bioihbjkbjnl/mcl2 huggingface dataset:
Phase 1/1b Study of Rilotumumab in Japanese Subjects With Advanced Solid Tumors or Advanced or Metastatic Gastric or GEJ
Condition: Part 1- Advanced Solid Tumors; Part 2- Advanced or Metastatic Gastric Cancer; Part 2- Advanced or Metastatic GEJ
MeSH terms: Stomach Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open label phase 1/1b study of Rilotumumab in Japanese subjects with advanced
      solid tumors or metastatic gastric esphagogastric (GEJ) adenocarcinoma.
    


Intervention name(s): Rilotumumab; Rilotumumab
Intervention type(s): Drug; Drug
Intervention description(s): Rilotumumab is a fully human monoclonal antibody immunoglobulin G, type 2 (IgG2) against human hepatocyte growth factor/scatter (HGF/SF) that blocks binding of HGF/SF to its receptor MET, inhibiting HGF/MET-driven activities in cells.; Drug: Rilotumumab Rilotumumab is a fully human monoclonal antibody immunoglobulin G, type 2 (IgG2) against human hepatocyte growth factor/scatter (HGF/SF) that blocks binding of HGF/SF to its receptor MET, inhibiting HGF/MET-driven activities in cells. Drug: Cisplatin A platinum containing chemo-therapy compound that reacts in vivo, binding to and causing crosslinking of DNA, which ultimately triggers apoptosis (programmed cell death). Drug: Capecitabine A chemo-therapy prodrug, that is enzymatically converted to 5-fluorouracil in the tumor, where it inhibits DNA synthesis and slows growth of tumor tissue.
Other intervention name(s): AMG 102; AMG 102
Intervention MeSH terms: Rilotumumab; Antibodies, Monoclonal
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Advanced Solid Tumors; Advanced or Metastatic Gastric Cancer; Advanced or Metastatic GEJ; Gastric Cancer
ARIA (Atacand Renoprotection In NephropAthy Pt.)
Condition: Non-diabetic Nephropathy With Hypertension
MeSH terms: Kidney Diseases; Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      To determine the effective dose of candesartan cilexetil for reduction of urinary protein
      excretion in hypertensive patients with non-diabetic chronic kidney disease with baseline
      urinary protein/creatinine ratio between 500mg/g and 5000mg/g, by assessing the change in
      urinary protein/creatinine ratio from baseline to the end of 28-week treatment
    


Intervention name(s): Candesartan Cilexetil; Candesartan Cilexetil; Candesartan Cilexetil 32mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 8 mg oral once daily dose; 16 mg oral once daily dose; 32 mg oral once daily dose
Other intervention name(s): Atacand; Atacand; Atacand
Intervention MeSH terms: Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Candesartan Cilexetil; Non-diabetic Nephropathy; hypertension; urine protein creatinine ratio
Safety, Tolerability, and PK of AN2728 in Adolescents With Atopic Dermatitis
Condition: Dermatitis, Atopic
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to investigate the safety, tolerability, and systemic exposure
      of AN2728 Topical Ointment, 2%, in subjects with atopic dermatitis.
    


Intervention name(s): AN2728 Topical Ointment, 2%
Intervention type(s): Drug
Intervention description(s): AN2728 Topical Ointment, 2%
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: atopic dermatitis
Multi-strain Probiotic in the Management of IBS-D
Condition: Irritable Bowel Syndrome
MeSH terms: Irritable Bowel Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      1. To assess the effect of multistrain probiotics on abdominal pain using a validated
           symptom severity score in IBS patients.

        2. To assess the efficacy of a multi-strain probiotic supplement as a treatment option for
           IBS in a tertiary referral centre
    

Detailed description: 
      Background: Accumulating evidence supports the view that an imbalance of gut bacteria
      contributes to IBS, and that increasing the mass of beneficial species may reduce the numbers
      of pathogenic bacteria and help alleviate symptoms.

      Methods: In this double-blind trial 360 adult patients with moderate-to-severe symptomatic
      diarrhea-predominant IBS (IBS-D) were randomized to treatment with the multi-strain probiotic
      (Bio-Kult®; 14 different bacterial strains; 8 billion colony-forming units per day) or
      placebo for 16 weeks. The change in severity and frequency of abdominal pain was the primary
      outcome measure.
    

Intervention name(s): Probiotic Formula Capsule
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: a randomized, double-blind, placebo-controlled clinical trial
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficacy and Safety of Acitretin Plus Pioglitazone in Patients With Psoriasis
Condition: Psoriasis
MeSH terms: Psoriasis
Study type: Interventional
Phase: Phase 2

Summary: 
      Acitretin, when given in combiantion with pioglitazone might achieve better and/or more rapid
      control of moderate to severe chronic plaque type psoriasis.
    


Intervention name(s): Pioglitazone; Acitretin
Intervention type(s): Drug; Drug
Intervention description(s): Acitretin
Intervention MeSH terms: Pioglitazone; Acitretin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Ankle Support on Muscle Activation and Function
Condition: Ankle Sprain
MeSH terms: Ankle Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to examine the effects of ankle taping on improving muscle
      function and ankle motion in individuals who frequently twist (sprain) their ankle. It is
      thought that ankle taping may increase muscle function and ankle motion which would benefit
      individuals who frequently sprain their ankle.
    

Detailed description: 
      Previous research has demonstrated improved dynamic balance following the application of
      fibular taping. The effects of fibular taping on ankle dorsiflexion ROM and muscle activation
      in individuals with CAI are unknown. The purpose of this study is to determine the acute
      effects of fibular taping on muscle activation of the fibularis longus (peroneus) and soleus
      muscles, ankle dorsiflexion range of motion (ROM) and dynamic balance. The investigators
      hypothesize that fibular taping will have similar effectiveness as mobilization interventions
      which have been shown to improve muscle activation, ankle dorsiflexion ROM,and dynamic
      balance. Outcomes will be measured immediately before and after intervention. A crossover
      design will be used and participants will complete two visits at least 48 hours apart, but
      not more than 1 week apart. After participants complete both arms of the study their
      participation will be complete (average time to completion for each subject is 1 week).
    

Intervention name(s): Fibular Taping; Sham Taping
Intervention type(s): Other; Other
Intervention description(s): Tape with be applied with tension.; Tape will be applied without tension
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ankle tape; Hoffmann reflex; Balance
This Study Will Evaluate the Persistence of Hepatitis A Antibodies, 8 Years and 10 Years Later, in Children Who Had Received Havrix at Selected Health Centres of Panama
Condition: Hepatitis A Vaccine
MeSH terms: Hepatitis A; Hepatitis
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the persistence of hepatitis A antibodies,
      approximately 8 years and 10 years post vaccination with the complete series of Havrix (2
      doses) and the partial series completion (1 dose).
    

Detailed description: 
      The study comprises of two independent cross-sectional surveys (Year 8 and Year 10). The
      first cross-sectional serosurvey will evaluate the long term persistence of immunity
      approximately 8 years post vaccine administration and the second cross-sectional study will
      evaluate long term persistence, approximately 10 years post vaccine administration.
    

Intervention name(s): Blood sample collection
Intervention type(s): Other
Intervention description(s): A blood sample (~5mL) will be collected from all subjects at each cross-sectional survey (Year 8 and Year 10).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Havrix; Cross-sectional seroprevalence survey; Panama; Long-term persistence; Hepatitis
Effects of Nevirapine on the Steady State Pharmacokinetics of Fluconazole in HIV Positive Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to determine the effects of nevirapine on the steady state
      pharmacokinetics of fluconazole and to assess the steady-state pharmacokinetics of nevirapine
      when given in combination with fluconazole.
    


Intervention name(s): Fluconazole; Nevirapine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Fluconazole; Nevirapine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Test-retest Effect of the "d2 Test of Attention".
Condition: Cognition and Attention in Surgeons and Nurses
Study type: Interventional

Summary: 
      The "d2 test of attention" has been used in studies regarding sleep deprivation due to night
      shifts in hospital staff, in order to determine whether sleep deprivation has an impact on
      performance. However, by repeating the test there appears to be a test-retest effect, as the
      participants improve when performing the test more than once. The aim of this study is to
      determine, whether the "d2 test of attention" has a test-retest effect.
    

Detailed description: 
      20 surgeons and 20 surgical nurses will be included in this study. They will be asked, after
      thorough instruction, to perform the d2 test of attention after a designed schedule. The
      participants will on day 1 and 2 perform the test 3 times consecutively at intervals of 5
      minutes. On day 3, 4 and 5 the test will be repeated only once. After the 5th day follows a
      7-day-break. On day 13 the test will again be performed once.
    

Intervention name(s): d2 test of attention
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Safety and Performance Trial of DIALIVE Liver Dialysis Device in Acute On Chronic Liver Failure Patients
Condition: Acute on Chronic Liver Failure
MeSH terms: Liver Failure; Hepatic Insufficiency; End Stage Liver Disease; Acute-On-Chronic Liver Failure
Study type: Interventional

Summary: 
      The First-In-Man study is a multi-centre, randomised, controlled, study to generate data for
      the evaluation of safety and performance of DIALIVE Liver Dialysis Device in 24 evaluable
      patients with Acute on Chronic Liver Failure (ACLF) versus standard of care (SOC).
    

Detailed description: 
      The First-In-Man study will evaluate the safety and performance of DIALIVE Liver Dialysis
      Device in Acute on Chronic Liver Failure (ACLF) patients and will compare the outcome with
      patients treated under standard of care (SOC).

      The hypothesis is that DIALIVE will significantly improve the prognosis of ACLF patients by
      modulating systemic inflammation.

      The target patient population are men and women ≥18 years, ≤81yr. Patients with ACLF grade 1
      and ACLF grade 2 on the background of alcoholic cirrhosis. During the study, inclusion
      criteria were expanded to include also AKI-1 and ACLF 3a patients. Treatment will be
      undertaken in an intensive care (ICU) or renal dialysis unit setting if the patients are
      randomised to the DIALIVE treatment arm. For patients randomised to the 'Standard of care'
      arm, the location of treatment (ICU or general ward) will be determined by their clinical
      need and will be decided by the site Principal Investigator.

      This project has received funding from the European Union's Horizon 2020 research and
      innovation programme under grant agreement No 733057.
    

Intervention name(s): DIALIVE Liver Dialysis Device
Intervention type(s): Device
Intervention description(s): ACLF patients will receive dialysis treatment for 8-12 hrs/day and on three to five consecutive days over a 10-day time period. Dialysis treatment is performed by using the DIALIVE device provided by YAQRIT Ltd.
Other intervention name(s): YAQ 002
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: The design is a multi-centre, randomised, controlled, study to generate data for the evaluation of safety (as measured by the percentage of subjects who experience at least one serious adverse event (SAE)) and performance (as measured by lowering of the plasma endotoxin concentrations, and improved albumin function) of DIALIVE in 24 evaluable patients with Acute on Chronic Liver Failure (ACLF) versus standard of care (SOC). During the study the sample size was increased to include a total 30 evaluable patients.
Masking: None (Open Label)
Primary purpose: Device Feasibility
Keywords: Medical device; Liver dialysis; Haemofilter; ACLF
Cognitive Training for Firefighters With Tinnitus
Condition: Tinnitus
MeSH terms: Tinnitus
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this research study is to determine whether the Brain Fitness Program-Tinnitus
      affects how tinnitus is perceived and if its use aids in the recovery of cognitive functions
      that may be affected by tinnitus. The investigators hope to better understand areas of the
      brain involved with or changed because of tinnitus. The investigators also hope to see if the
      Brain Fitness Program-Tinnitus impacts changes in those areas of the brain the investigators
      believe may be affected by tinnitus.
    

Detailed description: 
      The objective of this pilot research project is to advance knowledge about the role of
      attention, control, and other cortical networks in the development and maintenance of
      bothersome tinnitus.

      The investigators have three specific aims. First, determine whether the Brain Fitness
      Program-Tinnitus affects the tinnitus percept and aids the recovery of cognitive functions
      apparently "highjacked" by the tinnitus. Brain Fitness Program-Tinnitus was developed to
      improve cognitive function by engaging the brain's neuroplasticity; the program is novel,
      non-invasive, and inexpensive. Second, establish specific default mode, attention system, and
      cognitive control network deficits in patients with bothersome tinnitus through the use of
      advanced neuroimaging techniques. Third, assess whether exposure to the Brain Fitness
      Program-Tinnitus impacts changes in the default mode, attention system, and cognitive control
      network deficits.

      The investigators will employ a randomized clinical trial design among a cohort of
      active-duty firefighters who experience bothersome tinnitus. A planned enrollment of 40
      firefighters with tinnitus in the clinical trial will have sufficient statistical power to
      detect a 17-point change in Tinnitus Handicap Inventory scores. In addition, a previously
      developed fcMRI protocol will be used to study brain activity in regions associated with
      voluntary, involuntary, and executive control of attention in 60 firefighters (40
      firefighters enrolled in the clinical trial and 20 firefighters without tinnitus).
    

Intervention name(s): Brain Fitness Program - Tinnitus
Intervention type(s): Behavioral
Intervention description(s): Brain Fitness Program-Tinnitus was developed to improve cognitive function by engaging the brain's neuroplasticity; the program is novel, non-invasive, and inexpensive.
Other intervention name(s): Posit Science
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Tinnitus
Study to Evaluate the Safety, Reactogenicity, and Immunogenicity of mRNA Vaccine Candidate Variations in Healthy Adults
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      The main purpose of the study is to evaluate the safety, reactogenicity, and the
      immunogenicity of mRNA-1010 vaccine candidate variations.
    


Intervention name(s): mRNA-1010; mRNA-1010.4; mRNA-1010.6
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Sterile liquid for injection; Sterile liquid for injection; Sterile liquid for injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: mRNA-1010; Influenza Vaccine; Moderna
Bioequivalence Study of Lamotrigine Tablets 25 mg (2 x 25 mg Tablets) Under Fasting Condition
Condition: Fasting State
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open Label, randomized, two-period, two-treatment, two-sequence, crossover,
      balanced, single dose pivotal study. The purpose of this study is to assess the
      bioequivalence between Test Product and the corresponding Reference Product under fasting
      condition in healthy adult human subjects.
    

Detailed description: 
      Objective of this pivotal study was to assess the bioequivalence between Test Product:
      Lamotrigine Tablets 25 mg (2 x 25 mg)of M/s Ipca Laboratories Limited, India and the
      corresponding Reference Product: LAMICTAL® (Lamotrigine) Tablets 25 mg (2 x 25 mg) of
      GlaxoSmithkline, USA, under fasting condition in healthy adult human subjects in a randomized
      crossover study.

      The study was conducted with 28 healthy adult subjects. In each study period, a single 2 X 25
      mg dose of either test or reference was administered to the subjects as per the randomization
      schedule in each study period with about 240 mL of water at ambient temperature in sitting
      position.

      The duration of the clinical phase was approximately 26 days including washout period of at
      least 21 days between administrations of study drug in each study period.
    

Intervention name(s): Lamotrigine Tablets 25 mg; Lamotrigine
Intervention type(s): Drug; Drug
Intervention description(s): 2 x 25 mg tablet once a day; 2 x 25 mg tablet once a day
Other intervention name(s): Test Product; LAMICTAL®
Intervention MeSH terms: Lamotrigine; Anticonvulsants
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Very-Low-Density-Lipoprotein-Triglyceride(VLDL-TG) Metabolism During Acute Hyperglycemia
Condition: Type 1 Diabetes
MeSH terms: Diabetes Mellitus, Type 1; Hyperglycemia
Study type: Observational

Summary: 
      The purpose of this study is to estimate the acute effect of hyperglycemia on
      Very-Low-Density-Lipoprotein-triglyceride(VLDL-TG) secretion.
    


Intervention name(s): Hyperglycemia
Intervention type(s): Other
Intervention description(s): Hyperglycemia with a blood glucose of 15 mmol/L
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Type 1 diabetics
      
Biospecimen description: 
      Blood Samples
    
Keywords: Type 1 diabetes; Very-Low-Density-Lipoprotein(VLDL); Hyperglycemia
Effects of White Wine vs. Tea Intake During and an Alcoholic Digestive Following a High Fat, High Calorie Cheese Fondue Meal on Gastric Emptying and Abdominal Symptoms in Healthy Volunteers
Condition: Healthy Participants
Study type: Interventional
Phase: Phase 4

Summary: 
      Tradition holds that the intake of different drinks with a meal has an important influence on
      the digestion of food and postprandial symptoms such as fullness, bloating and satiety;
      however this assumption have never been subjected to controlled study

      A classic example is the Swiss cheese fondue. The intake of white wine, tea and cherry
      schnapps (Kirsch) are often attributed either positive or negative effects on the
      gastrointestinal tract.

      In this study the effect of white wine vs. tea intake during and an alcoholic digestive
      following a high fat, high calorie Swiss fondue meal on gastric emptying and visceral
      perception will be investigated using a randomized, controlled study design.

      The fondue will be labeled with non-radioactive 13C octanoate for assessment of gastric
      emptying by breath-test.
    


Intervention name(s): Ingestion of white wine vs. tea during and an alco
Intervention type(s): Dietary Supplement
Intervention description(s): 4 x 50ml glasses of white wine (12% alcohol) or tea will be taken according to a randomization scheme After the meal 1 x 20ml of Kirsch (40% alcohol) or tea will be taken
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research