bioihbjkbjnl/mcl2 huggingface dataset:
Melphalan With or Without Holmium Ho 166 DOTMP Followed by Peripheral Stem Cell Transplantation in Treating Patients With Multiple Myeloma
Condition: Multiple Myeloma and Plasma Cell Neoplasm
MeSH terms: Multiple Myeloma; Neoplasms, Plasma Cell; Plasmacytoma
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radioactive drugs such as holmium Ho 166 DOTMP can kill cancer
      cells without harming healthy cells. Peripheral stem cell transplantation may be able to
      replace immune cells that were destroyed by chemotherapy or radiation therapy used to kill
      tumor cells.

      PURPOSE: Randomized phase III trial to compare the effectiveness of melphalan with or without
      holmium Ho 166 DOTMP followed by peripheral stem cell transplantation in treating patients
      who have multiple myeloma.
    

Detailed description: 
      OBJECTIVES: I. Compare the efficacy of melphalan with or without holmium Ho 166 DOTMP
      followed by autologous peripheral blood stem cell transplantation in patients with multiple
      myeloma. II. Compare the response rate and overall survival of these patients treated with
      these regimens. III. Compare the hematologic recovery rate and time to granulocyte
      engraftment of these patients treated with these regimens. IV. Compare the toxicity of these
      regimens in this patient population.

      OUTLINE: This is a randomized, open label, multicenter study. Patients are stratified
      according to their beta 2 microglobulin (B2M) test at initial diagnosis (B2M no greater than
      4 mg/L vs B2M greater than 4 mg/L vs unknown B2M). Patients are randomized to one of two
      treatment arms. Prior to stratification and randomization, patients receive a diagnostic dose
      of holmium Ho 166 DOTMP within days -31 to -10. Patients with adequate skeletal uptake of the
      diagnostic dose are randomized for therapy. Arm I: Patients receive holmium Ho 166 DOTMP IV
      over no more than 10 minutes within days -10 to -7 (at least 1 week and no more than 3 weeks
      after the diagnostic dose), melphalan IV over 20-30 minutes within days -3 to -1 (at least 24
      hours prior to autologous peripheral blood stem cell (PBSC) transplantation), and autologous
      PBSC transplantation on day 0. Arm II: Patients receive melphalan and autologous PBSC
      transplantation as in arm I. Following transplantation, patients receive filgrastim (G-CSF)
      daily until blood counts recover. Patients are followed at 1 year, every 6 months for 3
      years, and then annually thereafter.

      PROJECTED ACCRUAL: Approximately 300 patients (150 per treatment arm) will be accrued for
      this study within 9 months.
    

Intervention name(s): filgrastim; melphalan; peripheral blood stem cell transplantation; holmium Ho 166 DOTMP
Intervention type(s): Biological; Drug; Procedure; Radiation
Intervention MeSH terms: Melphalan
Primary purpose: Treatment
Keywords: stage I multiple myeloma; stage II multiple myeloma; stage III multiple myeloma
A Study To Compare Giving AVODART And FLOMAX Together Or In A Combination Capsule In The Fed And Fasted State
Condition: Prostatic Hyperplasia
MeSH terms: Prostatic Hyperplasia; Hyperplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be an open-label, randomized, single dose, three way partial crossover study
      in healthy male subjects. The aim of the study is to evaluate bioequivalence of a fixed dose
      combination (FDC) capsule of dutasteride and tamsulosin hydrochloride (HCl) (0.5 milligram
      [mg]/0.4 mg) relative to co-administration of dutasteride 0.5 mg capsules and tamsulosin
      hydrochloride 0.4 mg tablets in both the fed and fasted states. Approximately 98 healthy
      adult male subjects will be enrolled into the study. Subjects will receive single oral doses
      in 3 treatment periods and be randomized to one of twelve different treatment sequences (ABC,
      ACB, BAC, BCA, CAB, CBA, ABD, ADB, BAD, BDA, DAB, DBA) wherein A= commercially available
      tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fed state, B= fixed dose
      combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4
      mg tamsulosin hydrochloride) in a fed state, C= commercially available tamsulosin
      hydrochloride 0.4 mg and dutasteride 0.5 mg in a fasted state, D= fixed dose combination
      formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg
      tamsulosin hydrochloride) in a fasted state. Each treatment period will be separated by a
      minimum 28 day washout period. The total duration of a subject's involvement in this study is
      approximately 15-18 weeks.
    

Detailed description: 
      An Open-Label, Randomized, Single Dose Three-Period Partial Crossover Study to Determine the
      Bioequivalence and Food Effect of a Combination Capsule Formulation of Dutasteride and
      Tamsulosin Hydrochloride (0.5mg/0.4mg) Compared to Concomitant Dosing of AVODART 0.5mg and
      FLOMAX 0.4mg Commercial Capsules in Healthy Male Subjects
    

Intervention name(s): Treatment sequence A; Treatment sequence B; Treatment sequence C; Treatment sequence D
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fed state; Fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fed state; Commercially available tamsulosin hydrochloride 0.4 mg and dutasteride 0.5 mg in a fasted state; Fixed dose combination formulation of dutasteride and tamsulosin hydrochloride (0.5 mg dutasteride, 0.4 mg tamsulosin hydrochloride) in a fasted state
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: benign prostatic hyperplasia,; AVODART,; FLOMAX
Subcutaneous vs. Intramuscular Testosterone
Condition: Testosterone Deficiency; Hypogonadism, Male
MeSH terms: Hypogonadism; Eunuchism
Study type: Interventional
Phase: Phase 4

Summary: 
      In this randomized, cross-over study 20 subjects who are undergoing testosterone (T) therapy
      for the treatment of T deficiency will receive both subcutaneous testosterone therapy and
      intramuscular testosterone therapy. One group will receive a SQ injection followed by an IM
      injection and one group will receive an IM injection followed by a SQ injection. The primary
      objective of this study is to measure testosterone concentration in men after these two
      treatment routes and determine if there are any significant differences due to modes of
      administration. Endpoints will include total serum testosterone and calculated free
      testosterone. A questionnaire will also be administered to assess overall patient experience
      with each route of administration.
    

Detailed description: 
      Subjects planning to initiate testosterone treatment via injection at MHB will be consented
      into the study. Upon enrollment in the study, the randomization will be completed for each
      subject.

      Blood collection will occur before each injection. Subjects will rate pain on the Likert
      scale following each injection. After treatment with the first mode of T administration (SQ
      or IM depending on randomization), subjects will come in for blood draws 3 days and 7 days
      following the injection. Two weeks after the initial injection, subjects will come in for
      treatment with the second mode of T administration (SQ or IM depending on randomization).
      Subjects will come in for blood draws 3 days and 7 days following the second injection. Two
      weeks after the second injection, subjects will complete an end of study assessment with an
      Investigator and will complete a survey assessing their satisfaction with treatment. Subjects
      will likely continue testosterone therapy at Men's Health Boston after completion of the
      study.
    

Intervention name(s): Testosterone
Intervention type(s): Drug
Intervention description(s): Testosterone cypionate injection
Other intervention name(s): Testosterone cypionate; Testosterone injection
Intervention MeSH terms: Methyltestosterone; Testosterone; Testosterone undecanoate; Testosterone enanthate; Testosterone 17 beta-cypionate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Thoracic Manipulation and Mobilization for Neck Pain
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      The purpose of this randomized clinical trial was to examine the widespread effects of
      thoracic spine thrust manipulation and thoracic non-thrust mobilization on pressure pain
      sensitivity and neck pain intensity in patients with chronic mechanical neck pain.
    


Intervention name(s): Thoracic mobilization; Thoracic manipulation
Intervention type(s): Other; Other
Intervention description(s): Patients will receive 20 seconds bouts of grade III-IV of central posterior-anterior (PA) non-thrust mobilization from T3 to T6 spinous process as described by Maitland et al for an overall intervention time of approximately 2 minutes; A high-velocity, end range, anterior-posterior thrust applied through the elbows to the mid-thoracic spine will be applied
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: manipulation; mobilization; spine; pressure pain
Respiratory Biofeedback Sensor for Yoga Practice for Youth With Chronic Pain.
Condition: Pain, Chronic
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      This project will develop and test a wearable breathing monitor that will measure the
      synchrony in breathing between the diaphragm and chest of children with a pain diagnosis
      while receiving yoga therapy. Specifically, we will develop a biofeedback system to help
      improve breathing in pain patients.
    

Detailed description: 
      This Small Business Technology Transfer (STTR) Phase I application proposes the development
      and trial of a novel non-invasive real-time breathing sensor - pneuRIP- to show the
      beneficial effects of respiratory biofeedback on yoga. PneuRIP will be employed to monitor
      and improve asana (posture) and pranayama (breathing) in yoga in youth with chronic pain. The
      sensor consists of two inductive bands worn around the chest and abdomen that measure and
      differentiate diaphragmatic and chest breathing through Respiratory Inductance
      Plethysmography (RIP). Readings are recorded and analyzed on a small chest-worn unit and
      wirelessly transmitted to an iPad. Measures include the phase angle between the chest and
      abdomen; percentage breathing through the ribcage; respiratory rate; and labored breathing
      index. This sensor takes little time to set up and readings are provided instantaneously.

      The first part of the proposal will develop the biofeedback software. The biofeedback
      component will be related to the synchrony between diaphragmatic and chest breathing, and the
      relative depth of breathing. This information will be presented to the user visually on an
      iPad screen in the form of 2 moving bars - one corresponding to the chest and one to the
      belly.

      In the second part of the study, we will test the pneuRIP with biofeedback with 20 youth with
      pain enrolled in an interdisciplinary pediatric chronic pain program in a large pediatric
      hospital receiving yoga as one of the therapies. The yoga regimen is 8 sessions, once per
      week. Subjects will be randomized into two groups: one receiving instruction only on
      synchronous breathing; the second group will receive biofeedback in addition. Outcomes will
      be standardized measures of pain (recorded before and after entire regimen) and breathing
      indices (recorded during each session). Outcomes will inform the feasibility of using
      real-time biofeedback in yoga with a non-invasive respiratory monitor.
    

Intervention name(s): PneuRIP; biofeedback to assist with breathing
Intervention type(s): Device; Other
Intervention description(s): Measuring respiratory indices through Respiratory Inductance Plethysmography; Measuring respiratory indices through Respiratory Inductance Plethysmography and providing visual biofeedback on a tablet screen
Other intervention name(s): Non-invasive breathing monitor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effectiveness of Group Psychotherapy in Patients With Fibromyalgia Syndrome
Condition: Fibromyalgia Syndrome
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Syndrome
Study type: Interventional

Summary: 
      The hypothesis of the study is that group therapy in fibromyalgia patients can provide
      significant improvement in pain, fatigue, anxiety and depression levels and emotional
      expressions.
    

Detailed description: 
      The purpose of our study; to determine the effectiveness of group psychotherapy in the
      treatment of Fibromyalgia Syndrome.

      Patients who received 9 weeks of group therapy and those who did not, at the beginning of
      treatment, at the end of 9 weeks and 6 months after treatment will be evaluated using The
      Short Form-36, Fibromyalgia Impact Questionnaire, Revised Fibromyalgia Impact Questionnaire,
      Hospital Anxiety and Depression Scale, Fatigue Severity Scale, Beck Depression Inventory,
      Beck Anxiety Inventory, Pain Beliefs Scale, Emotional Expression Questionnaire, Visual
      Analogue Scale, Childhood Trauma Questionnaire, 2016 Fibromyalgia Diagnostic Criteria.

      At the end of the study, individuals are expected to show less depressive symptoms and
      anxiety symptoms compared to the beginning of the study, and it is thought that their
      complaints about pain will decrease.
    

Intervention name(s): Group Psychotherapy
Intervention type(s): Other
Intervention description(s): 9 week group psychotherapy, given by a psychologist trained in group psychotherapy.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: fibromyalgia; group therapy; group psychotherapy; pain; depression; anxiety
Cognitive Anxiety Sensitivity Treatment for Suicide
Condition: Anxiety
MeSH terms: Anxiety Disorders; Suicide
Study type: Interventional

Summary: 
      The purpose of this study is to test the effectiveness and usability of a computer-based
      treatment for mood and anxiety relevant risk factors. The target of the treatment is related
      to cognitive stress, which has been shown to be associated with several negative mental
      health outcomes such as suicidal ideation, substance use disorders, and Post-Traumatic Stress
      Disorder.
    

Detailed description: 
      CAST is a newly developed computerized treatment targeting specific risk factors associated
      with PTSD, substance use, anxiety, and suicide. Eligible individuals will be randomized to
      one of two conditions. In both conditions, participants will complete various self-report
      questionnaires and a computerized presentation. Additionally, all participants will be asked
      to complete a one month follow-up appointment.
    

Intervention name(s): Anxiety Risk Reduction
Intervention type(s): Behavioral
Intervention description(s): Involves psychoeducation and interoceptive exposure exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Pupillary Response After Glaucoma Medication
Condition: Drug Effect (Glaucoma Drugs)
MeSH terms: Glaucoma
Study type: Interventional

Summary: 
      Investigation of the effect on the pupillary constriction by latanoprost, dorzolamide,timolol
      in healthy subjects. The pupillary constriction is compared to no drug.
    


Intervention name(s): Latanoprost; Timolol; Dorzolamide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1 drop of latanoprost was given to study eye after washout period of 1 week between drugs; 1 drop of timolol was given to study eye after washout period of 1 week between drugs; 1 drop of dorzolamide was given to study eye after washout period of 1 week between drugs
Other intervention name(s): Optimol
Intervention MeSH terms: Timolol; Dorzolamide; Latanoprost
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Study of Imatinib-Combined Chemotherapy for BCR-ABL-Positive Acute Lymphoblastic Leukemia (ALL)
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the clinical efficacy and safety of
      imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL.
    

Detailed description: 
      Philadelphia chromosome (Ph) is a translocation abnormality leading to the formation of the
      BCR-ABL gene rearrangement. This genetic abnormality occurs in up to 30% of adult acute
      lymphoblastic leukemia (ALL), and its presence is known to be the most adverse prognostic
      factor for ALL. Because long-term survival cannot be achieved by conventional chemotherapy
      alone, there is a clear medical need for alternative treatment approaches. Imatinib is a
      potent selective inhibitor of the BCR-ABL protein kinase, and it has been reported that
      single-agent imatinib induced response in a substantial proportion of Ph-positive ALL
      (Ph+ALL) patients, but that the response was not durable. The Japan Adult Leukemia Study
      Group (JALSG) has therefore started a phase 2 study designed to evaluate the clinical effect
      of imatinib-combined chemotherapy on newly diagnosed BCR-ABL-positive ALL.
    

Intervention name(s): imatinib; cyclophosphamide; daunorubicin; vincristine; prednisolone; methotrexate; cytarabine; dexamethasone
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Cytarabine; Dexamethasone; Prednisolone; Cyclophosphamide; Methotrexate; Vincristine; Imatinib Mesylate; Daunorubicin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute lymphoblastic leukemia; BCR-ABL; Philadelphia-chromosome; newly diagnosed
Targeting Physical Activity to Improve Cardiovascular Health in Type 2 Diabetes
Condition: Motor Activity; Health Behavior; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      This study plans to learn more about physical activity and physical function in sedentary
      older adults with type 2 diabetes.
    

Detailed description: 
      The purpose of this study is to conduct a randomized controlled trial with 1:1 patient-level
      randomization to an evidence-based physical activity program intervention versus usual care
      in sedentary older adults with type 2 diabetes in two primary care clinic sites.
    

Intervention name(s): Physical Activity; Questionnaires
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Physical Activity Program Intervention; Participants in the usual care arm will receive three mailings during the intervention phase.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Physical Activity; Physical Function; Physical Impairment; Sedentary Lifestyle
Effect of Exenatide on Glucose Homeostasis Determinants in Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine in type 2 diabetic patients in secondary failure to
      combined oral therapy whether, besides improvement in glycemic control, addition of
      exenatide, a new drug introduced to treat diabetes before addition of insulin to current
      therapy, over 6 months is associated with improvement in beta-cell function, insulin
      sensitivity following 24-hours discontinuation of the drug.
    


Intervention name(s): exenatide (Byetta)
Intervention type(s): Drug
Intervention description(s): all patients receive 5 then 10 µg exenatide subcutaneously BID for 6 months
Intervention MeSH terms: Exenatide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: T2DM; exenatide; HbA1c; weight; waist circumference; insulin sensitivity; beta-cell function
Phase 1 Pharmacokinetic Study of Tapentadol Prolonged-Release 250 Milligram (mg) Formulation in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate pharmacokinetics (explores what the body does to the
      drug), safety and tolerability of single and multiple-dose of tapentadol in healthy
      participants.
    

Detailed description: 
      This is an open-label (all people know the identity of the intervention), single-center,
      Phase 1 and, single and multiple-dose study of tapentadol tamper resistant prolonged-release
      formulation (TRF) 250 milligram (mg) tablet in healthy participants. The total study duration
      will be approximately of 29 days per participant. The study consists of 3 parts: Screening
      (that is, 21 days before study commences on Day 1); Treatment (single-dose of tapentadol on
      Day 1, and multiple dose from Day 4-6 [followed by washout period of 24 hours]); and
      End-of-study (Day 8). All the eligible participants will receive single oral dose of
      tapentadol TRF 250 mg on Day 1 and twice daily from Day 4-6 (total 5 doses). Participants
      will keep upright position until 4 hours after study drug administration. Study drug will be
      administered 30 minutes after breakfast in the morning. Blood samples will be collected for
      evaluation of pharmacokinetics at pre-dose and post-dose of study treatment. Participants'
      safety will be monitored throughout the study.
    

Intervention name(s): Tapentadol
Intervention type(s): Drug
Intervention description(s): Tapentadol tamper resistant prolonged-release formulation (TRF) will be administered as 250 milligram oral tablet once (in the morning, 30 minutes after breakfast) on Day 1 and 6, and twice daily (in the morning, 30 minutes after breakfast and in the evening) on Day 4 and 5.
Intervention MeSH terms: Tapentadol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy; Tapentadol
Biomechanical Properties in Intensive Care Unit (ICU) Survivors 12-month After Discharge
Condition: Intensive Care (ICU) Myopathy
MeSH terms: Muscular Diseases
Study type: Observational

Summary: 
      Intensive care unit (ICU) admission is associated with muscle weakness and ICU survivors
      report persevering limitation of physical capacity for years after discharge. Limited
      information is available about the underlying biomechanical properties responsible for this
      muscle function impairment.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        ICU survivors 12 months after discharge compared to age and gender matched controls
      
Keywords: ICU acquired weakness