BI 894416 in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Investigate the relative bioavailability of BI 894416 as tablet formulation following a
      high-fat, high calorie breakfast (Test, T) compared with administration in the fasting state
      (Reference, R)
    


Intervention name(s): BI 894416
Intervention type(s): Drug
Intervention description(s): 3 tablets with 10 milligram (mg) of BI 894416 (total: 30 mg) were administered as one single oral dose with 240 milliliter (mL) of water.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Continuous Versus Intermittent Oxytocin Infusion for Induction of Labor
Condition: Induced; Birth
Study type: Interventional

Summary: 
      The study will compare 2 treatment modalities. One group will receive the routine protocol of
      intermittent pitocin induction for 6 hours and the second group will receive continous
      pitocin infusion for 16 hours.

      The primary aim is to observe which protocol leads to the fastest delivery and evaluate the
      time in each group from induction to delivery.
    

Detailed description: 
      After singing an informed consent, and prior to IOL initiation, study participants were
      randomly assigned (1:1) to receive either intermittent or continuous Oxytocin infusion. Both
      groups received the same primary infusion dose of Oxytocin 1.0 with an incremental increase
      of 2.5 every 30 minutes until 20, titered to a target of 3-5 contractions in a 10 minute
      period. During Oxytocin infusion, fetal heart rate was continuously monitored. Artificial ROM
      was performed according to the accepted indications, local protocol and by the staff
      physician discretion who was in charge on the labor ward at that time, regardless of oxytocin
      initiation time. In the intermittent Oxytocin infusion group, Oxytocin was discontinued after
      8 h if the patient did not go into active labor during by that time, and renewed 4 h later.
      In the continuous infusion group, patients received a continuous Oxytocin infusion for 16 h.
      If they did not go into active labor within this frame time, Oxytocin was discontinued for 4
      hours and then resumed. In addition, during Oxytocin infusion, sodium levels were monitored
      every 8 h.
    

Intervention name(s): Oxytocin; Oxytocin
Intervention type(s): Drug; Drug
Intervention description(s): Intermittent oxytocin Infusion; Continous oxytocin Infusion for 16 hours
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Glembatumumab Vedotin in Treating Patients With Recurrent or Refractory Osteosarcoma
Condition: Recurrent Osteosarcoma
MeSH terms: Osteosarcoma; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II trial studies how well glembatumumab vedotin works in treating patients with
      osteosarcoma that has come back (recurrent) or does not respond to treatment (refractory).
      Monoclonal antibodies, such as glembatumumab vedotin, may find tumor cells and help kill
      them.
    

Detailed description: 
      PRIMARY OBJECTIVES:

      I. To estimate whether CDX-011 (glembatumumab vedotin) therapy either increases the disease
      control rate at 4 months in patients with recurrent measurable osteosarcoma as compared to an
      historical Children's Oncology Group (COG) experience or produces an objective response rate
      in patients without previous eribulin (eribulin mesylate) treatment.

      SECONDARY OBJECTIVES:

      I. To assess the feasibility and toxicity profile of CDX-011 in patients with recurrent
      osteosarcoma.

      II. To describe the pharmacokinetics of CDX-011 in adolescents and young adults with
      recurrent osteosarcoma enrolled at COG sites and COG phase I consortium sites only.

      III. To determine if there is a relationship between tumor GPNMB expression by
      immunohistochemistry (IHC) and response to CDX-011 therapy.

      IV. To estimate, in the cohort of patients previously treated with eribulin, the proportion
      who will experience disease progression during the first 4 months of CDX-011 therapy and the
      proportion of patients who experience a Response Evaluation Criteria in Solid Tumors
      (RECIST)-defined complete or partial response.

      OUTLINE:

      Patients receive glembatumumab vedotin intravenously (IV) over 90 minutes on day 1. Treatment
      repeats every 21 days for up to 18 courses in the absence of disease progression or
      unacceptable toxicity.

      After completion of study treatment, patients are followed up periodically.
    

Intervention name(s): Glembatumumab Vedotin; Laboratory Biomarker Analysis; Pharmacological Study
Intervention type(s): Drug; Other; Other
Intervention description(s): Given IV; Correlative studies; Correlative studies
Other intervention name(s): Antibody-Drug Conjugate CR011-vcMMAE; CDX-011; CR011-vcMMAE; CR011-vcMMAE Immunotoxin
Intervention MeSH terms: Glembatumumab vedotin; Immunoconjugates; Immunotoxins; Antibodies, Monoclonal
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Yoga-based Exercises of Healthcare Workers During COVID-19 Pandemic: Prospective Clinical Trial
Condition: COVID-19 Pandemic; Yoga; Exercise Therapy; Mind-Body Therapies; Muscle Stretching Exercises
MeSH terms: COVID-19
Study type: Interventional

Summary: 
      To investigate the effect of yoga-based exercises therapy on functional capacity, dyspnea,
      quality of life, depression, anxiety, and sleep quality in healthcare professionals following
      COVID-19.
    

Detailed description: 
      Twenty-six healthcare professionals who were diagnosed with COVID-19, whose treatments were
      completed, and who were actively working during the subacute period with ongoing complaints
      were included in the study. The exercises program consisting of stretching, relaxation,
      isometric strengthening, breathing, and meditation exercises were given to the healthcare
      professionals under a 60-minute yoga-based exercises program held twice a week for a period
      of eight weeks. Flexibility and muscle strength measurements of the patients were calculated
      by the sit and reach test, shoulder flexibility test, and a hand dynamometer. Functional
      capacity was evaluated with the 6-minute walk test (6MWT), physical activity and dyspnea
      severity with the modified Medical Research Council (mMRC) dyspnea scale, depression and
      anxiety level with the Beck Depression and Anxiety Inventory, the quality of life with the
      SF-36, and sleep quality with the Pittsburgh Sleep Quality Index (PSQI).
    

Intervention name(s): yoga-based exercises therapy
Intervention type(s): Other
Intervention description(s): Accompanied by a certified yoga instructor, and under the supervision of an PMR specialist and a Sports Medicine specialist, YBEs were administered to our patients included in the study for 8 weeks, 2 sessions a week, and with sessions of 60 minutes, using personal mats and equipment in a 2475 m3 (18mx25mx5.5m) gym area that belonged to our hospital, in the form of group therapy for 5 (five) people and in accordance with the social distancing rules. The exercises program was applied as a exercise program consisting of physical postures (asana) to improve the body's muscle strength and flexibility, breathing exercises (pranayama) to increase respiratory function, and relaxation and meditation (dhyana) techniques.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: yoga; COVID-19; quality of life; healthcare workers; sleep quality
A Trial Comparing Treatment With the Springfusor Infusion Pump to the IV Magnesium Sulfate Regimen
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Interventional
Phase: Phase 4

Summary: 
      The trial will test the equivalence of a repeat bolus protocol of magnesium sulfate
      administered by the Springfusor® controlled pump to a continuous intravenous regimen. The
      goal of this pharmacokinetic study is to assess the pharmacological equivalence of the serum
      magnesium sulfate concentrations obtained in the treatment of severe preeclampsia with the
      continuous intravenous and Springfusor repeat bolus regimens. The study will also document
      the clinical outcomes, efficacy and acceptability of each treatment for patients and staff.
    


Intervention name(s): Springfusor infusion pump; IV administration; Magnesium Sulfate
Intervention type(s): Device; Other; Drug
Intervention MeSH terms: Magnesium Sulfate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: magnesium sulfate
The Influence of Heel Wedge Properties on Roll-over of the Intrepid Dynamic Exoskeletal Orthosis (IDEO)
Condition: Physical Disability
Study type: Interventional

Summary: 
      The Intrepid Dynamic Exoskeletal Orthosis (IDEO) is a type of ankle foot orthosis designed to
      reduce pain and improve function for individuals with foot/ankle pain and/or weakness.
      Because the IDEO restricts ankle movement, the geometry and mechanics of the device must be
      designed to allow for a smooth roll-over as the patient walks with the IDEO. The heel wedge,
      while not physically part of the IDEO, is an integral part of the IDEO-heel wedge-shoe
      "system". The goal of this research is to determine how heel wedge properties may contribute
      to the smoothness of roll-over during gait. Insight into the effects of heel wedge properties
      on roll-over will help optimize the design of the IDEO-heel wedge-shoe "system" and may
      produce guidelines for the customization of these features.
    

Detailed description: 
      The proposed study includes a between groups comparison (for Aim 1) and a fully repeated
      crossover design (for Aim 2). It will be conducted in the Military Performance Lab (MPL) at
      the Center for the Intrepid (CFI), Brooke Army Medical Center, Joint Base San Antonio
      (JBSA)Fort Sam Houston, Texas. Subjects who use IDEOs will come to the Military Performance
      Lab for one test session during which they will walk in standardized shoes with six different
      heel wedges in random order. Control data will also be collected on able-bodied individuals.
      Control subjects will also come to the MPL for one test session in which they will walk using
      the same standardized shoes. For all subjects, biomechanical gait data will be collected as
      the subjects walk along a walkway in the MPL. This data will be used to calculate roll-over
      shape, instantaneous radius of curvature, Center of Pressure (COP) velocity, and ankle
      moment.
    

Intervention name(s): Heel Cushion Material Bulk (foam)
Intervention type(s): Device
Intervention description(s): The heel wedge is made of a rubber style urethane foam. Heel wedges of specified heights and durometers will be inserted into the standard shoes, one at a time, during the test session only. The heel wedges used during the test session are made of the same foam as the heel wedges that are used clinically.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: rehabilitation; IDEO
A Study of the Effect of Polyphenon E (Green Tea Extract) on Breast Cancer Progression
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Disease Progression
Study type: Interventional
Phase: Phase 2

Summary: 
      To see if an extract of green tea can affect certain markers of breast cancer and breast
      cancer progression in women with a recent biopsy positive for cancer and who are scheduled
      for surgery.
    

Detailed description: 
      To evaluate the short-term effects of a daily dose of Polyphenon E administered during the
      interval between breast biopsy and surgery in women with recently diagnosed breast cancer.
      Endpoints will be changes in serum and tissue biomarkers related to progression of cancer.

      The effect of Polyphenon E on tumor cell c-Met expression and phosphorylation is the primary
      objective. Secondary objectives include the effects on the other tissue and serum biomarkers.
      Evaluation of the safety and tolerability of Polyphenon E in this subject population is
      another objective.

      1.1 Determine the effects of Polyphenon E on tumor cell c-Met expression and phosphorylation
      levels in patients with breast cancer

      1.2 Determine the effects of Polyphenon E on PI-3K activation in patients with breast cancer

      1.3 Determine the effects of Polyphenon E on MAPK activation in patients with breast cancer

      1.4 Determine the effects of Polyphenon E on expression levels of other proteins involved in
      motility and invasion such as Rho GTPases and extracellular proteinases in patients with
      breast cancer

      1.5 Determine the effects of Polyphenon E on markers of angiogenesis in patients with breast
      cancer

      1.6 Determine the effects of Polyphenon E on other serum markers: C-reactive protein (CRP),
      Insulin-Like Growth factor I (IGF-I), Insulin-like Growth Factor Binding Protein 3 (IGFBP-3)
      and Hepatocyte Growth Factor HGF

      1.7 Evaluate the safety and tolerability of Polyphenon E in this subject population
    

Intervention name(s): Polyphenon E
Intervention type(s): Drug
Intervention description(s): Four 200mg capsules daily taken with a meal, for the duration of the study.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: breast cancer; EGCG; Polyphenon E; c-Met; VEGF; HGF