bioihbjkbjnl/mcl2 huggingface dataset:
SCB-2019 as COVID-19 Vaccine
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, double blind, placebo controlled, first-in-human (FIH) study to assess
      safety, reactogenicity, and immunogenicity of SCB-2019 at multiple dose levels, administered
      as 2 injections IM in healthy subjects. Each study vaccine dose level will be evaluated with
      and without adjuvant.
    


Intervention name(s): SCB-2019; SCB-2019 with AS03 adjuvant; SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant; SCB-2019 with Alum adjuvant
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22).; SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with AS03 adjuvant.; SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with CpG 1018 plus Alum adjuvant.; SCB-2019 intramuscular vaccinations at 9 µg twice (on Day 1 and Day 22), and administered with Alum adjuvant.
Intervention MeSH terms: Aluminum Hydroxide; Aluminum sulfate; 1018 oligonucleotide
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Evaluation of Long-Term Immunogenicity in Children and Adolescents Boosted With a New Pediatric TBE Vaccine After Five Years
Condition: Encephalitis, Tick-Borne
MeSH terms: Encephalitis, Tick-Borne; Encephalitis
Study type: Interventional
Phase: Phase 4

Summary: 
      blood draw five years after booster-immunization with TBE vaccine to investigate
      immunogenicity in children
    


Intervention name(s): blood draw
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: blood draw five years after booster-immunization with TBE vaccine to investigate immunogenicity in children; TBE
General Practice Research Database Seroquel XR Safety Study
Condition: Schizophrenia; Major Depressive Disorder; Bipolar Disorder
MeSH terms: Schizophrenia; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder
Study type: Observational

Summary: 
      The main objective of this observational study is to characterize new users of quetiapine XR
      as well as new users of other study drugs (i.e. the comparison group) and to quantify the
      risk of developing newly diagnosed outcomes of interest in new users of quetiapine XR as well
      as in other study drugs.
    

Detailed description: 
      Epidemiology study to assess the safety of a new slow-release form of Seroquel (quetiapine)
      in the post-marketing phase in the UK.
    

Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        A sample of the general population in the UK consisting of 3 millions inhabitants.
      
Keywords: atypical; antipsychotics; quetiapine
Clinical Trial to Evaluate the Safety and Tolerability of Lagricel® Ofteno Multi-dose Ophthalmic Solution
Condition: Dry Eye
MeSH terms: Dry Eye Syndromes
Study type: Interventional
Phase: Phase 1

Summary: 
      Study design: Phase I clinical trial, single-center, controlled, parallel group, open,
      randomized.

      Number of subjects: n = 34 evaluable subjects, 17 evaluable subjects per group (both eyes).

      Estimated duration of the study: 5 months

      Therapeutic indication: Eye lubricant Use: Dry Eye

      Objective:To evaluate the safety and tolerability of Lagricel® Ofteno multidose manufactured
      by Laboratorios Sophia on the ocular surface of clinically healthy subjects.

      Hypothesis:

      H0 = Lagricel® Ofteno multidose ophthalmic solution has a safety and tolerability profile
      similar to Lagricel® Ofteno single dose in healthy subjects.

      H1 = Lagricel® Ofteno multidose ophthalmic solution has a different safety and tolerability
      profile than Lagricel® Ofteno single dose in healthy subjects.

      Main inclusion criteria: Clinically healthy subjects
    


Intervention name(s): lagricel ofteno multidose; lagricel ofteno single dose
Intervention type(s): Drug; Drug
Intervention description(s): Dosage: 1 drop 4 times a day per 7 days, both eyes
Route of administration: Ophthalmic; Dosage: 1 drop 4 times a day per 7 days, both eyes
Route of administration: Ophthalmic
Other intervention name(s): sodium hyaluronate 0.4%; sodium hyaluronate 0.4%
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: single-center, controlled, parallel group, open, randomized
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dry eye; eye lubricant; sodium hyaluronate
Safety and Immunogenicity of 2 Formulations of Tuberculosis Vaccine GSK692342 Given at 0,1 Months to Healthy Adults
Condition: Tuberculosis
MeSH terms: Tuberculosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will assess the safety and immunogenicity of 2 different formulations of
      tuberculosis vaccine GSK692342 in healthy adults.
    

Detailed description: 
      The study is designed to have a vaccination phase (includes screening, 2 doses of vaccine 1
      month apart and follow-up until 1 month post dose 2), which will be performed in an observer
      blinded manner. This will be followed by 3 years of follow-up which will continue in an open
      manner.

      No new subjects will be recruited at the follow-up phase. The Protocol Posting has been
      updated in order to comply with the FDA Amendment Act, Sep 2007.
    

Intervention name(s): GSK's candidate Mycobacterium tuberculosis vaccine 692342; Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and adjuvant system; Comparator vaccine with recombinant Mycobacterium tuberculosis antigen and physiological saline; Control vaccine with the adjuvant system.
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Intramuscular injection, 2 doses at 0, 1 month; Intramuscular injection, 2 doses at 0, 1 month; Intramuscular injection, 2 doses at 0, 1 month; Intramuscular injection, 2 doses at 0, 1 month
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Tuberculosis
The PK and PD of Dapagliflozin Therapy in Combination With Insulin in Japanese Subjects With T1DM
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This randomized, single-blind, 3 arm, parallel group, placebo controlled PK/PD study will
      enrol 30 Japanese male and female patients with T1DM and age 18 to 65 years, with inadequate
      glycemic control on insulin defined as HbA1c ≥ 7.0% and ≤ 10.0% at screening visit.
      lacebo-controlled design. Patients will be randomized in a 1:1:1 ratio into one of the 3
      single-blinded treatment arms; dapagliflozin 5 mg, dapagliflozin 10 mg or placebo. CSII user
      are excluded.
    


Intervention name(s): Dapagliflozin 5mg; Dapagliflozin 10mg; Placebo tablet
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Dapagliflozin, a blood glucose lowering drug. Oral dose; Dapagliflozin, a blood glucose lowering drug. Oral dose; Placebo tablet. Oral dose
Intervention MeSH terms: Dapagliflozin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Japanese patients with type 1 diabetes with inadequate glycemic control on insulin
Efficacy and Safety Study of MP-513 in Patients With Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety and to determine the
      appropriate dose for phase 3 confirmatory trial, of MP-513 (Teneligliptin) in patients with
      type 2 Diabetes based on the change of HbA1c and adverse events after 12 weeks administration
      once daily in multi-center, randomized, double-blind, placebo-controlled, parallel assignment
      manner.
    


Intervention name(s): Teneligliptin 10mg; Teneligliptin 20 mg; Teneligliptin 40 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Other intervention name(s): MP-513; MP-513; MP-513
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: insulin resistance
Honduras Liger Thermocoagulator Study
Condition: Cervix Cancer; Cervix Lesion
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      This was a prospective study to evaluate the short-term safety and acceptability of the Liger
      Medical thermal coagulation device for treatment of cervical precancerous lesions. Study
      results will inform the Honduras Ministry of Health regarding potential use of the Liger
      device for precancer treatment in Honduras and results may be of interest to other Latin
      American settings as well.

      The research was conducted in the Tegucigalpa Region in Honduras in 4 health facilities in
      urban and peri-urban settings. Participants were women ages 30-49 who met the study
      eligibility criteria. Human papilloma virus (HPV) and visual inspection with acetic acid
      (VIA)-positive women who were eligible for ablative treatment were offered thermal
      coagulation with the Liger instrument to treat their lesions and asked about acceptability of
      the treatment. At this visit, biopsies were also be taken. Women were followed-up at 1 month
      to evaluate short-term safety outcomes with a physical exam and receive their biopsy results.
      Depending on their biopsy results, they will be asked to return for repeat screening,
      referred for further treatment or asked to come back for a 12-month study visit. At the
      12-month visit after treatment, women were followed up to evaluate cure rates.

      A second investigational device, Pocket Colposcope, was used to take cervix photos at the
      enrollment and 12-month study visit with participant consent. The photos were used to explore
      factors influencing treatment failure. De-identified photos and women's diagnosis information
      were also shared with the device developers, Duke University, for the purposes of improving
      their device. Women had the option to opt out of having cervix photos taken and still
      participate in the treatment portion of the study.
    


Intervention name(s): Liger Medical Thermocoagulator
Intervention type(s): Device
Intervention description(s): Thermocoagulation treatment by Liger Medical device (US FDA "510K" clearance received)
Intervention model: Single Group Assignment
Intervention model description: Thermal coagulator ablation treatment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Thermocoagulation; Treatment; Cervical precancer
DAS181 Single Dose Escalation Study in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate the safety, tolerability, and systemic exposure of an experimental
      influenza (flu) treatment medication called DAS181. DAS181 is a dry powder that is
      administered via oral inhalation using a special device. Study participants will include
      healthy non-smoking males and females, ages 18-65. They will be given either DAS181 or
      placebo. Participants will remain in the clinic overnight to be watched for health changes
      for 24 hours after receiving the medication. Study procedures include: physical exams, chest
      x-rays, ECGs, lung function tests, collection of blood and urine samples, and throat swabs.
      Follow-up visits will occur on study days 2, 7, 14 and 30.
    


Intervention name(s): DAS181; Lactose
Intervention type(s): Drug; Drug
Intervention description(s): DAS181 is formulated as dry powder and packaged in capsules containing DAS181. The delivered dose of DAS181 dry powder at each fill size is 5 mg, 10 mg and 20 mg.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Healthy Adults
Study to Evaluate the Pharmacokinetic (PK) Interactions Between GSK3640254 and Dolutegravir (DTG)
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-sequence, two-way drug interaction study to investigate the PK,
      safety and tolerability of GSK3640254 and DTG when administered alone or in combination in
      healthy subjects. Treatment of human immunodeficiency virus (HIV) infection frequently
      involves combination therapy. Data from this study will contribute to dosing recommendations
      when GSK3640254 and DTG are given in combination. The study will consist of a Screening
      period and 3 sequential treatment periods. Subjects will be administered DTG 50 milligrams
      (mg) once daily (QD) in Period 1 followed by GSK3640254 200 mg QD in Period 2. There will be
      a washout period of 4 days between Periods 1 and 2. In Period 3, subjects will be
      co-administered DTG 50 mg QD and GSK3640254 200 mg QD. The total duration of the study will
      be approximately 55 days, including Screening.
    


Intervention name(s): GSK3640254; DTG
Intervention type(s): Drug; Drug
Intervention description(s): GSK3640254 will be available as 100 mg capsules. Subjects will be administered GSK3640254 200 mg QD via the oral route.; DTG will be available as 50 mg tablets. Subjects will be administered DTG 50 mg QD via the oral route.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GSK3640254, dolutegravir, healthy subjects, two-way interaction, HIV
Special Investigation in Patients With Rheumatoid Arthritis (Working Productivity Activity Impairment)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Observational

Summary: 
      This is a single-arm, multi-center, prospective cohort study (post-marketing observational
      study). The observation period for each participant is 48 weeks.

      This study is designed to provide additional data on treatment effects of adalimumab during
      48 weeks of treatment in patients with RA under conditions of routine rheumatology care.
      Course of work productivity and work ability, the course of health-related quality of life,
      and changes in functionality during 48 weeks treatment with adalimumab are to be documented.
    

Detailed description: 
      This study was designed as a non-interventional observational study. Adalimumab was
      prescribed in the usual manner in accordance with the terms of the local market authorization
      with regards to dose, population and indication as well as local guidelines.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Single-arm, Multi-center, Prospective Cohort
      
Keywords: Rheumatoid arthritis
Bioequivalence Study of Sertraline Hydrochloride 100mg Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The purpose of this study was to evaluate the relative bioavailability of the test
      formulation of sertraline 100 mg tablets with an already marketed reference formulation
      Zoloft® 100 mg tablets (Pfizer), under non-fasting conditions in healthy male and female
      adult subjects.
    

Detailed description: 
      This randomized, single-dose, two-way, crossover study was conducted to compare the relative
      bioavailability of two formulations of 100 mg sertraline hydrochloride tablets under
      non-fasting conditions. The study was conducted with 36 (34 completing) healthy adults in
      accordance with protocol No.

      10540324 (Revision 0). In each study period, a single 100 mg dose was administered to the
      subjects following a standardized high fat breakfast preceded by an overnight fast of at
      least 10 hours. The test formulation was Ranbaxy Research Laboratory's Sertraline
      Hydrochloride 100 mg Tablets and the reference formulation was ZOLOFT® (sertraline
      hydrochloride) 100 mg Tablets Manufactured by Roerig (Division of Pfizer). The subjects
      received the test product in one study period and the reference product in the other period;
      the order of administration was according to the dosing randomization schedule. There was a
      14-day interval between treatments.

      Blood samples were collected pre-dose and at intervals over 144 hours after each dose. The
      plasma samples for all subjects completing both periods of the study were sent to Helen
      Fassoulas, B.Sc., Director of Operations, Warnex Bioanalytical Services Inc., 3885 boul
      Industriel, Laval, Quebec, H7LAS3 Canada, Telephone: 450-663-6724, ext. 438, FAX:
      450-975-8111 for determination of sertraline plasma concentration.

      Statistical analysis was performed by Yetta I. Wilbur, Biostatistician, Novum Pharmaceutical
      Research Services, 5900 Penn Avenue, Pittsburgh, PA 15206, USA, Telephone: 412-363-3300, Fax:
      412-362-5783 to evaluate the relative bioavailability of the test formulation to that of the
      reference product.

      A total of 36 healthy adult subjects.
    

Intervention name(s): sertraline 100 mg tablets
Intervention type(s): Drug
Intervention MeSH terms: Sertraline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Bioequivalence sertraline 100 mg tablets under fed conditions
Evaluation of Surgically Resected Colorectal Adenomas and Carcinomas After 7 Days Pretreatment With Celecoxib
Condition: Colorectal Adenoma; Colorectal Carcinoma
MeSH terms: Carcinoma; Adenoma; Colorectal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess how effective celecoxib is in limiting production of a
      hormone, prostaglandin, in the subject's body. It is felt that this hormone is involved in
      the evolution of pre-cancerous growths in the colon to cancerous stage or in the progression
      of an existing cancer. To answer this question, some subjects are given the new
      investigational drug, and other subjects a placebo. A placebo is a capsule that contains
      inactive ingredients. Only by comparing the response of two subject groups, one receiving
      placebo (inactive), and one receiving celecoxib (active), will we be able to know whether or
      not celecoxib actually works. The outcome we are assessing is the hormone activity before and
      after celecoxib is given.
    

Detailed description: 
      We propose to test the hypothesis that celecoxib, a specific inhibitor of cyclooxygenase -2
      (COX-2), will effectively inhibit the enzymatic activity in all tissues sampled after oral
      administration of celecoxib for 7 days preoperatively. One hundred twenty patients (120)
      undergoing standard surgical resection for the treatment of primary colorectal adenomas or
      carcinomas would be randomized to celecoxib or placebo given for 7 days prior to operation.
      Peripheral blood will be drawn prior to drug or placebo administration, and then morning of
      operation. At the time of definitive resection of the specimen, normal intestinal mucosa and
      primary tumor would be harvested and immediately snap frozen at -80 degrees. Levels of COX-2
      activity (prostaglandin production) as well as expression of COX-2 and other markers (matrix
      metalloproteinases(MMPs), tissue inhibitors of MMPs (TIMPs), cell adhesion and cell cycle
      control molecules will be evaluated in normal mucosa and primary tumor compared between
      celecoxib and placebo treated patients.
    

Intervention name(s): Celecoxib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 400 mg twice a day for 7 days prior to surgery; one tablet of placebo will be given for 7 days prior to surgery
Other intervention name(s): study drug
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Anti-fibrinolytic and Anti-inflammatory Effects of Local Infiltration of Tranexamic Acid in Patients With Calcaneal Fractures
Condition: Tranexamic Acid; Fibrinolysis; Inflammatory; Fracture
MeSH terms: Fractures, Bone
Study type: Interventional

Summary: 
      Background. Consensus is lacking regarding the use of tranexamic acid (TXA) in calcaneal
      fracture surgery. This study aims to investigate the hypothesis that local infiltration of
      TXA in the post-operation would maintain hemoglobin (Hb) level, reduce incision drainage
      volume and risk of infection in patients with displaced intra-articular calcaneal fractures.
      Methods. A total of 120 patients with displaced intra-articular calcaneal fractures who
      received extensible lateral L-shaped approach were included in this trial and equally
      randomized to receive one single dose of 1g TXA or 1g normal saline after closing incision.
      The demographic data and fracture characteristics, intra-operative indicators, laboratory
      tests and Visual Analogue Scale (VAS) scores, incision drainage volume, and incision-related
      complications were collected and compared between the two groups.
    


Intervention name(s): Tranexamic acid
Intervention type(s): Drug
Intervention description(s): local infiltration of TXA or normal saline in the post-operation would
Other intervention name(s): Normal saline
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Ankle Instability in Flamenco Dancers
Condition: Ankle Disease; Dance
Study type: Observational [Patient Registry]

Summary: 
      The injuries in the dancers are usually associated with different factors such as the
      characteristics of the footwear, height of the heel and physical requirements, the
      articulation of the ankle being the most susceptible when the loads are not adequately dealt.
      The main objective is to evaluate in a sample of subjects if there is a difference in the
      stability of the ankle, as a consequence of previous sprains, between flamenco dancers and
      dancers and a dance-free control group.
    

Detailed description: 
      An observational study. This study has involved a population of 26 subjects divided into two
      groups of 13 each is studied (40,15 ± 4,675 años); the experimental group is characterized by
      the practice of flamenco dance
    

Intervention name(s): Flamenco dance
Intervention type(s): Behavioral
Intervention description(s): evaluation of ankle injuries in the flamenco dancers
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        This study has involved a population of 26 healthy subjects divided into two groups of 13
        each one
      
Keywords: ankle; dance