bioihbjkbjnl/mcl2 huggingface dataset:
Study Investigating the Safety, Tolerability, and Pharmacokinetic Properties of Lu AE58054 in Healthy Japanese and Caucasian Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of single- and multiple doses of Lu AE58054 in
      healthy young Japanese men in comparison with Caucasian men.
    

Detailed description: 
      The study will be conducted in two parts.

      Part A consists of two cohorts (named cohort A1 and A2), which are randomised, double-blind,
      parallel-group, placebo-controlled, single- and multiple dose regimens investigating the
      safety, tolerability, and pharmacokinetics of Lu AE58054 in healthy young men.

      Part B consists of one cohort, B1, which is a randomised, open-label, two-way cross-over,
      single dose investigation of the effect of food on the pharmacokinetics of Lu AE58054 in
      healthy young Japanese men.
    

Intervention name(s): Cohort A1: Lu AE58054 or placebo; Cohort A2: Lu AE58054 or placebo; Cohort B1: Lu AE58054
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One single oral dose 60 mg (one 60 mg tablet) followed by 60 mg once daily for 7 days, or matching placebo.; One single oral dose 120 mg (two 60 mg tablets) followed by 120 mg once daily for 7 days, or matching placebo.; Two single oral doses 60 mg with >=7 days washout.
Intervention MeSH terms: (2-(6-fluoro-1H-indol-3-yl)-ethyl)-(3-(2,2,3,3-tetrafluoropropoxy)benzyl)amine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
BonyPid-500TM Bone Graft Substitute Study
Condition: Peri Implantitis
MeSH terms: Peri-Implantitis
Study type: Interventional

Summary: 
      This study is designed to assess the safety and effectiveness of BonyPid-500TM implantation
      for intrabony peri-implantitis defects.

      BonyPid-500™ is a bone graft substitute, which contains an antibiotic drug - doxycycline, and
      is intended for filling and reconstruction of bone defects caused by peri-implantitis.
    

Detailed description: 
      This is a pilot, randomized, single-blind, two arm controlled, multicenter study in subjects
      undergoing surgical treatment for peri-implantitis disease. Eligible subjects will undergo a
      surgical treatment and be randomly assigned during surgical intervention (after flap opening)
      in a 1:1 ratio to adjunct BonyPid-500TM implantation or no BonyPid-500TM implantation.

      Randomization will be stratified by site and number of eligible implants, i.e., single or
      multiple.

      The study population includes male and female subjects, 20 - 80 years of age at screening,
      diagnosed with peri-implantitis and recommended for surgical treatment of peri-implantitis
      disease.

      Up to 77 subjects will be enrolled to this study which will be conducted in two medical
      centers in Israel.
    

Intervention name(s): BonyPid 500TM implantation concomitantly to SOC treatment; SOC treatment only
Intervention type(s): Device; Other
Intervention description(s): BonyPid 500TM implantation concomitantly to SOC treatment; Standard of care treatment (Manual and ultrasonic debridement, and surface decontamination)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Effects of Chronic Smoking on Circulating Endothelial and Platelet-derived Microparticle
Condition: Atherosclerosis
MeSH terms: Atherosclerosis
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The investigators hypothesized that circulating EMP is a useful surrogate marker of early
      stage of endothelial damage. To determine the effects of chronic smoking on circulating EMP,
      from healthy volunteers who have habit of chronic smoking, peripheral blood is drawn at the
      time of flow-mediated dilatation (FMD) examination. Spot urine is also collected. Circulating
      EMPs are counted using flow-cytometry. After 2-week smoking cessation, the measurements were
      repeated.
    


Intervention name(s): smoking cessation
Intervention type(s): Behavioral
Intervention description(s): After baseline examination, the group is asked to quit smoking for 2 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Proof-of-Concept Study of a Selective p38 MAPK Alpha Inhibitor, Neflamapimod, in Subjects With Mild Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2b, double-blind, placebo controlled proof-of-concept study of a an oral
      small molecule selective inhibitor of p38 alpha kinase, neflamapimod, administered for 24
      weeks in subjects with mild Alzheimer's disease. The primary objective is to demonstrate
      significant improvement relative to placebo-treatment in episodic memory function, as
      assessed by the Hopkins Verbal Learning Test. Secondary endpoints include Clinical Dementia
      Rating scale (CDR), Wechsler Memory Scale (WMS), Mini-Mental-Status-Examination (MMSE) and
      Cerebrospinal fluid (CSF) biomarkers of AD disease activity and progression.
    

Detailed description: 
      Details provided elsewhere.
    

Intervention name(s): neflamapimod; placebo
Intervention type(s): Drug; Other
Intervention description(s): 40 mg neflamapimod capsule; matching placebo capsule
Other intervention name(s): VX-745
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double-blind, placebo-controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Does Guanfacine Attenuate Stress-Induced Drinking?
Condition: Alcohol Drinking
MeSH terms: Alcohol Drinking
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluating the effect of guanfacine on alcohol consumption. The investigators hypothesize
      that guanfacine versus placebo will decrease the amount of alcohol consumption (mls consumed)
      during the 2-hour self-administration period across two laboratory sessions.
    


Intervention name(s): Guanfacine 3mg/day; Guanfacine 1.5mg/day; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 3 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper.; 1.5 mg/day Guanfacine with 3-week lead-in period. Maintained at steady state throughout lab sessions. After lab sessions, given taper supply of medication. Follow up 2 weeks after completion of taper.
Other intervention name(s): Tenex; Tenex
Intervention MeSH terms: Guanfacine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Alcohol; Drinkers; Guanfacine
Ascending Dose Study of Investigational SARS-CoV-2 Vaccine ARCT-021 in Healthy Adult Subjects
Condition: SARS-CoV-2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Determine safety and tolerability and immungenicity of investigational vaccine ARCT-021 in
      healthy adult volunteers.
    

Detailed description: 
      Randomized, double blinded (study site staff, subjects and Sponsor), placebo controlled,
      adaptive, ascending dose study evaluating administration of ARCT-021 in healthy adult
      subjects. 0.9% sterile saline will serve as a placebo control. Study drug (ARCT-021 or
      control) will be administered as an intramuscular (IM) injection. The study comprises two
      parts. In the Phase 1 part escalating dose levels given as a single injection to younger
      adults (21 to 55 years) will be evaluated sequentially. Two dose levels will be further
      evaluated in the Phase 2 part of the study in two expansion cohorts in younger adults (21 to
      55 years) and in two elderly subject (56 to 80 years) cohorts.
    

Intervention name(s): ARCT-021 Dose 1; ARCT-021 Dose 2; ARCT-021 Dose 3; ARCT-021 Dose 4; ARCT-021 Dose Regimen 1; ARCT-021 Dose Regimen 2; Placebo
Intervention type(s): Biological; Biological; Biological; Biological; Biological; Biological; Other
Intervention description(s): ARCT-021 Dose 1 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP); ARCT-021 Dose 2 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021; ARCT-021 Dose 3 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021; ARCT-021 Dose 4 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021; ARCT-021 dose regimen 1 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021; ARCT-021 dose regimen 2 is an investigational vaccine comprising a self-replicating (replicon) mRNA that encodes for the full length spike protein of 2019-nCoV formulated in a lipid nanoparticle (LNP): ARCT-021; Sterile 0.9% saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparisons Between Dexmedetomidine and Magnesium Sulfate in Controlled Hypotension During Rhinoplasty Surgeries
Condition: Hypotension
MeSH terms: Hypotension
Study type: Interventional
Phase: Phase 1

Summary: 
      General anesthesia organizes the best option for controlled blood pressure during rhinoplasty
      surgery. The primary agent applied in controlling hypotension should have particular unique
      characteristics. The dexmedetomidine central and peripheral sympatholytic performance is
      usually indicated by low blood pressure and low heart rate. magnesium sulfate is among the
      best agents used.
    

Detailed description: 
      This is a prospective comparative randomized study. 56 patients got enrolled and then divided
      into two groups. Group 1 received dexmedetomidine (n=28), while the group 2 received
      magnesium sulfate (n=28). MAP, as well as heart rate, were recorded. Surgeon satisfaction was
      approximated for the surgical field quality. The amount of blood loss during the entire
      process was measured. The score of pain was evaluated using the NRS rating scale. Sedation
      score through Ramsey sedation score. The time required for the first requirement of analgesia
      was also recorded as well as intraoperative and postoperative problems.
    

Intervention name(s): Dexmedetomidine; Magnesium sulfate
Intervention type(s): Drug; Drug
Intervention description(s): Group 1 received dexmedetomidine; the group 2 received magnesium sulfate
Other intervention name(s): magnesium sulfate
Intervention MeSH terms: Magnesium Sulfate; Dexmedetomidine
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: 56 patients got enrolled and then divided into two groups. Group 1 received dexmedetomidine (n=28), while the group 2 received magnesium sulfate (n=28). MAP, as well as heart rate, were recorded. Surgeon satisfaction was approximated for the surgical field quality.
Masking: Single (Investigator)
Primary purpose: Prevention
Bevacizumab And Combination Chemotherapy in Rectal Cancer Until Surgery
Condition: Rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy, toxicity and feasibility of FOLFOX/
      bevacizumab and FOLFOXIRI/ bevacizumab neoadjuvant therapy in poor prognosis rectal cancer as
      defined by MRI.
    

Detailed description: 
      The purpose of this study is to look at two different combinations of anticancer drugs to see
      how effective they are at shrinking your cancer and preventing it from coming back after
      surgery. Patients with locally advanced rectal cancer are sometimes treated with
      radiotherapy, with or without chemotherapy, before having surgery. Radiotherapy treats only
      the main tumour in the rectum. This means that if tiny deposits of cancer have spread to
      other parts of the body (metastases), these could continue to grow. Giving chemotherapy and
      radiotherapy together (chemoradiotherapy) can treat both the main tumour and any spread.
      However, due to the side-effects we can't give as much chemotherapy in combination with
      radiotherapy than if chemotherapy were given on its own and treatment of possible metastases
      may not be as good as it could be. If the risk of the main tumour coming back is quite small,
      then giving treatment that targets metastases should be the best option.

      This study looks at two well known combinations of chemotherapy drugs: FOLFOX (folinic acid,
      5-fluorouracil, oxaliplatin) and FOLFOXIRI (folinic acid, 5-fluorouracil, oxaliplatin,
      irinotecan). Chemotherapy works by killing cancer cells. In addition, the anticancer drug
      bevacizumab will be given with both the FOLFOX and FOLFOXIRI. Bevacizumab is an
      "anti-angiogenesis" drug. It works by stopping tumours from making new blood vessels. Without
      new blood vessels, the cancer cells do not get the food and oxygen they need to survive and
      grow. Attacking the cancer in these ways may be more effective than chemotherapy alone.
    

Intervention name(s): Bevacizumab; Irinotecan; Oxaliplatin; 5-Fluorouracil
Intervention type(s): Biological; Drug; Drug; Drug
Intervention description(s): 5 mg/kg, IV (in the vein) over 30-90 minutes, on day 1 of each 2 weekly cycles. Number of cycles: 1-5 (bevacizumab should not be administered during cycle 6).; 165 mg/m2 IV (intravenous) over 1 hour on day 1 of two weekly cycle. Number of cycles: 1-6; 165 mg/m2 IV (intravenous) over 1 hour on day 1 of two weekly cycle. Number of cycles: 1-6; 3200 mg/m2 IV (intravenous), continuous infusion over 48 hours starting on day 1 of two weekly cycle. Number of cycles: 1-6
Other intervention name(s): Avastin; Campto; Eloxatin; 5-FU
Intervention MeSH terms: Bevacizumab; Fluorouracil; Oxaliplatin; Irinotecan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rectal Cancer; Bevacizumab; Neoadjuvant; Chemotherapy; Randomised
Biomarkers in Predicting Response to Rituximab Treatment in Samples From Patients With Indolent Follicular Lymphoma
Condition: Lymphoma
MeSH terms: Lymphoma
Study type: Observational

Summary: 
      RATIONALE: Studying samples of blood and tumor tissue from patients with cancer in the
      laboratory may help doctors learn more about changes that occur in DNA and identify
      biomarkers related to cancer. It may also help doctors predict how well patients will respond
      to treatment.

      PURPOSE: This research study is studying biomarkers in predicting response to rituximab
      treatment in samples from patients with indolent follicular lymphoma.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Genotype the full cohort of samples available from the RESORT clinical trial
           (ECOG-E4402) for FCGR3A 158V/F in parallel to independently verify results.

        -  Correlate the FCGR3A 158V/F polymorphisms to response, response duration, and time to
           rituximab resistance.

      Secondary

        -  Quantify copy number variation in FCGR3A in this cohort.

      OUTLINE: Archived DNA samples isolate from peripheral blood mononuclear cells and from
      formalin-fixed paraffin-embedded tissue samples are analyzed for FCGR3A 158V/F polymorphisms
      using different complementary genotyping methods. Assay results are reviewed and compared
      with patients' outcome data.
    

Intervention name(s): rituximab; DNA analysis; gene expression analysis; polymorphism analysis; laboratory biomarker analysis; medical chart review
Intervention type(s): Biological; Genetic; Genetic; Genetic; Other; Other
Intervention MeSH terms: Rituximab
Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Samples from patients enrolled in E4402 from whom samples were submitted for research
      
Keywords: recurrent grade 1 follicular lymphoma; recurrent grade 2 follicular lymphoma
Biomarkers in Prehospital Rule-out of Intracranial Lesions in TBI Patients
Condition: Traumatic Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Observational

Summary: 
      The PreTBI I study will investigate whether prehospital blood samples drawn already in the
      ambulance can rule-out intracranial lesions in patients suffering head trauma. The study aims
      to improve triage and treatment of patients suffering mild head trauma, who are considered
      low-risk patients. These patients do not always benefit from hospitalization, but are
      nevertheless admitted on precaution, as clinical assesment can be difficult.

      Hypotheses:

        1. A prehospital measurement of serum S100B ≤ 0,10 microgram/L in mild TBI patients rules
           out traumatic intracranial lesion with a sensitivity >97%.

        2. A prehospital measurement of serum GFAP (glial acidic fibrillary protein) in mild TBI
           patients rules out traumatic intracranial lesion with sensitivity >97% and results in
           lower false positive rate than S100B.

        3. Prehospital measurements of both GFAP and S100B results in lower false positive rates
           than in-hospital measurements.
    


Intervention name(s): Blood sampling
Intervention type(s): Other
Intervention description(s): Blood sampling from peripheral venous catheter routinely inserted in trauma patients during transportation
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients (≥ 18 years) suffering isolated head trauma and receiving an ambulance
        dispatched by the prehospital emergency medical services in the Central Denmark Region.
      
Biospecimen description: 
      Blood samples
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adult (18-40 Years Old)
Condition: Typhoid Fever
MeSH terms: Typhoid Fever
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is aimed to evaluate the safety and immunogenicity profiles of a new Vi-CRM197
      conjugate vaccine against S. Typhi in healthy human adults in comparison with the currently
      licensed Vi polysaccharide vaccine.
    


Intervention name(s): Typherix; NVGH Vi-CRM197
Intervention type(s): Biological; Biological
Intervention description(s): 1 dose, 0.5 mL containing 25 mcg of Vi polysaccharide; 1 dose of 0.5 mL containing 25 mcg of Vi-CRM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Typhoid fever; Glycoconjugate vaccine; Carrier protein; Immunogenicity
An Exploratory Study Investigating Safety, Tolerability and Pharmacokinetics of Ascending Doses of Lu AE04621 in Parkinson Disease Patients
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability, pharmacokinetics, and efficacy of the Lu AE04621 and
      metabolite after ascending oral doses of Lu AE04621 in patients with Parkinson's Disease.
    

Detailed description: 
      The study comprised 5 cohorts (Cohorts 1 to 5), with each cohort consisting of 3 patients
      with Parkinson's disease (men and/or women). Each patient will be treated for 3 or 4 days,
      with increasing dose each day.

      Dosing regimen will be decided at a dosing conferences. Dose levels can be increased,
      maintained or reduced both between cohorts but also within same cohort. The results are
      presented by dose level and reflect the actual doses administered.

      A follow-up safety visit was scheduled approximately 7 days after the last dose of IMP.
    

Intervention name(s): 0.04 mg Lu AE04621; 0.08 mg Lu AE04621; 0.2 mg Lu AE04621; 0.4 mg Lu AE04621; 0.6 mg Lu AE04621; 0.8 mg Lu AE04621; 1.0 mg Lu AE04621; 1.2 mg Lu AE04621
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): 0.04 mg dose group; 0.08mg dose group; 0.2 mg dose group; 0.4 mg dose group; 0.6 mg dose group; 0.8 mg dose group; 1.0 mg dose group; 1.2 mg dose group
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Intervention model description: The study comprised 5 cohorts (Cohorts 1 to 5), with each cohort consisting of 3 patients (men and/or women). The dosing regimen planned for Cohort 1 was a dose of 0.2 mg Lu AE04621 on Day 1 followed by a dose of 0.4 mg Lu AE04621 on Day 2, and a dose of 0.6 mg Lu AE04621 on Day 3. • The dosing regimen planned for Cohort 2 was 0.4 mg Lu AE04621 on Day 1 followed by a dose of 0.6 mg Lu AE04621 on Day 2, and a dose of 0.8 mg Lu AE04621 on Day 3. The dosing regimen planned for Cohort 3 was 0.2 mg Lu AE04621 on Day 1 followed by a dose of 0.4 mg Lu AE04621 on Day 2, a dose of 0.6 mg Lu AE04621 on Day 3, and a dose of 1.0 mg Lu AE04621 on Day 4. The dosing regimen planned for Cohorts 4 and 5 was 0.2 mg Lu AE04621 on Day 1 followed by a dose of 0.4 mg Lu AE04621 on Day 2, a dose of 0.6 mg Lu AE04621 on Day 3, and a dose of 1.2 mg Lu AE04621 on Day 4. The results are presented by dose groups and are based on the actual doses administered.
Masking: None (Open Label)
Primary purpose: Treatment
A Pharmacokinetic Study of Ruxolitinib Phosphate Cream in Pediatric Subjects With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability and the pharmacokinetics
      (PK) of topical ruxolitinib cream applied to pediatric subjects (age ≥ 2 to 17 years) with
      atopic dermatitis (AD).
    

Detailed description: 
      Study has been modified to include younger pediatric subjects (age ≥2 to 11) in four
      additional cohorts.
    

Intervention name(s): Ruxolitinib phosphate cream
Intervention type(s): Drug
Intervention description(s): Ruxolitinib phosphate cream at the protocol-defined dose strength based on cohort assignment.
Other intervention name(s): INCB018424
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Atopic dermatitis; Janus kinase (JAK) inhibitor; pediatric; inflammation
Efficacy Study of Genexol-PM and Cisplatin in Locally Advanced Head and Neck Cancer
Condition: Locally Advanced Head and Neck Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 2

Summary: 
      This clinical trial is Phase II trial for evaluating efficacy of induction chemotherapy using
      Genexol-PM + cisplatin for locally advanced head and neck cancer. The investigators try to
      evaluate response rate of Genexol-PM + cisplatin chemotherapy, and safety profile.
    


Intervention name(s): genexolPM + cisplatin
Intervention type(s): Drug
Intervention MeSH terms: genexol-PM
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment