bioihbjkbjnl/mcl2 huggingface dataset:
Preventing Respiratory Health Problems in Bakery Employees
Condition: Chronic Obstructive Lung Disease; Rhinitis
MeSH terms: Rhinitis; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The study is a follow-up of investigations done in the years 1999-2002 in bakery employees.
      The main purposes are to look at the associations between flour dust exposure and respiratory
      disease, and to find out the best ways to reduce the flour dust levels in the working
      environment.
    

Detailed description: 
      Background and Methods:

      Supported by the The Confederation of Norwegian Enterprise (CNBI) Working Environment Fund a
      follow-up study of 184 bakery workers in 5 bakeries was done in 2012, appr. 10 years after a
      similar study in 1999-2002. In addition a cross-sectional study in 2 other bakeries (one
      'bread-factory', and a traditional bakery with three small bake shops) was added.

      Altogether 253 participants, among them 61 former bakery workers, were investigated with use
      of questionnaires, allergy-testing (skin prick testing, and blood samples for specific IgE
      and total IgE), spirometry with reversibility testing, exhaled NO-measurement, and nasal
      measurements.

      As in 1999-2002 an extensive exposure assessment was performed including personal samples of
      total dust (Gelman), inhalable dust (PAS6), as well as direct reading measurements of dust
      (Dust Track). A Job Exposure Matrix (JEM) was created enabling each participant to be
      assigned an exposure value of probable mean daily flour-dust exposure based on work-tasks and
      bakery.

      Aim of study:

        -  Follow-up of the participants in the 1999-2002 study, both still active bakery workers
           and former workers, on health-status focusing on respiratory disease, sensitization to
           common and occupational allergens, level of sick-leave and reasons for quitting as a
           baker.

        -  Inclusion of 'new' bakery workers into the cohort as a cross-sectional study, and to
           compare health-status in two cross-sectional cohorts.

        -  To assess personal exposure to flour-dust among workers in 7 bakeries, as part of the
           cross-sectional study described above.

        -  To identify implemented flour-dust exposure reduction measures in bakeries participating
           in 1999-2002, and to assess the potential impact of these measures on the exposure to
           flour dust.
    

Observational model: Cohort
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        1. All the employees in 5 bakeries investigated in 1999-2002 (one of the original 6
             bakeries has fused with one of the others)

          2. All the employees in additional 2 bakeries located in the same Hordaland county,
             Norway, as the other 5 bakeries
      
Biospecimen description: 
      Serum, Nasal lavage fluid (without cells)
Non-invasive Vagus Nerve Stimulation for the Prevention of Migraines
Condition: Migraine Disorders
MeSH terms: Migraine Disorders
Study type: Interventional

Summary: 
      The purpose of the study is to investigate if the use of gammaCore Sapphire™ device reduces
      the number of migraines preventatively.
    

Detailed description: 
      The study is a prospective randomized, multi-center, double-blind, parallel, sham-controlled
      study, designed for comparison of two parallel groups, gammaCore®-Sapphire (active treatment)
      and a sham (inactive) treatment.

      The study period will begin with a four-week run-in period, during which there is no
      investigational treatment. The purpose of the run-in period will be to establish a baseline
      of the subject's headache/migraine history for longitudinal comparison.

      The run-in period will be followed by a 12-week randomized period when the subjects will be
      randomized (1:1) to either active treatment or sham (inactive) treatment.

      Subjects will dose themselves 3 times per day for 12 weeks.
    

Intervention name(s): gammaCore Sapphire active; gammaCore Sapphire Sham
Intervention type(s): Device; Device
Intervention description(s): GammaCore Sapphire™ is a handheld, non-invasive, low voltage electrical device which stimulates the vagus nerve by producing weak 120 second electrical stimulation cycles that may help reduce, ease, lessen or stop your migraine symptoms. GammaCore Sapphire™ has been approved for the treatment of headache, including migraine by the United States Food and Drug Administration (FDA).; The sham device is a hand-held portable device that appears identical to gammaCore Sapphire, in look, weight, visual and audible feedback, user application, and control. Like gammaCore Sapphire, the sham device is a multi-use device.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Two parallel groups, gammaCore®-Sapphire (active treatment) and a sham (inactive) treatment.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Prevention; Episodic; Chronic
A Study of JNJ-64281802 in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics (PK) of JNJ-64281802 in healthy
      participants when administered in different multiple dose regimens and as different dose
      strengths.
    


Intervention name(s): JNJ-64281802
Intervention type(s): Drug
Intervention description(s): JNJ-64281802 tablets will be administered orally as per the defined regimens.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
D Vitamin Intervention in VA
Condition: Impaired Fasting Glucose; Impaired Glucose Tolerance; Vitamin D Insufficiency
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      This study will supplement African American male (AAM) veterans at risk for diabetes and
      newly diagnosed T2DM with vitamin D (low or higher dose) and evaluate whether vitamin D helps
      to improve early markers of diabetes. The study will be done at Veteran Administration
      Medical Center in Chicago.
    

Detailed description: 
      The goal of this randomized clinical trial (RCT) is to determine vitamin D efficacy and
      safety for improving early markers of T2DM in African American male (AAM) veterans at risk
      for T2DM (n=205, duration 12 months).

      The primary outcome will be change in oral glucose insulin sensitivity (OGIS). The secondary
      outcomes will include various parameters of glucose metabolism and other biomarkers.

      Analysis based on primary and secondary goal as well as predetermined levels of A1C, OGTT and
      25OHD at the end of the study.
    

Intervention name(s): Placebo; 50K vitamin D2
Intervention type(s): Drug; Drug
Intervention description(s): Supplement of vitamin D 400 units provided to all subjects, in addition Arm 1 will get placebo and Arm 2 will get D2 50K; Supplement of vitamin D 400 units provided to all subjects, in addition Arm 1 will get placebo and Arm 2 will get D2 50K
Intervention MeSH terms: Vitamin D; Ergocalciferols
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Vitamin D; Glucose intolerance; African American men
Evaluating Ureteral Length Using Computed Tomography (CT)
Condition: Ureteral Calculi; Hydronephrosis; Ureteral Obstruction
MeSH terms: Hydronephrosis; Ureteral Calculi; Ureterolithiasis; Ureteral Obstruction; Calculi
Study type: Interventional

Summary: 
      Proper selection of ureteral stent length might help in reducing comorbidities associated
      with ureteral stenting, currently there is no standardized way of measuring ureteral length.

      Measurement of ureteral length according to Computed Tomography (CT) scan might provide
      useful information when selecting the length of a ureteral stent. Our aim in this study is to
      compare ureteral measurements using CT scan and measurement of actual ureteral length
      measured during ureteral stenting.
    


Intervention name(s): Ureteral catheterization - Cook Urological Inc. open end ureteral catheter 5FR
Intervention type(s): Device
Intervention description(s): During a planned procedure involving ureteroscopy or ureteral stenting, after retrograde pyelography and insertion of a safety wire, ureteral catheterization will be performed using Cook Urological Inc. open end ureteral catheter 5FR for the purpose of measuring exact ureteral length.
Measurement results will be compared to measurements performed on CT scan (obtained before surgery).
Other intervention name(s): Cook Urological Inc. open end ureteral catheter 5FR; Karl Storz cystoscope 19-22F
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Temporal Dynamics and Pharmacokinetics of Intranasally Administered Oxytocin
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether effects of intranasal oxytocin on amygdala
      response vary as a function of treatment dose and dose-test latency.
    

Detailed description: 
      The objective of the present study is to determine whether intranasal oxytocin (IN-OXT)
      effects on blood oxygenation level-dependent functional magnetic resonance imaging (BOLD
      fMRI) in the amygdala vary as a function of dose and latency. In particular, the
      investigators plan to compare effects of three different IN-OXT doses (12, 24, and 48
      international units, IU) and three different dose-test latencies of IN-OXT administration
      (task starting at 15, 45 and 75min after administration) on established neural and
      behavioural correlates of emotion processing. As effects of OXT are particularly promising in
      autism, the investigators further want to investigate how autistic-like traits influence the
      OXT effects in exploratory post-hoc analyses
    

Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Fenoldopam and Acute Renal Failure
Condition: Acute Renal Failure
MeSH terms: Renal Insufficiency; Acute Kidney Injury
Study type: Interventional
Phase: Phase 3

Summary: 
      Patients undergoing cardiac surgery could develop postoperative acute renal failure requiring
      renal replacement therapy.

      Fenoldopam, already used for patients with hypertensive emergencies, could improve renal
      function in critically ill patients with or at risk for acute renal failure.
    


Intervention name(s): fenoldopam; placebo
Intervention type(s): Drug; Drug
Intervention description(s): fenoldopam 0.1 ug/kg/min (from 0.025 to 0.3 ug/kg/min)for up to 4 days; placebo
Other intervention name(s): corlopam
Intervention MeSH terms: Fenoldopam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: fenoldopam; acute renal failure; renal replacement therapy; mortality; cardiac surgery; cardiac anesthesia; intensive care unit
An Open Study of Tipepidine Hibenzate in Patients With Attention Deficit Hyperactivity Disorder (ADHD)
Condition: Attention Deficit Disorder With Hyperactivity
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      Accumulating evidence suggests a role of G protein-coupled inwardly-rectifying potassium
      (GIRK) channel in the pathology of excitement of nerve, and the medicine with the action
      (like the Tipepidine Hibenzate) is expected as a new curative medicine of Attention Deficit /
      Hyperactivity Disorder (AD/HD).

      The purpose of this research is to confirm the effect by carrying out the additional dosage
      of the Tipepidine Hibenzate to the AD/HD patients.

      If suggestion is obtained by this research about the effect on AD/HD of Tipepidine Hibenzate,
      it can contribute to development of the medical treatment of AD/HD.
    


Intervention name(s): Tipepidine Hibenzate
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
To Evaluate the Pharmacokinetics (PK) and Safety of Tavapadon in Participants With Mild and Moderate Hepatic Impairment Compared to Participants With Normal Hepatic Function
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of the study is to assess the effect of hepatic impairment on the PK of
      tavapadon following administration of a single oral dose in participants with mild and
      moderate hepatic impairment relative to age, body weight, and sex-matched participants with
      normal hepatic function.
    


Intervention name(s): Tavapadon
Intervention type(s): Drug
Intervention description(s): Oral tablets
Other intervention name(s): CVL-751
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteer; Mild Hepatic Impairment; Moderate Hepatic Impairment
Chemotherapy Plus Radiation Therapy in Treating Patients With Previously Untreated Thyroid Cancer
Condition: Head and Neck Cancer
MeSH terms: Thyroid Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Radiation therapy uses high-energy x-rays to damage tumor cells.
      Combining radiation therapy with chemotherapy may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy plus radiation
      therapy in treating patients who have previously untreated anaplastic thyroid cancer.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the activity of chemotherapy with hyperfractionated radiotherapy in
      terms of complete and overall response rate, time to progression, pattern of failure,
      incidence of second primary tumors, and overall survival in patients with previously
      untreated anaplastic thyroid cancer.

      OUTLINE: This is a multicenter study. Patients receive oral hydroxyurea every 12 hours on
      days 0-5, fluorouracil IV and paclitaxel IV continuously over days 1-5, and hyperfractionated
      radiotherapy twice daily on days 1-5. Patients receive filgrastim (G-CSF) subcutaneously
      daily on days 6-12. Treatment repeats every 2 weeks for 5 courses. Following completion of
      concurrent chemoradiotherapy, patients with no prior initial modified neck dissection who
      have residual macroscopic nodal disease or initially staged nodal disease with no evidence of
      residual disease undergo neck dissection. Patients with macroscopic residual disease at the
      primary site undergo complete excision of disease. Patients with any progressive disease or
      recurrence of disease undergo conventional surgical management. Patients are followed at 4-6
      weeks, every 3 months for 1 year, and then annually thereafter.

      PROJECTED ACCRUAL: Approximately 16-46 patients will be accrued for this study.
    

Intervention name(s): filgrastim; fluorouracil; hydroxyurea; paclitaxel; conventional surgery; radiation therapy
Intervention type(s): Biological; Drug; Drug; Drug; Procedure; Radiation
Intervention MeSH terms: Paclitaxel; Fluorouracil; Hydroxyurea
Primary purpose: Treatment
Keywords: anaplastic thyroid cancer
Effect of Yogurt With Polydextrose,L Acidophilus and B Lactis in Chronic Constipation
Condition: Constipation
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Background and aims:Constipation is a frequent complaint and the combination of a prebiotic
      and probiotics would have a potentially synergic effect on the intestinal transit. The
      present study therefore aims to investigate the combination of polydextrose (Litesse®), L.
      acidophilus NCFM® and B. lactis HN019 in a yogurt on intestinal transit in subjects who
      suffer from constipation.

      Methods: Patients with constipation were randomly divided into two groups, Placebo Group (PG)
      and Treatment Group (TG), and had to eat 180 ml of unflavored yogurt every morning for 14
      days. Those in the CG received only yogurt, while the TG received yogurt containing
      polydextrose, L. acidophilus NCFM® (ATCC 700396) and B. lactis HN019 (AGAL NM97/09513).
      Expect that patients who took a combination of polydextrose has a decrease in the colonic
      transit time (CTT) when comparing initial and final transit time.
    


Intervention name(s): yogurt containing: polydextrose L. acidophilus NCFM® B. lactis HN019
Intervention type(s): Dietary Supplement
Intervention description(s): NCFM Group
Other intervention name(s): acidophilus NCFM® (ATCC 700396); lactis HN019 (AGAL NM97/09513)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: chronic constipation; Lactobacillus acidophilus NCFM; Bifidobacterium lactis HN019
The Effect of Fluvastatin XL® Treatment in Patients With Metabolic Syndrome
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluated safety, tolerability and efficacy of Fluvastatin XL® -extended release
      (80 mg once daily) in patients with metabolic syndrome
    


Intervention name(s): Fluvastatin XL®
Intervention type(s): Drug
Intervention description(s): Fluvastatin extended release 80 mg
Other intervention name(s): Lescol XL
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metabolic syndrome,dyslipidemia,fluvastatin extended release
Study Comparing Trifarotene Cream, 0.005% To AKLIEF ® (Trifarotene 0.005% Cream) In The Treatment Of Acne Vulgaris
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 3

Summary: 
      To compare the safety and efficacy of the test (Trifarotene 0.005% cream), placebo (vehicle
      cream) and reference AKLIEF® (Trifarotene 0.005% cream) treatments to demonstrate clinical
      equivalence in subjects with acne vulgaris.
    

Detailed description: 
      To compare the safety of Test, Reference, and Placebo treatments in patients with acne
      vulgaris. Subjects in this randomized, double-blind, three-arm, placebo controlled,
      parallel-design, multi-site study will be randomly assigned in a 1:1:1 ratio to treatment
      with the test product, reference product or placebo control, respectively.
    

Intervention name(s): Trifarotene 0.005 % Topical Cream; AKLIEF®; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Cream; Cream; Cream
Other intervention name(s): Trifarotene 0.005 % Topical Cream; Vehicle of Test Product
Intervention MeSH terms: Trifarotene
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Modification of Cerebral Activity of Obsessive Compulsive Disorder (OCD) Patients During Cognitive and Behavioral Therapy
Condition: Obsessive Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      Obsessive compulsive Disorder (OCD) is a frequent psychiatric disorder. Obsessions and
      compulsions are the two manifestations of this disease. Obsessions are recurrent anxious
      ideas, and compulsions repetitive behavior aiming to decrease this anxiety.

      OCD symptoms have been associated with cortical and sub-cortical dysfunctions and more
      precisely an hyperactivity of prefrontal cortex / basal ganglia loops.

      Functional neuro-imagery studies have shown a significant decrease of orbito-frontal cortex,
      anterior cingulate cortex, caudate nucleus and cerebellum activities after two OCD reference
      treatments : medication and Cognitive and Behavioral Therapy (CBT).

      Two groups of 20 patients are included in this study and follow a CBT for 15 sessions. They
      are randomised in two groups : one proposing a "reference CBT", the other associate CBT to a
      new psychopedagogic task developed by the investigators team.

      Clinical investigations and neuro-imagery data are collected at the main steps of therapies :
      before, during (half-therapy), at the end of therapies and 6 month later. Symptoms severity,
      patients and relatives quality of life are also assessed.
    


Intervention name(s): Cognitive and behavioral Therapy
Intervention type(s): Behavioral
Intervention description(s): 15 CBT sessions with a psychologist expert in OCD treatment
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Cognitive and Behavioral Therapy