bioihbjkbjnl/mcl2 huggingface dataset:
Effects of Workplace Intervention in Occupational Rehabilitation on Return to Work
Condition: Mental Disorders; Musculoskeletal Diseases; Fatigue Syndrome, Chronic
MeSH terms: Musculoskeletal Diseases; Fatigue Syndrome, Chronic; Mental Disorders
Study type: Interventional

Summary: 
      Aim is to study the effect of a work place intervention during a multicomponent
      return-to-work rehabilitation program on return-to-work. The intervention is compared with
      inpatient rehabilitation only, and participants will be recruited from the diagnostic groups
      dominating the sick-leave statistics, namely musculoskeletal disorders, common mental
      disorders (e.g. stress, depression and anxiety), and unspecific disorders including chronic
      fatigue.
    

Detailed description: 
      Long-term sick-listing from work has considerable impact on social function, on the families
      of the sick-listed persons, the companies they work for, and society as a whole. Hence, the
      need for documented effective vocational rehabilitation programs is pressing. Vocational
      rehabilitation services described in the scientific literature have been specific to one
      single or a specific group of medical conditions (e.g.low back pain). In contrast, most
      people on sick leave have several health complaints, and many of the factors influencing sick
      leave are shared regardless of disorder (e.g. social surroundings, workplace environment),
      calling for rehabilitation programs that can be employed for both musculoskeletal, unspecific
      and common mental disorders. Research indicates that interventions on the work place might
      facilitate return to work. The aim of this study is therefore to investigate the effect of a
      work place intervention during a multicomponent return-to-work rehabilitation program on
      return-to-work.
    

Intervention name(s): Work place intervention
Intervention type(s): Behavioral
Intervention description(s): Meeting at the work place including the patient, the employer and the rehabilitation therapist. Aim of meeting is to discuss challenges and possibilities in the patient's return to work process and to make a plan for return to work.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rehabilitation; Return to Work
Larsen & Toubro (L&T) Noninvasive Blood Pressure Module Performance Validation
Condition: Blood Pressure
Study type: Observational

Summary: 
      To validate accuracy of the readings of noninvasive blood pressure (NIBP) module with
      sphygmomanometer as per the requirements of AAMI SP10:2002. This study is for adult and
      pediatric population.
    


Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Total 92 numbers of subjects or patients were studied during this study.
      
Keywords: Non-Invasive Blood Pressure
Effect of Vitamin E on Skin Aerobic Bacteria in Palmar Arsenical Keratosis
Condition: Chronic Arsenic Poisoning
MeSH terms: Arsenic Poisoning; Poisoning
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will be conducted to observe any change in aerobic bacterial pattern on the skin
      of arsenicosis patients before and after administration of vitamin E (200 IU) capsules.
    

Detailed description: 
      Arsenicosis has emerged as one of the main and hazardous public health problem in Bangladesh.
      Melanosis and keratosis are the most common manifestations of arsenicosis. The exact
      mechanism of development of keratosis is not clear. With chronic ingestion of arsenic
      contaminated water the excretion of arsenic through skin increases and also the oxidative
      stress, which in turn cause cellular damage. These changes may influence the growth of normal
      bacteria and consistency of skin, which may be responsible for keratosis. In different study
      results shown that, vitamin E, a potential antioxidant that halts lipid peroxidation and
      maintains cell membrane integrity, also detoxified arsenic from the body. Normal skin
      bacteria mainly composed of Gram +ve bacteria. In arsenicosis, this pattern changes from Gram
      +ve bacteria to Gram -ve bacteria. Still now no study have been conducted to see, the effect
      of vitamin E on skin bacteria in arsenicosis, as skin bacteria changes. Therefore, this study
      will be conducted to observe any change in aerobic bacterial pattern on the skin of
      arsenicosis before and after administration of vitamin E capsules. Fifteen patients with skin
      manifestations, 15 arsenic exposed control, 15 healthy volunteers will be recruited on the
      basis of inclusion and exclusion criteria. They will be provide vitamin E capsules 200 IU
      twice daily for 12 weeks without any interruption. Water and nail samples will be collected
      for confirming the diagnosis. Skin samples will be collected two times (before and after
      giving vitamin E) for qualitative analysis of bacteria. All the patients, arsenic exposed
      controls and healthy subjects will be provided with same capsule in same dosage schedule. So,
      this study will find any change of skin bacteria pattern after administrating vitamin E
      capsule.
    

Intervention name(s): Vitamin E capsule
Intervention type(s): Drug
Intervention description(s): Capsules will be distributed to each participant free of cost
Other intervention name(s): E-Cap, Batch No. 461016
Intervention MeSH terms: Vitamin E
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Turmeric and Curcumin on Sebum Production
Condition: Inflammation; Skin
MeSH terms: Dermatitis; Inflammation
Study type: Interventional

Summary: 
      A noticeably increasing number of patients are asking for naturally based extracts and
      ingredients as supplementary dermatologic remedies. Patients are seeking natural and
      cost-effective skin care alternatives in place of prescription medications and procedures.
      Our study will evaluate the effects of oral curcumin and turmeric on sebum production in
      healthy subjects.
    

Detailed description: 
      Turmeric extracts and curcumin have been shown to be safe, even at high doses without
      significant side-effects. Previous clinical studies in other inflammatory skin diseases have
      shown that a dosage of curcumin at 6,000 mg daily was effective while lower doses were not.
      In a human phase I clinical trial examining the effects of high dose curcumin in preventing
      premalignant lesions, even curcumin doses as high as 8,000 mg/day resulted in no toxic
      effects after 3 months. This study will involve participant ingestion of 6,000 mg/day of
      turmeric or curcumin to assess how this affects their sebum production.

      The investigators will also be collecting stool from the study subjects, and examining how
      the curcumin and turmeric may modulate their gut microbiome. The investigators will
      specifically be looking to see if curcumin or turmeric have any changes on the gut flora
      towards bacteria that produce more short chain fatty acids. Certain bacteria that make up the
      microbiome produce short chain fatty acids, such as butyrate and propionate, which have
      demonstrated anti-inflammatory properties. Thus, it would be interesting to see if turmeric
      or curcumin exert any of its anti-inflammatory effects via modulation of the microbiome.
    

Intervention name(s): Turmeric tablets; Curcumin and Bioperine tablets; Placebo tablets
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Curcumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Effectiveness of Self-Management Skills for Metabolic Syndrome Fatty Liver Disease Adults
Condition: Metabolic Syndrome
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      The multidimensional self-management intervention program focusing on healthy dietary habit
      and exercise effectively prevents metabolic syndrome. Thus, the purpose of this study was to
      assess the efficacy of multidimensional self-management intervention program on metabolic
      syndrome subjects in Taiwan.
    

Detailed description: 
      The study is a 2-parallel groups' randomized controlled trial. Participants with metabolic
      syndrome (three or more risk factors - triglycerides (TG) >150 mg/dL, systolic blood pressure
      (SBP) ≥130 mm Hg, diastolic blood pressure (DBP) ≥85 mm Hg, or fasting blood glucose≥100
      mg/dL; high-density lipoprotein cholesterol<50 mg/dL, or waist circumference ≥80 cm) are
      enrolled. The four community units are randomized to receive a lifestyle intervention
      (intervention arm) or an education leaflet (control arm). The parameters are obtained from
      physical examination and biochemical assessments by well-trained case manager at baseline and
      each follow visit (6th months and 18th months). All participants complete a structured
      questionnaire, including basic information, physical activity, and food-frequency.
    

Intervention name(s): self-management intervention
Intervention type(s): Behavioral
Intervention description(s): lifestyle modification, goal setting, coaching and peer support, problem-solving
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: self-management intervention; metabolic syndrome; women
A Study to Evaluate HB0034 in Healthy Adult Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study is to investigate the safety and tolerability of HB0034 in healthy
      subjects following a single dose.
    

Detailed description: 
      This is a first-in-human (FIH) study of HB0034 to evaluate the safety, tolerability,
      pharmacokinetics, and immunogenicity of HB0034.
    

Intervention name(s): HB0034; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Recombinant Humanized Anti-IL-36R Monoclonal antibody; Palcebo
Other intervention name(s): no other invention names; no other invention names
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Drug Interaction Study With Albiglutide and Warfarin
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label study evaluates the pharmacokinetics of warfarin when coadministered with
      albiglutide in healthy adult subjects. The primary objective is to assess the effect of
      albiglutide doses on the pharmacokinetics of warfarin.
    

Detailed description: 
      This Phase I open-label study evaluates the pharmacokinetics of warfarin when coadministered
      with albiglutide in healthy adult subjects. The primary objective is to assess the effect of
      albiglutide doses on the pharmacokinetics of warfarin.
    

Intervention name(s): warfarin plus albiglutide
Intervention type(s): Biological
Intervention description(s): A single dose of 25mg warfarin on day 1 followed by 5 weekly doses of subcutaneous albiglutide followed by a single dose of 25mg warfarin on day 45.
Intervention MeSH terms: Warfarin; rGLP-1 protein
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: pharmacokinetics; albiglutide; warfarin; Healthy volunteers
Antibody Persistence, and Safety and Tolerability of a Booster Dose of the Meningococcal B Vaccine After the Completion of the Vaccination Course in Study V72_28
Condition: Meningoccocal Disease; Meningococcal Meningitis
MeSH terms: Meningitis, Meningococcal; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this extension study is to explore the antibody persistence 24 to 36 months after
      the last dose of vaccine, in infants that received a two or three dose primary series plus a
      booster dose at 11 months of age, of the Novartis meningococcal B vaccine (Bexsero®) in
      groups I to III of the parent V72_28 study.

      This study will also explore the antibody persistence 24 to 36 months after two catch-up
      doses of the Novartis meningococcal B vaccine (Bexsero®) administered in children (2 to 10
      years old) in group IV of the parent V72_28 study.
    


Intervention name(s): Bexsero® vaccine (1 dose at study month zero); Bexsero® vaccine (2 doses 1 month apart)
Intervention type(s): Biological; Biological
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Meningococcal B disease,; Antibody persistence
PXVX0200 (CVD103-HgR) vs Shanchol in Mali
Condition: Cholera
MeSH terms: Cholera
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare the ability of a single dose of PXVX0200 at two different dose levels, to placebo
      to elicit a significant antibody response 14 days after vaccination, compared to baseline.

      To compare the ability of a single dose of PXVX0200 to a comparator vaccine Shanchol, a two
      dose administration, to elicit antibody response by 14 days after vaccination.
    

Detailed description: 
      Currently there are two licensed inactivated vibrio oral vaccines (Dukoral® [Crucell; Leiden,
      The Netherlands] and Shanchol™ [Shantha Biotechnics; Hyderabad, India]) that are
      pre-qualified by the World Health Organization (WHO) for procurement by United Nations (UN)
      agencies. Each of these vaccines requires a two-dose regimen which is difficult to implement
      in the face of explosive outbreaks of cholera in unsettled situations in developing
      countries. For this reason there is great interest in identifying a cholera vaccine that can
      provide rapid onset of protection following the ingestion of just a single oral dose.

      This Phase 2 randomized, observer-blinded and subject-blinded clinical trial to be conducted
      in Bamako, Mali will assess the immunogenicity of the 10^8 cfu versus the 10^9 cfu
      formulation of PaxVax-manufactured CVD 103-HgR.
    

Intervention name(s): PXVX0200 10E8; PXVX0200 10E9; Placebo; Shanchol
Intervention type(s): Biological; Biological; Biological; Biological
Intervention description(s): Oral dose of PXVX0200 10E8; Oral dose of PXVX0200 10E9; Oral dose of sodium bicarbonate buffer; Licensed comparator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Cholera; Vaccine; Mali
Glycemic Control and Diabetic Macular Edema
Condition: Diabetic Macular Edema
MeSH terms: Macular Edema; Edema
Study type: Observational

Summary: 
      Does diabetic patients' glycemic control affect their response to laser and/or intravitreal
      injection therapy in terms of visual and anatomical outcomes.
    

Detailed description: 
      To evaluate the visual and anatomical response to therapy in patients with diabetic macular
      edema (DME) in relation to their glycemic control.

      Patients with DME with central foveal thickness (CFT) > 250µm with no proliferative disease
      had their glycosolated hemoglobin (HbA1c) measured at baseline and 3 months. CFT by optical
      coherence tomography, and best corrected visual acuity (BCVA) in logMARs were measured at
      baseline, 1, and 3 months. Exclusion criteria: laser or intravitreal injections within 6
      months, hard exudates within 500um of the foveal center, or macular traction. Therapy
      included laser and intravitreal anti VEGFs. HbA1c graded as: G1=<7%, G2= 7-7.9%, G3= 8-8.9%,
      G4 = >9%; and as: low <8%, high ≥ 8%.
    

Intervention name(s): Respond to therapy for diabetic macular edema
Intervention type(s): Other
Intervention description(s): Correlate HBA1c with visual acuity outcome to therapy.
Other intervention name(s): Diabetic Macular Edema and Glycemic Control Using glycosylated hemoglobin
Intervention MeSH terms: Chrysarobin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Diabetic patients with macular edema with central foveal thickness more than 250 microns
        and no proliferative changes.
      
Keywords: Diabetic Macular Edema, Glycemic Control
Glutamate and Diastolic Function in Patients Undergoing Aortic Valve Repair
Condition: Hypertrophy, Left Ventricular; Aortic Stenosis; Myocardial Ischemia; Cardiopulmonary Bypass
MeSH terms: Aortic Valve Stenosis; Myocardial Ischemia; Hypertrophy, Left Ventricular; Ischemia; Hypertrophy
Study type: Interventional
Phase: Phase 4

Summary: 
      Purpose: The effect of intravenous glutamate infusion on myocardial diastolic function and
      overall hemodynamics were studied in patients undergoing elective aortic valve replacement
      with severe aortic stenosis and associated left ventricular hypertrophy .

      Methods: 25 patients will be included in this double-blind randomized placebo-controlled
      study. Glutamate was administered intravenously immediately after aortic cross-clamp release.
      The patients receive either a low dose of 30mg kg-1 h-1 (LG-group) or high dose of 60 mg kg-1
      h-1 (HG-group) or placebo (P-group) at a rate of 3.3ml kg-1h-1 for 2h. Transesophageal
      echocardiography (TEE) is used to measure diastolic and systolic ventricular function before
      sternotomy (T0), and 2h (T2), 3h (T3) and 6h (T4) after release of cross clamp. Additionally
      routine hemodynamic parameters are measured intraoperatively.
    


Intervention name(s): LG-group; HG-group; Placebo-group
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
A Study to Evaluate ALKS 5461 in Subjects With Major Depressive Disorder (MDD)
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will evaluate the efficacy of ALKS 5461 when administered daily for 4 weeks to
      adults with Major Depressive Disorder (MDD) and inadequate response to antidepressant
      therapy.
    

Detailed description: 
      The study will measure efficacy using the HAM-D-17, the MADRS, and the CGI-S as well as using
      other scales and assessments.
    

Intervention name(s): ALKS 5461; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Two active tablets, given daily; Two placebo tablets, given daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Anastrozole Reduced Proliferation and Progesterone Receptor Indexes in Short Term Hormone Therapy
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      Background: Identification of new biomarkers with potential predictive and prognostic role
      has contributed unequivocally to breast cancer treatment.

      Although traditionally endocrine therapy is based on hormonal receptors status (estrogen - ER
      and progesterone- PR), some patients become hormone resistant. In order to identify a
      possible profile associated to hormonal resistance, some biomarkers have been assessed after
      short period primary hormone therapy (HT).

      Objectives: To compare the expression of Ki-67, Bcl2, Bax, Bak, ER and e PR in postmenopausal
      women with ER positive invasive ductal carcinomas (IDC), prior and after tamoxifen and
      anastrozole in short term hormone therapy.
    


Intervention name(s): Anastrozole
Intervention type(s): Drug
Intervention description(s): Tamoxifen 20mg and anastrozole 1 mg
Intervention MeSH terms: Anastrozole
Allocation: Randomized
Masking: Double
Primary purpose: Basic Science
Keywords: Breast cancer; Short Term; Homontherapy; aromatase inhibitor; Short term hormonetherapy in breast cancer
Accuracy of eDiagEPU, a Medical Computerized Tool for EPU
Condition: Pregnant Women Less Than 14 Weeks of Gestation
Study type: Observational

Summary: 
      In a recently published study, a poor knowledge of guidelines in the field of early pregnancy
      was observed in France, Belgium and Switzerland. To improve the respect of the most recent
      criteria of diagnoses, a computerized tool was developped.
    

Detailed description: 
      In December 2018, the investigators published an prospective multinational survey, with 17
      questions that assessed the participants' knowledge, interest, and management of early
      pregnancy in France, Belgium and Switzerland1. Knowledge about early management of pregnancy
      was limited among the practitioners surveyed ; 211/306 (69.0%) participants reported
      incorrect management when they visualized a gestational sac without embryo and 265/306
      (86.6%) misinterpreted changes in serum levels of chorionic gonadotropin during early
      pregnancy.

      To fill this gap, the investigators developped a computerized tool who is following strictly
      the most recent criteria of diagnoses in the field of early pregnancy. This tool should be
      evaluated in an observational study, using data of real patients without modification of
      their management.
    

Intervention name(s): Help to diagnosis software
Intervention type(s): Other
Intervention description(s): Help to diagnosis software
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Pregnant women less than 14 weeks of gestation
      
Keywords: Viable pregnancy; miscarriage; ectopic pregnancy; early pregnancy
Assessment of Peripheral Perfusion in the Critically Ill Patient
Condition: Peripheral Perfusion
Study type: Observational

Summary: 
      The purpose of this study is to evaluate PPI as a surrogate for clinical signs of peripheral
      perfusion in patients in septic shock and after cardiac surgery.
    

Detailed description: 
      The aim of this study is to validate PPI as a continuous, objective measurement of peripheral
      perfusion indicated by clinical sings of tissue perfusion in patients with septic shock.
      Furthermore, PPI shall be compared to the perfusion of solid organs evaluated by ultrasound
      of liver, kidney and gut. In a group of healthy volunteers the investigators will determine
      normal values in ambient temperature and after cooling of an extremity. Another group of
      patients after cardiac surgery, where usually a poor tissue perfusion without metabolic
      failure is present will serve as another "control" population in their post-surgery
      stabilization period. The values from healthy volunteers and cardiac surgery patients will be
      compared to those of patients in septic shock.
    

Intervention name(s): Peripheral Perfusion index by Carescape Patientenmonitor
Intervention type(s): Device
Intervention description(s): Peripheral Perfusion index measured with pulse-oximetry by Carescape Patientenmonitor
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Female and male septic shock patients with ICU admission Female and male patients after
        cardiac surgery with ICU admission healthy volunteers
      
Biospecimen description: 
      blood samples for detecting lactate
    
Keywords: critically ill patients; septic shock; peripheral perfusion index; capillary refill time; mottling score; microcirculation