bioihbjkbjnl/mcl2 huggingface dataset:
Vonoprazan in Helicobacter Pylori Treatment an RCT
Condition: Helicobacter Pylori Infection
Study type: Interventional
Phase: Phase 4

Summary: 
      RCT for comparison of Standard Triple therapy (Omeprazole+Amoxil+Clarithromycin) for H Pylori
      erradication with Vonoprazan+Amoxil dual therapy.
    

Detailed description: 
      OBJECTIVE To compare the efficacy of Vonoprazan based dual treatment versus PPI based
      treatment for the eradication of Helicobacter pylori infection.

      OPERATIONAL DEFINITION

      Helicobacter Pylori infection: Hp infection will be labelled by any one of following
      investigation:

        -  Helicobacter Pylori Stool Antigen

        -  Histopathology on Giemsa Stain

      MATERIAL AND METHODS:

      Study Design: Randomized control trial. Setting: This study will be conducted in the Medical
      OPD and Medical Unit 1 of Dr. Ruth K.M. Pfau, Civil Hospital Karachi affiliated with Dow
      University of Health Sciences

      DATA COLLECTION PROCEDURE:

      All patients presenting to the OPD or Medical Unit 1 of Dr. Ruth KM Pfau, Civil Hospital
      Karachi and fulfilling the inclusion criteria will be included after taking informed consent.

      The participants will be randomly allocated to 2 groups with help of random number table and
      will be treated for 2 weeks.

      Group A: will be given:

      Capsule Amoxicillin 1 gm twice daily Tablet Clarithromycin 500 mg twice a day Capsule
      Omeprazole 20 mg twice a day

      Group B will be given:

      Capsule Amoxicillin 1 gm twice daily Tablet Vonoprazan 20 mg twice a day Confirmation of Hp
      eradication will be done by stool Hp antigen test 4 weeks after completion of treatment.

      DATA ANALYSIS Data will be stratified according to age & gender. Frequency of gender & mean
      (SD) of age will be compared between groups using Pearson's Chi-square test and Student's
      t-test respectively. Frequency of Hp eradication between two groups will be compared using
      Pearson's chi-square test. A p value < .05 will be taken as significant.
    

Intervention name(s): Omeprazole 20 MG Capsule; Amoxicillin 1000 MG; Clarithromycin 500 MG; Vonoprazan 20 MG; Amoxicillin 1000 MG
Intervention type(s): Drug; Drug
Intervention description(s): Orally twice daily for 2 weeks; Orally twice daily for 2 weeks
Other intervention name(s): Omeprazole Group; Vonoprazan Group
Intervention MeSH terms: Amoxicillin; Clarithromycin; Omeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Control Trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: helicobacter pylori; Vonoprazan; potassium-competitive acid inhibitor
Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of Velpatasvir in Participants With Chronic HCV Infection
Condition: Chronic Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the safety, tolerability, and antiviral
      activity of velpatasvir (formerly GS-5816) in HCV treatment naive participants with genotypes
      1-6.
    


Intervention name(s): Velpatasvir; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Tablets administered orally; Tablets administered orally
Other intervention name(s): GS-5816
Intervention MeSH terms: Velpatasvir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatitis C; HCV; Genotype 1; Genotype 2; Genotype 3; Genotype 4; Genotype 5; Genotype 6; Liver Disease
A Study to Evaluate the Onset of Effect and Time Course of Change in Lung Function With Benralizumab in Severe, Uncontrolled Asthma Patients With Eosinophilic Inflammation
Condition: Asthma
MeSH terms: Asthma; Inflammation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate the onset and maintenance of effect of
      benralizumab on lung function, blood eosinophils, asthma control metrics and quality of life
      during 12-week treatment in patients with uncontrolled, severe asthma with eosinophilic
      inflammation. A subset of patients will take part in body plethysmography substudy to further
      investigate the effect on lung function.
    


Intervention name(s): Benralizumab; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Benralizumab administered subcutaneously at Visit 1 (Day 0), Visit 8 (Day28 +/- 3 days) and Visit 9 (Day 56 +/- 3 days); Placebo administered subcutaneously at Visit 1 (Day 0), Visit 8 (Day28 +/- 3 days) and Visit 9 (Day 56 +/- 3 days)
Intervention MeSH terms: Benralizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: Asthma, Bronchial Diseases, Respiratory Tract Diseases, Lung Diseases, Obstructive Lung Diseases
A Study of Pegasys (Peginterferon Alfa-2a) Added to Nucleos(t)Ide Analogue Treatment in Participants With HBeAg-Negative Chronic Hepatitis B Genotype D Showing Stable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Suppression
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This open-label, single-arm, multicenter study will evaluate the efficacy and safety of
      adding Pegasys (peginterferon alfa-2a) to nucleos(t)ide analogue (NAs) treatment in
      participants with HBeAg-negative chronic hepatitis B genotype D showing stable HBV DNA
      suppression. After a 12-week Lead-in period on treatment with NA, participants with a HBsAg
      decline <0.5 log10 IU/ml will enter the Add-on period to receive Pegasys 180 mcg
      subcutaneously weekly for 48 weeks in addition to their current NA treatment. Follow-up will
      be a further 48 weeks, during which the participants will continue their NA treatment.
    


Intervention name(s): Pegylated Interferon (Peginterferon) Alfa-2a; Nucleos(t)ide Analogues (NA)
Intervention type(s): Drug; Drug
Intervention description(s): Peginterferon alfa-2a 180 mcg, subcutaneously (SC) once weekly for 48 weeks.; Nucleos(t)ide analogues includes adefovir, entecavir, lamivudine or tenofovir.
Other intervention name(s): Pegasys
Intervention MeSH terms: Interferons
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Repeated Neurocognitive Measurements in Depressed Patients
Condition: Depression, Unipolar
MeSH terms: Depressive Disorder
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this project, we will A) track the functioning of a collection of potential
      neurobiological targets for depression over time, B) examine how fluctuations in the
      functioning of those targets relates to real-world functioning, and C) in a subset of the
      sample, determine how the functioning in those targets is altered by a single dose of
      ketamine.
    


Intervention name(s): Intravenous Ketamine
Intervention type(s): Drug
Intervention description(s): Single infusion of intravenous racemic ketamine (0.5mg/kg over 40min)
Intervention MeSH terms: Ketamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Atrosimab (ATM001) in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blind, parallel group and placebo-controlled clinical study to assess safety
      tolerability, pharmacokinetics and pharmacodynamics of Atrosimab in healthy volunteers
    


Intervention name(s): ATM001; ATM001 Placebo
Intervention type(s): Biological; Biological
Intervention description(s): monovalent anti-TNF-receptor 1 antibody format; ATM001 Placebo
Other intervention name(s): Atrosimab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study to Investigate the Absorption, Metabolism, and Excretion of [14C]-GDC-0941 Following Single Oral Dose Administration in Healthy Male Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be an open-label, non-randomized, absorption, metabolism, and excretion study
      of [14C]-GDC 0941 administered as an oral dose to 6 healthy male subjects following at least
      a 10-hour fast from food (not including water).
    


Intervention name(s): GDC-0941
Intervention type(s): Drug
Intervention description(s): Single oral dose\n \n\n\n\n
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
HDDO-1614 Intervention Trial
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, Open-label, Single-dose, 3-period, 6-sequence, 3-way crossover Study
    


Intervention name(s): Bazedoxifene 20 mg; Cholecalciferol; Bazedoxifene 20mg and Cholecalciferol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): To estimate the drug-drug interaction between Bazedoxifene and combination of Bazedoxifene and Cholecalciferol, Subject will take Bazedoxifene 20mg 1 tablet one time.; To estimate the drug-drug interaction between Cholecalciferol and combination of Bazedoxifene and Cholecalciferol, Subject will take Cholecalciferol 2 tablets one time.; For estimate the Drug-Drug Interaction, Subject will take Bazedoxifene 1 tablet and Cholecalciferol 2 tablets at once.
Intervention MeSH terms: Cholecalciferol; Vitamin D; Bazedoxifene
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Reactogenicity and Protectivity Following Measles- Rubella (MR) Routine Immunization in Indonesian Infants and Children
Condition: Safety Issues; Immunogenicity
MeSH terms: Measles; Rubella
Study type: Interventional
Phase: Phase 4

Summary: 
      to assess safety and immunogenicity of measles-rubella (MR) routine immunization in
      Indonesian Children and Infants
    

Detailed description: 
      -  to asses serious immediate systemic events,

        -  to assess local and systemic reaction after Measles-Rubella (MR) vaccine in infants and
           children,

        -  to evaluate protectivity and antibody response to measles and rubella after 1 dose of MR
           vaccine
    

Intervention name(s): Measles-Rubella (MR) Vaccine
Intervention type(s): Biological
Intervention description(s): Measles and Rubella Vaccine, live attenuated (Serum Institute of India) Form : Freeze dried Dose : 1 dose 0.5 ml contains not less than 1000 CCID50 of measles virus and 1000 CCID50 of rubella virus.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Safety Group: open labeled, prospective intervention study, only assess the safety outcome Sub Group: open labeled, prospective intervention study, evaluate safety and protectivity outcome
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Measles-Rubella; Vaccine; Safety; Immunogenicity; Reactogenicity; Protectivity
AYActive Study! A Physical Health Activity Intervention
Condition: Cancer
Study type: Interventional

Summary: 
      The purpose of this pilot study is to explore the feasibility, acceptability, and efficacy of
      a 6-week mobile health (mHealth) physical activity intervention among adolescent and young
      adult (AYA) cancer survivors being treated at the University of Iowa Hospitals and Clinics.
    

Detailed description: 
      The purpose of this pilot study is to explore the feasibility, acceptability, and efficacy of
      a 6-week mobile health (mHealth) physical activity intervention among adolescent and young
      adult (AYA) cancer survivors being treated at the University of Iowa Hospitals and Clinics.
      Eligible participants will receive a Fitbit activity monitor and access to the mHealth
      physical activity intervention for 6 weeks. The intervention will include regular
      motivational messages to encourage activity, a social media thread to provide social support,
      and a series of fun virtual walking races. AYA cancer survivors between 13-39 years are
      invited to participate and the impact of this intervention will be tested over 6 weeks.
    

Intervention name(s): mHealth Activity Intervention
Intervention type(s): Behavioral
Intervention description(s): Eligible participants will receive a Fitbit activity monitor and access to our mHealth physical activity intervention for 6 weeks. The intervention will include regular motivational messages to encourage activity, a social media thread to provide social support, and a series of fun virtual walking races.
Intervention model: Single Group Assignment
Intervention model description: The intervention will include an activity monitor and access to the mHealth physical activity intervention for 6 weeks. The intervention will include regular motivational messages to encourage activity, a social media thread to provide social support, and a series of fun virtual walking races.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Adolescents; Young Adults
Abuse Potential of Intranasal VYCAVERT Tablets (Hydrocodone Bitartrate/Acetaminophen) in Recreational Opioid Users
Condition: Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      To determine the relative abuse potential of VYCAVERT (hydrocodone bitartrate and
      acetaminophen) compared to GENERIC H/A (hydrocodone bitartrate and acetaminophen) when
      crushed and administered intranasally to non dependent, recreational opioid users.
    


Intervention name(s): Placebo taken first; Generic H/A taken first; Vycavert taken first; Generic H/A plus i taken first; Generic H/A plus p taken first
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): Snorted in both nostrils within 5 minutes; 48 hours washout between doses; Snorted in both nostrils within 5 minutes; 48 hours washout between doses; Snorted in both nostrils within 5 minutes; 48 hours washout between doses; Snorted in both nostrils within 5 minutes; 48 hours washout between doses; Snorted in both nostrils within 5 minutes; 48 hours washout between doses
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Appropriate Dose of Neostigmine for Reversal of Rocuronium and Cisatracurium
Condition: Observation of Neuromuscular Block
Study type: Interventional

Summary: 
      This study aims to find appropriate dose of neostigmine which is possible to reverse
      rocuronium or cisatracurium till train of four (TOF) 0.9 within 10 minutes.
    


Intervention name(s): Injection of neostigmine
Intervention type(s): Drug
Intervention description(s): At induction, we will inject rocuronium 0.6 mg/kg for rocuronium arms and cisatracurium 0.15 mg/kg for cisatracurium arms.
During surgical procedure, we will monitor train of four(TOF)using nerve stimulator. When TOF ratio recover to 0.5, normal saline 5 ml will be injected in placebo arms. And neostigmine 10, 20, or 40 ㎍/kg will injected in each arms.
Intervention MeSH terms: Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Development of Physical Activity Features for Ear-worn Devices
Condition: Hearing Loss; Well Aging
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      This study incorporates data collection to aid in development of software features related to
      physical activity for users of ear-worn devices.
    

Detailed description: 
      This exploratory study involves data collection of adults performing physical activities and
      activities of daily living for the purpose of comparing data collected by the ear-worn device
      under test and established gold standard/reference devices and consumer electronic devices.
      Data collected will be used in the development of software features related to physical
      activities to benefit the experience of ear-worn device users.
    

Intervention name(s): Ear-worn prototype devices
Intervention type(s): Device
Intervention description(s): Hearing instrument including sensors to track movement and estimations of biological information.
Other intervention name(s): Phonak Audeo
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Natriuretic Effect of Telmisartan Versus Placebo in Patients With Mild-to-Moderate Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      Study to compare the natriuretic effect of telmisartan to placebo in mild-to-moderate
      hypertensive patients on a controlled sodium diet as well as to explore the effects of
      telmisartan on norepinephrine, plasma renin activity (PRA), plasma aldosterone, urine
      potassium, creatinin, chloride, bicarbonate and uric acid excretion. Additionally it was
      assessed whether the natriuretic effect disappears after treatment when telmisartan is
      stopped. The effects of telmisartan on seated clinic blood pressure and the relationship
      between urine sodium loss and decrease in ambulatory blood pressure after the first dose were
      assessed descriptively. Assessment of safety was also considered.
    


Intervention name(s): Telmisartan, low dose; Telmisartan, high dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Telmisartan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Novel Approach to Assess Metabolic Flexibility in a Respiratory Chamber
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The overarching aim of this study: To determine the effect of different meal compositions
      (high- vs. low-fat) on metabolic flexibility as it relates to meal-stimulated change in
      respiratory quotient (ΔRQ1) and sleep (ΔRQ2) metabolic flexibility, as well as the time
      course changes in respiratory quotient, RQ (i.e., peak RQ, time to peak RQ, nadir RQ, time to
      nadir, slope).
    


Intervention name(s): High fat meal; Low fat meal
Intervention type(s): Other; Other
Intervention description(s): 60% fat meal; 20% fat meal
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Efficacy of the Memory Motivation (MEMO) Web Application Training
Condition: Neurocognitive Disorders
MeSH terms: Neurocognitive Disorders
Study type: Interventional

Summary: 
      Memory, attentional, and behavioural symptoms are the clinical hallmarks of Neurocognitive
      disorders (NCD) such as Alzheimer's disease and related disorders. The World Health
      Organisation (WHO) guidelines for risk reduction of cognitive decline and dementia indicate
      that Cognitive training may be offered to older adults with normal cognition and with mild
      cognitive impairment to reduce the risk of cognitive decline and/or dementia. The use of
      Information and Communication Technologies (ICT) in the health domain is progressively
      expanding. The Alzheimer Innovation Association have developed MeMo (Memory Motivation) a
      free web application that can be used at home by patients.

      The objective of the present study was to assess the effectiveness of employing the MeMo
      platform on cognitive performance in patients suffering from NCD.
    

Detailed description: 
      The objective of this study is to evaluate the effectiveness of the MeMo cognitive training
      exercise platform in patients suffering from neurocognitive disorders. These exercises ,have
      been developed by the association Innovation Alzheimer and the CoBTeK research team, located
      with the Nice memory Center at the Institut Claude Pompidou. MeMo can be used freely at home
      by patients. More specifically, it is a randomized controlled study that aims to compare the
      evolution of activities cognition and behavior between patients not using these exercises,
      and patients using these exercises for 12 weeks, 4 sessions per week.
    

Intervention name(s): MeMo web application; Control group
Intervention type(s): Device; Other
Intervention description(s): The patient betwenn 2 consultation could use the application MeMo. MeMo is a web application that can thus be used on any web browser (computer or tablet). On tablet, the application can be installed on home screen to look like a native app, and used offline.; the patient have the classical follow up at the memory center (consultation)
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: regular use of a web application at home to train cognition and behavior
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cognition; motivation; technology; non pharmacological intervention
Study Evaluating Effects of SAM-531 on Sleep Electroencephalogram (EEG) and Quantitative Wake EEG in Healthy Subjects
Condition: Healthy; Adult
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary: To evaluate the pharmacologic effect of single doses of SAM-531 on sleep EEG in
      healthy subjects.
    


Intervention name(s): SAM-531; placebo; Donepezil
Intervention type(s): Drug; Other; Drug
Intervention description(s): dosage form : 0.5 mg and 5 mg capsules 3 different single doses : 1 mg, 3mg and 10 mg of SAM-531; placebo; dosage form: 5 mg encapsulated tablets one single dose of 5 mg.
Intervention MeSH terms: Donepezil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Keywords: Alzheimer Disease
Hydroxyurea in Treating Patients With Recurrent and/or Unresectable Meningioma
Condition: Brain and Central Nervous System Tumors
MeSH terms: Meningioma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die.

      PURPOSE: Phase II trial to study the effectiveness of hydroxyurea in treating patients who
      have recurrent and/or unresectable meningioma.
    

Detailed description: 
      OBJECTIVES:

        -  Determine complete, partial, or stable response to hydroxyurea in patients with
           recurrent and/or nonresectable meningioma.

        -  Determine response at 2 years to this regimen in these patients.

        -  Determine overall and disease free survival of these patients after this regimen.

        -  Determine quality of life of these patients.

        -  Determine the toxicities of this regimen in these patients.

      OUTLINE: This is a multicenter study. Patients are stratified according to grade of disease
      (I vs II or III).

      Patients receive oral hydroxyurea daily for 2 years.

      Quality of life is assessed before treatment, then every 3 months for 2 years.

      PROJECTED ACCRUAL: A total of 60 patients (30 per stratum) will be accrued for this study.
    

Intervention name(s): hydroxyurea
Intervention type(s): Drug
Intervention MeSH terms: Hydroxyurea
Primary purpose: Treatment
Keywords: recurrent adult brain tumor; adult grade III meningioma; adult grade I meningioma; adult grade II meningioma