bioihbjkbjnl/mcl2 huggingface dataset:
A Pilot Trial of Herpesvirus Treatment in Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The investigators will conduct a single-center, prospective, randomized, placebo-controlled,
      double-blind pilot study of anti-herpesvirus therapy in patients with idiopathic pulmonary
      fibrosis (IPF). Patients with mild, moderate or severe IPF with serologic evidence of current
      or past Epstein-Barr Virus (EBV) or cytomegalovirus (CMV) infection. Randomization will be to
      pirfenidone plus placebo or pirfenidone plus valganciclovir. Thirty subjects will be enrolled
      and randomized to treatment with pirfenidone plus valganciclovir (20 subjects) or pirfenidone
      plus placebo (10 subjects) for 12 weeks. The primary outcome will be safety and tolerability
      will be determined by type, frequency and duration of adverse events (AEs) and serious
      adverse events (SAEs) after 12 weeks of study drug treatment. All study subjects will be
      offered bronchoscopy with bronchoalveolar lavage (BAL) at study initiation and upon
      completion of treatment (12 weeks). Subjects will then be followed up at routine clinic
      visits at 6, 9 and 12 months for data collection.
    


Intervention name(s): Valganciclovir; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.; Subjects with IPF currently tolerating pirfenidone treatment who have evidence of prior EBV or CMV infection will be randomized to valganciclovir or placebo for 12 weeks.
Other intervention name(s): Valcyte
Intervention MeSH terms: Valganciclovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: IPF; Herpesvirus; Valganciclovir
The Effects of Apathy on Different Forms of Fatigue
Condition: Apathy; Fatigue
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      60 participants with light neuro-cognitive disorders (30 apathetic, 30 non-apathetic) will be
      recruited from the CMRR (Centre Mémoire Ressources et Recherche) in Nice University Hospital
      and from the " Fragilily " Platform of the Nice University Hospital.

      After verification by the investigator, if they meet the inclusion criteria and sign the
      informed consent, participants will have to wear an actigraph for one week in order to
      measure their level of activity.

      Afterwards, participants will have to complete assessments and questionnaires to evaluate
      apathy (Apathy Motivation Index, Apathy Inventory), perceived fatigue (Fatigue Severity
      Scale, Borg scale), fatigability (6-min walking test, isometric strength test, double task),
      the stress level (Perceived Stress Scale) and depression (Geriatric Depression Scale).

      Regarding the activity level, they will also be asked to perform tasks to evaluate their
      kinematic movements( through an actigraph), and their particular sensitivity towards effort
      and reward (through serious game 'Tap-piscine').

      The total duration of the evaluation is a maximum of 2 hours.
    


Intervention name(s): Follow up and Assessment
Intervention type(s): Other
Intervention description(s): each patient should wear an actigraph during a week and will be do some tests during 2hours (6min walk, apathy inventory, fatigue severity scale etc...)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Deep vs Moderate Neuromuscular Blockade With Rocuronium in Patients Undergoing Endolaryngeal Procedures
Condition: Laryngoscopic Surgical Procedures
Study type: Interventional
Phase: Phase 4

Summary: 
      It is unknown the impact of deep neuromuscular paralysis and using a novel agent, sugammadex
      as an reversal in endolaryngeal surgery.

      We will conduct a clinical study aiming to compare two treatment strategies; Deep
      neuromuscular Blockade and moderate Neuromuscular Blockade. We hypothesize that deep NMB will
      offer better stillness. We will also descriptively examine if patients would be safely
      discharged from a recovery room.
    


Intervention name(s): Deep Neuromuscular Blockade; Moderate Neuromuscular Blockade; Sugammadex; Rocuronium
Intervention type(s): Procedure; Procedure; Drug; Drug
Intervention description(s): During maintenance phase, if recovery after 1 Post-Tetanic-count (PTC) responses, a continuous infusion can be initiated to maintain deep NMB (TOF =0, PTC 1-2).
At the end of surgery, continuous infusion Rocuronium and Propofol are discontinued and paralysis will be simultaneously reversed by Sugammadex 4mg/kg from PTC 1-2.; - During maintenance phase, if recovery at the presence of <10% of control T1 of TOF from initial doses of 0.6 mg rocuronium, a continuous infusion can be initiated to maintain TOF = 1 - 2. The initial pump rate will be set at 0.5 mg/kg per hour.
Intervention MeSH terms: Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: "surgical conditions"; "deep neuromuscular blockade"; "deep neuromuscular paralysis"
Games to Overcome Late Life Depression
Condition: Major Depressive Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major
Study type: Interventional

Summary: 
      This is a pilot study divided into two phases. IN phase 1 (completed) participants will be
      randomized to receive 8 weeks of Problem Solving Therapy (PST) alone or 8 weeks of a
      cognitive training game called, Evolution (Evo) plus clinical management. In Phase 2 (now
      recruiting), participants will be randomized to Evo, PST, and a different cognitive training
      program called Words. Words is similar to Evo in that it is an adaptive training program and
      includes case management. IN both studies participants will be assessed for clinical and
      functional magnetic resonance imaging (fMRI) outcomes at baseline, 4 weeks and 8 weeks.
    

Detailed description: 
      Evo is a computer game that targets parts of the brain (i.e. the cognitive control network)
      that we think may be associated with depressive symptoms. This study is exploratory and will
      inform future hypotheses the research team will test in subsequent research.
    

Intervention name(s): Problem Solving Therapy; Evolution; Words
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Problem solving therapy is an evidence based behavioral intervention for late life depression. It consist of 8 weekly session of talk therapy, whereby the therapist helps the patient solve problems that are thought to be causing depressive symptoms.; Evo is a video game that has therapeutic elements targeting the cognitive control network. Impairment in this neural network is associated with a specific subtype of late life depression that puts people at risk for poor response to SSRIs. Evo is built from a research grade training paradigm that has shown to induce improvements in this network in healthy older adults; Words is a cognitively challenging crossword/word search type of video game that will serve as the control condition for the second phase of this project
Other intervention name(s): PST; Neuroracer; Evo; Project: Evolution
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Depression; mood; cognitive training
A Clinical Trial Investigating the Intra-subject Variability of Pharmacokinetics and Glucodynamics of BioChaperone Insulin Lispro U-100 Product and U-200 Product in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a double-blinded, randomised, single-centre phase I pilot trial for exploring the
      feasibility of a pivotal clinical trial establishing bioequivalence between BioChaperone
      insulin lispro U-200 and BioChaperone insulin lispro U-100 in healthy subjects.

      Each subject will be randomly allocated to a sequence of four treatments, i.e. two single
      doses of BioChaperone insulin lispro U-200 of 0.2 U·kg BW-1 and two single doses of
      BioChaperone insulin lispro U-100 of 0.2 U·kg BW-1 on four separate dosing visits.
    


Intervention name(s): BioChaperone Lispro U-100; BioChaperone Lispro U-200
Intervention type(s): Drug; Drug
Intervention description(s): Injection of BioChaperone Lispro U-100; Injection of BioChaperone Lispro U-200
Intervention MeSH terms: Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Efficacy and Safety of Vildagliptin as add-on Therapy to Insulin in Patients With Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      To assess the efficacy and safety of vildagliptin add-on therapy to reduce HbA1c in patients
      with T2DM inadequately controlled by insulin, with or without concurrent metformin therapy.
    


Intervention name(s): Vildagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vildagliptin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Add-on to insulin
Pantoprazole Magnesium 40 mg Versus Esomeprazole 40 mg in Patients With Erosive Gastroesophageal Reflux Disease
Condition: GERD
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this trial is to evaluate the complete remission of erosive gastroesophageal
      reflux disease with pantoprazole magnesium 40 mg once daily versus esomeprazole 40 mg once
      daily during four-week treatment with an extension treatment for non-responding patients. The
      study includes a baseline period up to 14 days and a treatment period of either 4 weeks (28
      -2 + 5 days), or 8 weeks depending on the cure of esophagitis due to gastroesophageal reflux.
      The study will provide further data on safety and tolerability of pantoprazole magnesium.
    


Intervention name(s): Magnesium Pantoprazole; Magnesium Esomeprazole
Intervention type(s): Drug; Drug
Intervention description(s): 1 capsule daily, 40 mg, orally, 30 minutes before breakfast; 1 capsule daily, 40 mg, orally, 30 minutes before breakfast
Intervention MeSH terms: Esomeprazole; Pantoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Gastroesophageal; Pantoprazole; erosive; Erosive GERD grades A-D, acc. to Los Angeles classification
Brain Stimulation and Cognitive Training
Condition: Bipolar Disorder; Schizo Affective Disorder; Schizophrenia
MeSH terms: Schizophrenia; Bipolar Disorder; Mood Disorders; Psychotic Disorders
Study type: Interventional

Summary: 
      People with serious mental illness often report difficulties with thinking skills like
      memory. These difficulties can make it harder to perform day-to-day activities. The purpose
      of this study is to test whether combining a type of non-invasive brain stimulation with
      computerized cognitive exercises is acceptable to participants, and whether it is helpful in
      improving a specific type of memory skill in people who have mental health conditions and
      memory deficits.

      This study is designed so that all participants will get both treatments: the non-invasive
      brain stimulation and computerized cognitive exercises. Half of the participants will start
      with both the brain stimulation and the cognitive exercises (dual therapy), and half will
      start with just the computerized exercises (monotherapy). After three weeks, participants
      will switch to the other condition: the people who did both treatments first will switch to
      just the cognitive exercises alone, and the people who started with the cognitive exercises
      alone will then switch to doing both the brain stimulation and cognitive exercises.

      Overall, participants will be in the study for about 7-8 weeks. The brain stimulation
      treatment involves 10 visits to the clinic over 3 weeks. The computerized cognitive exercises
      can be done at home, and involve 10 hours of exercises over 3 weeks. Participants will also
      complete paper-and-pencil assessments at the beginning, middle, and end of treatment.
    


Intervention name(s): tDCS; BrainHQ
Intervention type(s): Device; Other
Intervention description(s): tDCS is a non-invasive procedure in which electrodes are attached to the scalp and send a small direct current to stimulate brain function; BrainHQ is a web-based, commercially available cognitive training program that includes exercises to enhance working memory
Other intervention name(s): Transcranial direct current stimulation; Computerized cognitive exercises
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Participants will be randomized to receive either dual therapy (cognitive exercises plus brain stimulation) or monotherapy (cognitive exercises alone) first; after 3 weeks participants will switch to the other condition
Masking: None (Open Label)
Primary purpose: Other
Self-sampling for Non-participants in an Organised Cervical Cancer Screening Programme
Condition: Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      The trial will evaluate the effect on participation in organised screening programme of a
      human papilloma virus (HPV) self-sampling kit directly mailed home or mailed on demand
      compared with the standard second reminder for regular screening.
    

Detailed description: 
      The CHOice trial is a parallel randomised controlled, open label trial. Participants will be
      equally randomised into three arms: 1) Directly mailed a second reminder including a HPV
      self-sampling kit; 2) Mailed a second reminder offering a HPV self-sampling kit, to be
      ordered by e-mail, by text message, by phone, or by website; and 3) Mailed a second reminder
      for a conventional practitioner-collected sample (control group).
    

Intervention name(s): HPV self-sampling kit mailed directly; HPV self-sampling kit on demand; Second reminder
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): Women in intervention group 1 will be mailed a modified second reminder, a leaflet entitled Information about HPV self-sampling, and a self-sampling kit. The leaflet provides information about HPV and cervical cancer including benefits and harms about HPV self-sampling compared to regular screening. The kit includes a brush device (Evelyn Brush, Rovers Medical Devices B.V, Oss, Netherlands) to collect a cervico-vaginal sample for subsequent hrHPV testing, written and drawn instructions on how to obtain and mail the sample, and a pre-stamped return envelope addressed to the Department of Pathology, Randers Regional Hospital performing the hrHPV testing.; Women in intervention group 2 receive the same material as arm 1, except for the kit, which will only be mailed to the women on demand. Additionally, the leaflet for this group contains information on how to order the kit.
The modified second reminder in both intervention groups informs of the opportunity to collect a self-sample if wanted, but also about the opportunity to have a conventional specimen taken at a general practitioner (usual procedure).; The standard second reminder informs women about the ongoing opportunity to have a conventional cervical sample taken by a general practitioner. (control group)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: HPV self-sampling, cervical cancer screening
Study of Modified Stem Cells (SB623) in Patients With Chronic Motor Deficit From Ischemic Stroke
Condition: Chronic Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke; Cerebral Infarction; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Controlled study of stereotactic, intracranial injection of SB623 cells in patients with
      fixed motor deficits from ischemic stroke
    

Detailed description: 
      This is a double-blind, sham-surgery controlled study of stereotactic, intracranial injection
      of SB623 cells in patients with fixed motor deficits from ischemic stroke. The study will be
      conducted at approximately 65 sites in the United States.

      Two cohorts, Group 1 (2.5 and 5 million SB623 cells combined) and Group 2 (sham placebo),
      will be included in this study. Subjects who are randomized into this study will receive
      either 2.5 million SB623 cells, 5 million SB623 cells or sham surgery at a 1:1:1
      randomization ratio. Randomization will be performed via an interactive web/voice response
      system (IXRS), stratified by Screening mRS score (recorded in the IXRS at the clinical site).
    

Intervention name(s): SB623 Implant (2.5M); SB623 Implant (5.0M); Sham surgery
Intervention type(s): Biological; Biological; Procedure
Intervention description(s): 2.5 million SB623 cells; 5 million SB623 cells
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ischemic stroke; chronic stroke; fixed motor deficits
A Double-blinded, Randomised, Three-period Crossover Euglycaemic Clamp Trial Investigating the Pharmacokinetics, Glucodynamics and Safety of BioChaperone Human Insulin, Human Insulin (Huminsulin® Normal) and Insulin Lispro (Humalog®) in Subjects With Type 1 Diabetes
Condition: Diabetes Mellitus Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The addition of BioChaperone to already marketed prandial human insulin preparations may
      accelerate the onset and shorten the duration of action due to facilitation of the insulin
      absorption after subcutaneous injection.

      The aim of the trial is to assess the efficacy and safety of BioChaperone human insulin in
      subjects with type 1 diabetes under a dose of 0.2 U/kg.

      This trial is a single center, randomised, double-blinded, three treatment, three-period
      cross-over, 10-hour euglycaemic clamp trial in subject with type 1 diabetes mellitus. Each
      subject will be randomly allocated to a single dose of BioChaperone human insulin 0.2 U/kg, a
      single dose of Huminsulin® Normal 0.2 U/kg and a single dose of Humalog® 0.2 U/kg on 3
      separate dosing visits.
    


Intervention name(s): BioChaperone human insulin; Huminsulin® Normal; Humalog®
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single dose of 0.2 U/kg body weight injected subcutaneously; Single dose of 0.2 U/kg body weight injected subcutaneously; Single dose of 0.2 U/kg body weight injected subcutaneously
Intervention MeSH terms: Insulin; Insulin Lispro; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effectiveness of Paritaprevir/Ritonavir - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Belgium
Condition: Chronic Hepatitis C, Genotype 1 or 4
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Observational

Summary: 
      The interferon-free combination regimen of ombitasvir/paritaprevir/ritonavir/ with or without
      dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC)
      has been shown to be safe and effective in randomized controlled clinical trials with strict
      inclusion and exclusion criteria under well-controlled conditions. This observational study
      was the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to
      local label, under real world conditions in Belgium in a clinical practice patient
      population.
    

Detailed description: 
      This was a prospective, multi-center observational study in participants receiving the
      interferon-free ABBVIE REGIMEN ± RBV in Belgium. The prescription of a treatment regimen was
      at the discretion of the physician in accordance with local clinical practice and label, was
      made independently from this observational study and preceded the decision to offer the
      participant the opportunity to participate in this study. Adults chronically infected with
      hepatitis C virus (HCV), receiving the interferon-free ABBVIE REGIMEN, were offered the
      opportunity to participate in this study during a routine clinical visit at the participating
      sites.Follow-up visits, treatment, procedures, and diagnostic methods followed physicians'
      routine clinical practice. Data were collected at the following time windows: baseline, early
      on-treatment visit, mid-treatment visit (for participants with a treatment duration of 24
      weeks), end of treatment (EoT), early post-treatment, and 12 and 24 weeks after the end of
      treatment (representing sustained virologic response 12 weeks after the end of treatment
      [SVR12] and sustained virologic response 24 weeks after the end of treatment [SVR24]).
    

Intervention name(s): Ombitasvir/paritaprevir/ritonavir; Dasabuvir; Ribavirin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Co-formulated tablet; Tablet; Tablet
Other intervention name(s): Ombitasvir also known as ABT-267; Paritaprevir also known as ABT-450; ABT-333
Intervention MeSH terms: Ritonavir; Ribavirin
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with chronic hepatitis C virus infection, genotype 1 or 4, receiving
        combination therapy with the interferon-free ABBVIE REGIMEN ± ribavirin
      
Keywords: Effectiveness; Influence of adherence; Patient reported outcomes; Ombitasvir/paritaprevir/ritonavir ± dasabuvir; Chronic Hepatitis C genotype 1; Chronic Hepatitis C genotype 4