bioihbjkbjnl/mcl2 huggingface dataset:
Trial of a Chikungunya Vaccine, PXVX0317 CHIKV-VLP, in Healthy Adults
Condition: Chikungunya Virus Infection
MeSH terms: Chikungunya Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of this Phase 2 trial is to evaluate the immune response to and safety profile of
      various doses/formulations/and schedules of administration of PXVX0317 in healthy adults.

      Primary Objective:

      To assess the immune response to the vaccine

      Secondary Objectives:

      To assess the kinetics of the immune response to different doses/formulations/schedules To
      assess the persistence of immune responses to different doses/formulations/schedules To
      assess the effect of a booster dose of the vaccine

      Safety Objective:

      To assess local and systemic reactions to the vaccine and to describe the safety profile of
      the vaccine
    

Detailed description: 
      The trial will explore 8 formulation/schedule combinations of CHIKV VLP vaccine with or
      without Alhydrogel adjuvant, and will also explore different dose schedules of Day 1 and 15
      or Day 1 and 29 or Day 29 only.
    

Intervention name(s): CHIKV VLP/unadjuvanted; CHIKV VLP/adjuvanted; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Vaccine consists of virus-like particles of chikungunya virus antigens; Adjuvanted formulation includes Alhydrogel; Placebo is vaccine diluent alone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
A Phase II, Randomized, Double-blind, Placebo-controlled Study to Assess MEDI3506 in Participants With COPD and Chronic Bronchitis
Condition: Chronic Obstructive Pulmonary Disease (COPD); Chronic Bronchitis
MeSH terms: Bronchitis; Bronchitis, Chronic; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Acute Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a research study to determine the efficacy and safety of investigational drug
      MEDI3506 for the treatment of adult subjects with Chronic Obstructive Pulmonary Disease and
      Chronic Bronchitis.
    

Detailed description: 
      Study D9180C00002 is a Phase II, randomised, double-blind, placebo-controlled, parallel
      group, proof of concept study to evaluate the efficacy and safety of MEDI3506 in adult
      participants with moderate to severe Chronic Obstructive Pulmonary Disease and Chronic
      Bronchitis.

      Approximately 85 sites globally will participate in this study. Approximately 144
      participants will be randomized to 2 treatment groups in a 1:1 ratio to receive MEDI3506 or
      placebo.
    

Intervention name(s): MEDI3506; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Dose 1; Dose 1
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomised to recieve either MEDI3506 or placebo.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MEDI3506; IL-33; COPD; Chronic Bronchitis; Lung function; Inflammation
OrACELL™ vs. Connective Tissue in Miller Class 3 Defects
Condition: Gingival Recession
MeSH terms: Gingival Recession
Study type: Interventional

Summary: 
      The purpose was to compare root coverage outcomes between autogenous connective tissue graft
      (CTG) and decellularized human dermis (OrACELL™) in areas of facial gingival recession.
    

Detailed description: 
      Twenty-four non-smoking, healthy patients, with 2mm or greater facial gingival recession at a
      minimum of one site that classified as a Miller Class I, II, or III recession defect were
      included. Patients were randomly assigned to either control (CTG) or OrACELL™ (test) groups,
      which were treated with identical surgical techniques. All root coverage clinical parameters
      were evaluated at baseline, 3-, and 6-months.
    

Intervention name(s): OrACELL; Connective Tissue Graft
Intervention type(s): Device; Device
Intervention description(s): OrACELL is human dermis that undergoes the MATRACELL process. MATRACELL is a patented and validated process that renders allograft tissue acellular, without compromising the biomechanical or desired biochemical properties of an allograft bio-implant for its intended surgical application.; A measured layer of dermis is surgically removed from the palate for use as a graft to cover gingival recession
Other intervention name(s): Subepithelial Connective Tissue Graft
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Controlled Trial between two treatment modalities for gingival recession with 6 month follow-up
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gingival Recession; Connective Tissue Graft; OrACELL; Decellularized Dermis; Periodontics
Patterns of Prescribing and Monitoring of Palbociclib
Condition: Metastatic Breast Cancer; Advanced Breast Cancer; Estrogen Receptor-positive Breast Cancer; Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      The purpose of this study is to determine if patients with ER+, human epidermal growth factor
      2 negative (HER2-), advanced breast cancer are receiving dosing adjustments and monitoring
      based on manufacturer recommendations at a tertiary academic medical center.
    

Detailed description: 
      This study was a retrospective, single-center study that included women receiving palbociclib
      for the treatment of ER+, HER2- advanced breast cancer. Exclusion criteria were the presence
      of brain metastases or active enrollment in a palbociclib clinical trial.

      The primary endpoint was the proportion of patients who were maintained on a palbociclib dose
      according to the adjustment schedule in package insert recommendations.

      The secondary endpoints were the number of patients dose adjusted for hematologic toxicities,
      the number of patients experiencing neutropenia, duration of therapy, progression-free
      survival (PFS), and adherence to manufacturer monitoring recommendations.
    

Intervention name(s): Palbociclib
Intervention type(s): Drug
Intervention description(s): Observe patients receiving palbociclib for dose adjustment and lab monitoring
Other intervention name(s): IBRANCE
Intervention MeSH terms: Palbociclib
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients seen at RUMC
Skin Irritation of LEO 90100 Foam (Calcipotriol Hydrate Plus Betamethasone Dipropionate) in Healthy Japanese Subjects
Condition: Psoriasis Vulgaris
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is looking at whether the LEO 90100 foam causes irritation of the skin in healthy
      Japanese male adults without psoriasis. A single application of LEO 90100 foam and its
      vehicle will each be made to 2 body sites in 20 subjects.
    


Intervention name(s): LEO 90100 foam; Vehicle of LEO 90100 foam
Intervention type(s): Drug; Drug
Intervention description(s): Each subject has each of the 2 treatments applied at the same time on 2 different sites on the back; Each subject has each of the 2 treatments applied at the same time on 2 different sites on the back
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Determining Equivalence Dose for Oral Versus Sublingual Administration of Tacrolimus in Hepatic Receptors
Condition: Evidence of Liver Transplantation; Effects of Immunosuppressant Therapy
Study type: Interventional

Summary: 
      After liver transplantation one of the most important cost, for both patients and their
      health insurance system, is immunosuppressive drug therapy. Tacrolimus (FK 506) is considered
      the cornerstone of immunosuppressive therapy in solid organ transplantation. Oral
      administration is the usual route, however, sublingual (SL) administration has been recently
      reported. This method of administration avoids first pass metabolism and allows an
      alternative route after transplant surgery, particularly in those patients who should extend
      the period of fasting (prolonged intubation, ileus, etc). Interestingly, in some studies, the
      dose of tacrolimus SL required to maintain similar plasma concentrations compared with oral
      administration, is significantly lower, even up to 50%, which can result in considerable
      savings in short and long term. Among these studies, only one was conducted in liver
      recipients. This study suggest that SL administration of tacrolimus could allow to obtain
      similar concentrations compared with oral administration. The design of this study did not
      assess the existence of differences in the dose required and only included six patients.
    

Detailed description: 
      The patient will be scheduled fasting to liver transplant unit where the pharmacokinetic
      study was performed. After installation of the venous needle, blood samples will be collected
      on 4 ml tubes with EDTA as an anticoagulant at the following intervals of time in hours: 0
      (immediately before the oral administration of tacrolimus); 0.5; 1.0; 1.5; 2; 4; 6; 9 and 12
      h. post-dose. Once the blood samples taken, the tubes will be plugged, invest gently to mix
      with anticoagulant and stored at -20 ° C until analysis.

      Subsequently, tacrolimus administration was change to sublingual route and dose was adjusted
      to obtain similar trough levels to those determined on per oral administration. The capsule
      be opened and its contents shall be deposited in the sublingual mucosa. To be ensure that
      drug will be absorted the patient will be instructed to insistently that after sublingual
      placement of the drug, should not swallow the capsule content for at least 15 minutes. The
      same pharmacokinetic study described for the oral route will be performed.

      Breakfast will be administered 2 hours after ingesting the drug and lunch and dinner 6 and 10
      hours after respectively. Fluid intake is discretionary.
    

Intervention name(s): Tacrolimus
Intervention type(s): Drug
Intervention description(s): compared oral administration versus sublingual administration of tacrolimus.
Other intervention name(s): FK506
Intervention MeSH terms: Tacrolimus
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Neuroimaging the Expectancy Versus Pharmacotherapy Effect of Adderall on Cognitive Performance
Condition: Expectancy Versus Pharmacotherapy Effect of Adderall
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this balanced-placebo design study is to pilot a larger study to further
      explore the current evidence that stimulant medications are not cognitive enhancers, despite
      this rampant belief in young adults. While the lack of cognitive enhancement from stimulant
      medication has been documented in prior research, this study is the first to utilize
      neuroimaging technology to examine brain regions activated during neurocognitive tasks when
      participants believe they have been administered stimulant medication or placebo.
    

Detailed description: 
      This is a 2 X 2 within subjects, balanced placebo design and all participants will experience
      each of the four conditions during four sequential weeks. Medication administered (Adderall
      vs. placebo) is crossed with instructional set (truth vs. deception) and participants'
      performance on neurocognitive tasks is compared across these groups. For example,
      participants are either given stimulant medication or placebo, and are either accurately told
      or inaccurately told that they received stimulant medication or placebo. Neuroimaging is
      being utilized to investigate whether participants' expectations regarding the benefits of
      stimulant medication affects their performance on neurocognitive tasks. The hypothesis of the
      study is that participants' expectations regarding stimulant medication will affect their
      performance on neurocognitive tasks, rather than the actual effect of the medication.
    

Intervention name(s): Adderall; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Participants will be administered Adderall; Participants will be administered placebo
Intervention MeSH terms: Adderall
Allocation: Randomized
Intervention model: Factorial Assignment
Intervention model description: 2 X 2, within-subjects, balanced placebo design
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Intermittent Pneumatic Compression for Treating Lower Limb Lymphoedema
Condition: Lymphoedema of Leg
MeSH terms: Lymphedema
Study type: Interventional

Summary: 
      The treatment of lymphoedema and its associated complications represent a considerable drain
      on increasingly limited NHS resources. Intermittent pneumatic compression (IPC) represents an
      innovative treatment for this condition, however the efficacy of IPC as a treatment for lower
      limb lymphoedema needs to be investigated via robust clinical research.
    

Detailed description: 
      The primary aim of this research is to evaluate the effectiveness of intermittent pneumatic
      compression (IPC) as a treatment for lower limb lymphoedema as a whole, and to compare the
      effectiveness of a new generation device, in this case the LymphAssist (Huntleigh
      Healthcare), against older sequential models. The study methodology consists of a pilot
      randomised control trial of two groups - Intervention group A will continue to receive their
      standard lymphoedema care but will also be provided with a LymphAssist IPC device to use,
      mimicking manual lymph drainage therapy. Participants in intervention group B will receive
      their standard care plus an IPC device that uses sequential therapy. Each participant will
      act as a control for a 5 week period continuing with their standard treatment only. Outcome
      measures include impact on limb volume, skin stiffness and elasticity score and impact on
      quality of life scores.
    

Intervention name(s): Intermittent Pneumatic Compression
Intervention type(s): Device
Intervention description(s): Participants administer an intermittent pneumatic compression device in addition to their standard lymphoedema care for a 5 week treatment period
Other intervention name(s): LymphAssist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison Between Rectal & Sublingual Misoprostol Before Caesarian Section To Reduce Intra & Post-Operative Blood Loss
Condition: Postpartum Hemorrhage
MeSH terms: Postpartum Hemorrhage; Hemorrhage; Postoperative Hemorrhage
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The aim of the work is to evaluate & compare the effectiveness of rectally administered PGE1
      synthetic analogue (misoprostol) 400 microgram versus sublingually administered misoprostol
      before caesarean section to decrease blood loss during and after the operation.
    


Intervention name(s): Misoprostol; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Comparison of different routes of administration of 400 micro gram misoprostol
Other intervention name(s): Misotac; Cytotec
Intervention MeSH terms: Misoprostol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Postpartum hemorrhage; Intrapartum blood loss; Misoprostol
Cheese Intake,CLA and Hypercholesterolemia
Condition: Modifications of LDL Cholesterol; Modifications of Enocannabinoid Levels
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      In this study the investigators aimed at verifying whether consumption of a sheep cheese,
      naturally enriched in ALA, CLA and VA, would modify the plasma lipid and endocannabinoid
      profiles in mild hypercholesterolemic subjects. This study was a 3-week, randomized, double
      blind, controlled, cross over clinical trial, conducted at the State Hospital Brotzu in
      Cagliari, Italy. The subjects were randomly assigned to eat 90g/d of the control or enriched
      cheese for 3 weeks, with a cross over after 3 weeks of washout.
    


Intervention name(s): CLA enriched cheese; CLA enriched cheese
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): This study was a 3-week, randomized, double blind, controlled, cross over clinical trial, conducted at the State Hospital Brotzu in Cagliari, Italy. The subjects were randomly assigned to eat 90g/d of the control or enriched cheese for 3 weeks, with a cross over after 3 weeks of washout. The study included 5 visits: 2 screening/baseline visits at weeks -1 and 0, 1 end of intake of 90 g/d of cheese visit at week 3, 1 end of the first wash out visit at week 6, and 1 end of treatment after crossing over visit at week 9. This procedure was subsequently repeated with a cheese intake of 45 g/d; This study was a 3-week, randomized, double blind, controlled, cross over clinical trial, conducted at the State Hospital Brotzu in Cagliari, Italy. The subjects were randomly assigned to eat 90g/d of the control or enriched cheese for 3 weeks, with a cross over after 3 weeks of washout. The study included 5 visits: 2 screening/baseline visits at weeks -1 and 0, 1 end of intake of 90 g/d of cheese visit at week 3, 1 end of the first wash out visit at week 6, and 1 end of treatment after crossing over visit at week 9. This procedure was subsequently repeated with a cheese intake of 45 g/d
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Conjugated Linoleic Acid; LDL-cholesterol; Endocannabinoids
Bioequivalence Study of Ritonavir Versus NORVIR in Healthy Chinese Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics and bioequivalence of Ritonavir
      tablet 100 mg versus NORVIR 100 mg tablet in healthy Chinese adult participants under fasting
      or fed condition.
    

Detailed description: 
      The study design is an Open-Label Randomized, Single-Dose, 2-way Crossover Bioequivalence
      Study with a washout period of 6 days. During each session, the subjects will be administered
      a single dose of 100mg Ritonavir (one Ritonavir Tablet 100mg or one NORVIR Tablet 100mg)
      under fasting or fed condition.
    

Intervention name(s): Ritonavir for cycle1 and NORVIR for cycle 2; NORVIR for cycle 1 and Ritonavir for cycle 2
Intervention type(s): Drug; Drug
Intervention description(s): During the study session, healthy subjects will be administered a single dose of Ritonavir Tablet 100mg in cycle 1 and NORVIR tablet 100mg in cycle 2 .; During the study session, healthy subjects will be administered a single dose of NORVIR Tablet 100mg in cycle 1 and Ritonavir tablet 100mg in cycle 2 .
Intervention MeSH terms: Ritonavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7049389 in Healthy Volunteers and Chronic Hepatitis B Virus (HBV) Infected Participants
Condition: Hepatitis B, Chronic
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is a multicenter, three-part study. Parts 1 and 2 are randomized, investigator-
      and participant-blinded, placebo-control, single-ascending dose (SAD) and multiple-ascending
      dose (MAD) study to evaluate the safety, tolerability, pharmacokinetics (PK) and
      pharmacodynamics (PD) of RO7049389 following oral administration in healthy volunteers and
      chronic HBV infected participants. Part 3 is a non-randomized, non-controlled, open-label
      part to assess the efficacy and safety of RO7049389 when administered in combination with
      standard-of-care therapies for up to 48 weeks in nucleos(t)ide (NUC)-suppressed and
      treatment-naive chronic hepatitis B (CHB) participants.
    


Intervention name(s): Midazolam; Placebo; RO7049389
Intervention type(s): Drug; Other; Drug
Intervention description(s): Single dose of 100 mcg midazolam solution will be administered orally, before (Day -1) and after (Day 14) the treatment with RO7049389 or matching placebo; Placebo matching to RO7049389 will be administered as per schedule described in individual arm.; RO7049389 will be administered as per schedule described in individual arm.
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy of Favipiravir Against Severe Ebola Virus Disease
Condition: Ebola Virus Disease
MeSH terms: Virus Diseases; Hemorrhagic Fever, Ebola
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to explore the therapeutic efficacy of Favipiravir, a
      broad-spectrum antiviral drug against severe cases of Ebola Virus Disease (EVD), which is the
      most difficult aspect for clinical management of EVD due to its high fatality rate.
    

Detailed description: 
      This is a prospective, open-label, controlled phase 2 trial of Favipiravir among severe cases
      (cases with hemorrhage, severe dehydration, consciousness disorders, shock, and high blood
      viral load with Ct value below 20) of confirmed EVD patients in the capital area of Sierra
      Leone. Patients with 13 years of age or older would be assigned in an 1:1 randomised manner
      to receive WHO-recommended therapy (mainly symptomatic and supportive therapies, control
      group. WHO, World Health Organization.) or oral Favipiravir (1600 mg twice on the first day,
      followed by a twice-daily dose of 600 mg until negative blood viral load detection or death)
      plus WHO-recommended therapy (treatment group). The primary efficacy end point was case
      fatality rate.The secondary efficacy endpoint is blood (plasma)viral load. Optimal inclusion
      number is 240 cases (120 for each group), but considering the actual situation of pandemic
      area, the front line doctors have the right to reset the inclusion number, and modify the
      study protocol according to the actual situation in the front.
    

Intervention name(s): WHO-recommended therapies; Favipiravir
Intervention type(s): Other; Drug
Intervention description(s): symptomatic and supportive treatments according to the WHO manual; oral administration of Favipiravir tablets
Other intervention name(s): T-705
Intervention MeSH terms: Favipiravir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment