bioihbjkbjnl/mcl2 huggingface dataset:
Pathways to Vocational Rehabilitation: Enhancing Entry and Retention
Condition: Poverty; Unemployment
Study type: Interventional

Summary: 
      This study will examine the barriers and supports for entering and receiving work-related
      services for veterans with a serious mental illness. It will also determine the effectiveness
      of a brief motivational interviewing intervention designed to help veterans receive these
      services.
    

Detailed description: 
      Randomized clinical trials and naturalistic studies show that among patients meeting criteria
      for chronic mental illness, those participating in vocational rehabilitation (VR) have
      significantly reduced days of inpatient hospitalization. Unfortunately, the majority of
      eligible adults fail to enter VR and almost half of those who do, drop out or are
      involuntarily discharged. The reasons for nonparticipation and drop out and their impact on
      rehabilitation outcomes are poorly understood.

      The study will provide needed naturalistic data documenting:

        1. the way in which barriers function to reduce entry to services and contribute to the
           high rate of dropout,

        2. the outcomes associated with different patterns of participation, and

        3. relative rates of entry and retention in a non-VHA VR exemplar of the Intensive
           Placement and Support (IPS) model at the Manchester Mental Health Center in Manchester,
           New Hampshire.

      While we need to know more about these "barriers" in order to develop the range of
      appropriate interventions, the enhancement of client motivation for work and rehabilitation
      is likely to have a positive impact both on entry and sustained compliance. We are proposing
      a random assignment single blind trial of a brief Motivational Interviewing (MI) intervention
      designed to address the low entry and retention rates of veterans with Serious Mental Illness
      (SMI) in Veterans Health Administration's (VHA) VR services.
    

Intervention name(s): single session of Motivational Interviewing
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Counseling; Motivation; Psychotherapy, brief
A Randomized, Blinded, Placebo-controlled Phase I Clinical Trial Evaluating the Safety and Preliminary Immunogenicity of a 11-valent Recombinant Human Papillomavirus Vaccine (Hansenulapolymorpha) in Chinese Women Aged 9-45 Years
Condition: HPV Infection; HPV-Related Cervical Carcinoma
MeSH terms: Papillomavirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      A total of 90 Chinese women aged 9-45 years old were divided into three age groups: 27-45
      years old, 18-26 years old, and 9-17 years old. The experimental group and the placebo group
      were randomly assigned in a ratio of 2:1. Sixty patients had a placebo group of 30 patients.
      All subjects enrolled in the upper arm deltoid muscle were injected with 3 doses of test
      vaccine or placebo according to the 0, 2, and 6 months immunization program.
    


Intervention name(s): 11-valent recombinant human papilloma virus vaccine (Hansenula polymorpha); Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Injection vaccine produced by ChinaVaccineSerum ,containing HPV antigen protein, 270μg/1ml/bottle; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Humoral and Cellular Response in Shift Workers
Condition: Other Condition That May be a Focus of Clinical Attention
MeSH terms: Hepatitis A
Study type: Interventional

Summary: 
      The purpose of this study is to access whether shift workers (morning, afternoon or night)
      vaccinated against hepatitis A would have some humoral and cellular response impairment.
    

Detailed description: 
      Sleep regulates immune functions. In this sense, we asked whether shift workers (morning,
      afternoon or night) vaccinated against hepatitis A would have some humoral and cellular
      response impairment. Men (18 to 55 years) will be recruited through different forms of media
      (electronic, newspapers, radio and magazines). The shift workers sleep pattern will be
      recorded polysomnographically. Subsequently, the volunteers will be underwent vaccination
      against hepatitis A (2 doses) and after 30, 60 and 90 days, blood samples will be collected
      to assess the humoral response in the experimental groups. The hormones prolactin, growth
      hormone, cortisol, adrenaline and noradrenaline will also be evaluated. Indeed, stimulations
      in culture will be conducted to assess the cellular response profile against the vaccination
      through the production assessment of IL-4, IFN-γ, IL-2 and TNF-α.
    

Intervention name(s): Vaccination against hepatitis A; No Intervention
Intervention type(s): Biological; Other
Intervention description(s): Vaccination against hepatitis A (2 doses) into the deltoid muscle of the nondominant arm twice, i.e., at 0 and 6 months.; No Intervention
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Shift work; Hepatitis A vaccination; humoral response; cellular response
Feasibility of an Integrated Medical Care Program for Patients With Continuing Health Complaints After Amalgam Removal
Condition: Health Complaints Attributed to Previous Amalgam Fillings
Study type: Interventional

Summary: 
      Some patients report relief of symptoms after amalgam removal. However, a large group of
      patients are still suffering from partly severe health complaints even after the removal of
      amalgam. To date, no biological/medical explanation for these Amalgam attributed health
      complaints is available.

      The objective of this study is to develop an integrated medical care rehabilitation program
      and determine if it is a valid and feasible treatment for patients with persistent symptoms
      after amalgam removal. Such a comprehensive concept has to date not been operationalized in
      Norway, but information about the feasibility and the challenges around such a rehabilitation
      program are required, in order to prepare for a possible controlled and randomized study
      evaluating the effects of the suggested integrative care treatment program. This treatment
      program will focus on "learning by practicing", hence the study participants will be enrolled
      into a group program focusing on life-style changes. In addition to the life-style oriented
      group program, an individualized treatment strategy with therapies out of the spectrum of
      Complementary and Alternative Medicine (CAM) will be part of the treatment program. This part
      of the program is based on the results of a survey, related to use of CAM therapies,
      conducted in 2012 among the members of the patient organization "Forbundet Tenner og Helse".

      Participants of this treatment program must amongst other inclusion criteria have removed all
      dental amalgam fillings and experience symptoms which have not disappeared after removal of
      the dental fillings. Specific exclusion criteria are stated. The group program consists of 12
      sessions which are held once per week for a whole day. Added to this is a choice of CAM
      therapies from a hierarchic list, established from the survey, and which accordingly is based
      on risk/benefit judgment. Data collection will take place at baseline, after 12 weeks (end of
      treatment), and three month later. The aim of this study is to test the feasibility of an
      integrated medical care rehabilitation program for patients in Norway who have had their
      Amalgam fillings removed, but still suffer from Amalgam attributed symptoms. It combines a
      lifestyle oriented group program with individualized CAM therapies in form of an outpatient
      program.
    


Intervention name(s): lifestyle intervention
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Amalgam attributed health complaints; feasibility pilot study; integrated medical care program; lifestyle
Safety, Biomarker Study of RL-007 in Subjects With Schizophrenia
Condition: Cognitive Impairment; Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the safety and effects on electrical activity in the
      brain of an investigational drug (RL-007) for improving cognition in patients with
      schizophrenia
    

Detailed description: 
      Potential participants will first be given an Informed Consent document and have the study
      explained to them. All patients who provide written informed consent will undergo screening
      to determine eligibility for the study. Patients who meet all eligibility criteria will be
      admitted to the clinic for 5 days / 4 nights as an in-patient. During this time, participants
      will be assigned to a specific dose cohort and will receive sequence that includes both
      placebo and RL-007. Brain activity and cognitive performance will be assessed on study days 2
      and 4.
    

Intervention name(s): RL-007; RL-007 Matching Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cohorts are 10 mg, 20 mg, 40 mg, and 80 mg with TID dosing; Cohorts are 10 mg, 20 mg, 40 mg, and 80 mg with TID dosing
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Intervention model description: Four dose cohorts will be enrolled sequentially.
Masking: Single (Participant)
Primary purpose: Treatment
Study of Docetaxel in Breast Cancer Patients
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objectives:

        -  To compare the disease free survival (DFS) in patients treated with the sequential
           epidoxorubicin, cyclophosphamide, methotrexate, and fluorouracil (CMF) regimen to that
           in patients treated with the same treatment plus docetaxel given sequentially after
           epidoxorubicin

      Secondary objectives:

        -  To compare the DFS in patients treated with the sequential epidoxorubicin, docetaxel and
           CMF (only patients with > or = 4 lymph nodes) regimen to that in patients treated with
           sequential intensified epidoxorubicin/docetaxel/high dose (HD) cyclophosphamide regimen

        -  To evaluate the overall survival in each arm

        -  To evaluate the tolerability of a sequential intensified
           epidoxorubicin/docetaxel/HD-cyclophosphamide (arm C)

        -  To compare the safety of a sequential epidoxorubicin/docetaxel/CMF (arm B) regimen
           versus a standard sequential epidoxorubicin/CMF regimen (arm A)
    


Intervention name(s): epidoxorubicine, ciclophosphamide, methotrexate, fluorouracile; epidoxorubicine, docetaxel, ciclophosphamide, methotrexate, fluorouracile; epidoxorubicine, docetaxel, cyclophosphamide
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Sequential Epidoxorubicin followed by ciclophosphamide/Methotrexate/fluorouracile (±TAM); Sequential Epidoxorubicin followed by Docetaxel followed by ciclophosphamide/methotrexate/fluorouracile (± TAM); Sequential Intensified Epidoxorubicin followed by Docetaxel followed by Cyclophosphamide (± TAM)
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Open-label Extension Evaluating Methylphenidate Hydrochloride Extended Release in Adults With Attention Deficit/Hyperactivity Disorder
Condition: Attention Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the long-term safety of methylphenidate hydrochloride extended
      release in adults with attention deficit/hyperactivity disorder
    


Intervention name(s): Ritalin LA (methylphenidate hydrochloride extended release)
Intervention type(s): Drug
Intervention description(s): Ritalin LA 20 mg or 30 mg (a racemic mixture of d- and l-thre-Methylphenidate Hydrocloride (MPH), Extended release hard capsules) taken orally once daily in doses of 40, 60, or 80 mg. For 40mg dose patients took (2) Ritalin LA 20mg daily, for 60mg patients took (2) Ritalin LA 30mg daily and for 80mg patients took (2) Ritalin LA 30mg daily + (1) Ritalin LA 20mg daily for their optimal dose.
Other intervention name(s): Ritalin LA, methylphenidate hydrochloride extended release, RIT124D
Intervention MeSH terms: Methylphenidate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Attention Deficit /Hyperactivity Disorder,; hyperactivity
A Clinical Trial to Evaluate the Pharmacokinetics and Safety of Fimasartan and Amlodipine in Healthy Male Subjects
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics and safety when administrated
      Fimasartan/Amlodipine and when co-administrated Fimasartan and Amlodipine.
    

Detailed description: 
      This is an open-label, randomized, 3x3 partial replicated crossover study to evaluate the
      pharmacokinetics and safety/tolerability. Within each period, randomized subjects will be 2
      dosing regimens with a fixed dose combination of Fimasartan/Amlodipine and co-administration
      of Fimasartan and Amlodipine.
    

Intervention name(s): Fimasartan/Amlodipine; Fimasartan + Amlodipine
Intervention type(s): Drug; Drug
Intervention description(s): Treatment B; Treatment A
Intervention MeSH terms: Amlodipine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Fimasartan
Probiotics for Treatment of Chalazion in Adults
Condition: Chalazion
MeSH terms: Chalazion
Study type: Interventional

Summary: 
      There is growing evidence encouraging probiotics use in several diseases. The aim of the
      investigator's study is to define the possible beneficial impact of probiotics on adults
      suffering from chalazia.
    

Detailed description: 
      Prospective comparative pilot study on 20 adults suffering from chalazion randomly divided
      into two groups. The first group, received conservative treatment with lid hygiene, warm
      compression, and dexamethasone/tobramycin ointment for at least 20 days. The second group, in
      addition to the conservative treatment, received a mixture of probiotic microorganisms once a
      day up to 3 months. Chalazia were classified according to their size into three groups: small
      (≤2 mm), medium (2-4 mm), or large (>4 mm). When conservative treatment (with and without
      probiotics supplementation) failed to resolve the lesion, invasive methods were used,
      (intralesion steroid injection in medium size chalazion and surgical incision and curettage
      for the largest ones).
    

Intervention name(s): conservative treatment; probiotics
Intervention type(s): Other; Dietary Supplement
Intervention description(s): lid hygiene, warm compression, and dexamethasone/tobramycin ointment for at least 20 days.; use specific probiotics in addiction to conservative treatment to modify the intestinal microbiome to ameliorate the clinical course of adults chalazia by re-establishing intestinal and immune homeostasis
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective comparative pilot study with two groups randomly divided
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: microbiome/microbiota; probiotics; adults
Recombinant Human Fibroblast Growth Factor-2 (rhFGF-2) In Gingival Recession Defects
Condition: Periodontitis
MeSH terms: Periodontitis; Gingival Recession
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study was a single-arm trial to obtain preliminary data on the efficacy of collagen
      membranes impregnated with recombinant human fibroblast growth factor (rhFGF-2) in the
      treatment of Miller's class I and class II gingival recessions.
    

Detailed description: 
      Soft tissues can be regenerated to cover root exposure and a thin biotype can be converted
      into a thick biotype by using recombinant human growth factor technology. A recent review
      stated that growth factors could enhance soft tissue regeneration which includes restoration
      of mucogingival architecture and regeneration of periodontal hard and soft tissues including
      bone, cementum and periodontal ligament fibers. Fibroblast growth factor-2 (FGF-2), a
      heparin-binding cytokine with strong angiogenic activity stimulates the proliferation of
      undifferentiated mesenchymal cells. These functions can be applied in mucogingival surgery as
      FGF-2 promotes bone and cementum formation and exhibits an increased potential to promote
      periodontal regeneration in recession defects.
    

Intervention name(s): FGF 2
Intervention type(s): Drug
Intervention description(s): Following a standard surgical protocol, rhFGF-2 impregnated membranes will be placed in sites with gingival recession.
Other intervention name(s): FGF+Collagen
Intervention model: Single Group Assignment
Intervention model description: This study was a single-arm trial to obtain preliminary data on the efficacy of collagen membranes impregnated with recombinant human fibroblast growth factor (rhFGF-2) in the treatment of Miller's class I and class II gingival recessions.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Gingival Recession; Fibroblast Growth Factor 2; Periodontal Atrophy
Efficacy and Safety of MRI-based Thrombolysis in Wake-up Stroke
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 3

Summary: 
      WAKE-UP is an investigator initiated European multicenter randomized controlled clinical
      trial of MRI based thrombolysis in acute stroke patients with unknown time of symptom onset,
      e.g. due to recognition of stroke symptoms on awakening. Objective of WAKE-UP is to prove
      efficacy and safety of MRI-based intravenous thrombolysis with Alteplase in patients waking
      up with stroke symptoms or patients with otherwise unknown symptom onset.
    

Detailed description: 
      WAKE-UP is a clinical trial of MRI based thrombolysis in acute stroke patients with unknown
      time of symptom onset, e.g. due to recognition of stroke symptoms on awakening. Intravenous
      thrombolysis with Alteplase is available as effective and safe treatment of acute stroke
      within 4.5 hours of symptom onset. However, in about 20% of acute stroke patients time of
      symptom onset is unknown. This large group of patients is currently excluded from treatment
      with Alteplase. The objective of the research proposed in the WAKE-UP project is to provide
      effective treatment options for this large group of acute stroke patients.

      WAKE-UP is designed to prove efficacy and safety of MRI-based intravenous thrombolysis with
      Alteplase in patients waking up with stroke symptoms or patients with otherwise unknown
      symptom onset. Patients will be enrolled based on MRI findings indicative of acute ischemic
      stroke less than 4.5 hours of age.
    

Intervention name(s): Alteplase; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Intravenous tissue plasminogen activator (Alteplase) 0.9 mg/kg body-weight up to a maximum of 90 mg, 10% as bolus, 90% over 1 hour as infusion; lyophilised powder to be reconstituted as solution indistinguishable from the active drug
Other intervention name(s): Actilyse; Activase; rt-PA
Intervention MeSH terms: Tissue Plasminogen Activator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: wake-up stroke; thrombolysis; magnetic resonance imaging (MRI); diffusion weighted imaging (DWI); fluid attenuated inversion recovery (FLAIR)
Effect of Gastrectomy and Anastomosis on Diabetes and Hypertension in Early Gastric Cancer Patients
Condition: Early Gastric Cancer
MeSH terms: Stomach Neoplasms; Hypertension
Study type: Observational

Summary: 
      The purpose of this study is to determine whether the extent of gastrectomy and anastomosis
      type affect chronic metabolic disease such as diabetes and hypertension in early gastric
      cancer patients.
    


Intervention name(s): gastrectomy; Endoscopic submucosal dissection
Intervention type(s): Procedure; Procedure
Intervention description(s): subtotal gastrectomy with gastroduodenostomy or loop gastrojejunostomy or Roux Y gastrojejunostomy total gastrectomy with Roux Y esophagojejunostomy; endoscopic submucosal dissection
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients diagnosed as early gastric cancer
      
Keywords: early gastric cancer, diabetes, hypertension
Bioequivalence Study of Fenofibrate 160mg Tablets Under Fed Conditions
Condition: Healthy
MeSH terms: Malnutrition
Study type: Interventional

Summary: 
      The objective of this study was to compare the single-dose relative bioavailability of
      Ranbaxy and Abbott (TriCor) 160 mg fenofibrate tablets under fed conditions.
    

Detailed description: 
      This was an open-label, randomized, single-dose, 2-way crossover, relative bioavailability
      study performed on 24 healthy adult male and female volunteers A total of 23 subjects (16
      males and 7 females) completed the clinical phase of the study. In each period, subjects were
      housed from the evening before dosing until after the 24-hour blood draw. Subjects returned
      for all subsequent blood draws. Doses were separated by a washout period of 10 days.

      Of the 24 healthy adult male and female volunteers enrolled in the study, 23 subjects (16
      males and 7 females) completed the clinical phase of the study. Subject No. 10 failed to
      return for Period 2 check-in.
    

Intervention name(s): Fenofibrate 160 mg tablets
Intervention type(s): Drug
Intervention MeSH terms: Fenofibrate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: bioequivalence fenofibrate tablets