bioihbjkbjnl/mcl2 huggingface dataset:
Optimal Timing of Parasternal Intercostal Nerve Block Application for Acute Pain Management in Cardiac Surgery
Condition: Pain, Acute
MeSH terms: Acute Pain
Study type: Interventional

Summary: 
      Patients experiencing pain after undergoing cardiac surgery may also experience prolonged
      immobilization, insufficient respiratory functions, and the inability to cough due to median
      sternotomy. Therefore, duration of mechanical ventilation, length of intensive care unit
      (ICU) stay, and length of hospital stay of these patients will increase significantly.

      many facial plane blocks have been introduced as simple and safe intervention for thoracic
      wall anesthesia and analgesia. Parasternal intercostal nerve block (PSIB) is a "superficial
      block" which involves local anesthetic (LA) infiltration in the intercostal space around the
      sternum where the anterior branches of intercostal nerves exist.

      Intraoperative LA administration under direct vision of the surgeon ensures adequate delivery
      of drugs and minimizes bleeding complication or inadvertent administration in blood vessels.
      Meanwhile, Preoperative administration of LA guided by ultrasound imaging has been used in
      variable surgical settings with noticeable success because of preemptive inhibition of
      noxious stimuli.
    


Intervention name(s): pre-incisional parasternal intercostal block; post-incisional parasternal intercostal block
Intervention type(s): Procedure; Procedure
Intervention description(s): LA will be administrated by the anesthesiologist under ultrasound guidance and before surgical incision On either side of thorax, 2 cm lateral to sternal edge from 2nd to 6th intercostal space, A volume of (4 mL) of 0.25% bupivacaine will be used; LA will be administered by the cardiac surgeon before the sternal closure. injection will introduced 2 cm lateral to sternal edge from 2nd to 6th intercostal space and volume (4 mL) of 0.25% bupivacaine will be used.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Insulin Resistance in Women With Prolactinoma
Condition: Prolactinoma; Insulin Resistance; Hyperlipidemia
MeSH terms: Prolactinoma; Insulin Resistance; Hyperlipidemias
Study type: Observational

Summary: 
      Prolactin is suggested to influence insulin resistance, but scarce data is available on the
      metabolic profile of patients with prolactinoma.

      The purpose of the protocol was to evaluate cardiovascular disease risk factors in women with
      prolactinoma treated with dopamine agonists and to study the influence of disease control and
      anthropometry on their metabolic profile.
    

Detailed description: 
      A cross-sectional study was performed in non-obese premenopausal women with prolactinoma
      treated with dopamine agonists evaluated regarding glucose, insulin, Homeostasis Model
      Assessment (HOMA), lipid profile, C reactive protein (CRP), body mass index (BMI), waist
      circumference, prolactin, estradiol, testosterone, and sex hormone binding globulin (SHBG).
      They were compared with control women of similar age and BMI distribution.
    

Observational model: Defined Population
Time perspective: Other
Keywords: Insulin; glucose; lipids; prolactinoma; hyperprolactinemia
Study to Compare Pharmacokinetic Profiles of TRK-100STP in Japanese, Chinese, and South Korean Non-elderly Healthy Adult Males
Condition: Healthy Adult Male; Pharmacokinetics of TRK-100-STP
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to evaluate the pharmacokinetics and safety of TRK-100STP in Japanese, Chinese, and
      South Korean non-elderly healthy adult males.
    


Intervention name(s): TRK-100STP
Intervention type(s): Drug
Intervention description(s): oral
Other intervention name(s): beraprost; Careload LA; YM533
Intervention MeSH terms: Beraprost
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: TRK-100STP; PK; beraprost sodium
Immediate Effects of Manipulation Versus Stretching on Upper Trapezius Pressure Pain Thresholds
Condition: Neurophysiological Mechanisms Manipulation
Study type: Interventional

Summary: 
      The purpose of this study is to determine the immediate effects of cervicothoracic
      manipulation and upper trapezius stretching on upper trapezius pressure pain threshold and
      cervical ROM.
    


Intervention name(s): CT Manipulation; Upper trapezius stretch
Intervention type(s): Procedure; Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Safety, Efficacy and Tolerability Study of Sativex for the Treatment of Spasticity in Children Aged 8 to 18 Years
Condition: Cerebral Palsy
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to assess the effects of Sativex treatment on spasticity in a population of children
      and adolescents aged from 8 to 18 years with cerebral palsy or traumatic central nervous
      system injury. Efficacy (ability to improve symptoms), safety and tolerability will be
      monitored.
    

Detailed description: 
      A 12 week randomised, double-blind, placebo-controlled,parallel group study followed by a
      24-week open-label extension phase.

      The primary objective is to assess the efficacy of Sativex treatment using a spasticity 0-10
      numerical rating scale (NRS). The endpoint for analysis is the comparison between Sativex and
      placebo in the change from baseline to the end of the acute phase in mean spasticity 0-10 NRS
      scores (week 12 or last seven days prior to withdrawal).

      The secondary objectives are to assess the safety and tolerability of Sativex via volunteered
      adverse events, laboratory parameters and vital signs. The efficacy of Sativex compared to
      placebo is also investigated for the following outcomes: spasticity (modified tardieu scale
      (MTS) score of the most affected limb and the modified ashworth scale (MAS) score of the main
      muscle groups of the upper and lower limb), sleep quality (sleep 0-10 NRS), pain (paediatric
      pain profile [PPP]), quality of life (of both the participant and the caregiver; cerebral
      palsy quality of life (QOL) questionnaire and caregiver QOL questionnaire), comfort (comfort
      questionnaire), depression assessment (childrens depression inventory (CDI 2)) and the
      caregiver's global impression of change (CGIC).
    

Intervention name(s): Sativex; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oromucosal spray containing THC (27 mg/mL):CBD (25 mg/mL), in ethanol: propylene glycol (50:50) excipients, with peppermint oil (0.05%) flavouring. Each 100 μL spray delivered THC 2.7 mg and CBD 2.5 mg. The maximum number of daily sprays was 12.; Oromucosal spray containing ethanol: propylene glycol(50:50) excipients, with peppermint oil (0.05%) flavouring and colourings FD&C Yellow No.5 (E102 tartrazine) (0.0260%), FD&C Yellow No.6 (E110 sunset yellow) (0.0038%), FD&C Red No. 40 (E129 Allura red AC) (0.00330%) and FD&C Blue No.1 (E133 Brilliant blue FCF) (0.00058%). Each 100 μL spray administered to the sub-lingual or oral mucosa delivered the colourants plus excipients. The maximum daily dose was 12 sprays per day.
Other intervention name(s): Nabiximols; THC:CBD spray; GW-1000-02; GW-4000-01
Intervention MeSH terms: Nabiximols
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Spasticity
Study of Pulmozyme to Treat Severe Asthma Episodes
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      Even with current standard ED treatments 20-25% of patients presenting to the ED with an
      acute asthma episode will still require hospitalization. For patients unresponsive to
      beta-agonists the admit rates will be higher. Of those well enough to be discharged from the
      ED nearly 30% will relapse within one month. More than 5,000 patients with asthma still die
      each year in the USA. For patients who do not respond to beta-agonists, there are relatively
      few treatment options for rapid improvement of symptoms and pulmonary function. Presumably,
      mucous secretion and plugging play an important role in the pathogenesis of severe asthma
      unresponsive to beta-agonists. The use of agents to promote clearance of intra-luminal
      secretions and mucous plugs may represent an important advance in the management of acutely
      ill asthmatics, both to hasten recovery and prevent deterioration in the acute care setting
      and to prevent relapse after discharge from the ED.

      OBJECTIVES

      2.1 Study Hypothesis: rhDNAse can be safely used in patients presenting to the Emergency
      Department with acute moderate-severe asthma who do not have adequate responses to
      beta-agonists

      Project Specific Aim: This is a pilot study to determine the safety of three different doses
      of pulmozyme® (2.5mg, 5.0mg and 7.5mg) in patients presenting to the ED with acute asthma. In
      addition to safety trends for improvement in pulmonary function and clinical outcomes will be
      monitored and data analyzed. Based on the safety profile and observable responses to
      treatment, this information may be used to develop larger trials to determine the efficacy
      and dosing strategy for treating acutely ill asthmatics with rhDNAse.
    


Intervention name(s): rhDNAse (pulmozyme)
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: acute disease
Exploratory Study of Pagoclone in Men With Premature Ejaculation.
Condition: Premature Ejaculation
MeSH terms: Premature Birth; Premature Ejaculation
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate pagoclone in the treatment of premature ejaculation.
    

Detailed description: 
      The primary objective of this study is to evaluate the effect of 3 dose levels of pagoclone
      (0.15 mg, 0.30 mg, and 0.60 mg) versus placebo on intravaginal ejaculation latency time
      (IELT) male patients with primary premature ejaculation.
    

Intervention name(s): pagoclone
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: investigational drug; ejaculation
Bioequivalence Study of Dr. Reddy's Laboratories Limited, Finasteride Tablets 1 mg Under Fasting Condition
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to compare the single-dose relative bioavailability of Dr.
      Reddy's Laboratories, Ltd. and Merck & Co. (Propecia®)

      1 mg finasteride tablets under fasting conditions following administration of a 3 mg dose.
    

Detailed description: 
      Detailed Description : The study was conducted as an open-label, randomized, single-dose,
      2-way crossover, relative bioavailability study performed on 24 healthy adult male volunteers
      and 2 alternates. A total of 24 subjects completed the clinical phase of the study. In each
      period, subjects were housed from the evening before dosing until after the 36-hour blood
      draw. Single oral 3 mg doses were separated by a washout period of 7 days.
    

Intervention name(s): Finasteride
Intervention type(s): Drug
Intervention description(s): Finasteride tablets 1 mg
Other intervention name(s): Propecia
Intervention MeSH terms: Finasteride
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioequivalence,Finasteride,Crossover
Research Study Investigating Study Medicine (NNC9204-1177) for Weight Management in People With Overweight or Obesity
Condition: Metabolism and Nutrition Disorder; Obesity
MeSH terms: Obesity; Overweight; Nutrition Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study looks at a new study medicine for weight management in people with overweight or
      obesity. The aim of this study is to find out how safe and tolerable the study medicine is.
      The study also looks at how the study medicine behaves in the body and how it is removed from
      the body.

      Participants will either get NNC9204-1177 (the new study medicine) or placebo (a formula that
      looks like the study medicine but does not have active ingredients). Which treatment
      participants get will be decided by chance.

      NNC9204-1177 has not been approved by the United States Food and Drug Administration. Its use
      in this study is experimental. Participants will get 1 or more injections into the skin of
      the stomach area once each week for 12 weeks.

      The study will last for about 5 months. Participants will have 19 clinic visits with the
      study doctor. At certain times during the study, participants will have blood draws and 3
      different kinds of electrocardiograms. Participants will answer mental health questionnaires.
      Women: Women cannot take part if pregnant, breast-feeding or plan to become pregnant during
      the study period.
    


Intervention name(s): NNC9204-1177 A 1.0 mg/mL; PLACEBO
Intervention type(s): Drug; Drug
Intervention description(s): Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks.
Dose gradually increased to 6000 μg.; Participants will get 1 or more injections into the skin of the stomach area once each week for 12 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Somatosensory Profiling in Radicular Pain Patients And it's Correlation With Treatment Outcome
Condition: Radiculopathy; Lower Extremity Radicular Pain
MeSH terms: Radiculopathy
Study type: Interventional

Summary: 
      The investigators hypothesize that there may exist different quantitative sensory profiles
      between radicular pain patients who respond and those who do not respond to the standard
      therapy of epidural steroid injections (ESI).
    

Detailed description: 
      The investigators are comparing warm/cold sensation, heat/cold pain threshold, heat/cold pain
      tolerance, wind-up, and conditioned pain modulation (CPM) as measured by Quantitative Sensory
      Testing (QST) between subjects with a radicular pain condition. The investigators are
      comparing those who respond and those who do not respond to standard therapy (ESI) before and
      after the treatment.
    

Intervention name(s): Quantitative Sensory Testing (QST); Epidural Steroid Injection (ESI)
Intervention type(s): Device; Procedure
Intervention description(s): Subjects will undergo hot and cold temperature testing using the QST device at two points: 1) Before ESI and 2) after ESI.; Subjects will receive an ESI by their clinical physician as part of their clinical treatment. This procedure is not given as part of the research study.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Radicular; Pain; Epidural Steroid Injection
Group Interpersonal Psychotherapy for Treatment of Major Depressive Disorder Following Perinatal Loss
Condition: Major Depressive Disorder; Miscarriage; Stillbirth; Neonatal Death
MeSH terms: Abortion, Spontaneous; Stillbirth; Perinatal Death; Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional

Summary: 
      The purpose of this study is to conduct a randomized pilot trial in a sample of 60 women who
      meet criteria for Major Depressive Disorder (MDD) 1-18 months after a perinatal loss to
      demonstrate the feasibility of the proposed recruitment methods and research design, of the
      therapist training methods, and of delivering the adapted Interpersonal Psychotherapy group
      treatment.

      The investigators would like to examine preliminary evidence for the following hypotheses:

        -  Perinatal-loss specific IPT-G will be more acceptable to women who experience MDD
           following perinatal loss than will Coping with Depression (CWD).

        -  Perinatal-loss specific IPT-G will result in reduced time to remission from MDD and
           reduced depressive symptoms relative to CWD.

        -  Perinatal-loss specific IPT-G will result in increased social support and social
           functioning, reduced couple distress, and reduced grief relative to CWD.
    


Intervention name(s): Group Interpersonal Psychotherapy (IPT-G); Coping with Depression (CWD)
Intervention type(s): Behavioral; Behavioral
Other intervention name(s): IPT-G; CWD
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Major Depressive Disorder (MDD); Miscarriage; Stillbirth; Neonatal death; Interpersonal psychotherapy; Group Therapy; Coping with Depression (CWD)
Preventive Strategies in Colorectal Carcinogenesis Production and Meat Processing
Condition: Colorectal Cancer
MeSH terms: Carcinogenesis
Study type: Interventional

Summary: 
      Colorectal Cancer is, in non-smokers for both sex, first cause of cancers mortality in
      Western country.

      The main risk factors associated with colorectal cancer depend of lifestyle, and processed
      meat and red meat could be involved in carcinogenesis by cytotoxic and genotoxic compound
      linked to lipid peroxidation and nitrosation.

      The aim of this study is to study the impact of the daily consumption of beef, processed or
      not, on lipid peroxidation induced heme iron ; and to study the impact of the daily
      consumption of ham, processed or not, on the nitrosilation induced heme iron.
    

Detailed description: 
      24 healthy volunteers will be randomized and will start the study. The study will last 12
      weeks for each subject. The first week will be a week of adaptation (or run-in period) to the
      diet which they will have to follow for the duration of study. During this period, they will
      collect 3 samples of stools and urine. Then subjects will alternate 4 days of diet either
      with ham, or with ham and pomegranate extract, or with ham enriched with vitamin E or sirloin
      steak, marinated sirloin steak or marinated cooked sirloin steak. At least, 3 days will
      separate every period (wash-out) of nutritional intervention. Urines and stools will be
      collected last 3 days of every interventional period and also last day of every wash out
      period.
    

Intervention name(s): ham; ham + pomegranate extract; ham + tocopherol; rare sirloin steak; marinated rare sirloin steak; marinated cooked sirloin steak
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): 160g per day during 4 days; 160g per day during 4 days; 160g per day during 4 days; 110g per day during 4 days; 110g per day during 4 days; 110g per day during 4 days
Intervention MeSH terms: Tocopherols; Vitamin E; Tocotrienols; alpha-Tocopherol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Manikin To Patient Intubation: Does It Translate?
Condition: Intubation; Difficult or Failed
Study type: Interventional

Summary: 
      This study evaluates a new approach to the instruction of pediatric residents in the skill of
      neonatal intubation. Half of the participants will receive focused simulation training and
      cognitive instruction while the other half will not. The collected data from both groups will
      be compared.
    

Detailed description: 
      Current findings suggest that the training of pediatric residents is not sufficient prior to
      "live" tracheal intubations in the critical care setting. The current one to two days of
      airway management training as a part of resuscitation training (such as Pediatric Advanced
      Life Support (PALS) or Neonatal Resuscitation Program (NRP) is not sufficient to provide safe
      intubation skills.

      This study will develop and implement tracheal intubation training using concepts of
      deliberate practice modeled after Ericsson. The concepts include focused training on a
      specific task, immediate feedback, time for problem solving and evaluation, and opportunities
      for repeated performance using a manikin. This proposal is an attempt to develop such a
      training model. Video recordings of live intubations will be reviewed and evaluated. The data
      between the two groups will be compared to see if there is improved intubation skills of live
      patients.
    

Intervention name(s): Intervention: Receives Training; Intervention: Control No Training
Intervention type(s): Procedure; Other
Intervention description(s): • Complete a Hands-on Intubation in the Simulation Lab with PI instructing:
Using state of the art technology, a Storz C-MAC video laryngoscope
Identifying anatomical landmarks
Practice on the manikin until intubation occurs within 15 seconds; • Does not receive simulation training with PI. Only standard training.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research