bioihbjkbjnl/mcl2 huggingface dataset:
Near Infrared Spectroscopy for Detection of Cerebral Desaturation After Positioning for Neurosurgical Procedures
Condition: Cognitive Dysfunction; Patient Positioning
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The occurrence of postoperative cognitive dysfunction (POCD) might be related to
      intraoperative cerebral desaturation. Positioning for neurosurgical procedures are associated
      with head rotation, elevation, flexion or extention that may affect blood brain inflow and
      outflow. Anatomical variations of Willis circle could affect the cerebral blood flow in
      extreme head position with the development of cerebral ischemia or functional changes of
      brain. Investigators suppose that detection of cerebral tissue desaturation and its prompt
      correction could modify the occurence of POCD after these procedures.
    

Detailed description: 
      Standardized anesthesia and perioperative care will be provided to all patiens with
      positioning for neurosurgical or spinal procedures, where the head is elevated, extended.
      flected or rotated. In group A before the start of general anesthesia, the baseline level of
      cerebral tissue oxygenation (rScO2) will be measured using the near-infrared spectroscopy
      NIRS (Invivo Medtronic) . Continuous measurement of rScO2 will be used for detection of
      cerebral tissue desaturation. Each desaturation episode will be managed according to a
      standardized protocol - correction of extreme head position will be followed by
      optimalisation of mean arterial pressure (MAP), arterial hemoglobin oxygen saturation, end
      tidal carbon dioxide concentration and a level of hemoglobine concentration. In group B
      neither measurement of rScO2 nor interventions are provided. Cognitive dysfunction will be
      assessed by Adenbrooke test before operation and on the fifth postoperative day.
    

Intervention name(s): NIRS based protocol
Intervention type(s): Other
Intervention description(s): Each desaturation episode will be managed according to a standardized protocol - correction of extreme head position will be followed by optimisation of mean arterial pressure (MAP), arterial hemoglobin oxygen saturation, end tidal carbon dioxide concentration and a level of hemoglobine concentration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Near-Infrared Spectroscopy; Neurosurgical Procedures; Cognitive Dysfunction
Identification of Potential Biomarkers of Response to Peptide Immunotherapy for Ragweed Allergy
Condition: Ragweed Allergy
MeSH terms: Rhinitis, Allergic, Seasonal; Hypersensitivity
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to identify changes in potential biomarkers after peptide
      immunotherapy for that may subsequently be developed as biomarkers that correlate with
      clinical efficacy.
    


Intervention name(s): ToleroMune Ragweed; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Intradermal administration 1x8 administrations, 2 weeks apart; Intradermal injection 1x8 administrations, 2 weeks apart
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Keywords: ragweed allergy; immunotherapy
The Effect of Magnesium Sulfate on Motor and Somatosensory Evoked Potentials in Children Undergoing Scoliosis Surgery
Condition: Scoliosis
MeSH terms: Scoliosis
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this study is to determine whether magnesium sulfate has a
      clinically important effect on the amplitude and latency of somatosensory and motor evoked
      potentials in patients undergoing surgical correction of idiopathic scoliosis.
    

Detailed description: 
      Motor and somatosensory evoked potentials are continuously monitored in the setting of
      scoliosis surgery to evaluate the integrity of spinal cord pathways. Detection of neural
      irritation or injury using motor or somatosensory evoked potentials allows the surgeon to
      modify technique to reverse the insult and proceed without spinal cord compromise. To
      facilitate evoked potential monitoring, anesthetic agents that attenuate the evoked responses
      must be avoided.Several different agents have been studied to try to diminish the acute
      opioid tolerance and/or hyperalgesia seen with remifentanil.

      Two studies investigated the effect of magnesium sulfate on intraoperative
      remifentanil-induced hyperalgesia. In both studies, post-operative pain scores and opioid
      consumption were decreased in those patients who received magnesium.

      Our aim is to establish that magnesium sulfate does not adversely affect somatosensory evoked
      potentials (SEPs) and motor evoked potentials (MEPs) in patients undergoing correction of
      idiopathic scoliosis. Future clinical trials can then be performed investigating the effect
      of magnesium sulfate on remifentanil-induced hyperalgesia in the same population.
    

Intervention name(s): Magnesium
Intervention type(s): Drug
Intervention description(s): Magnesium will be administered intravenously at a dose of 50 mg/kg bolus followed by an infusion of 10 mg/kg/hr.
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: pediatrics; Anaesthesia; Scoliosis; Magnesium
A Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers
Condition: Cold Sore
MeSH terms: Herpes Labialis
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison of the efficacy of penciclovir 10 mg/g (1%) cream with that of vehicle at 72 hours
      in preventing the appearance of classical lesions following prodromal symptoms (tingling or
      burning sensation) based on thermographic assessment among recurrent cold sore sufferers.
    


Intervention name(s): Penciclovir; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Penciclovir every 2 hours during waking hours for 96 hours; Placebo every 2 hous during waking hours for 96 hours
Intervention MeSH terms: Penciclovir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: cold sore
Effect of Oral L-carnitine Supplement on Lipid Profile, Anemia, and Quality of Life of Patients
Condition: Complication of Hemodialysis
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine Effect of oral L-carnitine supplement on lipid
      profile, anemia, and quality of life.
    

Detailed description: 
      In patients under maintenance hemodialysis several factors reduce the body stored carnitine
      which in turn affected dyslipidemia, anemia, and general health in these patients. The
      investigators evaluated the effect of oral L-carnitine supplementation on lipid profiles,
      anemia, and quality of life in hemodialysis patients.
    

Intervention name(s): L-carnitine; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg,twice daily, 16 weeks; 500 mg,twice daily, 16 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Renal failure, hemodialysis, dyslipidemia, L-carnitine.
The Effects of Mogroside Sweetener on Viral Load in TreatmenT Naive Genotype 1 (GT 1) Subjects CHC
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if administering Mogroside Sweetener "PureLo" (the
      study substance) for 14 days will lower the hepatitis C viral load and liver function alanine
      aminotransferase (ALT) levels.
    

Detailed description: 
      The primary objectives of the study are to assess the safety and efficacy of administering
      Mogroside Sweetener "PureLo" to genotype 1 subjects at a dose level of 5 grams every 6 hours
      for 14 days on hepatitis C viral load and serum ALT levels. Percentage change in HCV load
      over the first 48 hours and daily for 14 days and change in serum ALT levels over the two
      week period of study, will be calculated for each patient. The number of subjects who show a
      decline in viral load of at least 50% will then be calculated, as will the number of subjects
      who decrease their serum ALT levels by at least 50%. All efficacy and safety analysis will be
      conducted at the end of the study.
    

Intervention name(s): Mogroside sweetener (PureLo)
Intervention type(s): Dietary Supplement
Intervention description(s): Mogroside sweetener administered at a dosage level of 5g every 6 hours for 14 days
Other intervention name(s): Pure Lo
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic Hepatitis C
IX-01 Effect on Intravaginal Ejaculatory Latency Time (IELT) and Patient Reported Outcomes in Men With Premature Ejaculation (PE)
Condition: Premature Ejaculation
MeSH terms: Premature Birth; Premature Ejaculation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the effectiveness of IX-01 in men with lifelong
      premature ejaculation.
    


Intervention name(s): IX-01; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Cockroach Nasal Allergen Challenge Pilot
Condition: Asthma; Cockroach Hypersensitivity
MeSH terms: Asthma; Hypersensitivity
Study type: Interventional
Phase: Phase 1

Summary: 
      This research is being done to look at the body's response to cockroach extract, an allergen,
      when sprayed into the nose. The spraying of the cockroach extract into the participant's nose
      is called Nasal Allergen Challenge (NAC). The purpose of this study is to evaluate the safety
      and tolerability of a intranasal cockroach extract given to participants with asthma.
    

Detailed description: 
      This is a multi-center, open label pilot study to assess the safety and determine the
      feasibility of cockroach nasal allergen challenge in children with asthma. This pilot study
      will occur in two phases:

        -  Phase 1 will enroll 10 cockroach sensitive adults with asthma who will undergo a nasal
           allergen challenge with increasing doses of cockroach allergen. Phase 1 will consist of
           two parts, Phase 1a and Phase 1b. In Phase 1a, participants will undergo a nasal
           allergen challenge. In Phase 1b, participants will undergo a repeat nasal allergen
           challenge to assess reproducibility of the NAC with cockroach allergen in a population
           with asthma. The data from Phase 1a will be used to identify a range of doses that is
           safe and elicits a threshold of nasal symptoms (TNSS ≥8).

        -  Phase 2 will enroll 25 cockroach sensitive children with asthma ages 8-14 years who will
           undergo a nasal allergen challenge using the dose range identified in Phase 1a.

      Study mandated procedures include: blood draws (venipuncture); pulmonary function testing
      (PFTs); nasal allergen challenge (NAC); allergen skin testing; and peak expiratory flow.
    

Intervention name(s): Glycerinated German Cockroach Allergenic Extract
Intervention type(s): Biological
Intervention description(s): Participants will receive escalating doses intranasally. Briefly: per protocol- Phase 1a NAC: N=10 cockroach sensitive adults with asthma will undergo nasal allergen challenge with dose escalation (up to 8 doses per protocol). Phase 1b: Phase 1a subjects will have repeat NAC with dose escalation (up to 8 doses).
Phase 2: N=25 cockroach sensitive children with asthma (ages 8 - 14 years) will undergo NAC with doses determined by Phase 1a data (e.g., symptoms and safety data).
Other intervention name(s): Blattella germanica allergenic extract; Cockroach antigen (CR antigen)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Glycerinated German cockroach allergenic extract; Cockroach Nasal Allergen Challenge
A Web App for Patients With Alcohol and Drug Use Problems in Primary Care
Condition: Alcohol Abuse; Drug Abuse
MeSH terms: Alcoholism; Substance-Related Disorders
Study type: Interventional

Summary: 
      The objective of this pilot study is to evaluate the feasibility and technical merit of a web
      application for patients in primary care called Check-up and Choices (CC).
    

Detailed description: 
      The overall objective of this project is to develop, evaluate, and disseminate a web
      application called Check-up and Choices (CC). CC will be developed for use in primary care.
      It would tightly integrate screening for heavy drinking and drug use, a brief motivational
      intervention for hazardous or heavy drinkers, a moderation training protocol for less
      dependent problem drinkers, and an abstinence-oriented protocol for more dependent drinkers
      and drug abusers. The brief motivational intervention will be tailored to the patient's age.
      Its purpose will be to motivate problem drinkers to change their drinking. The
      action-oriented moderation and abstinence protocols are cognitive-behavioral interventions
      (CBIs) that provide patients with the skills to maximize their chances of success with
      changing their drinking and/or drug use.

      The investigators have already developed these elements but they are not integrated into a
      single program with appropriate branching between them. Nor has the content been tailored for
      use in primary care.
    

Intervention name(s): Web app
Intervention type(s): Behavioral
Intervention description(s): The Checkup and Choices web application
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: alcohol abuse; drug abuse; hazardous alcohol use; hazardous drug use
Nicotine Pharmacokinetics and Pharmacodynamics, Safety and Tolerability of P3P
Condition: Pharmacokinetics
Study type: Interventional

Summary: 
      This is a single-center, open-label, randomized, crossover study to evaluate the
      pharmacokinetic (PK) profiles of four P3P variants (differing in nicotine aerosol particle
      size, nicotine concentration and in the absence or presence of a flavoring system), following
      a fixed puffing regimen and an ad libitum use period. In addition, pharmacodynamic (PD)
      effects (subjective effects and related behavioral assessments), as well as human puffing
      topography, will be evaluated, to provide further insights on product safety, acceptance, and
      use.
    

Detailed description: 
      The goal of the proposed study is to evaluate the pharmacokinetic profiles of four P3P
      variants. Variants with two different nicotine contents (1 mg/product and 2 mg/product), two
      different nicotine aersol particle sizes and presence/absence of a flavoring system will be
      tested to identify which one would yield plasma nicotine concentrations as close as possible
      to those achieved after smoking a single cigarette. All of the subjects will initially use
      the lowest nicotine content product (P3P 3). Subject will continue the study using the three
      remaining products (P3P 1, P3P 2 and P3P 4) containing 2 mg nicotine/product in a randomly
      assigned sequence.

      Two product use regimens: fixed puffing and ad libitum use will be applied to provide insight
      into nicotine absorption. The fixed puffing regimen with consistent use conditions across
      subjects will be applied in order to minimize variability. The 1 hour ad libitum use period
      will provide information on nicotine PK and product acceptance when subjects use the P3P
      according to their own puffing behavior which is closer to a real-world setting.

      Safety and tolerability will also be assessed throughout the study.
    

Intervention name(s): P3P 1; P3P 2; P3P 3; P3P 4
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 2 mg of nicotine; no flavor; nicotine powder particle size of 2.25 ± 0.2 μm; 2 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm; 1 mg of nicotine; flavor; nicotine powder particle size of 2.25 ± 0.2 μm; 2 mg of nicotine; flavor; nicotine powder particle size of 1.8 ± 0.2 μm
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: A single-center, open-label, randomized, crossover study.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Nicotine; Nicotine-containing product
Effects of Parathyroid Hormone in Men With Osteoporosis
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      Alendronate is a drug that blocks or reduces bone loss, while parathyroid hormone (PTH)
      stimulates the formation of new bone. The purpose of this study is to compare the
      bone-building effects of PTH alone, alendronate alone, and both PTH and alendronate in men
      with osteoporosis over a two-and-a-half year period.
    

Detailed description: 
      Osteoporosis causes bones to weaken and break more easily. Alendronate is used to treat or
      prevent osteoporosis. PTH is a protein hormone that increases the calcium and phosphorus
      release from bone, leading to formation of new bone. This study will examine the changes in
      bone density measured at multiple places in the skeleton and changes in chemicals in the body
      that indicate bone breakdown and bone formation. The study will indicate whether some
      breakdown of bone is required for PTH to have an overall bone-building effect in men.

      Participants will be randomly assigned to receive PTH alone by daily injection under the
      skin, alendronate alone taken by mouth, or both PTH and alendronate. The study will last 2.5
      years. All participants will receive some form of treatment for osteoporosis. Blood, urine,
      and bone density tests will be performed at 6-month intervals. During the first 6 months,
      participants will come in for additional study visits.

      Participants who complete the initial 2.5 years of their assigned treatment will be eligible
      for a 12 month extension to monitor bone density and bone turnover after PTH is stopped.
      Participants who were receiving alendronate will continue taking alendronate. The goal of
      this extension is to determine what happens to bone density and turnover after PTH is stopped
      and whether alendronate is needed to prevent loss of PTH-induced bone gain.

      Participants who complete the 12 month extension while on their assigned treatment will be
      eligible for a second 12 month extension in which all participants receive PTH therapy.
      Participants who have been receiving alendronate continue taking alendronate. The goal of the
      second extension is to determine if responsiveness to PTH is enhanced by a 12 month
      suspension of PTH treatment.
    

Intervention name(s): Parathyroid hormone; Alendronate
Intervention type(s): Drug; Drug
Intervention MeSH terms: Alendronate; Hormones; Parathyroid Hormone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Parathyroid Hormone (PTH); Alendronate; Bone metabolism; Bone mineral density (BMD); Bone loss; Postmenopausal osteoporosis; Osteoporosis in men
Genetic Information and Dietary Intake Behaviour
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study's primary objective is to determine if providing individuals with personal genetic
      information impacts dietary intake behaviour. Specifically, the investigators will be
      examining whether providing dietary advice based on genes that affect the metabolism of or
      sensitivity to caffeine, vitamin C, sugar and sodium will impact the intake of these dietary
      components. The study hypothesis is that providing dietary advice based on genetics will
      impact dietary behaviour to a greater extent than general dietary recommendations.
    


Intervention name(s): Dietary advice with genetic information; General dietary recommendations
Intervention type(s): Other; Other
Intervention description(s): This group will receive dietary advice for caffeine, vitamin C, sugar and sodium based on genes that affect the metabolism of or sensitivity to caffeine, vitamin C, sugar and sodium.; This group will receive general dietary recommendations from recognized health organizations for caffeine, vitamin C, sugar and sodium, with no genetic information.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Nutrigenomics; Diet; Nutrition
Treatment of Antipsychotic-associated Obesity With a GLP-1 Analogue
Condition: Obesity; Metabolic Syndrome X; Drug-induced Obesity; Schizophrenia
MeSH terms: Obesity; Metabolic Syndrome; Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      To examine if 3 months of treatment with a GLP-1 (glucagon-like-peptide-1) analogue can
      induce weight loss in obese, non-diabetic patients with a diagnosis within the schizophrenic
      spectrum.

      The investigators will also examine possible associations between GLP-1 treatment and
      peripheral metabolic parameters such as change in body fat and HbA1c. Moreover, the GLP-1
      analogue treatment will be associated with the effects/changes on cognition and subjective
      quality of life. Possible cerebral effects (pro-cognitive) of the GLP-1 analogue treatment
      will associated and correlated with changes in the brain, functional magnetic resonance
      imaging (fMRI).
    

Detailed description: 
      The primary endpoint is weight loss after 3 months of treatment with the GLP-1 analogue
      exenatide (Bydureon®).

      Secondary endpoints comprise both physiological/metabolic parameters and cognitive
      measurements:

        -  Metabolic endpoints include amongst others: changes in body fat (DEXA-scan) and changes
           of the HbA1c(average blood glucose levels), cholesterol and triglycerides. Moreover
           physiological effects will be examined eg possible effect on central/peripheral
           bloodpressure and heart rate.

        -  Cerebral endpoints will be investigated via functional magnetic resonance imaging
           (fMRI); including potential neuroprotective effects of exenatide. The main focus is
           potential hippocampal volume changes and potential changes in cerebral blood flow.
           Functional MRI will provide this data and the images will be correlated to both
           cognitive tests and questionnaires.

        -  Cognitive endpoints comprise potential improvements in cognition with focus on specific
           memory tests (BACS, DART and Rey's Complex Figure) and possible improvements in
           subjective quality of life (questionnaires).
    

Intervention name(s): Exenatide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Subcutaneum injection of exenatide once-weekly for 3 months; Subcutaneum injection of placebo once-weekly for 3 months
Other intervention name(s): Bydureon
Intervention MeSH terms: Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Obesity; The Metabolic Syndrome/disturbances; Drug-induced adipositas; Schizophrenia; GLP-1 analogue; cerebral effects