bioihbjkbjnl/mcl2 huggingface dataset:
COVID-19 Vaccination Using a 2nd Generation (E1/E2B/E3-Deleted) Adenoviral-COVID-19 in Normal Healthy Volunteers
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase 1b, open-label study in adult healthy subjects. This clinical trial is
      designed to assess the safety, reactogenicity, and immunogenicity of the hAd5-S-Fusion+N-ETSD
      vaccine and select a dose for future studies.
    


Intervention name(s): hAd5-S-Fusion+N-ETSD vaccine
Intervention type(s): Biological
Intervention description(s): The hAd5-S-Fusion+N-ETSD Vaccine is a human adenovirus serotype 5 (hAd5) vector with E1/E2b/E3 deletions expressing SARS-CoV-2 viral antigen spike fusion protein and nucleocapsid with an enhanced T-cell stimulation domain.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparing an Investigational Medication Versus an Approved Medication in Reducing Cholesterol Levels (0653-025)
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether an investigational medication will be more
      effective than an approved medication in reducing cholesterol levels.
    


Intervention name(s): MK0653, ezetimibe / Duration of Treatment: 28 weeks; Comparator: atorvastatin / Duration of Treatment: 28 weeks
Intervention type(s): Drug; Drug
Intervention MeSH terms: Atorvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Brief Intervention and/or Distribution of Free Condoms for Travelers
Condition: Sexually Transmitted Infections
MeSH terms: Sexually Transmitted Diseases
Study type: Interventional

Summary: 
      The objective of this study is to assess the impact of a structured intervention and/or free
      distribution of condoms during the pre-travel consultation on sexual risk behavior of young
      persons traveling alone.
    

Detailed description: 
      All persons aged 18 - 44 years planning to travel alone and attending the travel clinic of
      the Medical Outpatient Clinic in Lausanne will be asked to participate. The subjects will be
      randomized into three groups: 1. no intervention, 2. free condoms without further
      explanations, 3. a structured intervention of 5 minutes on STI risk reduction plus free
      condoms. The structured interventions will include information about the number of travelers
      engaging in new sexual relationships, the different types of STI and their prevalence in
      different countries and population groups. The subjects will complete a pre-travel
      questionnaire prior to the medical consultation. A post-travel questionnaire will be sent to
      them 10 days after their trip. The questionnaires will include questions on demographic
      characteristics, sexual habits, alcohol/tobacco/marijuana consumption and sexual
      relationships during the trip.
    

Intervention name(s): Structured intervention for the prevention of sexually transmitted infections (STI).; Free condoms
Intervention type(s): Behavioral; Device
Intervention description(s): The structured intervention will include information about the number of travelers engaging in new sexual relationships, the different types of STI and their prevalence in different countries and population groups. The intervention will last approximately 5 minutes. At the end of the structured intervention the subjects will be offered free condoms.; Subjects will be proposed free condoms at the end of the pre-travel consultation.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Travel; casual sexual relationships; condoms; Structured intervention
A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease; Dementia; Psychomotor Agitation
Study type: Interventional
Phase: Phase 3

Summary: 
      Active treatment extension study of the 331-14-213 trial, to assess the long-term safety and
      tolerability of oral brexpiprazole as treatment in adult participants with agitation
      associated with dementia of the Alzheimer's type (AAD).
    


Intervention name(s): Brexpiprazole; Brexpiprazole
Intervention type(s): Drug; Drug
Intervention description(s): 2 or 3 mg tablet; 0.5 to 3 mg tablet
Intervention MeSH terms: Brexpiprazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Agitation
Effectiveness and Safety of the Dexcom™ G4 Continuous Glucose Monitoring System in Pediatric Subjects With Diabetes Mellitus
Condition: Pediatric Subjects With Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Observational

Summary: 
      The primary objective of the study is to evaluate the safety and effectiveness of the G4
      System (System) when used as an adjuvant to blood glucose testing over a 7-day period in
      pediatric subjects with diabetes mellitus.

      System effectiveness will be primarily evaluated with comparison to laboratory reference
      Yellow Springs Instrument (YSI) venous sample measurements. The system performance will be
      evaluated in terms of point and rate accuracy of the system in reference to YSI. The point
      accuracy is measured as the proportion of G4 System values that are within ±20% of YSI
      reference value for glucose levels >80 mg/dL and ±20 mg/dL at YSI glucose levels <80 mg/dL.
      The trend accuracy of the device performance, i.e., continuous glucose error grid analysis,
      will be evaluated as well as the temporal accuracy at different glucose rates of changes and
      different glucose ranges (hypoglycemic, euglycemic, and hyperglycemic ranges). The primary
      matched paired (Sensor-YSI) measurements will be collected during one in-clinic session.
      System effectiveness will also be evaluated with SMBG measurements similarly.

      Safety data of the system will also be collected and safety will be characterized by the
      incidence of Adverse Device Effects (ADE) experienced by study participants.

      Other objectives include the evaluation of device performance at an alternate site (the upper
      buttocks).
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pediatric subjects with diabetes mellitus
      
Keywords: pediatric; diabetes mellitus
A Study of Cybis™ 10:25 THC:CBD Oil in Adults With Chronic Back/Neck Pain
Condition: Chronic Pain; Neck Pain; Back Pain; Pain; Pain, Chronic; Pain, Back; Pain, Neck; CBD; THC
MeSH terms: Back Pain; Chronic Pain; Neck Pain
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a non-randomised, single arm, open-label study of medical cannabis, Cybis™ 10:25, in
      participants with chronic back or neck pain in which participants receive escalating doses of
      Cybis™ 10:25.
    

Detailed description: 
      This is a non-randomised, single arm, open-label study of Cybis™ 10:25 in participants with
      chronic back or neck pain in which participants receive escalating doses of Cybis™ 10:25.

      The purpose of the study is to demonstrate the safety and tolerability of Cybis™ 10:25 in
      participants with moderate to severe chronic back or neck pain that is unresponsive to
      over-the-counter non-opioid analgesics.

      Participants will undergo a screening visit, then seven clinic visits (Day 1, 2, 8, 15, 22,
      29, and 35). Cybis™ 10:25 will be administered oromucosally at doses varying from 0.5 mL once
      daily to 1.5 mL twice daily. Total duration of dosing is 28 days.
    

Intervention name(s): Cybis™ 10:25 THC:CBD oil
Intervention type(s): Drug
Intervention description(s): Cybis™ 10:25 containing 10 mg/mL of D9-THC and 25 mg/mL of CBD, formulated in medium chain triglycerides (MCT)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: medical cannabis; THC; CBD; chronic pain; neck pain; back pain; pain; dose-ranging; dose-finding
PMZ-2010 (Centhaquine) as a Resuscitative Agent for Hypovolemic Shock
Condition: Hypovolemic Shock; Blood Loss
MeSH terms: Shock; Hypovolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a prospective, multi-centric, randomized, double-blind, parallel, controlled phase-II
      efficacy clinical study of PMZ-2010 therapy in patients with hypovolemic shock.

      Centhaquine is highly safe and well tolerated. Toxicological studies showed high safety
      margin in preclinical studies. Its safety and tolerability has been demonstrated in a human
      phase I study in 25 subjects (CTRI/2014/06/004647; NCT02408731).
    

Detailed description: 
      Centhaquine (previously used names, centhaquin and PMZ-2010; International Non-proprietary
      Name (INN) recently approved by WHO is centhaquine) has been found to be an effective
      resuscitative agent in rat, rabbit and swine models of hemorrhagic shock, it decreased blood
      lactate, increased mean arterial pressure, cardiac output, and decreased mortality. An
      increase in cardiac output during resuscitation is mainly attributed to an increase in stroke
      volume. Centhaquine acts on the venous α2B-adrenergic receptors and enhances venous return to
      the heart, in addition, it produces arterial dilatation by acting on central α2A-adrenergic
      receptors to reduce sympathetic activity and systemic vascular resistance.

      Unlike presently used vasopressors, centhaquine increased mean arterial pressure by
      increasing stroke volume and cardiac output, and it decreased systemic vascular resistance.
      The most common adverse effects of vasopressors as a class include arrhythmias, fluid
      extravasation, and ischemia. Centhaquine does NOT act on beta-adrenergic receptors, and
      therefore the risk of arrhythmias is mitigated. It is NOT a vasopressor; however, it
      increases blood pressure and cardiac output by augmenting venous blood return to the heart
      and enhanced tissue perfusion by arterial dilatation. Enhancing tissue perfusion is a
      significant advantage over existing vasopressors.
    

Intervention name(s): Normal Saline; Centhaquine
Intervention type(s): Drug; Drug
Intervention description(s): In addition to standard of care normal saline to be used as vehicle in the phase-II study to assess efficacy of PMZ-2010 as a resuscitative agent for hypovolemic shock; In addition to standard of care PMZ-2010 to be used as an experimental drug in the phase-II study to assess its efficacy as a resuscitative agent for hypovolemic shock
Other intervention name(s): Vehicle; PMZ-2010
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Resuscitative agent; Vasopressor
Open-Label Pharmacokinetic Study of Final Formulations of ATX-101
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of this trial are to evaluate the safety and tolerability of ATX-101
      injections and to characterize the pharmacokinetic profile of the two ATX-101 formulations.
    

Detailed description: 
      The objectives of this trial are to evaluate the safety and tolerability of ATX-101
      injections and to characterize the pharmacokinetic profile of the two ATX-101 formulations
      that are expected to be the final formulations. ATX-101 will be administered into the
      submental fat as subcutaneous injections using the maximum proposed dosing regimen that is
      intended for labeling.
    

Intervention name(s): ATX-101 - U.S.; ATX-101 - EU
Intervention type(s): Drug; Drug
Intervention description(s): US ATX-101, 10 mg/mL, one dosing session in the submental area; EU ATX-101, 10 mg/mL, one dosing session in the submental area
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy volunteers
Phase II Double Blind Controlled Trial of Nigral Grafting in Patients With Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      OBJECTIVES:

      I. Determine the effectiveness of fetal nigral transplantation in patients with Parkinson's
      disease.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a placebo controlled, randomized, double blind study. Patients are
      randomly assigned to 1 of 3 treatment groups. All patients receive 2 separate operations in
      which the substantia nigra from either 4 fetuses (Group A) or 1 fetus (Group C) is implanted
      into the striatum of each side.

      Group B patients receive 2 separate placebo operations without fetal transplantation.

      The second surgical procedure begins approximately 1 week after the first operation.

      After 2 years, treatments are compared. If transplant is shown to benefit Parkinson's
      disease, then patients who received placebo operation will be offered transplant surgery in
      the final year of the study.
    

Intervention name(s): fetal nigral transplantation
Intervention type(s): Procedure
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: Parkinson disease; neurologic and psychiatric disorders; rare disease
Randomized, Double-blind, Placebo-controlled, Phase I Dose-escalation Study of Single Dose GHB01L1 in Healthy Volunteers
Condition: Seasonal Human Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this phase I trial is to evaluate safety and tolerability of GHB01L1
      administered as single dose intranasal aerosol for vaccination against influenza A (H1N1)
      virus.

      This study is performed further to assess local and systemic immune response and to analyse
      pharmacokinetics (shedding) of a single dose GHB01L1 aerosol administered intranasally.
    

Detailed description: 
      GHB01L1 intends to provide a novel vaccination for influenza virus infection. Data indicate
      that the GHB01L1 virus is a promising, safe and immunogenic vaccine candidate with a high
      protection efficacy against the pathogenic wild-type virus challenge.

      48 healthy volunteers will be included in a phase I dose escalation study investigating five
      dose levels. 8 subjects per each of the five dose levels and additional 8 subjects at the
      highest dose level respectively the maximum tolerated dose level will be randomized at a
      ratio of 6:2 for GHB01L1 or placebo according to a fixed dose escalation plan.

      After all subjects of one dose level have been treated and observed for the safety
      observation period of one week, an interim safety review will be performed by an Expert
      Committee. The Expert Committee will review any occurred adverse event and will decide on
      dose escalation to the next dose level.

      Only male healthy volunteers aged 18-50 and seronegative with respect to the applied virus
      antigens (with antibody titers <1:10 detected in hemagglutination inhibition assay) will be
      randomized.

      GHB01L1 will be administered once on day 1. After a 3 days inpatient period follow-up visits
      will be performed on day 4, 5, 8, 15 and the study will be terminated on day 29.
    

Intervention name(s): GHB01L1
Intervention type(s): Biological
Intervention description(s): Study medication administered as a single intranasal aerosol (520ul) at doses of 6.4 log10, 6.7 log10, 7.0 log10, 7.4 log10 and 7.7 log10 TCID50/volunteer
Other intervention name(s): A/New Caledonia/20/99 (H1N1) -like delNS1 virus; GHB01NC(H1N1)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: live attenuated flu vaccines; Influenza A (H1N1); intranasally application; replication-deficient influenza virus
Melatonin and Glucose Tolerance Among Individuals With a Variant of the MTNR1B Gene
Condition: Diabetes; Glucose Tolerance
Study type: Interventional
Phase: Phase 3

Summary: 
      The effect of 3 months of melatonin 4mg treatment on glucose tolerance in different variants
      of the melatonin receptor 1B gene will be evaluated. The following will be done at 0 and 3
      months:

        -  OGTT

        -  questionnaires about sleep and activity

        -  Actigraph

        -  Anthropometry

        -  Blood pressure
    

Detailed description: 
      http://www.sciencedirect.com/science/article/pii/S1550413116301607
    

Intervention name(s): Melatonin
Intervention type(s): Drug
Intervention description(s): All subjects receive the same dose of melatonin
Other intervention name(s): Circadin
Intervention MeSH terms: Melatonin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: diabetes; melatonin; glucose tolerance; sleep
Using Different Kinds of B-cun Scales to Mark Some Acupoints at Governor Vessel on the Head
Condition: to Research the Feasibility of the Proportional Bone(Skeletal) Measurement Method on the Head Region.
Study type: Observational

Summary: 
      We are expecting that there are remarkable differences location at BaiHui(GV20) or
      Houding(GV19)showing from same person in our study.
    


Observational model: Case-Only
Sampling method: Probability Sample
Study population: 
        community sample: This experiment will recruit 100 volunteers age ranged 18-80 years old
        and 60 children under 10 years old.
      
Keywords: Acupuncture
Study to Evaluate the Potential Effect of Benralizumab on the Humoral Immune Response to the Seasonal Influenza Vaccination in Adolescent and Young Adult Patients With Severe Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, parallel group, placebo-controlled study designed to
      investigate the potential effect of a fixed dose of benralizumab administered subcutaneously
      (SC) on antibody responses following seasonal influenza virus vaccination
    

Detailed description: 
      This study is designed to investigate the potential effect of benralizumab on the antibody
      response to the seasonal influenza virus vaccine in patients 12-21 years of age with asthma.
      Benralizumab will be given subcutaneously (SC) at Weeks 0, 4, and 8 weeks, at which time
      benralizumab levels will reach steady state. Patients will then receive 1 dose of
      intramuscular (IM) seasonal influenza virus vaccine at Week 8 and samples drawn at Week 8 and
      Week 12 to measure the antibody response to the influenza virus
    

Intervention name(s): Benralizumab; Benralizumab Placebo; Seasonal influenza virus vaccine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Benralizumab SC administered every 4 weeks for 3 doses (Weeks 0, 4, and 8).; Placebo administered every 4 weeks for 3 doses (Weeks 0, 4, and 8).; Patients will receive 1 dose of seasonal influenza virus vaccine Intramuscular (IM) at Week 8.
Intervention MeSH terms: Benralizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Male and female adolescent patients; severe asthma
Parecoxib Versus Celecoxib Versus Oxycodone in Pain Control for Transcatheter Chemoembolization Procedure
Condition: Liver Cancer; Pain Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      This phase III, randomized, prospective clinical study, aiming to compare the analgesic
      effects of celecoxib, parecoxib, and oxycodone in patients with inoperable hepatic carcinoma
      undergoing TACE procedure in postoperative pain control.
    

Detailed description: 
      Studies reported that almost 75% of patients with hepatocellular carcinoma undergoing
      transcatheter arterial chemoembolization (TACE) experienced severe pain (in a three-grade
      mild, moderate, and severe classification), and 93% of patients required opioid treatment
      during the first 12 hours after TACE.

      Opioids and nonsteroidal anti-inflammatory drugs (NSAIDs) are most commonly used analgesic
      medications in the control of postoperative surgical pain. Previous studies has indicated
      that both controlled-release oxycodone, which is an oral semisynthetic opioid µ and κ
      agonist, and parecoxib sodium, a parenteral COX-2 selective inhibitor, were effective and
      safe on peri- and post-procedural pain in HCC patients undergoing TACE.

      To the investigators's knowledge, no studies have been developed on comparing differences of
      efficacy and feasibility of analgesics with different action mechanism (opioids vs. NSAIDs)
      and administration route (oral path vs. injective path) on pain control for patients
      undergone TACE. In this phase III, randomized, prospective clinical study, the investigators
      aimed to compare the analgesic effects of celecoxib (oral NSAIDs), parecoxib (injective
      NSAIDs), and controlled-release oxycodone (oral opioids) in patients with inoperable hepatic
      carcinoma undergoing TACE procedure in postoperative pain control.
    

Intervention name(s): Celecoxib 200mg oral capsule; parecoxib sodium; controlled-release oxycodone
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Celecoxib; Parecoxib; Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pain control; TACE; Opioids; NSAIDs
Pilot Study: The Effect of Ergocalciferol on Plasma Mucin-1 Levels
Condition: Ergocalciferol
Study type: Interventional
Phase: Early Phase 1

Summary: 
      To determine if a one-time oral administration of ergocalciferol results in a decline in
      plasma mucin-1 levels in healthy individuals and individuals with ADTKD-MUC1.
    

Detailed description: 
      This is a pilot, open-labelled, to determine if oral administration of a single dose of
      ergocalciferol lowers plasma mucin-1 levels. The study population will include 40 healthy
      individuals and 40 individuals with ADTKD-MUC1.

      The study consists of an initial screening, signing of consent of interested individuals,
      performance of pregnancy test in women of child-bearing age and screening labs, and
      administration of 200,000 units of ergocalciferol on Day 0 (On Study). Laboratory studies
      will be performed at baseline, on Days 3, 7, and 10.
    

Intervention name(s): Ergocalciferol
Intervention type(s): Drug
Intervention description(s): Investigational drug will be administered to eligible participants in a single dose of 200,000 USP units vitamin D
Other intervention name(s): Drisdol; Calciferol; Calcidol; Vitamin D2
Intervention MeSH terms: Vitamin D; Ergocalciferols
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Vitamin D Deficiency; Drisdol; Rickets; Plasma; Healthy Subjects; Autosomal Dominant Tubulo Interstitial Kidney Disease