bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Dynamic Sitting on Pain Development
Condition: Lower Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      Worksite based prolonged static sitting postures can cause musculoskeletal pain. While the
      development of pain increases due to the constant growth of digitalization at work, numerous
      interventions to reduce prolonged sitting periods have been created. The effects of such
      interventions have not yet been properly examined. Thus, the "DynSit-Pain" project was
      initiated to investigate the influence of dynamic sitting on the pain development of pain
      developers in office environments.
    

Detailed description: 
      This clinical investigation is a prospective, randomized, controlled, counter-balanced,
      two-arm field study investigating the effect of dynamic sitting on musculoskeletal pain in
      office workers classified as pain developers.

      The study consists of a pre-screening visit and 4 assessment days / visits. During this
      pre-screening visit and after proving the study eligibility (inclusion / exclusion criteria),
      half of the study participants will randomly be allocated to one of the two study arms.
      Depending on the arm allocation, participants will receive a dynamic (= intervention) or
      static (= control) office chair for 6 weeks. After a wash-out of at least 4 weeks the 6-week
      intervention resp. control will be switched. The randomization will be realized with opaque
      envelopes.

      Overall participants will execute the identical assessments within the control and the
      intervention chair group. The wash-out phase between the control and the intervention periods
      will ensue identical baseline conditions for both chairs. The overall duration of study
      participation amounts to 16 weeks.
    

Intervention name(s): Dynamic office chair
Intervention type(s): Device
Intervention description(s): The dynamic office chair has a typical office chair design (e.g. seat pan and a lumbar support). The seat pan is mounted on a flexible mechanic construction that allows hip movements in the frontal plane while sitting.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Sedentary Behavior; Occupational Diseases; Pain Developer; Lower Back Pain; Office Environments
A Clinical Proof-of-principle Trial in Adult Subjects With Newly Diagnosed Type 1 Diabetes Mellitus Investigating the Effect of NNC0114-0006 and Liraglutide on Preservation of Beta-cell Function
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial is conducted globally. The aim of this trial is to assess the clinical
      proof-of-principle of NNC0114-0006 and liraglutide on preservation of beta-cell function in
      adult subjects with newly diagnosed type 1 diabetes mellitus.
    


Intervention name(s): NNC0114-0006; liraglutide; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): NNC0114-0006 12 mg/kg administered i.v (intravenously) every 6 weeks. Subjects will continue their pre-trial insulin treatment; Liraglutide 1.8 mg administered s.c. (subcutaneously) daily. Subjects will continue their pre-trial insulin treatment; Placebo administered s.c (subcutaneously) or i.v ( intravenously). Subjects will continue their pre-trial insulin treatment
Intervention MeSH terms: Liraglutide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of ChimeriVax™ Dengue Tetravalent Vaccine in Adult Subjects
Condition: Dengue; Dengue Fever; Dengue Hemorrhagic Fever; Dengue Virus
MeSH terms: Dengue; Hemorrhagic Fevers, Viral; Severe Dengue; Fever; Hyperthermia
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate effect of previous flavivirus exposure on the safety and immunogenicity of the
      ChimeriVax™ dengue tetravalent vaccine

      Primary Objectives:

        -  To describe the safety of one injection of ChimeriVax™ dengue tetravalent vaccine.

        -  To describe the immune response against dengue before and after one injection of
           ChimeriVax™ dengue tetravalent vaccine
    

Detailed description: 
      This study will evaluate a dengue tetravalent vaccine formulation in subjects aged 18 to 40
      years and previously immunised with a dengue or YF vaccine.
    

Intervention name(s): Chimeric dengue serotype (1, 2, 3, 4); Chimeric dengue serotype (1, 2, 3, 4); Chimeric dengue serotype (1, 2, 3, 4)
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 0.5 mL, Subcutaneous, 1 dose; 0.5 mL, Subcutaneous, 1 dose; 0.5mL, Subcutaneous, 1 dose
Other intervention name(s): ChimeriVax™ Dengue Tetravalent Vaccine; ChimeriVax™ Dengue Tetravalent Vaccine; ChimeriVax™ Dengue Tetravalent Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Dengue; Dengue fever; Dengue hemorrhagic fever; Dengue virus
Effects of Chiropractic Care in Patients With Hip Osteoarthritis
Condition: Hip Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Hip
Study type: Interventional

Summary: 
      The purpose of the study is to explore the short term effects of chiropractic care on pain
      and function in patients with hip osteoarthritis.
    

Detailed description: 
      Research over the last years have reported a scarce of trails investigating chiropractic
      treatment of lower extremities. Osteoarthritis, also called joint failure, is a common
      rheumatic joint disease often affecting the hipjoint, contributing to pain, decreased
      mobility and loss of function. Individuals with osteoarthritis can also be affected in many
      other ways, e.g. economically, socially and emotionally.

      Chiropractic care may be considered as a complement to the conventional allopathic treatment
      of hip osteoarthritis. Joint manipulation is a well-established treatment technique to
      restore optimal joint function of the locomotor system. The aim of the study is to explore
      the effects of chiropractic vs. continued conventional care (waiting list controls) on pain
      and function during a three week trail period among patients with hip osteoarthritis waiting
      for arthroplasty.
    

Intervention name(s): Chiropractic care
Intervention type(s): Other
Intervention description(s): Clinical examinations and treatments were performed at the outpatient clinic. The patients were assessed and treated by research assistants and the clinical care was supervised by state registered chiropractors. The choice of therapy and modality was pragmatic and based on the analysis of different functions such as mobility, tenderness, muscle tension and tone, and each patient's relative symptoms. Chiropractic care included high-velocity and low-amplitude techniques, soft-tissue or myofascial techniques, and arthrokinematic stabilizing exercises or a combination of these. Patients were treated in 1-2 sessions per week during the trial.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: chiropractic; hip osteoarthritis; hip arthroplasty; pain; activities of daily living.
Capecitabine in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of capecitabine in treating patients who
      have metastatic prostate cancer that has not responded to hormone therapy.
    

Detailed description: 
      OBJECTIVES: I. Determine the efficacy of capecitabine in terms of PSA response, PSA response
      duration, and time to PSA progression in patients with metastatic hormone refractory prostate
      cancer. II. Evaluate the toxicity of this treatment in these patients. III. Evaluate the
      correlation between PSA response and quality of life in these patients.

      OUTLINE: This is a multicenter study. Patients receive oral capecitabine twice daily on days
      1-14. Treatment continues every 21 days for up to 8 courses in the absence of disease
      progression or unacceptable toxicity. Quality of life is assessed on days 1 and 8 of the
      first course of treatment, on day 1 of each course thereafter, and at treatment failure.
      Patients are followed every 3 months until disease progression.

      PROJECTED ACCRUAL: A total of 14-25 patients will be accrued for this study.
    

Intervention name(s): capecitabine
Intervention type(s): Drug
Intervention MeSH terms: Capecitabine
Primary purpose: Treatment
Keywords: stage IV prostate cancer; recurrent prostate cancer
The Effect of Holistic Corrective Exercise Program
Condition: Kyphosis Thoracic
MeSH terms: Kyphosis
Study type: Interventional

Summary: 
      This study was planned to investigate the effect of holistic approach corrective exercise
      program on the degree of kyphosis, balance and quality of life in kyphotic adolescents. A
      holistic approach corrective exercise program including corrective exercises and postural
      perception training was applied to one group. Thoracic region focused exercise program was
      applied to the other group. The programs of the exercise groups were applied three days a
      week, for 12 weeks. The kyphosis angle of all individuals participating in the study was
      evaluated using the flexible ruler, the Romberg index measured with balance pedobarography,
      and the quality of life using the Scoliosis Research Society-22 Questionnaire (SRS-22). In
      our study, a decrease in the degree of kyphosis was detected in the holistic approach
      corrective exercise and thoracic region-focused exercise group after 12 weeks of exercise
      training (p<0.001), while no change was observed in the control group (p>0.05). Balance
      improved after exercise training in the holistic corrective exercise group (p=0.006). The
      quality of life increased in the holistic approach corrective exercise and thoracic region
      focused exercise groups after the training (p<0.001). The use of postural perception training
      together with corrective exercise programs in applications for thoracic kyphosis reveals a
      holistic approach and may increase the effect of the intervention.
    


Intervention name(s): Holistic Corrective Exercise Program; Thoracic exercise program
Intervention type(s): Behavioral; Other
Intervention description(s): A holistic approach corrective exercise program including corrective exercises and postural perception training,; Thoracic region focused exercise program
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluate the Pharmacokinetics of BAT2606 Injection in Healthy Chinese Male Subjects
Condition: Severe Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the pharmacokinetics, safety and immunogenicity of BAT2606 in healthy China male
      subjects.
    

Detailed description: 
      This is a single-center, randomized, double-blind, single-dose, parallel three arms
      comparative study of pharmacokinetics, safety and immunogenicity.
    

Intervention name(s): Mepolizumab Injection (BAT2606 Injection); Mepolizumab Injection (EU-licensed Nucala); Mepolizumab Injection (US-licensed Nucala)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): In this group, each subject will receive single subcutaneous injection of 100 mg BAT2606 Injection.; In this group, each subject will receive single subcutaneous injection of 100 mg Mepolizumab Injection (EU-licensed Nucala®).; In this group, each subject will receive single subcutaneous injection of 100 mg Mepolizumab Injection (US-licensed Nucala®).
Other intervention name(s): BAT2606 Injection; EU-licensed Nucala; US-licensed Nucala
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: It's a randomized, double-blinded, single-dose, 3-arm parallel comparative study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study on the Influence of Electroconvulsive Therapy (ECT) on Homocysteine Levels
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 4

Summary: 
      Elevated homocysteine levels are associated with depression and cognitive impairment. When
      depression ameliorates due to treatment, homocysteine serum levels often normalize. Aim of
      the present study is to investigate, whether repeated ECT treatment leads to changes in
      homocysteine levels and if these changes are associated with the occurrence of cognitive
      impairment after ECS.

      10 patients suffering from therapy-resistant depression shall be enrolled. Patients are
      treated with repeated ECT (three times the week). Before, directly after and one day after
      ECT treatment, blood samples are drawn and patients receive cognitive testing. Depressive
      symptomatology is checked with different rating scales.
    

Detailed description: 
      BACKGROUND:

      Elevated homocysteine levels have been found in depressive disorders. The modulating effects
      of homocysteine on glutamatergic neurotransmission have been discussed to be an underlying
      cause of depression and can also lead to cognitive impairment and may facilitate seizures.
      Electroconvulsive therapy is the most effective treatment for depression, but often leads to
      cognitive impairments.

      HYPOTHESIS:

      Homocysteine levels normalize during rECT. This normalization is associated with the clinical
      improvement of depression. Short term changes in homocysteine levels (i.e. increase directly
      after ECT) may explain the cognitive impairments of the patients.

      METHOD:

      10 patients with therapy-resistant depressive disorder are to be enrolled into the trial.
      Patients are treated with rECT, two to three times a week. Blood withdrawal and psychometric
      analysis will be performed before, directly after and one day after ECT treatment
      1,4,7,10,(13). Necessity of further treatment will be checked after the first 6 ECTs.
    

Intervention name(s): ECT treatment
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: ect; depression; homocysteine; mthfr genotype
Care Coordination and Proactive Care to Improve Utilization of Resources and Reduce Expenditure in High Risk Inflammatory Bowel Disease (IBD) Patients
Condition: Inflammatory Bowel Diseases
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases
Study type: Interventional

Summary: 
      The study team performed a randomized controlled trial to evaluate the efficacy of a care
      coordination intervention composed of proactive symptom monitoring and algorithm-based
      triggers to improve patient reported outcomes (PROs) and healthcare expenditures for
      high-risk patients with IBD. Enrolled patients with IBD were randomized to proactive symptom
      monitoring with the support of a care coordinator or usual care.
    


Intervention name(s): Proactive Symptom Monitoring and Care Coordination
Intervention type(s): Behavioral
Intervention description(s): Patients randomized to the intervention arm were assigned an IBD-focused care coordinator who facilitated a symptom-based monitoring algorithm and supported patient navigation to complement usual care. Symptom monitoring was facilitated through regular push notifications to participants to complete a validated PRO instrument through the Epic EMR patient portal or telephone. These notifications were scheduled on a monthly basis. The IBD-focused care coordinator made two attempts to reach each participant using portal messaging, followed by a phone call to reduce non-response. PRO questionnaires were reviewed by the care coordinator and out of range scores triggered algorithm-based recommendations to the IBD specialist including stricter monitoring of disease activity, behavioral and medication adherence counseling, facilitation of expedited follow-up with treating providers, and referrals to social work, mental health, and gastroenterology-specific behavioral health services.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Enhancing Heart Failure Self-Care
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      To test the effectiveness of a motivational intervention compared with standard patient
      education in improving economic and clinical outcomes in patients enrolled in an existing
      heart failure (HF) disease management program.
    


Intervention name(s): telephone management plus a motivational intervention; telephone management with standard patient education
Intervention type(s): Other; Other
Intervention description(s): heart failure intervention; heart failure intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: motivational therapy
A Study to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Pelacarsen (ISIS 681257) in Healthy Japanese Participants
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the safety, tolerability, and pharmacokinetics (PK) of
      single and multiple subcutaneous (SC) doses of Pelacarsen (ISIS 681257) in healthy Japanese
      participants.
    

Detailed description: 
      This was a randomized, placebo-controlled, participant and investigator-blinded, single
      ascending and multiple-dose study of Pelacrsen (ISIS 681257) in up to 29 healthy Japanese
      male and female participants. The study was conducted in two parts:1) Single ascending dose
      (SAD) including up to a 28-day screening period, a baseline period, dose with study drug on
      Day 1, a 2-day (48 hours) post-dose in-patient observation period, followed by an out-patient
      observation period up to Day 90; 2) Multiple doses (MD) including up to a 28-day screening
      period, a baseline period, dose with study drug up to Day 85, a 2-day (48 hours) post-dose
      in-patient observation period, followed by an out-patient observation period up to Day 204.

      In the SAD period, participants were randomized to receive single dose of Pelacarsen or
      placebo.

      Upon completion of the SAD period participants were randomized to receive multiple doses of
      Pelacarsen.
    

Intervention name(s): Placebo; Pelacarsen
Intervention type(s): Drug; Drug
Intervention description(s): Pelacarsen-matching placebo administered by SC injection.; Pelacarsen administered by SC injection.
Other intervention name(s): AKCEA-APO(a)-LRx; TQJ230; ISIS 681257
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Motion Style Acupuncture Treatment for Low Back Pain With Severe Disability
Condition: Complete Immobility Due to Severe Physical Disability
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Motion style acupuncture treatment(MSAT) is a treatment method in which the patient is
      exposed to active or passive movement and exercise during acupuncture, as opposed to
      conventional acupuncture. The purpose of this study is to investigate the effect of MSAT in
      the treating pain and severe functional disability in acute LBP patients.
    

Detailed description: 
      58 patients with acute LBP and severe disability with an Oswestry Disability Index(ODI) of
      60% or higher were randomly allocated and divided into 2 groups. The experimental group was
      treated with MSAT and the control group was treated with intramuscular injections of
      diclofenac(NSAID). All administrations were limited to 1 session, and comparisons were made
      of measurements before and after treatment. Primary outcomes were measured by the
      NRS(numerical rating scale) of back pain in active movement. Secondary outcomes were measured
      by the NRS of radiating pain, ODI scores, and the patient's global impression of change(PGIC)
      etc. Post-treatment follow-up will be performed to measure primary and secondary outcomes
      with the exception of ROM and SLR at 2, 4, and 24 weeks after treatment.
    

Intervention name(s): acupuncture, injection
Intervention type(s): Other
Intervention description(s): MSAT and intramuscular injections of diclofenac(NSAID)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acute low back pain; motion stlye acupuncture treatment; disability; MSAT
Use of Mobile Teledermatology in the Care of Acne Patients
Condition: Acne
MeSH terms: Acne Vulgaris
Study type: Interventional

Summary: 
      The purpose of the present study is to determine whether a mobile teledermatology care model
      can achieve better clinical outcomes as compared to conventional, outpatient care for the
      management of severe acne treated with isotretinoin.

      The superiority of mobile care in comparison to conventional, outpatient care will be
      investigated regarding

        1. effectiveness: Global evaluation Acne (GEA) score -response at week 24

        2. safety: drop out rates and medication side effects

        3. overall patient satisfaction with acne care and therapy

        4. overall physician satisfaction with mobile acne care
    


Intervention name(s): Mobile Teleconsultation Arm (MTA); Outpatient Consultation Arm (OCA)
Intervention type(s): Other; Other
Intervention description(s): In addition to a face-to-face visit at baseline, patients will conduct "mobile visits" at home every two weeks. The general practitioner of choice will perform examinations, such as laboratory or occasionally pregnancy tests every 4 weeks according to the treatment guidelines.; Patients will receive routine outpatient care at the clinic according to the treatment guidelines, and will be scheduled for outpatient visits every 4 weeks.
Other intervention name(s): MTA; Health Care Service Modality; OCA; Health Care Service Modality
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Mobile Teledermatology; Telemedicine; Acne