bioihbjkbjnl/mcl2 huggingface dataset:
Palliative Strategies in Spinal Cord Injury (SCI)
Condition: Spinal Cord Injury
MeSH terms: Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      Spinal cord injury (SCI) leads to muscle atrophy, hyperreflexia and spasticity, symptoms that
      decrease quality of life and prevent effective rehabilitation. Previous findings from our
      labs found that a passive cycling exercise program, motorized bicycle exercise training
      (MBET), in adult spinally transected animals reduced muscle atrophy and normalized
      hyperreflexia. We found that MBET could prevent the onset of hyperreflexia after spinal
      transaction, that MBET could also be used to rescue from hyperreflexia once it had set in,
      and that MBET could induce savings in normalization of reflexes after MBET ceased. We also
      demonstrated that MBET was effective in rescuing from hyperreflexia in a chronic ASIA B SCI
      patient, and that short-term MBET could lead to brief savings in normalization of reflexes
      once MBET ceased. The proposed studies will test the ability to MBET to prevent the onset of
      hyperreflexia in a group of acute SCI patients trained before hyperreflexia has had a chance
      to set in. In addition, the proposed research will attempt to confirm the possibility that
      long-term MBET in chronic SCI patients will rescue from hyperreflexia once it has set in, and
      also produce significant savings in normalization of reflexes if carried out for long periods
      of time. We will also test the possibility that MBET in acute and/or chronic SCI patients
      could reduce or prevent muscle atrophy. The experimental design calls for assessing muscle
      mass using MRI scans, bone density using Dual-Energy X-ray Absortiometry (DEXA) scans,
      spasticity measures and electrophysiological measurements to determine low frequency
      habituation of the H-reflex. Assessments will be carried out before MBET, during a 25 week
      MBET block of time, and during a 12 week post MBET monitoring period. Changes in muscle mass,
      bone density, spasticity scales and H-reflex habituation will be compared across these
      interventions and between treated SCI victims and a group of control acute and chronic SCI
      victims undergoing standard of care during the same period.
    


Intervention name(s): Motorized bicycle exercise training
Intervention type(s): Device
Intervention description(s): Passive exercise with a bicycle to bilateral legs. 5 days per week for 3 months
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: spinal cord injury
Preoperative Anti-PD-1 Antibody Combined With Chemoradiotherapy for Locally Advanced Squamous Cell Carcinoma of Esophagus
Condition: Esophageal Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Esophageal Squamous Cell Carcinoma
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety and feasibility of preoperative immune checkpoint therapy
      with concurrent chemoradiotherapy in patients with locally advanced esophageal squamous cell
      carcinoma. And this study will provide valuable information for further clinical trials of
      preoperative pembrolizumab and other immune checkpoint therapy in esophageal cancer
      treatment.
    

Detailed description: 
      Esophageal cancer ranks the eighth most common cancer (the fifth most common cancer in
      China), while ESCC is the most common subtype in Asia (more than 90 % in china). Radical
      resection is thought to be the mainstay of esophageal cancer treatment and preoperative CRT
      is well applied in treating locally advanced esophageal cancer. In a multicohort, phase IB
      study, pembrolizumab was used in 23 unresectable esophageal cancer patients. In this clinical
      trial, the incidence of grade 3 treatment-related adverse events was 39 % without the
      appearance of grade 4 and higher-grade adverse event, while the overall response rate reached
      30 %. The safety of immune checkpoint therapy for unresected esophageal cancers using
      nivolumab, a different PD-1 monoclonal antibody, has also been confirmed by high quality
      clinical trials.

      This study will evaluate the safety and feasibility of preoperative immune checkpoint therapy
      using pembrolizumab with concurrent chemoradiotherapy in patients with locally advanced
      esophageal squamous cell carcinoma. And this study will provide valuable information for
      further clinical trials of preoperative pembrolizumab and other immune checkpoint therapy in
      esophageal cancer.
    

Intervention name(s): Pembrolizumab
Intervention type(s): Drug
Intervention description(s): Arm1：Pre-operative Pembrolizumab+chemoradiotherapy
Other intervention name(s): Keytruda
Intervention MeSH terms: Pembrolizumab
Intervention model: Single Group Assignment
Intervention model description: Participants will receive carboplatin (AUC=2) IV and paclitaxel (50mg/m²) IV on day 1,8,15,22,29. And radiotherapy will start on day 1 of chemotherapy. A total of 41.4 Gy, 23 fractions of 1.8 Gy, 5 fractions a week. Participants will also receive pembrolizumab (2mg/kg) IV on days 1 and 22. Surgery will be performed within 6 weeks after completion of preoperative therapy described above
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: esophageal squamous cell carcinoma; neoadjuvant chemoradiotherapy; pembrolizumab; immune therapy; checkpoint inhibitor
Master Study of the Acticor/Rivacor ICDs/CRT-Ds and the Plexa ProMRI S DX Lead
Condition: Heart Failure; Tachyarrhythmia
MeSH terms: Tachycardia
Study type: Interventional

Summary: 
      Post-Market Clinical Follow-up of the new Cor Family ICDs/CRT-Ds (Acticor, Rivacor) and the
      new Plexa ProMRI S DX right ventricular lead to provide post-market data and supporting
      evidence for the clinical safety and performance of the devices.
    


Intervention name(s): Acticor/Rivacor ICDs/CRT-Ds; Plexa S DX
Intervention type(s): Device; Device
Intervention description(s): pre-defined device programming, measurements and follow-up schedule; Implantation, measurements and follow-up schedule
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy and Effectiveness of PegInterferon and Ribavirin in Korean Patients With Chronic Hepatitis C
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate the efficacy and effectiveness of peginterferon
      alfa-2a and ribavirin therapy in Korean chronic hepatitis C patients.
    

Detailed description: 
      A retrospective analysis of a prospective, multicenter, industry-sponsored, open-label,
      uncontrolled, community-based clinical trial of combination of peginterferon alfa-2a and
      ribavirin (Pegasys Expanded Access Program) conducted at 6 tertiary referral centers in Korea
      between 2003 and 2004 and a cohort of hepatitis C patients who were treated in a single
      tertiary referral hospital (Asan Medical Center, Seoul, Korea) between 2004 and 2008
    

Intervention name(s): Peginterferon alfa-2a plus ribavirin for HCV genotype 1; Peginterferon alfa-2a plus ribavirin for HCV genotype 2/3
Intervention type(s): Drug; Drug
Intervention description(s): Patients with genotype 1: treatment with peginterferon α-2a (Roche, Basel, Switzerland) 180 μg/week and daily ribavirin dose of 1,000 mg (for patients with body weight <75kg) or 1,200 mg (for patients with body weight ≥75kg) for 48 weeks.; Patients with genotype 2 or 3: treatment with peginterferon α-2a 180 μg/week and daily ribavirin dose of 800 mg for 24 weeks.
Other intervention name(s): Pegasys; Copegus; Pegasys; Copegus
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a; Interferon-alpha
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study for the Assessment of the Words Used by Patients and Physicians to Express the Symptoms of Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      Chronic obstructive pulmonary disease (COPD) is characterized by a progressive decline in
      lung function and increased symptoms such as breathlessness/dyspnoea, cough and
      expectoration.

      Even though subjective in nature, the symptomatology of COPD and mainly that of
      breathlessness/dyspnoea has been studied with the use of objective measurement tools. Taking
      into consideration that the symptoms experienced by the patient who suffers from a
      progressive disease such as COPD can only be perceived and interpreted by the patient him- or
      herself, and thus difficult to be quantified, COPD remains a challenge in clinical research.

      Therefore, there is a need to carry out qualitative studies that will provide insight into
      the wide spectrum of COPD symptomatology from the patient's perspective. In addition, a
      further mapping of the impact that COPD symptoms' perception has on a patient's life is
      required, as well as of the different pathways through which symptoms' perception is
      interpreted regarding the limitations of daily living activities, and the subsequent impact
      on disease management. The more the physician learns on the embodied experience of COPD, the
      better he/she may assist the patient in achieving optimal COPD management.

      Thus this cross-sectional observational study was designed aiming to obtain these data.
      Specifically, the study aims to evaluate the most frequently used words by the patients and
      the physicians to express the symptoms of COPD as well as the limitation of activities that
      it causes.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients with Chronic Obstructive Pulmonary Disease
      
Keywords: Chronic Obstructive Pulmonary Disease, symptoms
Angiogenesis in Early Breast Cancer for Prognosis Prediction
Condition: Breast Lesions
Study type: Interventional

Summary: 
      This study will investigate the association of angiogenesis in breast cancer measured by
      magnetic resonance imaging and biomarkers with long-term prognosis of patients.
    


Intervention name(s): magnetic resonance imaging
Intervention type(s): Procedure
Intervention description(s): MRI contrast agent, 0.1 mmol/kg
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Myocardial Stress Perfusion Imaging With Dual Source CT
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional

Summary: 
      The investigators propose a novel technique using dual source multidetector computed
      tomography (DSCT) where information on both coronary anatomy and myocardial perfusion is
      obtained in a single scan. The investigators hypothesize that a coronary CTA protocol can be
      devised to obtain resting myocardial perfusion, myocardial perfusion after stress, and
      coronary anatomy. Hence, one diagnostic test will be able to detect the presence of coronary
      plaque as well as assess the functional significance of a stenosis.
    


Intervention name(s): Adenosine Stress Dual-source CTP
Intervention type(s): Other
Intervention description(s): Adenosine- continuous infusion at 140mcg/ kg/ min for 2.5 min; Iopamidol (IV contrast)- total dose of 150cc; Siemens SOMATOM Definition CT scanner (CT scan radiation) - effective radiation dose of approximately 13mSv (tube voltage 120kV, tube current 340mAs for one retrospectively gated cardiac CT with tube current modulation and two prospectively gated cardiac CTs on a Dual Source scanner)
This is an observational trial, and all patients will undergo the Adenosine Stress Dual-source CTP procedure.
Other intervention name(s): Adenosine; Iopamidol 370; Siemens SOMATOM Definition
Intervention MeSH terms: Adenosine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Coronary Artery Disease; Multidetector Computed Tomography; Myocardial Perfusion Imaging
Predictors of Constipation in Healthy Children
Condition: Constipation
MeSH terms: Constipation
Study type: Observational

Summary: 
      The purpose of this research is to see if a questionnaire on bowel habits can help identify
      children who will have constipation 12 months later.
    

Detailed description: 
      Constipation in children is a common complaint, accounting for an estimated 3% of all
      pediatric office visits and 20% of visits to a pediatric gastroenterologist. Unfortunately,
      constipation can become chronic in many children even before the problem has been recognized
      by a parent or primary care physician. We have previously characterized the bowel habits of
      more than 3300 primarily middle class Caucasian children 1 to 8 years of age presenting to
      their primary care practitioner for a health maintenance visit. However, the validity of
      information concerning bowel habits of children obtained by recall is not well established.
      The potential benefit of this study to society will be the demonstration that a bowel habit
      questionnaire can predict the outcome of clinically important constipation.
    

Observational model: Cohort
Sampling method: Non-Probability Sample
Study population: 
        Children ages 5 through 8 who present for a health maintenance visit at eleven general
        pediatric offices.
      
Keywords: constipation; bowel habits
Role of Flexible Cystoscopy in Laparoscopic Stone Surgery
Condition: Kidney Calculi; Ureteral Calculi
MeSH terms: Kidney Calculi; Nephrolithiasis; Ureteral Calculi; Ureterolithiasis; Calculi
Study type: Observational

Summary: 
      Authors want to investigate the usefulness of flexible cystoscopy in performing laparoscopic
      pyelolithotomies and ureterolithotomies by comparing operative results of a single surgeon's
      experience.
    

Detailed description: 
      Previous trials to increase stone clearance rates have been recently reached using flexible
      equipment in laparoscopic surgery, however, it is not clear whether using flexible equipment
      is really helpful in performing pyelolithotomies and the clearance rates using flexible
      equipment varies 71% to 100%. Therefore, authors plan to investigate the usefulness of
      flexible cystoscopy in performing laparoscopic pyelolithotomies and ureterolithotomies by
      comparing operative results of a single surgeon's experience.
    

Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        71 patients with complex renal stones and large or impacted ureter stones. All the patients
        underwent laparoscopic pyelolithotomies with concomitant calyceal stone removal or
        ureterolithotomy using a flexible cystoscopy or not.
      
Keywords: kidney calculi; ureteral calculi; cystoscopes; laparoscopes
A Study Evaluating the Efficacy of Administered Maintenance Treatments in Bipolar Disorder I and II.
Condition: Bipolar Disorder
MeSH terms: Bipolar Disorder
Study type: Observational

Summary: 
      The primary objective of the study is to evaluate the efficacy of administered maintenance
      treatments in bipolar disorder I and II, defined as the percentage of patients who experience
      a relapse episode during the first 9 months after a mood event (manic or depressive).
    


Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Outpatients diagnosed with bipolar disorder I or II (as per DSM-IV), who have received
        therapy with at least one atypical antipsychotic for the acute episode and whose treating
        physician has considered they have entered the maintenance phase.
      
Keywords: Bipolar disorder I and II; mood event; manic or depressive; Greece
LEO19123 Cream in the Treatment of Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the efficacy and safety of two different dose combinations of LEO19123
      (calcipotriol and LEO80122) with LEO19123 cream vehicle for 3 weeks in the treatment of
      patients with atopic dermatitis
    


Intervention name(s): Calcipotriol and LEO80122 (LEO19123 cream)
Intervention type(s): Drug
Intervention MeSH terms: Calcipotriene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
The Pharmacokinetics, Safety and Tolerability of IN-C009 in Healthy Subjects
Condition: Diabetes Mellitus
Study type: Interventional
Phase: Phase 1

Summary: 
      This study was conducted as a randomized, open-label, single-dose, crossover study design.
      All participants were randomly allocated for group A (Period 1: Individual components (ICs),
      period 2: FCDP) and group B (Period 1: FCDP, period 2: ICs), and each group was administered
      either a single dose of IN-C009 (FCDP, dapagliflozin 10mg/linagliptin 5 mg) (HK inno.N.,
      Seoul, Korea) or co-administration of a single dose of dapagliflozin (Forxiga 10 mg,
      AstraZeneca, Cambridge, England, UK) and linagliptin (Trajenta 5mg, Beringer-Ingelheim,
      Ingelheim, Germany) after at least 10 hours of overnight fasting. After the 28 days of the
      washout period, the participants received the opposite treatment (Group A: IN-C009; Group B:
      dapagliflozin and linagliptin). The dosage of dapagliflozin and linagliptin in the study is
      commercially used and recommended amount for the control of T2DM currently.

      On the day 1 (the day of each drug administration), the serial blood samples were drawn
      immediately before (0 h) and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, and 72
      h (for dapagliflozin), and 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 4, 6, 8, 12, 24, 48, and 72 h
      (for linagliptin) after the each dosing to assess pharmacokinetics of each drugs.
    


Intervention name(s): FCDP, dapagliflozin 10mg/linagliptin 5 mg or co-administration of a single dose of dapagliflozin and linagliptin
Intervention type(s): Drug
Intervention description(s): FCDP, dapagliflozin 10mg/linagliptin 5 mg or ICs, co-administration of a single dose of dapagliflozin and linagliptin
Intervention MeSH terms: Dapagliflozin; Linagliptin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fruquintinib CYP3A Inhibitor and Inducer Study
Condition: Drug Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess the effect of itraconazole, a strong CYP3A inhibitor, and the effect of
      rifampin, a strong CYP3A inducer, on the pharmacokinetics of fruquintinib in healthy
      subjects.
    

Detailed description: 
      This study will be a single-center, open-label, 2-part, 2-period fixed sequence crossover
      study to be conducted with 28 healthy male and female subjects. The study will consist of a
      Screening Phase (Screening and Day -1), a Treatment Phase (Period 1 and Period 2), and an End
      of Study (EOS) Phase. Screening will occur within 21 days before the first study drug
      administration. There will be at least a 14-day washout of fruquintinib between treatment
      periods.

      Part A: subjects will be administered fruquintinib alone in treatment Period 1 and in
      combination with itraconazole in treatment Period 2.

      Part B: subjects will be administered fruquintinib alone in treatment Period 1 and in
      combination with rifampin in treatment Period 2.
    

Intervention name(s): Fruquintinib; Itraconazole; Rifampin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): oral VEGFR inhibitor; a synthetic triazole antifungal agent; a semisynthetic antibiotic derivative of rifamycin SV
Other intervention name(s): HMPL-013
Intervention MeSH terms: Itraconazole; Rifampin
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: CYP3A
A Study To Evaluate The Safety, Tolerability And Pk Of Pazopanib Eye Drops In Healthy Adult And Elderly Subjects.
Condition: Macular Degeneration; Age-related Macular Degeneration
MeSH terms: Macular Degeneration
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a two-part study to evaluate the safety, tolerability and pharmacokinetics of single
      (Part A) and repeat (Part B) eye drop doses of pazopanib in healthy adult and elderly
      subjects.
    


Intervention name(s): Pazopanib eye drops and Allergen Refresh Plus eye drops
Intervention type(s): Drug
Intervention MeSH terms: Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Diagnostic
Keywords: Age-related macular degeneration (AMD),; vascular endothelial growth factor (VEGF)receptor (VEGFR); choroidal neovascularization,
Helium Oxygen Mixture in the Treatment of Meconium Aspiration Syndrome
Condition: Neonatal Meconium Aspiration
MeSH terms: Meconium Aspiration Syndrome
Study type: Interventional

Summary: 
      Helium-oxygen mixture(heliox) was suggested to be beneficial in meconium aspiration syndrome
      in previous studies，but the evidence was limited．The aim of the study was to assess the
      effectiveness of synchronize intermittent mandatory ventilation (SIMV) with heliox (70%
      helium and 30% oxygen) on length of ventilation(LoV) and cardiopulmonary protection in
      meconium aspiration syndrome.
    


Intervention name(s): helium oxygen mixture
Intervention type(s): Device
Other intervention name(s): Air oxygen mixture
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: helium oxygen mixture; Meconium aspiration syndrome
Adult Attention Deficit Hyperactivity Disorder (ADHD) Study With Amphetamine Sulfate
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the AR19.004 study is to assess the efficacy of AR19 compared to placebo using
      the Adult ADHD Investigator Symptom Rating Scale (AISRS)
    

Detailed description: 
      This is a randomized, fixed-dose, double-blind, multicenter trial to investigate the safety
      and efficacy of AR19 in the treatment of ADHD in adults from 18 through 55 years of age.
      Safety parameters and therapeutic effect will be evaluated throughout the trial. A target of
      312 subjects is set for enrollment. Once subjects are determined to meet all inclusion
      criteria and were screened, they will be randomized to 20 or 40 mg AR19 daily or placebo.
    

Intervention name(s): Amphetamine Sulfate; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): active experimental AR19; Matching placebo
Other intervention name(s): AR19; inactive drug
Intervention MeSH terms: Amphetamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment