bioihbjkbjnl/mcl2 huggingface dataset:
To Compare the Pharmacokinetics and Pharmacodynamics of HR20014, INS068 and INS062 After Single Subcutaneous Injection in Healthy Subjects
Condition: Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, open, six-sequence, three-period crossover phase I
      clinical trial in healthy subjects to compare the PK/PD and safety profiles of single dose of
      HR20014, INS068, and INS062. In this study, 12 subjects were randomly assigned to 6
      administration sequences in a ratio of 1:1:1:1:1:1, and HR20014, INS068 or INS062 injection
      were given subcutaneously three times before and after each sequence.
    


Intervention name(s): INS062 injection、INS068 injection、HR20014 injection
Intervention type(s): Drug
Intervention description(s): INS062 injection：A single dose of 0.4 DU/kg is administered to healthy subjects.
INS068 injection：A single dose of 0.4 U/kg is administered to healthy subjects.
HR20014 injection：A single dose of 0.4 U/kg is administered to healthy subjects.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: The study was a single-center, randomized, open, six-sequence, three-cycle crossover phase I study in healthy subjects. The objective of this trial was to compare the PK/PD and safety of HR20014, INS068 and INS062 in a single subcutaneous injection of the same dose.
Masking: None (Open Label)
Primary purpose: Treatment
Role of Gut Microbiome in the Health Benefits
Condition: Normal Population
Study type: Interventional

Summary: 
      Beneficial effects of moderate chronic consumption of beer have been extensively reported,
      however, the mechanisms have not been elucidated yet. Gut microbiota is an important mediator
      in the homeostasis of the host. Polyphenols act as bacterial substrates and modulators of the
      gut microbiota. Indeed, the investigators have previously observed that the chronic moderate
      consumption of red wine by metabolic syndrome patients triggered in an amelioration of the
      metabolic syndrome variables, and this effect was mediated, at least partially, by the
      interaction of the gut microbiota with the polyphenols of the red wine. In this manner, beer
      has a medium content of polyphenols. Thus, the investigators propose that the beneficial
      effects of moderate chronic consumption of beer could be because of the action of the gut
      microbiota with the beer polyphenols. The investigators are going to perform an intervention
      study in which normal volunteers will consume three different beer types with different
      content in polyphenols and it will be analyzed the gut microbiota profile (Metagenomics),
      metabolites (Metabolomics) and metabolic syndrome markers (gene expression, ELISA) to
      establish the correspondent relationships, trying to decipher the implication of the gut
      microbiota in the beneficial effects of moderate chronic consumption of beer.
    


Intervention name(s): Beer
Intervention type(s): Dietary Supplement
Intervention description(s): A daily beer will be consumed by the participants during a total of 6 weeks, changing every 2 weeks from alcohol-free lager beer, lager beer and dark beer
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: beer
A Study Comparing the Acceptability of Pentasa® Sachets Versus Pentasa® Tablets in Children With Crohn´s Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the clinical trial is the assessment of the acceptability of the new
      Pentasa formulation - PentasaR Sachets in comparison with the reference PentasaR tablets 500
      mg in children with Crohn's disease. After the screening period (which includes medical
      history, physical examination, basic haematology, serum chemistry , urine analysis and stool
      microbiology , PCD Activity Index )patients will receive (visit I) Pentasa sachets 1g or
      Pentasa tablets 500mg for next 4 weeks according to the randomisation scheme in common dose
      2× 1 g of PentasaR Sachets 1 g or PentasaR tablets 500 mg. The formulation of Pentasa will be
      switched at Visit 2, patients will receive the medication for next 4 weeks. Patients will
      record the acceptability of the both forms of the medication.

      In 6 patients from each group (selected by the randomization), stool and urine will be taken
      to assess concentrations of mesalazine and N-acetylmesalazine during Visit 2 and Visit 3.
      Adverse events will be recorded during the whole course of the treatment period.
    


Intervention name(s): Crohn's Disease
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single
Primary purpose: Prevention
A 2-year Longitudinal Study on the Structural and Optical Effects of Orthokeratology Treatment on Eye
Condition: Myopic Progression
MeSH terms: Disease Progression
Study type: Interventional

Summary: 
      This is a two-year longitudinal study investigating the optical and structural effects of
      increased compression factor of orthokeratology lens on eyes and the corresponding effect on
      change in choroidal thickness and therefore myopic control.
    


Intervention name(s): Orthokeratology
Intervention type(s): Device
Other intervention name(s): ortho-k
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: myopia control; orthokeratology
A Trial of a Botanical Drug (EISO) for Treatment of Mild-to-Moderate Plaque Psoriasis
Condition: Plaque Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      This trial will be a double-blind, multi-center, randomized, placebo controlled study to
      evaluate the safety, tolerability, and efficacy of SAN021 study drug when administered for up
      to 42 days to adults between the ages of 18 to 65 years who have a clinical diagnosis of
      mild-to-moderate plaque psoriasis.
    

Detailed description: 
      Patients will enter the Screening Period once the informed consent and photographic consent
      process has been completed. Patients with mild-to-moderate plaque psoriasis, as defined by a
      Psoriasis Area and Severity Index (PASI) score between 2 and 12, appropriate for topical
      treatment that covers a minimum of 1.0% and a maximum of 10% BSA, in the permitted treatment
      areas, and who meet all of the inclusion and none of the exclusion criteria will be enrolled.

      Once subject eligibility is confirmed and the screening procedures completed, all enrolled
      subjects will start the Treatment Period of the study. All enrolled subjects will receive
      either 10% SAN021 or placebo serum (randomized in a 2:1 ratio) with the first dose applied at
      the Day 1 Study Visit. Subjects will be instructed on how to apply the study medication twice
      daily for 42 days.

      Subjects will return to the clinic for study-related assessments on Study Days 7, 14, 28 and
      a final visit on Day 42. On Study Day 49, subject will receive a Follow-up phone call and be
      queried for condition status since going off study.
    

Intervention name(s): SAN021 Serum; SAN021 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SAN021 is a serum containing 10% East Indian Sandalwood Oil. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.; SAN021 Placebo is a serum that does not contain East Indian Sandalwood Oil however, does contain a synthetic sandalwood fragrance. It is packaged in an amber glass bottle with a dropper top. The dose is 5 drops per 1% BSA involvement twice daily.
Other intervention name(s): Active; Placebo Serum
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Pneumatic Retinopexy Versus Vitrectomy With Gas for Retinal Detachment Due to Myopic Macular Hole
Condition: Retinal Detachment
MeSH terms: Retinal Detachment; Retinal Perforations; Dissociative Disorders
Study type: Interventional

Summary: 
      To undertake a prospective randomized clinical study for treating retinal detachment due to
      myopic macular holes, utilizing pneumatic retinopexy versus pars plana vitrectomy with gas
      tamponade.To determine the efficiency of pneumatic retinopexy with C3F8 in the treatment of
      retinal detachment due to myopic macular hole.
    

Detailed description: 
      Retinal detachment caused by macular hole predominantly happened in high myopic eyes. This is
      a common type of retinal detachment in Asia and often seen in the old people aged around 50 ~
      60, mainly in female. Treatment of retinal detachment due to macular holes has changed over
      the years, and several methods have been described. Some surgeons have used transscleral
      diathermy or cryotherapy or laser photocoagulation and drainage subretinal fluid without
      sclera buckling, other surgeons have used radial silicone explants beneath the macular
      combined with cryo, diathermy or laser. This method entails the difficulty of placing sclera
      sutures far posterior, especially hazardous if there is a posterior staphyloma with very thin
      sclera. Besides the technically difficult, the extensive macular scarring caused by different
      coagulations limited the functional result to peripheral vision only. Because of this, it is
      not generally used in the initial treatment.

      In 1982, Gonvers and Machemer4 proposed a new treatment technique that combined pars plana
      vitrectomy (PPV), partial air-fluid exchange, and face down positioning for 24 hours. Since
      then vitrectomy with gas tamponade become the most common procedure for retinal detachment
      with macular hole.

      In 1984, Miyake performed a simple gas injection into the vitreous followed by a face-down
      position. The effective of this simplified method was then reported by many observers.But
      these studies may have insufficiency because of small sample, nonrandomized, no defined
      eligibility criteria for patients selection.

      Intraocular gas tamponade with or without pars plana vitrectomy (PPV) has commonly been
      performed nowadays. We conducted a multicenter randomized controlled clinical trial to
      compare their anatomic results and visual outcomes of both surgical techniques, to estimate
      the efficiency of both surgical methods in the treatment of retinal detachment with myopic
      macular hole.
    

Intervention name(s): Pneumatic Retinopexy; Vitrectomy with Gas
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single
Primary purpose: Treatment
Keywords: Pneumatic Retinopexy; vitrectomy; retinal detachment; macular hole; treatment; multi-center; Retinal Detachment due to Myopic Macular hole
A Drug Interaction Study to Assess the Effect of LY317615 on the Metabolic Pathway of Warfarin
Condition: Solid Tumor; Lymphoma, Malignant
MeSH terms: Lymphoma
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of enzastaurin (LY317615), on a protein
      (enzyme CYP2C9) which is involved in the metabolic pathway of warfarin in participants with
      solid tumors or lymphomas. Information about any side effects that may occur will also be
      collected. This is a drug interaction study so the treatment of the disease will not be the
      main purpose of the study.

      This is a Phase 1, open label, fixed sequence, 2 period study conducted in participants with
      solid tumors or lymphomas. The duration of participation in this study will be up to
      approximately 38 days not including screening, after which participants will be allowed to
      continue receiving enzastaurin. There is no planned duration for the extension phase of this
      study; participants will be allowed to continue to receive enzastaurin until fulfilling one
      of the criteria for discontinuation, such as unacceptable toxicity or disease progression.
    


Intervention name(s): warfarin; enzastaurin
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally; Administered orally
Other intervention name(s): LY317615
Intervention MeSH terms: Warfarin
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Efficacy Evaluation of the Esophagogastric Junction Exposure Obtained by the Flexible Liver Retractor in Gastroplasty
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Evaluation of a new technique of liver retraction for the exposure of the His angle in
      gastric bypass Roux-en-Y surgery.
    

Detailed description: 
      Obesity is a chronic disease of clinical treatment initially, but with precise surgical
      indications regulated by national and international health organizations. Among the surgical
      techniques, the gastric bypass Roux-en-Y is considered the "gold standard" for its efficiency
      and low morbidity and mortality. In gastric laparoscopic surgery it is necessary to move the
      liver in order to ensure adequate working space and a good view. Conventional laparoscopic
      retractors surgery are generally coarse, require an additional incision for its installation,
      or handling by an assistant during surgery and involve risk of liver injury. The objective of
      this study was to evaluate the efficacy of a flexible liver retractor in the exposure of the
      His angle in Roux-en-Y gastric bypass for morbid obesity. This was a prospective, controlled,
      open and comparative study, with 100 patients randomly divided into two groups (conventional
      and flexible retractor), with medical indication for bariatric surgery. Data were recorded
      during surgery in both groups for comparison of the two hepatic retraction techniques.
    

Intervention name(s): CONVENTIONAL LIVER RETRACTOR DEVICE; FLEXIBLE LIVER RETRACTOR DEVICE; LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY
Intervention type(s): Device; Device; Procedure
Intervention description(s): LIVER RETRACTION FOR THE EXPOSURE OF THE ESOPHAGOGASTRIC JUNCTION USING CONVENTIONAL RETRACTOR DEVICE; LIVER RETRACTION FOR THE EXPOSURE OF THE ESOPHAGOGASTRIC JUNCTION USING FLEXIBLE LIVER RETRACTOR DEVICE; LAPAROSCOPIC ROUX-EN-Y GASTRIC BYPASS SURGERY
Intervention MeSH terms: Liver Extracts
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: liver; laparoscopy; Bariatric Surgery; Esophagogastric Junction; obesity
Sham CPAP vs. Straight CPAP for Chronic Cough
Condition: Chronic Cough; OSA
MeSH terms: Cough
Study type: Interventional

Summary: 
      Chronic cough is an important clinical problem in primary care and sub-specialty practice.
      Besides the distress experienced by patients with chronic cough, significant healthcare
      resources are expended to understand the role of gastroesophageal reflux, asthma and
      post-nasal drip in understanding their contribution to cough.

      Obstructive sleep apnea (OSA) is common in patients with chronic cough. More importantly,
      treatment of OSA with continuous positive airway pressure (CPAP) has led to improvement in
      cough for chronic cough patients. Mechanisms by which OSA therapy with CPAP can improve cough
      includes beneficial effects on reflux and airway inflammation.

      The aim of this study is to definitively establish that CPAP therapy for treatment of OSA in
      chronic cough patients improves cough. While these patients with chronic cough are not
      routinely screened and treated for OSA, this study aims to evaluate these chronic cough
      patients with screening questionnaires for OSA and if necessary with polysomnography and
      randomize them to either CPAP or sham CPAP for 6 weeks.
    


Intervention name(s): Straight CPAP; Sham CPAP
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obstructive Sleep Apnea; CPAP
Proof of Concept, Twice Daily Applications of LEO 124249 Ointment in the Treatment of Chronic Hand Eczema
Condition: Hand Eczema
MeSH terms: Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the efficacy of twice daily applications of LEO 124249 ointment with LEO 124249
      ointment vehicle for up to 8 weeks in the treatment of subjects with chronic hand eczema.
    


Intervention name(s): LEO 124249 ointment; LEO 124249 ointment vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Ointment; Ointment vehicle
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Evaluating the Pharmacokinetic Interaction Between AD-2011 and AD-2012
Condition: Hyperlipidemias; Hypertension
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the Pharmacokinetic Interaction Between AD-2011 and
      AD-2012 in healthy male volunteers.
    

Detailed description: 
      To evaluate the pharmacokinetic Interaction, safety and tolerability of the combination
      compared with the single administration of AD-2011 and AD-2012.
    

Intervention name(s): AD-2011 10/20 mg; AD-2012 80mg; AD-2011 10/20 mg + AD-2012 80mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AD-2011 10/20 mg tablet; AD-2012 80mg tablet; AD-2011 10/20 mg + AD-2012 80mg tablet
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Intra-anal Nifedipine, Used As Add-on to Conservative Therapy, on Pain in Patients With Anal Fissure
Condition: Chronic Anal Fissure
MeSH terms: Fissure in Ano
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The objective of the study is to examine the effect of Nifedipine, applied intra-anally
      through our drug delivery device, on rectal pain severity in anal fissure patients that are
      being managed with conservative treatment.
    

Detailed description: 
      This is a randomized, double-blinded study. All patients in the study will be treated with
      the conservative standard of care for anal fissure. Study medication will be used as an
      add-on to conservative therapy, and will consist of 3 groups:

        1. Treatment Group 1- 12 mg of Nifedipine to be self-administered twice daily.

        2. Treatment Group 2- 12 mg of Nifedipine to be self-administered once daily in the morning
           hours and placebo to be self-administered in the evening.

        3. Placebo Group - Placebo to be self-administered twice daily. Approximately 330 subjects
           will participate in this study. A screening visit will be used to determine subject
           suitability for inclusion in the trial. Within one week of the screening visit, subjects
           who meet all inclusion criteria and none of the exclusion criteria will receive either
           Nifedipine 12 mg X2 a day (BID) (24 mg/day total) or Nifedipine 12 mg X1/day to be
           administered in the morning hours and a matching placebo X1/day to be administered in
           the evening hours (12 mg/day total) or a matching placebo X2 a day (BID) (0 mg/day
           total) for a period of 8 weeks. During this period, 4 study visits (at 0, 2, 5, and 8
           weeks) will take place. Study medication and placebo will be administered BID (in the
           morning and in the evening). In addition to receiving study medication, subjects will be
           maintained on a conservative standard treatment for Anal Fissure: sitz baths, high fiber
           diet, stool softeners and plenty of fluids.

      Upon completion of the treatment cycle, patients will be contacted by phone (at weeks 10, 13
      and 16) and will be questioned about recurrent symptoms e.g. pain or bleeding.

      Patients that:

        1. Were enrolled to one of the investigational groups ,and completed the 8 weeks treatment
           period or discontinued treatment because the investigator deemed them as healed AND

        2. Experience symptoms of recurrence AND ARE

        3. Willing to participate in an open label extension will receive Nifedipine 12 mg X2 a day
           (BID) for a period of 8 weeks. During this period, 4 study visits (at 0, 2, 5, and 8
           weeks from the start of retreatment) will take place.
    

Intervention name(s): Nifedipine
Intervention type(s): Drug
Intervention MeSH terms: Nifedipine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Prevalence of Low Back and Pelvic Pain in Pregnant Women
Condition: Low Back Pain; Pelvic Pain
MeSH terms: Back Pain; Low Back Pain; Pelvic Pain
Study type: Observational

Summary: 
      The purpose of this study is to determine the prevalence of low back and pelvic pain in
      Spanish pregnant women. The results should allow for the identification of factors associated
      with a greater risk of having it during pregnancy. Once risk factors are identified, other
      studies can assess the effectiveness of measures to reduce this pain.
    

Detailed description: 
      Validated methods were used to gather data on the prevalence of LBP, LP and PGP,
      anthropometric and socio-demographic characteristics, history of LBP, obstetrical history,
      physical activity before and during pregnancy, mattress and sleep characteristics,
      disability, anxiety, and depression. Separate multiple logistic regression models were
      developed to identify the variables associated with LBP, LP and PGP.
    

Intervention name(s): Set of questionnaires
Intervention type(s): Other
Intervention description(s): A set of questionnaires to determine the existence of low back and pelvic pain during the pregnancy, and to identify possible risk factors.
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women who are 28 weeks pregnant or more (in the third trimester of the pregnancy).
      
Keywords: low back pain; pelvic pain; pregnancy
Efficacy and Safety of PERIOGEN in the Treatment of Periodontal Bone Defect
Condition: Intrabony Periodontal Defect
Study type: Interventional
Phase: Phase 3

Summary: 
      PERIOGEN, containing rhPDGF and -beta-TCP, promotes gingival healing and corrects periodontal
      defects. This study will test the safety and efficacy of PERIOGEN in the treatment of
      periodontal disease
    

Detailed description: 
      Sixty eligible patients with periodontal defect will randomly receive either beta-TCP
      implantation (control group) or PERIOGEN implantation, containing beta-TCP and rhPDGF (drug
      group). The specified primary and secondary end points related to efficacy and safety will be
      assessed during 6 months study period.
    

Intervention name(s): PERIOGEN; Beta TCP alone
Intervention type(s): Drug; Drug
Intervention description(s): Implantation of rhPDGF-BB (0.3 mg/ml) + β-TCP (0.5 g); Implantation of β-TCP (0.5 g) alone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: rhPDGF,; periodontal disease