bioihbjkbjnl/mcl2 huggingface dataset:
Relative Bioavailability of MN-166 (Ibudilast) in Extended Release Tablet vs. Intermediate-release Capsule in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate the PK, relative bioavailability, safety, and tolerability of the
      extended release (ER) 50 mg MN-166 (ibudilast) tablet formulation as compared to the
      intermediate-release (IR) capsule formulation of MN-166 (ibudilast) and to examine the effect
      of food on the pharmacokinetics of the ER formulation.
    

Detailed description: 
      This is a Phase 1, open-label, single-center study in at least 12 healthy volunteers or
      participants.

      Participants (at least n=2/sequence) meeting study eligibility and providing informed consent
      will be randomized to one of six treatment sequences. The three treatments of each sequence
      will be administered in a crossover fashion, separated by one week apart. Thus, participation
      in the study is 3 weeks long per participant.

      During each single-dose treatment, participants will check in the study facility the night
      before dosing and remain at the facility until 32 hours after dosing. For example, the
      participant would arrive at the study facility at 8:00 PM Sunday night, receive a single dose
      at 8:00 AM Monday morning, and blood samples will be taken prior to dosing and 30 minutes, 1,
      2 4, 6, 8, 10, 12, 24, and 32 hours after dosing. After the 32-hour sample collection,
      participants may leave the study facility. Participants will return to the study facility for
      outpatient visits at each remaining PK sampling day (48, 72, and 96 hours after dosing) and
      after last treatment in each sequence. Participants will be discharged from the study after
      the last treatment.
    

Intervention name(s): MN-166
Intervention type(s): Drug
Intervention description(s): MN-166 (ibudilast) is an orally available small molecule drug currently being investigated for human treatment in multiple sclerosis, amyotrophic lateral sclerosis, glioblastoma, and alcohol and drug use disorders.
Other intervention name(s): ibudilast; Pinatos capsule
Intervention MeSH terms: Ibudilast
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: 12 healthy male and female participants (enrollment is 6 female and 6 male participants). Each enrolled/consented participant will be randomly assigned to 1 of 6 treatment sequences which consists of 3 treatments (ER fasted, ER fed, and IR fasted) in a crossover design, administered one week apart.
Masking: None (Open Label)
Primary purpose: Treatment
Smoking Cessation Aid for Young Smokers
Condition: Smoking Cessation
Study type: Interventional
Phase: Phase 1

Summary: 
      This study, sponsored jointly by the George Washington University School of Public Health and
      the NICHD, will compare the effectiveness of two self-help quit-smoking programs for young
      people.

      Smokers between 18 and 22 years of age who are interested in quitting smoking may be eligible
      for this 6-month study. Candidates must be enrolled in school at least part time.

      Participants are randomly assigned to one of two treatment groups. Both groups receive a
      brief counseling session and self-help guide, and one group also receives email counseling
      related to quitting smoking. All participants have three interviews-one in person at the
      beginning of the program, one over the phone after 2 months in the program, and one in person
      after 6 months, at the end of the program. The surveys cover the participant's intentions and
      behaviors related to smoking cessation and their opinions about the self-help materials. In
      addition, participants may be asked to provide saliva samples at the beginning and end of the
      program for verifying smoking status.
    

Detailed description: 
      While young smokers have a demonstrated interest in quitting and make frequent quit attempts,
      they often fail in their quit attempts. This group may benefit from aids which promote higher
      rates of success in their quit attempts. The lack of promising approaches for adolescent and
      young adult smoking cessation is a recognized problem.

      The goal of this study is to build on previous work in developing a smoking cessation kit for
      youth, which is based on the principles of social marketing and social cognitive theory. This
      study aims to test the acceptability and efficacy of the X-Pack intervention. It is our
      belief that with minimal assistance--in the form of the X-Pack product and supporting
      e-mails--the quit attempts that young people make can result in long-term abstinence.

      The design of this study is a two-arm randomized trial where participants are randomized to
      the X-Pack condition or to the control condition. Study participants consist of current
      smokers between the ages of 18-22 who are interested in quitting in the next 6 months. The
      first 292 participants who meet eligibility criteria will be enrolled in the study and
      randomized to one of two conditions. Participants in the intervention condition will receive
      the X-Pack, an in-person counseling session, and supporting e-mails. Participants in the
      control condition will receive the control materials, Clearing the Air, and an in-person
      counseling session. Participants will be measured at baseline, 2 and 6 months.
    

Intervention name(s): Smoking cessation
Intervention type(s): Behavioral
Primary purpose: Treatment
Keywords: Smoking Cessation; Young Adults; Quit Smoking; Email; Social Marketing
Prebiotics in Prevention of Atopy
Condition: Atopic Dermatitis
MeSH terms: Dermatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The study objective is to evaluate whether a specific prebiotic (GOS/PDX) may have an effect
      in preventing atopic dermatitis, food allergy, intestinal and/or respiratory infections in
      infants at risk of atopy. In infants with dermatitis, the hypothesis will be tested that
      prebiotics reduce the severity of the disease.
    

Detailed description: 
      This study is a prospective, double blind, randomised, 24 month study trial comparing formula
      with 50/50 mixture of GOS/PDX (Enfamil Premium Infant Formula 1 for children <6 months and
      Formula 2 for children ≥ 6 months) versus standard formula (Enfamil Premium Formula 1 and 2).

      Study population is composed by newborns at risk for allergy that will be identified at time
      of delivery. Infants will be eligible if at least one parent or one older sibling have a
      physician-diagnosed atopic disease (asthma, allergic rhinoconjunctivitis , atopic dermatitis,
      allergic urticaria, and food allergy as follow described. At time of enrolment (within the
      first 4 weeks of life) infants will be randomised 1:1 to receive once they will start formula
      feeding before the day of the 6th month birthday.
    

Intervention name(s): Supplemented Formula
Intervention type(s): Dietary Supplement
Intervention description(s): 50:50 mixture of GOS/PDX formula will be administered
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Safety, Reactogenicity and Immunogenicity Study of ReCOV
Condition: Covid19
MeSH terms: COVID-19
Study type: Interventional
Phase: Early Phase 1

Summary: 
      Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the pathogen that causes a
      coronavirus-associated acute respiratory disease called coronavirus disease 19 (COVID-19),
      which is spreading all over the world. This virus can cause acute respiratory distress
      syndrome (ARDS) with a high fatality rate.

      In this phase I first-in-human clinical trial, healthy volunteers in two different age
      cohorts and two dose cohorts will be vaccinated twice with the candidate vaccine ReCOV.

      The aim of the study is to assess the safety and reactogenicity of the candidate vaccine and
      to characterize its immunogenicity.
    

Detailed description: 
      A total of 100 participants will receive the following vaccine regime:

      First, 20 young adult participants (18 to 55 years old) will receive 20μg of ReCOV vaccine on
      days 0 and 21.

      Then, 20 young adult participants (18 to 55 years old) will receive 40μg of ReCOV vaccine on
      days 0 and 21, and 20 old adult participants (56 to 80 years old) will receive 20μg of ReCOV
      vaccine on days 0 and 21.

      Finally, 20 old adult participants (56 to 80 years old) will receive 40μg of ReCOV vaccine on
      days 0 and 21.

      In the same time, 8 participants for each cohort, total 32 participants will receive 0.5ml of
      normal saline on days 0 and 21.

      Safety and immunogenicity data will be collected throughout the study, which concludes at 12
      month after the second dose.
    

Intervention name(s): Recombinant two-component COVID-19 vaccine (CHO cell); Placebo
Intervention type(s): Biological; Other
Intervention description(s): The spike (S) protein is the main surface antigen of SARS-CoV-2, mediates entry of SARS CoV-2 into cells expressing the angiotensin-converting enzyme 2 (ACE2). The RBD interacts with ACE2 and can generate potent neutralizing anti-RBD antibodies.; Normal saline (0.9% sodium chloride solution),
Other intervention name(s): ReCOV; Normal saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Predictors Associated With Seeking Orthodontic Treatment, Compliance and Treatment Success
Condition: Malocclusion, Angle Class II
MeSH terms: Malocclusion; Malocclusion, Angle Class II; Overbite
Study type: Interventional

Summary: 
      Aim: to search for reasons for seeking orthodontic treatment, compliance during orthodontic
      treatment, drop-out from orthodontic treatment and success of orthodontic treatment.

      Methods: evaluation before, during and at the end of orthodontic treatment. Clinical and
      diagnostic evaluation of complexity before and at the end of orthodontic treatment,
      evaluation of awareness of treatment need, impact on social and psychological aspects,
      functional disturbances, impact of malocclusion on quality of life, social interaction,
      ability to perform daily activities.
    

Detailed description: 
      Data will include diagnostic measurements on study casts, x-rays, and data from
      questionnaires given to children and parents. Statistical analyses will explore predictors of
      treatment success with treatment need, compliance and psycho-social domains.
    

Intervention name(s): Twin Block; Sander bite jumping appliance
Intervention type(s): Device; Device
Intervention description(s): functional appliances for the stimulation of the mandibular growth; functional appliances for the stimulation of the mandibular growth
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: quality of life
Effects of 12 Weeks Walking on Cognitive Function in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      This study is a 12-week randomized-controlled clinical trial. It will be planned to conduct
      in a total of 120 male and female subjects from the Department of Psychiatry at Kaohsiung
      Chang Gung Memorial Hospital. Eligible subjects will be psychiatric patients, aged between
      20-65 years old, who have psychiatric diagnosis of schizophrenia and fulfill the inclusion
      and exclusion criteria. The intervention with aerobic walking programs will be initiated
      after randomization for patients who continue their usual treatment. Subjects will be
      enrolled for 12 weeks aerobic walking treatment and randomly assigned to (1)
      treatment-as-usual, (2) treatment-as-usual plus aerobic walking. We will measure the
      treatment response to clarify the effect of aerobic walking in patients with schizophrenia.
      This study is being performed to investigate the possibly beneficial effects of aerobic
      walking on cognitive function and energy metabolites in schizophrenia.
    

Detailed description: 
      This 12-week randomized-controlled clinical trial will be planned to conduct in a total of
      120 male and female subjects from the Department of Psychiatry at Kaohsiung Chang Gung
      Memorial Hospital. Eligible subjects will be psychiatric patients, aged between 20-65 years
      old, who have psychiatric diagnosis of schizophrenia and fulfill the inclusion and exclusion
      criteria. The intervention with aerobic walking programs will be initiated after
      randomization for patients who continue their usual treatment. Subjects will be enrolled for
      12 weeks aerobic walking treatment and randomly assigned to (1) treatment-as-usual, (2)
      treatment-as-usual plus aerobic walking. The wearable watch will be used during the
      participants join the walking programs. We will measure the treatment response to investigate
      the effect of aerobic walking in patients with schizophrenia. This study is being performed
      to investigate the possibly beneficial effects of aerobic walking on cognitive function in
      schizophrenia.
    

Intervention name(s): treatment-as-usual plus aerobic walking
Intervention type(s): Other
Intervention description(s): aerobic walking
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Different Obturation Techniques on Postoperative Pain
Condition: Pain, Postoperative; Pain; Endodontic Inflammation
MeSH terms: Pulpitis; Inflammation; Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluated the postoperative pain after the endodontic treatment by using three
      different obturation techniques. ( Cold lateral condensation (CLC), thermoplasticized
      solid-core carrier method (GuttaCore) and cold free-flow compation tecnique ( GuttaFlow2))
    


Intervention name(s): Root Canal Obturation Technique
Intervention type(s): Other
Intervention description(s): This study aims to compare the effects of three different obturation techniques(cold lateral condensation,thermoplasticized solid-core carrier method, cold free flow compaction technique) on postoperative pain following the endodontic therapy
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Single (Participant)
Masking: Single (Participant)
Primary purpose: Other
Keywords: cold lateral condensation; Postoperative Pain; GuttaCore; GuttaFlow 2; Obturation Techniques
Genetic Analysis for Predicting of Relapse During Steroid Treatment for Autoimmune Pancreatitis (AIP)
Condition: Pancreatitis
MeSH terms: Pancreatitis; Autoimmune Pancreatitis; Recurrence
Study type: Observational

Summary: 
      To determine whether certain alleles or haplotypes of major histocompatibility complex gene
      are associated with AIP in Korean population, we undertook this study with high-resolution
      typing for HLA (sequence-based typing).

      Primary outcomes: detection of novel allele associated with AIP in Korean population
      Secondary outcomes: detection of genetic factor for relapse of AIP during steroid treatment
    

Detailed description: 
      Autoimmune chronic pancreatitis (AIP) can be defined as a chronic inflammation of the
      pancreas due to an autoimmune mechanism; autoimmunity is responsible for producing the
      pancreatic lesion. AIP is a distinctive type of chronic pancreatitis that shows reversible
      improvement of pancreatic morphology and function with oral steroid therapy, in comparison to
      other types of chronic pancreatitis which hardly respond to various treatments. AIP is
      increasingly being recognized to be a worldwide entity. The sudden increment in cases
      reported probably reflects the growing awareness of the entity, rather than a rise in the
      true incidence. In previous Japanese report, HLA DRB1*0405-DQB*0401 haplotype may be
      associated with autoimmune pancreatitis in the Japanese population. However, to date there
      was no subsequent data for supporting these results. In addition, this Japanese study had a
      limitation in methodology by using a low-resolution typing for HLA. Although this entity is
      well responsive to steroid therapy, relapse of AIP during steroid treatment is not uncommon.
      Unfortunately, there has been no laboratory or genetic predictor for responsiveness to
      steroid therapy in patients with AIP. To further clarify and confirm high-risk and protective
      genotypes for autoimmune diseases, therefore, high-resolution typing for HLA should be
      needed. Thus, to determine whether certain alleles or haplotypes of major histocompatibility
      complex gene are associated with AIP in Korean population, we undertook this study with
      high-resolution typing for HLA (sequence-based typing).
    

Observational model: Case-Control
Time perspective: Prospective
Keywords: Autoimmune pancreatitis, HLA, relapse, Sequence-based typing
Coronary Artery Assessement by TEE in Congenital Heart Disease
Condition: Congenital Heart Disease
MeSH terms: Heart Diseases; Heart Defects, Congenital
Study type: Interventional

Summary: 
      This study aims to establish normal coronary artery pulse Doppler flow patterns and
      velocities using transoesophageal echocardiography (TEE) in patients with a variety of
      congenital heart disease. This will be accomplished by performing pre-operative and
      intra-operative TEEs on up to 250 patients undergoing surgery for congenital heart disease.
    

Detailed description: 
      Little is known about coronary artery flow patterns in children. Invasive and non invasive
      studies in normal children have demonstrated that coronary artery flow velocities decrease
      with age and therefore heart rate. 'Normal' flow velocities in the left coronary artery are
      usually accepted between 0.3-0.6m/sec depending on age of the patient. Less is known about
      coronary flow patterns and velocities in patients with congenital heart disease. In addition
      the effects of coronary artery bypass and altered loading conditions may affect coronary flow
      patterns and velocities and in theory alter short and long term outcomes. This study hopes to
      is to establish normal coronary artery pulse Doppler flow patterns and velocities using
      transoesophageal echocardiography (TEE) in patients with a variety of congenital heart
      disease.
    

Intervention name(s): Transesophageal echocardiogram (TEE)
Intervention type(s): Diagnostic Test
Intervention description(s): All patients enrolled in the study will undergo a pre-operative research TEE and an intra-operative clinical TEE.
Intervention model: Single Group Assignment
Intervention model description: The purpose of the study is to establish normal coronary artery pulse Doppler flow patterns and velocities using transoesophageal echocardiography (TEE) in patients with a variety of congenital heart disease
Masking: None (Open Label)
Primary purpose: Other
Keywords: Transesophageal echocardiography
Randomized Trial With Trastuzumab Versus Observation in Breast Cancer Patients
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Epithelial tumor cells can be detected in the bone marrow and/or the peripheral blood
      [disseminated and circulating tumor cells, (DTCs) and (CTCs) respectively] of otherwise
      metastases-free patients with early breast cancer. Several studies have shown that the
      presence of these cells is an independent factor associated with an increased incidence of
      early disease relapse and disease-related death. In almost 50% of the patients, adjuvant
      chemotherapy cannot eliminate these occult tumor cells and this is also associated with a
      higher probability of early relapse and death. In 60-70% of the patients, DTCs and/or CTCs
      express the HER2/c-neu molecule and one or two administrations of their monoclonal antibody
      trastuzumab (HERCEPTIN) could eliminate these cells for a period ranging from 3-12 months.
    

Detailed description: 
      This pilot trial will compare the efficacy of the anti-HER2/erb-B2 monoclonal antibody
      trastuzumab (HERCEPTIN) given after the completion of the standard adjuvant chemotherapy and
      radiotherapy versus observation in patients with stage I-III operable breast cancer who have
      detectable cytokeratin-19 (CK-19) mRNA-positive tumor cells in the bone marrow or the
      peripheral blood before and/or after the adjuvant treatment.
    

Intervention name(s): Trastuzumab
Intervention type(s): Drug
Intervention description(s): Trastuzumab,first administration at the dose of 8mg/Kg IV, subsequent administrations at the dose of 6mg/Kg IV,every 3 weeks for 6 cycles
Other intervention name(s): Herceptin
Intervention MeSH terms: Trastuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Occult tumor cells; Micrometastatic cells; Cytokeratin-19; Trastuzumab; Completion of Adjuvant Treatment
Plaque REgression With Cholesterol Absorption Inhibitor or Synthesis Inhibitor Evaluated by IntraVascular UltraSound
Condition: Hypercholesterolemia; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Hypercholesterolemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to evaluate the difference in the effect of coronary plaque
      regression (as measured by intravascular ultrasound [IVUS] imaging) between cholesterol
      absorption inhibitor and cholesterol synthesis inhibitor.
    


Intervention name(s): Combination therapy with Lipitor [Atorvastatin] and Zetia [Ezetimibe]; Lipitor (Atorvastatin) monotherapy
Intervention type(s): Drug; Drug
Intervention description(s): Zetia 10 mg/dl + Lipitor. The dosage of Lipitor will be titrated up to a maximum of 20 mg/day with a treatment goal of lowering LDL-C below 70 mg/dl.; The dosage will be titrated up to a maximum of 20 mg/day, which is the highest approved regimen by the Ministry of Health, Labor and Welfare of Japan, with a treatment goal of lowering LDL-C below 70 mg/dl.
Intervention MeSH terms: Atorvastatin; Ezetimibe
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heart Diseases; Hyperlipidemia; Atorvastatin; Ezetimibe; Cardiovascular Diseases; Hypercholesterolemia; Coronary Artery Disease; Dyslipidemias; Intravascular Ultrasound