bioihbjkbjnl/mcl2 huggingface dataset:
Anti-inflammatory Effects of Enriched Enteral Nutrition During Human Experimental Endotoxemia
Condition: Endotoxemia
MeSH terms: Endotoxemia
Study type: Interventional

Summary: 
      During sepsis and septic shock the immune response can be overwhelming leading to excessive
      tissue damage, organ failure and death. Ideally, the inflammatory response is modulated
      leading to both adequate protection to invading pathogens as well as limitation of an
      exuberant immune response. In the last years, experimental evidence has been accumulating
      that enteral administration of lipid-enriched nutrition attenuates inflammation and preserves
      organ integrity in several inflammatory models. The current study investigates the
      immune-modulating potential of enriched enteral nutrition in a human setting of experimental
      endotoxemia.
    


Intervention name(s): control enteral nutrition; enriched enteral feeding
Intervention type(s): Other; Other
Intervention description(s): This feeding consists of 20en% fat, 16en% protein and 49en% carbohydrates; This feeding contains 46 energy percent (en%) fat, 24en% protein and 30en% carbohydrates and is enriched with phospholipids.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: enteral nutrition; endotoxemia; innate immunity; nutritional anti-inflammatory pathway; intestinal damage
Care for Late Stage Parkinsonism
Condition: Parkinson's Disease; Late Stage Parkinson's Disease
MeSH terms: Parkinson Disease; Parkinsonian Disorders
Study type: Interventional

Summary: 
      The aim of this project is to evaluate the needs and provision of care for patients in the
      late stages of Parkinsonism and their carers in several European countries, to compare the
      effectiveness of different health and social care systems, and to lay the foundation for
      improved outcomes in this population. The investigators will undertake an in-depth assessment
      of patients and their care arrangements in a population recruited through networks in six
      European countries. The systems and procedures that are used in the provision of care will be
      reviewed through a systematic literature review, interviews and assessments of patients,
      carers and health care providers, and through a trial comparing assessment by a specialist
      with management suggestions, guidance and access to telephone advice to that of usual care.
      Through interviews, questionnaire assessment and review of current health-care and social
      care arrangement, the investigators will assess the needs, provision of care and use of
      health-care resources, and their impact on patient and carer outcomes in different countries.
      National and regional databases will also be interrogated to identify current practice and
      use of healthcare resources and drug usage. A systematic literature review of the evidence
      for effective management strategies, analysis of the study data, and evaluation of change in
      outcomes following specialist review will provide the basis for recommendations in the
      management of late stage Parkinsonism. The investigators will also evaluate potentially
      useful outcome measures for use in this patient group. In addition to charting the needs and
      current care provision for late stage Parkinsonism in different European countries, its cost
      and effectiveness, and an analysis of health-care and social care predictors of improved
      outcome, the project will produce a platform for the assessment of patients with late stage
      Parkinsonism, their current treatment and care provision, as well as guidelines on the
      management of this late disease phase.
    


Intervention name(s): Specialist review
Intervention type(s): Other
Intervention description(s): Specialist review with individually tailored treatment strategies suggested by specialist
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parkinson's disease, Late stage
A Study of Safety, Tolerability, and Pharmacokinetics of Single Doses of PHP-303 in Healthy Subjects
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1, randomized, double-blind, placebo-controlled single ascending dose (SAD)
      study designed to evaluate the safety, tolerability, and pharmacokinetics (PK) of PHP-303 in
      healthy volunteer subjects. Within each ascending dose cohort, subjects will be randomized in
      a 3:1 ratio to receive PHP-303 or placebo. The primary objective is to establish the safety
      and tolerability of orally-administered PHP-303.
    


Intervention name(s): PHP-303; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Investigational drug; Matching placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study of the Effect of Tirzepatide on How the Body Handles Birth Control Pills in Healthy Female Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to look at how the body processes the commonly prescribed birth
      control pill, ethinylestradiol + norgestimate (EE/NGM), in healthy female participants and
      the effect of tirzepatide on how EE/NGM is processed by the body. Information about any side
      effects that may occur will also be collected.

      Screening is required within 28 days prior to the start of the study. For each participant,
      the study will last about 20 weeks, including screening.
    


Intervention name(s): Tirzepatide; EE/NGM
Intervention type(s): Drug; Drug
Intervention description(s): Administered SC; Combination oral contraceptive administered orally
Other intervention name(s): LY3298176
Intervention MeSH terms: Tirzepatide
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
The Safety Evaluation of Drug Combinations Against High Altitude Pulmonary Hypertension
Condition: High Altitude Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary; Altitude Sickness; Hypertension
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, three period, two sequence, open-label, randomized, crossover study, with
      the primary objective of testing the safety and tolerability of combined oral doses of
      theophylline and bambuterol in healthy human subjects. The secondary objective is to assess
      the pharmacokinetic profiles of theophylline and bambuterol when administered alone or in
      combination. It is hypothesized that the combination of these drugs is generally safe, and
      that no drug interaction can be observed.
    

Detailed description: 
      This is a Phase I, three period, two sequence, single-center, open-label, randomized,
      crossover study design. Periods I and II consist of the oral administration of either a
      single dose of theophylline or bambuterol alone, followed by a 7 day wash out interval.
      Subsequently, Period III consists of the simultaneous administration of both drugs. All
      subjects are to be confined to the Oslo University Hospital Research Unit throughout all
      treatment periods [Study Day 1, 7 and 14]. A sufficient number of healthy adult subjects will
      be consented in order to enroll 20 and complete 16 subjects who complete all three periods.
      Replacement of subjects is permitted, if necessary.

      Qualified subjects will be randomized into one of two sequences consisting of three Periods
      as indicated below:

      -------------Period 1-----Period 2-----Period 3

      Sequence A: Treatment 1 Treatment 2 Treatment 3

      Sequence B: Treatment 2 Treatment 1 Treatment 3

      TREATMENTS:

      Treatment 1: Theophylline 300 mg.

      Treatment 2: Bambuterol 20 mg.

      Treatment 3: Theophylline 300 mg plus Bambuterol 20 mg.

      After completion of each treatment period, the subjects will proceed to the next period
      provided no Stopping Rules criteria have been met
    

Intervention name(s): Theophylline and Bambuterol
Intervention type(s): Drug
Intervention description(s): Treatment 3: Theophylline, 300 mg plus Bambuterol, 20 mg
Intervention MeSH terms: Theophylline; Bambuterol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Primed vs Unprimed Facilitatory and Depressive Paired Associative Stimulation
Condition: Healthy
Study type: Interventional

Summary: 
      Following brain injury (e.g. stroke), application of non-invasive brain stimulation may
      improve rehabilitative efforts. However, the most effective method of non-invasive brain
      stimulation is unknown. Paired associative stimulation (PAS) is a method of non-invasive
      brain stimulation that pairs an electrical peripheral nerve stimulus with a magnetic stimulus
      to the head. This method can be applied in a manner that increases (facilitates) or decreases
      (depresses) excitability within the brain. Furthermore, applying two consecutive PAS sessions
      within minutes of each other (called primed PAS) may augment changes in excitability more
      than a single PAS session alone.

      Thus, the purpose of this study is to compare the effect of a double PAS session (primed PAS)
      to the effect of a single PAS session (unprimed PAS) and a sham PAS session in healthy
      individuals.
    


Intervention name(s): Transcranial Magnetic Stimulation (Magstim)
Intervention type(s): Device
Other intervention name(s): TMS; Magstim
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Device Feasibility
Comparison Between Local and Imported Skin Prick Testing Result of Rat and Mouse Allergen Extracts
Condition: Allergic Rhinitis Due to Animal Hair and Dander
MeSH terms: Rhinitis; Rhinitis, Allergic
Study type: Interventional

Summary: 
      In respiratory allergy patients, skin prick test results of local rat and mouse allergen
      extracts are not significant different from imported ones
    

Detailed description: 
      Many researches proposed that rodent deteriorate symptoms in patients with respiratory
      allergy who sensitized. The test that can identify rodent sensitization will be very useful.
      The investigators found lots of problems from imported mouse and rat allergen extract, eg.
      expensive cost and hard to find importing agency in Thailand. Making own local allergen
      extract will be the good solution for the country. This study aim to compare the results of
      locally rat and mouse allergen to imported ones.
    

Intervention name(s): rat and mouse skin test
Intervention type(s): Diagnostic Test
Intervention description(s): Comparison between local and imported skin prick testing result of rat and mouse allergen extracts in respiratory allergy patients
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
A Study of ARQ 197 in Healthy Volunteers to Assess the Pharmacokinetic (PK) Profile in Extensive and Poor Metabolizers as Defined by Cytochrome P450 2C19 (CYP 2C19) Genotype
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To assess the PK and safety profiles of ARQ 197 in extensive and poor metabolizers, as
      defined by CYP 2C19 genotype
    

Detailed description: 
      This is a pharmacokinetic study designed to compare the metabolism of ARQ 197 in normal
      healthy volunteers who are extensive metabolizers (EM) or poor metabolizers (PM) as defined
      by CYP 2C19 genotype. This is an open-label, single-dose, parallel group design in which
      healthy volunteer subjects will receive a single dose of ARQ 197
    

Intervention name(s): Treatment with ARQ 197
Intervention type(s): Drug
Intervention description(s): Treatment with ARQ 197
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: PK and safety profile of ARQ 197
Effect of Delayed Remote Ischemic Preconditioning on Myocardial Injury
Condition: Myocardial Injury
MeSH terms: Wounds and Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate delayed myocardial protective effect of RIPC in
      patients undergoing cardiac valve replacement surgery.
    

Detailed description: 
      Ischemic preconditioning is one of the strategies that can reduce perioperative myocardial
      injury. It is a concept that briefly induced ischemia and reperfusion before the myocardial
      injury can reduce the myocardial injury. But it is difficult to apply ischemic
      preconditioning in operative field, because cross-clamping of aorta or coronary artery is
      difficult and invasive. Afterward concept of remote ischemic preconditioning(RIPC) has
      introduced that ischemia of remote organs like kidneys, skeletal muscles can reduce distant
      myocardial injury.

      It is known that myocardial protective effect of ischemic preconditioning have biphasic
      pattern. Early protective effect wanes after a few hours, then recurs after 24-48 hours, and
      can persist for up to 3-4 days. It is called second window of preconditioning or delayed
      ischemic preconditioning. Delayed ischemic preconditioning is similar to early ischemic
      preconditioning in mechanism but it is different that it produces protein that can mediate
      myocardial protection effect.

      Unlike ischemic preconditioning, it is little known about delayed effect of RIPC. RIPC can be
      done by applying compression cuff on upper or lower extremities and it is noninvasive and
      easy to deliver compared to ischemic preconditioning that is done by aorta or coronary artery
      clamping.

      Delayed ischemic preconditioning is performed one day before the surgery, and it is safe and
      easy to apply RIPC in a clinical setting. And in this study investigators are going to
      evaluate cardioprotective effect of delayed RIPC. Myocardial injury can be predicted by
      elevation of cardiac enzyme. Investigators are going to perform RIPC one day before the valve
      replacement surgery and compare troponin I with control group to assess cardioprotective
      effect of delayed RIPC.
    

Intervention name(s): delayed remote ischemic preconditioning; control
Intervention type(s): Procedure; Procedure
Intervention description(s): In the delayed RIPC group, RIPC is performed 24-48 hr before surgery by 5 minutes limb ischemia and reperfusion with pneumatic cuff up to 200 mmHg repeated by four times.; In the control group, all the procedures were the same with delayed RIPC group, except for the fact that the three-way stopcock between the pneumatic cuff and the cuff inflator was opened and therefore the cuff pressure did not increase.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: delayed remote ischemic preconditioning; troponin; valve replacement surgery
Treating Drug-Resistant Childhood Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia; Schizophrenia, Childhood
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare clozapine and olanzapine (Zyprexa®) for the treatment of children and
      adolescents who have failed standard antipsychotic treatment for schizophrenia.
    

Detailed description: 
      Schizophrenia is a devastating illness regardless of the age at which it presents. When this
      disorder occurs in childhood or adolescence, the consequences in terms of functional
      impairment, loss of developmental opportunities, and family and societal burden are
      particularly dramatic.

      Evidence supports the improved efficacy and/or side effect profile of atypical antipsychotic
      medication in adults. Thus, it is essential to examine whether the potential benefits of
      these agents can be extended to children, particularly children who have failed standard
      treatment.

      Patients are randomly assigned to receive either clozapine or olanzapine daily for 12 weeks.
      Patients meet with the study team once a week to discuss progress and record side effects.
      Three parent meetings take place during the study. During these meetings, questions are
      discussed and support and education about schizophrenia are given to parents. Various scales
      to measure psychotic, manic, aggressive, and depressive symptoms are used to assess patients.
    

Intervention name(s): Olanzapine; Clozapine
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive olanzapine for 12 weeks.; Participants will receive 12 weeks of clozapine.
Intervention MeSH terms: Olanzapine; Clozapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Validation of Actigraph Measured Sleep During Acute Diverticulitis
Condition: Acute Diverticulitis
MeSH terms: Diverticulitis
Study type: Observational

Summary: 
      The purpose of this study is to investigate the accuracy of actigraph measured sleep compared
      to the golden standard (polysomnography) during Acute uncomplicated diverticulitis. Our
      hypothesis is the actigraph is accurate for sleep-monitoring for this group of patients
    

Detailed description: 
      The actigraph has been proven to measured sleep data with an accuracy about 80% (compared
      with Polysomnography) in patients who have undergone surgery.

      But this accuracy has not been validated in relation to none surgical inflammatory diseases.
      This study will investigate the accuracy of actigraph measured sleep in diverticulitis
      patients.

      Following methods will be applied

      Device: Wrist-Actigraph - Octagonal Basic Motionlogger, Ambulatory monitoring Inc, New York,
      USA

      Other: Sleep-diary

      Device: Polysomnograph - Embla Titanium (Natus Medical Incorporated, USA)
    

Observational model: Case-Crossover
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        16 x Acute uncomplicated diverticulitis (Hansen and stock stage 1) patients aged 18-75
        years managed by antibiotic treatment at Herlev Hospital.
Safety and Efficacy of 1550nm Fractional Laser Treatment for Acne Scars in Fitzpatrick Type IV-VI Skin
Condition: Acne Scarring
MeSH terms: Cicatrix
Study type: Interventional

Summary: 
      Fractionated laser resurfacing is commonly used as a treatment for acne scarring in fair
      skinned individuals. This study aims to test the efficacy and safety in darker skin types.
      Patients are randomized to either the 10mJ 40mJ dosages and receive a total of five
      treatments at 17% one month apart. Improvement is judged by a dermatologist as 0-25%, 25-50%,
      50-75% or 75-100%. Side effects such as pigmentary abnormalities and pain are also evaluated.
    

Detailed description: 
      Background: Ablative resurfacing lasers are effective for treatment of acne scars, but they
      have a high risk of complications. Fractional lasers have less severe side effects but more
      moderate efficacy than ablative devices. Studies were performed in individuals with
      Fitzpatrick skin type I to VI.

      Objective: To determine the efficacy and safety of an erbium 1,550-nm fractional laser in the
      treatment of facial acne scars in Fitzpatrick skin types IV to VI.

      Methods: We conducted a prospective, single-blind, randomized trial in patients with acne
      scars (n=15), skin type IV to VI, with a 1,550-nm erbium fractionated laser. Patients were
      divided into two groups; one was treated with 10 mJ and the other with 40 mJ. Five monthly
      laser sessions were performed. A patient questionnaire was distributed.
    

Intervention name(s): Fractionated Laser Resurfacing
Intervention type(s): Procedure
Other intervention name(s): Fractionated Laser: FRAXEL
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acne scarring; Post inflammatory hyperpigmentation
Alpha Lipoic Acid to Decrease Pain and Side Effects in Concurrent Treatment of HNSCC
Condition: HNSCC
MeSH terms: Squamous Cell Carcinoma of Head and Neck
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I, single-center, non-randomized, 3+3 dose-escalation study of alpha lipoic
      acid given during chemotherapy-radiation in HNSCC patients with non-metastatic disease.
    

Detailed description: 
      The study will be completed when the MTD and RP2D are determined. This will be either when 2
      or more patients have a DLT at a particular dose level, or when 6 patients have completed
      treatment at the highest dose level (600 mg TID). The final 3 patients enrolled at the
      highest tolerated dose will also complete PK studies.
    

Intervention name(s): Alpha Lipoic Acid
Intervention type(s): Drug
Intervention description(s): Stage II-IVB HNSCC patients receiving concurrent systemic therapy and radiation in the definitive, adjuvant, or palliative setting will receive ALA according to their prescribed dose level. ALA will be taken orally or per feeding tube. It will start 1 week prior to the start of CRT, continue on through CRT, and then continue for 2 weeks after the completion of CRT. Patients will be given dosing diaries to document date and time of each drug administration as well as any missed doses. They will also have weekly visits to report AEs and concurrent medications, have a history and physical exam, report VAS pain scores and OMAS scores, and fill FACT-HN surveys.
Intervention MeSH terms: Thioctic Acid
Intervention model: Sequential Assignment
Intervention model description: 3+3 Dose Escalation: Dose Level -2: ALA 300 mg daily Dose Level -1: ALA 600 mg daily Dose Level 1: ALA 600 mg BID Dose Level 2: ALA 600 mg TID
Masking: None (Open Label)
Primary purpose: Supportive Care