bioihbjkbjnl/mcl2 huggingface dataset:
Phase 2 Study of NGM282 in Patients With Type 2 Diabetes
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety, tolerability, and activity of NGM282 in
      patients with Type 2 Diabetes.
    


Intervention name(s): NGM282; Placebo
Intervention type(s): Biological; Other
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Mucosal Impedance and Eosinophilic Esophagitis
Condition: Eosinophilic Esophagitis
MeSH terms: Esophagitis; Eosinophilic Esophagitis
Study type: Interventional

Summary: 
      Do patients with eosinophilic esophagitis have baseline increased esophageal mucosal
      impedance?

      And will treatment that reverses esophageal eosinophilia in patients, correct abnormalities
      in mucosal impedance?
    


Intervention name(s): Mucosal Impedance; Upper Endoscopy
Intervention type(s): Device; Procedure
Intervention description(s): A tiny tube will be placed through the endoscope into the esophagus. 5 cm above where the stomach and esophagus meet for 5 seconds. At 10 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds. And at 20 cm above where the stomach and esophagus meet the catheter will be placed for 5 seconds.; Esophagogastroduodenoscopy, also called by various other names, is a diagnostic endoscopic procedure that visualizes the upper part of the gastrointestinal tract down to the duodenum.
Other intervention name(s): ph impedance; ph monitor; Esophagogastroduodenoscopy (EGD)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Mucosal Impedance; Eosinophilic Esophagitis; EoE
Validity and Reliability of the Turkish Version of the Pectus Carinatum Evaluation Questionnaire for Patients With Pectus Carinatum
Condition: Pectus Carinatum; Compliance; Brace
MeSH terms: Pectus Carinatum
Study type: Observational

Summary: 
      Based on the hypothesis that the chest wall was still pliable in adolescence and could be
      reshaped in a normal position with the external suppressor applied on the chest, a pressure
      orthosis was started to be used in the pectus carinatum. It is the focus of attention as it
      is an alternative method to surgery for patients. However, the patient's compliance with the
      orthosis is difficult. Therefore, in our study, we aimed to investigate the Turkish Validity
      and Reliability of the Pectus Carinatum Evaluation Questionnaire, which is a questionnaire
      investigating the compliance with orthosis treatment in patients diagnosed with Pectus
      Carinatum by the doctor.
    


Intervention name(s): Brace Treatment
Intervention type(s): Other
Intervention description(s): Compliance to brace compression used for the correction of pectus carinatum will be evaluated.
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with Pectus Carinatum
The Effect of Television Watching on Liking of Food
Condition: Hunger
Study type: Interventional

Summary: 
      The purpose of the study is to investigate the effect of television viewing on liking of
      food.
    

Detailed description: 
      The objective of this investigation is to determine whether participants will have a change
      of liking of food based on television viewing. The specific aims of the study are:

        1. Determine the effect of television on liking of food.

        2. Determine the effect of no television on liking of food.
    

Intervention name(s): Television; No Television
Intervention type(s): Other; Other
Intervention description(s): The purpose is to determine whether television impacts liking of food.; The purpose is to determine whether the lack of television impacts liking of food.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Other
Keywords: Lunch; Television; Macaroni and Cheese; Salad tossed in dressing
Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke (CLEAR Stroke) Trial
Condition: Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is determine the effects of using of a combination of two
      drugs--integrilin (eptifibatide) and activase (recombinant tissue plasminogen activator,
      rt-PA, or recombinant t-PA)--to dissolve blood clots in patients who have a stroke.
    

Detailed description: 
      The Combined Approach to Lysis Utilizing Eptifibatide and rt-PA in Acute Ischemic Stroke
      (CLEAR Stroke) trial is part of the Specialized Program on Translational Research in Acute
      Stroke (SPOTRIAS). The overall goals of SPOTRIAS are to enhance delivery of acute stroke
      patient care and train acute stroke translational researchers.

      Stroke most often occurs when blood flow to the brain stops because it is blocked by a blood
      clot. When a blood clot blocks the blood supply to the brain, parts of the brain may not get
      enough blood and oxygen to survive. As a result, permanent brain damage can occur, which can
      affect a person's ability to walk, talk, and function independently. In order to reduce the
      risk of permanent damage, it is important to restore blood flow to the brain as quickly as
      possible.

      The CLEAR Stroke study will enroll 100 participants with acute stroke due to a blood clot.
      The purpose of this multi-center, randomized, double-blind study is to determine the effects
      of using a combination of two drugs, integrilin (or eptifibatide) and activase (or
      recombinant tissue plasminogen activator, rt-PA, recombinant t-PA), to dissolve blood clots.
      More specifically, the CLEAR study is being done to determine if a lower dose of activase,
      given in combination with a second drug, integrilin, is a safe treatment for acute stroke.

      Activase, used alone, is already approved by the Food and Drug Administration (FDA) as
      treatment for patients with a stroke caused by blockage of an artery in the brain and when
      given within 3 hours of the onset of stroke symptoms. Integrilin is also already FDA-approved
      as a treatment for blood clots causing heart attack. The investigational aspect of this study
      is the use of integrilin for a stroke victim in combination with activase.
    

Intervention name(s): activase; integrilin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Tissue Plasminogen Activator; Eptifibatide
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: stroke; integrilin; eptifibatide; activase; recombinant tissue plasminogen activator; rt-PA; recombinant t-PA; SPOTRIAS
Oxytocin Suppresses Substance Use Disorders Associated With Chronic Stress
Condition: Alcohol Use Disorders
MeSH terms: Substance-Related Disorders; Alcoholism
Study type: Interventional
Phase: Phase 1

Summary: 
      In comparison to the general population, military personnel and veterans are at increased
      risk of developing both substance use disorders (SUDs) and post-traumatic stress disorder
      (PTSD). Despite promising developments in the past decade, the treatment of patients with
      SUDs and comorbid PTSD is woefully inadequate (Back, 2010; Back et al., 2014; Brady et al.,
      2007; McCauley et al., 2012). One of the adverse effects of abused drugs is their long-term
      negative impact on social behavior that is thought to involve oxytocin (OT) dysregulation
      (McGregor et al., 2008). In preclinical and clinical experiments, local, intra-nasal, or
      systemic OT administration decreases activation of the amygdala in response to visual
      fearful/threatening stimuli (Kirsch et al., 2005), ameliorates the effects of stressful
      events, and decreases drug-taking and seeking behavior (McGregor et al., 2008; Baskerville
      and Douglas, 2010; Carson et al., 2010a; Bowen et al., 2011; Cox et al 2013). However, little
      attention has been focused on whether OT decreases SUD vulnerability after exposure to
      traumatic stress in preclinical or clinical studies. This clinical project will determine
      whether intra-nasally administered OT will decrease craving (Aim 1) to use alcohol and
      decrease stress reactivity (Aim 2) following exposure to laboratory-induced stress (Trier
      Social Stress Task) among veterans with a dual diagnosis of alcohol use disorder and PTSD.
    


Intervention name(s): Oxytocin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): One 40 IU dose of intranasal oxytocin will be self-administered (5 puffs in each nostril) by participants.; Each participant will self-administer a 40 IU dose of intranasal saline.
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Alcohol; Oxytocin; Stress reactivity
Inspiratory Muscle Training in Chronic Obstructive Pulmonary Disease
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Respiratory Aspiration
Study type: Interventional
Phase: Phase 3

Summary: 
      Uncertainty persists regarding the usefulness of incorporating inspiratory muscle training
      (IMT) in pulmonary rehabilitation programs for patients with chronic obstructive pulmonary
      disease. In this study the investigators investigate whether IMT associated with exercise
      training would be better than exercise training alone, with regard to exercise capacity,
      inspiratory muscle strength and dyspnea.
    

Detailed description: 
      Study design: A double-blind parallel controlled trial Setting: outpatient clinic Inclusion
      criteria: Subjects between 40 and 75 years of age referred by a physician to the Pulmonary
      Rehabilitation Program, with a clinical and spirometric diagnosis of moderate to severe COPD
      according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD).

      Outcome measurements: Inspiratory muscle strength (using maximal inspiratory pressure, MIP),
      exercise capacity (using six-minute walk test) and dyspnea were measured.
    

Intervention name(s): Inspiratory muscle training
Intervention type(s): Other
Intervention description(s): The training was performed using a threshold inspiratory muscle trainer (Respironics HealthScan, Inc, Cedar Grove, New York, USA).
The patients performed the IMT training in a seated position, with the upper limbs supported. The total duration of the respiratory training was 30 minutes, with sequences of three minutes of training followed by pauses of two minutes. The initial load was equivalent to 30% of the individual's MIP. This load was progressively increased over the first four weeks, according to the patients' tolerance, to reach 60% of the MIP. This level was then maintained until the end of the training.
Other intervention name(s): IMT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD; inspiratory muscles; diaphragm
Clinical Effectiveness of Various Professionally Applied Fluoride Prophylaxes in Groups at High Risk
Condition: White Spot Lesion; Caries
Study type: Interventional

Summary: 
      The study is to compare the prophylactic and therapeutic clinical effectiveness of two
      fluoride varnishes in children at high caries risk.

      It was hypothesized, the use of Fluor Protector S (I) fluoride varnish in children with
      deciduous teeth at high risk of caries (P) reduces caries and the activity/remineralisation
      of carious enamel spots (transformation of White Spot Lesion into D (decay)) (O), similarly
      to what occurs after the use of Duraphat varnish (C).
    

Detailed description: 
      The study is to compare the prophylactic and therapeutic clinical effectiveness of two
      fluoride varnishes in children at high caries risk.

      It was hypothesized, the use of Fluor Protector S (I) fluoride varnish in children with
      deciduous teeth at high risk of caries (P) reduces caries and the activity/remineralisation
      of carious enamel spots (transformation of White Spot Lesion into D (decay)) (O), similarly
      to what occurs after the use of Duraphat varnish (C).

      The question set bases on a Caries Assessment by Risk Management system basing on the
      occurrence of major caries causative agents (biological and medical), and also of the
      protective/preventive ones. Questions related to the social and economical status will be
      left out because of the difficulty of getting them answered honestly. Teeth will be scored
      according to International Caries Detection System II classification, and oral hygiene
      according to the Greene and Vermillion simplified Oral Hygiene Index (OHI-S) (1964). Children
      and their parents/guardians will receive hygienic, dietary and prophylactic guidelines.
    

Intervention name(s): Fluor Protector S
Intervention type(s): Other
Intervention description(s): Fluor Protector S intervention group A (25 ml) Duraphat group B (25ml)
Other intervention name(s): Duraphat Colgate
Intervention MeSH terms: Sodium fluoride topical preparation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: white spot lesion; caries
Chewing in Children With Repaired Esophageal Atresia-tracheoesophageal Fistula
Condition: Chewing Problem
MeSH terms: Esophageal Atresia; Tracheoesophageal Fistula; Fistula
Study type: Observational

Summary: 
      The investigators aim to evaluate chewing function in children with repaired esophageal
      atresia-tracheoesophageal fistula (EA-TEF). Patients with repaired EA-TEF will be evaluated
      for age, sex, type of atresia. Each child will be required to bite and chew a standardized
      biscuit. Chewing function will be scored with the Karaduman Chewing Performance Scale (KCPS).
      The International Dysphagia Diet Standardisation Initiative (IDDSI) will be used to determine
      the tolerated food texture of children.
    

Detailed description: 
      The diet of children with normal feeding skills includes a combination of liquid, semisolid
      and/or solid foods. Chewing dysfunction (CD) in children may cause restrictions in solid food
      intake, thereby may result in insufficient food intake and delay in growth. It is aim to
      evaluate chewing function in children with repaired esophageal atresia-tracheoesophageal
      fistula (EA-TEF). Patients with repaired EA-TEF will be evaluated for age, sex, type of
      atresia. Each child will be required to bite and chew a standardized biscuit. Chewing
      function will be scored with the Karaduman Chewing Performance Scale (KCPS). The
      International Dysphagia Diet Standardisation Initiative (IDDSI) will be used to determine the
      tolerated food texture of children.
    

Intervention name(s): Chewing evaluation
Intervention type(s): Other
Intervention description(s): Each child was required to bite and chew a standardized biscuit while chewing video recording. Chewing function was scored with the Karaduman Chewing Performance Scale (KCPS).
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Children with repaired esophageal atresia-tracheoesophageal fistula
Intramuscular Ketamine Effect on Postnasal Surgery Agitation
Condition: Agitation, Emergence
MeSH terms: Psychomotor Agitation; Emergence Delirium
Study type: Interventional
Phase: Phase 2

Summary: 
      Emergence agitation (EA) is a common complication after nasal surgery. In this study, we
      aimed to investigate the effect of intramuscular ketamine on EA following septoplasty and
      open septorhinoplasty (OSRP) when administered at subanesthetic doses at the end of surgery.
      Sedation and Agitation scores were recorded using The Richmond agitation-sedation score after
      extubation.
    

Detailed description: 
      At the end of surgery and immediately after the inhalational agent was discontinued, 2mL of
      normal saline containing 0.7 mg/kg racemic ketamine was administered intramuscularly to
      Group-K, whereas 2 mL of normal saline was administered intramuscularly to Group-S using a 3
      ml syringe. The injection site of both groups was at the lateral thigh. For postoperative
      analgesia, 0.07 mg/kg morphine was also given when turning off the inhalational agent. A
      nasal pack was used in all of the patients. The patients were ventilated with 100% oxygen at
      a flow rate of 7 L/min. Once the patients met the extubation criteria, they were extubated.

      The EA level of the patients was evaluated immediately after extubation till the patient was
      handed over to the PACU using Richmond Agitation-Sedation Scale (RASS), Table 1, and the
      highest score was documented by the main investigators. In this study patients with a RASS
      score of +2 or more were considered to have EA.
    

Intervention name(s): Ketamine Hydrochloride
Intervention type(s): Drug
Intervention description(s): intramuscular ketamine hydrochloride at dose of 0.7 mg/kg at the time of turning the inhalational agent off
Intervention MeSH terms: Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Agitation; Emergence; Ketamine; Intramuscular; Nasal surgery
Observational Study of the Preventive Trial With HIV-1 Tat Protein
Condition: Healthy Subjects
Study type: Observational

Summary: 
      The results of the Phase I Safety and Immunogenicity Trial of Recombinant HIV-1 Tat (ISS
      P-001 and ISS T-001) indicate that the vaccine based on the recombinant Tat protein is safe,
      well tolerated and immunogenic. The present study is intended to extend the follow-up of the
      volunteers for additional 3 years to evaluate the persistence of the anti-Tat humoral and
      cellular immune response. The results of the present study will be key for the design of
      future phase II trials, particularly for the definition of the optimal schedule for boosting
      immunizations.

      All individuals (20) will be enrolled in a 120-weeks observational study and monitored every
      24 weeks for the following 3 years. During these visits, in addition to the hematological and
      biochemical assessment, the anti-Tat specific humoral and cellular immune responses will be
      evaluated.
    


Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Subjects previously included in the Preventive Phase I Clinical Trial with Tat
        protein
      
Biospecimen description: 
      Whole blood, serum, PBMCs
    
Keywords: HIV; Tat protein; Preventive vaccine
Efficacy of the Consumption of a Spinach Extract on Muscle Function in Subjects Over 50 Years of Age
Condition: Sarcopenia; Physical Exercise
MeSH terms: Sarcopenia
Study type: Interventional

Summary: 
      Controlled, randomized, single-center, double-blind clinical trial, with two parallel
      branches depending on the product consumed, to measure the efficacy of a supplement extracted
      from spinach on muscle strength in subjects over 50 years of age.
    

Detailed description: 
      Subjects who meet the selection criteria will make two visits to the laboratory to perform
      the tests established in the protocol. In addition, all subjects will develop a program of
      strength, polyarticular, individualized and progressive exercises in which the main muscle
      groups are worked. The program will be held three days a week (36 sessions). Subsequently, a
      statistical analysis will be performed with the variables measured in the study to obtain
      results.
    

Intervention name(s): Dietary supplement consumption and physical exercise
Intervention type(s): Dietary Supplement
Intervention description(s): The consumption time of the experimental product was 90 days and the control consumption time was 90 days.
During this time, training should be done three times a week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
To Evaluate the Hormonal Response to Low Blood Sugar After a Single Oral Dose of AZD1656 Suspension
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the hormonal response to low blood sugar after a single oral dose of AZD1656
      suspension.
    


Intervention name(s): Insulin; AZD1656
Intervention type(s): Drug; Drug
Intervention description(s): Insulin infusion given during 3 hours at one occasion.; Single dose oral suspension given at one occasion.
Intervention MeSH terms: Insulin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 diabetes, hormonal response
Prediction of Neonatal Hyperbilirubinemia
Condition: Hyperbilirubinemia, Neonatal
MeSH terms: Hyperbilirubinemia, Neonatal; Hyperbilirubinemia
Study type: Observational

Summary: 
      Objective: To develop an evidence-based strategy for assessing the risk of significant
      hyperbilirubinemia in healthy term and near-term (late-preterm) neonates.

      Hypothesis: A stepwise strategy which combines clinical parameters and serial non-invasive
      transcutaneous bilirubin (TcB) values could reliably predict significant neonatal
      hyperbilirubinemia.

      Methods: Data from neonates >34 weeks' gestation included in the registry for neonatal
      hyperbilirubinemia of the well-baby nursery of the University Hospital of Patras, from
      January 2008 to December 2010 will be reviewed.

      The registry includes prospectively collected data such as sex, gestational age, gestation
      and perinatal information, mother's and infant's ABO group and Rh, G6PD deficiency, Coombs
      test, type of delivery and complications, birthweight, postnatal medications and
      interventions, type and volume of feeding (daily), extension of jaundice, TcB measurements at
      intervals of 12+/-4 hours until discharge, total serum bilirubin values (if obtained), TcB or
      TSB measurements at follow-up, weight at discharge, need of phototherapy (inpatient or after
      discharge). TcB and TSB values are plotted on a hour-specific chart.

      A novel predictive nomogram based on TcB measurements (Varvarigou et al. Pediatrics
      2009;124:1052-9) will be used to classify TcB values as high, intermediate, and low risk.

      Significant hyperbilirubinemia will be defined as a TSB value above the phototherapy
      threshold level according to the AAP 2004 guidelines

      Statistics: Independent and joint effects of various clinical factors on the development of
      significant hyperbilirubinemia will be evaluated by logistic regression analysis Cluster
      analysis and Chi-squared Automatic Interaction Detection (CHAID) tree method will be used to
      develop the strategy. At each step, CHAID chooses the independent (predictor) variable that
      has the strongest interaction with the dependent variable. Categories of each predictor are
      merged if they are not significantly different with respect to the dependent variable.
    


Observational model: Cohort
Sampling method: Non-Probability Sample
Study population: 
        Healthy term and late-preterm neonates