bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Effectiveness of BIOSURE RG in Cruciate Ligaments Reconstruction in Chinese
Condition: Cruciate Ligament Reconstruction; Knee
Study type: Interventional

Summary: 
      The objective of this study is to compare the safety and effectiveness of Biosure Regenesorb
      Interference Screw versus BIOSURE HA Interference Screw (control device) in patients
      requiring reconstruction of cruciate ligaments of the knee. The trial results will be used
      for registration of Biosure Regenesorb Interference Screw in China.

      The primary efficacy endpoint of this study is Lysholm score at 12 months after operation.
      The non-inferiority testing is performed for efficiency of primary efficacy endpoint, and the
      test hypothesis is as follows:

      Invalid hypothesis: H0: μ1-μ2 ≤-δ Alternative hypothesis: H1: μ1-μ2 > -δ, where, μ1 and μ2
      are the Lysholm scores in the investigational group and control group, respectively. δ is a
      non-inferiority critical value.
    

Detailed description: 
      The clinical trial is designed to be a prospective, multi-center, randomized,
      evaluator-blinded, parallel-controlled, non-inferiority trial.
    

Intervention name(s): Investigational device: Biosure Regenesorb Interference Screw; Control device: BIOSURE HA Interference Screw
Intervention type(s): Device; Device
Intervention description(s): The Biosure Regenesorb Interference Screw, an absorbable screw designed with an open structure and made of biocomposite material made of PLGA, β-TCP and calcium sulfate, is used to fix ligaments, tendons, soft tissues or bone-tendon-bone grafts in knee surgery. Its open structural design enables rapid bone ingrowth to make the screw integrated with bone tissues so as to promote healing.; BIOSURE HA Interference Screws and Drivers are designed for durability and reduced screw breakage. Both the screws and driver have been enhanced to allow screws to fully seat on the driver all the way to the tip of the screw, helping stress distribution and force transfer. The screw design also incorporates a consistent wall thickness throughout the length of the screw for added durability and features a tapered body for ideal ease of insertion.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Biosure Regenesorb; Chinese; Cruciate ligaments reconstruction; Prospective; Randomize; Evaluator-blinded
Circadian Modulation of Grape Consumption and Oxidative Stress Response
Condition: Oxidative Stress
Study type: Interventional

Summary: 
      This study investigated the effects of time-of-day of grape consumption on high-fat
      meal-induced oxidative stress.
    

Detailed description: 
      Grape consumption acts on the immune system to produce antioxidant and anti-inflammatory
      effects. Since immune activity demonstrates circadian rhythmicity, with peak activity
      occurring during waking hours, the timing of grape intake may influence the magnitude of its
      antioxidant effect. This study followed a 2 x 2 factorial randomized, controlled design
      wherein healthy men and women (n = 32) consumed either a grape or placebo drink with a
      high-fat meal in the morning or evening. Urine was collected for measurements of biomarkers
      of oxidative stress and grape metabolites at baseline and post-meal at hour 1 and hours 1-6
    

Intervention name(s): Grape
Intervention type(s): Other
Intervention description(s): Reconstituted whole grape powder
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Basic Science
CD19 CAR T Cells in Patients With Relapsed or Refractory CD19 Positive B-cell Lymphoma
Condition: Lymphomas Non-Hodgkin's B-Cell; Relapse
MeSH terms: Lymphoma; Lymphoma, B-Cell; Recurrence
Study type: Interventional
Phase: Phase 1

Summary: 
      In this single-center, open-label, no control, prospective clinical trial, a total of 10
      relapsed or refractory CD19 positive B-cell Non-Hodgkin Lymphoma (NHL) patients will be
      enrolled.CD19 CAR T cells(total dose of 2×10^6/kg-1×10^7/kg) will be intravenously infused to
      patient in a three-day split-dose regimen: 10% on day 0, 30% on day 1 and 60% on day 2. The
      purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells
      in patients with relapsed or refractory CD19 positive B-cell lymphoma.
    

Detailed description: 
      In this single-center, open-label, nonrandomized, no control, prospective clinical trial, a
      total of 10 relapsed or refractory CD19+ B-cell Non-Hodgkin Lymphoma (NHL) patients will be
      enrolled. CD19 CAR T cells transduced with a lentiviral vector to express anti-CD19 scFv
      TCRζ:4-1BB, will be administered by i.v. injection in a three-day split-dose regimen: 10% on
      day 0, 30% on day 1 and 60% on day 2. Side effects of CD19 CAR T cells therapy will be
      monitored. The purpose of current study is to determine the clinical efficacy and safety of
      CD19 CAR T cells therapy in patients with relapsed or refractory CD19 positive B-cell
      lymphoma.
    

Intervention name(s): CD19 CAR T cells
Intervention type(s): Biological
Intervention description(s): CD19 CAR T cells was transduced with a lentiviral vector to express anti-CD19 scFv TCRζ:4-1BB.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: lymphoma; non-hodgkin; B-cell; CD19 CAR T cells; refractory; relapse
A Trial Investigating the Influence of Oral Semaglutide on the Pharmacokinetics of Levothyroxine and the Influence of Co-administered Tablets on the Pharmacokinetics of Semaglutide Administered Orally in Healthy Subjects.
Condition: Diabetes; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the influence of
      oral semaglutide on the pharmacokinetics (the exposure of the trial drug in the body) of
      levothyroxine and the influence of co-administered tablets on the pharmacokinetics of
      semaglutide administered orally in healthy subjects.
    


Intervention name(s): Semaglutide; SNAC; Levothyroxine; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Oral administration once daily alone or together with levothyroxine or Placebo; Oral administration once daily alone or together with levothyroxine or semaglutide; Oral administration alone or together with SNAC or oral semaglutide; Oral administration once daily together with semaglutide
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Lung and Gut Microbiome in Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      Increasing evidence have implied that microbiota from airway and gut might be involved in the
      pathogenesis of chronic obstructive pulmonary disease (COPD). However, the cross-talk between
      respiratory and gastrointestinal microbiome in COPD is still undetermined. The study is aimed
      to investigate the interaction between lung and gut flora, and their role in the process of
      COPD.
    

Detailed description: 
      Despite the high prevalence of chronic obstructive pulmonary disease (COPD), there continues
      to be a large gap in our understanding of disease pathogenesis and mechanisms accounting for
      large variability in disease phenotype. Cigarette smoking is the principal cause of COPD, but
      only approximately 15% of adults with substantial tobacco exposure develop clinical COPD.
      Besides, bacterial colonization or infection is also considered as an important factor in
      COPD. There are very limited data from microbiome studies that suggest that respiratory and
      gastrointestinal microbiota may be involved in the pathogenesis of COPD. However, the
      cross-talk between between lung and gut microbiome, and their relationship with various
      clinical phenotypes of COPD. Here, we conducted 16S rRNA-based pyrosequencing to evaluate the
      link between the lung-gut axis and the clinical phenotypes of COPD, such as lung function,
      emphysema, symptoms, exacerbations, inflammation levels and metabolic features.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Clinically stable patients with COPD and controls without COPD are enrolled.
      
Biospecimen description: 
      Throat swab, induced sputum, bronchoalveolar lavage fluid (BALF) and faeces
Evaluation of Bioavailability of Diclofenac Dermal Products
Condition: Bioavailability
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The study will utilize already FDA-approved marketed diclofenac products in healthy adults to
      generate data for establishing rate of drug delivery comparisons between diclofenac epolamine
      patches and diclofenac sodium solution in healthy adults and to determine skin
      concentrations.
    

Detailed description: 
      The study will utilize already FDA-approved marketed diclofenac products in healthy adults to
      generate data for establishing rate of drug delivery comparisons between diclofenac epolamine
      patches and diclofenac sodium solution in healthy adults and to determine skin
      concentrations. This study supports FDA's continuing effort to identify the most accurate,
      sensitive, reproducible and efficient methods to evaluate topical dermatological drug
      products.
    

Intervention name(s): Diclofenac Epolamine Patch; diclofenac sodium solution
Intervention type(s): Drug; Drug
Intervention description(s): patch; solution
Other intervention name(s): patch; solution
Intervention MeSH terms: Diclofenac; Diclofenac hydroxyethylpyrrolidine; Pharmaceutical Solutions
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: The same 12 volunteers received all treatments in three separate study arms.
Masking: None (Open Label)
Primary purpose: Other
Study in Healthy Male Subjects to Demonstrate Bioequivalence of 1600 μg Selexipag Administered as Eight Tablets of 200 μg or as Single Tablet of 1600 μg
Condition: Bioequivalence
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary aim of this study is to demonstrate bioequivalence in the rate and extent of
      absorption between 1600 μg selexipag test drug (administered orally as film-coated tablets of
      1600 μg, twice a day (b.i.d.) and 1600 μg selexipag reference drug (administered orally as 8
      film-coated tablets of 200 μg b.i.d.) at steady-state in healthy male subjects following a
      multiple-dose up-titration scheme.
    


Intervention name(s): selexipag
Intervention type(s): Drug
Intervention MeSH terms: Selexipag
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: selexipag; ACT-333679
Comparison of Diagnostic Accuracy for Predicting Histology of Colorectal Lesions
Condition: Colorectal Neoplasms
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      Chromoendoscopy (indigo carmine or acetic acid) and Narrow Band Imaging (NBI) could make
      accurate evaluation in predicting of invasive depth of colorectal neoplasia. NBI could be the
      first choice.
    

Detailed description: 
      To compare the diagnostic accuracy of chromoendoscopy indigo carmine or acetic acid and NBI
      for differentiating neoplastic from non-neoplastic colorectal lesions, differentiating
      adenomas from carcinomas, and differentiating early carcinomas from invasive ones.

      Included colorectal lesions consecutively distribute in a 1:1 ratio to 2 groups.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        consecutive adult patients undergoing colonoscopy and find out more than one lesion ≧ 6mm
        from Jan 2009 to Dec 2010.
      
Biospecimen description: 
      All the lesions will be removed endoscopically or surgically and examine histologically by an
      independent gastrointestinal pathologist.

      Histological diagnosis is determined according to the World Health Organization (WHO)
      criteria. Pedunculated lesions are categorized according to Haggitt's classification.
    
Keywords: narrow band imaging（NBI）; indigo carmine; acetic acid; colorectal lesions; predicting histology
Ivermectin Solution Bioequivalence Study - With Food (Repeat)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to compare the pharmacokinetic and bioavailability profile
      (rate and amount of absorption into the bloodstream) of a test formulation of Ivermectin
      solution 1 mg/ml with a marketed reference formulation of Ivermectin 3 mg tablets when taken
      after a standard meal. The study is designed in accordance with the EU Note for Guidance on
      the Investigation of Bioavailability and Bioequivalence 2001.
    

Detailed description: 
      Ivermectin is an antiparasitic medicine (i.e. a medicine used to eliminate parasitic worms)
      for oral administration, and is approved in the US and some other countries in a tablet form.
      A new liquid formulation of ivermectin has been developed to facilitate dosing. This is a
      single dose, randomised, crossover study in healthy adult male and female volunteers, with
      doses taken 20 minutes after a standard breakfast. Doses will separated by washout period of
      at least 14 days. Twenty-one blood samples will be taken from each volunteer over 144 hours
      in each period. Concentrations of Ivermectin in plasma will be measured using a validated
      chromatographic assay (LC-MS/MS). Standard pharmacokinetic parameters will be obtained and
      bioequivalence on the basis of rate and extent of drug absorption will be assessed.
    

Intervention name(s): ivermectin
Intervention type(s): Drug
Intervention description(s): Each subject will receive single doses of (i) 22.5 ml ivermectin oral solution (22.5 mg) and (ii) 10 x 3 mg tablets of ivermectin (30 mg) in 2 separate dosing periods. Doses will be administered 20 minutes after a standard breakfast.
Other intervention name(s): Stromectol
Intervention MeSH terms: Ivermectin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: therapeutic equivalency; pharmacokinetics; food; Healthy volunteers
A Pilot Trial of Modafinil for Treatment of Methamphetamine Dependence
Condition: Methamphetamine Addiction
MeSH terms: Behavior, Addictive
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients treated for methamphetamine dependence have high rates of relapse, and no
      pharmacotherapy has yet been demonstrated to be efficacious. Modafinil (d,
      l-2-[(diphenylmethyl) sulfinyl] acetamide) is a novel wake- and vigilance- promoting agent
      that is chemically and pharmacologically dissimilar to CNS stimulants such as the
      amphetamines, methylphenidate, and pemoline. It is well tolerated and has low abuse liability
      compared to CNS stimulants. Modafinil is FDA approved for a variety of sleep disorders, may
      relieve methamphetamine withdrawal symptoms, improves cognitive function, has been shown to
      reduce cocaine use in dependent users, and is safe when co-administered with intravenous
      methamphetamine. We will conduct a pilot, open-label clinical trial of modafinil to establish
      its safety and efficacy as a pharmacotherapy for methamphetamine dependence.

      Specific Aims:

        1. Determine the safety of modafinil in the treatment of methamphetamine dependence.

        2. Determine the efficacy of modafinil in the treatment of methamphetamine dependence.

        3. Assess the effect of modafinil on cognitive function in methamphetamine users.

        4. Assess the effect of modafinil on methamphetamine withdrawal symptoms.

        5. Compare the validity of a cellular telephone-based reporting system for assessing
           medication regimen adherence to conventional electronic medication monitoring.

      Hypotheses:

        1. Modafinil will be as safe and well tolerated as placebo in a comparison group from
           another study.

        2. Subjects given modafinil will use less methamphetamine than subjects given placebo.

        3. Subjects given modafinil with demonstrate improvements in cognitive function when
           compared to subjects given placebo.

        4. Subjects given modafinil will have reduced withdrawal symptoms when compared to subjects
           given placebo.

        5. Adherence will be recorded more accurately by cellular telephone than by conventional
           electronic medication monitoring.
    


Intervention name(s): modafinil
Intervention type(s): Drug
Intervention description(s): 400mg vs. 200mg (PO) daily
Other intervention name(s): Provigil
Intervention MeSH terms: Modafinil
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: amphetamine; methamphetamine; addition; treatment study; drug use; modafinil
Irrigating Fluid and Blood Coagulation
Condition: Blood Coagulation Disorder
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Observational

Summary: 
      Irrigating fluid absorbed during the endoscopic surgery may alter whole blood coagulation.
      However, little is known about the dose-response relationships of hemodilution. The
      investigators have therefore performed the present study to measure the effect of a mixture
      of 2.7% sorbitol-0.54% mannitol solution on the coagulation pathway according to the
      hemodilution level using a rotational thromboelastometry (ROTEM®) tests.
    


Intervention name(s): A mixture of 2.7% sorbitol-0.54% mannitol solution
Intervention type(s): Other
Intervention description(s): Venous blood was taken from 12 healthy volunteers and divided into four specimen bottles, which were diluted with different levels (0%, 10%, 20%, and 40%) using a mixture of 2.7% sorbitol-0.54% mannitol solution.
Intervention MeSH terms: Mannitol; Sorbitol
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Healthy volunteers
A Study of RG7667 in Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, double-blind, placebo-controlled study will evaluate the safety and
      pharmacokinetics of RG7667 in healthy volunteers. Subjects will be randomized in cohorts to
      receive either single/multiple doses of RG7667 intravenously or placebo. Anticipated time on
      study treatment is up to 57 days with a 12-week follow-up.
    


Intervention name(s): Placebo; RG7667
Intervention type(s): Drug; Drug
Intervention description(s): Single/multiple doses; Single/multiple ascending doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Pelvic vs Virtual Reality Simulator
Condition: Laparoscopic Training
Study type: Interventional

Summary: 
      The aim of this study is to evaluate the proper sequence of Pelvic trainer and VR simulator
      training in order to improve gynecological laparoscopic skills and assess training levels.
    

Detailed description: 
      In this study, the investigators will determine the proper sequence of simulation training.
      Pelvic Trainer Versus Virtual reality Simulator in order to improve laparoscopic skills of
      residents with no or little previous laparoscopic experience.

        -  This study will compare the proper sequence of simulation training. Pelvic Trainer
           Versus Virtual reality Simulator of two groups: Group A versus Group B.

        -  Group A will start training on the pelvic trainer (training on educational intervention
           1) and assessment will be via assessment via a checklist (test 1). Then at a later time,
           they will be trained on VR simulator (Sim Surgery) (educational intervention 2) and
           assessment will be via Electronic auto assessment via the Simulator (test 2).

        -  Group B will start training on the VR simulator (Sim Surgery) (educational intervention
           2) and assessment will be via Electronic auto assessment via the Simulator (test 2).
           Then at a later time, they will be trained on the pelvic trainer (training on
           educational intervention 1) and assessment will be via assessment via a checklist (test
           1).
    

Intervention name(s): Virtual reality Simulator; Pelvic trainer:
Intervention type(s): Device; Device
Intervention description(s): LapSim is a device designed by Surgical Science Device & software at Swedan; Video-box trainers include a box with a lid and holes cut on the lid for the trocar's insertion. A laparoscope inside the box is connected with a digital camera and provides video output to a monitor on which the trainees are watching their own movements, while performing the teaching task. Laparoscopic instruments, such as laparoscopic graspers and laparoscopic scissors are inserted through the trocars into the box, where the tasks are taught
Other intervention name(s): LapSim
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Simulation training; Pelvic trainer; Virtual reality Simulator
Bioequivalence Study of Tetrabenazine Tablets 25 mg Under Fasting Conditions
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, randomized, four-period, two-treatment, two-sequence, balanced, single
      dose, crossover, oral bioequivalence study in healthy, adult, human subjects under fasting
      conditions.
    

Detailed description: 
      An open label, balanced, randomized, two-treatment, four-period, two-sequence, single dose,
      crossover, fully replicated oral bioequivalence study of Tetrabenazine Tablets 25 mg of Dr.
      Reddy's Laboratories Limited, India comparing with XENAZINE® (tetrabenazine) Tablets 25 mg of
      Lundbeck Inc., USA in healthy, adult, human subjects under fasting conditions.
    

Intervention name(s): Tetrabenazine Tablets 25 mg
Intervention type(s): Drug
Other intervention name(s): Xenazine
Intervention MeSH terms: Tetrabenazine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment