bioihbjkbjnl/mcl2 huggingface dataset:
Trial of Bendamustine And Rituximab for Patients With Previously Untreated Extranodal Mucosa-Associated Lymphoid Tissue (MALT) Lymphoma
Condition: MALT LYMPHOMA
MeSH terms: Lymphoma; Lymphoma, B-Cell, Marginal Zone
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to assess the therapeutic activity and safety of the combination of
      Bendamustine and Rituximab in MALT lymphomas.

      Primary endpoint:

        -  Event-free-survival (EFS) (failure or death from any cause) for all patients.

      Secondary endpoints:

        -  Complete and partial remission rates for all patients

        -  Response duration (time to relapse or progression) for responder patients

        -  Progression-free-survival (PFS) (disease progression or death from lymphoma: for all
           patients

        -  Overall survival for all patients

        -  Acute and long-term toxicity
    


Intervention name(s): Rituximab and Bendamustine
Intervention type(s): Drug
Intervention description(s): Rituximab 375 mg/m2 iv. day 1 Bendamustine 90 mg/m2 iv. day 1 and 2
Intervention MeSH terms: Rituximab; Bendamustine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CD 20 positive
A Phase 1 Study In Japanese Subjects With Type 2 Diabetes Mellitus As Monotherapy
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      Study B1621018 will assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics
      of Two Dose Levels of Pf-04937319 in Japanese Subjects with Type 2 Diabetes Mellitus As
      Monotherapy
    


Intervention name(s): PF-04937319 high dose; PF-04937319 low dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): tablets, 150 mg with breakfast plus 100 mg with lunch, 7 days; tablets, 50 mg with breakfast plus 50 mg with lunch, 7 days; tablets, breakfast plus lunch, 7 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: Phase 1; type 2 diabetes; monotherapy; PF-04937319
Pharmacokinetics and Safety of ORF Tablets in Pediatric Patients
Condition: Opioid Analgesia
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the pharmacokinetics (PK) of single-dose ORF
      tablets in pediatric patients aged 6 to 16 years, inclusive.
    


Intervention name(s): Oxycodone hydrochloride controlled-release (ORF) tablets
Intervention type(s): Drug
Intervention description(s): Oxycodone hydrochloride controlled-release (ORF) tablets (10 mg, 15 mg or 20 mg) taken every 12 hours
Intervention MeSH terms: Oxycodone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Pediatric; Post-operative; Nonsurgical; patients; Opioid
Engaging Patients in Weight Loss Tools
Condition: Obesity
Study type: Interventional

Summary: 
      The overall aim of this study is to evaluate the acceptability and feasibility of a
      primary-care based approach to facilitating engagement in online behavior tracking and
      community support networks for weight loss ("facilitation condition") over 12 weeks among
      adults with obesity.
    


Intervention name(s): Facilitation Intervention
Intervention type(s): Behavioral
Intervention description(s): See "arm" description
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Aerobic Exercise as add-on Treatment for Inpatients With Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the effect of 6 weeks of aerobic endurance exercise as
      adon treatment for moderately to severely depressed inpatients. Endpoints are symptom
      severity, psychological variables, cognitive symptoms, sleep, hypothalamic-pituitary-adrenal
      axis (HPA-axis), Brain-derived neurotrophic factor (BDNF) and heartrate variability (HRV).

      Amendment 1 (Nov. 2016): additional evaluation of TNF-alpha at baseline, +2 weeks and post
      (+6weeks) in already existing blood samples.
    

Detailed description: 
      Patients are randomly assigned to the intervention group (IG) or control group (CG). The IG
      will train three times per week on indoor bicycles at 60 to 75% of maximal heartrate aiming
      at a weekly total of 17.5kcal/kg bodyweight for 6 consecutive weeks. The exercise will take
      place under supervision. CG will absolve a basic stretching and mobilisation program 3 times
      per week, also under supervision for 6 consecutive weeks. At the end of every week physical
      fitness is evaluated by the queens step test. No other activities with moderate or high
      intensity are allowed throughout the intervention time.

      All patients will participate in the multimodal treatment program of the depression ward,
      which includes pharmacotherapy, psychotherapy and specialized therapies such as art therapy
      and ergotherapy.
    

Intervention name(s): Aerobic exercise; Placebo control
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Lixisenatide Compared to Liraglutide on the Postprandial Plasma Glucose in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of the study is to compare the pharmacodynamic effects of lixisenatide (AVE0010),
      in comparison to liraglutide, as an add-on treatment to metformin, over a period of 4 weeks
      of treatment.

      The primary objective is to assess the effects of lixisenatide, in comparison to liraglutide,
      in reducing postprandial plasma glucose (PPG) assessed as area under the plasma glucose
      concentration curve (AUC) after a standardized breakfast at Week 4.

      The secondary objectives are to assess the effects of lixisenatide on the maximum PPG
      excursion, and on the changes in insulin, pro-insulin, C-peptide and glucagon plasma
      concentrations following a standardized breakfast, 24-hour profile of plasma glucose,
      glycosylated hemoglobin (HbA1c), satiety markers (obestatin, peptide YY [PYY3-36] and
      oxyntomodulin); and to assess the clinical and laboratory safety profile.
    

Detailed description: 
      The duration of the study for each patient is up to 7 weeks including a screening period up
      to 2 weeks, a treatment period of 4 weeks (Day 1 to Day 28), and an end-of-study visit 7 +/-
      2 days after last study drug administration.
    

Intervention name(s): Lixisenatide (AVE0010); Pen auto-injector; Liraglutide; Pre-filled pen injector; Metformin
Intervention type(s): Drug; Device; Drug; Device; Drug
Intervention description(s): Self administered by subcutaneous injections once daily 30 minutes before breakfast.; Self administered by subcutaneous injections once daily 30 minutes before breakfast.; Metformin to be continued at stable dose (1.5 gram per day) up to Week 4.
Other intervention name(s): OptiClik®; Victoza®
Intervention MeSH terms: Metformin; Liraglutide; Lixisenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Itacitinib for Low Risk GVHD
Condition: Low Risk Acute Graft-versus-host Disease; Graft-versus-host-disease; GVHD
MeSH terms: Graft vs Host Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Graft-versus-host disease (GVHD) is treated with high doses of systemic steroids which can
      lead to serious complications. A new blood test can identify patients whose GVHD is most
      likely to respond to well to treatment (low risk GVHD). This study will test whether patients
      with low risk GVHD can be successfully treated without steroids. Patients who participate
      with this study will be treated with itacitinib instead of steroids. Itacitinib is an
      experimental drug with an excellent safety record and appears to have activity as a GVHD
      treatment.
    

Detailed description: 
      Patients with newly diagnosed low risk acute GVHD defined as Minnesota standard risk based on
      symptoms and Ann Arbor 1 GVHD based on biomarkers were eligible if they met all other
      eligible criteria (see eligibility criteria below). Enrolled patients were required to start
      treatment within 4 days of confirmation of Ann Arbor 1 status. Treatment consisted of
      itacitinib 200 mg daily for 28 days. Patients with a clinical response on day 28 were
      eligible for a second 28 day cycle of itacitinib 200 mg daily. Missed doses could be made up
      by extending the treatment duration for up to 2 additional weeks. Medications given for GVHD
      prophylaxis and topical treatments for GVHD were allowed. Supportive care was provided
      according to institutional standards. Itacitinib was permanently discontinued after any of
      the following:

      administration of 56 doses of itacitinib or initiation of systemic corticosteroids or any
      other systemic treatment for GVHD or patient withdrawal from the study or general or specific
      changes in the patient's condition render the patient unacceptable for further treatment in
      the judgment of the investigator OR ten weeks elapsed since the first dose of itacitinib.
    

Intervention name(s): Itacitinib
Intervention type(s): Drug
Intervention description(s): for up to 56 days
Other intervention name(s): INCB389110
Intervention model: Single Group Assignment
Intervention model description: Open label, single arm, non-inferiority study
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Graft-versus-host disease; Itacitinib
Study to Assess Resource Utilization and Quality of Life of Patients With RRMS Treated With Tecfidera in Greece
Condition: RRMS
Study type: Observational

Summary: 
      This is a non interventional, multicenter clinical trial, in adult patients receiving
      Tecfidera per approved SmPC and routine clinical practice. The primary objective of this
      study is to evaluate the total societal costs to the healthcare system related to the use of
      Tecfidera in RRMS patients. The study will capture data in a simple matter that can be easily
      interpreted providing an advantage in a country where efforts in the market access arena are
      in their infancy. For the aforementioned reasons, the proposed study may prove quite valuable
      in supporting DMF as a cost-effective therapy, valuable not only for patients but for the
      public health care system as well, providing all the necessary information for the evaluation
      that need to be examined regarding the positive reimbursement list and future decisions.
    

Detailed description: 
      The study will take place in Greece. Investigators will participate from a broad geographical
      distribution in order to ensure a proper representation from all areas of Greece.
      Investigator's decision to prescribe DMF (Tecfidera®) (according to the indication for
      treatment as defined in the summary of product characteristics, SmPC and the current clinical
      practice), should precede entry into the study.
    

Intervention name(s): Dimethyl Fumarate (DMF)
Intervention type(s): Drug
Intervention description(s): The non-interventional design allows the observation of patients in a broad range of settings reflecting routine clinical practice. All decisions on therapeutic or diagnostic procedures, treatments, management of the disease, or resource utilisation will be at the full discretion of the treating physician without interference by a sponsor or study protocol. All treatment decisions will follow the real-life treatment behaviour.
Other intervention name(s): Tecfidera
Intervention MeSH terms: Dimethyl Fumarate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        400 previously DMF-naïve adult patients who have been diagnosed with RRMS and will initiate
        treatment with Dimethyl Fumarate up to 1 week before study enrolment will be included
Mannitol Bronchoprovocation Challenge Ancillary Study/ACRN
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This is an ancillary study conducted as part of the BASALT trial [NCT00495157].

      The overall hypotheses are: 1) an indirect airway challenge procedure using mannitol can
      safely characterize asthma phenotypes, predict asthma control and exacerbations, predict
      responses to interventions, and perform more specifically than a direct methacholine
      challenge and; 2) PX27 pore function in whole blood correlates with measures of airway
      hyperresponsiveness induced by methacholine and/or mannitol challenges
    


Intervention name(s): mannitol
Intervention type(s): Drug
Intervention description(s): indirect mannitol challenge
Intervention MeSH terms: Mannitol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: asthma; bronchoprovocation challenge test; mannitol; methacholine
A Study of GDC-0853 in Participants With Refractory Chronic Spontaneous Urticaria (CSU).
Condition: Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy, safety and pharmacokinetics of
      GDC-0853 compared with placebo in participants with Refractory Chronic Spontaneous Urticaria
      (CSU) already treated with anti-histamines. Participants have the option to enter the
      Open-Label Extension (OLE) study after completing the 8-week treatment period.
    


Intervention name(s): GDC-0853; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GDC-0853 will be administered orally at dosages of 50, 150 and 200mg to participants, as per the dosing schedules described above.; Matching Placebo will be administered orally, as per the dosing schedules described above.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety of Combination Therapy of Moderate-intensity Statin and Ezetimibe Compared to High-intensity Statin
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a multicenter, randomized, open-label, parallel, phase IV trial.

      The purpose of this study efficacy and safety of combination therapy of moderate-intensity
      statin and ezetimibe compared to high-intensity statin.
    

Detailed description: 
      The study is planned to include 272 patients with a clinical atherosclerotic cardiovascular
      disease requiring optimal statin therapy.

      After enrollment, subjects are randomized into two groups in a 1:1 manner. The combination
      therapy group will receive a single-pill combination of rosuvastatin 10 mg and ezetimibe 10
      mg once daily.

      The subjects in the intensive statin group will receive rosuvastatin 20 mg once daily.

      Subjects will visit at weeks 12 and 24 to identify medication adherence and clinical side
      effects.

      The primary endpoint of this study is a % change of low-density lipoprotein cholesterol at 12
      weeks.
    

Intervention name(s): Efficacy and safety of combination therapy of moderate-intensity statin and ezetimibe compared to high-intensity statin
Intervention type(s): Drug
Intervention description(s): This study is a multicenter, randomized, open-label, parallel, phase IV trial. The study is planned to include 272 patients with clinical ASCVD requiring optimal statin therapy.
After enrollment, subjects are randomized into two groups in a 1:1 manner. patients in combination therapy group(rosuvastation 10mg and ezetimibe 10mg daily) will be provided a fixed-dose single pill comibation and patients in the intensive statin group will receive rosuvastatin 20mg daily.
Intervention MeSH terms: Ezetimibe; Hydroxymethylglutaryl-CoA Reductase Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Dose-finding of PB-119 Administered Subcutaneously Once Weekly Versus Placebo in Subjects With Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus (T2DM)
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      A phase 2, multicenter study to evaluate the efficacy and safety of twelve once weekly
      subcutaneous doses of PB-119 to patients with type 2 diabetes mellitus (T2DM) not
      well-controlled by metformin mono therapy.
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort,
      multiple dose study to evaluate the efficacy, safety, and tolerability of different doses of
      PB-119 to patients with T2DM not well-controlled by metformin monotherapy. Patients will be
      assessed for eligibility over a 2 week screening period prior to a 4-week run-in period and a
      12-week double-blind treatment period.A phase 2, multicenter, randomized, double-blind,
      placebo-controlled, parallel dose cohort study to evaluate the efficacy and safety of twelve
      once weekly subcutaneous doses of PB-119 to patients with type 2 diabetes mellitus (T2DM) not
      well-controlled by metformin monotherapy The eligible patients will be randomized to 1 of 3
      dose cohorts (A, B, or C). Each patient will subsequently be randomized within the designated
      cohort to 1) active drug or placebo at a 3:1 active drug:placebo ratio and 2) exclusion from
      or inclusion in the pharmacokinetic (PK) blood sample collection subgroup at a 3:1
      excluded:included ratio
    

Intervention name(s): PB-119 100 μg+ Glucophage®; PB-119 150 μg+ Glucophage®; PB-119 200 μg+ Glucophage®; PB-119 placebo + Glucophage®
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Each patient will subsequently be randomized within the designated cohort to active drug or placebo; Each patient will subsequently be randomized within the designated cohort to active drug or placebo; Each patient will subsequently be randomized within the designated cohort to active drug or placebo; Each patient will subsequently be randomized within the designated cohort to active drug or placebo
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of Norethisterone Enanthate on Recurrent Bacterial Vaginosis
Condition: Bacterial Vaginosis; HIV
MeSH terms: Vaginosis, Bacterial; Vaginal Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The proposed study, Hormonal Contraception & BV (HCBV), will investigate the effect of NET-EN
      and DMPA on recurrent BV, vaginal microbiota and inflammatory markers among women at high
      risk for HIV in Kampala, Uganda. The hypothesis is that NET-EN will show a similar beneficial
      effect on recurrent BV and vaginal microbiota as DMPA, without inducing signs of mucosal
      inflammation.
    

Detailed description: 
      Bacterial vaginosis (BV) is highly prevalent among women in Africa and is associated with HIV
      acquisition. BV has been described as a dysbiosis, or a microbial imbalance, and is treated
      with metronidazole; however, once treated, it often recurs rapidly. Developing robust
      treatment strategies to prevent recurrent BV is important for HIV prevention in key
      populations at high risk for HIV infection.

      There is evidence that hormonal contraceptives, including depot medroxyprogesterone acetate
      (DMPA), decrease BV recurrence; however, there is also evidence that DMPA increases the risk
      of HIV infection. Encouraging women to start or switch to an alternative progestin injectable
      such as norethisterone enantate (NET-EN) may mitigate HIV risk whilst decreasing the risk of
      recurrent BV. To date, there are no published studies that have investigated the effect of
      NET-EN on vaginal microbiota.

      The proposed study will investigate the effect of NET-EN and DMPA on recurrent BV, vaginal
      microbiota and inflammatory markers among women at high risk for HIV in the Good Health for
      Women Project in Kampala, Uganda. Consenting and eligible women will be treated for BV, and
      randomised to either NET-EN plus condoms or condoms only. Women currently using DMPA will be
      enrolled as an observational comparison arm. All participants will be interviewed and
      examined; samples for vaginal microbiota, sexually transmitted infections, and inflammatory
      markers will be obtained. Women will be followed up after 1 week, and 1, 2, 3, 4 and 6
      months. The primary outcomes will be differences in vaginal microbiota clusters, time to
      recurrent BV, and inflammatory markers. Qualitative research will be carried out to assess
      the acceptability of, and adherence to, NET-EN.
    

Intervention name(s): Norethisterone enantate; Condoms
Intervention type(s): Drug; Device
Intervention description(s): Noristerat® 200mg, solution for intramuscular injection given every 8 weeks; Latex male condoms
Other intervention name(s): Noristerat
Intervention MeSH terms: Norethindrone; Norethindrone enanthate; Norethindrone Acetate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Bioequivalence Study of Cefprozil Tablets, USP 500 mg Under Fasting Conditions
Condition: Healthy
MeSH terms: Disease
Study type: Interventional

Summary: 
      The objective of this study was to assess the single-dose relative bioavailability of Ranbaxy
      and Bristol-Myers Squibb Company (CEFZIL ®) 500 mg cefprozil tablets, under fasting
      conditions.
    

Detailed description: 
      This was a blinded, randomized, single dose, 3-way crossover comparative bioavailability
      study performed on 27 healthy adult volunteers (13 males and 14 females). In each period,
      subjects were housed from at least 10 hours before dosing until after the 10 hour post dose
      events. Subjects received a single oral 500 mg cefprozil dose of their assigned formulation,
      with 240 mL of water under fasting condition. Food was restricted from 10 hours before dosing
      until 4 hours post dose and water was not permitted from 2 hours before dosing and was
      restricted until 2 hours following dosing but was allowed ad libitum at all other times. The
      doses were separated by a washout period of 14 days.

      A total of twenty seven (27) healthy adult volunteers (13 males and 14 females) were enrolled
      in the study, out of which only twenty four (24) subjects (11 males and 13 females) completed
      the clinical phase of the study.
    

Intervention name(s): cefprozil 500mg tablets
Intervention type(s): Drug
Intervention MeSH terms: Cefprozil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Keywords: Bioequivalence cefprozil 500mg tablets fasting conditions