bioihbjkbjnl/mcl2 huggingface dataset:
Adolescent Idiopathic Scoliosis (AIS) Gold Standard for Blood Loss
Condition: Adolescent Idiopathic Scoliosis
MeSH terms: Scoliosis; Hemorrhage
Study type: Interventional

Summary: 
      The purpose of this study is to establish a benchmark for measuring blood loss by directly
      measuring the change in red cell volume before and after surgery and to compare established
      blood loss estimators to this benchmark in order to determine the most accurate and precise
      method for estimating blood loss in adolescent idiopathic scoliosis surgery patients
    

Detailed description: 
      Bleeding is a necessary and unavoidable part of spine surgery. It is important to the
      surgeons and anesthesiologists to know how much blood a patient has lost during surgery in
      order to care for them in the best way possible. Different methodology has been employed to
      estimate how much blood is lost during surgery, but unfortunately none of the methods used
      have been reliable. The study will calculate surgical blood loss by determining perioperative
      change in red cell volume that is directly measured by using a special method that relies on
      radioisotope I-131-labeled albumin administration (BVA-100) during the surgery. This
      benchmarked blood loss estimate will then be compared to estimates calculated using the Gross
      equation, the Bourke and Smith equation, and the Camarasa formula. In addition, blood loss
      will be estimated volumetrically by utilizing formulas based on the amount of salvaged blood
      produced by an intraoperative salvaging system (Cell Saver®). Blood loss estimates based on
      salvaged blood volume will also be compared to the benchmark.
    

Intervention name(s): Radioisotope I-131-labeled albumin
Intervention type(s): Other
Intervention description(s): 1 mL of radioisotope I-131-labeled albumin x 2
Intervention model: Single Group Assignment
Intervention model description: Participants include 45 adolescent subjects undergoing spinal fusion for correction of idiopathic scoliosis.
After obtaining a baseline sample of 5 mL of blood, 1 mL of I-131-labeled albumin will be injected intravenously over 1 min. At the time the baseline sample is obtained, a hematocrit will be simultaneously acquired. Five milliliter blood samples will then be collected at 12, 18, 24, 30, and 36 min post-injection, and the Plasma volume (PV) will be measured by extrapolating to time zero. This entire process will occur twice per patient: once pre-procedure and once post-procedure.
Masking: None (Open Label)
Primary purpose: Other
Keywords: Scoliosis; Pediatric surgery; Orthopedics; Blood loss
Quality of Life After Laparoscopic Inguinal- Incisional and Umbilical Herniotomy.
Condition: Inguinal Hernia; Incisional Hernia; Umbilical Hernias
MeSH terms: Hernia, Umbilical; Hernia; Hernia, Inguinal; Incisional Hernia
Study type: Observational

Summary: 
      LIFE-IN. Quality of life after operation for hernias are not well investigated and lack a
      good and easy-to-understand-tool to measure it. Carolina Comfort Scale (CCS) is a
      disease-specific quality of life questionnaire, designed by an American group, to monitor
      quality of life in patients undergoing operation for hernias.

      The investigators wish to test this questionnaire against Visual Analogue Scale (VAS) scores
      for core-hernia symptoms, to see if the CCS is a good way to monitor the changes in quality
      of life and other well-known core-symptoms before and after herniotomies.
    

Detailed description: 
      The investigators include consecutively all in all 140 patients. 100 with inguinal hernias;
      50 who is getting a Lichtenstein operation and 50 who is getting a laparoscopic operation.
      Furthermore minimum 20 patients who is getting a laparoscopic operation for incisional hernia
      and minimum 20 who went through umbilical herniotomy. The investigators monitor their pain,
      sensation of mesh, movement limitations, over-all well-being, fatigue and life-quality, with
      both CCS and VAS questionnaires 5 times. One time preoperative and 4 times after operation,
      on the 1sth, 7th, 30th and 90th day after operation.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Primary care
      
Keywords: inguinal hernia; incisional hernia; quality of life; disease-specific
Assessment of Efficacy and Safety of Insuman Comb 25 Versus Novolin® 30R Twice Daily Over 24 Weeks in Type 2 Diabetes Patients With Insulin Therapy
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary Objective:

      To compare the efficacy of Insuman Comb 25 versus Novolin® 30R on HbA1c reduction during a
      24-week treatment period in patients with type 2 diabetes mellitus.

      Secondary Objectives:

        -  To assess the effects of Insuman Comb 25 versus Novolin® 30R in patients with type 2
           diabetes mellitus on fasting plasma glucose (FPG)

        -  To assess the safety and tolerability of Insuman Comb 25 versus Novolin® 30R in patients
           with type 2 diabetes mellitus
    

Detailed description: 
      The study duration per patient is about 27 weeks (up to 2 weeks screening + 24 weeks
      open-label treatment + 1 week follow-up).
    

Intervention name(s): Insulin human/Insuman Comb 25 (HR1799); Insulin human/Novolin® 30R
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical form:Suspension
Route of administration: Subcutaneous; Pharmaceutical form:Suspension
Route of administration: Subcutaneous
Intervention MeSH terms: Insulin; Insulin, Globin Zinc
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Single, High-Dose Azithromycin Extended Release (60 mg/kg) Compared With 10 Days of High-Dose Amoxicillin Clavulanate in Children With Ear Infections at High Risk of Persistent/Recurrent Ear Infections
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 3

Summary: 
      A phase 3 randomized, multicenter, double blind, double dummy study to assess the efficacy,
      safety, and compliance of a single dose of azithromycin extended release compared with a
      10-day course of amoxicillin/clavulanate twice daily in children at high risk for persistent
      or recurrent ear infections
    


Intervention name(s): amoxicillin/clavulanate postassium (Augmentin ES-600); azithromycin SR
Intervention type(s): Drug; Drug
Intervention description(s): amoxicillin/clavulanate postassium 90/6.4 mg/kg/day, given in divided doses q12h, for 10 days; azithromycin SR 60 mg/kg x 1 dose
Intervention MeSH terms: Amoxicillin; Azithromycin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Study of the Effect of Armodafinil Treatment in Healthy Subjects With Excessive Sleepiness Associated With Jet Lag Disorder
Condition: Excessive Sleepiness
MeSH terms: Disorders of Excessive Somnolence; Sleepiness
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a randomized, double-blind, placebo-controlled, parallel-group study of armodafinil
      and placebo treatment in healthy subjects with excessive sleepiness associated with jet lag
      disorder.
    


Intervention name(s): armodafinil; armodafinil; placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 50 mg/day orally, once daily in the morning for 3 days; 150 mg/day orally, once daily in the morning for 3 days; placebo tablets, once daily in the morning for 3 days
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effects of Fast Bar on Physiological Fasting
Condition: Fasting
Study type: Interventional

Summary: 
      This study evaluates how Fast Bar(TM), a specially formulated energy bar, affects the
      physiological condition in participants after an overnight fasting. Participants will fast
      for 19 hours (Fast Group), consume a breakfast Bar (Breakfast Group) or a Fast Bar(TM) (Fast
      Bar Group) after an approximately 15-hour overnight fasting. Participants will be assessed
      for physiological parameters associated with fasting.
    

Detailed description: 
      Interest in fasting-based programs (i.e. intermittent fasting) for improvement of health and
      longevity continues to grow. While benefits of intermittent fasting have been convincingly
      demonstrated in rodent models, the more limited data in humans is less clear.

      The short-term fasting (e.g. 12 to 48 hours in duration) utilized in many intermittent
      fasting programs are considered safe, but some individuals may find them subjectively
      difficult. As such, the question of whether the benefits of fasting can be obtained while
      small amounts of food are consumed is of substantial interest.

      One commercially available product that is designed to be consumed during periods of
      intermittent fasting is the Fast Bar™,which stems out of the well-researched
      fasting-mimicking diet to assist prolonged fasting. The unique formulation of the Fast Bar™
      is hypothesized to minimize deviations in metabolic biomarkers associated with a fasting
      state. This may allow for extension of a fasting period through reduced subjective difficulty
      of fasting.The objective of this study is to evaluate the metabolic and subjective effects of
      consuming a novel food product (Fast Bar™) after a short period of fasting.
    

Intervention name(s): Dinner; Fasting; Study food
Intervention type(s): Other; Other; Other
Intervention description(s): Study subjects will consume a standardized ready-to-eat meal as dinner.; Subjects in all groups will be asked to consume a standardized ready-to-eat dinner meal before 5 pm on day 1 and then fast overnight for approximately 15 hours.; Study subjects will either continue to fast for 6 hours (Fast Group), consume either a breakfast (Breakfast Group) or a Fast Bar (Fast Bar Group).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Fast Bar; Fasting; Intermittent fasting; Ketone bodies; ß-hydroxybutyrate
Cardiopulmonary Outcomes and Household Air Pollution Trial
Condition: Blood Pressure; Carotid Intima Media Thickness; Endothelial Function; Signs and Symptoms, Respiratory; Respiratory Function Tests
MeSH terms: Signs and Symptoms, Respiratory
Study type: Interventional

Summary: 
      The purpose of this randomized controlled field trial is to determine whether a liquefied
      petroleum gas (LPG) stove and fuel distribution intervention reduces personal and kitchen
      exposure to household air pollutants and improves cardiopulmonary health outcomes when
      compared to usual cooking practices with open-fire biomass-burning stoves in adult women aged
      25-64 years.
    

Detailed description: 
      Randomized, controlled field trial of an LPG stove and fuel distribution intervention
      compared to standard cooking practices with open-fire biomass-burning stoves in the homes of
      participating adult women aged 25-64 years. The aim is to determine whether provision of
      cleaner fuels will result in important reductions in household air pollutants and
      consequently in an improvement in cardiopulmonary health outcomes over a one-year period.
      Participants randomly assigned to the intervention arm will receive a free LPG stove and fuel
      delivered to their homes during the one-year intervention period. Participants randomly
      assigned to the control arm will receive a free LPG stove and vouchers that can be used to
      obtain free fuel for an entire year at LPG fuel distribution centers at the end of the
      one-year intervention period. All participants will be followed for a second year to assess
      patterns and impacts of sustained use (intervention arm) and initial adoption (control arm).
    

Intervention name(s): Three-burner LPG stove; Delivery of LPG tanks; Vouchers for LPG tanks
Intervention type(s): Device; Other; Other
Intervention description(s): The intervention arm will receive a three-burner LPG stove upon enrollment. The control arm will receive the stove one year after enrollment.; One year supply of LPG fuel, in the form of delivery of 20 kg tank that holds 10 kg of LPG. Delivered to homes.; One year supply of LPG, in the form of vouchers to obtain a free LPG tanks from a distribution center. (Beginning one year after enrollment, for one year)
Other intervention name(s): propane stove; SURGE three-burner liquefied petroleum gas stove; propane tank; coupon
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Investigator)
Primary purpose: Prevention
Keywords: Air Pollution; Liquefied Petroleum Gas; Cookstove; Behavioral Intervention; Propane Stove
Effects of COVID-19 in Chronic Pain
Condition: Chronic Pain; Covid19
MeSH terms: COVID-19; Chronic Pain
Study type: Observational

Summary: 
      The aim of this study is to evaluate the effects of the COVID-19 pandemic on pain, stress,
      sleep and quality of life in patients with chronic musculoskeletal pain and the relationships
      between them. In this cross-sectional study, 100 volunteer patients aged 18-65 years with
      chronic (longer than 3 months) musculoskeletal pain were included. Age, gender, body-mass
      index (BMI) and systemic diseases of the participants were recorded as demographic data. Data
      were collected regarding the area of the body where pain is most dominant in the
      musculoskeletal system and how long the pain has been in these area, whether there is routine
      use of analgesics before and after the pandemic and the amount if any, whether the person or
      the person's relatives have a history of COVID-19, whether exercising regularly before and
      after the pandemic. Afterwards, the participants were asked to evaluate their general pain
      severity and global well-being assesment with the visual analog scale (VAS) in the
      pre-pandemic period and in the last month. For pain severity, the patients marked their pain
      severity on a line of 10 centimeters (cm) with the starting point (0) expressing no pain, and
      the end point (10) expressing the most severe pain experienced in life; for patient's global
      assesment the patients marked their global assesment on a line of 10 centimeters (cm) with
      the starting point (0) expressing very good, and the end point (10) expressing very bad. The
      distance between the point marked by the patient and the starting point was measured. The
      higher the measured value meant the greater the severity of the patient's pain and the worse
      the patient's global assessment [11]. Subsequently, the patients were asked to answer
      questions on the Perceived Stress Scale (PSS), Pittsburgh Sleep Quality Index (PSQI) and
      Nottingham Health Profile (NHP) scales.
    


Intervention name(s): Survey
Intervention type(s): Other
Intervention description(s): Survey
Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Patients aged 18-65 years with chronic (longer than 3 months) musculoskeletal pain
A Dose-escalation Study to Evaluate the Safety, Tolerability and Pharmacokinetic of LPM3770164 in Healthy Subjects
Condition: Huntington Disease; Tardive Dyskinesia
MeSH terms: Dyskinesias; Huntington Disease; Tardive Dyskinesia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single-center, randomized, double-blinded, placebo-controlled, dose escalation
      trial to evaluate the safety, tolerability and pharmacokinetic of LPM3770164
      sustained-release tablets orally administered in healthy subjects under fasting state,
      providing the rationale information for subsequent clinical trials.
    


Intervention name(s): LPM3770164 sustained release tablet; LPM3770164 sustained release tablet simulant
Intervention type(s): Drug; Drug
Intervention description(s): LPM3770164 sustained release tablet will be administrated orally single-dose on day 1; LPM3770164 sustained release tablet simulant will be administrated orally single-dose on day 1
Other intervention name(s): LY03015; LY03015 simulant
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Single Dose Intranasal Oxytocin and Cognitive Effects in Autism
Condition: Autism Spectrum Disorders
MeSH terms: Autistic Disorder; Autism Spectrum Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Autism spectrum disorder (ASD) is a group of severe, life-long developmental disorders.
      Oxytocin (OT) is a neurohormone involved in both repetitive/rigid and social behaviors. This
      study is focusing on how a single dose of intranasal OT (IN-OT) affects cognitive rigidity
      and social perception tasks. Taking OT as a spray through the nose increases social and
      decreases repetitive behavior in some adults with ASD, and we are exploring if it helps
      children with ASD similarly. However, it is unclear whether every person with ASD has an
      abnormal OT level, and if OT affects restrictive or social behavior differently.
      Consequently, we aim to study whether OT treatment can be effective in treating subgroups
      with specific features of ASD. We will use approaches utilizing both behavioral and
      physiological responses to clarify the role of OT in ASD. We will develop a deeper
      understanding of the range of social and rigid behaviors and use that information to identify
      persons with ASD who would benefit from OT treatment. Potential subjects will be asked if
      they want to participate in two sessions in our clinical laboratory where they will get
      either single dose IN-OT or placebo. After receiving the substance, they will be asked to do
      a handful of tasks while we monitor heart rate, eye movements, and collect baseline and post
      intranasal blood, urine and saliva. The levels of hormones, metabolites and peptides related
      to or interacting with OT will be measures in the collected samples of blood plasma, urine
      and saliva. Additionally DNA will be extracted from the blood samples to study genes related
      to OT and ASD.
    


Intervention name(s): Intranasal Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Bioavailability of Aliskiren and Valsartan as a Single Tablet vs. the Same Doses of the Two Drugs Given Separately to Healthy Subjects.
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will assess the bioavailability of aliskiren and valsartan as a single tablet
      compared to the same doses of the two drugs given as two separate tablets in healthy
      subjects.
    


Intervention name(s): Aliskiren; Valsartan
Intervention type(s): Drug; Drug
Intervention MeSH terms: Valsartan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Aliskiren , Valsartan , bioavailability, hypertension; Healthy male and female subjects
Safety and Immunogenicity Study of the Eastern Equine Encephalitis (EEE) Vaccine
Condition: Eastern Equine Encephalitis
MeSH terms: Encephalomyelitis, Equine; Encephalomyelitis, Eastern Equine; Encephalitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is being conducted to collect safety and immunogenicity data for the Eastern
      Equine Encephalitis (EEE) vaccine.
    

Detailed description: 
      This study is being conducted to collect safety and immunogenicity data for the Eastern
      Equine Encephalitis (EEE) vaccine. To determine the frequency of adverse events in this
      Eastern Equine Encephalitis (EEE) vaccine study for all intent-to-treat subjects will be
      evaluated. Also the frequency of clinically confirmed and documented cases of Eastern Equine
      Encephalitis (EEE) disease among vaccinated subjects compliant with titer schedule after
      working with Eastern Equine Encephalitis (EEE) virus.
    

Intervention name(s): Eastern Equine Encephalitis Vaccine, Inactivated, Dried, TSI-GSD 104
Intervention type(s): Biological
Intervention description(s): Eastern Equine Encephalitis Vaccine, Inactivated, Dried
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Contextual Associations During Episodic Recall of Everyday or Virtual Reality
Condition: Healthy Volunteers
Study type: Interventional

Summary: 
      The project is dedicated to development of new paradigms to investigate memory and attention
      in the rich and realistic environments. The investigator will use modern interactive digital
      technologies for encoding complex episodes either using mobile phone technology in everyday
      life or using a virtual reality life-like simulation.

      He aims to characterize the role of the medial temporal lobe and prefrontal cortex during
      recall of naturalistic episodic experiences, using functional neuroimaging (fMRI) in healthy
      participants. The secondary aim is assess how the allocation of attention during memory
      encoding contribute to mechanisms of the subsequent recall. He will achieve this by
      monitoring gaze direction during encoding and by analyzing the retrieval data as a function
      of the elements that participants attended / fixated during encoding.

      The protocol will involve, first, behavioral testing of memory performance with encoding in
      the real-life or in virtual reality, followed by the main hypothesis testing phase when fMRI
      will be used to measure brain activity during retrieval.
    


Intervention name(s): Functional brain imaging without any contrast agent
Intervention type(s): Other
Intervention description(s): During the fMRI protocol, the subject will perform the retrieval tasks while whole-brain activity will be recorded using Echo Planar Imaging (EPI) that measures the Blood Oxygen Level Dependent (BOLD) signal (2x2x2 isotropic voxels, Echo Time (TE) = 30 ms, Repetition Time (TR) = 2.5 sec). The functional session will be subdivided into several parts ("Runs", duration: 10-15 min). Together with the functional data, the protocol will include a structural scan (T1 weighted, 1x1x1 mm voxels; duration 5-7 min) and a field mapping sequence (duration: 1 min).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Memory; naturalistic; context; fMRI; Attention