bioihbjkbjnl/mcl2 huggingface dataset:
A One Year Open Label Study Assessing the Safety and Tolerability of Vilazodone in Patients With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 3

Summary: 
      This open label 52-week clinical trial is designed to assess the safety and tolerability of
      vilazodone and to analyze genetic markers of response to vilazodone in adult patients
      diagnosed with MDD. This study will enroll approximately 600 patients.
    

Detailed description: 
      Patients will be enrolled at approximately 40 US investigative sites and receive vilazodone
      for 52 weeks of open label treatment. Safety measurements will include adverse events, vital
      signs, laboratory, ophthalmologic exams, Changes in Sexual Function Questionnaire (CSFQ)
      scale and electrocardiogram (ECG) findings collected over the course of the treatment period.
      Effectiveness measurements will be done at baseline and each visit until week 52 or
      end-of-treatment. A deoxyribonucleic acid (DNA) sample will be collected for genetic analysis
      related to response to vilazodone.
    

Intervention name(s): vilazodone
Intervention type(s): Drug
Intervention description(s): titration to 40 milligrams (mg) every day (qd) for 1 year
Other intervention name(s): EMD 68843, SB-659746
Intervention MeSH terms: Vilazodone Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial to Evaluate the Optimal Dose of MV-LASV (V182-001)
Condition: Lassa Virus Infection
MeSH terms: Infections; Virus Diseases; Lassa Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, placebo-controlled, single-center, dose finding phase I trial in
      healthy adult volunteer participants consisting of two phases, an unblinded dose escalation
      and an observer-blinded treatment phase.

      The aim is to investigate the safety, tolerability and immunogenicity of MV-LASV after
      administration of two different dose levels of MV-LASV. Placebo will be applied to blind the
      different Treatment schedules.
    

Detailed description: 
      This is a prospective, interventional, observer-blinded, randomized, phase I trial, comparing
      different dose levels of MV-LASV. As safety precaution, the study will begin with enrollment
      of two successive unblinded dose groups of sentinel participants randomized into groups of
      four in an open-label fashion (group A and B).

      Thereafter, 52 participants will be enrolled in an observer-blinded, randomized manner into
      one of the three treatment groups (A, B or C). Placebo will be applied to blind the different
      Treatment schedules.

      After the screening visit, participants will bei enrolled to one of three Treatment groups.
      Visits for immunogenicity sample collection and safety assessments will be performed for 56
      days, and additionally subjects will for long-term follow-up up to 365 days.

      The investigator and site personnel assessing Adverse Events (AEs), all participants, as well
      as the sponsor's representatives involved in the monitoring and conduct of the study will be
      unblinded to which vaccine was administered within the unblinded treatment phase. Only the
      site personnel performing randomization, reparation and administration of Investigational
      Medicinal Product (IMP) will be unblinded within the randomized observer-blinded treatment
      phase.
    

Intervention name(s): MV-LASV; Placebo
Intervention type(s): Biological; Other
Intervention description(s): The MV-LASV vaccine candidate is a recombinant live attenuated viral vectored vaccine, based on the backbone of the measles Schwarz virus strain for prophylaxis of Lassa infection and will be administered in two different dose levels by intra muscular (i.m.) injection.; A sterile physiological saline solution will be used as placebo to ensure blinding of the treatment with low dose MV-LASV and placebo within treatment group A. Additionally, the Placebo will be used as a control arm to enable comparison of treatment reactions within treatment groups B and C.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lassa Virus Infection; Prevention; Vaccine; Phase 1; Lassa Fever
Study the Effect of Blood Transfusion on Oxidant-antioxidant Status in Term and Near-term Neonates
Condition: Blood Transfusion Complication; Oxidative Stress
MeSH terms: Transfusion Reaction
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Primary aim is to evaluate the effect of blood transfusion on oxidant-antioxidant status in
      premature neonates. Secondary aim is to assess the effect of the age of transfused red blood
      cells on the biological markers of oxidative stress.
    

Detailed description: 
      Oxidant-antioxidant status will be assessed by measuring total antioxidant capacity (TAC) and
      malondialdehyde (MDA), as well as antioxidant minerals, in 65 term and near-term neonates.
    

Intervention name(s): packed red blood cells transfusion
Intervention type(s): Biological
Intervention description(s): packed red blood cells transfusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Evaluation of Sofosbuvir and Daclatasvir Combo in COIVD-19 Patients in Egypt
Condition: Covid19
Study type: Interventional
Phase: Phase 4

Summary: 
      Sofosbuvir has been recently recommended as a possible antiviral for COVID-19, based on
      structural studies and multiple alignment analysis. By comparing the positive-stranded RNA
      genomes of HCV and SARS-CoV-2, it has been postulated that sofosbuvir might be an optimal
      nucleotide analogue to repurpose for COVID-19 treatment
    


Intervention name(s): Sofosbuvir 400 MG/ Daclatasvir 60mg
Intervention type(s): Drug
Intervention description(s): Giving these two drugs for treatment of COVID patients
Intervention MeSH terms: Sofosbuvir
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Sofosbuvir; Daclatasvir
Mechanisms of the Nicotine Metabolism Effect on Tobacco Dependence
Condition: Cigarette Smoking
MeSH terms: Tobacco Use Disorder
Study type: Interventional

Summary: 
      The purpose of the study is to learn more about tobacco dependence and nicotine metabolism in
      African-Americans and whites, by studying to see if how fast a person metabolizes nicotine
      (how the body breaks down nicotine into inactive compounds) affects how dependent they are on
      smoking cigarettes. The investigators believe that people with a faster rate of metabolism
      may have more severe nicotine withdrawal symptoms and also may have a harder time trying to
      quit smoking.
    

Detailed description: 
      Our studies will use the nicotine metabolite ratio (NMR) (the ratio between the nicotine
      metabolites 3'hydroxycotinine and cotinine)as a simple and clinically feasible biomarker for
      the rate of nicotine metabolism. The investigators hypothesize that a faster rate of
      metabolism leads to faster elimination of nicotine from the body and a more rapid dissipation
      of brain tolerance to nicotine in the interval between cigarettes, leading in turn to (1)
      more severe nicotine withdrawal symptoms and (2) greater subjective reward from the cigarette
      smoked following deprivation. These effects would help to explain why smokers with faster
      rates of nicotine metabolism have a poorer response to smoking cessation therapy when
      compared to those with slower rates of metabolism.

      The investigators will explore the relationship of the NMR to the endophenotypes of
      withdrawal, craving and reward, with the assumption that these factors are likely
      intermediaries for the mechanism linking nicotine metabolism to tobacco dependence and
      smoking cessation rates with pharmacotherapy. Our study design uses a brief (6 hour) interval
      of smoking abstinence followed by a "reward" cigarette to elicit the subjective responses
      relating to withdrawal and reward. Because smoking behavior and severity of nicotine
      dependence vary by race and sex the investigators will also compare the relationship between
      NMR and withdrawal and reward in African American vs white smokers and in men vs women.

      Secondary analyses will examine whether nicotine half-life mediates the observed effects of
      NMR on primary response measures.
    

Intervention name(s): Smoking abstinence
Intervention type(s): Behavioral
Intervention description(s): 6 hour smoking abstinence
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
To Evaluate the Effect of Food on Pharmacokinetics(PK), Phase I Clinical Study of LCB01-0371
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess safety, tolerability of LCB01-0371 after
      fasting/non-fasting food taken in healthy male subjects.
    

Detailed description: 
      A Randomized, Open-label, Single dose, Crossover, Phase Ⅰ Trial to evaluate the effect of
      food on the pharmacokinetics of LCB01-0371 in healthy male subjects.
    

Intervention name(s): LCB01-0371 Tablet 800 mg(R); LCB01-0371 Tablet 800 mg(T)
Intervention type(s): Drug; Drug
Intervention description(s): Reference: taken drug before meal; Test: taken drug after meal
Other intervention name(s): LCB01-0371 Tablet 400 mg 2 Tablet; LCB01-0371 Tablet 400 mg 2 Tablet
Intervention MeSH terms: Delpazolid; Oxazolidinones
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Intravenous Infusion of Paracetamol for Intrapartum Analgesia of Labor
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a double-blind randomized trial evaluates the efficacy of intravenous infusion of
      Paracetamol as intrapartum analgesic in the first stage of labour.
    

Detailed description: 
      Comparison of efficacy and safety of intravenous infusion of paracetamol versus placebo
      (intravenous sterile water infusion) in parturient women in active first phase of labour and
      requiring intrapartum analgesia.
    

Intervention name(s): (1) Paracetamol injection; Sterile water
Intervention type(s): Drug; Other
Intervention description(s): Drugs: (1) Bottle containing 1000 mg Paracetamol in 100 ml solution for intravenous infusion; Drugs: (2) Bottle containing 100 ml sterile water for intravenous infusion
Intervention MeSH terms: Acetaminophen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: intravenous paracetamol; intrapartum analgesia; labor pain; intrapartum pains
PET Imaging of Cannabinoid CB1 Receptors Using [11C]MePPEP
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this protocol is to measure brain CB1 receptors in the hope to better
      understand how they work, so that one day we can understand how the CB1 receptors are
      involved in psychiatric, neurological, and behavioral disorders.
    

Detailed description: 
      MePPEP is a ligand that is highly selective for the cannabinoid type 1 (CB1) receptor. This
      receptor is considered the most common G-coupled protein receptor in the brain (Pacher et
      al., 2006). The CB1 receptor is the site of action of Delta-9-tetrahydrocannbinol (THC), the
      active compound in marijuana, and is found primarily on the presynaptic terminals of
      dopaminergic, glutamatergic, GABAergic neurons (Howlett et al., 2002). The function of the
      CB1 receptor is not entirely clear; however, it has been implicated in several neurological
      and psychiatric disorders, and a selective inverse agonist, rimonabant, is currently in use
      in Europe for the treatment of obesity (Van Gaal et al., 2005). [11C]MePPEP was developed to
      enhance our understanding of the in vivo characteristics of the CB1 receptor (e.g., receptor
      density and receptor occupancy with pharmaceuticals).

      The purpose of this protocol is to establish an accurate method to measure CB1 receptor
      levels in brain by performing test/retest brain imaging studies. The results of this overall
      study are required to apply this PET ligand in various neurological and psychiatric disorders
      in the future.
    

Intervention name(s): [11C]MePPEP
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Cannabinoid; CB1 Receptor; Brain Imaging; PET Imaging; [11C]MePPEP; Healthy Volunteer; HV
Comparison of Nicotine Plasma Concentrations and Subjective Effects for Three Menthol Electronic Cigarettes vs Combustible Menthol Cigarettes and Nicotine Gum
Condition: Smoking
Study type: Interventional

Summary: 
      The purpose of this study is to measure plasma nicotine uptake parameters, physiological
      measures, and subjective effect measures in smokers during and following a single ad libitum
      use of three menthol electronic cigarettes versus combustible menthol cigarettes and nicotine
      gum.
    

Detailed description: 
      This study will assess various elements that may provide information regarding the potential
      for menthol electronic cigarettes (e-cigarettes) to be adopted by current smokers. These
      various elements include: a) nicotine pharmacokinetics (PK), b) physiological measures of
      pulse rate and blood pressure, and c) subjective effects measured by Urge to Smoke, Urge for
      Product, Product Rating, Intent to Use Product Again, and Product Effects.
    

Intervention name(s): Own Brand Menthol Cigarette; Electronic Menthol Cigarette #1; Electronic Menthol Cigarette #2; Electronic Menthol Cigarette #3; Leading U.S. Nicotine Gum
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): combustible menthol cigarette brand style smoked most frequently by subject; VUSE® Digital Vapor Cigarette (menthol flavor, 14 mg nicotine); VUSE® Digital Vapor Cigarette (menthol flavor, 29 mg nicotine); VUSE® Digital Vapor Cigarette (menthol flavor, 36 mg nicotine); 4 mg nicotine polacrilex gum
Intervention MeSH terms: Menthol; Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: adoption; electronic cigarettes; e-cigarettes; menthol; combustible cigarettes; nicotine polacrilex; own brand cigarette; subjective measures; pharmacokinetics; pharmacodynamics; cigarette
Performance Evaluation of Two Silicone Hydrogel Toric Lens Designs in Habitual Soft Contact Lens Wearers
Condition: Astigmatism
MeSH terms: Astigmatism
Study type: Interventional

Summary: 
      The objective of the study is to compare the clinical performance of two monthly toric
      silicone hydrogel contact lenses in habitual wearers, when worn for 1-month each.
    

Detailed description: 
      This study is a prospective, bilateral eye, subjected-masked, randomized, 1-month cross-over,
      daily-wear design involving two different silicone hydrogel toric lens types. Each lens type
      will be worn bilaterally for approximately one month.
    

Intervention name(s): Lens A (comfilcon A toric lens); Lens B (lehfilcon A toric lens)
Intervention type(s): Device; Device
Intervention description(s): One month wear; One month wear
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Safety and Tolerability of MEDI9314 as Single Ascending Dose in Healthy Subjects
Condition: Safety; Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1a randomized, blinded, placebo-controlled, single-ascending dose study to
      assess the safety and tolerability of MEDI9314 in healthy adult subjects
    

Detailed description: 
      This is a phase I study to assess the safety, tolerability pharmacokinetics, and
      immunogenicity of MEDI9314 following single dose administration to healthy subjects
    

Intervention name(s): MEDI9314; placebo
Intervention type(s): Drug; Drug
Intervention description(s): single dose of MEDI9314; single dose of placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: MEDI9314; Safety; Tolerability; Pharmacokinetics; Immunogenicity
Spinal Aesthesia in Women With Placenta Previa Percreta
Condition: Complications; Cesarean Section
MeSH terms: Placenta Previa
Study type: Observational

Summary: 
      Placenta previa percreta is a dangerous complication during surgery. Due to the high risk of
      hemorrhage, most parturients with placenta previa have to accept cesarean section. In this
      study investigators compare the effect of different anesthetic techniques on these patients.
    


Intervention name(s): spinal anesthesia; general anesthesia
Intervention type(s): Procedure; Procedure
Intervention description(s): bupivacaine injected by spinal puncture; general anesthesia with intubation
Intervention MeSH terms: Anesthetics
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        parturients with placenta praevia/accreta scheduled for cesarean section
      
Keywords: cesarean section; spinal anesthesia; general anesthesia
Pharmacokinetics, Safety and Tolerability of Zavesca (Miglustat) in Patients With Infantile Onset Gangliosidosis: Single and Steady State Oral Doses
Condition: GM2 Gangliosidoses; Tay-Sachs; Sandhoff Disease
MeSH terms: Gangliosidoses; Gangliosidoses, GM2; Tay-Sachs Disease; Sandhoff Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      We want to see if Zavesca (or miglustat) is safe and can be tolerated by patients with acute
      infantile onset GM2 gangliosidosis - classical Tay-Sachs and infantile onset Sandhoff
      disease. We know that miglustat inhibits the formation of GM2 ganglioside, the compound that
      is stored in the brains of children with Tay-Sachs and Sandhoff disease. Since it inhibits
      the synthesis of ganglioside, miglustat may be able to reduce or delay the onset of clinical
      symptoms.
    

Detailed description: 
      Specific Aims

      The primary objective of the study is to investigate the pharmacokinetics of ZAVESCA®
      (miglustat, OGT918), when given as a single dose and at steady state, in infantile patients
      with GM2 gangliosidosis. The secondary objectives are to evaluate the tolerability and safety
      of single and multiple doses of miglustat and to monitor disease progression using physical
      and developmental assessments and disease-specific biomarkers.
    

Intervention name(s): Zavesca (Miglustat)
Intervention type(s): Drug
Intervention MeSH terms: Miglustat
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate the Long-term Safety, Tolerability, and Durability of Treatment Effect of ALKS 3831
Condition: Schizophrenia; Schizophreniform Disorder; Bipolar I Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the long-term safety, tolerability, and durability of treatment
      effect of ALKS 3831 in subjects with schizophrenia, schizophreniform disorder, or bipolar I
      disorder
    


Intervention name(s): ALKS 3831
Intervention type(s): Drug
Intervention description(s): Olanzapine + samidorphan, daily oral dosing
Intervention model: Single Group Assignment
Intervention model description: Open-label
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Alkermes; ALKS 3831; Olanzapine; Samidorphan; Schizophrenia; Schizophreniform; Bipolar I
The Effect of Oral Vitamin D Supplements on Fusion Outcome in Patients Receiving Elective Lumbar Spinal Fusion
Condition: Vitamin D; Spinal Fusion; Lumbar Spine Disease
MeSH terms: Spinal Diseases
Study type: Interventional

Summary: 
      The process of bony fusion is a dynamic bone remodeling process and a variety of risk factors
      have been identified to contribute to pseudoarthrosis.Vitamin D deficiency has been reported
      to be associated with more pseudoarthrosis, prolonged time to fusion, and poorer spine
      function and quality of life after spinal fusion.However, as the review article presented, it
      lacks high-quality evidence to investigate the role of vitamin D supplements in spinal
      fusion. Therefore, this randomized controlled trial aimed to evaluate the effectiveness of
      oral vitamin D supplements on fusion outcomes in patients receiving elective lumbar spinal
      fusion.
    


Intervention name(s): vitamin D3; calcium
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): vitamin D3 (cholecalciferol) 800 IU QD; calcium citrate 600 mg QD
Intervention MeSH terms: Vitamin D; Cholecalciferol; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Endometrial Injury and IVF Outcome Parameters in Patients With Failed IVF Cycles
Condition: Repeated Implantation Failures
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The iatrogenic induction of local endometrial injury caused through hysteroscopy or pipelle
      sampling in the preceding non- transfer cycle improves the IVF outcome parameters in patients
      with previous IVF failures.
    

Detailed description: 
      Endometrial injury was preformed either through hysteroscope during office hysteroscopy
      through the non touch technique or through pipelle biopsy in the early follicular phase (days
      5 to 9) in the preceding cycle of the IVF treatment.
    

Intervention name(s): Endometrial injury by hysteroscopy or pipelle sampling; Proceed to COH directly
Intervention type(s): Procedure; Procedure
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Failed IVF cycles; IVF outcome parameters; endometrial injury; hysteroscopy; pipelle sampling; Repeated implantation failures