bioihbjkbjnl/mcl2 huggingface dataset:
PH94B in the Treatment of Adjustment Disorder With Anxiety
Condition: Adjustment Disorder With Anxious Mood
MeSH terms: Adjustment Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      This placebo-controlled clinical study is designed to evaluate the efficacy, safety and
      tolerability of administration of PH94B nasal spray four times per day as a treatment of
      Adjustment Disorder with Anxiety symptoms in adults. Subject participation in the Study will
      last a total of 6 to 10 weeks, depending on the duration of the screening period and whether
      they need a washout of concomitant anxiolytics. Upon signing an investigation review board
      approved informed consent, all subjects will complete Visit 1 (Screening) and enter a
      screening period lasting 7 to 35 days that could include taper of concomitant anxiolytics, if
      necessary. Screening visit will consist of safety assessments (medical history, physical
      examination, laboratory samples, electrocardiogram, urine drug screen, and urine pregnancy
      test [if appropriate]) and psychiatric assessments to determine eligibility. Subjects will
      then return to complete Visit 2 (Baseline). If the subject continues to meet inclusion and
      exclusion criteria, the subject will be randomized 1:1 to PH94B or placebo. Subjects will
      then commence 4 weeks of double-blind treatment with randomized investigational product
      (PH94B or placebo) four times per day.

      Subjects will return for weekly site visits (Visits 3, 4, 5, and 6), in which the subject
      will return the vial dispensed at the previous visit and receive a new vial, except at Visit
      6 in which no new vial will be dispensed. Changes in AEs and concomitant medications will be
      collected. During these visits, psychiatric scales will be completed. When the subject
      returns for Visit 6, besides the assessments completed at Visits 3 through 5, the subjects
      will complete a brief physical examination, electrocardiogram, laboratory tests (chemistry
      and blood), and urinalysis. Any remaining IP vials will be collected. The subject will then
      come back after a one week washout period for Follow-up visit (Visit 7).
    


Intervention name(s): PH94B; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intranasal administration of 100 microliters to each nostril 4 times a day; Intranasal administration of 100 microliters to each nostril 4 times a day.
Other intervention name(s): Aloradine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of Pharmacokinetics and Safety of HS627(2 Specifications) Versus PERJETA With a Single Injection
Condition: Similarity of Pharmacokinetics and Safety
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the bioequivalence of HS627(2 specifications) with PERJETA in a single
      intravenous administration in healthy subjects
    

Detailed description: 
      This is a randomized, double-blind, parallel controlled，single-dose phase I study to compare
      the pharmacokinetics and safety of HS627 (2 specifications) with PERJETA in Chinese healthy
      male adults
    

Intervention name(s): HS627(210mg/7ml); HS627(420mg/14ml); Perjeta
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Intravenous drip of 420mg HS627; Intravenous drip of 420mg HS627; Intravenous drip of 420mg PERJETA
Intervention MeSH terms: Pertuzumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
STOPPER CHINA:With Tandem Microspheres in the Treatment of Localized Hepatocellular Carcinoma
Condition: Localized Hepatocellular Carcinoma
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional

Summary: 
      A Single-arm Trial of Transcatheter Arterial Chemoembolization with Tandem Microspheres in
      the Treatment of Localized Hepatocellular Carcinoma
    

Detailed description: 
      It is a prospective, single-arm, multicenter study. The primary effectiveness endpoint for
      this clinical trial is 6-month overall objective tumor response (ORR).
    

Intervention name(s): Tandem Microsphere loaded with Epirubicin
Intervention type(s): Device
Intervention description(s): The primary objective of this study is to evaluate the safety and efficacy of transcatheter arterial chemoembolization with Tandem Microspheres loaded with Epirubicin in the treatment of patients with localized hepatocellular carcinoma (HCC)
Intervention MeSH terms: Epirubicin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety Study of Elvucitabine in HIV-1 Subjects
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this 28 day study is to assess the viral kinetics and safety of elvucitabine.
    

Detailed description: 
      This is a 14 day on treat/14 day off treatment randomized, double blind viral kinetic study
      of elvucitabine versus lamivudine administered once daily to HIV infected subjects with a
      documented M184V variant.
    

Intervention name(s): elvucitabine
Intervention type(s): Drug
Intervention MeSH terms: Dexelvucitabine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: HIV-1; Treatment Experienced
Safety and Efficacy of Pembrolizumab (MK-3475) in Combination With TS-1+Cisplatin or TS-1+Oxaliplatin as First Line Chemotherapy in Gastric Cancer (MK-3475-659/KEYNOTE-659)
Condition: Gastric Cancer
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to estimate objective response rates (ORRs) of pembrolizumab +
      oxaliplatin + TS-1 and pembrolizumab + cisplatin + TS-1, as first-line treatment for gastric
      cancer in programmed death-ligand 1 (PD-L1) positive, human epidermal growth factor receptor
      2 (HER2/neu)-negative participants with advanced gastric or gastroesophageal junction (GEJ)
      adenocarcinoma.
    

Detailed description: 
      Approximately 45 participants will be assigned to pembrolizumab + oxaliplatin + TS-1
      combination therapy (Cohort 1) first, and then 45 participants will be assigned to
      pembrolizumab + cisplatin + TS-1 combination therapy (Cohort 2).
    

Intervention name(s): Pembrolizumab; Oxaliplatin; TS-1; Cisplatin
Intervention type(s): Biological; Drug; Drug; Drug
Intervention description(s): 200 mg Q3W on Day 1 by IV infusion; 130 mg/m^2 Q3W on Day 1 by IV infusion; 40 to 60 mg orally according to Body Surface Area (BSA) BID Q3W on Days 1-14; 60 mg/m^2 Q3W on Day 1 by IV infusion
Other intervention name(s): MK-3475
Intervention MeSH terms: Pembrolizumab; Oxaliplatin
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Peer-led Social Media Intervention to Prevent HIV Among Young Men Who Have Sex With Men (YMSM)
Condition: Pre-Exposure Prophylaxis; Hiv; Men
Study type: Interventional

Summary: 
      The aim of this study is to examine the effect of social media intervention on the use of
      pre-exposure prophylaxis (PrEP) by young men who have sex with men (YMSM) in the greater New
      Haven area.
    

Detailed description: 
      There are three specific aims of this study. In the first specific aim, two focus group
      discussions (FGDs) of YMSM will be conducted to assess the feasibility and acceptability of
      social media intervention. In the second specific aim of the study, a quasi-pre-post
      experimental study will be conducted to examine the effect of social media intervention on
      PrEP uptake (primary outcome) and PrEP use intention, HIV testing, PrEP knowledge,
      self-efficacy and social support (secondary outcome). In the third specific aim of the study,
      the most important topics around PrEP will be assessed on the Facebook page of the
      intervention group by conducting a content analysis.
    

Intervention name(s): PrEP messages; Heath messages
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The peer leaders and the study staff will post PrEP related health messages; The peer leaders and study staff will post general health messages that are not related to sexual health
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: pre-exposure prophylaxis (PrEP); social media intervention
The Long Term Outcomes of Micronutrient Antioxidant Supplementation in Patients With Chronic Pancreatitis
Condition: Chronic Pancreatitis
MeSH terms: Pancreatitis; Pancreatitis, Chronic
Study type: Observational

Summary: 
      This is a anonymised case note study looking at the long term outcomes of patients with
      Chronic Pancreatitis on micro nutrient antioxidant treatment.
    

Detailed description: 
      Chronic pancreatitis is the medical term for chronic inflammation of the pancreas. This
      illness is associated with long-term abdominal pain. In the 1980s it was proposed that
      chronic pancreatitis was due to a deficiency of protective "antioxidants" in the pancreas and
      on this basis antioxidant therapy was introduced. This therapy was highly controversial until
      a large randomised trial of antioxidant therapy in chronic pancreatitis, undertaken in
      Manchester showed that 6 months intervention with antioxidant therapy was not associated with
      any change in pain score or improvement in quality of life. Antioxidant therapy is no longer
      used in modern day pancreatic practice.

      However, as with any study, the randomised trial raised some specific questions.

      First, does treatment for more than 6 months provide benefit? Second, are there disease
      sub-types of chronic pancreatitis where antioxidant therapy may benefit?

      Given the lack of contemporary use of antioxidant therapy, this question cannot be answered
      in a prospective study. However, the case records of the Manchester Royal Infirmary contain
      information on antioxidant treatment in patients who received this therapy over a prolonged
      period.

      Thus the aim of the present study is to review the case notes of patients given a discharge
      code from the Manchester Royal Infirmary of chronic pancreatitis during the period 1st
      January 1990 to 1st January 1998 in order to assess whether there is a record of improvement
      in outcome. Only the case notes will be reviewed and patients will be given an opportunity to
      opt out.

      The study accepts the limitations of assessing pain from clinical notes but also notes that
      more objective findings such as development of diabetes mellitus (a long term complication of
      chronic pancreatitis) can be assessed from the notes.
    

Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients diagnosed with Chronic Pancreatitis using the Zurich workshop criteria
A STUDY TO COMPARE THE PHARMACOKINETICS OF PF-06835919 IN PARTICIPANTS WITH AND WITHOUT HEPATIC IMPAIRMENT
Condition: Hepatic Impairment; Healthy Participants
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is proposed to characterize the effect of varying degrees of hepatic impairment on
      the plasma PK of PF-06835919
    


Intervention name(s): PF-06835919 25 mg
Intervention type(s): Drug
Intervention description(s): PF-06835919 in 25 mg oral tablet will be administered on Day 1
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Non-alcoholic Fatty Liver Disease; Non-alcoholic steatohepatitis
Rehabilitation Trajectories
Condition: Musculoskeletal Disease
MeSH terms: Musculoskeletal Diseases
Study type: Observational

Summary: 
      The main aim of this multicentre cohort study is to provide evidence that can be used to
      improve continuity and quality in rehabilitation practice and rehabilitation processes across
      health care levels for patients with rheumatic and musculoskeletal diseases (RMDs).
    

Detailed description: 
      There is an urgent need to develop rehabilitation trajectories that ensure coordination and
      communication between health care levels, support of self-management and self-monitoring, and
      follow-up tailored to patients' needs. Such trajectories should be based on evidence from
      current practice. The "Rehabilitation trajectories" project will systematically explore and
      describe current practice of planned and implemented follow-up and self-management strategies
      in primary health care during the first year after rehabilitation for patients with
      musculoskeletal diseases. Further, a newly developed core set of PROMs designed for
      evaluation of rehabilitation in RMDs and a self-monitoring web-based system will be tested
      for feasibility. Knowledge of patients' experiences and use of this self-monitoring system as
      a self-management and communication tool is needed in order to improve and integrate such
      e-technology in future care.

      The Rehabilitation Trajectory study is a multi-centre study, led by the National Unit on
      Rehabilitation in Rheumatology and including participants at four rheumatology hospital
      departments and five specialized rehabilitation institutions. Participants will thus be
      included from all four health regions in Norway.

      The study has five points of assessment. In an electronic portal, delivered by CheckWare,
      patients will log in with their Bank ID and complete the core set of PROMs at admission,
      discharge, and 4, 8 and 12 months following discharge.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with rheumatic and musculoskeletal diseases from Norway admitted to rehabilitation
        at one of the nine participating rehabilitation centres.
Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections
Condition: Otitis Media; Tonsillitis; Pharyngitis; Bronchitis
MeSH terms: Bronchitis; Pharyngitis; Tonsillitis; Otitis; Otitis Media
Study type: Interventional
Phase: Phase 3

Summary: 
      This study was performed in children with upper respiratory tract infections (acute ear
      infection, infection of the tonsils or throat, or bacterial inflammation of the bronchi) who
      needed treatment with an antibiotic (clarithromycin). The study investigated a new technology
      which delivers the antibiotic in a straw (dose sipping technology, DST) in comparison to a
      marketed syrup.
    

Detailed description: 
      The study population were children aged 2-12 years (weight 12-40 kg) suffering from upper
      respiratory tract infections (acute otitis media, tonsillitis, pharyngitis, or acute
      bacterial bronchitis) and who needed antibiotic treatment. The study compared treatment
      satisfaction and treatment adherence of oral clarithromycin DST (125 mg, 187.5 mg, or 250 mg
      twice daily) with the established oral clarithromycin syrup administered via a graduated
      syringe (Klacid Syrup Forte®, 250 mg/5mL) at the same fixed daily doses.

      Fixed doses of 125 mg, 187.5 mg and 250 mg of clarithromycin DST offer the pediatrician the
      flexibility to treat children of different body weight and age adequately at the recommended
      daily dose of 15 (12.5-20) mg/kg. All children were treated for 7 to 10 day (14 to 20 doses).
      Treatment satisfaction by the guardian/caregiver in terms of handling and administration of
      the clarithromycin DST straw and the comparator clarithromycin syrup, convenience of the
      administration, acceptance of taste and aftertaste, and treatment satisfaction with respect
      to future use was evaluated by means of a Parents' Questionnaire once on either Day 3, 4, or
      5 and once on either Day 11, 12, 13, or 14. In addition, treatment adherence/willingness of
      medication intake and the child's health status were assessed. The safety program comprised
      recording and evaluation of adverse events and countermeasures.
    

Intervention name(s): Clarithromycin DST (125 mg); Clarithromycin DST (187.5 mg); Clarithromycin DST (250 mg); Clarithromycin Syrup (125 mg); Clarithromycin Syrup (187.5 mg); Clarithromycin Syrup (250 mg)
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Clarithromycin DST (125.0 mg clarithromycin / straw).; Clarithromycin DST (187.5 mg clarithromycin / straw).; Clarithromycin DST (250.0 mg clarithromycin / straw).; Clarithromycin Syrup 2.5 ml (125 mg).; Clarithromycin Syrup 3.75 ml (187.5 mg).; Clarithromycin Syrup 5 ml (250 mg).
Other intervention name(s): Klacid Syrup® Forte 250 mg/5mL; Klacid Syrup® Forte 250 mg/5mL; Klacid Syrup® Forte 250 mg/5mL
Intervention MeSH terms: Clarithromycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Pilot Study to Assess the Immunogenicity and Reactogenicity of High Versus Standard Dose TIV
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The objective of this pilot study is to assess the immunogenicity and reactogenicity of
      Fluzone High Dose with Fluzone (standard adult dose) influenza vaccines in healthcare
      workers.
    

Detailed description: 
      This is a prospective, randomized controlled, observer blind trial of Fluzone High Dose
      trivalent inactivated influenza vaccine (HDTIV) versus Fluzone, standard dose TIV (SDTIV) in
      100 healthcare workers 18-64 years of age. Participants will receive, in a 1:1 ratio, one
      dose of either SDTIV or HDTIV containing the strains of influenza virus as recommended by the
      World Health Organization for the season of recruitment. All adverse events will be collected
      for 7 days following the injection, serious adverse events will be collected through day 21,
      and serum for antibody testing will be obtained on day 0 and day 21. The primary outcome will
      be seroconversion to each strain of vaccine included in the vaccine, as measured by change in
      hemagglutination inhibition assay (HAI) titer between day 0 to day 21.
    

Intervention name(s): Fluzone High-Dose; Fluzone (standard dose)
Intervention type(s): Biological; Biological
Intervention description(s): Influenza vaccine; Influenza vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: influenza vaccine; adult; immunogenicity; reactogenicity
LESs Surgical Radicality for EaRly Stage Cervical Cancer
Condition: Uterine Cervical Neoplasms
MeSH terms: Uterine Cervical Neoplasms
Study type: Interventional

Summary: 
      This study is an open-label, multicenter, randomized, phase II non-inferiority trial (proof
      of concept study). Its purpose is to evaluate the safety and efficacy of extrafascial
      hysterectomy plus pelvic-lymph node dissection compared with the standard modified radical
      hysterectomy in patients with stage IA2-IB1 cervical cancer ≤ 2cm.
    

Detailed description: 
      The purpose of this study is to evaluate the safety and efficacy of extrafascial hysterectomy
      compared with modified radical hysterectomy, both plus level 1 pelvic lymph-node dissection,
      in patients with early stage IA2-IB1 cervical cancer ≤ 2cm. The experimental procedure will
      be considered to be promising for treatment of stage IA2-IB1 cervical cancer ≤ 2cm if the
      Bayesian posterior probability of "the difference of the 3-y DFS rate is less than the
      non-inferiority margin of 5%" is at least 50%. Thus, using this proof of concept design, the
      planned sample size is 40, with 20 cases per arm, which provides 72% chance of satisfying the
      above criteria, under the hypothesis that the lowest 3-y DFS rate in each arm is 90%. As
      required, adjuvant therapy will include cisplatin-based chemo-radiation or pelvic radiation
      alone (EBRT +/- intracavitary brachytherapy) indicated according to the #GOG92 and #GOG109
      criteria.
    

Intervention name(s): Extrafascial Hysterectomy; Modified radical hysterectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): Hysterectomy plus Pelvic Lymph-Node Dissection; Hysterectomy plus Pelvic Lymph-Node Dissection
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Proof of concept design (phase II non-inferiority trial)
Masking: Single (Participant)
Primary purpose: Treatment
PRP for the Treatment of Erectile Dysfunction (ED)
Condition: Erectile Dysfunction
MeSH terms: Erectile Dysfunction
Study type: Interventional
Phase: Phase 1

Summary: 
      Researchers are trying to determine the safety and efficacy of Platelet Rich Plasma (PRP) in
      the treatment of Erectile Dysfunction (ED).
    


Intervention name(s): Autologous Platelet Rich Plasma
Intervention type(s): Biological
Intervention description(s): One 4-5mL platelet rich plasma injection administered to each side of the intracavernosal space on the right and left side of the corpus cavernosum at the base of the penis, every two weeks for 6 weeks.
Intervention model: Sequential Assignment
Intervention model description: Subjects treated in this study will be divided into 3 cohorts of 5. After the first cohort of 5 subjects have been treated and evaluated for safety, the second cohort of 5 subjects will proceed with treatment followed by review of events for safety. If determined safe to proceed the third cohort of 5 subjects will proceed with treatment.
Masking: None (Open Label)
Primary purpose: Treatment
GW501516 In Subjects Who Have Low Level Of High-Density Lipoprotein Cholesterol
Condition: Dyslipidaemias; Dyslipidaemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this clinical research study is to compare up to 3 doses of an investigational
      drug GW501516 to placebo (an inactive pill that looks like GW501516) to see if it is safe,
      well tolerated and effective in improving (raising) low levels of "good cholesterol",
      high-density lipoprotein cholesterol (HDLc), as compared to placebo.
    

Detailed description: 
      A multicentre, two-staged with interim analysis, parallel, randomised, double blind,
      placebo-controlled, dose-ranging study of the safety, tolerability, and effects on plasma
      high-density lipoprotein cholesterol (HDLc) of 12 weeks treatment with 2.5mg, 5mg and 10mg
      daily doses of GW501516 in subjects with low HDLc
    

Intervention name(s): GW501516 oral tablets
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: HDLc; high-density lipoprotein; Dyslipidemia