bioihbjkbjnl/mcl2 huggingface dataset:
Stem Cell Transplantation In-patient With Neurological Sequelae Due to Encephalitis or Meningitis
Condition: Encephalitis; Meningitis
MeSH terms: Meningitis; Encephalitis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      To evaluate the safety and efficacy of autologous bone marrow-derived mononuclear cell
      transplantation in-patient with neurological sequelae due to encephalitis or meningitis
    

Detailed description: 
      The purpose of this study is to evaluate the safety and effectiveness of autologous bone
      marrow-derived mononuclear cell in 22 patients with neurological sequelae due to encephalitis
      or meningitis at Vinmec International Hospital, Hanoi, Vietnam
    

Intervention name(s): Stem cell transplantation
Intervention type(s): Combination Product
Intervention description(s): Transplantation of Autologous Bone Marrow Mononuclear Cells
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: encephalitis; meningitis; neurological sequelae due
Needlescopic-assisted Uniportal vs Uniportal VATS
Condition: Lung Cancer; Lung Cancer Metastatic; Bullous Disease Lung; Nodule Solitary Pulmonary; Mediastinal Tumor
MeSH terms: Lung Neoplasms; Mediastinal Neoplasms
Study type: Interventional

Summary: 
      The investigators' study aims is to evaluate the safety and efficacy of uniportal VATS under
      assistance of needlescopic instruments through additional 2-3 mm ports compared to
      conventional uniportal VATS in patients with lung lesions.
    


Intervention name(s): Thoracoscopic surgery
Intervention type(s): Procedure
Intervention description(s): Video-assisted thoracoscopic surgery for pulmonary or mediastinal lesions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Thoracoscopy; VATS; Needlescopy; Uniportal
Spermotrend in the Treatment of Male Infertility
Condition: Male Infertility
MeSH terms: Infertility; Infertility, Male
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether the administration of the dietary
      supplement Spermotrend improves spermatogenesis parameters in subjects with male infertility
      unrelated to major testicular conditions. The duration of this double-blind placebo
      controlled phase 3 clinical trial will be 24 weeks. The estimated number of males with
      infertility to be recruited and randomized for the study is 86.
    


Intervention name(s): Placebo; Spermotrend
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): One Placebo tablet (Orally administered) twice a day, for 12 weeks.; One Spermotrend tablet (Orally administered) twice a day, for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Dietary supplement; male infertility; spermatogenesis
Comparison of Straumann Bone Ceramic and Bio-Oss With Guided Tissue Regeneration for Alveolar Ridge Preservation
Condition: Bone Loss
Study type: Interventional

Summary: 
      The purpose of this study is to compare a new biomaterial with an already existing treatment
      principle (Bio-Oss/Bio-Gide) with regard to their ability to preserve the dimensions of the
      alveolar ridge and to promote bone regeneration and to evaluate the early survival rate of
      dental implants placed in the augmented socket area and to assess radiographically and
      clinically changes of peri-implant soft and hard tissues.
    

Detailed description: 
      This is prospective, randomized, single-blind, controlled, single center study. The total
      study duration for each patient should be 12 +/- 1 month.

      In total 13 visits per patient are scheduled in this study.

      The study devices Straumann Bone Ceramic and Bio-Oss are CE-marked, and approved by the FDA.
      The products are used within the indication.

      One center in the Inited Kingdom will participate.
    

Intervention name(s): Straumann Bone Ceramic; Bio-Oss
Intervention type(s): Device; Device
Intervention description(s): Bone augmentation, after tooth extraction, with Straumann Bone Ceramic (synthetic bone graft material) in combination with resorbable collagen membrane Bio-Gide.; Bone augmentation, after tooth extraction, with Bio-Oss (bovine-derived xenograft)in combination with resorbable collagen membrane Bio-Gide.
Other intervention name(s): Synthetic Bone Substitute; Xenograft
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
A Study to Assess the Safety of Hep C Vaccine Candidates in HIV Seropositive Individuals
Condition: Hepatitis C Infection
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is aimed at assessing the safety of candidate Hepatitis C (Hep C) vaccines
      AdCh3NSmut1 and MVA-NSmut when administered to Human Immunodeficiency Virus (HIV)
      seropositive individuals. This study also aims to assess the cellular immune response
      generated by these vaccines when administered as mentioned above.
    

Detailed description: 
      Hepatitis C (Hep C) is a common infection. Worldwide, over 180 million people are infected.
      Hep C is a blood borne viral infection spread through direct contact with the blood of an
      infected person. People with Hep C frequently have no symptoms and infection can lead to
      fibrosis (scarring of the liver), liver failure and cancer. Infection with the Hep C virus
      (HCV) progresses more rapidly to liver damage in Human Immunodeficiency Virus (HIV)-infected
      individuals.

      Researchers at the University of Oxford have developed a novel candidate vaccine against HCV
      ('NSmut'). This vaccine has been inserted into the carrier viruses Chimpanzee Adenovirus 3
      (AdCh3) and modified vaccinia virus Ankara (MVA), both of which have excellent safety records
      and have been previously tested in people.

      However, the objective of this study is to use exploratory immunological assays to assess
      whether vaccines for Hep C can induce immune responses in HIV positive individuals that are
      similar in strength to those in healthy volunteers.
    

Intervention name(s): AdCh3NSmut1; MVA-NSmut
Intervention type(s): Biological; Biological
Intervention description(s): Genetic vaccine against Hepatitis C virus infection; Genetic vaccine against Hepatitis C virus infection
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Evaluatıon Of The Possible Effect Of Inspıratory Muscle Training On Inflammation Markers And Oxıdatıve Stress In Childhood Asthma
Condition: Asthma in Children; Children, Adult
MeSH terms: Asthma; Respiratory Aspiration; Inflammation
Study type: Interventional

Summary: 
      As inflammation and oxidative stress increase in asthma patients, the severity of symptoms
      and clinical findings increase. Therefore, this study was planned to evaluate the possible
      effect of inspiratory muscle training (IMT) on inflammation markers and oxidative stress in
      childhood asthma.

      The study included asthma patient; 35 routine medication, 35 drug therapy and inspiratory
      muscle training (IMT), and 35 healthy total 105 children aged 8-17 years. Demographic
      information and hemogram values were recorded. Functional capacity was evaluated with the
      6-minute walking test, quality of life PedsQL, respiratory muscle strength oral pressure
      measuring device, respiratory function test, dyspnea severity with Modified Borg Scale.
      C-Reactive Protein (CRP), Periostin, Transforming Growth Factor-βeta (TGF-β), Total
      Antioxidant Status (TAS), Total Oxidant Status (TOS), Oxidative Stress Index (OSI) were
      analyzed. IMT was given with a Threshold IMT device for 7 days/6 weeks at 30% of maximal
      inspiratory pressure, and then a second evaluation was made.
    


Intervention name(s): Inspıratory muscle training; Used routine medicine; Control group
Intervention type(s): Other; Other; Other
Intervention description(s): The MIP/MEP value of the group that will receive inspiratory muscle training was determined and Thershold IMT training was given with 30%.
In the training, the subjects were asked to sit in a relaxed position with their upper chest and shoulders relaxed.
After the nose clip was attached, the children were asked to inhale and exhale by tightly closing the mouthpiece of the instrument with their lips.
A 30-minute training session was carried out for 6 weeks, with 10-15 repetitive breathing apparatus and 5-10 seconds rest breaks every day.; After the first evaluation was made, a second evaluation was made after 6 weeks of follow-up.; A healthy child compatible with the age and sex of the patient group was evaluated once.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized clinical trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Childhood Asthma; Inspiratory Muscle Training; Inflammation
A Bioequivalence Study of Darunavir, Emtricitabine, and Tenofovir Alafenamide, in the Presence of Cobicistat in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the single-dose pharmacokinetics and pivotal
      bioequivalence of Darunavir (DRV) 800 milligram (mg), Emtricitabine (FTC) 200 mg, and
      tenofovir alafenamide (TAF) 10 mg when administered as a fixed-dose combination (FDC)
      (D/C/F/TAF) relative to the separate agents (DRV 800 mg tablet formulation and FTC/TAF 200/10
      mg FDC) in the presence of 150 mg Cobicistat (COBI), under fed conditions, in healthy
      participants.
    

Detailed description: 
      This is a Phase 1, open-label, randomized, 2-way crossover study in 96 healthy adult
      participants. The study consists of 2 treatment sessions. Participants will receive in one
      session a single dose of darunavir/cobicistat/emtricitabine/tenofovir alafenamide (D/C/F/TAF)
      800/150/200/10 milligram (mg) tablets as fixed-dose combination (FDC) and in another session
      Darunavir (DRV) as 1x 800 mg tablet, Emtricitabine/ tenofovir alafenamide (FTC/TAF) as 1x
      200/10 mg FDC tablet, and Cobicistat (COBI) 150 mg as 1x 150 mg tablet all under fed
      conditions. Treatment sessions will be separated by a washout period of at least 7 days. The
      duration of the study for an individual participant will be at least 12 days, Screening and
      Follow-up not included. Participants safety will be monitored throughout the study.
    

Intervention name(s): Darunavir/Cobicistat/Emtricitabine/Tenofovir Alafenamide fixed-dose combination (FDC); Emtricitabine/tenofovir alafenamide FDC; Darunavir; Cobicistat
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A single tablet containing DRV 800 mg, COBI 150 mg, FTC 200 mg and TAF 10 mg will be administered.; A single tablet containing FTC 200 mg and TAF 10 mg will be administered.; A single tablet containing darunavir 800 mg will be administered.; A single table containing cobistat 150 mg will be administered.
Intervention MeSH terms: Tenofovir; Emtricitabine; Darunavir; Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination; Cobicistat; Emtricitabine tenofovir alafenamide; Cobicistat mixture with darunavir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Immunodeficiency Virus Type 1, Human; Darunavir; Cobicistat; Emtricitabine; Tenofovir alafenamide; Healthy participants
Primary & Booster Study in Infants to Demonstrate Non-inferiority, Persistence & Immunogenicity of Hib-MenC Vaccine
Condition: Neisseria Meningitidis; Haemophilus Influenzae Type b
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this primary vaccination phase is to demonstrate the non-inferiority of two
      doses of Biologicals' Hib-MenC conjugate vaccine when given with Infanrix™ penta to infants
      (at 3 & 5m) compared to NeisVac-C™ given with Infanrix™ hexa.

      The purpose of the booster vaccination phase is to evaluate the immunogenicity, safety and
      reactogenicity of a booster dose of the Hib-MenC vaccine given with Infanrix™ penta at 11 m
      of age versus NeisVac-C™ given with Infanrix™ hexa, as well as the antibody persistence prior
      to the administration of the booster doses. The Protocol Posting has been updated in order to
      comply with the FDA Amendment Act, Sep 2007.
    

Detailed description: 
      This multicenter study is open and consists of a primary and a booster phase. The study has 2
      treatment groups with NeisVac-C™ + Infanrix™ hexa as active controls. In the primary phase,
      one blood sample will be collected from all subjects for immunogenicity analyses- one month
      after the second vaccination dose. In the booster phase, two blood samples will be collected:
      prior to and one month post booster vaccination.
    

Intervention name(s): Haemophilus influenzae type b- and meningococcal serogroup C (vaccine); Infanrix Penta; Infanrix hexa; Neis-Vac-C
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.; Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age.; Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age; Two primary vaccination doses at 3 and 5 months of age and a booster dose at 11 months of age
Intervention MeSH terms: PENTA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of KRP-104 in Patients With Type 2 Diabetes Inadequately Controlled on Metformin Alone
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the safety and efficacy of chronic therapy with KRP-104, a novel DPP-IV inhibitor,
      in patients with Type 2 Diabetes on stable metformin therapy. In addition, an estimate of how
      much of the HbA1c response is attributable to nocturnal coverage will be explored.
    


Intervention name(s): KRP-104 QD Drug: Placebo Drug: Metformin; Placebo Drug: Metformin; KRP-104 BID Drug: Placebo Drug: Metformin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): KRP-104 120 mg: KRP-104 two 50 mg tablets and two 10 mg tablets 15 to 30 minutes before morning meal and 2 placebo tablets 15 to 30 minutes before evening meal; Two tablets 15 to 30 minutes before each meal, morning and evening.; KRP-104 60 mg: KRP-104 one 50 mg tablet plus one 10 mg tablet 15 to 30 minutes before each meal, morning and evening.
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Study to Evaluate the Pharmacodynamics After Single Oral Dosing of Tegoprazan, EAPA115 and RAPA115 in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study aims to evaluate the pharmacodynamics after single oral dosing of tegoprazan,
      EAPA115 and RAPA115 in healthy volunteers.
    

Detailed description: 
      Evaluation Criteria

        -  Pharmacodynamic assessments with intragastric pH

        -  Safety assessments with adverse event monitoring including subjective/objective
           symptoms, physical examination, vital signs, electrocardiogram, and laboratory test
    

Intervention name(s): Tegoprazan 50 mg; EAPA115; RAPA115
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tegoprazan 50 mg tablet; EAPA115; RAPA115
Other intervention name(s): K-CAB
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Clinical Trial on the Candidate Vaccine cAd3-EBOZ in Healthy Adults in Switzerland
Condition: Ebola Vaccines
MeSH terms: Hemorrhagic Fever, Ebola
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of this trial is to assess in healthy adults the safety and reactogenicity of a
      new candidate vaccine, cAd3-EBOZ, made of a chimpanzee Adenovirus vector encoding the
      glycoprotein of Zaire Ebola virus. The secondary objectives will be to assess the
      immunogenicity of the candidate vaccine and find the most suitable dose for further
      deployment in epidemic areas in Africa. The 120 planned study subjects will be composed of
      possibly exposed volunteers owning to organisations such as "Médecins sans frontières" and
      susceptible to be deployed in the outbreak zone (named as "possibly exposed volunteers"). The
      other volunteers will be adults with no planned travels to the epidemic zone (named as "not
      exposed volunteers"). The first group will be randomly allocated to two different groups (low
      dose = single injection of 2.5x10e10 viral particles (vp), high dose = single injection of
      5x10e10 vp). The second group will be randomly allocated to three different groups (low dose
      = single injection of 2.5x10e10 viral particles (vp), high dose = single injection of 5x10e10
      vp or placebo = single injection of vaccine diluent). The design will be double-blind.
      Follow-up visits will take place at Day 1, 7, 14, 28, 90 and 180.
    


Intervention name(s): cAd3-EBOZ vaccine; Placebo (for cAd3-EBOZ vaccine)
Intervention type(s): Biological; Biological
Intervention description(s): Diluent
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Ebola, Ebolavirus
Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap. in Rheumatoid Arthritis Patients
Condition: Pelubiprofen; Celebrex; Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      A Randomized, Double-blind, Multicenter, Phase 3 Study of Pelubiprofen Tab. & Celebrex Cap.
      for Comparative Evaluation of Safety & Efficacy in Rheumatoid Arthritis Patients
    


Intervention name(s): Pelubiprofen 30 mg; Celebrex 200 mg
Intervention type(s): Drug; Drug
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Incidence of Post-operative Pain After Single-visit Versus Two-visit Treatment
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Aim :to compare incidence of post-operative pain and apical healing after single-visit versus
      two-visit root canal treatment of teeth with necrotic pulp and apical periodontitis.
    

Detailed description: 
      Aim to compare incidence of post-operative pain and apical healing after single-visit versus
      two-visit root canal treatment of teeth with necrotic pulp and apical periodontitis.

      Methodology: All teeth of the one and two-visit group were asymptomatic (92) and symptomatic
      (18) with a diagnosis of pulp necrosis (RCT cases) determined by hot and cold sensitivity
      tests and radiographically all teeth showed a small and irregular radiolucency at the tooth
      apex. Working length was established with EAL and confirmed radiographically. Reciprocating
      files (VDW, Munich Germany) were used to complete root canal preparation. EDTA served as a
      lubricant.
    

Intervention name(s): One visit RCT; Post operative pain in two-visits RCT
Intervention type(s): Procedure; Procedure
Intervention description(s): Root canal treatment in one vist; Root canal treatment in Two visits
Other intervention name(s): Endodontic therapy; Endodontic Therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Ibuprofen for post operative pain. after RCT in one visit
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Pain,; one-visit; two visits
Volasertib in Combination With Azacitidine in Japanese Patients With Myelodysplastic Syndrome or Chronic Myelomonocytic Leukemia
Condition: Myelodysplastic Syndromes; Leukemia, Myelomonocytic, Chronic
MeSH terms: Leukemia; Preleukemia; Leukemia, Myelomonocytic, Chronic; Leukemia, Myelomonocytic, Juvenile; Myelodysplastic Syndromes; Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      To identify the maximum tolerated dose or recommended dose for further development of
      volasertib in combination with azacitidine in Japanese patients with myelodysplastic
      syndromes or chronic myelomonocytic leukemia, and evaluate the safety and tolerability,
      pharmacokinetics and the preliminary efficacy of this combination.
    


Intervention name(s): Azacitidine; Volasertib
Intervention type(s): Drug; Drug
Intervention description(s): Azacitidine (subcutaneous); Volasertib escalating doses (intravenous)
Intervention MeSH terms: Azacitidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Vascular Health and Risk Factors in Children With Down Syndrome
Condition: Down Syndrome; Cardiovascular Risk Factor; Atherosclerosis
MeSH terms: Down Syndrome; Atherosclerosis; Syndrome
Study type: Observational

Summary: 
      This is a prospective, multicenter, cross-sectional study to evaluate prevalence of vascular
      risk factors in children with Down Syndrome and to determine the association between vascular
      disease risk factors and objective markers of early atherosclerosis.
    


Intervention name(s): Evaluate vascular disease risk factors in children with Down Syndrome; Determine the associations between cardiovascular disease risk factors and markers of early atherosclerosis in children with Down Syndrome
Intervention type(s): Other; Other
Intervention description(s): We will determine CV disease risk profiles in children with DS at our centers. We will compare these data to published national norms of children without DS. Risk factor data will include: anthropometric measures; blood pressure; history of congenital heart disease and associated surgery, sleep apnea, hypothyroidism, and cancer; fasting blood draw [lipid panel with subfractions (NMR), insulin, glucose, and CRP].; We will perform PWV, CIMT, and CD studies in children with DS and compare these data to available data in children without DS. We will also perform multivariable analysis of the influence of combinations of CV disease risk factors on markers of early atherosclerosis in children with DS. Hypothesis: CV disease risk factors will correlate with markers of early atherosclerosis in children with DS but the associations between risk factors and markers of early atherosclerosis will differ between children with DS vs. the general population of children.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        All children with DS (10.0-18.0 years of age) will be eligible, including those with
        translocations and mosaicism
      
Keywords: Down Syndrome; Cardiovascular Risk Factor; Atherosclerosis