bioihbjkbjnl/mcl2 huggingface dataset:
Epicutaneous 1-Chloro-2, 4-Dinitrobenzene (DNCB) Patch in HIV Infection.
Condition: HIV Infections
MeSH terms: Infections; Communicable Diseases; HIV Infections; Acquired Immunodeficiency Syndrome
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the efficacy of dinitrochlorobenzene (DNCB) in patients with early HIV infection
      by monitoring immunologic parameters and serum HIV RNA. To facilitate the understanding of
      possible alterations in the immunological status of the HIV+ patient cohort.
    


Intervention name(s): Dinitrochlorobenzene
Intervention type(s): Drug
Primary purpose: Treatment
Keywords: Cohort Studies; RNA, Viral; Administration, Cutaneous; Anti-HIV Agents; Dinitrobenzenes
Safety and Tolerability of GATE-251 in Normal Human Volunteers
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety and tolerability of single ascending doses of GATE-251 in normal human
      volunteers
    

Detailed description: 
      Single ascending dose (SAD), double-blind placebo-controlled study in normal human
      volunteers.

      Secondary objectives:

      To evaluate the pharmacokinetics (PK) and eeg biomarker of target engagement of GATE-251
      following increasing single doses of GATE-251.

      GATE-251 or Placebo: Dose/Mode of Administration: Single dose; oral
    

Intervention name(s): GATE-251; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of GATE-251; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Double blind placebo controlled
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: NMDA receptor; NMDA receptor positive allosteric modulator; pharmacokinetics; biomarker; eeg
The Effects of Including Almonds in a Weight Loss Trial
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether inclusion of almonds in a weight loss
      regimen will augment the rate of weight loss, promote a greater fat mass/fat-free mass ratio
      of weight loss, improve blood pressure and ameliorate the post-lunch dip in cognitive
      function.
    

Detailed description: 
      The purpose of this study is to determine whether inclusion of almonds in a weight loss
      regimen will augment the rate of weight loss, promote a greater fat mass/fat-free mass ratio
      of weight loss, improve blood pressure and ameliorate the post-lunch dip in cognitive
      function.
    

Intervention name(s): Energy restriction; Almonds (15% kcal/day)
Intervention type(s): Behavioral; Behavioral
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Almonds; Energy restriction; Obesity; Body weight; Body fat; Blood pressure; Cognitive function
Treatment of Posttraumatic Stress Disorder in Kosovar High School Students Using Mind-Body Skills Groups
Condition: Stress Disorders, Post-traumatic
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the participation in a group program which
      includes meditation, biofeedback, drawings, autogenic training, genograms, and a variety of
      movement and breathing techniques will decrease symptoms of posttraumatic stress in high
      school students.
    

Detailed description: 
      The objective of this study is to determine whether participation in a group program
      incorporating mind-body techniques decreases symptoms of posttraumatic stress in adolescents.
      Students will be screened for posttraumatic stress using the Harvard Trauma Questionnaire and
      eighty-two qualifying students will be randomly assigned to a 12-session mind-body group
      program or a wait-list delayed intervention group. The program will be conducted by the
      teachers at a high school in Kosovo and include meditation, biofeedback, drawings, autogenic
      training, genograms, and a variety of movement and breathing techniques. Changes in
      posttraumatic stress symptoms will be measured using the Harvard Trauma Questionnaire.
    

Intervention name(s): Mind-Body Skills Groups
Intervention type(s): Behavioral
Intervention description(s): 12 week mind-body skills group program including guided imagery, relaxation techniques,autogenic training, meditation, biofeedback, drawings, genograms and movement techniques.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: posttraumatic stress; mind-body techniques; war; adolescents
Acute Posttraumatic Osteomyelitis in Patients With High-energy Tibial Fractures and Biomarkers
Condition: Osteomyelitis Tibia; Surgical Site Infection
MeSH terms: Surgical Wound Infection; Osteomyelitis; Tibial Fractures
Study type: Observational [Patient Registry]

Summary: 
      The present trial was aimed to identify which biomarkers could be associated in perioperative
      period after surgical treatment of tibial fracture to the development of POM.
    

Detailed description: 
      Early diagnosis of acute posttraumatic osteomyelitis (POM) is of vital importance for
      avoiding devastating complications. Diagnosing POM is difficult due to the lack of a highly
      specific and sensitive test, such as in myocardial infarct, stroke and intracranial bleeding.
      Serum inflammatory markers, C-reactive protein (CRP), procalcitonin (PCT), white blood cells
      (WBC) can support clinical findings but they are not able to differentiate between
      inflammatory response to infection and the host response to non-infection insult with high
      specificity and sensitivity.

      The prospective nonrandomised cohort study included 86 patients after high-energy injury to
      the shin requiring primary surgical treatment (open or closed reduction and internal fixation
      of tibial fracture). Values of the biochemical and immunoinflammatory profile were measured
      on admission (ADD), first postoperative day (POD1) and fourth-postoperative day (POD4).

      The objectives of the study were to investigate that the biochemical and immunoinflammatory
      profile could facilitate postoperative monitoring, guide the antibiotic treatment and timing
      of revision surgery.
    

Intervention name(s): blood sample on admission (ADD), first postoperative day (POD1) and fourth postoperative day (POD4)
Intervention type(s): Diagnostic Test
Intervention description(s): Laboratory analyses of peripheral venous blood on admission (blood sample ADD), 24 hours after surgery (blood sample POD1) and fourth-day after surgery (blood sample POD4) included biochemical analysis, complete blood count, C-reactive protein (CPR), procalcitonin (PCT), albumin/protein level, prothrombin time and international normalized ratio (INR) (only on admission) and for determination of cytokines: tumor necrosis factor alpha (TFN-α), interleukin-6 (IL-6), interleukin-10 (IL-10).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients admitted to the Department of Traumatology at University Clinical Centre Ljubljana
        were included after written informed consent.
      
Keywords: osteomyelitis; tibial fracture; cytokines; PCT; CRP; albumin
The Effect of Chlorhexidine on the Oral and Lung Microbiota in Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      Determine the effect of twice-daily chlorhexidine oral rinse on oral and lung microbiota
      biomass in subjects with chronic obstructive pulmonary disease (COPD) with chronic
      bronchitis. Our primary outcome will be to compare the microbiota biomass (number of bacteria
      as measured by 16S rRNA copy number) of induced sputum and the oral cavity before and after 8
      weeks of twice-daily chlorhexidine oral rinse (n=25) compared to controls (n=25) using qPCR
      and next-generation sequencing of the bacterial 16S rRNA gene comparing total bacterial
      biomass
    

Detailed description: 
      Our hypothesis is that 8 weeks of chlorhexidine oral rinse will decrease microbiota biomass
      compared to baseline and those on placebo. Furthermore, we hypothesize that chlorhexidine
      treatment will: i) decrease lung and oral microbiota diversity; ii) alter microbiota
      taxonomic composition in the lung and oral cavity; iii) decrease systemic inflammation as
      measured by blood high sensitivity C-reactive protein (hsCRP), fibrinogen and leukocyte
      count; and iv) demonstrate a trend towards improvement in respiratory health status as
      measured by the Breathlessness, Cough, and Sputum Scale (BCSS)[1, 2] and St. George's
      Respiratory Questionnaire (SGRQ).

      Subaim 1: Determine if chlorhexidine alters the lung and oral rinse microbiota diversity and
      taxonomic composition. Our hypothesis is that chlorhexidine oral rinse will decrease the
      diversity (Shannon and inverse Simpson diversity indices) and taxonomic composition of both
      oral and lung microbiota compared to those on placebo as determined by next-generation
      sequencing of the bacterial 16S rRNA gene.

      Subaim 2: Determine the impact of chlorhexidine on systemic inflammation. Our hypothesis is
      that the decrease in lung microbiota biomass is associated with a decrease in systemic
      inflammation as measured by blood hsCRP, fibrinogen, and leukocyte count.

      Subaim 3: Determine if respiratory symptoms associate with the lung microbiota biomass. Our
      hypothesis is that chlorhexidine will demonstrate improved respiratory health status as
      measured by the BCSS and SGRQ.
    

Intervention name(s): Chlorhexidine; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Oral Rinse; Oral Rinse
Intervention MeSH terms: Chlorhexidine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: COPD; Bacteria
Nalbuphine as an Adjuvant to Levobupivacaine in Caudal Analgesia in Children
Condition: Caudal Anesthesia
Study type: Interventional

Summary: 
      Caudal anesthesia is the single most important pediatric regional anesthetic technique and is
      increasingly performed in pediatric regional anesthesia practices. It is preferred in order
      to relieve intra-operative and postoperative pain in children of all age groups undergoing
      pelvi-abdominal or lower limbs surgeries using levobupivacaine 0.25%.Various adjuvants have
      been added to levobupivacaine to prolong postoperative caudal analgesia. Nalbuphine as many
      opioids can be added in caudal analgesia. This prospective randomized double blind study was
      done to compare the effects of plain levobupivacaine versus Levobupivacaine plus nalbuphine
      single-shot for postoperative pain relief in children undergoing hypospadius repair surgery.
    


Intervention name(s): caudal block
Intervention type(s): Procedure
Intervention description(s): caudal block
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Study to Assess the Long-term Safety, Tolerability, Efficacy of Secukinumab in Pediatric Patients of Age 6 to <18 Years, With Moderate to Severe Plaque Psoriasis
Condition: Moderate to Severe Chronic Plaque-type Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 3

Summary: 
      This was an open-label, parallel-group, two-arm, multicenter study in pediatric subjects aged
      6 years to less than 18 years, at randomization, with moderate to severe chronic plaque
      psoriasis. 84 subjects (most with moderate severity) were enrolled. Subjects were stratified
      by weight and disease severity.
    

Detailed description: 
      This was an open-label, parallel group, two-arm, multi-center, trial in pediatric subjects
      aged 6 years to less than 18 years, at randomization, with moderate to severe chronic, plaque
      psoriasis. The study consists of 3 periods: screening (up to 4 weeks), treatment (of 208
      weeks) and post-treatment follow-up (of 16 weeks).

      Approximately 80 subjects (at least 60 subjects with moderate psoriasis) were planned to be
      enrolled in about 40 centers worldwide and targeted to have at least 5 subjects in the < 25kg
      body weight, and at least 10 subjects in each of the other two weight groups (25-< 50 kg and
      ≥ 50 kg). Adolescents (12-< 18 years) and children (6-< 12 years) were included from the
      beginning of this study, since the DMC had approved already the enrollment of children (6-<
      12 years) in the study CAIN457A2310. Subjects received the appropriate dose based on their
      body weight category.

      If the subject moved into a higher or lower weight group at two consecutive visits with
      weight measurements during the maintenance (from Week 12 onwards as assessed at 4 weekly
      visits or during extension treatment period (as assessed at scheduled site visits), then the
      subject was dosed according to the new (higher or lower) weight group respectively.
    

Intervention name(s): secukinumab low dose; secukinumab high dose
Intervention type(s): Drug; Drug
Intervention description(s): dose depends on the weight group; dose depends on the weight group
Other intervention name(s): AIN457; AIN457
Intervention MeSH terms: Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatric; secukinumab; plaque psoriasis; AIN457A; Skin condition; skin disease; itching condition; psoriasis vulgaris; relapsing/remitting psoriasis; immune-mediated systemic disease; skin lesions; red skin lesions; scaly patches; papules; plaques; itching
Effect of Opicapone at Steady State on Warfarin Pharmacokinetics
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      Single-centre, open-label, fixed-sequence design consisting of 2 periods separated by a
      washout period of at least 14 days.
    

Detailed description: 
      Single-centre, open-label, fixed-sequence design consisting of 2 periods separated by a
      washout period of at least 14 days. In Period 1, a single dose of 25 mg warfarin was
      administered alone. In Period 2, subjects received 475 mg OPC, on Day 1 and D2 followed by 50
      mg OPC once daily for 5 days (D3 to D7). On D8, 50 mg OPC was administered with a single dose
      of 25 mg warfarin.
    

Intervention name(s): BIA 9-1067; Warfarin
Intervention type(s): Drug; Drug
Other intervention name(s): OPC, Opicapone; Uniwarfin
Intervention MeSH terms: Opicapone; Warfarin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of Postprandial Glycaemia in a Healthy Population After Intake of Milk and Oat Based Products
Condition: Healthy
Study type: Interventional

Summary: 
      The objective of this study is to investigate the effect on postprandial glycaemia in a
      healthy population after intake of milk and oat based products.
    

Detailed description: 
      Postprandial glycaemia, insulinaemia and GLP-1 will be measured after intake of test meals
      with equal amount of carbohydrates (adjusted using bread) and equal amount of total water.
    

Intervention name(s): Bread reference; Product 1: Milk; Product 2: Full fat milk + oat; Product 3: Skim milk + oat, high fibre; Product 4: Skim milk + oat, low fibre
Intervention type(s): Other; Other; Other; Other; Other
Intervention description(s): Commercially available white wheat bread; Developed reference product based on milk; Developed product based on full fat milk with addition of oat; Developed product based on skim milk with addition of oat giving a high fiber content to the product; Developed product based on skim milk with addition of oat giving a lower fiber content to the product
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
A Six Week Efficacy, Safety and Tolerability Study of V565 in Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of V565 in participants with
      active Crohn's Disease (CD).
    

Detailed description: 
      This study will be a multiple-site, double-blind, placebo-controlled, parallel-group study in
      approximately 126 subjects with a confirmed diagnosis of CD for at least three months and
      have CD involving the ileum and/or colon. Following a screening period of up to 28 days,
      subjects will be randomly allocated into one of two treatment arms: either V565 or placebo
      using a 2:1 active:placebo ratio for a treatment period of 6 weeks.

      Subjects will be treated with study drug as an add-on to any permitted stable medications
      already being taken for CD.
    

Intervention name(s): V565; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Daily dosing of V565 three times a day orally for 6 weeks; Daily dosing of placebo three times a day orally for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Multicenter Study to Evaluate the Efficacy and Safety of Oral ACT-539313 in the Treatment of Adults With Moderate to Severe Binge Eating Disorder
Condition: Binge-Eating Disorder
MeSH terms: Bulimia; Feeding and Eating Disorders; Binge-Eating Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Placebo-controlled study to evaluate the efficacy and safety of oral ACT-539313 in the
      treatment of adults with moderate to severe binge eating disorder
    


Intervention name(s): ACT-539313; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): ACT-539313 as capsules at a strength of 100 mg, taken orally, b.i.d. in the morning at breakfast and in the evening at dinner, with a glass of water during the treatment period.; Matching placebo as identical capsules indistinguishable from ACT-539313, taken orally, b.i.d. in the morning at breakfast and in the evening at dinner, with a glass of water during the treatment period.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Multicenter, double-blind, randomized, placebo-controlled, parallel-group, proof-of-concept study
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Measurement of Soluble Factors and Particulate Matter in Induced Sputum and EBC in Inflammatory Diseases of the Lung
Condition: Asthma; Chronic Obstructive Pulmonary Disease; Interstitial Lung Diseases; Occupational Lung Diseases
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Lung Diseases, Interstitial
Study type: Observational

Summary: 
      In the present study inflammatory mediators will be isolated in induced sputum and exhaled
      breath condensate and will be correlated with particulate matter measured in these
      samples.Particulate matter will be assessed by partcle size distribution method and shape
      analysis.

      The aim of the study is to perform biological monitoring in environmental and occupational
      diseases in a non invassive fashion.
    


Intervention name(s): no generic names
Intervention type(s): Other
Time perspective: Retrospective
Keywords: Primary disease or condition being studied: Asthma -COPD-Interstitial Lung Diseases-Occupational Lung Diseases
Effects of Phlebotomy on Insulin Sensitivity in Insulin Resistance-associated Hepatic Iron Overload Patients
Condition: Insulin Resistance; Iron Overload
MeSH terms: Insulin Resistance; Iron Overload
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate efficacy of phlebotomy on insulin sensitivity as
      evaluated by euglycemic-hyperinsulinic clamp in insulin resistance-associated hepatic iron
      overload patients.
    

Detailed description: 
      The main objective of this study is to evaluate in patients with HSD effects of treatment
      with phlebotomy rules with lifestyle and dietary rules versus lifestyle modifications alone
      on peripheral insulin resistance (assessed by hyperinsulinemic clamp).

      Secondary objectives are:

        -  to study in all patients with HSD the relationship between the amount of iron
           intrahepatic and degree of peripheral insulin resistance and liver before therapeutic
           intervention.

        -  to study and compare the effects of phlebotomy treatment versus no treatment on:

             -  Plasma levels of adipocytokines,

             -  Plasma concentrations of inflammatory markers and markers of insulin resistance,

             -  The serum ferritin,

             -  The post-hepatic clearance of insulin,

             -  The surface of the abdominal visceral fat and subcutaneous abdominal.
    

Intervention name(s): phlebotomy; dietary and lifestyle counseling
Intervention type(s): Procedure; Behavioral
Intervention description(s): 7 ml/kg without exceeding 500 mL; dietary and lifestyle counseling
Other intervention name(s): Non applicable.; Non applicable.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Phlebotomy; Insulin Resistance; Iron Overload
Combination Study Of S-555739/Cetirizine HCl In Adult Patients With Seasonal Allergic Rhinitis
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study was to examine the efficacy and safety of
      S-555739/cetirizine HCl compared with the individual components and placebo.
    


Intervention name(s): S-555739 Dose 1; S-555739 Dose 2; Cetirizine HCl Dose 1; S-555739 placebo; Cetirizine HCl placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Cetirizine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Agents, anti allergic; Nasal congestion; Sneezing; Nasal discharge; D prostanoid (DP) receptor antagonist