bioihbjkbjnl/mcl2 huggingface dataset:
Behaviour Intervention to Decrease Melamine Exposure
Condition: Healthy Subjects
Study type: Interventional

Summary: 
      One source of melamine exposure in the modern life is from the use of melamine tableware.
      This study examines whether the use of stainless steel containers can decrease melamine
      exposure in the daily life. The investigators hypothesize that, compared to those without use
      of stainless steel containers, university student volunteers with use of stainless steel
      containers excrete significantly lower melamine levels in urine.
    

Detailed description: 
      Study subjects:

      Two tiers:

        1. Recruit 88 student volunteers from two university buildings and collect their morning
           one-spot urine specimens for 3 consecutive days (44 students in each building (Building
           A and Building B)

        2. Select appropriate study subjects with high excretion of urinary melamine and with
           consuming melamine tableware containing hot water or hot soup by questionnaire in the
           past 3 days for intervention.

      Study protocol:

      This is a cluster randomized crossover intervention. We will conduct this study for 9 days
      and each experimental step lasts for 3 days. We randomly assign one building with 8
      appropriate study subjects to a serial of control-intervention-intervention steps and another
      building with also 8 appropriate study subjects to a serial of control-control-intervention
      steps. Intervention step means study subjects will carry one big bag containing two stainless
      containers, one stainless spoon, and one stainless chopstick and use them for each meal
      during the trial (Some subjects will need to take pictures randomly and email back before the
      meal). Control means study subjects will carry one big bag without those stainless container,
      spoon, and chopstick and only use the containers provided by vendors for each meal during the
      trial (Some subjects will need to take pictures randomly and email back before the meal to
      check their adherence). Collect 24-hr urine samples for 9 days for melamine levels.

      Inclusion criteria: 20-30 healthy students Exclusion criteria: Subjects with cancer,
      hypertension, diabetes, chronic hepatic or renal diseases, including urinary tract infection,
      or renal stones; Family history of renal stones; Body weight less than 50 kg.
    

Intervention name(s): One bag, stainless container
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Melamine; Melamine tableware
The Combination of PECS II Block and Parasternal Block for Radical Mastectomy
Condition: Breast Cancer
Study type: Interventional

Summary: 
      The combination of PECS II and parasternal Block provides analgesia after radical mastectomy
    

Detailed description: 
      The cambionation of PECS II block and parasternal block
    

Intervention name(s): PECS II and parasternal block; Levobupivacaine
Intervention type(s): Procedure; Drug
Intervention description(s): 10 ml of Levobupivacaine 0.375% injected between minor and major pectoralis muscles. 20 ml of Levobupivacaine 0.375% injected between minor and serratus muscles. 10 ml of Levobupivacaine 0.375% injected between major and intercostal muscles at II and IV intercostal space.; Levobupivacaine
Other intervention name(s): Pectoral nerve block II type and parasternal block; Locali anesthetic
Intervention MeSH terms: Anesthetics; Levobupivacaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: PECS II block, parasternal block, analgesia
TD-1607 SAD Study in Healthy Subjects
Condition: Serious Infections Due to Known or Suspected Gram-positive Pathogens
MeSH terms: Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      TD-1607, administered intravenously as single doses, will be investigated in healthy subjects
      to assess its tolerability, safety, and pharmacokinetics.
    


Intervention name(s): TD-1607; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Gram-positive; Infections; Bacterial infections
Oxycodone (10, 20 mg) in a Postoperative Dressing
Condition: Burns
Study type: Interventional
Phase: Phase 4

Summary: 
      The study mainly focuses on pain management using 10- or 20mg oxycodone burn wound dressing
      at Poznan University of Medical Sciences.
    

Detailed description: 
      Subjects were randomly assigned to one of the two treatment groups, A and B. Patients
      scheduled for burn surgery will sign written consent pre-operatively about procedural pain
      management. Group A received 10mg of oxycodone in wound dressing, while those in Group B
      received 20mg of oxycodone in wound dressing.
    

Intervention name(s): Oxycodone 10mg; Oxycodone 20mg
Intervention type(s): Drug; Drug
Intervention description(s): 10mg of oxycodone was added to Octenisept in the wound dressing.; 20mg of oxycodone was added to Octenisept in the wound dressing.
Other intervention name(s): 10mg oxycodone; 20mg oxycodone
Intervention MeSH terms: Oxycodone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Study to Assess the Plasma Concentration of Tolebrutinib Given as a Tablet to Adult Participants With Renal Impairment Compared to Healthy Participants
Condition: Renal Impairment
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this parallel group, Phase 1, open-label, 2-arm study is to assess the effect
      of severe (Part A) and moderate (Part B, conditional) renal impairment (RI) on
      pharmacokinetics (PK), safety and tolerability of tolebrutinib tablets compared with normal
      renal function, in male and female participants aged 18 to 79 years.
    

Detailed description: 
      The total duration of the study per participant will be up to 38 days including:

        -  A screening period of up to 4 weeks.

        -  A 5-day, open-label treatment period.

        -  Up to 7 days post-treatment follow-up period
    

Intervention name(s): tolebrutinib
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form: Film-coated tablets Route of administration: oral
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Peppermint Oil for the Treatment of Irritable Bowel Syndrome: Optimizing Therapeutic Strategies Using Targeted Delivery
Condition: Irritable Bowel Syndrome; Abdominal Pain; Colonic Diseases, Functional
MeSH terms: Irritable Bowel Syndrome; Colonic Diseases; Colonic Diseases, Functional; Syndrome; Abdominal Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      Peppermint oil has shown to be effective in the treatment of Irritable Bowel Syndrome (IBS)
      symptoms in several meta-analyses. However, the level of evidence is moderate and peppermint
      oil remains relatively under-used in IBS. Therefore, the investigators will conduct a
      multicenter randomized, placebo controlled trial to investigate the effects of an eight-week
      peppermint oil treatment in IBS patients according to current European Medicines Agency (EMA)
      / US Food and Drug Administration (FDA) guidelines. To improve efficacy and to reduce side
      effects, the investigators aim to study the use of a new peppermint oil formulation, a
      colon-targeted-delivery capsule that will release the oil in the (ileo-) colonic region
      specifically.
    


Intervention name(s): Ileocolonic release peppermint oil; Placebo; Small intestinal release peppermint oil
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Peppermint oil, menthae piperitae aetheroleum; Placebo capsule, containing microcrystalline cellulose; Peppermint oil, menthae piperitae aetheroleum
Other intervention name(s): Tempocol
Intervention MeSH terms: Peppermint oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Irritable Bowel Syndrome; Abdominal pain; Targeted Delivery; Peppermint oil
Bioequivalence Study of Fingolimod From Sphingomod 0.5 mg Hard Gelatin Capsules (Hikma Pharma, Egypt) Versus Gilenya 0.5 mg Hard Capsules (Novartis Pharma AG, Basle, Switzerland).
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      An open label randomized, single dose, two-way crossover bioequivalence study to determine
      the bioequivalence of Fingolimod From Sphingomod 0.5 mg Hard Gelatin Capsules (Hikma Pharma,
      Egypt) Versus Gilenya 0.5 mg Hard Capsules (Novartis Pharma AG, Basle, Switzerland) in
      Healthy Human Volunteers Under Fasting Condition.
    

Detailed description: 
      Open-label, randomized, single dose, two-sequence, two-way crossover study, separated by 49
      days washout interval from the first study drug administration.

      Healthy volunteers, 18-55 years of age, selected from the Egyptian population fulfilling the
      selection criteria. 30 subjects will participate in the study. All dosed subject samples will
      be analyzed and their data will be included in the final study report.

      Primary Pharmacokinetic Parameters: Cmax, AUC0→t and AUC0→∞ Secondary Pharmacokinetic
      Parameters: Ke, tmax and t1/2e. ANOVA using 5% significance level for transformed (with the
      90% confidence intervals) and untransformed data of Cmax, AUC0→t and AUC0→∞ and for
      untransformed data of Ke, tmax and t1/2e.

      The confidence intervals of logarithmically transformed Test/Reference ratios for Cmax,
      AUC0→t and AUC0→∞ to be within 80.00-125.00%.

      A comprehensive final report will be issued upon the completion of the study.
    

Intervention name(s): Sphingomod; Gilenya
Intervention type(s): Drug; Drug
Intervention description(s): 1 capsule contains 0.5 mg Fingolimod; 1 capsule contains 0.5 mg Fingolimod
Other intervention name(s): Gilenya
Intervention MeSH terms: Fingolimod Hydrochloride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Study in Healthy Volunteers to Prove That Two Rotigotine Patches From Different Manufacturing Sites Deliver Equivalent Drug Amount to the Body
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The major aim of this study is to investigate and compare the drug amount delivered to the
      body after sequential application of 2 rotigotine transdermal patches from 2 different
      manufacturing sites.
    


Intervention name(s): rotigotine transdermal patch (Neupro®)
Intervention type(s): Drug
Intervention description(s): Rotigotine 4.5 mg/10 cm^2 patch applied for 24 hours
Other intervention name(s): Neupro®
Intervention MeSH terms: Rotigotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Rotigotine; Neupro®
Mobile Goal-setting Intervention to Improve Vegetable Intake Among Young College Students
Condition: Diet, Healthy
Study type: Interventional

Summary: 
      This study used a two-group pre-posttest experimental design. After completing a background
      survey, participants used their smartphones to uploaded photos and/or descriptions of their
      meals to an online platform for three days. In addition, those in the intervention group were
      asked to use a checklist to count the number of times they ate red/orange vegetables and to
      set a goal to eat one more time the next day. The dependent variable was a measure of eating
      behavior-an estimate (number of times/day) of red/orange vegetable intake on that day based
      on review of uploaded photos and descriptions. Those in the intervention group, who were
      asked to use a checklist to count their red/orange vegetable intake and set a goal to eat one
      more the next day, improved their vegetable intake.
    


Intervention name(s): Mobile goal-setting intervention
Intervention type(s): Behavioral
Intervention description(s): This intervention applied two constructs from the goal setting theory-self-monitoring and goal setting. Briefly, all participants were asked to take photos of all their meals and upload them with descriptions to an online platform. The participants in the experimental group were taken through two additional processes that represented these two constructs. Self-monitoring was operationalized by asking those in the experimental group to count the number of times they ate red/orange vegetables using a counting checklist. Goal setting was operationalized as asking them to set a goal to eat red/orange vegetables one more time tomorrow.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomized to either an experimental or a control group after they completed a preliminary questionnaire.
Masking: Single (Participant)
Primary purpose: Prevention
COPD MSA 3 Regions: Epidemiology and Risk Factors of COPD in Rural Environment (BM3R)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      The agricultural environment presents a unique profile in terms of epidemiology of pulmonary
      diseases. Certainly due to persistent exposure to organic particles, the prevalence of COPD
      is higher in farmers than in the general population, despite less smoking. It is likely that
      the risk of COPD depends on several factors, such as the type of farm, local conditions and
      the region where the farm is located. It is important to diagnose COPD at an early stage in
      order to initiate appropriate therapy, and implement secondary prevention with a view to
      limiting deterioration of respiratory function and reducing complications. In this context,
      the aims of BM3R project were: (1) to study the epidemiology of COPD in a large
      representative sample of French farmers, in order to identify the types of farming, working
      conditions and regions that are associated with the presence of COPD; and (2) to develop a
      score to identify patients at risk and optimise diagnosis of COPD in the context of a
      screening programme.
    


Intervention name(s): Spirometry
Intervention type(s): Diagnostic Test
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Data were collected between October 2012 and May 2013 in two French regions (Brittany and
        Franche-Comté) among affiliated members (farmers and administrative workers of both sexes)
        of the MSA.
Single-dose AME Study With [14C]AR882 in Healthy Male Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study
      following a single dose of [14C]AR882 in healthy adult male subjects. Whole blood, plasma,
      urine, and fecal samples will be analyzed for at least 144 hours following the single dose of
      AR882 to measure total radioactivity and plasma drug concentrations.
    


Intervention name(s): [14C]AR882
Intervention type(s): Drug
Intervention description(s): Single dose of [14C]AR882
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effects of Cervical Stabilization Exercises on Pulmonary Functions and Respiratory Muscle Strength
Condition: Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      This study aims to assess the effects of stabilization exercises on pulmonary functions and
      respiratory muscle strength. 42 participants with neck pain enrolled the study.
    

Detailed description: 
      This study aims to assess the effects of stabilization exercises on pulmonary functions and
      respiratory muscle strength. 42 participants with neck pain enrolled the study. Participants
      were divided into two groups, stabilization group (n=21) and the control group (n=21). The
      participants underwent a total of 24 sessions of treatment thrice a week for eight weeks
      under the supervision of a physiotherapist.
    

Intervention name(s): cervical stabilization exercises; conventional exercises
Intervention type(s): Other; Other
Intervention description(s): cervical stabilization exercises; conventional exercises
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: neck pain; pulmonary function test; respiratory muscle strength; cervical stabilization exercises
Eccentric Training and Cryotherapy Vs Eccentric Training and Whole Body Vibration in Achilles Tendinopathy
Condition: Achilles Tendon; Tendinopathy
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effectiveness of eccentric exercise combined
      with vibration or cryotherapy in Achilles tendon pathology.

      The investigators hypothesis is that the combined eccentric exercise is better than the
      results presented by the exclusive eccentric exercise.

      This intervention differs from the classic studies in that we maintain the intensity
      throughout the treatment.
    


Intervention name(s): Cryotherapy and eccentric exercise; Vibration and eccentric exercise
Intervention type(s): Other; Other
Intervention description(s): 12 weeks, 5 days/week, once a day, 2 exercises, 3 sets/exercise, 15 repetition/set. Of excentric exercise of foot plantar flexors. First exercise with knee in extension. Second exercise with knee in flexion. Previously subjects should cool their leg in ice water during sixteen minutes at a temperature of 8ºC (+/-2ºC); 12 weeks, 5 days/week, once a day, 2 exercises, 3 sets/exercise, 15 repetition/set. Of excentric exercise of foot plantar flexors. First exercise with knee in extension. Second exercise with knee in flexion. During the exercise subjects will be subjected to vibration. Vibration parameters: Frequency: 35Hz, Amplitude: 4 millimeters, Force: 3,9G
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: Eccentric exercise; Whole body vibration; Cryotherapy
Stereotactic Laser Ablation for Temporal Lobe Epilepsy
Condition: Temporal Lobe Epilepsy
MeSH terms: Epilepsy; Epilepsy, Temporal Lobe
Study type: Interventional

Summary: 
      The study is designed to evaluate the safety and efficacy of the Visualase MRI-guided laser
      ablation system for mesial temporal epilepsy (MTLE).
    

Detailed description: 
      The purpose of the study is to evaluate the safety and efficacy of the Visualase MRI-guided
      laser ablation system for necrotization or coagulation of epileptogenic foci in patients with
      intractable mesial temporal lobe epilepsy.

      The study will include approximately 150 adult patients with drug-resistant MTLE treated at
      selected epilepsy centers across the United States. After the Visualase procedure, patients
      will be followed for 12 months and evaluated for freedom from seizures, quality of life,
      adverse events, and neuropsychological outcomes.
    

Intervention name(s): Visualase MRI-Guided Laser Ablation
Intervention type(s): Device
Intervention description(s): All subjects will undergo MRI-guided laser ablation of the amygdala and hippocampus with the Visualase System.
Other intervention name(s): Visualase System; Visualase procedure; Laser interstitial thermal therapy; Stereotactic laser ablation
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: epilepsy; laser ablation; Visualase; laser interstitial thermal therapy
Safety Study of Human Anti-Cytomegalovirus Monoclonal Antibody
Condition: Cytomegalovirus Infections
MeSH terms: Cytomegalovirus Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety profile in healthy adult volunteers of
      single or multiple intravenous administrations of TCN-202 as compared with placebo.
    

Detailed description: 
      Human cytomegalovirus (HCMV) disease remains an unmet medical need: In the US, the estimated
      prevalence of congenital HCMV infection is ~1% and is one of the leading causes of permanent
      hearing loss and neurological deficits in children. In immunocompromised individuals such as
      transplant recipients it can cause serious life-threatening disease and may significantly
      increase the risk of graft rejection. As existing therapies for HCMV can have serious side
      effects, there remains a medical need for safe and effective treatment of HCMV disease.
    

Intervention name(s): TCN-202; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Human monoclonal neutralizing antibody that recognizes a broadly conserved functional epitope on HCMV. One or two doses will be administered by intravenous infusion.; One or two doses administered by intravenous infusion.
Other intervention name(s): Human Anti-Cytomegalovirus Monoclonal Antibody; 0.9% Sodium chloride for Injection, USP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Cytomegalovirus; Monoclonal antibody
Study Mild Intermittent Asthma to Assess the Topical Safety and Tolerability of Albuterol Sulfate Acu-30™ DPI
Condition: Allergic Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 1

Summary: 
      This open label single blind study will determine the safety of albuterol sulfate dry powder
      in a novel inhaler by observing for the potential occurrence of reflex bronchial constriction
      after inhalation of increasing doses of the compound.
    

Detailed description: 
      This is a single blind (investigator unblinded), open label, single exposure, non-randomized,
      single center, outpatient, stepwise, rising dose study in male subjects with mild
      intermittent asthma to assess topical safety and tolerability of Albuterol Sulfate Acu-30™
      DPI, compared with Placebo Acu-30™ DPI. Increasing doses of each drug will be administered in
      a sequential fashion in 4 steps to 3 different subjects at each step (a total of 12 subjects)
      with mild intermittent asthma in each step.
    

Intervention name(s): Albuterol sulfate
Intervention type(s): Drug
Intervention description(s): Single dose dry powder by inhalation
Intervention MeSH terms: Albuterol
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: asthma; inhaler device; albuterol sulfate