bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess Relative Bioavailability of Branebrutinib, From a Tablet Formulation to the Capsule Formulation, the Effect of Food on the Bioavailability of Branebrutinib From a Tablet Formulation, and the Safety and Drug Levels of Branebrutinib From a Tablet Formulation in Healthy Participants
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the relative bioavailability of branebrutinib tablet
      formulation relative to the capsule formulation in order to identify doses that would provide
      exposures similar to the capsule formulation over the dose range that may be used in future
      clinical studies, evaluate the effect of food on the bioavailability of branebrutinib from a
      tablet formulation at a dose projected to provide similar pharmacokinetics (PK) as the 9 mg
      capsule formulation, and evaluate the safety and the PK of multiple oral dose of tablet
      formulation of branebrutinib in healthy participants.
    


Intervention name(s): Branebrutinib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Specified dose on specified days; Specified Dose on specified days
Other intervention name(s): BMS-986195
Intervention MeSH terms: Branebrutinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioequivalence Study of Pantoprazole 40 mg DR Tablets and Protonix 40 mg Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to determine the single-dose bioequivalence of the test
      product, a potential generic 40 mg pantoprazole delayed-release tablet formulation, compared
      with the reference product, a pantoprazole 40 mg delayed-release tablet formulation
      (Protonix, Wyeth Pharmaceuticals), following a single dose in the fasted state.
    

Detailed description: 
      The 90% CI for pantoprazole ln(Cmax), ln[AUC(0-t)], and ln[AUC(0-inf)] for the comparison of
      the test product (pantoprazole) versus the reference product (Protonix) should be within the
      80 to 125% range required for the conclusion of bioequivalence.
    

Intervention name(s): Pantoprazole 40 mg DR Tablet vs. Protonix 40 mg DR Tablet
Intervention type(s): Drug
Intervention description(s): Single dose crossover BE study
Other intervention name(s): Protonix 40 mg DR Tablet (Wyeth Pharmaceuticals)
Intervention MeSH terms: Pantoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalency
Reduced Intensity Conditioning Transplant Using Haploidentical Donors
Condition: Chronic Myelogenous Leukemia; Acute Myelogenous Leukemia; Myelodysplastic Syndrome; Acute Lymphocytic Leukemia; Chronic Lymphocytic Leukemia; Hodgkin's Lymphoma; Non-Hodgkin's Lymphoma; Myelofibrosis; CMML; Multiple Myeloma
MeSH terms: Lymphoma; Leukemia; Multiple Myeloma; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Myeloid; Leukemia, Myelogenous, Chronic, BCR-ABL Positive; Leukemia, Myeloid, Acute; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Myelodysplastic Syndromes
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial will evaluate the safety and efficacy of a reduced intensity allogeneic HSCT from
      partially HLA-mismatched first-degree relatives utilizing PBSC as the stem cell source. The
      primary objective of the study is to estimate the incidence of graft rejection and acute
      GVHD. A secondary objective will be to estimate the incidence of the relapse, NRM, OS,
      chronic GVHD and EFS.
    

Detailed description: 
      Patients will receive a haploidentical transpalnt using a fludarabine melphalan prepartive
      regimen. Patients will get cyclophosphamide on days 3 & 4 post-transplant.
    

Intervention name(s): Fludarabine; Melphalan; Cyclophosphamide; peripheral blood stem cell transplant
Intervention type(s): Drug; Drug; Drug; Procedure
Intervention description(s): fludarabine (30mg/m2) given every day starting on Day -6 through Day -2;; cyclophosphamide (50mg/kg) given every day starting on Day 3 through Day 4.
Other intervention name(s): Fludara; melphalan (140mg/m2) given one time on Day -1.; Cytoxan; HSCT
Intervention MeSH terms: Cyclophosphamide; Melphalan; Fludarabine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CML; AML; MDS; ALL; CLL/CPL; HD; NHL; MPS; CMML; MM
Longo's Intervention in the Treatment of Hemorrhoids and Rectal Mucosal Prolapse
Condition: Hemorrhoids; Rectal Mucosa Prolapse
MeSH terms: Hemorrhoids; Rectal Prolapse; Prolapse
Study type: Interventional

Summary: 
      The aim of this study is to define the significance of the distance of the staple line to the
      dentate line of the anal canal in the efficacy of the Longo's intervention.
    

Detailed description: 
      Is going to be carried out with patients from 18 to 70 years old with hemorrhoids in a level
      III and IV in the Lord scale.

      In the surgery Longo's intervention would be done by two ways differing in the distance of
      the suture from the tobacco pouch to the anal margin (4.5 cm in the first group and 6 cm in
      the second group).
    

Intervention name(s): 4.5cm suture; 6cm suture
Intervention type(s): Procedure; Procedure
Intervention description(s): Suture confection of the Tobacco-pouch of 4.5cm from the anal margin.; Suture confection of the Tobacco-pouch of 6cm from the anal margin.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In the surgery, Longo's intervention would be done by two ways differing in the distance of the suture from the tobacco pouch to the anal margin (4.5 cm in the first group and 6 cm in the second group).
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Longo; Hemorrhoids; Rectal; Prolapse; Anal
Safety, Pharmacokinetics and Pharmacodynamics Study of HL-032 in Healthy Male Volunteers
Condition: Growth Hormone Deficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of
      HL-032 after oral administration in healthy male volunteers.
    


Intervention name(s): Somatropin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A single dose 5.0mg administered subcutaneously(under the skin) via Genotropin; Tablets, oral administrations
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pharmacokinetics; Pharmacodynamics; Safety; Male
Bereaving, But Not Alone : the Development and Actualization of a Mutual Aid Group for Children Who Have Lost a Parent.
Condition: Mourning,; Grief,; Bereavement.
Study type: Interventional

Summary: 
      The methodology of this clinical trial is based on the realisation of a group intervention
      with children who lost a parent. Interviews preintervention and postintervention with
      participants will be done as well. The purpose of this study is to answer the following
      question: "What are the benefits for children who are in the process of bereaving a parent to
      participate in a group work intervention based on the mutual aid model ?". The aim of the
      research is to explore the benefits for grieving children to participate in an group work
      intervention based on the mutual aid model. To do so, the research has three distinct
      objectives : 1) to develop and apply a program of group work interventions for grieving
      children based on the mutual aid model ; 2) to explore the extent to which participation in
      the group facilitates changes in the children's discourse about death and the loss of their
      parents, and 3) to examine, from the children's own perceptive, the possible impact that
      their participation in the group have on their experience of bereavement.
    


Intervention name(s): Group intervention based on mutual aid.
Intervention type(s): Behavioral
Intervention description(s): Development of a mutual aid group and his actualization on children between nine and twelve years old who had lost one of their parents.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: bereaved children, mutual aid group, death, group intervention.
Use Behavior, Nicotine Uptake, and Subjective Effects Comparison of Tobacco and Menthol e-Liquids by ENDS Consumers
Condition: Electronic Cigarette Use
Study type: Interventional

Summary: 
      This study is being conducted to evaluate the impact of within-flavor category (tobacco and
      menthol) differences in e-liquid flavors on product use behaviors, nicotine uptake, and
      subjective effects by current ENDS consumers when used in a closed-system electronic nicotine
      delivery system (ENDS).
    


Intervention name(s): RELX ENDS Tobacco Flavor 1; RELX ENDS Tobacco Flavor 2; RELX ENDS Menthol Flavor 1; RELX ENDS Menthol Flavor 2
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 2-week ad libitum use of the RELX ENDS tobacco flavor 1; 2-week ad libitum use of the RELX ENDS tobacco flavor 2; 2-week ad libitum use of the RELX ENDS menthol flavor 1; 2-week ad libitum use of the RELX ENDS menthol flavor 2
Intervention MeSH terms: Menthol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Electronic Nicotine Delivery System; Nicotine; Topography; Pharmacokinetics; E-cigarette; Subjective effects
Pupillary Changes as a Potential Biomarker for Escitalopram in Relation to CYP2C19 Polymorphism
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      To study the impact of CYP2C19 polymorphism on escitalopram pharmacokinetics and
      pharmacodynamics measured as changes in pupil diameter
    

Detailed description: 
      Escitalopram, the therapeutic active S-enantiomer of citalopram, is a selective serotonine
      reuptake inhibitor (SSRI) used for treatment of depression and anxiety disorders. The
      antidepressant effect is probably due to a stimulation of the serotonergic neurotransmission
      caused by the inhibition of the presynaptic serotonin reuptake. This inhibition may also be
      responsible for the increased pupil diameter seen in volunteers treated with racemic
      citalopram. Based on escitaloprams pharmacodynamic properties it is expected to have the same
      affect on pupil diameter. A dose/response relationship has not yet been established but
      theoretically the pupillary changes might serve as a biomarker for the serotonergic effect of
      escitalopram.

      Escitalopram is demethylated in part by the polymorphic cytochrome P450 enzyme 2C19
      (CYP2C19); but the impact of CYP2C19 polymorphism on the total metabolism of escitalopram is
      still to be investigated.

      Objective: The aim of this study is to investigate the pharmacokinetics and pharmacodynamics
      in CYP2C19 extensive metabolizers (EMs) and poor metabolizers (PMs) and to investigate
      whether change in pupil size reaction to a light stimulus can act as a biomarker for the
      serotonergic effect of escitalopram.

      The study will be conducted as a randomized, double blinded; placebo controlled two phases
      cross-over trial with single and repeated doses of 20 mg escitalopram and equivalent placebo.
      Sixteen healthy volunteers (8 EMs and 8 PMs) will participate in the trial. Prior to the
      trial, approximately 400 volunteers will be phenotyped by omeprazole metabolic ratio in order
      to identify the CYP2C19 EMs and PMs.

      During the two phases blood samples will be drawn and pupil sizes will be measured at fixed
      time points after drug administration.
    

Intervention name(s): Escitalopram
Intervention type(s): Drug
Intervention MeSH terms: Escitalopram
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Escitalopram; Pharmacokinetics; Pharmacodynamics; CYP2C19; Pupillometry; healthy volunteers
The Diurnal and Nocturnal Effect of Pilocarpine on Intraocular Pressure and Ocular Perfusion Pressure
Condition: Glaucoma, Open-angle; Hypertension, Ocular
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional

Summary: 
      The aim of this study will be to determine the effects of pilocarpine as an adjunct
      medication to latanoprost monotherapy at multiple intervals throughout a 24-hour period and
      compare these effects to latanoprost alone.
    

Detailed description: 
      This study plans to learn more about the effect of pilocarpine on intraocular pressure and
      ocular perfusion pressure for a full twenty-four hour period.

      In this study, the investigators seek to better characterize the knowledge base of the
      intraocular pressure (IOP) lowering effects of pilocarpine in patients with open angle
      glaucoma or ocular hypertension who are currently taking latanoprost. The goal is to define
      the potential additive effect of pilocarpine throughout a 24-hour period, not only for IOP,
      but for ocular perfusion pressure (defined as 2/3[diastolicBP + 1/3(systolicBP -
      diastolicBP)] - IOP). These data will allow to expand current knowledge of the effects of
      pilocarpine and help determine if this medication has a useful role as an adjunctive
      treatment in glaucoma.
    

Intervention name(s): Pilocarpine
Intervention type(s): Drug
Intervention description(s): Pilocarpine will be administered 4 times in addition to latanoprost.
Other intervention name(s): Pilocarpine Hydrochloride
Intervention MeSH terms: Pilocarpine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Open-angle glaucoma; Ocular hypertension; Latanoprost; Pilocarpine
A Study to Assess the Safety and Efficacy of Elezanumab When Added to Standard of Care in Relapsing Forms of Multiple Sclerosis
Condition: Multiple Sclerosis (MS)
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the safety and efficacy of elezanumab in
      participants with relapsing Multiple Sclerosis (RMS).
    


Intervention name(s): elezanumab; placebo
Intervention type(s): Drug; Drug
Intervention description(s): solution for infusion; solution for infusion
Other intervention name(s): ABT-555
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Relapsing multiple sclerosis; Multiple sclerosis; Elezanumab; ABT-555
Dragon III: Neoadjuvant Chemotherapy (FLOT Versus SOX) for Gastric Cancer
Condition: Gastric Cancer; Chemotherapy Effect
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Safety and efficacy study of neoadjuvant chemotherapy (FLOT versus SOX) for gastric cancer
      patients in high volume center of China
    

Detailed description: 
      DRAGON III research, Neoadjuvant Chemotherapy (FLOT versus SOX) for Gastric Cancer, is an
      investigator initiated; phase II, open label, randomised controlled study. This study will be
      conducted and analyzed by the Gastrointestinal department（Unit III）of the Ruijin Hospital and
      the project is supported by the Institute of Digestive Surgery, Shanghai, which is a state
      key research center. This study will be monitored by the Clinical Research Center of the
      Ruijin hospital (Official body which is responsible to guide and monitor all types of
      research at Ruijin hospital). Primary endpoint and secondary endpoint is described above. The
      aim of this study to obtain preliminary result and further conduct a large scale multi-center
      randomised controlled trial(RCT) study.
    

Intervention name(s): FLOT Chemotherapy; SOX Chemotherapy
Intervention type(s): Drug; Drug
Intervention description(s): 5-FU+Leucovorin+Docetaxel+Oxaliplatin; Oxaliplatin+Tegafur gimeracil oteracil potassium capsule (TGO)
Other intervention name(s): FLOT; SOX
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomly assigned(1:1) either to FLOT or SOX group.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Neoadjuvant chemotherapy; perioperative chemotherapy; Systemic chemotherapy; FLOT; SOX; Gastric cancer
Radiofrequency Non-ablation in the Treatment of Women With Urinary Stress Incontinence: Study Pilot
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis
Study type: Interventional
Phase: Phase 1

Summary: 
      Pilot study, case series conducted in women with a clinical diagnosis of urinary incontinence
      and were treated with radiofrequency technique for capacitive transfer non ablative in
      external urethral meatus. All participants did an hour Pad Test. The participants made five
      sessions of Radio Frequency (RF) with an interval of seven days between them. The application
      of RF was performed by physical therapist trained in the technique of radio frequency through
      the Tonederm® brand device with capacitive transfer method using non-ablative handle with
      electrode in the region of the external urethral meatro and coupling electrode placed on the
      participant's back. For application, the participants were in gynecological position. The
      session had an average duration of 20 minutes. The temperature was measured by an infrared
      thermometer when it reached 41graus radiofrequency was maintained for 2 minutes.
    


Intervention name(s): Tonederm® (Radiofrequency non ablative)
Intervention type(s): Device
Intervention description(s): The application of RF was performed by physical therapist trained in the technique of radio frequency through the Tonederm® brand device with capacitive transfer method using non-ablative handle with electrode in the region of the external urethral meatro and coupling electrode placed on the participant's back. For application, the participants were in gynecological position. The session had an average duration of 20 minutes. The temperature was measured by an infrared thermometer when it reached 41graus radiofrequency was maintained for 2 minutes.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: urinary incontinence; woman; radiofrequency
Feasibility Study of the Solo™ Insulin Pump
Condition: Type 1 Diabetes; Insulin Pump Users
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and usability of the Solo™ insulin
      MicroPump in subjects with type 1 diabetes who are pump users.
    

Detailed description: 
      This is a multi center, one arm, open label and prospective study to assess the safety and
      usability of the Solo™ MicroPump Insulin Delivery System .

      The study will include a 30 days treatment period with the Solo MicroPump with no special
      care required for maintaining glycemic control and with an optional extension period of up to
      six month.

      The study will consist of up to 5 visits and one follow up phone call one week after
      termination of the study. In case of participating the extension period, additional visits
      will consist once a month.

      Visit 1 includes eligibility, baseline evaluation and training in handling of the Solo™
      System. If no additional practice is required patients will be enrolled. Visit 2 will
      commence and Solo pump will be filled with insulin. If additional practice is required
      subject will be sent home for an additional training period of a few days practice using
      saline and then return for visit 2.

      Treatment visits will take place at 3, 14 and 30 days after the enrolment. Additional visits
      will take place at 60, 90 and 180 days depending on the extension period.

      Subjects will be asked to record blood glucose measurements, daily activities and
      carbohydrate consumptions between visits.

      Seven days after termination of study treatment a telephone contact with the study subject
      will take place for the purpose of adverse event reporting and the completion of DTSQ
      questionnaire.

      Measurements that will be used for assessing the safety of the device are glucose levels and
      any occurrence of AE's.

      Subjects will complete DTSQ and Performance questionnaires before and at the end of the
      treatment period for usability evaluation.

      Blood and urine tests will be taken at visit 1 and 5, vital signs and physical examination
      will be evaluated at all study visits.
    

Intervention name(s): Solo MicroPump
Intervention type(s): Device
Intervention description(s): 30 days treatment days with an optional extension period of up to 6 month of treatment.
Other intervention name(s): Solo System
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Insulin pumps; Diabetes
Effects of Unloading on Muscle Mass
Condition: Immobilization; Physical Inactivity
Study type: Interventional

Summary: 
      In the present study, the effects of 3 weeks of unloading on muscle mass and muscle fiber
      characteristics will be determined. In addition, the effects of 6 weeks of recovery will be
      assessed.
    


Intervention name(s): unloading
Intervention type(s): Behavioral
Intervention description(s): 2 weeks of unloading of a single leg
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Patient Registry in Patients Undergoing Contrast-Enhanced Harmonic Endoscopic Ultrasound Imaging
Condition: Hematopoietic and Lymphoid System Neoplasm; Malignant Solid Neoplasm
MeSH terms: Neoplasms
Study type: Observational

Summary: 
      This study creates a patient registry of patients undergoing contrast-enhances-harmonic
      endoscopic ultrasound imaging. In order to improve what doctors see on the ultrasound exam,
      sometimes intravenous contrast can be used to better emphasize the blood flow in a particular
      organ or lesion. Creating a local database that can be used as a patients registry may help
      doctors keep track of all patients that undergo contrast-enhanced endoscopic ultrasound
      procedures and also to monitor for possible procedure adverse events.
    

Detailed description: 
      PRIMARY OBJECTIVE:

      I. To describe the findings and outcomes of patient undergoing contrast-enhanced harmonic
      endoscopic ultrasound (CE-EUS) imaging.

      OUTLINE: This is an observational study.

      Patients who have undergo contrast-enhanced harmonic endoscopic ultrasound imaging have their
      medical records reviewed.
    

Intervention name(s): Electronic Health Record Review
Intervention type(s): Other
Intervention description(s): Review of medical records
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who undergo contrast-enhanced harmonic endoscopic ultrasound imaging in the
        gastroenterology department at Mayo Clinic Jacksonville, Florida