bioihbjkbjnl/mcl2 huggingface dataset:
The Effects of Chiropractic Care in Adults With Subclinical Spinal Pain
Condition: Subclinical Spinal Pain
Study type: Interventional

Summary: 
      This study aims to investigate long term and retention (in a subgroup) effects of
      Chiropractic care (CC) on neurological, behavioral, immunological functions and
      health-related quality of life in adults with subclinical pain.
    

Detailed description: 
      There is growing evidence that chiropractic care positively impacts various aspects of
      central and autonomic nervous system function. A single session of chiropractic adjustment
      has shown to alter pre-frontal cortex (PFC) activity, but there is a lack of robust research
      investigating the long-term benefits of such PFC changes. This study aims to investigate long
      term and retention (in a subgroup) effects of Chiropractic care (CC) on neurological,
      behavioral, immunological functions and health-related quality of life in adults with
      subclinical pain. In these parallel-group randomized controlled trials, participants aged
      18-60 years with subclinical spinal pain will be randomly allocated to receive either 12
      weeks of CC intervention or control intervention. Primary outcomes include functional
      near-infrared spectroscopy, heart rate variability (HRV), serum Brain-Derived Neurotrophic
      Factors (BDNF) levels and resting-state electroencephalography (EEG). The secondary outcomes
      include PFC activity (measured by cognitive and behavioral testing), immune and inflammatory
      markers and health-related quality of life. As data collected in the project is a combination
      of extrinsic (sociodemographic, clinical questionnaires etc.) and intrinsic physiological
      data (physiological measures like EEG, HRV etc.), the machine learning or artificial
      intelligence (AI) will be used to help the development of optimal chiropractic care plans in
      future.
    

Intervention name(s): Chiropractic Care; Control Group
Intervention type(s): Other; Other
Intervention description(s): The actual force applied to the patient's spine depends on the chiropractor, the patient, and the spinal location of the subluxation, the general shape of the force-time history of spinal adjustments is very consistent and the duration of the thrust is always less than 200 milliseconds.; The participants head and/or spine will be moved in ways that include passive and active movements, similar to what is done when assessing the spine by a chiropractor. The sham intervention will also include the participants moving into adjustment setup positions similar to how the chiropractor would typically set up a patient with no joint pre-loading or adjustive thrust
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: research
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Subclinical Spinal Pain
Biodentine Versus White MTA Pulpotomy
Condition: Extensive Decay in Primary Molars
Study type: Interventional
Phase: Phase 3

Summary: 
      A clinical trial to evaluate and compare three different products used for endodontic
      treatment (taking the infected nerve out of the teeth) of primary teeth.

      Null Hypothesis: The new biological products (WMTA and Biodentine) behave as good as the
      former iodoform product.
    


Intervention name(s): Biodentine pulpotomy; White MTA pulpotomy; Tempophore pulpotomy
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Tranexamic Acid in Pregnant Women Undergoing Cesarean Section.
Condition: Cesarean Section Complications
Study type: Interventional

Summary: 
      Purpose to evaluate the effects of topical tranexamic acid (TA) on reducing post-partum
      hemorrhage in pregnant women with hemorrhagic cesarean section
    

Detailed description: 
      Uterine atony is the major cause of postpartum hemorrhage (PPH), accounting for up to 80% of
      PPH cases. PPH is the leading cause of maternal morbidity and mortality worldwide, resulting
      in up to 28% of maternal deaths. Therefore, inducing a rapid and effective uterine
      contraction following delivery is an important issue. The aim of the study is to To explore
      the efficacy and safety of temporary uterine packing combined with topical tranexamic acid
      (TA) as an adjunct for reducing blood loss during a hemorrhagic cesarean delivery (CD),
      compared with placebo.
    

Intervention name(s): Topical tranexamic acid; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): temporary uterine packing with gauze of the dimensions soaked with 2 gm tranexamic diluted in 60ml saline acid; 2 placebo ampoules to TA in 100 ml saline by slow infusion
Other intervention name(s): Active Comparator; Placebo comparator
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: open label Randomized Clinical Tria
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: cesarean section; tranexamic acid; postpartum hemorrhage; oxytocin
Reproductibility of Cystometry in Multiple Sclerosis Patient
Condition: Lower Urinary Tract Symptoms; Cystometry; Multiple Sclerosis; Overactive Bladder; Overactive Detrusor
MeSH terms: Multiple Sclerosis; Urinary Bladder, Overactive; Sclerosis; Lower Urinary Tract Symptoms
Study type: Observational

Summary: 
      This study evaluates the reproductibility (quantitative and qualitative) of cystometry in
      mutiple sclerosis patients.
    

Detailed description: 
      Some studies have evaluated the reproductibility of urodynamics in women with stress
      incontinence, and demonstrated a poor reproductibility of urodynamic parameters for a part of
      the studies and a good reproductibility for the others. There is only three studies
      investigating the reproductibility of repeated cystometries in patients with overactive
      detrusor and neurogenic lower tract dysfunction. The most common etiology in these studies is
      spinal cord injury. Only one article includes MS patients with lower urinary tract symptoms
      (22 patients among 226 with other etiologies).

      The aim of this study was to assess the short term reproductibility in multiple sclerosis
      patients with qualitative and quantitative urodynamic data.

      The authors conducted a prospective analysis in our Neuro-urology department of a University
      Hospital . All patient with Multiple Sclerosis referred for urinary disorders, coming for a
      urodynamic evaluation with multiple cystometries during the study were included if they had a
      detrusor overactivity for a filling of 300 ml or less on the first cystometry. The main
      exclusion criteria were a significate difference between the filling volume during the study
      and the volume truly of water truly collected after catheterization, an urinary tract
      infection, or an other acute disease.The investigators performed a first cystometry and
      looked for a detrusor overactivity, if the investigators discovered an involuntary detrusor
      contraction for a filling of 300 ml or less, the authors realized two others cystometries
      (filling rate of 50 mL/min) after informed consent. The volume and pressure at which the
      first and the maximal involuntary detrusor contraction, MCC were documented.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Multiple sclerosis patients with overactive detrusor consulting in neurobiology center.
      
Keywords: Overactive Detrusor; Multiple Sclerosis; Reproductibility; Cystometry
A Study of AAV-hAADC-2 in Subjects With Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Safety Study in subjects with Parkinson's Disease
    

Detailed description: 
      In a patient with Parkinson's disease, the part of the brain called the substantia nigra
      progressively loses the ability to send dopamine signals to the striatum.

      To compensate for the loss of striatal dopamine, most patients take L-dopa, an approved drug
      which is converted to dopamine by an essential enzyme - AADC.

      With time, however, the brain loses its remaining ability to convert L-dopa to dopamine and
      thus the drug becomes progressively less effective.

      In the therapy being studied, the gene coding for the enzyme that converts L-dopa to dopamine
      (AADC) is inserted into a common, non-pathogenic virus (AAV) to which > 90% of humans have
      been exposed.

      The AAV will help to transport the AADC into the brain cells.

      AAV-hAADC-2, the investigational drug being studied, is injected into the striatum during a
      surgical procedure.

      Patients who undergo the procedure would continue to take L-dopa; AAV-hAADC-2 is intended to
      provide, directly to the brain, the missing enzyme needed to convert L-dopa to dopamine.
    

Intervention name(s): AAV-hAADC-2; AAV-hAADC-2
Intervention type(s): Genetic; Genetic
Intervention description(s): 9 x 10^10 vector genomes (vg) of AAV-hAADC-2 in a single dose of 200 µL bilaterally infused over 4 striatal targets; 3 x 10^11 vector genomes (vg) of AAV-hAADC-2 in a single dose of 200 µL bilaterally infused over 4 striatal targets
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Transversus Abdominis Plane Block and Quadratus Lumborum Block in Pediatric Patients
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      In the pediatric age group, postoperative pain is very important for the children to have a
      comfortable and problem-free postoperative period.

      In the present study, it was aimed to compare the postoperative analgesic efficacy of
      Transversus abdominis plane (TAP) Block, and quadratus lumborum block (QLB) Type 1 on the
      pediatric patients
    

Detailed description: 
      Patients included in the study were randomly divided into 2 groups. Cases were assessed
      ultrasonography-guided TAP block (Group B, n=20) or ultrasonography-guided QL Block. Total
      analgesic amounts in 24 hours and first analgesic requirement times recorded.
    

Intervention name(s): Tramadol hydrochloride
Intervention type(s): Drug
Intervention description(s): The Wong-Baker facial pain scale was used to assess pain (1: no pain, 10: worst possible pain). During monitoring patients with pain score ≥3 had intravenous 1 mg/kg tramadol hydrochloride administered, After 15 minutes following tramadol injection, cases with pain score continuing ≥3 were to be assessed as insufficient analgesia and had 0.1 mg/kg morphine hydrochloride planned for intravenous administration
Other intervention name(s): morphine hydrochloride
Intervention MeSH terms: Morphine; Tramadol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: quadratus lumborum block; pediatric anesthesia; transverse abdominal block
Stepped Care to Optimize Pain Care Effectiveness
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Pain is the most common physical symptom in primary care, accounting for an enormous burden
      in terms of patient suffering, quality of life, work and social disability, and health care
      and societal costs. Pain is particularly prevalent among veterans. Four major barriers to
      optimal care include underdetection of pain, inadequate initial treatment, failure to monitor
      adherence and symptom response, and failure to adjust treatment in patients not responding or
      intolerant of initial therapy. Therefore, we propose to conduct the Stepped Care to Optimize
      Pain care Effectiveness (SCOPE) study, a randomized clinical effectiveness trial in primary
      care.
    

Detailed description: 
      SCOPE will enroll 250 primary care veterans with persistent (3 months or longer)
      musculoskeletal pain of moderate severity, and randomize them to either the stepped care
      intervention or usual care control group. The intervention will be based upon the
      empirically-validated Three-Component Model which in SCOPE will involve collaboration between
      the primary care physician, a nurse pain care manager, and a supervising physician pain
      specialist. SCOPE will involve a telemedicine approach coupling automated home-based symptom
      monitoring with telephone-based nurse care management. The intervention will consist of
      optimized analgesic management using a stepped care approach to drug selection, symptom
      monitoring, dose adjustment, and switching or adding medications. All subjects will undergo
      comprehensive outcome assessment at baseline, 1, 3, 6 and 12 months by interviewers blinded
      to treatment group. Our principal aim is to test whether SCOPE is more effective than usual
      care in reducing pain as measured by the Brief Pain Inventory. Secondarily, we will test the
      impact on other pain outcomes (e.g., severity, self-efficacy, use of self-management
      strategies), emotional functioning, health-related quality of life, and treatment
      satisfaction.
    

Intervention name(s): Stepped care
Intervention type(s): Drug
Intervention description(s): Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study.
Other intervention name(s): Optimized analgesics with collaborative care management
Intervention MeSH terms: Analgesics
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain; Telecare; Collaborative care
The Effect of Food (High Fat and Low Fat Breakfast) on the Pharmacokinetics of Regorafenib
Condition: Dietary Fats; Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label, three way crossover study to determine the effect of a high fat breakfast or a
      low fat breakfast on the pharmacokinetics of a single dose of regorafenib.
    


Intervention name(s): Regorafenib (Stivarga, BAY73-4506); Regorafenib (Stivarga, BAY73-4506); Regorafenib (Stivarga, BAY73-4506)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A single dose of regorafenib will be administered immediately following a high fat breakfast; A single dose of regorafenib will be administered immediately following a low fat breakfast; A single dose of regorafenib will be administered following an overnight fast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Screening
Clarithromycin is an Adjunct to Scaling and Root Planing
Condition: Periodontitis
MeSH terms: Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      The present study was done to evaluate the effect of clarithromycin as an adjunct to scaling
      and root planning at baseline, three months and six months intervals . Clinical,
      microbiological and immunological parameters were taken. Clinical parameters include gingival
      index , probing depth and clinical attachment level. In the present study, improved clinical
      and microbiological outcomes were attained using adjunctive clarithromycin, including GI, PD
      reduction, CAL gain and reductions in the frequency of detection of C-reactive protein, Pg,
      Aa. These results together with the recommended easy dosage and limited side effects make the
      use of this antibiotic in the treatment of periodontitis patients but only for a shorter
      period of time.
    

Detailed description: 
      Background & Objectives: Along with conventional non-surgical periodontal therapy (NSPT)
      systemic antimicrobials may provide more effective treatment for chronic periodontitis by
      targeting tissue-invasive bacteria. The aim of this study was to evaluate the adjunctive
      effects of oral clarithromycin (CLM) to nonsurgical periodontal therapy for chronic
      periodontitis.

      Materials and Methods: 30 patients were categorized into two groups: test group - Base line
      scaling and root planing(SRP) was done. Clarithromycin tablet 500 mg( Clarino-500) was given
      for a period of 7 days orally two times per day. control group -only SRP done . Clinical
      parameters were recorded at baseline , 3 months, and six months interval .They included
      gingival index (GI), probing depth (PD), and clinical attachment level (CAL). Also microbial
      analysis of subgingival plaque samples was done at baseline, 3months and six months interval
      to estimate the levels of Pg and Aa bacteria using culture methods. Immunological parameter
      like estimation of C-Reactive protein was done in both groups at baseline 3 months and 6
      months period. tests were used for statistical analysis.
    

Intervention name(s): tablet clarithromycin 500 mg (Clarino-500) orally
Intervention type(s): Drug
Intervention description(s): orally
Other intervention name(s): Clarino-500
Intervention MeSH terms: Clarithromycin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Colony forming units Antimicrobial agents; Microbial colonization
A Study of RC48-ADC in Subjects With HER2-negative Locally Advanced or Metastatic Urothelial Cancer
Condition: Urothelial Carcinoma
MeSH terms: Carcinoma, Transitional Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy and safety of intravenous RC48-ADC in patients with
      locally advanced or metastatic HER2-negative urothelial cancer.
    


Intervention name(s): RC48-ADC
Intervention type(s): Drug
Intervention description(s): The eligible patients will be treated with RC48-ADC, an antibody-drug conjugate, 2.0 mg/kg, once every two weeks until investigator-assessed loss of clinical benefit, unacceptable toxicity, investigator or participant's decision to withdraw from therapy, or death (whichever occurs first).
Other intervention name(s): Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection
Intervention MeSH terms: Trastuzumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of Oral GKT137831 in Patient With Type 2 Diabetes and Albuminuria
Condition: Type 2 Diabetes Mellitus With Diabetic Nephropathy
MeSH terms: Diabetic Nephropathies; Albuminuria; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      NADPH oxidase enzymes (NOX) have been implicated in the development of several diabetic
      complications including diabetic nephropathy. GKT137831 is the first in class NOX1/4
      inhibitor.

      The primary objective of this study is to evaluate the efficacy of oral GKT137831 in patients
      with residual albuminuria despite maximal inhibition of the renin angiotensin aldosterone
      system.
    

Detailed description: 
      A double-blind, placebo-controlled, randomized, multicenter, parallel group Phase 2 study
      assessing a 12-week period of treatment with oral GKT137831 administered in addition to
      standard of care for patients with type 2 diabetes.
    

Intervention name(s): GKT137831; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 1 capsule of 100 mg twice a day for the first 6 weeks of treatment, and 2 capsules of 100 mg twice a day for next 6 weeks of treatment; 1 capsule of Placebo, twice a day, oral treatment self-administered by the patient for the 12 weeks of treatment.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 diabetes; Proteinuria; Albuminuria
A Study To Assess The Safety, Tolerability, And Pharmacokinetics (PK) Of Multiple Doses Of PF-06865571 In Healthy, Including Overweight And Obese, Adult Subjects
Condition: Healthy Subjects
MeSH terms: Overweight
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be an investigator- and subject-blinded (sponsor open), randomized, placebo
      controlled, sequential, ascending, multiple oral dose study, with 5 planned cohorts (optional
      sixth and seventh cohorts). A total of approximately 50 (if 5 cohorts), 60 (if 6 cohorts),
      and up to 70 (if 7 cohorts) subjects will be randomized in this study. Subjects in each
      cohort will be randomized to receive PF-06865571 or matching placebo with approximately 10
      subjects dosed in each cohort.

      For a given subject in any cohort, the total study duration from screening to follow-up phone
      call will be between approximately 7 to 11 weeks.
    


Intervention name(s): PF-06865571; PF-06865571; PF-06865571; PF-06865571; PF-06865571; PF-06865571; PF-06865571; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.; Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.; Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.; Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.; Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.; Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.; Multiple ascending dose of PF-06865571 as extemporaneously prepared suspension for 14 consecutive days with total daily dose of 90mg, 300mg, 900mg, 1800mg, 3000mg and TBD.; Matching Placebo for PF-06865571 for each cohort.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Toxicity/Benefit Ratio Optimization of Chemotherapy in Colorectal Cancer (CRC) Patients by Determination of Individual Genotypic Determinants
Condition: Metastatic Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      This study intends to optimize a fluorouracil/irinotecan chemotherapy regimen by the
      identification of individual thymidylate synthase (TS) and UDP-glucuronosyltransferase 1
      (UGT1A1) polymorphisms before the first administration.

      The results of this identification determine the chemotherapy type: high-dose irinotecan or
      not.
    


Intervention name(s): irinotecan; 5 fluorouracil
Intervention type(s): Drug; Drug
Intervention description(s): 180 mg/m² or 260 mg/m² in 90 minutes every 15 days; 400 mg/m² in bolus in day 1 and 2400 mg/m² in 46 hours perfusion
Intervention MeSH terms: Fluorouracil; Irinotecan
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: genotypic profile; metastatic colorectal cancer