bioihbjkbjnl/mcl2 huggingface dataset:
Effect of a Combination Oral Formulation of Hyaluronic Acid, Chondroitin Sulphate and Magnesium Trisilicate in Patients With Gastro-Esophageal Reflux Disease Not Fully Satisfied With Their Treatment
Condition: Gastro Esophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional

Summary: 
      This is a post-market, multi-center, double-blind, placebo-controlled, randomized, cross-over
      study with GERDOff Plus added on top of the current PPI treatment in patients with GERD. The
      aim of the study is to evaluate the performance of GERDOff Plus, a class III medical device,
      consisting in a hyaluronic acid, chondroitin sulphate and magnesium trisilicate, in addition
      to the PPIs, in patients with GERD not fully satisfied with their current treatment with
      PPIs.

      Patients will receive either GERDOff Plus or placebo q.i.d. for 21 days followed by a
      wash-out period of 3 weeks. After the wash-out period, the patients will receive either
      placebo or GERDOff Plus respectively
    


Intervention name(s): Hyaluronic acid with chondroitin sulphate and magnesium trisilicate, 1100 mg melt in mouth tablet; Placebo 1100 mg, identically-looking melt in mouth tablet
Intervention type(s): Device; Device
Intervention description(s): 1 tablet q.i.d. (three after meals, one before resting) for 3 consecutive weeks; 1 tablet q.i.d. (three after meals, one before resting) for 3 consecutive weeks
Other intervention name(s): GERDOff Plus; GERDOff Plus placebo
Intervention MeSH terms: Magnesium trisilicate; Hyaluronic Acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Intrapleural Docetaxel Administration Using Medical Pleuroscopy in Malignant Effusion With Lung Cancer
Condition: Pleural Effusion, Malignant; Non-small Cell Carcinoma
MeSH terms: Pleural Effusion, Malignant; Pleural Effusion
Study type: Interventional
Phase: Phase 2

Summary: 
      In this trial, the effect of intrapleural docetaxel administration using medical
      pleuroscopywill be evaluated in Lung Cancer patient with malignant effusion.
    

Detailed description: 
      This study is designed to be pilot, single-center, open-label, single-arm, prospective, phase
      II trial of patient with NSCLC with pleurla effusion. Approximately 40 patients will be
      enrolled into the trial, and study will be performed to 31Dec2018 from IRB and Korea: MFDS
      approval date.

      Docetaxel will be administed to interpleural space using medical pleuroscopy in malignant
      effusion with lung cancer. Response evaluation will be done until confiramtion of disease
      progression.
    

Intervention name(s): intrapleural docetaxel administration
Intervention type(s): Drug
Intervention description(s): intrapleural docetaxel administration using medical pleuroscopy in malignant effusion with lung cancer
Other intervention name(s): Pleurodesis_docetaxel
Intervention MeSH terms: Docetaxel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pleurodesis
Bioequivalence of LB80380 Free Base and Maleate Salt Tablets
Condition: Hepatitis B
MeSH terms: Hepatitis B
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is to compare pharmacokinetics of LB80331 and LB80317, which are the metabolites of
      LB80380, after a single oral administration of LB80380 free base 150 mg (60 mg + 90 mg)
      tablet or LB80380 maleate tablet 183 mg (150 mg as a free base) in healthy male subjects.
    


Intervention name(s): LB80380 maleate salt; LB80380 free base
Intervention type(s): Drug; Drug
Intervention description(s): 183 mg (150 mg as a free base); 150 mg
Intervention MeSH terms: Maleic acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: LB80380; bioequivalence
Effect of Preoperative Topical Ketorolac on Aqueous Cytokine Levels and Macular Thickness in Cataract Surgery Patients
Condition: Cystoid Macular Edema, Postoperative; Diabetes Mellitus
MeSH terms: Cataract; Macular Edema; Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether there is a relationship between
      inflammatory cytokines in the aqueous of the eye and thickness of the macula after treatment
      of topical ketorolac for patients undergoing cataract surgery.
    

Detailed description: 
      To compare aqueous levels of inflammatory cytokines in diabetic and non diabetic patients
      treated with preoperative topical ketorolac tromethamine 0.45%.

      To compare the macular thickness changes in diabetic and non diabetic patients treated with
      preoperative ketorolac tromethamine 0.45% and its correlation with the aqueous inflammatory
      cytokines.
    

Intervention name(s): Ketorolac tromethamine ophthalmic solution 0.45%
Intervention type(s): Drug
Intervention description(s): Indicated for the treatment of pain and inflammation following cataract surgery.
Other intervention name(s): Acuvail
Intervention MeSH terms: Ketorolac; Ketorolac Tromethamine; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: diabetes mellitus; aqueous humor; inflammatory cytokines; cystoid macular edema, postoperative; nonsteroidal anti-inflammatory drugs
Efficacy and Safety of LXI-15028 Comparing With Lansoprazole in the Treatment of Duodenal Ulcer
Condition: Duodenal Ulcer
MeSH terms: Duodenal Ulcer; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a multi-center, randomized, double-blind, double-dummy, parallel-group,
      active-controlled Phase III clinical study to evaluate the efficacy and safety of LXI-15028
      50mg comparing with Lansoprazole 30 mg after the treatment of duodenal ulcer in Chinese
      patients for up to 6 weeks.
    

Detailed description: 
      Screening-eligible subjects will be randomized into LXI-15028 50 mg group or Lansoprazole 30
      mg group at Visit 1 at the ratio of 1:1 and receive study treatment continuously for 4 or 6
      weeks.Subjects will take the first dose of the investigational drug on the morning of the
      randomization day or on the next morning of the randomization day, and start to complete the
      subject's diary from the day of study treatment initiation(Day 1). After 4 weeks treatment,
      subjects will return to the study institution for Visit 3. For the subjects who achieve
      endoscopic healing at Visit 3,the study treatment will be terminated.The subjects who fail to
      achieve endoscopic healing at Visit 3 will receive newly dispensed investigational products
      for another 2 weeks' treatment and then complete Visit 4.All subjects will receive telephone
      follow-up (Visit 5) on Day 28 ± 3 after the last dose of the investigational products.
    

Intervention name(s): LXI-15028 50mg group; Lansoprazole 30mg group
Intervention type(s): Drug; Drug
Intervention description(s): The investigational products are administrated orally, once in the morning every day, and each dose includes 2 tablets of investigational products (LXI-15028 50mg active agent + Lansoprazole 30mg matching placebo). If the investigational product is not taken in the morning, subjects can take it before 6:00 p.m. on the same day. The duration of treatment is 4 or 6 weeks; The investigational products are administrated orally, once in the morning every day, and each dose includes 2 tablets of investigational products ( LXI-15028 50mg matching placebo + Lansoprazole 30mg active agent ). If the investigational product is not taken in the morning, subjects can take it before 6:00 p.m. on the same day. The duration of treatment is 4 or 6 weeks.
Intervention MeSH terms: Lansoprazole; Dexlansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Transcranial Magnetic Stimulation (rTMS) Accelerates the Response to Escitalopram in Major Depression
Condition: Major Depression
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      A doubleblind randomised trial with active versus sham rTMS in combination with escitalopram
      in patients with prior treatment resistant depression in an acute 12 weeks trial with
      subsequent 24 weeks study phase with active versus placebo citalopram
    

Detailed description: 
      In this study we aimed at investigating to what degree rTMS applied over the left
      dorsolateral cortex relieves depressive symptoms when the treament is combined with
      antidepressive medication. The study will also be able to supply knowledge on how long any
      possible effect of the rTMS treatment lasts.

      In the first 12 weeks of the trial participants are randomised to either rTMS combined with
      escitalopram or sham rTMS combined with escitalopram. rTMS is given daily for the first 3
      weeks.

      The next phase is a relapse prevention study where the responders from the initial phase are
      randomised to either active or placebo escitalopram for 24 weeks.
    

Intervention name(s): rTMS; TMS; rTMS; rTMS
Intervention type(s): Device; Device; Device; Device
Intervention description(s): 15 treatments of rTMS active with a duration of 30 minutes each; Transcraniel Magnetic Stimulation active and sham; active Transcranial Magnetic Stimulation; daily for three weeks
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Transcranial magnetic stimulation (TMS); Major depression; treatment resistant major depression
An Study to Investigate the Recovery, Excretion, and Pharmacokinetics of 14C-GSK1265744 Administered as a Single Oral Dose and a Study to Describe the Pharmacokinetics of a Supratherapeutic Dose of GSK1265744 in Healthy Adult Subjects
Condition: HIV-associated Lipodystrophy Syndrome
MeSH terms: HIV-Associated Lipodystrophy Syndrome; Lipodystrophy
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a two-part study in healthy adults. Part A is a phase 1, non-randomized, open
      label, single-dose, single-centre mass balance study utilizing a radiolabeled dose to
      investigate the recovery, excretion, and pharmacokinetics of oral GSK1265744 in a cohort of 6
      healthy adult male subjects. Subjects will undergo a pre-study screening visit within 30 days
      of the first dose and those who successfully pass pre-study assessments and meet eligibility
      criteria will be enrolled into the study to receive the equivalent of a 30 mg dose of
      GSK1265744 as an oral solution, containing approximately 70 microcuries (mcg Ci) [0.96
      millisieverts (mSv)] of radioactivity under fasted conditions. Blood, urine and fecal samples
      will be collected for a maximum of 504 hours (21 days) following study drug administration.
      In Part B, approximately 10 healthy male and female subjects will be enrolled to evaluate the
      single-dose safety, tolerability and PK of supratherapeutic dose of GSK1265744 150 mg
      compared with placebo. Each subject will receive a single dose of GSK1265744 150 mg or
      placebo on Day 1 under fasting conditions in the morning. Blood, urine and fecal samples will
      be collected for 336 hours (14 days) following dosing.
    


Intervention name(s): GSK1265744B (sodium salt) containing 14C-GSK1265744B; 150 mg GSK1265744B; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): A white to slightly colored nonsterile crystalline powder for oral solution; This is GSK1265744B (sodium salt of GSK1265744), lactose monohydrate, Microcrystalline cellulose, hypromellose, sodium lauryl sulfate, croscarmellose sodium, magnesium stearate, Opadry film-coating, white OY-S-28876 tablet; Microcrystalline cellulose, Opadry film-coating, white OY-S-28876 tablet
Intervention MeSH terms: Cabotegravir
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: mass balance; GSK1265744; supratherapeutic; integrase inhibitor; healthy volunteer
Comparative Clinical Trial of Efficacy and Safety of BCD-057 and Humira® in Patients With Moderate to Severe Plaque Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      CALYPSO clinical study is a phase 3 study which is carried out to establish the efficacy,
      safety and pharmacokinetic equivalence of BCD-055 (adalimumab, manufactured by JSC BIOCAD,
      Russia) and Humira® when used in patients with moderate to severe plaque psoriasis.
    

Detailed description: 
      CALYPSO study is the next step of clinical evaluation of adalimumab biosimilar manufactured
      by joint-stock company (JSC) BIOCAD, Russia.The aim of this study is to establish that
      BCD-057 is equivalent to Humira® in terms of efficacy, safety and pharmacokinetics when used
      by the standard regimen in patients with plaque psoriasis.

      The study will enroll 344 patients with moderate to severe plaque psoriasis, who will be
      randomized into 2 groups (1:1 ratio): patients from the first group will receive BCD-057
      subcutaneously (SC) at a dose 80 mg on week 0, then at a dose 40 mg on weeks 1, 3, 5, 7, 9,
      11, 13, 15, 17, 19, 21 and 23. Then participants of this group will be invited for
      randomization at week 25 (in order to keep the double-blind design of the study), but it will
      have a formal character (assignment of a new randomization number and lot). Patients will
      continue to receive 40 mg of BCD-057 on weeks 25, 27, 29, 31, 33, 35, 37, 39, 41, 43, 45, 47,
      49 and 51.

      Patients from the second group will receive Humira® subcutaneously (SC) at a dose 80 mg on
      week 0, then at a dose 40 mg on weeks 1, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21 and 23. At week
      25 participants will re-randomized (1:1) to treatment with Humira® or will transitioned to
      BCD-057.They will receive Humira® or BCD-057 at a dose 40 mg on weeks 25, 27, 29, 31, 33, 35,
      37, 39, 41, 43, 45, 47, 49 and 51.
    

Intervention name(s): BCD-057; Humira®
Intervention type(s): Biological; Biological
Intervention description(s): BCD-057 is biosimilar of adalimumab (produced by BIOCAD).; Humira is the original adalimumab (produced by F. Hoffman-La Roche)
Other intervention name(s): adalimumab; adalimumab
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: adalimumab; biosimilar; BCD-057; psoriasis; tumor necrosis factor; monoclonal antibody
Long-Term Safety of Twice Daily Oxycodone Hydrochloride Controlled-release Tablets in Children Who Completed OTR3001
Condition: Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to characterize the long-term safety of oxycodone hydrochloride
      (HCl) controlled-release (CR) tablets in opioid experienced pediatric patients aged 6 to 17
      years, inclusive, with moderate to severe malignant and/or nonmalignant pain requiring opioid
      therapy who completed the 4 -week treatment period in OTR3001.
    


Intervention name(s): Oxycodone hydrochloride controlled-release tablets
Intervention type(s): Drug
Intervention description(s): Oxycodone hydrochloride controlled-release tablets at strengths of 10, 15, 20, 30, or 40 mg (20 mg to 240 mg daily) every 12 hours.
Other intervention name(s): OxyContin
Intervention MeSH terms: Oxycodone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malignant pain; Nonmalignant pain; Pain; Pediatric; Opioid; Moderate to severe
Safety and Efficacy in Premenopausal Women With Heavy Menstrual Bleeding (HMB) Associated With Uterine Fibroids (UF)
Condition: Heavy Uterine Bleeding; Uterine Fibroids
MeSH terms: Leiomyoma; Myofibroma; Uterine Hemorrhage; Menorrhagia; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2b randomized, double-blind, placebo-controlled study evaluating the safety
      and efficacy of elagolix alone and in combination with add-back therapy versus placebo on
      heavy menstrual bleeding in premenopausal women 18 to 51 years of age with uterine fibroids.
    


Intervention name(s): Elagolix placebo; Elagolix; 0.5 mg estradiol / 0.1 mg norethindrone acetate; 1 mg estradiol / 0.5 mg norethindrone acetate; E2/NETA placebo
Intervention type(s): Other; Drug; Drug; Drug; Drug
Intervention description(s): oral coated tablet; oral coated tablet; oral hard capsule; oral hard capsule; oral hard capsule
Other intervention name(s): ABT-620; Activelle, Activella, low dose (LD) E2/NETA; Activelle; Activella; standard dose (SD) E2/NETA
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Norethindrone; Norethindrone Acetate; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Uterine Fibroids; Leiomyomata; Elagolix; Menorrhagia; Elagolix sodium; Heavy Uterine Bleeding; ABT-620
Treatment of Chronic Obstructive Pulmonary Disease (COPD) With Iodinated Activated Charcoal
Condition: Chronic Obstructive Lung Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study s to determine whether treatment with Iodinated Active Charcoal can
      improve lung function and physical capacity in patients with chronic obstructive lung
      disorders. The rational for the study is the observation that COPD patients have an increased
      tissue load of mercury interfering with the function by NeuroEpithelial Endocrine (NEE) cells
      in the respiratory tract. Mercury binding to these NEE cells leads to an increased smooth
      muscle tonus and a reduced response to bronchodilator treatment. Initial observational data
      have shown an improved lung function and improved functional capacity after treatment
      motivating a larger placebo controlled POC study
    


Intervention name(s): Iodinated Active Charcoal (IodoCarb)
Intervention type(s): Drug
Intervention description(s): 3 g will be given as an oral suspension once daily for 56 days
Intervention MeSH terms: Charcoal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effect of High Dose N-acetylcysteine on Airtrapping and Airway Resistance in Chronic Obstructive Pulmonary Disease (COPD) Patients
Condition: COPD
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is to investigate the add-on effect of high dose NAC (600mg tablet twice daily) on
      reduction of airtrapping and airway resistance in stable COPD patients as well as to study
      it's effect in reducing exacerbation, improving exercise capacity and quality of life in
      stable COPD patients.
    

Detailed description: 
      Background: The mucolytic and antioxidant effects of N-acetylcysteine (NAC) may be of great
      value in treatment of COPD patients. However, previous studies fail to demonstrate the
      beneficial effect of NAC. This may be due to insufficient dose of NAC used as well as
      inadequate outcome parameters measured in the past studies.

      Objective of study: This study is to investigate the add-on effect of high dose NAC (600mg
      tablet twice daily) on reduction of airtrapping and airway resistance in stable COPD patients
      as well as to study it's effect in reducing exacerbation, improving exercise capacity and
      quality of life in stable COPD patients.

      Study design: Randomized double blinded placebo controlled trial in Kwong Wah Hospital

      Methodology: Patients are recruited in Kwong Wah Hospital if they fulfill the spirometric
      criteria of COPD. Eligible subjects will be randomized into the treatment (NAC 600mg tablet
      twice daily) and placebo group after completion of run in period. NAC and placebo will be
      prescribed accordingly in addition to their usual therapy. Both patients and investigators
      are blinded about the group allocation. Baseline assessment will be done and patients will be
      followed up at 16th weeks and 52th week of the study.

      During each follow-up visit, hyperinflation parameters like inspiratory capacity (IC) will be
      measured by plethysmography. Airway resistance will be measured by both plethysmography and
      impulse oscillometry machine. Exercise capacity (6 min walking distance) and quality of life
      are also recorded during each follow up.

      The difference of the above parameters between the 2 groups (drug and placebo group) will be
      analyszed by the Repeated measures ANOVA test
    

Intervention name(s): N-acetycysteine (600mg twice daily); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): N-acetycysteine (600mg twice daily) for one year; Placebo (600mg twice daily)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; N-acetylcysteine; airtrapping; airway resistance; antioxidant
CO2 Laser Phototherapy for Management of Mature Burn Scars
Condition: Burn Scar
MeSH terms: Cicatrix; Burns
Study type: Interventional

Summary: 
      Evaluate mature burn scars before and after treatment with CO2 for patients age 3-21 while
      comparing the treated areas to an untreated control area in the same patient.
    

Detailed description: 
      Laser phototherapy has gained growing acceptance and popularity for management of burn scars.
      The most commonly used laser is the Carbon Dioxide (CO2) Laser. At this institution, the
      investigator has used CO2 for management of Burn Scars since 2012. While the existing
      literature and the investigator's anecdotal experience thus far has been positive overall,
      there is no conclusive evidence to support that CO2 does indeed improve the quality of mature
      burn scars

      The primary objective of this study is to evaluate mature burn scars before and after
      treatment with CO2 for patients age 3-21 while comparing the treated areas to an untreated
      control area in the same patient.
    

Intervention name(s): Laser phototherapy treatment
Intervention type(s): Procedure
Intervention description(s): Laser phototherapy treatment administered in OR
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The study patient will have one portion of their scar, measuring 5x5 cms (or 50% of the scar, for scars smaller than 5x10 cms) left untreated at the time of the study.
Masking: Single (Participant)
Primary purpose: Treatment