bioihbjkbjnl/mcl2 huggingface dataset:
Modified Process Hepatitis B Vaccine in Japanese Young Adults (V232-062)
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a study to evaluate immunogenicity, safety, and tolerability of 2XP HEPTAVAX™-II
      compared with the 1XP HEPTAVAX™-II in healthy Japanese young adults.
    

Detailed description: 
      2XP HEPTAVAX™-II is manufactured using a modified process in which the composition of the
      amorphous aluminum hydroxyphosphate sulfate adjuvant has been modified by increasing the
      phosphate content by approximately 2-fold. Thus the modified process HEPTAVAX™-II is referred
      to as 2XP HEPTAVAX™-II.
    

Intervention name(s): 2XP HEPTAVAX™-II SC; 1XP HEPTAVAX™-II SC; 2XP HEPTAVAX™-II IM
Intervention type(s): Biological; Biological; Biological
Other intervention name(s): RECOMBIVAX HB; HBVAXPRO; RECOMBIVAX HB; HBVAXPRO
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Evaluate the Safety and Efficacy of a Steerable Catheter in the Treatment of Vascular Interventional Access
Condition: Peripheral Vascular Diseases
MeSH terms: Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
Study type: Interventional

Summary: 
      This is a prospective, multicenter, single-arm clinical trial to evaluate safety and efficacy
      of a steerable catheter in the establishment of vascular intervention access. five centers
      participate in this study. The total enrollment number is 68. In the procedure of vascular
      interventional surgery or angiography diagnosis, the steerable catheter are used to building
      vascular interventional access. Evaluate the safety and efficacy of the product, by the
      observation and record the relative index of subjects intraoperative and postoperative
      (discharge) before and after 30 days .
    

Detailed description: 
      This is a prospective, multicenter, single-arm clinical trial to evaluate safety and efficacy
      of a steerable catheter in the establishment of vascular intervention access. five centers
      participate in this study. The total enrollment number is 68. In the procedure of vascular
      interventional surgery or angiography diagnosis, the steerable catheter are used to building
      vascular interventional access. Evaluate the safety and efficacy of the product, by the
      observation and record the relative index(like catheter compliance, catheter directivity, and
      catheter visibility under X ray) of subjects in the procedure, telephone follow up at 30 days
      investigate the subjects healthy condition.
    

Intervention name(s): steerable catheter
Intervention type(s): Device
Intervention description(s): peripheral vascular disease
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Efficacy of Implantable Collamer Lens Versus Implantable Phakic Lens IPCL in Myopic Patients; A Comparative Study
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      Phakic intraocular lenses (pIOL) have proven to be a great alternative to corneal refractive
      surgery in certain situations. They offer several advantages over corneal techniques, such as
      being suitable for high myopes and causing relatively fewer higher-order aberrations. In
      addition, pIOLs have been shown to provide better retinal image magnification and higher
      contrast sensitivity compared to laser in situ keratomileusis, regardless of whether the
      myopia is low or high.
    


Intervention name(s): Implantable Collamer Lens (ICL); Implantable Intraocular Lens (IPCL)
Intervention type(s): Procedure; Procedure
Intervention description(s): Phakic intraocular lenses (pIOL) have proven to be a great alternative to corneal refractive surgery in certain situations. They offer several advantages over corneal techniques, such as being suitable for high myopes and causing relatively fewer higher-order aberrations; The IPCL offers a distinct economic advantage as the cost of the IPCL implant is only 2. times that of the ICL implant. Moreover, the IPCL can correct higher degrees of myopia, up to -30. D, compared to the maximum correction of -18. D provided by the ICL.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
ANAVEX2-73 Study in Pediatric Patients With Rett Syndrome
Condition: Rett Syndrome
MeSH terms: Rett Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      ANAVEX2-73-RS-003 is a Phase 2/3, double-blind, randomized, placebo-controlled dose
      escalation safety, tolerability and efficacy study in patients 5-17 years of age with RTT
      using endpoints including multiple clinical and exploratory molecular and biochemical
      measures.
    

Detailed description: 
      This Phase 2/3 efficacy study is designed as a double-blind, randomized, placebo-controlled
      study.

      This is a 12-week placebo-controlled study of ANAVEX2-73 oral solution for the treatment of
      patients with RTT 5-17 years of age. A voluntary option will be offered for all patients who
      meet the exposure criteria for ANAVEX2-73 to continue a 48-week open label extension.
    

Intervention name(s): ANAVEX2-73 oral liquid; Placebo oral liquid
Intervention type(s): Drug; Drug
Intervention description(s): Liquid oral solution; Liquid oral solution
Other intervention name(s): Blarcamesine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Preoperative Non-steroidal Anti-inflammatory Drugs(NSAID) to Colorectal Cancer Patients
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms
Study type: Interventional
Phase: Phase 4

Summary: 
      The study is designed to evaluate effects of NSAIDs on immune activity inside and close to
      tumor tissue in patients with colorectal cancer.
    

Detailed description: 
      Study and control patients are randomized to receive preoperative treatment with indomethacin
      or celecoxib compared to sham treatment.Tumor biopsies are taken at operation and used for
      analyses of tumor immunity and gene expression.
    

Intervention name(s): Indomethacin, celecoxib, esomeprazole
Intervention type(s): Drug
Intervention MeSH terms: Celecoxib; Indomethacin; Esomeprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: MHC; CTLs; Colon carcinoma; NSAID; Survival
Exploring the Group Visit Model for Pediatric ADHD Management in the Medical Home
Condition: ADHD
Study type: Interventional

Summary: 
      Attention deficit hyperactivity disorder (ADHD) affects 8% of US youth. Even though evidence
      shows medications are effective in reducing ADHD symptoms, many families experience ongoing
      parenting stress around parent-child interactions. Children often have ongoing impairments in
      functioning. ADHD is a common condition identified and managed by primary care pediatricians.
      However current care in the clinic is not optimal to address parents' and children's needs
      around ADHD chronic care. Time is the biggest barrier. Group visits are a viable option to
      improve pediatric ADHD care, but requires extensive study. The goal of this proposed study is
      to test the feasibility and effectiveness of the group visit model for ADHD management within
      pediatric primary care. This study will be a randomized feasibility study that will generate
      important pilot data, as well as result in an innovative, exportable pediatric ADHD group
      curriculum for primary care practice.
    

Detailed description: 
      The specific research aims of this proposal are:

      Aim 1: Develop and test a group curriculum for parents of children (age 6 to 18 years) with
      ADHD to increase parental knowledge about ADHD and self-confidence in managing issues related
      to their child's functioning in school and home.

      Aim 2: Develop and test a group curriculum for children (age 6 to 18 years) with ADHD to
      teach social and educational skills to improve adaptive functioning at home and school.

      Aim 3: To assess any added benefits to the parents, children and providers (related to group
      visit logistics and satisfaction) the group visit model has over usual care.

      Aim 4: To assess whether the group visit model can be done efficiently and effectively in the
      setting of an actual general pediatric practice.
    

Intervention name(s): ADHD Group Curriculum
Intervention type(s): Behavioral
Intervention description(s): Study specific ADHD Group curriculum was designed and implemented for the study. Parent curriculum included the following topics: What is ADHD, medications, educational advocacy, how to prevent behavioral issues and how to defuse common behavioral challenges and manage stress. Child curriculum included the following topics: what is ADHD, social skills and friendships, handling school and organization skills, understanding feelings and managing negative emotions
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: primary care; pediatrics; parenting; education
A Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Participants With Bipolar I Disorder.
Condition: Bipolar I Disorder; Acute Mania
MeSH terms: Mania
Study type: Interventional
Phase: Phase 3

Summary: 
      This study evaluated the safety and evaluate the safety and tolerability of open-label
      brexpiprazole (2 - 4 mg/day, with a starting dose of 2 mg/day) for the treatment of adult
      subjects with bipolar I disorder. All participants received a starting dose of brexpiprazole.
    

Detailed description: 
      While the availability of atypical antipsychotics had increased the therapeutic options
      available, there remains a need for safer and more effective therapies in the treatment of
      manic and depressive episodes of bipolar I disorder. Brexpiprazole's specific receptor
      activity profile likely correlates with its established efficacy in schizophrenia and major
      depressive disorder, and may prove to be an effective target for the treatment of acute mania
      of bipolar I disorder.
    

Intervention name(s): Brexpiprazole
Intervention type(s): Drug
Intervention description(s): Brexpiprazole tablets
Other intervention name(s): OPC-34712
Intervention MeSH terms: Brexpiprazole
Intervention model: Parallel Assignment
Intervention model description: Group composed of eligible rollover participants who completed one of the double-blind, phase 3 efficacy trials (331-201-00080 (NCT03259555) or 331-201-00081 (NCT03257865)).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bipolar; Mania; Brexpiprazole
Perfusion and Diffusion Mechanism of Intervertebral Disc-Significance With Age, Degeneration, Posture and Stress Loading.
Condition: Spinal Cord Injury, Degenerative Spinal Disease.
MeSH terms: Spinal Diseases; Spinal Cord Injuries
Study type: Interventional

Summary: 
      The purpose of our study is to evaluate the perfusion of the IVDs and their diffusion ability
      by using the Dynamic contrast-enhanced MR perfusion technique and Diffusion weighted image
      with ADC value measurement, and to determine the relationship between these data and the
      degeneration of IVDs, the different posture, and different stress-loading status.
    


Intervention name(s): imaging diagnostics
Intervention type(s): Procedure
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Diagnostic
Vitamin C Supplementation as a Preventive Treatment of Diabetic Peripheral Neuropathy
Condition: Diabetic Neuropathies
MeSH terms: Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this pilot study is to determine whether vitamin C supplementation is
      beneficial in treating and/or preventing diabetic peripheral neuropathy in people with type 2
      diabetes.
    

Detailed description: 
      Painful diabetic peripheral neuropathy (DPN), a condition characterized by pain affecting the
      feet, legs and hands that is often characterized as burning or a "pins and needles"
      sensation, is estimated to affect up to 66% of the U.S. diabetic population. This pilot study
      will examine the effect of a daily dose of ascorbic acid, a known aldose reductase inhibitor,
      versus placebo, and the effect that it can have on intracellular erythrocyte (red blood cell)
      sorbitol levels, aldose reductase activity and aldose reductase enzyme levels utilizing
      benchtop methods, and effects on clinical DPN-associated pain reporting and changes in
      quantitative sensory testing in the lower extremities via touch discrimination and vibratory
      sensory testing in patients with Type 2 Diabetes Mellitus (T2DM) over the course of 90 days
      of treatment.
    

Intervention name(s): Vitamin C; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1000mg Vitamin C capsules orally twice daily; 1000mg Placebo capsules orally twice daily for 90 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Vitamin C; Ascorbic Acid; Diabetic Neuropathies
Efficacy and Safety of Celecoxib as Add-on Therapy to Risperidone Versus Risperidone Alone in Patients With Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the efficacy and safety of celecoxib as add-on therapy to risperidone versus
      risperidone alone in patients with schizophrenia
    


Intervention name(s): Celecoxib; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 200 mg oral capsules twice daily as add-on therapy to risperidone twice daily (range 2-8 mg/day) for 11 weeks; Matched oral placebo as add-on to risperidone twice daily (range 2-8 mg/day) for 11 weeks
Intervention MeSH terms: Celecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Enhanced Recovery After Surgery Protocal Versus Traditional Care in Laparoscopic Hepatectomy
Condition: Liver Diseases
MeSH terms: Liver Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the clinical value of enhanced recovery after
      surgery protocal in laparoscopic hepatectomy by assessing its outcomes and hospital stay days
      comparing with traditional care .
    

Detailed description: 
      The ERAS programs has been proved to be a useful solutions in patients undergoing colorectal
      surgery in terms of significantly reduced postoperative complications and shorter length of
      hospital stay, compared to the patients of conventional treatment.

      But few studies reported about the ERAS programs in the laparoscopic hepatectomy.

      The purpose of this study is to investigate the clinical value of enhanced recovery after
      surgery protocal in laparoscopic hepatectomy by assessing its outcomes and hospital stay days
      comparing with traditional care .
    

Intervention name(s): ERAS perioperative cares; Conventional perioperative cares
Intervention type(s): Procedure; Procedure
Intervention description(s): Patient's preoperative counseling & education before surgery
No Bowel preparation
Drug: Oral Carbohydrate Solution (OCS). Take 250ml OCS orally 2 hours before surgery
Fluid restriction & Management by pulse contour analysis or transesophageal doppler
Early mobilization
Early oral feeding (postoperative 1 day - liquid diet, 2 days - semifluid diet (SFD), 3 days - normal diet)
Intravenous patient controlled analgesics (no opioids analgesics)
Postoperative Nausea Active Control
No nasogastric tube
No drain insertion
Patients will be discharged at POD#4 if there's no problem; No Patient's preoperative counseling & education before surgery
Bowel preparation
No Oral Carbohydrate Solution (OCS) loading until 2hours before surgery
Conventional Fluid Management by clinical signs (Urine output, heart rate etc.)
Conventional Mobilization
Conventional oral feeding (POD#2 SOW, #3 SFD, #4 SBD)
IV PCA
Postoperative Nausea Control if needed
No Thromboembolism prophylaxis
No or Low Content Oxygen therapy
Drainage tube insertion if needed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: enhanced recovery after surgery protocal; laparoscopic hepatectomy
Correlations of 3D Urethral and Paraurethral Sonographic Findings With Urodynamic Studies, Lower Urinary Tract Symptoms & Sexual Dysfunction in Female Patients With Lower Urinary Tract Symptoms.
Condition: Lower Urinary Tract Dysfunction; Overactive Bladder Syndrome
MeSH terms: Urinary Bladder, Overactive; Lower Urinary Tract Symptoms
Study type: Observational [Patient Registry]

Summary: 
      The main purpose of this study is to get the urethra and pelvic sonographic imaging by 4D
      ultrasound examinations, and to correlate the sonographic findings with urodynamic variables,
      pad weights and LUTS. Besides, the associations of the blood flow of vagina/urethra and
      sexual dysfunction can be explored.
    

Detailed description: 
      Female lower urinary tract dysfunction includes stress urinary incontinence, overactive
      bladder syndrome and voiding dysfunction. There are a lot of bladder studies, such as
      researches of bladder wall thickness and bladder volume. However, there were few studies of
      urethra for female patients with lower urinary tract symptoms (LUTS), especially for storage
      disorder. Thus, the main purpose of this study is to get the urethra and pelvic sonographic
      imaging by 4D ultrasound examinations, and to correlate the sonographic findings with
      urodynamic variables, pad weights and LUTS. The investigators hope to identify important LUTS
      sonographic biomarkers that can be used by primary physicians as a tool for assess female
      LUTS, and thus decreasing the need of further invasive urodynamic studies.

      Besides, the associations of the blood flow of vagina/urethra and sexual dysfunction
      (assessed by female sexual function index) can be explored.

      In addition, women who receive antimuscarinics treatment will receive follow-up 4D imaging
      and request to complete questionnaire 12 weeks later.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women with lower urinary tract symptoms
      
Keywords: lower urinary tract symptoms; overactive bladder syndrome; antimuscarinic drug; three-dimensional power Doppler ultrasound; sexual dysfunction
A Dose-escalation Study of AND017 in Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, randomized, double-blind, placebo-controlled, dose-escalation study in
      healthy subjects to evaluate safety, tolerability, PKs and PDs of AND017 following oral
      single and multiple dose administration.
    


Intervention name(s): AND017 single dose; AND017 multiple dose; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): AND017 administrated as oral single-dose on Day 1 in Part A; AND017 administrated once daily from Day 1 to Day 10 in Part B; Placebo administrated once on Day 1 in Part A or daily from Day 1 to Day 10 in Part B
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
CKD-506 Drug-Drug Interaction Study in Healthy Male Subjects
Condition: Drug Drug Interaction
Study type: Interventional
Phase: Phase 1

Summary: 
      This will be a Phase 1, open-label, 1-sequence crossover drug-drug-interaction study in 16
      healthy male subjects to assess the effect of single and multiple doses of CKD-506 on the
      single-dose PK of oral midazolam. Midazolam will be used as a cytochrome P450 (CYP)3A4
      substrate in this study.
    


Intervention name(s): Midazolam; CKD-506
Intervention type(s): Drug; Drug
Intervention description(s): Substrate of CYP3A4; Perpetrator of CYP3A4
Other intervention name(s): Single dose; Single and multiple dose
Intervention MeSH terms: Midazolam; CKD-506
Intervention model: Sequential Assignment
Intervention model description: One arm and 1-sequence crossover
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: CYP3A4; Midazolam
Pharmacokinetics and Safety Study of LBAL in Healthy Subjects
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare PK, safety and tolerability of LBAL developed by LG Life Sciences Ltd. With those
      of Humira®.
    


Intervention name(s): LBAL; Humira
Intervention type(s): Biological; Biological
Intervention description(s): Anti-inflammatory agents; Anti-inflammatory agents
Other intervention name(s): Adalimumab; Adalimumab
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Laser Versus Surgery in Anal Diseases in Inflammatory Bowel Patients
Condition: Inflammatory Bowel Diseases; Anal Fissure; Hemorrhoids
MeSH terms: Intestinal Diseases; Inflammatory Bowel Diseases; Hemorrhoids; Fissure in Ano
Study type: Interventional

Summary: 
      This is a randomized comparative clinical trial carried out to compare between laser ablation
      and surgery in treating anal diseases in inflammatory bowel diseases patients and find out if
      one is superior to the other.

      Inflammatory bowel diseases patients with anal problems were divided into 2 groups, one group
      had traditional surgery and the other had laser ablation for anal diseases and results were
      compared between the 2 groups.
    


Intervention name(s): treatment of anal diseases in inflammatory bowel patients; Laser; traditional surgery
Intervention type(s): Procedure; Device; Procedure
Intervention description(s): treatment of anal diseases in inflammatory bowel patients; laser; traditional surgery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: anal fissure; hemorrhoids; inflammatory bowel disease; crohn's disease; ulcerative colitis
A Phase I Pharmacokinetic Study of TVB-2640 (Denifanstat) in Subjects With Mild, Moderate, or Severe Hepatic Impairment Compared to Subjects With Normal Hepatic Function
Condition: Non-alcoholic Steatohepatitis; Hepatic Impairment; Cirrhosis
MeSH terms: Fatty Liver; Liver Diseases; Non-alcoholic Fatty Liver Disease; Fibrosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The goal of this phase 1 study is to assess the pharmacokinetics, safety and tolerability
      following multiple oral doses of TVB-2640 in subjects with mild, moderate, or severe hepatic
      impairment compared to healthy subjects with normal hepatic function.
    


Intervention name(s): TVB-2640 - 50 mg
Intervention type(s): Drug
Intervention description(s): TVB-2640 -50 mg administered orally once daily
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: NASH; Hepatic impairment; Cirrhosis