bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety Study With Visonac Photodynamic Therapy (PDT)
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this trial is to study the efficacy and safety of Visonac PDT in patients from
      9 to 35 years old with Aktilite® CL512. Patients was randomized to Visonac or vehicle cream
      without occlusion and red light(dose: 37J/cm2)
    

Detailed description: 
      Double blinded, prospective, randomized, stratified, placebo-controlled, multi-center study
      in patients with moderate to severe acne vulgaris. Patients with facial severity grades 3 to
      4 on the Investigator's Global Assessment (IGA) scale will be included. Each patient will be
      classified according to age in the two age groups 9 to 12 years and 13 to 35 years and
      randomized to either Visonac or vehicle cream within each age group. All patients will
      receive 4 treatments 2 weeks apart (at week 0, 2 ,4 and 6 week). Efficacy evaluation will be
      done after each treatment and at 12 weeks after the first treatment. Safety evaluations will
      be performed at each treatment visit and at 12 weeks after the first treatment.

      Photographs of patients will be taken before and after treatment at first and last treatment
      visit, and at 12 weeks after first treatment.

      Blood samples will be drawn at 3 visits; pre-treatment visit, one week after first treatment
      and at one week after last treatment visit.
    

Intervention name(s): Visonac PDT (MAL PDT); Vehicle cream (placebo); PDT
Intervention type(s): Drug; Drug; Procedure
Intervention description(s): Cream application followed by illumination with red light.; Cream application followed by illumination with red light.; Photodynamic Therapy - Light dose 37 J/cm2
Other intervention name(s): Visonac; MAL PDT; red light; Vehicle cream; MAL PDT; red light; Red light
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Acne Vulgaris; Moderate to severe
Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH)
Condition: Paroxysmal Nocturnal Haemoglobinuria (PNH)
MeSH terms: Hemoglobinuria; Hemoglobinuria, Paroxysmal
Study type: Interventional
Phase: Phase 2

Summary: 
      Coversin in Paroxysmal Nocturnal Haemoglobinuria (PNH) in patients with resistance to
      Eculizumab due to complement C5 polymorphisms.
    

Detailed description: 
      Coversin, a small protein complement C5 inhibitor which prevents the cleavage of C5 by C5
      convertase into C5a and C5b, will be used in an open label, non-comparative clinical trial in
      patients with PNH and proven resistance to eculizumab due to C5 polymorphisms. Patients will
      be treated with Coversin by daily subcutaneous injection for 6 months in order to determine
      the safety and efficacy of the drug in these circumstances. If satisfactory control of the
      PNH is achieved, and at the discretion of the Principal Investigator (PI), patients will have
      the option of remaining on Coversin and being entered into the long term follow-up study for
      2 years.

      Please note, 'Coversin' is used throughout, but Nomacopan is the official name/INN.

      Please note, the end points were assessed for 6 months, but the adverse events were measured
      over the 2 year period.
    

Intervention name(s): Coversin
Intervention type(s): Drug
Intervention description(s): Patients enrolled in this protocol will initially be treated with an ablating dose of Coversin and daily repeat maintenance doses calculated according to body weight, the ablating dose to be 0.57mg/kg. Thereafter the daily repeat dose will be titrated according to clinical response and complement inhibition determined by CH50 ELISA. The initial repeat dose will be 25% of the ablating dose and this will be adjusted up or down if necessary once steady state is reached (5 days).
Other intervention name(s): rVA576; rEV576
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Role of Lung Ultrasound in Confirmation of Correct Double Lumen Endotracheal Tube Placement in Thoracic Surgeries
Condition: Diagnostic Accuracy
Study type: Observational

Summary: 
      to assess the efficacy of lung ultrasound versus conventional auscultation method and
      fiberoptic bronchoscopy in confirmation of double lumen tube position
    

Detailed description: 
      Confirmation of double lumen tube position by auscultation followed fiberoptic bronchoscopy
      then lung ultrasound. After double lumen intubation all patient tube position will be
      confirmed using auscultation then fiberoptic bronchoscopy then lung ultrasound
    

Intervention name(s): Lung auscultation; Fiberoptic bronchoscopy; Lung Ultrasound
Intervention type(s): Diagnostic Test; Device; Device
Intervention description(s): auscultation of air entry through chest wal; Checking correct double lumen position through direct vision using fiberoptic bronchoscopy; real time visualization of air entry to the lungs using trans-thoracic lung ultrasound
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        lung cancer patients undergoing thoracic surgeries requiring double lumen intubation
Glutamatergic Modulation of Cocaine-related Deficits
Condition: Cocaine Dependence
MeSH terms: Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Cocaine dependence involves problematic neuroadaptations, such as heightened reactivity to
      cocaine cues, that may be responsive to pharmacological modulation of glutamatergic circuits.
      Despite promising preclinical findings with n-methyl-d-aspartate receptor (NMDAr) modulators,
      studies with human subjects have been unsuccessful to date. The purpose of this investigation
      is to examine the effects of the NMDAr antagonist ketamine, recently found to have potent
      therapeutic effects in humans, on cue-induced craving and impaired motivation for quitting
      cocaine in cocaine dependent participants, 24-hours post-infusion.
    

Detailed description: 
      In this study, volunteers will undergo a 9 day inpatient trial during which they will receive
      three counter-balanced infusions (two doses of ketamine and a dose of lorazepam) on three
      separate days in a within-subject, double-blind, controlled design. Of the various glutamate
      antagonists available for human use, ketamine will be utilized because its safety profile,
      pharmacokinetics, and range of tolerable sub-anesthetic dosings have been very well studied.
      Also, ketamine has shown promise in managing opiate and alcohol use disorders in certain
      studies, and may therefore be the most likely glutamate antagonist to dampen cue reactivity
      and increase motivation in cocaine users. If ketamine significantly improves these deficits,
      this would suggest that the drug should be investigated further for potential utility as a
      treatment for cocaine dependence.
    

Intervention name(s): Ketamine 0.41 mg/kg; Ketamine 0.71 mg/kg; Lorazepam 2 mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 52 minute iv infusion of ketamine 0.41 mg/kg; 52 minute iv infusion of ketamine 0.71 mg/kg. This dose follows K1 in all 3 orderings.; 52 minute infusion of lorazepam 2 mg. This serves as an active control.
Other intervention name(s): K1; K2; LZP
Intervention MeSH terms: Ketamine; Lorazepam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Postprandial Inflammation and Fatty Acids
Condition: Cardiovascular Disease; Diabetes Type 2; Obesity
MeSH terms: Cardiovascular Diseases; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The main objective is to elucidate the acute effects of an oral intake of either saturated,
      monounsaturated or polyunsaturated fatty acids on peripheral blood mononuclear cells (PBMC)
      whole genome expression of obese and type 2 diabetic obese subjects.
    

Detailed description: 
      Consumption of high-fat diets can lead to postprandial dyslipidemia, impairment of
      endothelial function, activation of immune cells and changes in gene expression profiles of
      immune cells such as peripheral blood mononuclear cells (PBMC). Recently it was shown that
      postprandial gene expression profiles of PBMC and plasma triglyceride (TG) and free fatty
      acid (FFA) responses are dependent on the type of dietary fat consumed (i.e. saturated,
      monounsaturated and polyunsaturated). Since obese and diabetic subjects usually are in a
      pro-inflammatory state and have dyslipidemia and endothelial dysfunction we are interested in
      the effect of different fatty acids in a high load on the PBMC gene expression profiles,
      plasma cytokine profiles and endothelial function of these subjects.
    

Intervention name(s): High saturated fat shake; High monounsaturated fat shake; High polyunsaturated fat shake
Intervention type(s): Other; Other; Other
Intervention description(s): milkshake containing 95 gram of fat, high percentage of saturated fat; milkshake containing 95 gram of fat, high percentage of monounsaturated fat; milkshake containing 95 gram of fat, high percentage polyunsaturated fat
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: fatty acids; peripheral blood mononuclear cells; inflammation; nutrigenomics
Phase I Study to Compare the Safety, Pharmacokinetic Profiles of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge 10/160mg
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this study are:

        -  To compare the safety profile of CJ Amlodipine/Valsartan 10/160mg and Novartis Exforge
           10/160mg after a single oral administration in healthy male volunteers

        -  To compare the pharmacokinetic profile of CJ Amlodipine/Valsartan 10/160mg and Novartis
           Exforge 10/160mg after a single oral administration in healthy male volunteers
    


Intervention name(s): CJ Amlodipine/Valsartan 10/160mg; Novartis Exforge 10/160mg
Intervention type(s): Drug; Drug
Intervention description(s): single dose; single dose
Intervention MeSH terms: Amlodipine; Valsartan; Amlodipine, Valsartan Drug Combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Safety; Pharmacokinetics
Drinking Effect of Electrolyzed Alkaline Reduced Water on Functional Constipation
Condition: Chronic Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      The goal of this clinical trial is to investigate drinking effect of electrolyzed
      hydrogen-rich alkaline reduced water (EHARW) in chronic constipation patients. The main
      question is that drinking EHARW will improve the symptoms of chronic constipation for 4
      weeks.

      Participants will drink EHARW (20 mL/kg of body weight/day) generated from the experimental
      device for 4 weeks.
    

Detailed description: 
      Patients diagnosed with constipation will be recruited and screened according to the
      inclusion and exclusion criteria after sign in the informed consent form. The selected
      patients will be enrolled. The experimental device (BTM-1200, Bion-Tech, Gyeonggi-do, Korea)
      will be installed at each patient's house. The researcher will instruct patients drinking
      method. The patients will drink a total of 20 mL/kg of body weight/day of EHARW (pH 9.5) in
      3-different times, and drink directly from the device on an empty stomach for 4 weeks. The
      clinical trial is conducted in a single group without a control group, and the efficacy is
      evaluated by comparing the symptoms of constipation pre- and post-intervention. The primary
      outcome is the proportion of responders based on frequency of complete complete spontaneous
      bowel movement (CSBM).
    

Intervention name(s): Electrolyzed Alkaline Ionizer
Intervention type(s): Device
Intervention description(s): Patients will drink EHARW calculated by 20 mL/kg body weight/day which can be divided into several times a day for drinking. The patient is recommended to drink water in an empty stomach and to drink water generated from the device as soon as possible.
Other intervention name(s): BTM-1200
Intervention model: Single Group Assignment
Intervention model description: comparison between baseline and post-treatment in single group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: constipation; hydrogen-rich alkaline ionized water; complete spontaneous bowel movement; patient assessment of constipation-symptoms; patient assessment of constipation-quality of life
Evaluate the Efficacy and Safety of VVZ-149 Injections for the Treatment of Post-Operative Pain Following Abdominoplasty
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this phase 3 study is to evaluate the efficacy and safety of an analgesic drug
      candidate, VVZ-149 Injections for treating post-operative pain following abdominoplasty.
    


Intervention name(s): VVZ-149 Injections; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion of 1000 mg of VVZ-149; IV infusion of 0 mg of VVZ-149
Other intervention name(s): Opiranserin Injections
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Efficacy Study in Removing Excess Iron From the Heart
Condition: Thalassemia Major; Hemosiderosis
MeSH terms: Thalassemia; beta-Thalassemia; Hemochromatosis; Hemosiderosis
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether deferiprone has superior efficacy in
      removing excess iron from the heart when compared with deferoxamine.
    

Detailed description: 
      This study is a multi-center, randomized, open-label, controlled clinical trial. The study
      population is participants with thalassemia major who are receiving regular chelation therapy
      with deferoxamine. A total of sixty (60) participants will be enrolled among the
      investigative sites.

      The primary objective of this study is to determine whether deferiprone exhibits superior
      efficacy in removing excess iron from the heart compared to that of the standard therapy,
      deferoxamine.

      The secondary objective is to evaluate the relative efficacy of deferiprone with respect to
      that of deferoxamine as assessed by serum ferritin concentration and liver iron
      concentration.

      The primary efficacy measure in this study will be the participants' cardiac iron status, as
      determined by heart MRI T2* assessments.

      The secondary efficacy measure will be by serum ferritin concentration and liver iron
      concentration. This will be measured by the Superconducting Quantum-Interference Device
      (SQUID) BioSusceptometer.

      The duration of treatment is 12 months.
    

Intervention name(s): Ferriprox (deferiprone); Desferal (deferoxamine)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Deferiprone; Deferoxamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Iron Overload; Thalassemia; Haemosiderosis; Cardiac; Deferiprone; Chelation
A Trial to Assess Brexpiprazole Versus Placebo for the Treatment of Acute Manic Episodes, Associated With Bipolar I Disorder
Condition: Bipolar I Disorder; Manic Episode
MeSH terms: Mania; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      To demonstrate the efficacy of brexpiprazole for the acute treatment of manic episodes, with
      or without mixed features, in participants with a diagnosis of bipolar I disorder.
    

Detailed description: 
      A multicenter, randomized, double-blind trial of brexpiprazole versus placebo for the acute
      treatment of manic episodes, with or without mixed features, associated with bipolar I
      disorder. This study also demonstrated the safety and tolerability of brexpiprazole in the
      study population of males and females aged 18 to 65 years (inclusive, at time of consent).
    

Intervention name(s): Brexpiprazole; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Brexpiprazole was administered orally with flexible dosing from 2 to 4 mg/day; titrated to a maximum of 4 mg/day for 3 weeks.; Administered orally daily for 3 weeks.
Intervention MeSH terms: Brexpiprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants received a dose of brexpiprazole or placebo for a maximum of 21 days and were evaluated throughout the duration of the study.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Brexpiprazole; Bipolar; Manic episode
A Clinical Trial to Evaluate the Efficacy and Safety of Elvitegravir / Cobicistat / Emtricitabine / Tenofovir Alafenamide as a First-line Treatment in Naïve Patients With HIV-1 Infection With Severe Immunosuppression
Condition: HIV Infections; Severe Immunosuppression
MeSH terms: Infections; Communicable Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Phase IV, open, multicentre and single-arm study. 50 HIV infection naive patients with severe
      immunosuppression will be recruited to evaluate the efficacy and safety of elvitegravir /
      cobicistat / emtricitabine / tenofovir alafenamide as a first-line treatment.
    

Detailed description: 
      The patients included in the study will be treated during 48 weeks and will have to perform
      the selection/basal visit, week 4 visit, week 8 visit, week 12 visit, week 24 visit, week 48
      visit and follow up visit.
    

Intervention name(s): Genvoya®
Intervention type(s): Drug
Intervention description(s): Patents treated with elvitegravir (EVG) 150mg / cobicistat (COBI) 150mg / emtricitabine (FTC) 200mg / tenofovir (TAF) 10mg once a day as the first line treatment.
Other intervention name(s): TAF/FTC/EVG-cb
Intervention MeSH terms: Elvitegravir, Cobicistat, Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Intervention model: Single Group Assignment
Intervention model description: Single arm, phase 4 study. The naive patients will be treated with elvitegravir / cobicistat / emtricitabine / tenofovir alafenamide as a first-line treatment
Masking: None (Open Label)
Primary purpose: Treatment
dnaJ Peptide for Relieving Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      A small protein called dnaJ peptide may help people with rheumatoid arthritis (RA) by
      preventing their immune system cells from attacking their own tissues. The purpose of this
      study is to determine if small amounts of dnaJ peptide can "re-educate" immune cells in
      people with RA so that the cells stop attacking joint tissues.
    

Detailed description: 
      Immune modulation is a promising new approach for the treatment of RA. Studies have shown
      that immune cells in the joints of people in the early stages of RA react strongly against
      dnaJ peptides from bacteria. These immune cells may also cross-react with human dnaJ peptides
      in the joints to cause inflammation. dnaJ may help RA by "re-educating" the immune system and
      dampening the abnormal inflammatory immune response in RA.

      This study will last 7 months. Participants will be randomly assigned to receive either dnaJ
      or placebo by mouth. At screening, participants will have medical history, physical, and
      medication assessment. At screening, at 6 study visits every month after the start of
      treatment, and at 1 month follow-up, participants will have a joint exam, blood and urine
      collection, and will fill out a questionnaire about their condition.
    

Intervention name(s): dnaJ peptide; None-placebo
Intervention type(s): Drug; Drug
Intervention description(s): dnaJP1 was taken in pill form at 25mg/day for 6 months; placebo was taken in pill form at 25mg/day for 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: RA; Immune Modulation; Oral Tolerance; Peptide; dnaJ
Trial to Evaluate the Effects of OPC-34712 on QT/QTc in Subjects With Schizophrenia or Schizoaffective Disorder
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to establish pharmacodynamics (PD), pharmacokinetics (PK), and
      adverse event (AE) profile of OPC-34712 administered to schizophrenic/schizoaffective
      subjects. The goals of this trial are three-fold:

        -  To determine the effect of OPC-34712 on the individual QT interval (QTcI) corrected for
           placebo

        -  To determine the effect of moxifloxacin on QTcI

        -  To examine the concentration-effect relationship of OPC-34712 and moxifloxacin on QTcI
    


Intervention name(s): OPC-34712 (4mg); Moxifloxacin; OPC-34712 (12mg); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Arms assigned to this intervention receive 4mg.; Arms assigned to this intervention will receive 400mg.; Arms assigned to this intervention receive 12mg.; OPC-34712 placebo
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Schizophrenia; QTc Interval
Phase 1 Study of XAF5 Gel Applied to Skin of Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to assess the safety, tolerability, and pharmacokinetics of XAF5 Gel when
      applied to the skin of healthy volunteers.
    


Intervention name(s): XAF5, concentration A; XAF5, concentration B; XAF5, concentration C; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: volunteers
Retrospective Review of Amino Acid Formula Use at a Children's Center
Condition: Children Requiring Amino Acid-based Formula Tube Feeding; Enteral Feeding Intolerance
Study type: Observational

Summary: 
      This is a retrospective review of data documented in medical records.
    

Detailed description: 
      This is a retrospective review of data documented in medical records of patients consuming an
      amino-acid based enteral formula at a pediatric care facility in the United States.
    

Intervention name(s): Enteral Formula
Intervention type(s): Other
Intervention description(s): Enteral Feeding with an amino acid-based formula
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The population studied retrospectively will be children in a pediatric feeding center
        consuming an amino acid-based enteral fomula and meeting the inclusion/ exclusion criteria.