bioihbjkbjnl/mcl2 huggingface dataset:
Yoga Intervention to Improve Pediatric Cancer Patients' Sleep & Life Quality and Parents' Well-Being
Condition: Neoplasms
Study type: Interventional

Summary: 
      The proposed project will examine feasibility and preliminary efficacy of a yoga intervention
      in the pediatric oncology unit at Connecticut Children's Medical Center (CCMC) and includes
      two parts: (1) a survey of children and parents regarding preferences (e.g., convenient
      days/times), experiences and expectations regarding yoga (including barriers and positive
      expectancies) and (2) an eight week clinical trial of a yoga intervention in 10 pairs of
      children and parents.
    

Detailed description: 
      The specific aims and hypotheses for this seed grant are to collect and assess data on:

      Aim 1 feasibility - perceived barriers/solutions, interest and accrual rates, attendance per
      session, participant retention, evidence of institutional support and resource commitment
      Hypothesis 1: A yoga intervention is feasible among pediatric oncology patients and their
      parents; (2) preliminary efficacy - including effect sizes for calculating power Hypothesis
      2a: A yoga intervention improves pediatric oncology patients' fatigue, QOL, and sleep.

      Hypothesis 2b: A yoga intervention improves parental QOL and caregiver burden.

      We will be using the following questionnaires and scales to help answer the quesitons related
      to the hypotheses and aims:

      PedsQL 4.0 PedsQL 3.0 Cancer Module The Fatigue Scale SleepDiary Actigraphy data. Child Home
      Yoga Practice Diary Satisfaction survey

      Questionnaires noted below are given only to the parents:

      SF-12 Zarit Caregiver Burden Index Yoga Satisfaction Survey

      Study participants will have 4 yoga sessions and the questionnaires and surveys are done
      prior to the first yoga session and after the last yoga session.

      The yoga sessions are created with both the study participant and a certified yoga
      instructor. The patients are given the yoga routine to practice at home at their leisure.
    

Intervention name(s): Yoga
Intervention type(s): Other
Intervention description(s): There are 4 yoga sessions completed with a certified instructor during cancer treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Transcranial Direct Current Stimulation (tDCS) for Treatment of Negative Syndrome in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      Transcranial direct current stimulation (tDCS) showed beneficial effects on cognition in
      healthy subjects and depressed patients. In this study, patients with treatment resistant
      negative syndrome in schizophrenia will be treated with direct current stimulation. fMRI
      measures will be performed.
    


Intervention name(s): eldith DC-stimulator (neuroconn, Ilmenau, Germany); eldith DC-stimulator (Neuroconn, Ilmenau, Germany)
Intervention type(s): Device; Device
Intervention description(s): daily tDCS treatment over left DLPFC, 20 min, 2 mA; same as sham stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: schizophrenia; negative syndrome; PANSS
GnRH Agonist Pretreatment in Hysteroscopic Myomectomy
Condition: Uterine Myoma
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional

Summary: 
      The primary outcome of this study is to assess if the GnRHa administration before cold loop
      hysteroscopic myomectomy contributes to accomplish the treatment in only one surgical
      procedure. Moreover, we will investigate the intraoperative influence of such pharmacologic
      therapy in terms of distension liquid absorption and duration of the procedures.
    


Intervention name(s): Triptorelin 3.75 mg
Intervention type(s): Drug
Intervention MeSH terms: Triptorelin Pamoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Uterine myoma; GnRHa; Hysteroscopy; Cold loop
Pilot Study of Ensifentrine or Placebo Delivered Via pMDI in Hospitalized Patients With COVID-19
Condition: Coronavirus Infection; Covid-19; SARS-CoV-2
MeSH terms: COVID-19; Coronavirus Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This pilot study is being performed to assess the efficacy and safety of inhaled ensifentrine
      delivered via pMDI compared with a matching placebo in conjunction with standard of care
      treatments on recovery in patients hospitalized due to COVID-19 infection.
    

Detailed description: 
      Expploratory endpoint, pilot study, not statistically powered

      go to protocol
    

Intervention name(s): Ensifentrine Dose 1; Placebo pMDI
Intervention type(s): Drug; Drug
Intervention description(s): Study drug delivered twice daily via pMDI; Placebo delivered twice daily via pMDI
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Amyloid Imaging and Cognitive Impairment After Intracerebral Hemorrhage
Condition: Intracerebral Hemorrhage
MeSH terms: Cerebral Hemorrhage; Amyloidosis; Hemorrhage; Cognitive Dysfunction
Study type: Interventional

Summary: 
      To evaluate Pet AV-45 Amyloid imaging in the etiological diagnosis of primary non traumatic
      intracerebral hemorrhage (Cerebral Amyloid Angiopathy and hypertension related hemorrhage).We
      hypothesize that patients with lobar hemorrhage (probably related to Cerebral Amyloid
      Angiopathy) will have a greater AV45 cortical binding than patients with deep hemorrhage
      (probably related to hypertension).
    

Detailed description: 
      Cerebral Amyloid Angiopathy (CAA) and hypertension related hemorrhage are the main causes of
      non traumatic primary intracerebral hemorrhage. In vivo diagnosis of these two cerebral
      diseases may be difficult and is based on hematoma location and pattern of cerebral
      microbleeds (CMB) distribution. We aimed to evaluate a multimodal approach including brain
      MRI, Pet AV-45 Amyloid imaging and neuropsychological assessment to improve etiological
      diagnosis of primary intracerebral hemorrhage. 70 patients with acute primary non traumatic
      intracerebral hemorrhage will be prospectively included and two groups will be compared:
      lobar hemorrhage group and deep hemorrhage group. Brain MRI, Pet AV-45 Cerebral Amyloid
      imaging (during the first month) and neuropsychological assessment (Three months later) are
      performed. Differences between the two groups are evaluated for AV45 cortical binding, CMB
      distribution, White Matter Lesions and cognitive profile.
    

Intervention name(s): Pet AV-45
Intervention type(s): Other
Intervention description(s): AV-45 (Florbetapir F 18) : Bolus of 5 MBq/kg IV ; A 10-minutes Pet scan acquisition Starts at 50 minutes after injection.
Other intervention name(s): PET AV-45 (Florbetapir F 18) Cerebral Amyloid imaging
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Intracerebral Hemorrhage; Cerebral Amyloid angiopathy; Amyloid imaging; 18F-AV-45
Etanercept and Celecoxib Alone/Combined Treatment in Effectiveness and Safety of Active Ankylosing Spondylitis
Condition: Ankylosing Spondylitis
MeSH terms: Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a multi-center, open label, randomized clinical trial of etanercept and celecoxib
      alone/combined treatment in effectiveness and safety on active ankylosing spondylitis (AS).
      Subjects will be randomly assigned in a 1:1:1 ratio to one of the three groups (celexocib
      200mg bid, etanercept 50mg qw, etanercept plus Celecoxib group) for 54 weeks. Primary
      endpoints are the magnetic resonance imaging (MRI) Spondyloarthritis Research Consortium of
      Canada (SPARCC) score of sacroiliac(SI) joint and spine, as well as the Assessment of
      SpondyloArthritis International Society (ASAS)20 response rate at 52 weeks.
    

Detailed description: 
      A multi-center, open label, randomized clinical trial evaluating the effectiveness and safety
      of etanercept and celecoxib alone/combined treatment will be conducted on active ankylosing
      spondylitis (AS) patients. Disease activity is defined as fulfilling three aspects below:
      BASDAI ≥ 4 or ASDAS≥ 2.1；CRP>6 mg/L or ESR 28 mm/1st hour；more than 2 and less than 16
      syndesmophyts between cervical spine and lumber spine detected by X-ray. All patients were
      randomly assigned in a 1:1:1 ratio to one of the three treatment groups：celecoxib 200mg
      bid，etanercept 50mg qw and combined therapy for 52 weeks. Primary endpoints are the magnetic
      resonance imaging (MRI) Spondyloarthritis Research Consortium of Canada (SPARCC) score of
      sacroiliac(SI) joint and spine, as well as the Assessment of SpondyloArthritis International
      Society (ASAS) 20 response rate at 52 weeks. Key secondary Endpoints include the modified
      Stoke Ankylosing Spondylitis Spine Score (mSASSS), Spondyloarthritis Research Consortium of
      Canada (SPRACC) SI joint structural score (SSS), BASDAI, ASDAS, ASAS40, ASAS70 and ASAS5/6
      response rate at 52 weeks.
    

Intervention name(s): celebrex; Enbrel; Enbrel plus Celebrex
Intervention type(s): Drug; Drug; Drug
Other intervention name(s): celecoxib; etanercept; celecoxib plus etanercept
Intervention MeSH terms: Celecoxib; Etanercept
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: inflammation; etanercept; celecoxib; ankylsoing spondylitis
Evaluation of Tiotropium 2.5 and 5 mcg Once Daily Delivered Via the Respimat® Inhaler Compared to Placebo and Salmeterol HydroFluoroAlkane (HFA) Metered Dose Inhaler (MDI) (50 mcg Twice Daily) in Patient With Moderate Persistent Asthma I
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this trial is to evaluate the efficacy and safety of 2.5 and 5 mcg tiotropium over
      a 24-week treatment period as compared to placebo and salmeterol (50 mcg twice daily).
      Tiotropium inhalation solution delivered by the Respimat® inhaler will be examined on top of
      maintenance treatment with inhaled corticosteroid controller medication in patients with
      moderate persistent asthma. Efficacy and safety will be assessed by measuring effects on lung
      function, effects on asthma exacerbations, effects on quality of life, effects on asthma
      control, effects on health care resource utilisation, and number of adverse events.
    


Intervention name(s): Placebo; tiotropium Respimat® low dose; Placebo; Placebo; tiotropium Respimat® high dose; 50 mcg salmeterol HFA MDI; Placebo; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Placebo that represents comparator; IMP; Placebo that represents comparator; Placebo that represents comparator; IMP; Active comparator; Placebo that represents BI drug; Placebo that represents BI drug
Intervention MeSH terms: Tiotropium Bromide; Salmeterol Xinafoate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Metabolic Cost of Sandbag Training
Condition: Exercise Energy Expenditure
Study type: Interventional

Summary: 
      This study aims at investigating the metabolic cost of several fundamental exercises with
      sandbag. Sandbag training has become a popular training modality that is efficiently used to
      improve cardiovascular status and physical performance. Despite its widespread use and
      popularity the metabolic cost of exercises using sandbag remains to be elucidated. Therefore,
      the metabolic cost of various fundamental exercise with sandbag will be determined to aid the
      planning of exercise training programs.
    

Detailed description: 
      Ten healthy young adults will be assigned to this study. Participants will initially undergo
      a baseline assessment of their anthropometrics, body composition (by DXA), resting metabolic
      rate (RMR), cardiorespiratory fitness (VO2max), muscular strength [maximal strength (1RM) and
      muscular endurance] and functional capacity. After baseline screening, participants will
      execute in different days (one exercise per day) one set of each of the following 8 exercise:
      (1) lateral bag drag, (2) dead bag, (3) shoulder to shoulder thruster, (4) sumo DL with pull,
      (5) front lunge, (6) single leg RDL, (7) reverse lunge with rotation and (8) clean, in two
      different conditions: (i) 30 sec and (ii) 45 sec exercise duration, in a random order. Prior
      to each exercise resting heart rate, blood lactate concentration, oxygen consumption and rate
      of perceived exertion will be recorded. Heart rate and oxygen consumption (through portable
      gas analyzer) will be continuously monitored during the exercise and after the end of it,
      until the oxygen consumption reach the pre-exercise values (excess post-exercise oxygen
      consumption). Blood lactate and rate of perceived exertion will be reassessed post-exercise.
    

Intervention name(s): Sandbag exercise
Intervention type(s): Other
Intervention description(s): Both arms include an exercise intervention consisted of 8 different exercises with sandbag: (1) lateral bag drag, (2) dead bag, (3) shoulder to shoulder thruster, (4) sumo DL with pull, (5) front lunge, (6) single leg RDL, (7) reverse lunge with rotation and (8) clean
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Anaerobic energy expenditure; Functional training; Sandbag training; Excess post-exercise oxygen consumption; Aerobic energy expenditure
Phase 1 Dose Escalation and PK Study of Cu(II)ATSM in ALS/MND
Condition: Amyotrophic Lateral Sclerosis; Motor Neuron Disease
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Multicenter, open-label , single and multiple dose-escalation and pharmacokinetic study
    

Detailed description: 
      Multicenter, open-label, phase 1 study of Cu(II)ATSM administered orally to patients wit
      amyotrophic lateral sclerosis/motor neuron disease. The study will be conducted in three
      phases. In the first two phases, dose cohorts of six patients each will participate in a
      single dose pharmacokinetic study followed by a 28-day repeated daily dose study to establish
      the recommended phase 2 dose (RP2D). The first dose cohort will be treated at 3 mg/day;
      planned dose escalations are 6, 12, 24, and 48 mg/day, subject to observed safety
      assessments. In the third phase of the study, participants will be treated at the RP2D to
      confirm tolerability and assess preliminary evidence of efficacy.

      In both the dose escalation and expansion cohorts, once the first 28 days of treatment and
      assessments are completed, at the discretion of the investigator a patient may continue to
      receive Cu(II)ATSM treatment for a maximum of six 28-day treatment cycles.
    

Intervention name(s): Cu(II)ATSM
Intervention type(s): Drug
Intervention description(s): copper-containing synthetic small molecule
Other intervention name(s): diacetylbis(N(4)-methylthiosemicarbazonato) copper(II)
Intervention MeSH terms: Copper
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Aromatherapy Massage Applied on Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Aim: This study was conducted as a randomized controlled experimental study to examine the
      effect of abdominal massage with ginger and lavender oil on constipation in elderly
      individuals.

      Design: The study was completed with 40 elderly individuals in Kayseri nursing home,
      including 20 in intervention and 20 in control group who met the criteria for inclusion in
      the study. In the study, written informed volunteer consent was obtained from the individuals
      with the approval of the ethics committee and the permission of the institution.

      The elderly individuals in the intervention group underwent aromatherapy massage with ginger
      and lavender oils for a period of five days and 15 minutes on weekdays for four weeks
      according to the abdominal massage application protocol. No application was made to
      individuals in the control group.
    

Detailed description: 
      Aim: This study was conducted as a randomized controlled experimental study to examine the
      effect of abdominal massage with ginger and lavender oil on constipation in elderly
      individuals.

      Design: The study was completed with 40 elderly individuals in Kayseri nursing home,
      including 20 in intervention and 20 in control group who met the criteria for inclusion in
      the study. In the study, written informed volunteer consent was obtained from the individuals
      with the approval of the ethics committee and the permission of the institution. The data
      were collected by the researcher using the Questionnaire Form, Bristol Stool Scale, Rome IV
      Criteria, Constipation Severity Scale and Mini Mental Test.

      The elderly individuals in the intervention group underwent aromatherapy massage with ginger
      and lavender oils for a period of five days and 15 minutes on weekdays for four weeks
      according to the abdominal massage application protocol. No application was made to
      individuals in the control group. The "Bristol Stool Scale" and "Constipation Severity Scale"
      were re-applied to the individuals in the intervention and control group before, during the
      second week of practice and at the end of practice (fourth week).
    

Intervention name(s): Aromatherapy Massage
Intervention type(s): Other
Intervention description(s): The elderly individuals in the intervention group underwent aromatherapy massage with ginger and lavender oils for a period of five days and 15 minutes on weekdays for four weeks according to the abdominal massage application protocol.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Nurse; Elderly; Constipation; Aromatherapy; Abdominal Massage
Use of Compromised Lung Volume in Monitoring Usage of Steroid Therapy on Severe COVID-19
Condition: COVID-19 Pneumonia; Quantitative Computed Tomography
MeSH terms: COVID-19
Study type: Observational

Summary: 
      Since December 2019, the outbreak of coronavirus disease 2019 (COVID-19) has become a public
      health emergency of international concern. Although corticosteroid therapy represents a
      milestone in the management of COVID-19, many questions remain unanswered. The optimal type
      of corticosteroids, timing of initiation, dose, mode of administration, duration, and dose
      tapering are still unclear. An approach to resolve these issues is to develop accurate tools
      to assess or monitor the progression of COVID-19 during the corticosteroid therapy process.
      Quantitative computed tomography (QCT) analysis may serve as a tool for assessing the
      severity of COVID-19 and for monitoring its progress. However, the effect of steroids on
      quantitative chest CT parameters during the treatment process remains unknown. In this
      retrospectively study, we aimed to assess the association between steroid administration and
      QCT variables in a longitudinal cohort with COVID-19
    

Detailed description: 
      Since December 2019, the outbreak of coronavirus disease 2019 (COVID-19) has become a public
      health emergency of international concern. Although corticosteroid therapy represents a
      milestone in the management of COVID-19, many questions remain unanswered. The optimal type
      of corticosteroids, timing of initiation, dose, mode of administration, duration, and dose
      tapering are still unclear. An approach to resolve these issues is to develop accurate tools
      to assess or monitor the progression of COVID-19 during the corticosteroid therapy process.
      Quantitative computed tomography (QCT) analysis may serve as a tool for assessing the
      severity of COVID-19 and for monitoring its progress. However, the effect of steroids on
      quantitative chest CT parameters during the treatment process remains unknown. In this
      retrospectively study, we aimed to assess the association between steroid administration and
      QCT variables in a longitudinal cohort with COVID-19.
    

Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        From February 7, 2020 to February 17, 2020, consecutive patients with confirmed COVID-19
        admitted to the east campus of Renmin Hospital of Wuhan University were screened. The
        diagnosis of COVID-19 was based on the detection of SARS-CoV-2 nucleic acid by a real-time
        RT-PCR assay.
      
Keywords: Steroid; COVID-19; Quantitative computed tomography; Compromised lung volume
A Study Comparing Amounts of 2 Different Forms of Tafamidis (PF-6291826) in the Blood
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      2 different formulations and doses of tafamidis will be compared. All subjects will receive
      both doses/formulations. Subjects will take tafamidis for 7 days, on the first 2 days they
      will take tafamidis twice, 12 hours apart and then once a day for the next 5 days. Subjects
      will be fasted before taking the drug. Blood samples will be taken to measure the amount of
      tafamidis starting on day 7 and ending on day 8. At least 16 days after the first
      formulation/dose is given, all subjects will repeat the procedure with the other
      formulation/dose.
    


Intervention name(s): tafamidis
Intervention type(s): Drug
Intervention description(s): bioequivalence study
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science