bioihbjkbjnl/mcl2 huggingface dataset:
Singing for Wellness: Is Singing a Useful Way of Supporting People in South Devon to Self-manage Aspects of Their COPD
Condition: COPD
Study type: Interventional

Summary: 
      The aim of this study is to explore whether singing is a useful way of supporting people in
      South Devon to self manage aspects of their COPD and associated social isolation. It will
      also investigate whether a model of bespoke respiratory community choirs provides a useful
      service for our local community. The study will look at the impact of singing on breathing,
      wellbeing, frailty and engagement.
    


Intervention name(s): singing
Intervention type(s): Other
Intervention description(s): Singing for Wellness will use an uncontrolled observational study design. Two mixed-cohort, 12-week community choirs will be delivered by experienced vocal practitioners in South Devon localities:
Intervention model: Single Group Assignment
Intervention model description: Singing for Wellness will use an uncontrolled observational study design. Two mixed-cohort, 12-week community choirs will be delivered by experienced vocal practitioners in South Devon localities: Newton Abbott and Torquay.
Masking: None (Open Label)
Primary purpose: Supportive Care
A Study to Evaluate the Effect of Carbetocin on the QT/QTc Interval in Healthy Subjects
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage
Study type: Interventional
Phase: Phase 1

Summary: 
      Carbetocin is an oxytocin receptor agonist that selectively binds to receptors in the smooth
      muscle of the uterus, stimulates rhythmic contractions of the uterus, increases the frequency
      of existing contractions, and raises the tone of the uterine musculature. Carbetocin is
      approved in >100 countries for the prevention of postpartum hemorrhage due to uterine atony
      in women following cesarean or vaginal delivery. Per regulatory requirements, the current
      trial will evaluate the effects of high clinical exposure of carbetocin on the QT interval
      corrected for heart rate (QTc) as measured by ECG in healthy men and women.
    


Intervention name(s): Carbetocin; Placebo; Placebo and Moxifloxacin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single infusion of Carbetocin; Single IV infusion of matching placebo; Single IV infusion of matching placebo in combination with Single Oral dose of Moxifloxacin
Intervention MeSH terms: Moxifloxacin; Carbetocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Influence of Rapydan on Clinical Chemistry and Hematology Measurements
Condition: Healthy
Study type: Interventional

Summary: 
      There is an increasing awareness of the importance of treating procedure-related pain.
      Patients undergoing vascular access procedures are often afraid of needles and the discomfort
      associated with injections. This type of pain and/or fear can be stressful to patients. [1]
      For prevention of the pain associated with these procedures, the hospital is using Rapydan
      plasters. Rapydan consists out of two local anesthetics: lidocaine and tetracaïne. Rapydan
      produces topical anesthesia after an application time of 30 minutes and is used in the
      Martini Hospital for pain relieve by venipuncture and IV cannulation. The venous blood
      draining the anaesthetized skin contains a higher blood concentration of the local
      anesthetics than does venous blood in other parts of the body [2] Although the concentrations
      of the local anesthetics are low in patients with normal skin, the question is whether the
      presence of the local anesthetics which Rapydan contains might influence routine measurements
      in clinical chemistry and hematology.
    


Intervention name(s): Rapydan
Intervention type(s): Drug
Intervention description(s): lidocaine / tetracaine 70/70 mg patch
Other intervention name(s): Lidocaine Tetracaine Patch
Intervention MeSH terms: Lidocaine; Tetracaine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy
Bioavailability of Orfiril Long 500 mg Prolonged-Release Minitablets and Ergenyl Chrono 500 mg Prolonged-Release Tablets
Condition: Multiple Drug Use
Study type: Interventional
Phase: Phase 1

Summary: 
      Comparative bioavailability of valproate from Orfiril long 500 mg prolonged-release
      mini-tablets and Ergenyl chrono 500 mg prolonged-release tablets in healthy, male volunteers
      under fasting conditions.
    

Detailed description: 
      Pivotal, multiple-dose, randomized, open-label, two-period, two-sequence, two-treatment,
      single-centre, crossover, study designed to evaluate the comparative bioavailability of
      valproate for Orfiril long 500 mg prolonged release minitablets and Ergenyl chrono 500 mg
      prolonged-release tablet once daily for 6 days in healthy male subjects under fasting
      conditions.
    

Intervention name(s): Sodium valproate 500 MG; Valproic Acid 500 MG
Intervention type(s): Drug; Drug
Intervention description(s): oral intake; oral intake
Other intervention name(s): Orfiril long 500 mg; Ergenyl chrono 500 mg
Intervention MeSH terms: Valproic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dose Escalation of POL6326 in Combination With Eribulin in Patients With Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      POL6326 will be given by i.v. infusion over 2 hours. Treatment will occur on days prior to,
      on the day of and on days after treatment with eribulin. Different doses and dosing
      frequencies will be investigated
    


Intervention name(s): POL6326
Intervention type(s): Drug
Intervention description(s): POL6326 will be given by i.v. infusion over 2 hours. Treatment will occur on days prior to, on the day of and on days after treatment with eribulin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Overall survival; Progression free survival
A Safety and Tolerability Study OF PUR118 In Subjects With Cystic Fibrosis
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether PUR118 is safe and tolerable in a
      population of subjects with Cystic Fibrosis.
    


Intervention name(s): PUR118
Intervention type(s): Drug
Intervention description(s): low dose and high dose for 3 doses, BID
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lung Diseases; Respiratory Tract Diseases; Fibrosis
Oral Glucose Stimulation in Normal-weight and Obese Volunteers
Condition: Endocrine System Diseases
MeSH terms: Endocrine System Diseases
Study type: Interventional

Summary: 
      The objective of this study is to examine gastric emptying and satiety hormones after oral
      glucose stimulation in 2 different concentrations in normal-weight and obese patients.
    


Intervention name(s): Placebo; Glucose 25g; Glucose 10g
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: glucagon-like peptide-1; peptide tyrosine tyrosine; ghrelin; stomach; small intestine; gastric emptying
Coping Skills Training (CST) for Children With Chronic Health Conditions
Condition: Rheumatologic Conditions (JRA,Lupus); Epilepsy; Spina Bifida; Asthma
MeSH terms: Asthma; Epilepsy; Spinal Dysraphism; Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      Purpose of the study The purpose of this study is to pilot an adapted Coping Skills Training
      (CST) intervention for feasibility and preliminary efficacy with a sample of children 8 to 12
      years of age and their parents. The participants in this study at Children's Hospital of
      Wisconsin are dealing with one of three chronic health conditions (Rheumatologic Conditions,
      Epilepsy,Spina Bifida, and Asthma).

      Research Questions/Study Aims

      The research questions addressed in the full study are:

        1. What is the impact of CST on child depression, QOL, health motivation, attitude toward
           illness, and self-management efficacy?

        2. What is the impact of CST on parent depression, perception of child's quality of life,
           perception of impact of CHC on family, and family conflict?
    

Detailed description: 
      Many children with chronic health conditions (CHC) are at increased risk for poor adaptation
      such as psychosocial problems, behavioral disturbances, and decreased quality of life (QOL).
      Their parents face economic, social and emotional challenges. In addition, management of the
      CHC and the involvement of the child in that management can severely challenge both child and
      parent. Effective coping has been shown to moderate the negative impact of CHC. This study is
      a pilot study to evaluate the feasibility and preliminary efficacy of adapting a Coping
      Skills Training (CST) intervention developed for children with diabetes. The CST intervention
      will be adapted for an integrated sample of school-aged children 8 to 12 years of age with
      four health conditions (Rheumatologic Conditions, Epilepsy,Spina Bifida, and Asthma). The
      study will be a randomized clinical trial with a wait-list control group. Each arm will
      consist of 25 families. CST is a 6-session group intervention based on cognitive behavioral
      and learning theory. The impact of CST on both outcomes (child: depression, QOL; parent:
      depression, Child QOL, CHC impact on family) and protective factors (child: health
      motivation, attitude, self-management efficacy; parent: family conflict) will be measured.
    

Intervention name(s): Coping Skills Training
Intervention type(s): Behavioral
Intervention description(s): 6 session behavioral program
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Coping; psychosocial; Quality of Life; problem solving
The Efficacy and Safety of Tacrolimus in Refractory Rheumatoid Arthritis Patients for 6 Months and Long-term Treatment
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is designed to observed prospectively the efficacy and safety of 6 months and
      long-term treatment of Tacrolimus alone or with methotrexate (MTX) in moderate and severe
      Chinese RA patients who shown insufficiency response or intolerance to DMARDs
    

Detailed description: 
      This study will enroll 150 cases of refractory rheumatoid arthritis (RA) patients in
      Chinese，who are in moderate or severe disease activity and insufficiency response or
      intolerance to DMARDs. The participants plan to be treated with Tacrolimus alone, or along
      with methotrexate (MTX) if participants were tolerant to MTX. The efficacy and safety of 6
      month Tacrolimus treatment in RA patients will be evaluated with DAS28 and other disease
      activity indices.
    

Intervention name(s): Tacrolimus; MTX
Intervention type(s): Drug; Drug
Intervention description(s): Tacrolimus capsule: 0.5mg to 1mg, po, twice per day (Bid)，adjusted by its concentration in blood or due to patient response. Then may titer down until the endpoint.; MTX：5mg to 15mg, po, once per week (Qw) until the endpoint or adjusted due to unacceptable toxicity develops.
Other intervention name(s): FK506; methotrexate
Intervention MeSH terms: Methotrexate; Tacrolimus
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Arthritis, Rheumatoid; Tacrolimus; Treatment outcome; Safety
The Role of Vitamin D3 in Pediatric Bronchiectasis Severity
Condition: Cystic Fibrosis and Non CF Bronchiectasis
MeSH terms: Cystic Fibrosis; Bronchiectasis
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Vitamin D3 therapy was effective in decreasing the frequency of pulmonary exacerbations and
      preserving lung functions , thereby improving the disease severity even more in non CF than
      CF bronchiectasis patients
    

Detailed description: 
      Objectives: To compare the effect of vitamin D3 on modifying the disease severity in CF and
      non CF bronchiectasis pediatric patients.

      Patients and Methods: This was a randomized clinical trial evaluating the role of oral
      vitamin D3 supplementation for 6 months in forty patients with CF and non CF bronchiectasis
      under the age of 18 years with vitamin D deficiency or insufficiency . The primary outcome
      was to reach the sufficient Vitamin D level. The secondary outcome was to follow up the
      frequency of pulmonary exacerbations and lung function after vitamin D3 supplementation.
    

Intervention name(s): Cholecalciferol (vitaminD3)
Intervention type(s): Drug
Intervention description(s): Theraputic vitamin D3 for CF and non CF bronchiectasis children
Intervention MeSH terms: Cholecalciferol; Vitamin D
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Functional Remediation for Bipolar Disorder
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Interventional

Summary: 
      Bipolar disorder is a severe, chronic and recurrent illness, that affects nearly the 5% of
      the population. Recent research point at the relevance and persistence of cognitive
      dysfunctions in bipolar patients even beyond the acute phases, although cognitive impairment
      has been classically associated with schizophrenia and not bipolar disorder. Current findings
      suggest that some intervention is needed in order to improve not only affective symptoms but
      also cognitive dysfunctions, so that patients could benefit from cognitive remediation
      techniques to improve cognitive impairment and the functional outcome. There is no previous
      research on the efficacy of cognitive remediation programs on bipolar disorder.
    

Detailed description: 
      The method consists of a randomized clinical trial with 3 arms: 1) one group (n=66) will
      receive a cognitive rehabilitation program + pharmacological treatment, 2) another group
      (n=66) will receive a psychoeducation program + pharmacological treatment, and 3) a control
      group (n=66) will only receive pharmacological treatment. A psychopathological,
      neuropsychological and functional assessment will be administered pre and post-intervention
      and a 12-month follow-up to assess the long term effects of the intervention.
    

Intervention name(s): Functional remediation; Psychoeducation; Treatment as usual
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The functional remediation program is composed of 21 weekly sessions of 90 minutes, each aimed at improving the following cognitive domains: attention, memory and executive functions and psychosocial functioning.
The program will be performed in an 12- to 15-patient group conducted by 2 experienced neuropsychologists with previous experience with bipolar patients and specific training on patients' group management.; Group psychoeducation is a tested and manualized intervention consisting of 21 weekly sessions of 90 minutes aimed at improving 4 main issues: illness awareness, treatment adherence, early detection of prodromal symptoms and recurrences, and lifestyle regularity.; The patients will not receive any add-on psychosocial intervention. All patients will keep on receiving standard psychiatric treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: functional remediation; psychoeducation; neurocognition
Does the Relaxation Response Inhibit Acute Stress?
Condition: Healthy
Study type: Interventional
Phase: Phase 2

Summary: 
      The purposes of this study are:

        1. To examine molecular and biochemical changes, associated with the relaxation response
           (RR) that can counteract the effects of stress in healthy adults.

        2. To compare genomic, molecular and biochemical parameters between healthy adults with a
           long term meditative practice and those with no experience in meditation.

      Since stress is a factor in the development of many health conditions, a further
      understanding of the mechanisms of the RR should be developed. The project is designed to
      determine how the RR can improve the quality of life that has been adversely affected by
      stress.
    

Detailed description: 
      The purposes of this study are:

        1. To examine molecular and biochemical changes, associated with the relaxation response
           (RR) that can counteract the effects of stress in healthy adults.

        2. To compare genomic, molecular and biochemical parameters between healthy adults with a
           long term meditative practice and those with no experience in meditation.

      Since stress is a factor in the development of many health conditions, a further
      understanding of the mechanisms of the RR should be developed. The project is designed to
      determine how the RR can improve the quality of life that has been adversely affected by
      stress.
    

Intervention name(s): relaxation response- meditation
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Health Services Research
Keywords: nitric oxide, volumetric oxygen consumption
A Pilot Study of KPL-914 in Recurrent Pericarditis
Condition: Recurrent Pericarditis
MeSH terms: Pericarditis; Recurrence
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the preliminary efficacy and safety of KPL-914
      treatment in participants with recurrent pericarditis.
    

Detailed description: 
      This is an open-label, single-arm pilot study to explore clinical and biochemical endpoints
      of pericarditis symptomatology and to collect data to assess inter- and intra-subject
      variability on both at-baseline and on-treatment parameters. This study consists of 5
      distinct Parts, and all participants will be treated with once-weekly subcutaneously
      (SC)-administered injections of KPL-914.There is an optional 18-week extension period.
    

Intervention name(s): KPL-914
Intervention type(s): Drug
Intervention description(s): KPL-914 (rilonacept) will be provided in its commercially available formulation as a lyophilized powder to be reconstituted for SC administration.
Adult participants (≥ 18 years of age) KPL-914 will be administered as an initial loading dose of 320 mg SC, delivered as 2 subcutaneous injections of 160 mg SC each on Day 0, then 160 mg SC dosed once weekly for 5 subsequent weeks.
Pediatric participants (6 to <18 years of age) KPL-914 will be administered with an initial loading dose of 4.4 mg/kg, up to a maximum of 320 mg, delivered as 2 subcutaneous injections of 2.2 mg/kg each with a maximum single-injection volume of 2 mL.
Participants considered to be 'treatment responders' will be offered participation in an optional 18-week extension period (EP) in which KPL-914 can be continued for a total duration of KPL-914 treatment of up to 24 weeks.
Other intervention name(s): rilonacept
Intervention MeSH terms: Rilonacept
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Early Treatment Stratification Based on PET Scan Response to Chemotherapy in Patients With Diffuse Large B-cell Lymphoma
Condition: Diffuse Large B-cell Lymphoma; Follicular Grade 3B Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell; Lymphoma, Large B-Cell, Diffuse
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to evaluate the event free survival at three years in patients with
      diffuse large B-cell lymphoma with poor prognostic factors receiving R-MegaCHOP as induction
      therapy. Patients with positive PET after three cycles of R-MegaCHOP receive early salvage
      treatment with R-IFE and autologous stem cell transplantation. Patients with negative PET
      after three cycles of R-MegaCHOP are treated with three additional cycles of R-MegaCHOP
      without transplant.
    

Detailed description: 
      In addition to the above:

        -  To evaluate the overall survival after three years.

        -  To determine the rate of global responses and complete remissions, uncertain and
           partial.

        -  To determine the duration of the complete response after the treatment termination.

        -  To carry out an exploratory follow up of the event free survival and the overall
           survival at 5 years.

        -  To evaluate the treatment toxicity according CTC criteria (version 3.0) of the National
           Cancer Institute (NCI).

        -  To asses the role of PET in the disease stage and response evaluation compared to CAT.

        -  To identify the predictable response factors after 6 cycles of treatment with R-MegaCHOP
           administrated every 21 days; or 3 cycles of R-MegaCHOP, followed by IFE+TAPH in patients
           with DLBCL of severe prognosis.

        -  To evaluate the therapeutic fulfillment of the R-MegaCHOP and R+IFE cycles of treatment
           and/or R-IFE in reference with delays with the cycles administration and reductions of
           the chemotherapy dose (planned dose administrated in the planned term).
    

Intervention name(s): R-MEGACHOP
Intervention type(s): Drug
Intervention description(s): If PET + after third cycle: 2 cycles of R-IFE followed by PBSCT
If PET - after third cycle: 3 additional cycles of R-MegaCHOP - R-MegaCHOP: cycles every 21 days RITUXIMAB Dosage: 375mg/m2, IV, day 1 CICLOPHOSPHAMIDE Dosage: 1500 mg/m2, IV, day 1 DOXORUBICIN Dosage: 65 mg/m2, IV, day 1 VINCRISTIN: Dosage 1.4 mg/m2 (max. 2.0 mg/m2, IV, day 1 PREDNISONE Dosage: 60 mg/m2, IV, day 1-5
R-IFE: 2 cycles every 21 days:
IFOSFAMIDE Dosage: continuous perfusion of 10 gr/m2/iv during 72 hours. Therefore, 3.33 gr/m2/corporal weight 24 hours day +1, +2 and +3.
ETOPOSIDE Dosage: total 900 mg/m2, IV, which is 150 mg/m2 during 12 hours (days +1, +2 and +3).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: DLBCL; PET; IPI; R-MegaCHOP; Autologous stem cell transplantation