bioihbjkbjnl/mcl2 huggingface dataset:
Implementing Evidence Based Treatment of Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      This study examines the use of patient initiated discussions of blood pressure medication in
      the primary care setting. Additionally, this study examines different levels of patient
      incentive(s) to initiate discussions with providers including information only, information
      plus a financial incentive and reimbursement for 6 months of copay, and information/monetary
      incentive plus a reminder call prior to the index visit. Patient opinions about
      doctor/patient relationships will be assessed. Provider attitudes and prescribing behaviors
      will be analyzed as well.
    

Detailed description: 
      Patients will be randomized to Pure control, intervention control, intervention group a,
      intervention group b or intervention group c. Pure control patients will not receive any
      study information about diuretics and their providers will not see any patients who receive
      our study intervention letter. Patients in the intervention control group will not receive
      the intervention but will see providers who have other patients in the intervention groups.
      Patients in intervention group a will receive a customized letter prior to their next primary
      care appointment with information regarding the patient's specific blood pressure, current
      blood pressure medication and recommendation for switching or adding a thiazide. Patients in
      group b will receive the customized intervention letter as well as a financial incentive for
      discussing the information with their provider and a copay reimbursement for 6 months if a
      prescription is written for a thiazide. Patients in group c will receive the intervention
      letter, financial discussion incentive, copay reimbursement as well as a phone call reminder
      1-2 days prior to their primary care visit.
    

Intervention name(s): Patient educational letter to engage provider in hypertension rx discussion; Financial incentive (Arms B and C) and health educator phone call (Arm C)
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients will receive a customized/tailored letter (education) including most recent clinic blood pressure, current blood pressure medications and suggested htn medication(s). All the intervention arms (A, B and C) receive the letter.; Patients may receive a financial incentive for discussing the intervention letter with their provider and 6 months copay reimbursement and/or the financial incentive discussion incentive, 6 months copay reimbursement as well as a phone call reminder 1-2 days prior to their primary care appt. The Financial incentive is part of both Arms B and C. The health educator phone call is only in Arm C.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hypertension; Diuretics; Drug Therapy; Anti-Hypertensive Agents; Patient Intervention
Evaluation of Two Doses of QVAR by Breath Operated and Metered Dose Inhalers in Asthmatic Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to compare the QVAR-Easi-Breathe 100 mcg/day and
      QVAR-Easi-Breathe 200 mcg/day with placebo relative to changes in forced expiratory volume in
      1 second (FEV1) results following 12 weeks of treatment. Secondary objectives such as daily
      asthma symptoms scores (per week), morning peak expiratory flow (PEF) values, nocturnal
      awakening and utilization of rescue medication per day also will be evaluated. In addition,
      an exploratory evaluation will assess the comparability of the two devices (i.e.,
      QVAR-Easi-Breathe versus QVAR-MDI) at the same dose levels.
    


Intervention name(s): beclomethasone dipropionate
Intervention type(s): Drug
Intervention MeSH terms: Beclomethasone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
Condition: Congenital Hyperinsulinism
MeSH terms: Congenital Hyperinsulinism; Nesidioblastosis; Hyperinsulinism
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective of the trial is to evaluate the efficacy of dasiglucagon in reducing glucose
      requirements in children with persistent congenital hyperinsulinism (CHI) requiring
      continuous intravenous (IV) glucose administration to prevent/manage hypoglycemia.
    


Intervention name(s): dasiglucagon; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Glucagon analogue; Placebo for dasiglucagon
Other intervention name(s): ZP4207
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Berberine Treat Metabolic Syndrome in Schizophrenia
Condition: Metabolic Syndrome; Female; Schizophrenia
MeSH terms: Metabolic Syndrome; Syndrome; Schizophrenia
Study type: Interventional

Summary: 
      In early clinical study investigators confirmed that berberine could prevent glucose and
      lipid metabolism disorder in schizophrenia, so investigators intend to verify the effect and
      safety of berberine in treatment for metabolic syndrome in schizophrenia.
    

Detailed description: 
      This study is an open lable clinical intervention trial, include 30 female subjects with
      diagnosis of schizophrenia and metabolic syndrome.Participants will be given berberine（
      300mgTID） as an add-on therapy lasting 8 weeks.
    

Intervention name(s): berberine
Intervention type(s): Drug
Intervention description(s): berberine 300mg TID add-on for berberine adjunctive group
Other intervention name(s): berberine hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metabolic syndrome; Schizophrenia; Efficacy; Female; Berberine
An Observational Study of Cisatracurium 0.15 mg/kg in Young and Elderly (≥ 80 Years) Patients.
Condition: Onset Time of Cisatracurium; Duration of Action of Cisatracurium; Intubation Conditions
MeSH terms: Disease
Study type: Observational

Summary: 
      The aim of this study is to determine the onset time, duration of action and effect on
      intubation conditions of cisatracurium 0.15 mg/kg in elderly patients with age ≥ 80 years and
      in young patients aged 18 - 40 years.
    

Detailed description: 
      The aim of this study is to determine the onset time, duration of action and effect on
      intubation conditions of cisatracurium 0.15 mg/kg in elderly patients with age ≥ 80 years and
      in young patients aged 18 - 40 years. The hypothesis of this study is that cisatracurium
      administered in elderly patients (>80 years) has a longer onset time and duration of action
      compared to younger patients.
    

Intervention name(s): Cisatracurium
Intervention type(s): Drug
Intervention description(s): 0.15 mg/kg based on ideal body weight calculated as height (cm) minus 105 for women and height (cm) minus 100 for men or actual body weight, whichever is lower
Intervention MeSH terms: Cisatracurium
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Elderly patients (≥ 80 years) and younger patients (18-40 years) scheduled for elective
        surgery
A Phase 1, Dose-escalation Study of MEDI-551 in Japanese Adult Patients With Relapsed or Refractory Advanced B-cell Malignancies
Condition: Blood Cancer; Advanced B Cell Malignancies
MeSH terms: Neoplasms; Hematologic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this study is to evaluate the safety and tolerability of MEDI-551 in
      Japanese patients with relapsed or refractory advanced B-cell malignancies.
    


Intervention name(s): MEDI-551
Intervention type(s): Drug
Intervention description(s): MEDI-551 will be administered by intravenous infusion at dose of 2, 4 or 8 mg/kg once per week on Days 1 and 8 in the first cycle and then once every 28 days at the start of each subsequent cycle
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Phase I; advanced; B cell malignancies; dose escalation; CD19; Japanese
Efficacy of Seroquel SR in Combination With an Antidepressant in Treatment of Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate the efficacy of quetiapine fumarate sustained release (Seroquel SR™) in
      combination with an antidepressant versus an antidepressant alone in patients with Major
      Depressive Disorder.

      PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation
      was changed to XR after consultation with FDA.
    


Intervention name(s): Quetiapine; Amitriptyline; Bupropion; Citalopram; Duloxetine; Escitalopram; Fluoxetine; Paroxetine; Sertraline; Venlafaxine
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Duloxetine Hydrochloride; Amitriptyline; Quetiapine Fumarate; Citalopram; Bupropion; Fluoxetine; Paroxetine; Venlafaxine Hydrochloride; Sertraline; Escitalopram
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder; MDD
Bioavailability Study of Anastrozole Tablets 1 mg of Dr.Reddy's Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare bioavailability in healthy, post menopausal women
      subjects under fed conditions.
    

Detailed description: 
      Open label, balanced, randomized, two treatment, two-sequence, two periods, crossover, single
      dose, comparative oral bioavailability study in healthy, post menopausal women subjects under
      fed conditions.
    

Intervention name(s): Anastrozole
Intervention type(s): Drug
Intervention description(s): Anastrozole Tablets 1 mg of Dr.Reddy's Laboratories Limited
Other intervention name(s): Arimidex® Tablets 1 mg
Intervention MeSH terms: Anastrozole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability; Anastrozole; Crossover
Trial of Clindamycin / Benzoyl Peroxide Gel in Subjects With Acne
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy of a
      clindamycin / benzoyl peroxide gel in Subjects with Acne Vulgaris
    

Detailed description: 
      A multicenter, randomized, double-blind, comparator and vehicle-controlled study in subjects
      with acne vulgaris. Approximately 1320 subjects will be enrolled. Subjects will be randomized
      to 1 of 4 parallel study groups in a 1:1:1:1 ratio (clindamycin / benzoyl peroxide
      gel:clindamycin gel:BPO gel:vehicle gel).
    

Intervention name(s): clindamycin / benzoyl peroxide gel; clindamycin gel; BPO gel; vehicle gel
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Once a day application to the face; Once a day application to the face; Once a day application to the face; Once a day application to the face
Intervention MeSH terms: Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acne Vulgaris; Acne
A Study to Evaluate the Effect of Multiple Doses of Isavuconazole on the Pharmacokinetics of Repaglinide and Caffeine
Condition: Pharmacokinetics of Repaglinide; Pharmacokinetics of Caffeine; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of multiple doses of isavuconazole on the
      pharmacokinetics of Repaglinide and possible metabolites after single dose administration. In
      addition, this study will assess the effect of multiple doses of isavuconazole on the
      pharmacokinetics of caffeine and possible metabolites after single dose administration.
      Safety and tolerability of isavuconazole alone and in combination with Repaglinide or in
      combination with caffeine will be assessed.
    


Intervention name(s): Isavuconazole; Repaglinide; Caffeine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral; oral; oral
Other intervention name(s): BAL4815; Prandin®
Intervention MeSH terms: Repaglinide; Isavuconazole; Caffeine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Isavuconazole; Repaglinide; Caffeine; BAL4815; BAL8728; Healthy Subjects
A Single Case Study of Hypermetabolism
Condition: Hypermetabolism Due to Defect in Mitochondria; Luft Disease
MeSH terms: Mitochondrial Myopathies
Study type: Interventional

Summary: 
      In the Metabolic Disorder clinic at The Hospital for Sick Children, the investigators
      identified a male, proband with possible Luft's disease. The investigators hypothesize that
      Luft's disease is caused by excess or dysregulation of brown/beige fat tissue.

      To address the hypothesis, the investigators would like to assess brown fat distribution and
      activity in this subject.
    

Detailed description: 
      The subject will undergo a fluorine-18-fluorodeoxyglucose positron emission
      tomography/computed tomography (18F FDG PET/CT) at the Diagnostic Imaging unit of The
      Hospital for Sick Children.
    

Intervention name(s): 18F FDG PET/CT
Intervention type(s): Diagnostic Test
Intervention description(s): 18F FDG PET/CT imaging (fluorine-18-fluorodeoxyglucose positron emission tomography/computed tomography).
Intervention MeSH terms: Fluorodeoxyglucose F18
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
INDV-2000 First in Human
Condition: Opioid Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a single ascending dose (SAD) study conducted to identify the maximum tolerated
      dose (MTD) of INDV-2000. After completion of the SAD portion of the study and acceptable
      safety evaluation, a food-interaction, single-dose study under fed and fasted conditions will
      be conducted.
    


Intervention name(s): INDV-2000; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): INDV-2000 will be administered as either powder in solution or powder in capsule, depending on dose administered.; Placebo will be administered as either powder in solution or powder in capsule, depending on dose administered.
Other intervention name(s): C4X_3256
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: Part I - sequential escalating dose cohorts; within each dose cohort participants will be randomized to INDV-2000 or matching placebo in a 3:1 ratio.
Part II - single cohort crossover study in which participants will receive INDV-2000 on 2 occasions separated by a 1-week washout period, once under fasting conditions and once after a standard high-fat breakfast.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Evaluate Restylane Vital Light Using an Injector Device
Condition: Aesthetics
Study type: Interventional

Summary: 
      The purpose of the study is to evaluate the safety and efficacy of Restylane Vital White
      administered with an injector device on aged skin in the face, hands and décolletage.
    

Detailed description: 
      The objectives are to explore the safety and efficacy profile of Restylane Vital White
      administered with an injector device when one side of the face, one of the hands and one side
      of the décolletage is treated and the other side of the face, the other hand and the other
      side of the décolletage is left untreated. The face, the hands and the décolletage will be
      evaluated separately for both the efficacy and the safety parameters.
    

Intervention name(s): Restylane Vital Light; No treatment
Intervention type(s): Device; Other
Intervention description(s): Treatment of up to 4 ml for one side of the face, one hand and one side of the décolletage dispensed by 10ul doses 0.5-1 cm apart. 3 treatment sessions 4 weeks apart.; One side of face, one hand and one side of the décolletage is left untreated as a control.
Other intervention name(s): Restylane skinbooster
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Skin rejuvenation
Regenerative Endodontic Procedure of Immature Permanent Teeth With Apical Periodontitis Using PRF
Condition: Periapical Periodontitis; Tooth Diseases; Stomatognathic Diseases
MeSH terms: Periodontitis; Tooth Diseases; Periapical Periodontitis; Stomatognathic Diseases
Study type: Interventional

Summary: 
      This study evaluates the clinical effect of regenerative endodontic procedure using PRF in
      immature permanent teeth with apical periodontitis. Half of participants will receive the PRF
      instead of blood clots in the regenerative endodontic procedure, while the other half will
      receive a blood clots in the regenerative endodontic procedure.
    

Detailed description: 
      The conventional method of regenerative endodontic procedure using a blood clot as scaffold
      materials has shown successful results. However, it is very difficult to induce bleeding and
      place mineral trioxide aggregate over a blood clot. Platelet-rich fibrin (PRF), a
      second-generation platelet concentrate. PRF is a matrix of autologous fibrin containing a
      large quantity of platelets, growth factors and leukocytes. PRF preparation technique is very
      simple, inexpensive and doesn't require any chemical agents. The purpose of this study is to
      test the hypothesis that the use of PRF in regenerative endodontic procedure of immature
      permanent teeth with apical periodontitis will accelerate periapical bone healing and
      stimulate the root maturation.
    

Intervention name(s): PRF
Intervention type(s): Device
Intervention description(s): Regenerative Endodontic Procedure with PRF: autologous PRF will be used instead of blood clot in the second vist.
Other intervention name(s): mineral trioxide aggregate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: regenerative endodontic treatment; platelet-rich fibrin; Immature permanent tooth; apical periodontitis
Allogeneic Bone Marrow Transplantation From Unrelated Donors in Multiple Myeloma
Condition: Multiple Myeloma; Allogeneic Transplantation
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell
Study type: Observational

Summary: 
      Autologous hematopoietic cell transplantation is currently considered the standard therapy of
      multiple myeloma (MM) for elegible patients. On the contrary, despite new developments in
      transplant procedures and supportive care, allogeneic bone marrow transplantation is less
      commonly used due to high transplant related mortality (TRM).

      No consensus statement about allografting in MM has so far been reached and only a minority
      of patients undergoing allografting are enrolled in prospective clinical trials.

      Moreover, use of unrelated donors is considerably increased over the time and the recent
      activity survey of European Group for Blood and Marrow Transplantation (EBMT) showed that the
      number of allografts from unrelated donor is higher than that one from HLA-identical siblings
      in Europe.

      In order to evaluate trends in allograft from unrelated donors in multiple myeloma patients,
      the investigators plan to conduct a restrospective study through the Italian Bone Marrow
      Transplantation Registry (IBMDR) over a period ranging since 2000 to 2009. Data will be
      collected from the central data management system Promise (Project Manager Internet Server)
      used by EBMT and from IBMDR.

      The aim of the study is to evaluate the role of unrelated donor allograft in multiple myeloma
      over the last decade and hopefully offer recommendations on patient selection. Primary
      endpoints of the study are: a) Overall Survival (OS) from diagnosis and from the allograft b)
      Event-Free-Survival (EFS) from the allograft. Disease response criteria will be defined
      according to the International Uniform Response Criteria for multiple myeloma. Transplant
      related mortality, Graft-Versus-Host-Disease (GVHD), either acute or chronic
      (limited/extensive) will be evaluated as cumulative incidences. Univariate and multivariate
      analysis will be calculated for the transplant-related and patient-related characteristics.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Multiple Myeloma patients
      
Keywords: Allogeneic bone marrow transplantation; Multiple myeloma
TECHNIQUES USED IN EVALUATION OF GINGIVAL PHENOTYPE
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      This study evaluates the 4 different techniques used in clinical measurement of gingival
      phenotype. 1) Tranclusency of UNC-15 Periodontal Probe, 2) Transgingival probing with
      Endodontic file (#20), 3)Transgingival Probing with Modified Florida Probe and 4)
      Translucency Colorvue Biotype Probe.

      The aim of our study is to evaluate the reliability and applicability of the current
      examination methods recommended in order to improve the deficiencies of the traditional
      examination methods used in the evaluation of the gingival phenotype.
    


Intervention name(s): Gingival thickness
Intervention type(s): Device
Intervention description(s): After the classification the phenotype, gingival thickness was measured with Endodontic File and Modified Florida Probe from the 3 different points. First point was the probing depth level, second one was 1mm apical to this level and third one from the 2mm apical to probing depth.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: gingival phenotype; gingival thickness
IncobotulinumtoxinA (Xeomin) Versus Placebo in the Treatment of Cervical Dystonia
Condition: Cervical Dystonia
MeSH terms: Dystonia; Dystonic Disorders; Torticollis
Study type: Interventional
Phase: Phase 3

Summary: 
      At baseline patients received incobotulinumtoxinA (Xeomin) or placebo. Thereafter, all
      patients who entered the extension period were treated with up to five injection sessions of
      incobotulinumtoxinA (Xeomin) during the extension period.
    


Intervention name(s): incobotulinumtoxinA (Xeomin) (240 Units); incobotulinumtoxinA (Xeomin) (120 Units); Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (240 Units); incobotulinumtoxinA (Xeomin, also known as "NT 201" or "Botulinum toxin type A (150 kiloDalton), free from complexing proteins") (120 Units); Placebo
Intervention MeSH terms: incobotulinumtoxinA; Botulinum Toxins, Type A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment