bioihbjkbjnl/mcl2 huggingface dataset:
The Comparative Study Between Bowel Preparation Method
Condition: Colonoscopy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the efficacy, acceptability and preparation-induced
      mucosal inflammation of PEG + ascorbic acid vs. PEG for colonoscopy.
    

Detailed description: 
      This was a prospective randomized single-blinded clinical trial of ambulatory patients to
      assess the efficacy of bowel preparation and preparation-induced mucosal inflammation.

      Endoscopists who were blinded to the preparation taken, assessed both bowel cleansing by
      using the Ottawa bowel preparation assessment tool and preparation-induced mucosal
      inflammation. Acceptability was assessed by questionnaire.
    

Intervention name(s): Colonoscopy after bowel cleansing
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Keywords: BOWEL PREPARATION; PEG; Low-volume PEG Plus Ascorbic Acid
Cell Therapy for Venous Leg Ulcers Pilot Study
Condition: Venous Ulcer
MeSH terms: Varicose Ulcer; Leg Ulcer; Ulcer
Study type: Interventional
Phase: Phase 1

Summary: 
      Chronic venous leg ulcers (CVU) represent a medical problem associated with significant
      morbidity, increased work absenteeism and earlier retirement as a consequence of disability.
      This strongly affects the patient's quality of life and has a significant economic impact on
      healthcare systems.

      Reports of studies with animal models show that treatment with bone marrow-derived stem cells
      has a beneficial effect in healing chronic skin wounds.

      The purpose of this pilot study is to determine the safety and feasibility of cell therapy
      with bone marrow derived cells (BMDC) as a complementary healing therapy in chronic venous
      leg ulcers, and in addition to evaluate its effectiveness. The knowledge gained in the pilot
      study will be used to refine the clinical protocol procedures of a subsequent randomized
      study.

      Patients with venous legs ulcers meeting eligibility criteria and providing appropriate
      written informed consent will be enrolled for study participation. Enrolled patients will
      receive Autologous BMDC implantation at de venous ulcer in conjunction with standard of care
      (SOC) treatment.

      During follow up, adverse events will be assessed by ulcer clinical examination.
      Effectiveness of the experimental treatment will be assessed by evaluating ulcer healing
      (reduction of the ulcer area) and pain reduction over a six-month period.
    


Intervention name(s): Autologous BMDC implantation at the venous ulcer
Intervention type(s): Biological
Intervention description(s): An autologous bone marrow derived cell concentrate is obtained by bone marrow harvest (300 ml) from the iliac crest and subsequent processing using 6% hydroxyethyl starch to concentrate nucleated cells. The cells are injected using a 27 Gauge needle, in aliquots of 0.2 ml, along the venous ulcer edge. SOC treatment consisting of advanced wound management plus pressure therapy is administered simultaneously.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Venous ulcer; Cell therapy
The Effect of Sugammadex on the Outcome After Colorectal Cancer Surgery
Condition: Outcome, Fatal
MeSH terms: Colorectal Neoplasms
Study type: Observational

Summary: 
      This study is retrospective study. The purpose of this study is checking the effect of
      sugammadex on the outcome after colorectal surgery. The outcome is compared among the 2
      groups, sugammadex group and non-sugammadex group. The primary parameters of outcome are
      length of stay, readmission rate, postoperative complications, time interval for first
      successful oral intake.
    

Detailed description: 
      Abdominal surgery, like colorectal surgery, needs more than moderate neuromuscular block
      during surgery. After the surgery, reversal agent of neuromuscular blocking agent is given
      almost every pateints who underwent general anesthesia.

      Classic reversal agent is cholinesterase inhibitor, like pyridostigmine and neostigmine. Its
      action mechanism is competetive antagonist of rocuronium. But cholinesterase inhibitor cannot
      make complete reversal in moderate or deep neuromuscular block. Its incomplete reversal which
      is called residual block cause respiratory complications and prolongation hospital stay.

      Sugammadex has different mechanism compared to cholinesterase inhibitor. It captures
      neuromuscular agent, especially rocuronium, and prevent rocuronium's action. Even in deep
      neuromuscular block, sugammadex can reverse the action of rocuronium, and its reversal effect
      is fater and more reliable compared to cholinesterase inhibitor.

      Previous studies focused on only short term outcome of sugammadex, like postanesthetic care
      unit (PACU) discharge time, respiratory complications in PACU.

      But in this study, longer term outcome will be comapred between sugammadex group and
      cholinesterase inhibitor group (pyridostigmine).
    

Intervention name(s): Sugammadex
Intervention type(s): Drug
Intervention description(s): Sugammadex injection as a reverse agent of neuromuscular blocking
Other intervention name(s): Bridion
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients aged 21 and 80 years old, who took the colorectal surgery due to colorectal cancer
        from Jan, 2012 to Dec, 2017
      
Keywords: Sugammadex; Colorectal surgery; postoperative complication
Low-dose Rituximab Regimens in Chinese Adult Patients With Immune Thrombocytopenia
Condition: Immune Thrombocytopenic Purpura
MeSH terms: Thrombocytopenia; Purpura; Purpura, Thrombocytopenic, Idiopathic; Purpura, Thrombocytopenic
Study type: Interventional

Summary: 
      A comparative study with rituximab (100 mg weekly for 4 weeks and 375mg/m2 for once) shows
      low dose rituximab may be a useful alternative therapy in patients with ITP.The aim of this
      study is to compare the efficacy and tolerability of two different regimens of low doses
      rituximab for the treatment of adult patients with ITP.
    

Detailed description: 
      Hundreds of Patients without infection (age 18 to 60 years old) developed Chronic ITP. All
      patients will be enrolled in this study and will be randomly assigned to receive 100 mg
      rituximab weekly for 4 weeks (group A) or a single dose of 375 mg/m2 rituximab (group B).
      After treatment all patients will be followed for two years. During observation platelet
      count and B lymphocyte will be detected every month.
    

Intervention name(s): Rituximab
Intervention type(s): Drug
Other intervention name(s): Trade names Rituxan and MabThera
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Safety Study of LY3462817 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to determine how safe and how well tolerated LY3462817 is when
      given intravenously (IV) (into a vein) and subcutaneously (SC) (just under the skin) to
      healthy participants. Blood tests will be done to check how much LY3462817 is in the
      bloodstream and how long the body takes to get rid of it. Each enrolled participant will
      receive 1 dose of LY3462817 or placebo. The study will last about 16 weeks, including
      screening.
    


Intervention name(s): LY3462817 IV; LY3462817 SC; Placebo
Intervention type(s): Biological; Biological; Drug
Intervention description(s): Administered IV; Administered SC; Administered IV
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Generation of Biological Samples Positive to Salmeterol for Anti-Doping Control
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      Background:

      In terms of doping, there is controversy regarding the beneficial effects of β2-agonists like
      salmeterol on physical performance. Some studies show improvement with salmeterol
      administered orally, especially related to pulmonary function and muscle contractibility,
      while other works do not show such ergogenic effects of salmeterol by inhalation.

      Supratherapeutic use of salmeterol is prohibited by the World Anti-Doping Agency, but a
      maximum allowed urine concentration has not been determined.

      Urine concentrations of salmeterol are very low when administered at therapeutic doses, often
      below the lower limit of quantification. Some studies show that urine concentrations of
      α-hydroxy-salmeterol (the principal salmeterol metabolite) may be higher than those of the
      original drug. Thus, α-hydroxy-salmeterol might be a more suitable biomarker for detecting
      fraudulent use of this drug.

      Hypothesis:

      Inhaled administration of salmeterol in healthy subjects allows obtaining positive urine
      samples that will be used to identify analytical strategies for doping detection. Salmeterol
      concentrations and its metabolites (α-hydroxy-salmeterol and others) can be measured in
      urine.

      Objectives:

      Primary objective: To generate urine samples positive to salmeterol in order to be analyzed
      as control samples by anti-doping laboratories.

      Secondary objectives: To identify salmeterol metabolites (α-hydroxy-salmeterol and others) in
      urine.

      Methods:

      Phase I, open, non-randomized, uncontrolled clinical trial, with a treatment condition
      (salmeterol) administered daily by inhalation to 6 subjects during 3 consecutive days.
    


Intervention name(s): Salmeterol Xinafoate
Intervention type(s): Drug
Intervention description(s): Subjects receive a daily inhaled dose of 200 μg (4 inhalations of 50 μg each).
Intervention MeSH terms: Salmeterol Xinafoate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Salmeterol; Anti-doping control; Athletic performance
Safety and Efficacy of 333369 in the Treatment of Partial Epilepsy
Condition: Refractory Epilepsy
MeSH terms: Epilepsy; Drug Resistant Epilepsy
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to evaluate the efficacy, safety, and tolerability of
      4 daily doses of RWJ-333369 as adjunctive treatment of refractory partial epilepsy in
      subjects who are between 18 and 70 years of age, inclusive
    


Intervention name(s): RWJ-333369
Intervention type(s): Drug
Primary purpose: Treatment
Assessment of Walking-related Fatigability in Patients With Multiple Sclerosis.
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      The primary goal of this interventional study is to objectively examine the prevalence of
      walking-related performance fatigability, together with the psychometric properties of its
      measuring parameters. The secondary aim is to investigate the relation of other clinical
      symptoms to walking-related performance fatigability.

      The following three research questions will be addressed:

        1. How prevalent is walking-related performance fatigability and what are the psychometric
           properties of fatigability formulas in preparation of use as experimental outcome
           measure?

        2. What are associated symptoms of walking-related motor fatigability and how long does
           this manifest?

        3. What is the relationship between cognitive fatigability and walking-related performance
           fatigability?

      participants perform two six-minute walking test (6MWT), with 3-5 days in between. Before and
      after the 6MWT, three screenings test (spasticity, muscle strength, balance) are executed and
      the participants have to indicate the severity of eleven possible symptoms (= symptom
      inventory, SI) on a VAS scale. These screening tests and SI are continued every 10 minutes
      for half an hour. During a third test session, participants perform a 6-minute vigilance
      alphabet test in rest and while doing a 6MWT to investigate the relationship between
      cognitive and motor fatigability.
    


Intervention name(s): Assessment of walking-related fatigability
Intervention type(s): Diagnostic Test
Intervention description(s): participants perform two six-minute walking test (6MWT), with 3-5 days in between. Before and after the 6MWT, three screenings test (spasticity, muscle strength, balance) are executed and the participants have to indicate the severity of eleven possible symptoms (= symptom inventory, SI) on a VAS scale. These screening tests and SI are continued every 10 minutes for half an hour. During a third test session, participants perform a 6-minute vigilance alphabet test in rest and while doing a 6MWT to investigate the relationship between cognitive and motor fatigability.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Immediate Dentoalveolar Restoration Compared to Bio-oss
Condition: Fresh Sockets With Buccal Resorption
Study type: Interventional

Summary: 
      This randomised controlled trial compares the immediate dentoalveolar restoration and bovine
      demineralised bone in immediate implants placed in fresh sockets with buccal resorption. A
      total of 34 patients will be included and followed clinically and radiographically for 18
      months. Patient centred outcomes will also be evaluated.
    


Intervention name(s): Immediate dentoalveolar restoration; Demineralized bovine bone
Intervention type(s): Procedure; Procedure
Intervention description(s): Block of bone removed from the tuber and placed in the buccal resorption of the socket together with an immediate implant; Block of demineralised bovine bone placed in the buccal resorption of the socket together with an immediate implant
Other intervention name(s): IDR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: immediate dentoalveolar restoration; bio-oss; immediate dental implant; bovine bone
Study of Pidotimod in Children With Recurrent Respiratory Tract Infections (RRI)
Condition: Recurrent Respiratory Tract Infections
MeSH terms: Infections; Communicable Diseases; Respiratory Tract Infections; Recurrence
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess the efficacy of pidotimod as treatment in participants
      with recurrent respiratory tract infections.
    


Intervention name(s): Pidotimod; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be randomized in ratio of 1:1 to receive Pidotimod 400 milligrams (mg), once daily (no infection present) or twice daily (infection present) orally up to Day 60 during the double-blind treatment period.; Participants will be randomized in ratio of 1:1 to receive placebo matched to Pidotimod, once daily (no infection present) or twice daily (infection present) orally up to Day 60 during the double-blind treatment period.
Intervention MeSH terms: Pidotimod
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pidotimod; Recurrent Respiratory Tract Infections; Pediatrics Study
A Study of LY2922470 in Healthy Participants and Participants With Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this trial is to evaluate the safety of the study drug in healthy participant and
      participant with diabetes. It will investigate how much of the study drug gets into the blood
      stream and how long it takes the body to get rid of it. Information about any side effects
      that may occur will also be collected.

      The study consists of two parts. Part A will study healthy participants in up to 4 dosing
      periods over approximately 6 weeks. Part B will study participants with diabetes in up to 3
      dosing periods over approximately 5 weeks.
    


Intervention name(s): Placebo; LY2922470
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally as capsules; Administered orally as capsules
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
The Use of a Probiotic Lozenge in the Treatment of Peri-implantitis
Condition: Peri-implantitis
MeSH terms: Peri-Implantitis
Study type: Interventional

Summary: 
      This studies aims to investigate the effect of a probiotics in peri-implantitis patients as
      an adjunct to non-surgical therapy.
    

Detailed description: 
      This studies aims to investigate the effect of a probiotics in peri-implantitis patients as
      an adjunct to non-surgical therapy.

      Study design: This study will be a single centre (Department of Oral Health Sciences,
      University Hospitals Leuven), double blind randomized, placebo controlled clinical trial. The
      randomization (by means of a computer program) and double blind design are thought to
      minimize the bias of the investigator and patients.

      Selection of the study population: Adults, who consult at the departement of Periodontology
      at the University Hospital Leuven, with peri-implantitis and who fit the inclusion criteria
      will be asked to participate in this study.
    

Intervention name(s): Probiotic - BioGaia; Placebo
Intervention type(s): Other; Other
Intervention description(s): Use of a probiotic tablet; Use of a placebo tablet
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Detection and Characterisation of Varicella Zoster Virus From Dermal Lesions of Chickenpox-infected Patients
Condition: Varicella
MeSH terms: Chickenpox; Herpes Zoster
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is conducted in order to collect clinical samples from patients who are diagnosed
      of having chickenpox infection. The results of this study will provide basic scientific
      information about chickenpox disease.
    

Detailed description: 
      The study involves NO therapeutic or prophylactic treatment nor further observation of the
      patients. There is no product to be tested in this study.
    

Intervention name(s): Collection of clinical samples
Intervention type(s): Procedure
Intervention description(s): The following samples were obtained from each subject:
Vesicle fluid (VF) and vesicle swabs (VS) from four vesicles (for a total of eight samples)
Papule swabs (PS) from four papules
Crusts from two lesions
One throat swab (TS) Up to 15 samples were to be obtained for each subject, when possible. VFs, VSs, PSs, and crusts were either stored dry or in liquid medium. TS samples were stored in liquid medium.
After extraction of DNA, samples were tested for the presence of varicella virus using a Quantitative Polymerase Chain Reaction (Q-PCR) technique.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study of RAY1216 Tablets Compared With Placebo in Patients With Mild to Moderate COVID-19
Condition: Mild to Moderate COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, randomized, double-blind, placebo-controlled clinical trial to assess
      the efficacy and safety of RAY1216 tablets in the treatment of mild to moderate SARS-CoV-2
      infection. The total study duration is up to 28 days.
    


Intervention name(s): RAY1216; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): RAY1216（tablet）; placebo （tablet）
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Anti-COVID19 AKS-452 Fusion Protein Vaccine - ACT Study
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Combinatorial phase I/II safety, tolerability and immunogenicity single center open-label
      clinical study of AKS-452 COVID-19 vaccination study
    

Detailed description: 
      The study is designed as a combinatorial single-center open-label phase I and II clinical
      study design:

      I. a phase I dose-finding and safety / tolerability study combined with, II. a phase II
      safety / efficacy study on the biological activity of AKS-452 against COVID-19.

      To warrant more extensive development towards a phase III clinical study. The study will have
      a duration of approximately 4 months and will be executed at the University Medical Center
      Groningen, The Netherlands supported by the subsidizing party Akston Biosciences.
    

Intervention name(s): AKS-452
Intervention type(s): Biological
Intervention description(s): s.c. or i.m. vaccination
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: Single-center, open-label, combinatorial safety, tolerability and exploratory efficacy
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: vaccine; safety; immunogenicity; dose-finding; exploratory efficacy
A Study To Evaluate Different Formulations Of PF-06865571 In Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open-label study to understand the effect of different modified release and immediate
      release formulations on plasma PF-06865571 concentrations after single oral administration
      under fed conditions
    


Intervention name(s): PF-06865571 Immediate release suspension; PF-06865571 Slow release MR tablets; PF-06865571 Fast release MR tablets; PF-06865571 Immediate release tablets
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Suspension; Modified release tablets; Modified release tablets; Immediate release tablets
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Relative bioavailability; Modified release; Pharmacokinetics