bioihbjkbjnl/mcl2 huggingface dataset:
A Phase I Study to Evaluate XTR003 in Healthy Chinese Volunteers
Condition: Coronary Artery Disease (CAD)
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      18F-FDG PET imaging is now considered the most effective method used in the clinical
      evaluation of viable myocardium. However, the need for fasting or glucose and insulin loading
      in the 18F-FDG PET protocol makes it unfavorable for a certain group of patients (i.e.,
      insulin-resistance and diabetic patients). XTR003 is a fatty acid analog used for PET
      imaging, developed at the Beijing Anzhen Hospital affiliated to Sinotau Pharmaceutical Group.
      XTR003 is a promising fatty acid analog and perhaps have a potential clinical utility in the
      evaluation of viable myocardium. This phase I study investigated the safety, biodistribution,
      radiation dosimetry and Pharmacokinetics of XTR003 in 10 Chinese normal healthy volunteers
      both male and female between the ages of 18-40.
    

Detailed description: 
      XTR003 is a PET imaging radiopharmaceutical agent used to trace myocardial fatty acid
      metabolism. XTR003 is a modified fatty acid that enters the myocytes and passes through
      mitochondrial membrane by the same process as the natural existing fatty acids and then
      undergoes partial β-oxidation before being trapped in the mitochondria. In preclinical study
      XTR003 showed high myocardial uptake and retention [1].

      This is a phase I study, the study will be open-label, nonrandomised, single-arm,
      single-center clinical study. Subjects will receive single dose of XTR003.

      Safety, biodistribution, radiation dosimetry and Pharmacokinetics was investigated.
    

Intervention name(s): XTR003
Intervention type(s): Drug
Intervention description(s): Single dose of 8.0-10 mCi of XTR003 will be injected on the first day of the study (Day 1). Serial whole-body PET imaging will be acquired after dose injection.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: coronary artery disease; positron emission tomography (PET)
A Safety Study of LY3493269 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study in healthy participants is to learn more about the safety of
      LY3493269 and any side effects that might be associated with it. Blood tests will be
      performed to check how much LY3493269 gets into the bloodstream and how long it takes the
      body to eliminate it. For each participant, the study will last about 10 weeks and may
      include 12 visits, including five nights in a row in the clinical research center.
    


Intervention name(s): LY3493269; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Glaucoma Treatment Using Focused Ultrasound in Open Angle Glaucoma Patients
Condition: Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle
Study type: Interventional

Summary: 
      The purpose of the this study is to collect safety and efficacy data on Focused Ultrasound
      treatment (UCP procedure) in open angle glaucoma patients without previous glaucoma surgery.
    


Intervention name(s): EyeOP1 device
Intervention type(s): Device
Intervention description(s): Ultrasound Ciliary Plasty (UCP procedure) using Focused Ultrasound
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glaucoma; Ultrasound; Ciliary body
Role of the Striatal Cholinergic System in the Pathophysiology of Dystonia
Condition: Dystonia
MeSH terms: Dystonia; Dystonic Disorders
Study type: Interventional

Summary: 
      Dystonia is defined as a syndrome of sustained muscle contractions resulting in repetitive
      movements and abnormal postures. DYT1 is the most common form of genetic dystonia, but the
      link between genomic mutations and phenotypic expression remains largely unknown.
      Furthermore, secondary forms of dystonia have highlighted the role of the basal ganglia,
      particularly the putamen in the pathophysiology of the disease. Experimental results in a
      genetic model of dystonia in rodents suggest that cholinergic inter-neurons (ACh-I) of the
      putamen play a critical role in the pathological process of plasticity in the
      cortico-striatal synapse. However, these results have not been demonstrated in humans.
    

Detailed description: 
      The purpose of this study is to demonstrate that the phenotype of dystonia is associated with
      the degree of striatal ACh-I alterations.

      In this molecular imaging study, the investigators will directly test this hypothesis using a
      PET radiotracer of the vesicular acetylcholine transporter (VAT). Their goal is to explore
      the relationships between cholinergic dysfunction and clinical disease expression and the
      associated morphological and functional alterations. The experimental protocol will also
      include multimodal MRI, MRI diffusion tensor (to study the microscopic structure of white
      matter) and functional MRI of the resting state (to study the functional organization of
      cerebral cholinergic networks at rest).
    

Intervention name(s): PET (Positron Emission Tomography) imaging; MRI : Magnetic Resonance Imaging
Intervention type(s): Radiation; Other
Intervention description(s): Molecular imaging using a PET radiotracer of the vesicular acetylcholine transporter.; Multimodal MRI, MRI diffusion tensor (to study the microscopic structure of white matter) and functional MRI of the resting state (to study the functional organization of cerebral cholinergic networks at rest).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Dystonia; Binding potential; FEOBV
Non-interventional Study of the Effect of Smoking Status of the Patient on the Success of Etanercept Therapy in Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Observational

Summary: 
      Pilot observational study to describe the relationship between the smoking status of a
      psoriatic individual and the success of etanercept therapy in psoriasis treatment
    

Detailed description: 
      non-interventional study There is no sampling
    

Intervention name(s): smoking questionnaire
Intervention type(s): Behavioral
Intervention description(s): patients fill in a smoking questionnaire about their smoking habits
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        etanercept treated plaque psoriasis patients
      
Keywords: plaque psoriasis; smoking; etanercept
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple, Rising Oral Doses of BI 11634 Oral Solution in Healthy Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      First evaluation of safety, tolerability, pharmacokinetics, and the pharmacodynamic effect of
      BI 11634 on coagulation parameters after multiple-dose administration (no primary endpoint in
      a statistical sense defined)
    


Intervention name(s): BI 11634; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Fasting Comparative Bioavailability Study of 2 Meloxicam 15 mg Tablets in Healthy Volunteers Under Fasting Condition
Condition: Pharmacokinetics
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of the study was to compare the bioavailability of two formulations of meloxicam
      given to healthy volunteers and to demonstrate bioequivalence. The test product, Reumoxicam®
      15 mg tablets (Farmak PJSC, Ukraine), given in a single dose was compared with a licensed
      reference product Movalis 15 mg tablets ("Boehringer Ingelheim Ellas A.E.", Greece), in a
      randomized, laboratory-blind, single dose, two periods, crossover study.

      The secondary objective of the trial was to investigate the safety of both preparations on
      the basis of safety clinical and laboratory examinations (at the beginning and at the end of
      the trial) and registration of adverse events and/ or adverse drug reactions.
    

Detailed description: 
      Randomized, single-dose, crossover, two-period, two-sequence, laboratory-blinded, comparative
      bioavailability study of test medicinal product Reumoxicam® 15 mg tablets (PJSC "Farmak",
      Ukraine) and reference medicinal product Movalis 15 mg tablets ("Boehringer Ingelheim Ellas
      A.E.", Greece) in healthy volunteers under fasting condition.

      During each period 18 blood samples were taken: before dosing (0) and then at: 0.5; 1; 2; 3;
      4; 4.5; 5; 5.5; 6; 7; 8; 10; 12; 24; 36; 48 and 72 hours after dosing.
    

Intervention name(s): Reumoxicam® 15 mg tablets (PJSC "Farmak", Ukraine); Movalis 15 mg tablets ("Boehringer Ingelheim Ellas A.E.", Greece)
Intervention type(s): Drug; Drug
Intervention description(s): One tablet was administered orally and swallowed at once, without chewing, by study volunteers, followed by 200 ml of water, under fasting condition (after preliminary nocturnal fasting for 12 hours) in the morning at 8:00 hours on Day I Period I and Period II of the study.; One tablet was administered orally and swallowed at once, without chewing, by study volunteers, followed by 200 ml of water, under fasting condition (after preliminary nocturnal fasting for 12 hours) in the morning at 8:00 hours on Day I Period I and Period II of the study.
Other intervention name(s): Meloxicam; Meloxicam
Intervention MeSH terms: Meloxicam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: bioequivalence; pharmacokinetics; generic drugs; Meloxicam
Prospective Study of Motion Preservation Evaluation Below Fusions of the Spine in Adolescent Idiopathic Scoliosis
Condition: Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the relationship of A) The distal fusion level B)
      The total length of fusion and the post-operative range of motion in the unfused vertebral
      segments below the fusion in patients with Adolescent Idiopathic Scoliosis.
    

Detailed description: 
      The motion behavior in the unfused segments of the spine following instrumentation is poorly
      understood and the implications of hyper or hypo-mobility have not been clearly defined. The
      purpose of this study is to evaluate the relationship of A) The distal fusion level B) The
      total length of fusion and the post-operative range of motion in the unfused vertebral
      segments below the fusion in patients with Adolescent Idiopathic Scoliosis to answer the
      following specific clinical questions:

        1. Further elucidate the motion behavior of the distal unfused spinal segments,
           specifically:

             1. Does motion differ at various post-operative time points (2 year post-op patients
                versus 5 or 10 year post-op patients)?

             2. Can predictive factors be identified with post-operative altered motion?

        2. Further elucidate the relationship of the motion in the unfused spinal segments to the
           lowest instrumented vertebrae.

        3. Determine the relationship of the total length of fusion to the motion in the unfused
           spinal segments (i.e. compare unfused motion in the distal unfused segments in Lenke 5/6
           patients fused selectively (ThL/L only) versus nonselectively (TH and ThL/L)).

        4. Determine the relationship between clinical examinations (i.e. reports of pain or
           functional limitations) and patient reported outcomes (Health Related Quality of Life
           Outcome Tools) to motion in the distal unfused segments.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who present to the investigator's clinic, who meet the inclusion criteria will be
        offered enrollment in the study
      
Keywords: Adolescent Idiopathic Scoliosis; Spinal Deformity; Treatment Outcomes
A Study on Radiation-induced Pulmonary Fibrosis Treated With Clinical Grade Umbilical Cord Mesenchymal Stem Cells
Condition: Post-radiotherapy Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Radiation therapy is one of the main means for treating malignant tumor, during which
      radioactive lung injury is inevitable. Currently there is nearly no effective clinical
      treatment for late post-radiotherapy pulmonary fibrosis. This study intends to carry out an
      open, single-center, non-randomized phase I clinical trial. During the treatment, the local
      lesions will be fully lavaged, and then clinical grade umbilical cord mesenchymal stem cells
      (MSCs) will be injected directly into the lesion by fiberoptic bronchoscopy. After six-month
      observation, the investigators will initially evaluate the safety and effectiveness of the
      treatment by measuring two key indicators-the CT density histogram and the patients'
      self-evaluation, and one secondary indicator-the changes of TGF-β1 contents, both before and
      after the treatment. Meanwhile, the investigators will make a preliminary discuss about the
      possible immunomodulatory effects of the umbilical cord MSCs.
    


Intervention name(s): clinical grade umbilical cord mesenchymal stem cells
Intervention type(s): Biological
Intervention description(s): 10^6 (1 million) /Kg/person cells of clinical grade umbilical cord MSCs will be injected after fully lavage of the localized lesions
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: radiation-induced pulmonary fibrosis; MSCs
HP Improves Sleep and Overall Survival Rate in Maintenance Hemodialysis Patients
Condition: Hemoperfusion
Study type: Interventional

Summary: 
      Sleep disturbance has been long-standing torments in most of patients with maintenance
      hemodialysis (HD). In this study, we attempted to explore whether long-term hemoperfusion
      (HP) could improve sleep disorder and increase overall survival rate in HD patients.
    


Intervention name(s): hemoperfusion(HP)
Intervention type(s): Device
Intervention description(s): These patients were computer-matched into two groups, involving 100 patients with absolute HD vs. 100 cases with HD+HP.HP was performed 1-2 times/per 2 weeks, and each session lasted for two hours.Self-reported sleep disturbance was evaluated before and after observational time (two-year period), which lasted at least 7 hours based on the recommendations presented by National Institute of Health (NIH). Sleep efficiency (%) was calculated as the ratio of sleep duration to total time in bed, and was multiplied by 100.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Lactobacillus Reuteri and Nystatin Prophylaxis on Candida Colonization and Infection in Very Low Birth Weight Infants
Condition: Very Low Birth Weight Infants
MeSH terms: Birth Weight
Study type: Interventional
Phase: Phase 4

Summary: 
      Probiotics are favorable microorganisms that regulate the flora of the gastrointestinal
      system and stimulate the immune system. Lactobacillus reuteri was shown to reduce candida
      colonization. The objective of this study is to evaluate the efficacy of prophylactic
      Lactobacillus reuteri in reducing the candida colonization and infection in very low birth
      weight infants.
    


Intervention name(s): Lactobacillus reuteri; Nystatin
Intervention type(s): Dietary Supplement; Drug
Intervention description(s): Lactobacillus reuteri 100 million CFU/day for 3 months; 50000 unit/3 times a day, both for orally and by orogastric route
Other intervention name(s): BioGaia; Mikostatin
Intervention MeSH terms: Nystatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Lactobacillus reuteri; Nystatin; Very Low Birth Weight Infants; Candida Colonization
A Real-World Evidence Study to Evaluate Oral Health Related Quality of Life Using an Anti-Sensitivity Toothpaste
Condition: Dentin Sensitivity
MeSH terms: Dentin Sensitivity; Hypersensitivity
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate changes in oral health-related quality of life
      (OHrQoL) in participants suffering from Dentinal Hypersensitivity (DH) symptoms following the
      use of anti-sensitivity toothpaste for 24 weeks.
    

Detailed description: 
      This study will be a virtual, prospective, twenty-four weeks, open label study in
      participants with DH (self-reported symptoms). Participants self-perception of DH will be
      evaluated by completion of a validated OHrQoL questionnaire (Dentin Hypersensitivity
      Experience Questionnaire-48 [DHEQ-48]) at baseline, 4, 8, 12, 16, 20 and 24 weeks.
    

Intervention name(s): Potassium Nitrate + Sodium Fluoride
Intervention type(s): Other
Intervention description(s): Potassium Nitrate 5% weight/weight (w/w) and Sodium Fluoride 0.15% weight/volume (w/v) fluoride ion.
Intervention MeSH terms: Listerine; Fluorides; Sodium Fluoride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Olanzapine vs. Low-dose Olanzapine Plus Trifluoperazine
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators hypothesis is that an antipsychotic drug combination of low-dose olanzapine
      plus low-dose trifluoperazine is similar to regular-dose olanzapine monotherapy in efficacy
      and safety for treatment of schizophrenia.The goal of this study is to compare the efficacy
      and safety of the olanzapine (10 mg/d) and olanzapine (5 mg/d) plus trifluoperazine (5 mg/d)
      in the treatment of acute psychotic exacerbations of schizophrenia.
    

Detailed description: 
      Antipsychotic monotherapy is recognized as the treatment of choice for patients with
      schizophrenia. Surveys have shown that antipsychotic polypharmacy are frequently prescribed,
      yet few randomized, double-blind clinical trials have examined this practice. Olanzapine, an
      atypical antipsychotic agent, has low incidence of extrapyramidal symptom but with high cost
      compared to trifluoperazine. It has been reported that mean doses of typical antipsychotics
      less than 600 mg per day of chlorpromazine or its equivalent has no higher risk of
      extrapyramidal symptom than atypical antipsychotics. The objective of the study is to compare
      the efficacy and safety of the olanzapine (10 mg per day) and olanzapine (5 mg per day) plus
      trifluoperazine (5 mg per day) in the treatment of acute psychotic exacerbations of
      schizophrenia. In this 6-week, double-blind, fixed-dose study, patients with schizophrenia
      are randomly assigned to olanzapine (10 mg per day)) or olanzapine (5 mg per day) plus
      trifluoperazine (5 mg per day). The hypothesis is that the two treatment groups have the
      similar efficacy and safety, but different cost. The primary efficacy measure is change from
      baseline in Positive and Negative Syndrome Scale (PANSS) total scores; secondary outcomes
      include Clinical Global Impression-Severity (CGI-S), the Calgary Depression Scale for
      Schizophrenia (CDSS), Global Assessment of Functioning Scale (GAF), Short Form-36 (SF-36),
      Mini Mental State Examination (MMSE). Safety assessments include the change from baseline on
      Simpson-Angus Rating Scale (SAS), Abnormal Involuntary Movement Scale (AIMS), Barnes
      Akathisia Scale (BAS), and UKU Side-effects Rating Scale, and the change from baseline in
      prolactin levels, body weight, vital sign, blood pressure, Bazett's correction of QT interval
      (QTc interval), fasting glucose level, and lipid panel (cholesterol, high density lipid
      protein, low density lipid protein, and triglyceride).
    

Intervention name(s): full-dose olanzapine
Intervention type(s): Drug
Intervention description(s): trifluoperazine 5mg/d
Other intervention name(s): polypharmacy
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: schizophrenia; olanzapine; trifluoperazine; antipsychotic polypharmacy
Forced Oscillation Technique (FOT) and Expiratory Flow Limitation (EFL)
Condition: COPD
Study type: Observational

Summary: 
      The aim of this study is to distinguish COPD patients with expiratory flow limitation in body
      plethysmography (open loop) from the patients without expiratory flow limitation in body
      plethysmography (closed loop) with the obtained FOT parameters.
    

Detailed description: 
      In daily practice the expiratory flow limitation is measured by body plethysmography. An open
      loop in body plethysmography shows expiratory flow limitation in COPD patients. But body
      plethysmography requires that the patient quietly sits in a closed box and is not able to
      follow changes breath by breath. The goal of this study is to validate the Forced oscillation
      technique (FOT) for measuring expiratory flow limitation in COPD patients.30 COPD patients
      with an open loop in body plethysmography are compared to 30 COPD patients with a closed
      loop. The methods used in this study are the maximal overlap discrete short time Fourier
      transform (MODFT) combined with a total least squares analysis. It is hypothesized that the
      obtained FOT parameters are able to distinguish the patients with expiratory flow limitation
      in body plethysmography from the patients without expiratory flow limitation in body
      plethysmography.Secondary study questions are: 1) to what extend are the FOT parameters
      distorted by breathing artifacts and measurement noise. 2)What changes can be detected by FOT
      in expiratory flow limitation after administration of salbutamol.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Stable GOLD 2-4 COPD patients
      
Keywords: Forced oscillation Technique (FOT); Expiratory flow limitation (EFL); Breathing artifacts; COPD
To Assess the Bioequivalence of Brotizolam Tablets 250 Mcg vs. Lendormin Tablets 250 Mcg Administered to Healthy Adult Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of the study was to assess the bioequivalence of Lendormin Tablets (Delpharm
      Reims) vs. Lendormin Tablets (Synmosa Biopharma Co. Ltd.) following oral administration
    


Intervention name(s): Lendormin tablet; Brotizolam tablet
Intervention type(s): Drug; Drug
Intervention description(s): Lendormin tablet 250mc is administrated and compared; Brotizolam tablet 250mc is administrated and compared
Intervention MeSH terms: Brotizolam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment