bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study of CC-292 Versus Placebo as Co-therapy With Methotrexate in Active Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      CC-292 is an oral agent that is under clinical development for the treatment of rheumatoid
      arthritis an autoimmune inflammatory disorder.

      This study will test the clinical effectiveness and safety of an orally (PO) administered
      dose of CC-292 compared to placebo in US female patients currently on background Methotrexate
      (MTX) with active Rheumatoid Arthritis (RA
    

Detailed description: 
      This is a Phase 2a, multicenter, randomized, double-blind, placebo-controlled,
      proof-of-concept study to determine the efficacy and safety of CC-292 (375 mg PO daily) on a
      stable background of MTX therapy in female subjects with active RA.

      Approximately 80 female subjects with active RA will be randomized 1:1 into two dose groups:
      active CC-292 (375 mg PO daily) or identically-appearing placebo capsules for 4 weeks
    

Intervention name(s): CC-292; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 375 mg PO daily (250 mg in the AM and 125 mg in the PM for 28 days); Twice daily for 28 days
Intervention MeSH terms: Spebrutinib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Arthritis, Rheumatoid, Autoimmune, Inflammatory, Synovial, Bruton's tyrosine kinase (Btk), CC-292, Joint Disease
Telmisartan+Amlodipine Fixed Dose Combination in Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objectives of this trial is to evaluate the changes from baseline (Visit 2) in
      the 24-hour Ambulatory Blood Pressure Monitoring mean (relative to dose time) for diastolic
      blood pressure and systolic blood pressure after 8 weeks of treatment with Telmisartan
      80mg/Amlodipine 5mg in patients with moderate to severe hypertension
    


Intervention name(s): telmisartan+amlodipine fixed dose combination
Intervention type(s): Drug
Intervention description(s): after 2 weeks placebo wash-out, patients will be administered Telmisartan 80mg/Amlodipine 5mg for 8 weeks.
Intervention MeSH terms: Amlodipine; Telmisartan; Telmisartan amlodipine combination
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Study of KDT-3594 in Healthy Adult Males and Patients With Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study in healthy adult males is to investigate safety and
      pharmacokinetics of single and multiple oral doses of KDT-3594.

      The purpose of this study in patients with Parkinson's disease is to investigate safety and
      pharmacokinetics of single and multiple oral doses of KDT-3594. The exploratory efficacy of
      KDT-3594 will also be investigated.
    


Intervention name(s): KDT-3594; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration; Oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Healthy volunteer part -Multiple dose: Parallel, Healthy volunteer part -Single dose and Patient part: Single Group
Masking: Single (Participant)
Primary purpose: Other
Safety and Pharmacokinetics Study of CPL207280 Compound in Healthy Volunteers.
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The planned study is to determine the safety and pharmacokinetic properties of CPL207280
      compound after single and multiple (two weeks) administration in healthy volunteers.
    

Detailed description: 
      This is to be one-centre, single ascending dose and double-blind multiple ascending dose two
      part study of CPL207280 compound in healthy volunteers. PART A is a single dose, open-label
      part with CPL207280 compound administered with dose escalation between cohorts.Additionaly
      assessing the effect of food and effect of metformin on bioavailability of CPL207280 is to be
      done in additional cohort. PART B is a multiple, double-blind part with CPL207280 compound
      administered for 14 days with dose escalation between cohorts. Participants in this part are
      to be randomized to receive Investigational Medicinal Product (IMP) or placebo in 3:1 ratio.
      Safety and pharmacokinetic properties of CPL207280 compound is to be determined following
      different doses in single oral IMP administration in PART A and different doses of IMP
      administered orally for two weeks in PART B.
    

Intervention name(s): CPL207280; Placebo; Metformin hydrochloride 750 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IMP is a tablet with CPL207280 as an Active Pharmaceutical Ingredient (API).; matching placebo tablet; IMP is a tablet with Metformin hydrochloride as an Active Pharmaceutical Ingredient (API).
Other intervention name(s): Glucophage XR 750 mg
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Healing Touch in Treating Fatigue in Women Undergoing Radiation Therapy for Breast Cancer
Condition: Breast Cancer; Depression; Fatigue
MeSH terms: Breast Neoplasms; Fatigue; Depression
Study type: Interventional

Summary: 
      RATIONALE: Healing touch therapy may be effective in lessening fatigue in women with breast
      cancer who are undergoing radiation therapy.

      PURPOSE: This randomized clinical trial is studying how well healing touch works in treating
      fatigue in women undergoing radiation therapy for breast cancer.
    

Detailed description: 
      OBJECTIVES:

        -  To determine the ability to recruit and retain patients with breast cancer receiving
           curative radiotherapy in a Complementary and Alternative Medicine trial.

        -  To determine the acceptability of weekly healing touch therapy to patients with breast
           cancer who receive curative radiotherapy.

        -  To examine the effect of healing touch on fatigue and quality of life for patients with
           breast cancer receiving radiotherapy as a component of therapy.

      OUTLINE: Patients are stratified by type of treatment (radiotherapy alone vs chemotherapy
      completed prior to radiotherapy)

        -  Arm I:Patients receive healing-touch therapy administered once a week for 45 minutes by
           a healing-touch therapist for the duration of radiotherapy.

        -  Arm II: Patients receive sham-therapy administered once a week for 45 minutes by a
           sham-practitioner (NOT a healing-touch therapist) for the duration of radiotherapy.

      Patients complete the Hospital Anxiety and Depression Scale (HAD) and a demographic variables
      form (age, race/ethnicity, marital status, employment) at baseline. Patient fatigue is
      measured on a weekly basis throughout radiotherapy with completion of the Brief Fatigue
      Inventory (BFI). The Functional Assessment of Cancer Therapy-Breast form (FACT-B) is
      completed at baseline and the end of radiotherapy. Patients undergo a 20-minute interview at
      the end of study to determine the acceptability of the intervention.
    

Intervention name(s): Bio-field energy therapy; fatigue assessment and management; psychosocial assessment and care; quality-of-life assessment; therapeutic touch
Intervention type(s): Procedure; Procedure; Procedure; Procedure; Procedure
Intervention description(s): Practitioner's hands to influence the human energy field surrounding the patient's body.; duration; duration; duration; Practitioner's hands to influence the human energy field surrounding the patient's body
Other intervention name(s): biofield therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: fatigue; depression; psychosocial effects of cancer and its treatment; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; recurrent breast cancer
Efficacy and Safety of High-dose Interferon Alfa-2b (Intron A®) for the Adjuvant Treatment of Malignant Melanoma (Study P04083)
Condition: Melanoma
MeSH terms: Melanoma
Study type: Observational

Summary: 
      The aim of this observational study is to document the efficacy and tolerability of high-dose
      interferon therapy in adult participants with malignant melanoma at high risk of relapse and
      to compare them with the survival times and relapse rates in previous studies (historical
      control).
    

Detailed description: 
      Observational study to evaluate the tolerability and efficacy (vs historical controls) of a
      high-dose therapy scheme with interferon-α-2b (IntronA®):

      Adjuvant treatment with interferon-α-2 has been demonstrated in a number of studies to have
      an antiproliferative effect on malignant melanoma. In these cases a response rate of up to
      20% could be achieved with a dose of 10 million IU or more 3x/week or daily. Kirkwood et al.
      showed in a study carried out in ECOG (the Eastern Cooperative Oncology Group, study no.
      1684) that there was a clear and significant survival advantage versus the observation group
      with the following dose:

      20 mio IU/m² interferon-α-2b (IntronA®) 5x/week iv over the course of one month followed by
      11 months with 10 mio IU/m² 3x/week sc.
    

Intervention name(s): Interferon α-2b
Intervention type(s): Biological
Intervention description(s): 20 mio IU/m² interferon-α-2b 5x/week intravenously (IV) over the course of 1 month, followed by 10 mio IU/m² interferon-α-2b 3x/week subcutaneously (SC) for 11 months.
Other intervention name(s): Intron A
Intervention MeSH terms: Interferons
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult participants in Austria with malignant melanoma at high risk of relapse
      
Keywords: interferon-alpha
Single Ascending Dose Study of SAR443820 in Healthy Adult Chinese and Japanese Female and Male Participants
Condition: Multiple Sclerosis Healthy Subjects
MeSH terms: Multiple Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To assess the pharmacokinetic parameters of SAR443820 after ascending single oral doses in
      healthy East Asian (Chinese and Japanese) adult participants.

      Secondary Objective:

      To assess the tolerability and safety of SAR443820 after ascending single oral doses in
      healthy East Asian (Chinese and Japanese) adult participants
    

Detailed description: 
      The duration of the study for a participant will be up to approximately 7 weeks and include:

        -  Screening period: up to 4 weeks (Day -28 to Day -2).

        -  Institutionalization period at each period of treatment: 4 days (Day -1 to Day 3, single
           SAR443820 administration on Day 1).

        -  Wash-out period: at least 5 days between each dosing.

        -  End-of-study visit: Period 3/ Day 6±1 day.
    

Intervention name(s): RIPK1 inhibitor
Intervention type(s): Drug
Intervention description(s): Capsule Oral
Other intervention name(s): SAR443820
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
MK0524A Bioequivalence Study (0524A-059)
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the definitive bioequivalence of tablets of MK0524A (1000 mg
      Extended Release (ER) Niacin/ 20 mg laropiprant) from two sources.
    


Intervention name(s): niacin (+) laropiprant (Source 1); Comparator: niacin (+) laropiprant (Source 2)
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 1 in one of two treatment periods.; Single dose of MK0524A (ER Niacin/laropiprant 1000/20 mg) from Source 2 in one of two treatment periods.
Intervention MeSH terms: Niacin; Niacinamide; Nicotinic Acids
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 3 Study of BI 207127 in Combination With Faldaprevir and Ribavirin for Treatment of Patients With Hepatitis C Infection, Including Patients Who Are Not Eligible to Receive Peginterferon: HCVerso2
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to confirm efficacy and safety of treatment with 600 mg of BID BI
      207127 in combination with 120 mg QD FDV and RBV for 16 or 24 weeks in target chronically
      infected HCV GT1b treatment naïve patients, including patients with compensated cirrhosis.
    


Intervention name(s): BI 207127-placebo: 8-week treatment; Ribavirin: 24-week treatment; BI 207127: 24-week treatment; Faldaprevir: 24-week treatment; Faldaprevir: 24-week treatment; Ribavirin-placebo: 8-week treatment; BI 207127: 24-week treatment; Faldaprevir-placebo: 8-week treatment; Faldaprevir: 16-week treatment; Ribavirin: 16-week treatment; RBV: 24-week treatment; BI 207127: 16-week treatment
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 8 weeks of placebo treatment; 24 weeks of active treatment; 24 weeks of active treatment; 24 weeks of active treatment; 24 weeks of active treatment; 8 weeks of placebo treatment; 24 weeks of active treatment; 8 weeks of placebo treatment; 16 weeks of active treatment; 16 weeks of active treatment; 24 weeks of active treatment; 16 weeks of active treatment
Intervention MeSH terms: Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Lenalidomide Plus Bendamustine and Rituximab for Untreated CLL/SLL
Condition: Chronic Lymphocytic Leukemia; Small Lymphocytic Lymphoma; B Chronic Lymphocytic Leukemia
MeSH terms: Lymphoma; Leukemia; Leukemia, Lymphoid; Leukemia, Lymphocytic, Chronic, B-Cell
Study type: Interventional
Phase: Phase 1

Summary: 
      Lenalidomide belongs to a group of drugs called immunomodulatory drugs (IMiD) that can modify
      or regulate the functioning of the immune system. It is an FDA approved drug for people with
      multiple myeloma. It is not currently approved for use in Chronic Lymphocytic Leukemia (CLL),
      but it does appear effective in CLL when used alone, and is being studied for use in
      combination with chemotherapy in this and other lymphomas and leukemias.

      In this research study we are hoping to learn more about the effects of lenalidomide on CLL
      when given in combination with bendamustine and rituximab, which is a highly effective
      regimen for initial therapy of CLL/SLL. The investigators will be looking for the highest
      dose of lenalidomide that can be given safely, without causing any serious or unmanageable
      side effects.
    

Detailed description: 
      Subjects will receive lenalidomide, bendamustine and rituximab in cycles of 28 days (4
      weeks). Lenalidomide will be administered orally once daily on days 8-21 of cycle 1 and on
      days 1-21 of all subsequent cycles. Bendamustine will be administered through a vein (IV
      infusion) on days 1 and 2 of each cycle. Rituximab will be administered as an IV infusion on
      day 1 of each cycle.

      Subjects will receive routine blood tests and physical exam during each cycle. Tumor
      assessments by CT scan will be performed during cycles 2, 4, and 6.
    

Intervention name(s): Lenalidomide; Bendamustine; Rituximab
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Lenalidomide will be dose escalated until the maximum tolerated dose is reached. The starting dose is 2.5mg, followed by 5mg, followed by 10mg.; 90 mg/m^2 IV days 1-2 of each cycle for 6 cycles; 375 mg/m^2 IV day 1 (cycle 1), 500 mg/m^2 day 1 (cycles 2-6)
Other intervention name(s): CC-5013; Revlimid; Treanda; SDX 105; Rituxan; Mabthera
Intervention MeSH terms: Rituximab; Lenalidomide; Bendamustine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: CLL; Leukemia; Untreated; B-CLL; SLL
Improving Constipation by Stimulating Fiber Intake Using Personalized Dietary Advice
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Rationale: constipation-related complaints are prevalent in 5-20% of the population.

      Dietary fibers play a crucial role in improving and maintaining gut health, increasing stool
      weight, stool frequency and improvement of stool consistency. Currently, very few adults meet
      the recommendation of 30 (females) or 40 (males) grams of fiber per day. Personalized dietary
      advice may be the solution to increase dietary fiber intake and reduce constipation-related
      complaints in large populations. Objective: To investigate the effectiveness of personalized
      dietary advice (PDA) in reducing constipation-related complaints, by increasing dietary fiber
      intake in people with constipation-related complaints. Study design: This study has a
      one-group pre-test post-test design with a run-in period.

      The duration of the study is 8 weeks, which includes a 4-week run-in phase and a 4-week
      intervention period. All subjects receive the PDA. Study population: adult subjects with
      constipation-related complaints, defined as predominant Bristol stool form between 1-4 and
      not satisfied with their bowel habits (scale ranging from 1-10, cut-off <6). Possibly stool
      frequency ≤4 stools per week will be included as a definition. Subjects need to have a
      relatively low dietary fiber intake defined as <26 grams (females) or <33 grams (males),
      which is ≥15% below the recommendation of fiber intake. Intervention: personalized advice
      based on their habitual food pattern (as assessed using a food frequency questionnaire) and
      preferences. Based on a special algorithm, the PDA provides high fiber alternatives for
      low-fiber products that subjects currently use, close to their current eating behavior, to
      help increase dietary fiber intake. This PDA will be provided using an online web-portal.

      Main study parameters/endpoints:primary outcomes are stool pattern, gastrointestinal
      complaints and constipation quality of life and severity. Secondary parameters include
      dietary fiber intake, physical activity, body weight, psychological questionnaires, and fecal
      microbiota composition and metabolite levels. Furthermore, the PDA will be evaluated.
    


Intervention name(s): Personalized dietary advice
Intervention type(s): Behavioral
Intervention description(s): Via an self-developed website and algorithm, participants will receive digital personalized dietary advice to increase dietary fiber intake, aiming to reduce constipation complaints. The advice is personalized on phenotype (habitual diet, gender)
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: One group is followed over time (within person design)
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Dietary fiber; Personalized advice
Liposomal Bupivacaine for Pain Control Following Anterior Cruciate Ligament Reconstruction
Condition: Anterior Cruciate Ligament Rupture
MeSH terms: Rupture
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will consist of 80 patients ages 18 to 50 at the Emory Orthopaedic and Spine
      Center who are undergoing Anterior Cruciate Ligament (ACL) reconstruction with a quadriceps
      tendon autograft or bone patellar tendon bone autograft by Dr. Karas or Dr. Xerogeanes.
      Patients will be randomized into treatment and control arms. The treatment arm will include
      40 patients receiving liposomal bupivacaine intra-operatively in addition to the current
      standard pain control regimen. The control group will include 40 patients receiving the
      standard post-operative pain control regimen. Patients will be assessed to identify
      differences in post-operative pain, satisfaction, as well as concomitant pain medication use.
      Post-operative range of motion will also be assessed.
    


Intervention name(s): Exparel
Intervention type(s): Drug
Intervention description(s): For the treatment group a total of 40 cc consisting of 20 cc of 1.3% Exparel® and 20 cc of 0.5 % marcaine will be administered to the ACL harvest site, into the periosteum surrounding the distal tibial tunnel site, and in the proximity of the skin incisions. No infiltration of Exparel will be provided intra-articularly.
Other intervention name(s): Liposomal Bupivacaine
Intervention MeSH terms: Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effects of Projected Peripheral Defocus on Ocular Biometrics
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      Acucela Inc. intends to develop a medical device to significantly halt or reverse myopic
      progression, which is a significant public health concern across the world, especially in
      Asian demographics. Acucela is working towards a spectacle-like device (eSPECs), which will
      have a clear zone for unimpeded central visual tasks and a periphery that provides defocus in
      order to alter retinal physiology leading to myopia regulation. This study will establish the
      changes seen during a proof-of-concept that projected defocus in the periphery will stimulate
      physiological changes similar to those in the literature.
    


Intervention name(s): Tabletop prototype of eSpecs: Active projection of defocused image in the peripheral visual field; Tabletop prototype of eSpecs: No Active projection of defocused image in the peripheral visual field
Intervention type(s): Device; Device
Intervention description(s): For the right/test eye, a defocused image is projected onto the peripheral retina while the subject views a distant, in-focus image; For the left/control eye, no image is projected onto the peripheral retina. The subject views a distant, in-focus image.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment