bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Assess the Drug-Drug Interaction Between VX-787 and Oseltamivir
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the drug-drug interaction between VX-787 and
      oseltamivir, when co-administered at steady-state in healthy participants. In addition the
      safety, tolerability and pharmacokinetics (the study of the way a drug enters and leaves the
      blood and tissues over time) of VX-787 will be assessed.
    

Detailed description: 
      This study consists of 2 parts. Part 1 is an open-label (a medical research study in which
      participants and researchers are told which treatments the participants are receiving),
      randomized (treatment group assigned by chance), 3-way crossover (a method used to switch
      participants from one treatment group to another in a clinical trial) study to estimate
      drug-drug interaction between VX-787 and oseltamivir. It consists of 3 phases: a Screening
      phase, a Treatment phase and a Follow-up phase. Treatment phase will include 3 treatment
      sessions, each of the participant will receive Treatment A (VX-787, 600 milligram [mg] 2
      times a day on Day 1 to 4, followed by a single dose of VX 787, 600 mg on Day 5); Treatment B
      (Oseltamivir, 75 mg 2 times a day on Day 1 to 4, followed by a single dose of oseltamivir 75
      mg on Day 5) and Treatment C (VX-787, 600 mg 2 times a day + oseltamivir, 75 mg 2 times a day
      on Day 1 to 4, followed by a single dose of VX-787, 600 mg + a single dose of oseltamivir, 75
      mg on Day 5). Each treatment session will be separated by a wash-out period of 5 days. The
      order each participant will receive treatments A, B and C will be decided at randomization.

      Part 2 is double-blind (a medical research study in which neither the researchers nor the
      participants know what treatment the subjects is receiving), randomized, placebo-controlled.
      It consists of 3 phases: a Screening phase, a Treatment phase and a Follow-up phase. In
      Treatment phase participants will be randomly assigned VX-787, 600 mg or placebo 2 times a
      day, on Day 1 to 9, followed by a single dose of VX-787 600 mg or placebo in the morning on
      Day 10. Pharmacokinetic parameters will be assessed primarily. Participants' safety will be
      monitored throughout the study.
    

Intervention name(s): VX-787; Oseltamivir; Placebo
Intervention type(s): Drug; Drug; Other
Intervention description(s): Participants will receive VX-787, 600 mg either two times a day or once a day in either of the Part.; Participants will receive Oseltamivir 75 mg either two times a day or once a day in either of the Part.; Participants will receive placebo matching to VX-787 either two times a day or or once a day.
Intervention MeSH terms: Oseltamivir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Oseltamivir; VX-787
Safety, Tolerability, and Pharmacokinetic Study of TRK-250 for Patients With Idiopathic Pulmonary Fibrosis
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      TRK-250 is a nucleic acid medicine that inhibits the progression of pulmonary fibrosis by
      selectively suppressing the expression of transforming growth factor-beta 1 (TGF-β1) protein,
      at the gene expression level. This study is a double-blind, randomized, placebo-controlled
      Phase I study. The primary objective of the study is to assess the safety and tolerability of
      single and multiple inhaled doses of TRK-250 in subjects with idiopathic pulmonary fibrosis
      (IPF).
    


Intervention name(s): TRK-250; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single and multiple doses (4 weeks); single and multiple doses (4 weeks)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: TRK-250; Idiopathic Pulmonary Fibrosis
Placebo Controlled Study of ONO2506PO in the Presence of Riluzole in Patients With Amyotrophic Lateral Sclerosis (ALS)
Condition: Amyotrophic Lateral Sclerosis (ALS)
MeSH terms: Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if oral treatment with ONO-2506PO in patients
      diagnosed with ALS, who have had onset of muscle weakness within 14 months of randomization,
      could lead to the slowing of decline in respiratory function, functional status, muscle
      strength, quality of life and survival compared with placebo group.
    


Intervention name(s): ONO-2506PO; ONO-2506PO
Intervention type(s): Drug; Drug
Intervention description(s): 1200 mg QD / 18 months; 0 mg QD / 18 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ONO-2506PO; Amyotrophic Lateral Sclerosis; ALS
Effectivity of Bilateral Transversus Thoracis Muscle Plane Block After Open Heart Surgery
Condition: Interleukin-6; Cortisol
Study type: Interventional

Summary: 
      This Study aimed to assess The Effectivity of Bilateral Transversus Thoracis Muscle Plane
      Block to Reduce Pain and Stress Response After Open Heart Surgery
    

Detailed description: 
      This is a double blind randomized controlled trial. Thirty-two subject will be recruited with
      non-probability consecutive sampling method. Subjects who meet all inclusion criteria and do
      not have exclusion criteria will be asked to sign the informed consent form before included
      in this study. Subjects will be randomized into two groups. The first group is the treatment
      group who will get Bilateral Transversus Thoracis Muscle Plane Block after induction of
      anesthesia and the second group will be the control group who will not get any regional block
      during surgery. After surgery, time to first morphine dose, total morphine consumption in 24
      hours, extubation time, and adverse events will be recorded for both group.
    

Intervention name(s): Bilateral transversus thoracis muscle plane block; Control
Intervention type(s): Procedure; Procedure
Intervention description(s): The block will be performed in between intercostal space 4 and 5, lateral from sternum, with ultrasound guided. Twenty milliliters bupivacaine 0.5% 1mg/body weight will be injected between internal intercostal muscle and transversus thoracis muscle on both sides.; A needle will be place in the similar area to the transversus thoracis muscle plane block, but no drugs will be injected to the area
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
To Assess the Mildness of a Cosmetic Cleanser in Healthy Participants Using the Forearm-Controlled Application Technique (FCAT)
Condition: Skin Care
Study type: Interventional

Summary: 
      The objective of this clinical study is to assess the relative mildness of a cosmetic facial
      cleanser in comparison to water through repeated application to the volar forearm using the
      FCAT wash procedure.
    

Detailed description: 
      This is a test site randomized, examiner blinded, positive and negative-controlled,
      single-center; Forearm Controlled Application Technique clinical study in healthy
      participants to assess the mildness potential of a cosmetic facial cleansing product.
    

Intervention name(s): Test Product; Positive Control; Reference Product; No Treatment
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Micellar cleanser (0.09 ml); Bar Soap (rubbed for 6 seconds to generate a lather); Sterile Water (0.09 ml); Unwashed area of the forearm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
AZD6280 Multiple Ascending Dose Study
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to evaluate safety, tolerability, PK and PD effects of orally administered
      AZD6280 after single and repeated ascending doses.
    


Intervention name(s): AZD6280
Intervention type(s): Drug
Intervention description(s): oral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Phase I; Pharmacokinetics
Beneficial Bacteria to Prevent Malnutrition and Diarrhea in Pakistani Infants
Condition: Malnutrition; Diarrhea
MeSH terms: Malnutrition; Diarrhea
Study type: Interventional

Summary: 
      This study will determine whether lactobacillus GG (LGG), a beneficial bacterium, when given
      in yogurt, will reduce growth faltering in babies living in a poor area of Pakistan who are
      being weaned from breastfeeding.

      Study hypothesis: Use of the probiotic bacteria LGG at the time of weaning will lessen the
      impact of faltering growth in babies living in the slums of Pakistan.
    

Detailed description: 
      Faltering growth due to malnutrition and recurrent diarrhea is a serious public health
      concern in developing nations, particularly among infants who are being weaned from
      breastfeeding. Evidence suggests that the use of the probiotic bacterium LGG reduces the risk
      of diarrhea, shortens episodes of diarrhea, and enhances the immune system. Babies who are
      being weaned from breastfeeding will be given LGG-containing yogurt in this study to
      determine whether LGG will reduce faltering growth caused by diarrhea and malnutrition.

      Infant participants will be enrolled at or within 5 weeks of birth and followed throughout
      the weaning period. During the weaning period, participants will be randomly assigned to
      either receive LGG-containing yogurt or placebo yogurt everyday for 3 months. All
      participants will have height and weight measurements taken at study entry and at Month 3
      (study completion). The number of diarrhea episodes experienced by participants during the
      study will be assessed at study completion to determine participants' health.
    

Intervention name(s): LGG yogurt; Placebo yogurt
Intervention type(s): Drug; Other
Intervention description(s): Lactobacillus GG containing yogurt; Yogurt NOT containing the active LGG bacteria
Other intervention name(s): Lactobacillus GG containing yogurt
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Growth and Development; Pakistan; Weaning; Probiotics; Infant; Lactobacillus GG
Salt Intake and Antiproteinuric Effect of Paricalcitol in Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      Proteinuria is an independent risk factor for cardiovascular morbidity and mortality and for
      renal disease progression. More proteinuria is associated with faster progression, whereas
      treatments that reduce proteinuria are renoprotective in both diabetic and non diabetic
      chronic kidney disease. Of note, lower the residual proteinuria achieved by treatment slower
      is the disease progression in the long term. On the basis of the above findings, proteinuria
      has become a target of renoprotective therapy.

      Among different antihypertensive medications, those that inhibit the Renin Angiotensin
      System, such as angiotensin converting enzyme (ACE)inhibitors and angiotensin receptor
      blockers (ARBs), are those that at comparable blood pressure control, more effectively reduce
      proteinuria and slow renal disease progression. Thus they have become the key component of
      renoprotective therapy in patients with proteinuric chronic kidney disease. Observational
      studies found that their effectiveness, however, is limited or even fully blunted in patients
      who eat large amount of salt.

      Experimental evidence indicates a renoprotective role of the vitamin D system in chronic
      renal disease. A recent randomized, controlled trial, add-on therapy with selective Vitamin D
      receptor activator paricalcitol showed an additive antiproteinuric effect in subjects with
      type 2 diabetes and chronic kidney disease on background Renin-angiotensin-system inhibitor
      therapy. This effect, however, was largely restricted to subjects with daily sodium intake
      exceeding 12 grams and was negligible in those with lower sodium intake. Thus, treatment with
      paricalcitol appears to be effective in particular in those patients who do not appreciably
      benefit of renin angiotensin system (RAS) inhibitors therapy because of high salt intake.
      Thus, whether the antiproteinuric effect of paricalcitol is modified by concomitant salt
      intake in patients with chronic kidney disease (CKD) on background RAS inhibitors therapy, is
      worth investigating.

      The broad aim of this study is to evaluate the interaction between paricalcitol therapy and
      sodium intake in type 2 diabetes patients with proteinuric kidney disease on stable
      background RAS inhibitor therapy.
    


Intervention name(s): Paricalcitol; placebo
Intervention type(s): Drug; Other
Intervention description(s): 1-month Paricalcitol 2mcg/day; 1-month Placebo Treatment
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Type 2 diabetes; Paricalcitol; Proteinuria; Sodium intake
A Study to Evaluate the Incidence of Hypersensitivity After Administration of Sugammadex in Healthy Participants (MK-8616-101)
Condition: Hypersensitivity; Anaphylaxis
MeSH terms: Hypersensitivity; Anaphylaxis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the potential for hypersensitivity symptoms upon
      repeat exposure to sugammadex. Healthy participants will be randomized to one of three
      treatment arms: sugammadex 4 mg/kg, sugammadex 16 mg/kg or placebo. Participants will receive
      3 single intravenous (IV) doses of their randomized treatment, with an approximately 5-week
      washout between Dose 1 and Dose 2 and between Dose 2 and Dose 3. Participants will be
      confined at the study center from the day before each dose until completion of the 24-hour
      post dose assessments.
    


Intervention name(s): Sugammadex; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sugammadex 4 mg/kg or 16 mg/kg administered as a single IV bolus over 10 seconds; Placebo administered as a single IV bolus over 10 seconds
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: reversal of neuromuscular blockade
Effect of Almonds on Immune Strength and Response to Flu Vaccination in Overweight Men
Condition: Immune Response; Inflammation
MeSH terms: Overweight; Inflammation
Study type: Interventional

Summary: 
      This research study will test the effects of almonds on immune functions and immune response
      to influenza vaccine in overweight middle-aged men
    

Detailed description: 
      The proposed study is a parallel-group, free-living, observer-blind, randomized controlled
      dietary intervention trial on 54 overweight middle-aged men. This study will be carried out
      in two phases: Phase 1 will examine the effects of almonds on clinically relevant markers of
      immune function, and Phase 2 will assess the antibody response to influenza vaccination
      following almond consumption. Participants will attend a baseline clinic and will be
      randomized to one of two groups. The Almond group will receive 15% of daily energy intake in
      the form of almonds as a snack and the Control group will receive an isocaloric
      carbohydrate-based commercial snack (pretzels). The intervention will be for 12 weeks, at
      which time both group participants will receive the influenza vaccination, and continue the
      same dietary intervention for another 16 weeks.
    

Intervention name(s): Almond group; Control Group
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Participants in the Almond group will receive 15% of their daily energy intake in the form of almonds as a snack; Participants in the control group will receive an isocaloric carbohydrate based commercial snack (pretzel)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: this will be a parallel, free-living, randomized controlled trial, where 54 middle-aged men will be randomized to receive either the almonds or a placebo snack
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Almonds; Immunity; Inflammation
A Dose Escalation Phase I Study of PDC-1421 Capsule Targeting in Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety of PDC-1421 Capsule in healthy subject,
      find the effective adequate dose for the next stage of the study, and accumulate information
      of possible mechanism of its anti-depressive effect.
    

Detailed description: 
      Outcome measures: Physical examination, Vital sign, Electrocardiograph (ECG), Hematology,
      Blood chemistry, AEs/SAEs monitoring and Columbia-Suicide Severity Rating Scale (C-SSRS)
    

Intervention name(s): PDC-1421; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other
Keywords: Major depressive disorder; Depression
Evaluation of the Quality of Bowel Cleansing in a Real Clinical Practice Setting
Condition: Bowel Preparation for Colonoscopy
Study type: Observational

Summary: 
      Publications of the use of bowel cleansers in usual clinical practice are lacking. Patient
      adherence to investigational products increases in the context of clinical trials. By the
      same token, efficacy of interventions may be overestimated in clinical trials.

      For this reason, an observational study to collect data on the effectiveness of several
      colonic preparations when these are used under usual clinical practice is proposed.
    


Intervention name(s): Bowel preparation
Intervention type(s): Procedure
Intervention description(s): Bowel preparation for bowel cleansing in a real clinical practice
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients who have been performed a colonoscopy and who have received a bowel
        cleansing agent according to the investigator criteria
      
Keywords: bowel cleansing; bowel preparation
Optic Nerve Course Variants in Nepali Population
Condition: Optic Nerve
Study type: Observational [Patient Registry]

Summary: 
      A retrospective study was conducted on 367 patients. CT PNS and head of the patients were
      evaluated for type of course of optic nerve according to DeLano's Classification.
    

Detailed description: 
      A retrospective study was conducted on 367 patients aged 13 years and above. Four
      investigators, each with 2 to 6 years of experience in the field of radiology, evaluated
      computed tomography scans of the paranasal sinuses and the head of these patients. The optic
      nerves were classified into four types based on DeLano's classification, and their respective
      prevalence rates were determined. Additionally, the prevalence of optic nerve dehiscence and
      pneumatization of the anterior clinoid process was assessed.
    

Intervention name(s): No intervention done
Intervention type(s): Other
Intervention description(s): No interventions done
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patient of age 13 years and more undergoing NCCT PNS and Head for chronic rhinosinusitis ,
        headache and vertigo
      
Keywords: Optic Nerve Course; De Lano's Classification; Anterior Clinoid Process Pneumatization
Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective was to investigate the antiviral effect, safety, and pharmacokinetics of BI
      201335 (Faldaprevir), given as a soft gelatine capsule, in patients with hepatitis C virus
      (HCV) genotype 1 infection. Combination therapy of BI 201335 (Faldaprevir) with pegylated
      interferon α-2a (PegIFN) and ribavirin (RBV), with or without a 3-day lead-in, was assessed
      in treatment-naïve (TN) and treatment experienced (TE) patients.
    


Intervention name(s): BI 201335 NA 240 mg QD / LI; PegIFN/RBV; BI 201335 NA 120mg QD / LI; PegIFN/RBV; BI 201335 NA 240 mg QD; PegIFN/RBV; BI 201335 NA 240 mg QD; PegIFN/RBV; BI 201335 NA 240 mg BID; PegIFN/RBV; PegIFN/RBV; BI 201335 NA 240 mg QD; PegIFN/RBV; Placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 240mg BI 201335 NA (Faldaprevir) once daily with a 3 days lead-in phase of PegIFN/RB, 24 weeks; PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks; 120mg BI 201335 NA (Faldaprevir) once daily, for 24 weeks; PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks; 240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks; PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks; 240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks; PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks; 240mg BI 201335 NA (Faldaprevir) twice, 24 weeks; PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks; PegIFN (180 µg/wk) and RBV (1000/1200mg/d),48 weeks; 240mg BI 201335 NA (Faldaprevir) once daily, 24 weeks; PegIFN (180 µg/wk) and RBV (1000/1200mg/d), 24 or 48 weeks; Placebo
Other intervention name(s): Faldaprevir; Faldaprevir; Faldaprevir; Faldaprevir; Faldaprevir; Faldaprevir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment