bioihbjkbjnl/mcl2 huggingface dataset:
Thyromental Height Test (TMHT) as a Predictor of Difficult Airway in Obese Patients
Condition: Difficult Airway Intubation
Study type: Observational

Summary: 
      Difficult airway management is a major concern for anesthetists and contributes to
      perioperative morbidity and mortality. The incidence of difficult intubation in the obese
      population with a BMI of greater than 30 has been reported to be 15.8%. Thyromental height
      test (TMHT) is a new bedside test for difficult airway, it is a measure of the height between
      the anterior borders of the mentum and thyroid cartilage. TMHT can act as a surrogate for
      amount of mandibular protrusion; dimensions of submandibular space; and anterior position of
      the larynx. It appears promising as a single anatomical measure to predict the risk of
      difficult laryngoscopy.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients of both sex, aged between 18-60 years old, ASA physical status II& III with BMI >
        30 Kg/m2 who will undergo elective surgical procedures under general anesthesia using
        endotracheal intubation using conventional laryngoscopy
Impact of Exercise Training on Exercise Capacity in Patients With Severe Chronic Heart Failure
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      Patients with heart failure are limited in their exercise capacity due to skeletal muscle
      alteration and an impairment of peripheral perfusion. Regular physical exercise training has
      been shown to partially correct these peripheral maladaptations in patients with stable heart
      failure, which was associated with an improvement in exercise capacity. However, it is
      unknown so far, whether regular physical activity also exerts beneficial effects in patients
      with severe chronic heart failure.

      Aim of the trial is therefore to assess the effects of aerobic exercise training on exercise
      capacity, muscle maladaptations and peripheral perfusion in patients with severe chronic
      heart failure according to NYHA class III b.
    

Detailed description: 
      A total of 36 patients with severe chronic heart failure are prospectively randomized to
      either 3 months of aerobic ergometer training or a sedentary control group.

      Before and after the intervention period maximal exercise capacity is assessed by
      ergospirometry, endothelial function is determined by high-resolution A-mode ultrasound, and
      muscle mass is determined by CT. Skeletal muscle biopsies are obtained at begin and after 3
      months and are analyzed for markers of muscle catabolism/anabolism.
    

Intervention name(s): Aerobic endurance exercise training (ergometer)
Intervention type(s): Behavioral
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: chronic heart failure; exercise training
Increasing PrEP Among African Americans in Louisville KY
Condition: HIV/AIDS PREVENTION
MeSH terms: Acquired Immunodeficiency Syndrome; HIV Infections
Study type: Interventional

Summary: 
      This study evaluates the effectiveness of a multifaceted strategy to increase pre-exposure
      prophylaxis (PrEP; a medication regimen to reduce HIV risk) uptake among high risk African
      Americans in Louisville, KY. We will do this by 1) implementing a media campaign to raise
      awareness about PrEP, 2) providing PrEP education to medical personnel who can prescribe
      PrEP, and 3) partnering with AIDS service organizations to improve outreach and linkage to
      PrEP services.
    


Intervention name(s): Project Prevent
Intervention type(s): Behavioral
Intervention description(s): The Project Prevent intervention entails 1) a media campaign to raise PrEP awareness, 2) geographically targeted education initiatives with medical personnel to increase access to consumers, and 3) programming with AIDS service organizations to improve service delivery around PrEP.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Reference Interval for SPO2 in Neonates at High Altitudes During First 2 Hours and Umbilical Artery Blood Gas
Condition: Neonatal Disease; Altitude Hypoxia
MeSH terms: Altitude Sickness; Infant, Newborn, Diseases; Hypoxia
Study type: Observational

Summary: 
      Pulse oximetry offers real time and non-invasive estimation of arterial oxygen saturation in
      a cost-effective way, and has become a critical tool in guiding the usage of supplemental
      oxygen in sick newborns. During postnatal transition, pulmonary pressure decreases upon the
      activation of the lungs, and the ductus arteriosus constricts and closes upon the increase of
      partial oxygen pressure, which is negatively correlated with altitude. As a result, postnatal
      transition may be different at high altitudes. Umbilical cord blood gas analysis is now
      recommended in all high-risk deliveries because of its' value in providing information about
      preceding fetal hypoxic stress. But there are only limited studies about the SpO2
      measurements during the first few hours after birth and umbilical blood gas analysis at high
      altitudes, especially at altitudes above 2500m. The primary outcome of the study is to
      determine the reference intervals for preductal oxygen saturation during first 2 hours of
      life stratified by different gestational age. The secondary outcomes is to establish the pH
      and lactate cutoff value of umbilical arterial blood gas at different altitude level.
    


Intervention name(s): pulse oxygen saturation
Intervention type(s): Diagnostic Test
Intervention description(s): preductal oxygen saturation
Other intervention name(s): umbilical blood gas analysis
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study included infants with a gestational age between 35 to 42 weeks who were born
        alive and appearing well
      
Keywords: pulse oxygen saturation; neonate; altitude; umbilical arterial blood gas
Acupuncture as Adjuvant Therapy for Sleep Disorders in Parkinson's Disease
Condition: Parkinson Disease
MeSH terms: Parkinson Disease; Sleep Wake Disorders; Parasomnias
Study type: Interventional

Summary: 
      Sleep disorders correspond to a non-motor symptom present in DP, being represented by daytime
      sleepiness and maintenance insomnia. This study aims to evaluate the effects of acupuncture
      on sleep disorders in patients with PD assisted by Pró-Parkinson Program at University
      Hospital of Pernambuco, Brazil. Its a randomized clinical trial approved by the Ethics
      Committee for Research with Human. It was included patients with diagnosed with Idiopathic
      Parkinson's disease, Mini Mental State Examination (MMEE) according to education, stages 1, 2
      and 3 in the Hoehn-Yahr scale. It was used the sleep Scale for Parkinson's disease (PDSS), a
      self-administered scale designed to assess nighttime sleep problems, sleep disorders and
      excessive daytime sleep. Twenty-two subjects were allocated in two groups: experimental and
      control. Acupuncture was applied on the acupoints F3 - BP6- VB34- IG4 - TA5 - C7 - PC6 - IG11
      - VB20 - XIAOCHANXUE once a week, eight sessions in the experimental group. The control group
      no suffered intervention. The paired analyzes were performed using the Wilcoxon test and the
      independent analyzes using the Mann-Whitney test.
    


Intervention name(s): Acupuncture
Intervention type(s): Other
Intervention description(s): Acupuncture was applied on the acupoints F3 - BP6- VB34- IG4 - TA5 - C7 - PC6 - IG11 - VB20 - XIAOCHANXUE, once a week, eight sessions in the experimental group.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Behavioral Processes Underlying Reward Processing in Depression
Condition: Major Depressive Disorder; Bipolar Disorder
MeSH terms: Depression; Depressive Disorder; Depressive Disorder, Major; Bipolar Disorder
Study type: Observational

Summary: 
      The purpose of this project is to use behavioral techniques to investigate emotional
      processing in subjects with major depression and healthy comparison subjects.
    

Detailed description: 
      A promising strategy for parsing the heterogeneity of Major Depressive Disorder is to
      identify phenotypes characterized by reliable functional abnormalities. Anhedonia, the lack
      of reactivity to pleasurable stimuli, is considered a trait marker for depression. Using an
      objective behavioral task this project aims to investigate hedonic capacity in subjects
      meeting a DSM-IV diagnosis of Major Depressive Disorder.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Control participants, Participants with MDD, Participants with Bipolar Disorder
      
Keywords: Depression; Bipolar Disorder; Reward Processing
Evaluation of Bilateral Gamma Knife Thalamotomy in Patients Presenting With Severe Essential Tremor
Condition: Patients With Parkinson's Disease
MeSH terms: Parkinson Disease; Essential Tremor
Study type: Interventional

Summary: 
      Essential tremor (ET) is the most frequent movement disorder. Its prevalence is about 1/200
      implying that at least 300 000 peoples are concerned in France. Its frequency increase with
      age (14% of patients 65 yo). The diagnostic criteria are postural and kinetic tremor that can
      be associated with head/voice tremor. ET induces a social impairment but also difficulties to
      perform any task requiring dexterity. With time, tremor can be so severe that every activity
      of daily living is impaired with loss of autonomy.

      Treatment such as betablockers, primidone or antiepileptics might have some efficacy at the
      beginning. But as the severity of the tremor increases, there is lack of efficacy. Deep Brain
      stimulation (DBS) of the ventral intermediate nucleus (VIM) of the thalamus can be proposed.
      However, in case of medical or surgical contra-indication, Gamma Knife (GK) radiosurgery
      thalamotomy can be an alternative option.

      Patients will be included with a minimum of 12 months after having the first thalamotomy
      (Gamma Knife 1) (done on the most annoying side) subject to no significant deterioration in
      cognitive assessment, voice assessment and balance and postural assessment or
      neuroradiological abnormality.

      Patients will be assessed with Magnetic resonance imaging (MRI) cerebral, clinical assessment
      (tremor rating scale) impairment of activity of daily living, neuropsychological evaluation,
      voice assessment and balance and postural assessment.

      The second thalamotomy (Gamma Knife 2) will be proposed and a monitoring at M6 and M12 will
      be done.

      This study will demonstrate the feasibility and tolerance of bilateral GK radiosurgery
      thalamotomy in ET patients with severe impairment.
    


Intervention name(s): Gamma Knife® radiosurgery bilateral
Intervention type(s): Device
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase 1 Norwalk Vaccine Study
Condition: Norovirus
Study type: Interventional
Phase: Phase 1

Summary: 
      Randomized, double blind, multi-site, study in healthy adults, comparing safety and
      immunogenicity of two dosage levels of Norwalk VLP Vaccine with adjuvant/excipients and with
      placebo controls

      Primary Objective:

        -  Safety as determined by occurrence of local intranasal symptoms or other symptoms as
           reported by a self-administered memory aid for 7 days after each vaccination and
           hematology, blood chemistry and physical examinations performed by the clinical research
           staff

        -  Subjects will also be monitored for Serious Adverse Events (SAEs), and onset of any new
           medical conditions for 180 days following the last study vaccinations (Day 201).

      Secondary Objectives

      Evaluations of immunogenicity as determined by:

        -  Geometric mean titers and seroconversion rate of serum anti- Norwalk VLP IgG and IgA

        -  Stimulation of anti-Norwalk VLP IgA antibody secreting cells (ASC)

        -  Presence of antigen specific memory B-cell response

      Cells will be collected and stored for possible future evaluation of Norwalk VLP-specific
      cell-mediated immune (CMI) responses

      Study Hypothesis:

      The incidence of adverse events after intranasal Norwalk VLP Vaccine will be the same as the
      incidence of adverse events after intranasal adjuvant/excipients alone. Norwalk VLP Vaccine
      and adjuvant/excipients will have a higher incidence of mild to moderate nasal adverse events
      compared to placebo but similar incidence of other adverse events.

      Two doses of the 100 µg of Norwalk VLP Vaccine will be more immunogenic than two doses of 50
      µg of Norwalk VLP Vaccine. The post-vaccination serum antibody responses, the number of
      antibody secreting cells (ASC) and IgG and IgA memory B-cell responses directed against
      Norwalk Virus antigen will be increased after Norwalk VLP Vaccine compared to
      adjuvant/excipients and to placebo.
    


Intervention name(s): Adjuvant/Excipients; placebo; Norwalk VLP Vaccine; Norwalk VLP Vaccine
Intervention type(s): Drug; Device; Biological; Biological
Intervention description(s): intranasal,14 mg chitosan, 3 mg mannitol, 3 mg sucrose and 50 mcg of MPL, 2 doses 21 days apart; intranasal, puff of air, 2 doses, 21 days apart; intranasal, 50mcg, 2 doses--21 days apart; Intranasal, 100 mcg, 2 doses, 21 days apart
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Set Volume of Optimal Resistance Exercise to Generate Hypotension
Condition: Hypertension; Post-Exercise Hypotension; Resistance Training
MeSH terms: Post-Exercise Hypotension; Hypotension
Study type: Interventional

Summary: 
      This study evaluates the volume of optimal resistance exercise to generate postexercise
      hypotension after performing a single exercise in hypertensive elderly subjects. 20 subjects
      will perform 1 control session and 3 resistance training sessions with different volume: 3, 6
      and 9 sets
    


Intervention name(s): Resistance training
Intervention type(s): Other
Intervention description(s): 3, 6 or 9 sets of biceps curl with elastic bands at 20 repetition-maximum (RM)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Suplementation of Vitamin D in Gestational Diabetes Mellitus
Condition: Vitamin D3; Gestational Diabetes Mellitus in Pregnancy
MeSH terms: Diabetes, Gestational; Pregnancy in Diabetics; Diabetes Mellitus
Study type: Interventional

Summary: 
      Randomized double-blind placebo-controlled clinical trial. Consists of the administration of
      5,000 IU of vitamin D3 vs Placebo in patients with gestational diabetes mellitus during eight
      weeks. The objective is to analyze the effects of the intervention on the biochemical
      parameters that are part of the glycemic profile (insuline, HBA1c, glucose)
    

Detailed description: 
      Two groups of patients diagnosed with gestational diabetes mellitus. Once the selection
      criteria are verified, they will be assigned randomly in one of the two arms,one of them will
      recive 5,000 IU of vitamin D and the other one placebo (talcum food grade). Baseline
      measurements of vitamin D, glucose,insulin, HBA1c, calcium, phosphorus. At the end of the
      eight weeks will be determined again the aforementioned biochemical parameters.
    

Intervention name(s): Vitamin D3; Capsules with placebo (talcum food grade)
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Capsules with 5,000 IU of vitamin D3 once a day (one capsule); Capsules with placebo (talcum food grade)
Intervention MeSH terms: Vitamin D; Cholecalciferol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel design, two arms
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
IPG Replacement Study (PREFERENCE-H)
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Observational

Summary: 
      This post-marketing evaluation has been designed to consistently investigate the subject's
      preference when switching from a Medtronic® constant voltage or constant current device to a
      St Jude Medical Infinity™ or St Jude Medical Brio™ constant current system. As electrodes
      will not be re-positioned, differences in subject's preference are to be explained by the
      difference in shape of the delivered pulse or waveform between the two systems.
    


Intervention name(s): SJM Infinity™ DBS IPG or SJM Brio™ DBS IPG system
Intervention type(s): Device
Intervention description(s): Implanted Medtronic® IPG will be explanted and replaced by a SJM Infinity™ DBS IPG or a SJM Brio™ DBS IPG system
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects who have a diagnosis matching the approved indication and are being considered for
        an IPG replacement comprise the target population of this study. All subjects who meet the
        inclusion and none of the exclusion criteria and have signed an Ethics Committee (EC) or
        Institutional Review Board (IRB) approved informed consent will be considered enrolled in
        the study.
      
Keywords: SJM Infinity™; SJM Brio™; Implantable pulse generator (IPG) replacement; SJM-CIP-10135; Deep brain stimulation (DBS)
Investigating the Experience of Living With Down Syndrome and Obstructive Sleep Apnea Syndrome (Stage 1)
Condition: Down Syndrome; Obstructive Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Obstructive; Down Syndrome; Syndrome
Study type: Interventional

Summary: 
      To identify the perceptions, beliefs, and family-relevant outcomes regarding the treatment of
      obstructive sleep apnea syndrome (OSAS) with positive airway pressure (PAP) in children with
      Down's Syndrome (DS).
    

Detailed description: 
      This is a multi-center outpatient study to be performed at two clinical sites: Children's
      Hospital of Philadelphia and Cincinnati Children's Hospital. Forty Caregivers of children
      with DS and OSAS treated with PAP and their children will be enrolled. The study comprises
      one 30-minute open-ended semi-structured interview per caregiver. The duration of the
      interview is approximate. It will last up to 30 minutes as some families may want to include
      more details.
    

Intervention name(s): Open-ended semi-structured interviews
Intervention type(s): Behavioral
Intervention description(s): Semi-structured interviews will explore such key constructs as knowledge/belief about OSAS and PAP therapy, routines and resources that promote or limit PAP use, barriers, self-efficacy, and communication and attitudes about PAP. The interviews will be performed with the parent and that they will be audio-recorded.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Down Syndrome; Obstructive Sleep Apnea
MightySat - Clinical Performance Comparison Study
Condition: Healthy
Study type: Interventional

Summary: 
      This study compares the performance of respiratory rate from pleth (RRp) measured with
      MightySat device on healthy subjects.Subjects will be asked to breathe at specific rates
      ranging from 5 to 30 breaths per minute.
    


Intervention name(s): MightySat
Intervention type(s): Device
Intervention description(s): MightySat - investigational pulse oximeter that will be placed on the subject's right index finger for the duration of the study
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Docetaxel in Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Primary objective :

        -  To compare disease-free survival after treatment with docetaxel in combination with
           doxorubicin and cyclophosphamide to doxorubicin and cyclophosphamide followed by
           docetaxel in operable adjuvant breast cancer HER2neu negative patients with positive
           axillary lymph nodes.

      Secondary objectives :

        -  To compare toxicity and quality of life between the 2 above-mentioned arms.

        -  To evaluate pathologic and molecular markers for predicting efficacy.
    


Intervention name(s): docetaxel, doxorubicin, cyclophosphamide; Docetaxel,doxorubicin, cyclophosphamide
Intervention type(s): Drug; Drug
Intervention description(s): TAC x 6 : Docetaxel 75 mg/m² as 1 hour IV infusion on day 1 every 3 weeks in combination with doxorubicin 50 mg/m² as an IV bolus and cyclophosphamide 500 mg/m2 as IV on day 1 every 3 weeks. Sequence of administration is as follows: doxorubicin followed by cyclophosphamide followed by docetaxel.; AC x 4: Doxorubicin 60 mg/m² as an IV bolus in combination with cyclophosphamide 600 mg/m² as IV followed by docetaxel 100 mg/m² as 1 hour IV infusion on day 1 every 3 weeks for 4 cycles.
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Doxorubicin; Liposomal doxorubicin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of MK0859 in Patients With Primary Hypercholesterolemia or Mixed Hyperlipidemia (MK-0859-011)(COMPLETED)
Condition: Hypercholesterolemia; Hyperlipidemia
MeSH terms: Hypercholesterolemia; Hyperlipidemias; Hyperlipoproteinemias
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study to assess the safety, efficacy, and tolerability of MK0859 in patients with
      primary hypercholesterolemia (large amounts of cholesterol in the blood) or mixed
      hyperlipidemia (high levels of LDL cholesterol, triglycerides, and low levels of HDL
      cholesterol in blood) This is an early phase trial and some specific protocol information is
      in progress and not publicly available at this time. (Full information is available to trial
      participants).
    


Intervention name(s): MK0859
Intervention type(s): Drug
Intervention MeSH terms: Anacetrapib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Safety Study of Vasopressin V2 Receptor Antagonist on Patients With Severe Chronic Heart Failure (AQUAVIT).
Condition: Chronic Heart Failure
MeSH terms: Heart Failure
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, parallel-group forced up-titration
      study. Randomization will be stratified according to the patient's baseline serum sodium
      concentration (137-144 and <137 mmol/L). The dose of study drug will be increased to the next
      level on Day 15, and the total duration of the double-blind treatment period is 120 days.
    


Intervention name(s): Vasopressin V2 Receptor Antagonist
Intervention type(s): Drug
Intervention MeSH terms: Vasopressins; Arginine Vasopressin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Chronic Heart Failure; Heart Disease