bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic Study of AG200-15 Transdermal Patch to Three Anatomical Sites in Healthy Females
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pharmacokinetics and safety study over 3 weekly applications.
    

Detailed description: 
      Pharmacokinetic study to evaluate the safety and pharmacokinetic profile of AG200-15
      following application at three different anatomical sites (abdomen, buttock and upper torso).
    

Intervention name(s): AG200-15
Intervention type(s): Drug
Intervention description(s): A transdermal contraceptive delivery system for levonorgestrel (LNG) and ethinyl estradiol (EE). . A total of 3 patches will be worn during the study. Each patch will be worn for 1 week followed by a patch free week.
Other intervention name(s): Transdermal contraceptive delivery system
Intervention MeSH terms: Contraceptive Agents
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PK and safety; Pharmacokinetic profile (PK) and safety
Acute Effects of Vinyasa Yoga on Vascular Function
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The purpose of this investigation was to determine the acute effects of vinyasa yoga on
      arterial stiffness, wave reflection, and blood markers in normo- and hyper-tensive adults. To
      address this aim, fifteen normotensive adults and 15 adults with elevated blood pressure or
      stage 1 hypertension with a minimum of 3 months of yoga practice experience were enrolled.
      Carotid-femoral pulse wave velocity (cf-PWV), augmentation index (AIx), lipid profile, and
      glucose concentrations were assessed at baseline and immediately following a 1-hour vinyasa
      yoga session.
    


Intervention name(s): Yoga session
Intervention type(s): Behavioral
Intervention description(s): a 1-hour yoga session was completed by all participants following a DVD.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Effects of Weekly Dosing of D-cycloserine on Cognitive Function in Individuals With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The study aims to assess the effects of single dose and repeated weekly dosing of 50mg
      d-cycloserine versus placebo on cognitive and memory functioning in schizophrenia patients.
      The study will also examine the effects of 50mg d-cycloserine on positive symptoms and
      negative symptoms, as well as assess tolerability and side-effects.
    

Detailed description: 
      This is a ten-week, parallel-group, placebo-controlled trial examining the cognitive effects
      at weeks 1, 2, 3. 4, 5, 6, 7, 8 & 10 of once-weekly oral D-cycloserine 50 mg added to a
      stable dose of antipsychotic for 8 weeks in 60 adult outpatients with schizophrenia.

      Specific aims:

        1. Assess the effects of a single dose of D-cycloserine 50 mg on cognitive functioning
           compared to placebo.

        2. Assess the effects of repeated weekly dosing of D-cycloserine on cognitive functioning
           at week 8 compared to placebo.

        3. Assess the effects of repeated weekly dosing of D-cycloserine on memory functioning once
           a week 1 hour after medication administration compared to placebo.

        4. Assess the persistence of learned information in a no-treatment follow-up assessment at
           Week 10 in the D-cycloserine group compared to the placebo group.

        5. Assess effects of weekly D-cycloserine dosing on positive & negative symptoms at week 8
           compared to placebo.

        6. Assess tolerability and side effects of weekly D-cycloserine compared to placebo.

        7. Assess the effects of d-cycloserine dosed weekly for seven weeks on reward
           responsiveness as measured with the response bias task compared with placebo.

        8. Assess the effects of d-cycloserine dosed weekly for seven weeks on measures of
           functioning.
    

Intervention name(s): d-cycloserine
Intervention type(s): Drug
Intervention description(s): 50mg dose d-cycloserine v placebo
Intervention MeSH terms: Cycloserine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: schizophrenia; cognition; d-cycloserine; memory
Quality of Life in Adult Neurological Patients
Condition: Spinal Cord Injury; Acquired Brain Injury; Poliomyelitis
MeSH terms: Poliomyelitis; Brain Injuries; Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional

Summary: 
      The purposes of this study were to evaluate the influence of an interdisciplinary
      rehabilitation program in the improvement of the health-related quality of life among adult
      neurological patients and to identify the sociodemographic and clinical associated
      characteristics. Subjects with spinal cord injury, acquired brain injury and poliomyelitis
      survivors participated in the study. All participants underwent a rehabilitation program (RP)
      from January 2008 through July 2010, which consists of 40-minutes of many therapies for 1-2
      days a week. The WHOQOL-BREF was applied at the initial and discharge assessments.
    


Intervention name(s): Physical therapy, occupational therapy, psycotherapy, medical consultations
Intervention type(s): Other
Intervention description(s): The mean duration of the RP was 7.47 ± 4.45 months, but it was not standardized because this factor was not one of the parameters of interest for this study
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acquired brain injury; health-related quality of life; poliomyelitis survivor; rehabilitation; spinal cord injury; completed the WHOQOL-BREF
A Phase I Study to Evaluate the Immunologic Response and Virologic Impact of AGS-004
Condition: HIV
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to:

        -  find out the intensity and duration of the immune response after multiple injections of
           the investigational study product AGS-004 made from one's own dendritic cells and one's
           own strain of HIV;

        -  understand the changes in the body's HIV DNA , and HIV-1 RNA in peripheral and resting
           CD4+ cells prior to and following administration of AGS- 004.

        -  find out if low levels of HIV virus that are not detectable by standard HIV RNA assays
           will decrease following the administration of AGS-004.

        -  find out if it is safe to give individuals with HIV multiple injections of AGS-004 made
           from the person's own dendritic cells and their own strain of HIV.

        -  find out if administration of AGS-004 decreases the amount of latent HIV infection in
           resting CD4 cells
    

Detailed description: 
      This is a phase I, single-site, pilot study of the kinetics of the immunological response and
      virological impact of AGS-004 administered in participants with durable viral suppression on
      ART initiated during acute (AHI) and chronic HIV infection (CHI). Patients will be screened
      for eligibility in Step 1. Those meeting study eligibility and with successful production of
      Argos (AGS)-004 product will then enter Step 2 with administration of AGS-004. All
      participants will continue ART throughout the study.
    

Intervention name(s): AGS-004
Intervention type(s): Biological
Intervention description(s): All participants in both arms will receive the same treatment and doses of AGS-004 in Step 2 at weeks 0, 4, 8, and 12.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; Acute HIV Infection; Chronic HIV Infection; AGS-004; Phase 1; Antiretroviral Therapy; ART; UNC; Argos Therapeutics; The CARE Collaboratory of AIDS; Immunization; vaccination
A Phase II Trial of Adjuvant Radiotherapy Combined With Chemotherapy for Patients With High-risk Endometrial Cancer
Condition: Prosthesis Survival
MeSH terms: Endometrial Neoplasms; Prosthesis Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase II clinical trial was designed to assess the feasibility, safety, toxicity,
      recurrence and survival pattern when TP or CAP chemotherapy was combined with adjuvant
      radiation for patients with high-risk endometrial cancer.
    


Intervention name(s): radiotherapy; Cisplatin; Cisplatin and Doxorubicin and Cyclophosphamide; Paclitaxel and Carboplatin
Intervention type(s): Radiation; Drug; Drug; Drug
Intervention description(s): Pelvic radiation to 45 Gy, 1.8 Gy per day, five days per week (25 fractions) or intensive modulated pelvic radiotherapy, with brachytherapy boost to the vagina if total abdominal hysterectomy and bilateral salpingo-oophorectomy was done in surgery, or with paraaortic radiation if paraaortic lymphnode metastases were found after surgery.; Two courses cisplatin (50mg/m2) given on days 1 and 28 during radiotherapy.; Four courses of cisplatin (50mg/m2) and doxorubicin (60mg/m2) and cyclophosphamide (600mg/m2) chemotherapy given at 3 week intervals following completion of radiotherapy.; Or four courses of Paclitaxel(135mg/m2) and carboplatin (AUC=5) given at 3 week intervals following completion of radiotherapy.
Intervention MeSH terms: Paclitaxel; Cyclophosphamide; Cisplatin; Carboplatin; Doxorubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: disease free survival, overall survival
Efficacy and Safety of Osimertinib for HK Chinese With Metastatic T790M Mutated NSCLC-real World Setting.
Condition: Non-small Cell Lung Cancer
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Observational

Summary: 
      To assess the efficacy of single-agent osimertinib in relation to EGFR T790M mutant allele
      fraction (AF) in a real-world setting.
    

Detailed description: 
      This study will assess the efficacy and safety of single-agent osimertinib in patients with
      locally advanced or metastatic EGFR T790M-positive NSCLC within the context of the early
      access program in Hong Kong. In particular, osimertinib treatment efficacy will be assessed
      in the context of the relationship between EGFR T790M mutant AF and survival outcomes,
      particularly overall survival. In a real-world setting, analysis of overall survival benefit
      is considered less sensitive to differences in healthcare systems and standards. Other
      clinical outcomes including response rate (based on physician's judgement) and time to
      treatment discontinuation (TTD) will be examined. This study will also describe current
      practice for molecular testing and EGFR mutation profiles in this patient population.
    

Intervention name(s): Osimertinib
Intervention type(s): Drug
Intervention description(s): 80mg oral daily
Intervention MeSH terms: Osimertinib
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Locally advanced or metastatic T790M mutation-positive NSCLC patients progressed or
        discontinued from previous EGFR TKI treatment.
A Study To Observe Safety And Blood Concentrations Of PF-06649751 During And Following The Oral Administration Of Multiple Doses Of PF-06649751 In Healthy Adult Western and Japanese Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to evaluate the safety and plasma concentrations of PF-06649751 in
      healthy volunteers following one or two times daily oral dosing of PF-06649751 for 14 days
      (Cohorts 1 - 4), 21 days (Cohort 5), or 28 days (Cohorts 6 - 8). Cohort 9 will dose Japanese
      healthy volunteers in a manner identical to Cohort 4 and is intended to bridge the
      safety/tolerability and PK data from the Western and Japanese populations.
    


Intervention name(s): 0.15 mg PF-06649751; 0.5 mg PF-06649751; 0.5 mg PF-06649751; 1.5 mg PF-06649751; 1.5 mg PF-06649751 21 Days; 3.0 mg PF-06649751; 5.0 mg PF-06649751; 8.0 mg PF-06649751; 1.5 mg PF-06649751 in healthy Japanese subjects
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral dosing of 0.15 mg PF-06649751 extemporaneously-prepared solution given once-daily for 14 days.; Oral dosing of 0.5 mg PF-06649751 extemporaneously-prepared solution given once-daily for 14 days.; Oral dosing of tablets up to 0.5 mg PF-06649751 given once-daily for 14 days.; Oral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 14 days.; Oral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 21 days.; Oral dosing of tablets up to 3.0 mg PF-06649751 given once-daily for 28 days.; Oral dosing of tablets up to 5.0 mg PF-06649751 given once-daily for 28 days.; Oral dosing of tablets up to 8.0 mg PF-06649751 given once-daily for 28 days.; Oral dosing of tablets up to 1.5 mg PF-06649751 given once-daily for 14 days given in healthy Japanese subjects.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: pharmacokinetics; safety; tolerability; healthy volunteers; steady state; multiple doses; Japanese subjects
The Effect of Pre-emptive Analgesia on the Postoperative Pain in Children Undergoing Pediatric Stomatology Day Surgeries
Condition: Ankyloglossia; Oral Mucoceles; Supernumerary Teeth
MeSH terms: Mucocele; Ankyloglossia; Tooth, Supernumerary; Pain, Postoperative
Study type: Interventional

Summary: 
      The aim of this double-blinded, randomized, controlled trial was to test whether pre-emptive
      analgesia with ibuprofen suppository is effective for children undergoing pediatric
      stomatology day surgeries in the postoperative period.
    

Detailed description: 
      The recruited patients were randomly assigned into either the pre-emptive analgesia group or
      the control group. After the induction of anesthesia was performed, the nurse delivered the
      ibuprofen suppository at the dose of 5-10 mg/Kg for children of the pre-emptive analgesia
      group, and no measures were taken for the control group. All procedures of frenectomy,
      extraction of supernumerary teeth and excision of oral mucoceles were performed by a single
      surgeon. Postoperative pain was assessed using the Visual Analogue Scale (VAS), the
      Wong-Baker Faces Pain Rating Scale (WBS), and the Face, Leges, Activity, Cry, and
      Consolability (FLACC) scale, and Postoperative Parental Pain Assessment (PPPM) scale. The
      postoperative pain was measured 1, 4, and 24 hours after the surgery.
    

Intervention name(s): ibuprofen suppository
Intervention type(s): Drug
Intervention description(s): After the induction of anesthesia was performed, the nurse delivered the ibuprofen suppository at the dose of 5-10 mg/Kg for the pre-emptive analgesia group children.
Other intervention name(s): no medicine
Intervention MeSH terms: Ibuprofen
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The patients were randomly assigned into either the pre-emptive analgesia group or the control group
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: pre-emptive analgesia; pediatric stomatology day surgeries; postoperative pain
Immunogenicity And Safety of COVID-19 Vaccine , Inactivated Co -Administration With EV71 Vaccine (Vero Cell)
Condition: COVID-19
MeSH terms: COVID-19
Study type: Interventional
Phase: Phase 4

Summary: 
      This study is a randomized and controlled phase Ⅳ clinical trial of the COVID-19 vaccine
      (Vero cell), Inactivated manufactured by Sinovac Research & Development Co., Ltd. The purpose
      of this study is to evaluate the immunogenicity and safety of COVID-19 vaccine (Vero cell),
      Inactivated co-administration with EV71 vaccine
    

Detailed description: 
      This study is a randomized and controlled phase Ⅳ clinical trial in children aged 3-5 years
      old. The purpose of this study is to evaluate the immunogenicity and safety of COVID-19
      vaccine (Vero cell), Inactivated co-administration with EV71 vaccine.The COVID-19 vaccine was
      manufactured by Sinovac Research & Development Co., Ltd, and the EV71 vaccine was
      manufactured by Sinovac Biotech Co.A total of 520 subjects aged 3-5 years old will be
      enrolled.Subjects will be randomly divided into 2 groups in a ratio of 1:1.The experimental
      group is the combined immunization group, which will receive the first dose of COVID-19
      vaccine and the second dose of COVID-19 vaccine and EV71 vaccine on day 28;Control group is
      the Non-combined immunization group , which will receive the first dose of COVID-19 vaccine
      on day 0 ，the first dose of EV71 vaccine on day 14 ，the second dose of COVID-19 vaccine on
      day 28 and the second dose of EV71 vaccine on day 42.
    

Intervention name(s): Experimental Group; Control Group
Intervention type(s): Biological; Biological
Intervention description(s): The COVID-19 vaccine was manufactured by Sinovac Research & Development Co., Ltd, and the EV71 vaccine was manufactured by Sinovac Biotech Co. The COVID-19 vaccine:600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection;The EV71 vaccine:Inactivated EV71 virus antigen no less than 3.0EU in 0.5 mL of aluminium hydroxide solution per injection.; The COVID-19 vaccine was manufactured by Sinovac Research & Development Co., Ltd, and the EV71 vaccine was manufactured by Sinovac Biotech Co. The COVID-19 vaccine:600SU inactivated virus in 0.5 mL of aluminium hydroxide solution per injection;The EV71 vaccine:Inactivated EV71 virus antigen no less than 3.0EU in 0.5 mL of aluminium hydroxide solution per injection.
Other intervention name(s): Combined immunization group; Non-combined immunization group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
A Study of CCX168 in Japanese and Caucasian Healthy Adult Males
Condition: Anti-neutrophil Cytoplasmic Antibody-associated Vasculitis
MeSH terms: Vasculitis; Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The objectives of the study will be to investigate the safety and pharmacokinetics of a
      single oral administration and a twice-daily multiple oral administration of CCX168 in
      Japanese healthy adult males; and to compare the pharmacokinetics of a single oral
      administration and a twice-daily multiple oral administration of CCX168 between Japanese and
      Caucasian healthy adult males.
    


Intervention name(s): CCX168; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Administered orally.; Administered orally.
Other intervention name(s): Avacopan
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Human C5a receptor (C5aR); Vasculitis; Complement; Vascular disease
Comparison of Radiation Therapy Regimens in Treating Patients With Localized Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. It is not yet
      known which regimen of radiation therapy is more effective for prostate cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of different regimens of
      radiation therapy in treating patients who have localized prostate cancer.
    

Detailed description: 
      OBJECTIVES: I. Compare the 5-year survival rate, in terms of clinical and biological
      remission, in patients with localized prostate cancer treated with two different radiotherapy
      regimens using different doses and number of fractions. II. Compare the nadir of PSA and the
      delay in obtaining the nadir in patients treated with these two regimens. III. Compare acute
      and long-term toxicity of these two regimens in these patients. IV. Compare overall survival
      and quality of life in patients treated with these two regimens.

      OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
      participating center. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients
      receive radiotherapy to the seminal vesicles at 46 Gy in 23 fractions and to the prostate at
      70 Gy in 35 fractions, with 5 fractions per week. Arm II: Patients receive radiotherapy to
      the seminal vesicles as in arm I and to the prostate at 80 Gy in 40 fractions, with 5
      fractions per week. Treatment continues in both arms in the absence of disease progression or
      unacceptable toxicity. Quality of life is assessed annually. Patients are followed every 4
      months for a minimum of 5 years.

      PROJECTED ACCRUAL: A total of 306 patients (153 per arm) will be accrued for this study
      within 2.5 years.
    

Intervention name(s): radiation therapy
Intervention type(s): Radiation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer
Annex™ Adjacent Level System for Treatment of Adjacent Level Disease
Condition: Degenerative Disc Disease; Adjacent Level Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the clinical, radiological, and surgical outcomes of
      the Annex™ Adjacent Level System for the treatment of adjacent level disease of the lumbar
      spine. The Annex™ Adjacent Level System is a spinal fixation system intended to be used with
      commercially available pedicle screw fixation systems in order to extend existing pedicle
      screw constructs. Subjects will be evaluated over a 2 year period and compared to historical
      control.
    


Intervention name(s): Annex™ Adjacent Level System
Intervention type(s): Device
Observational model: Cohort
Time perspective: Other
Sampling method: Non-Probability Sample
Study population: 
        The subject population for both the treatment and control groups will include adult
        (skeletally mature) men and women who were previously implanted with rigid posterior
        fixation (pedicle screw/rod constructs) in the thoracolumbar spine and who later developed
        adjacent level disease (ALD) at a lumbar level.
Drug-Drug Interaction Study of "CG-651" in Healthy Volunteer
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This is randomized , open-label, multiple-dose, parallel study to compare the
      pharmacokinetics and to evaluate Drug-Drug Interaction of "CG-651" in healthy volunteers.
    

Detailed description: 
      Total of 39 health volunteers will be randomized to receive either of Group A,B or C. (13
      subjects each)

      [Group A] Pregabalin+ Polmacoxib. [Group B] Polmacoxib [Group C] Pregabalin
    

Intervention name(s): Polmacoxib; Pregabalin
Intervention type(s): Drug; Drug
Intervention description(s): Polmacoxib; Pregabalin
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Group A: Pregabalin + Polmacoxib
Group B: Polmacoxib
Group C: Pregabalin
Masking: None (Open Label)
Primary purpose: Treatment