bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2 Study to Evaluate Brincidofovir for the Prevention of Adenovirus Disease
Condition: Adenovirus Disease
MeSH terms: Adenoviridae Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This study was designed to assess the safety and efficacy of preemptive treatment with oral
      brincidofovir (BCV), as compared to placebo, for the prevention of adenovirus (AdV) disease
      in recipients of hematopoietic stem cell transplantation (HCT) with asymptomatic AdV viremia.
    

Detailed description: 
      This was a Phase 2, randomized, multicenter, placebo-controlled study for pediatric and adult
      subjects who had undergone hematopoietic stem cell transplantation (HCT) and who had been
      identified as having asymptomatic adenovirus (AdV) viremia [i.e., had detectable AdV DNA in
      plasma based on polymerase chain reaction testing performed at the local laboratory with no
      AdV disease symptoms]. The primary objectives of the study were to assess the safety and
      tolerability of oral brincidofovir (BCV), and to estimate the treatment failure rate based on
      an efficacy endpoint with 2 different dosing regimens of oral BCV versus placebo.
    

Intervention name(s): Brincidofovir; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Adult subjects: 200mg BCV administered as 50mg tablets taken orally either once weekly (QW; 4 tablets) or twice weekly (BIW; 2 tablets).
Pediatric subjects: 4mg/kg BCV (not to exceed a total single dose of 200mg) administered using a 10 mg/mL liquid formulation taken orally either QW (as 4 mg/kg) or BIW (as 2 mg/kg).; Adult subjects: Matching placebo tablets taken orally either once weekly (QW; 4 tablets) or twice weekly (BIW; 2 tablets).
• Pediatric subjects: Matching liquid placebo taken orally either QW (as 4 mg/kg) or BIW (as 2 mg/kg).
Other intervention name(s): BCV; CMX001
Intervention MeSH terms: Brincidofovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: AdV; Hematopoeitic Stem Cell Transplant; HSCT
Visual Performance of Senofilcon A With and Without a New UV/HEV-filter
Condition: Visual Performance
Study type: Interventional

Summary: 
      This study will occur in two non-dispensing phases: Phase 1 is a non-randomized, non-masked,
      non-dispensing study where subjects will wear their own contact lenses for approximately 1
      hour. Phase 2 is a controlled, randomized, double-masked, contralateral non-dispensing study
      where the study lenses will be worn in a daily wear modality for approximately 3 hours.
    


Intervention name(s): TRP-200; ACUVUE Oasys 1-Day
Intervention type(s): Device; Device
Intervention description(s): JJVC Investigational Contact Lens; JJVC Marketed Contact Lens
Other intervention name(s): TEST; CONTROL
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: In Phase 2, subjects will be randomized to a contralateral sequence where the study lenses will be worn throughout the duration of the study.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Reproducibility of Magnetic Resonance Myocardial Salvage Index
Condition: Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      The myocardial salvage assessed by using multimodal cardiac magnetic resonance imaging is a
      rather new technique which can be used as a surrogate endpoint to reduce the sample size in
      studies comparing different reperfusion strategies in myocardial infarction. As
      reproducibility of myocardial salvage has not been evaluated appropriately, we aim to scan 20
      patients on 2 subsequent days to evaluate reproducibility of myocardial salvage index.
    


Intervention name(s): second magnetic resonance imaging scan
Intervention type(s): Device
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        ST-elevation myocardial infarction
      
Keywords: reproducibility; contrast agent; magnetic resonance imaging; infarct size; myocardial salvage index; myocardial salvage assessment
Effect of Methylnaltrexone (MNTX) on Electrocardiogram (ECG) Parameters and Cardiac Repolarization
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will employ a single-center, randomized, double-blind parallel-group design for
      MNTX and placebo, with a positive control (moxifloxacin) dosed single-blind to confirm
      methodology, in normal healthy male and female volunteers. Multiple ECGs will be obtained
      after single clinical and supratherapeutic doses of MNTX to assess ECG effects compared to
      placebo.
    


Intervention name(s): Methylnaltrexone (MNTX); Methylnaltrexone (MNTX); Methylnaltrexone (MNTX); Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Dose 1; Dose 2; Dose 3
Intervention MeSH terms: Moxifloxacin; Naltrexone; Methylnaltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Anodic Oxidation of Implant Abutment Collar on the Peri-implant Soft Tissue Health
Condition: Dental Implants
Study type: Interventional

Summary: 
      This research aims to evaluate the effect of anodic oxidation of implant abutment collar on
      the peri-implant soft tissue health.
    

Detailed description: 
      A randomized controlled clinical trial will be implemented on 10 implant abutments in five
      patients, each having 2 dental implants in the same quadrant. Abutments with standard silver
      collars will be divided into two groups: Group 1 (test group) will undergo anodic oxidation
      of the abutment collar changing it into pink color. Group 2 (control group) untreated
      abutments.
    

Intervention name(s): Anodic oxidation; Untreated abutment
Intervention type(s): Other; Other
Intervention description(s): Abutments will undergo anodic oxidation process after etching with Hydrofluoric acid & Nitric acid mixture for 10 minutes for debridement in a bath of distilled water with citric acid for 5 minutes to turn the abutment collar into pink color. The stainless steel plate will be connected to the cathode (-) and titanium abutments will be connected to the anode (+) end of the DC Power Supply. After then abutments will be left in distilled water for 10 minutes and sterilized before insertion in patient mouth.; Abutment will be left untreated with its gray color.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study of S-3304 in Patients With Locally Advanced Non-Small Cell Lung Cancer
Condition: Non Small Cell Lung Cancer; Lung Cancer; Stage IIIA Non Small Cell Lung Cancer; Stage IIIB Non Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      A study to measure the safety and effectiveness of S-3304 when given in combination with
      conventional chemo-radiation therapy in patients with locally advanced non-small cell lung
      cancer.
    

Detailed description: 
      A two part study to evaluate the safety and efficacy of S-3304 in combination with standard
      therapy in patients with locally advanced non-small cell lung cancer. The first part of the
      study is a Phase I design to evaluate the maximum tolerated dose of S-3304 when given in
      combination with radiation and paclitaxel/carboplatin chemotherapy that is appropriate for
      further evaluation. The second part of the study is a randomized Phase II design to evaluate
      the efficacy of recommended S-3304 dose in combination with chemo-radiation.
    

Intervention name(s): S-3304; Chemo-irradiation
Intervention type(s): Drug; Other
Intervention description(s): S-3304 will be administered at the tolerable dose BID along with chemo-irradiation; Standard of care chemo-irradiation
Intervention MeSH terms: S 3304
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The Phase 1 part of the study will determine the tolerable dose of S-3304 in the presence of radiation and paclitaxel/carboplatin chemotherapy in a non-randomized manner.
The Phase 2 part will compare the effect combination of S-3304 in addition to chemo-irradiation therapy to the effect of radiation and paclitaxel/carboplatin chemotherapy alone on small cell lung tumors
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lung cancer; Lung carcinoma; Non small cell lung cancer; Stage IIIA non small cell lung cancer; Stage IIIB non small cell lung cancer; NSCLC; Stage III; chemotherapy; radiation; chemoradiation; matrix metalloproteinases; neovascularization; antiangiogenesis; type IV collagenases; Unresectable locally advanced non-small cell lung cancer
Study of Single-Ascending Doses of DS-6016a in Healthy Japanese Subjects
Condition: Fibrodysplasia Ossificans Progressiva
MeSH terms: Myositis Ossificans
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the safety, tolerability, and pharmacokinetics of DS-6016a after
      subcutaneous injection in healthy Japanese participants.
    


Intervention name(s): DS-6016a; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): DS-6016a will be administered as a single subcutaneous injection into the upper arm, upper part of the thigh, or abdominal wall; Placebo will be administered as a single subcutaneous injection into the upper arm, upper part of the thigh, or abdominal wall
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Fibrodysplasia Ossificans Progressiva; Bone Morphogenetic Protein; Activin Receptor-like Kinase-2
Cognitive Training in Heart Failure Study (CogTrain-HF)
Condition: Congestive Heart Failure; Cognitive Impairment
MeSH terms: Heart Failure; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The daily routine in clinical settings often showed cognitive impairments in patients with
      congestive heart failure, particularly in terms of executive functions, episodic memory,
      perceptual speed and attention. It is assumed that cognitive impairments in patients with
      congestive heart failure may lead to deficits in medication-adherence and self-care
      abilities, resulting in increased healthcare costs. Recent studies reported performance
      improvements after cognitive training that transferred to new, untrained tasks and abilities
      in healthy subjects across a wide range of ages. This study investigates the effects of
      cognitive training in patients with congestive heart failure.
    

Detailed description: 
      Cognitive functions of patients with congestive heart failure (NYHA II-III) before (pretest)
      and after (posttest) cognitive-training intervention are investigated. Changes in cognitive
      functions are compared to changes in two control groups: 1) age and gender matched active
      control group 2) age and gender matched passive waiting list control group.

      The neuropsychological test battery applied at pretest and posttest includes measures of
      episodic memory, working memory, short-term memory, executive functions, perceptual speed and
      intelligence. In addition, the investigators apply standardized questionnaires of
      self-assessed quality of life, cognitive functioning in daily life, selfcare, and
      psychological well-being (depression, anxiety and personality). Relevant physiological data
      such as ejection fraction, heartrate, N-terminal pro brain natriuretic peptide (NT-pro-BNP)
      as well as drug blood level are recorded.
    

Intervention name(s): Cognitive training; Test of general knowledge
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Cognitive training on computer. Six sessions with different tasks: "Tiere merken" & "Räumlich visuelles Training" (application BrainTwister) and "Taskswitching" (programmed with eprime); Training of general knowledge on computer. Six sessions with different topics.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pre-Test, Intervention, Post-Test, Follow-Up
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Cognitive training; Cognitive impairment; Heart failure; Cognition
A Study of FK199B to Compare Efficacy With Zolpidem by Polysomnography in Patients With Insomnia
Condition: Sleep Initiation and Maintenance Disorders
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is to investigate the efficacy and safety of FK199B (Zolpidem MR Tablet) by
      polysomnography in patients with insomnia, excluding patients with schizophrenia or
      manic-depressive psychosis.
    


Intervention name(s): FK199B; Zolpidem
Intervention type(s): Drug; Drug
Intervention description(s): oral; oral
Other intervention name(s): Zolpidem MR Tablet; Myslee
Intervention MeSH terms: Zolpidem
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: FK199B; Zolpidem
A Prospective Study of Combination of Peginterferon Alfa-2b (40kD, Y-shape) and GM-CSF in Chronic Hepatitis B
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is a multi-center, randomized, prospective open-label study to assess the efficacy
      and safety of combination of peginterferon alfa-2b (40kD, Y-shape) and GM-CSF in
      interferon-naïve chronic hepatitis B patients with HBeAg positive. Patients were randomized
      to one of the 2 groups to receive different antiviral treatment.
    


Intervention name(s): Ypeginterferon alfa-2b; Granulocyte-macrophage colony stimulating factor
Intervention type(s): Drug; Drug
Other intervention name(s): peginterferon alfa-2b; GM-CSF
Intervention MeSH terms: Peginterferon alfa-2b; Molgramostim; Sargramostim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
PPP-Botnia Exercise Intervention Study
Condition: Family History of Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The aim of the study is to evaluate the long-term effects of a prescription of exercise
      versus a group-based training program on aerobic fitness, muscle strength and metabolic
      variables in subjects with poor physical fitness. The participants are further stratified for
      a family-history of type 2 diabetes. The number of subjects in each group of intervention is
      planned to be 150, aged 30-70 years and non-diabetic.

      Intervention: All study subjects take part in two individual sessions for exercise
      prescription aiming at moderate exercise of 30 minutes at least 5 days a week. The
      prescription group perform exercise by themselves, while the training group will be offered
      supervised physical training, including both endurance training and training in gym twice a
      week during 12 months.

      The subjects will be followed up at 1, 2, 3 and 5 years after the basal visit.

      Methods of follow-up: At the study visits physical fitness will be measured by a 2 km walking
      test, glucose tolerance by oral glucose tolerance test with measurement of glucose and
      insulin. Lipids will be measured. Questionnaires will be used to follow lifestyle, physical
      activity, cardiovascular disease and medication.

      In the training group 30 subjects with and 30 subjects without a family history of type 2
      diabetes will participate in a sub-study including muscle- and fat-biopsy before the start of
      the study, after 1 and 5 years.
    


Intervention name(s): Physical activity
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Physical fitness; Family history of type 2 diabetes; Prescription of exercise
Dose Finding Study of Pioglitazone in Children With Autism Spectrum Disorders (ASD) (PIO)
Condition: Autism Spectrum Disorders
MeSH terms: Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      The investigators propose a pilot, single blind, placebo run-in, dose finding study of
      pioglitazone in children with autism with the ultimate goal of identifying appropriate dosing
      and outcome measures for a larger follow-up randomized placebo controlled clinical trial. The
      specific aims of this study are: 1) To examine the safety of pioglitazone in children with
      autism spectrum disorders (ASD) ages 5-12 years; 2) To identify appropriate outcome measures
      to be used in a follow-up multisite randomized control trial of pioglitazone in children with
      ASD; 3) To determine the maximum tolerated dose to be used in the follow-up multisite
      randomized controlled trial; 4) To examine the effect of pioglitazone on markers of
      inflammation (cytokine levels) and oxidative stress (superoxide dismutase, malonyl
      aldehydes); 5) To explore the relationship between different doses and response to treatment.
    


Intervention name(s): Pioglitazone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): A modified dose finding method will be used to determine safety and dose response among three dose levels (0.25mg/kg QD, 0.5mg/kg QD, and 0.75mg/kg QD). The dose has been based on the per weight maximum adult dose. Specifically, the FDA has approved 45mg as the maximum adult dose. For a 60kg adult, this is 0.75mg/kg. There will be 14 weeks of active treatment.; There will be a 2 week period of placebo run-in.
Intervention MeSH terms: Pioglitazone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: ASD
Study Evaluating IMA-638 in Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of, and blood drug levels for, single,
      ascending doses of IMA-638 in mild to moderate asthma subjects.
    


Intervention name(s): IMA-638
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Diagnostic
Keywords: healthy subjects
The Effect of Neu-P11 on Symptoms in Patients With D-IBS
Condition: Diarrhea- Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome; Diarrhea
Study type: Observational

Summary: 
      Placebo controlled double-blind study with 40 patients who have an diarrhea-predominant IBS,
      20 get Neu-P11, 20 get a placebo. Neu-P11 is a, Melatonin receptor-, Serotonin 5-HT- 1A and
      5-HT- 1D - agonist and a serotonin 5-HT- 2B - antagonist.
    

Detailed description: 
      This study aims to test a possible beneficial effect of NEU-P11 in patients with IBS.

      The effect on symptoms will be rated by symptom scores. The primary endpoint will be the
      symptomatic benefit reported by the patient answering the simple question: Did your symptoms
      improve compared to prior to the clinical trial.

      Additional secondary endpoints will capture sleep quality, changes in stool texture and
      individual symptom scores employing standardized symptom scores.

      The study design is a 4 week, randomised, placebo-controlled, double blind study where 40
      patients receive either placebo (20) or NEU-P11 (20). In the mid of the four week time of the
      Study the dose can be doubled of the patient does not recognize any relief of the D-IBS.
    

Intervention name(s): Neu-P11; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Neu-P11 is a new Melatonin receptor-, Serotonin 5-HT- 1A and 5-HT- 1D - agonist and a serotonin 5-HT- 2B - antagonist; Placebo
Other intervention name(s): there are no other names; there are no other names
Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Patients with diarrhea-praedominant Irritated Bowel Syndroms
      
Keywords: Irritable bowel syndrome; Neu-P11; Melatonin; D-IBS
Effect of 90% Effective Dose of Metaraminol in Supine and Left Tilt Positions on Cesarean Section
Condition: Cesarean Section Complications
Study type: Interventional
Phase: Phase 4

Summary: 
      For hypotension after spinal anesthesia, metaraminol has different 90% effective doses in the
      supine position and the left-tilt position. We plan to conduct a non-inferiority trial to
      compare the effects of the two on the fetus and the mother.
    


Intervention name(s): Metaraminol 2.7μg/kg/min; Metaraminol 2μg/kg/min
Intervention type(s): Drug; Drug
Intervention description(s): After spinal anesthesia, the patient was placed in a supine position until the fetus was delivered, and metaraminol was given at an initial rate of 2.7μg/kg/min throughout the process.; After spinal anesthesia, the patient was placed in left-tilt position until the fetus was delivered, and metaraminol was given at an initial rate of 2μg/kg/min throughout the process.
Intervention MeSH terms: Metaraminol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention