bioihbjkbjnl/mcl2 huggingface dataset:
Treating Phobia by a New Emotional Regulation Method (Tipi)
Condition: Phobic Fear
Study type: Observational

Summary: 
      -  Background In emotional regulation, the patient remembers an emotional situation,
           focuses his attention on his physical sensations when he relives a recent emotion, and
           let evolve his sensations.

        -  Method Evaluate the relevance of this method by an interventional study, in a pre-post
           mono group, on patients suffering from phobia.

        -  Objective The investigators aim to validate the effectiveness of this emotional
           regulation method and compare its results with that of conventional methods. Sessions
           are individual and repeated until the disappearance of phobic fear.

      The present study may contribute to propose a new possibility to treat phobias in a simple
      and fast way.
    

Detailed description: 
      Between 2003 and 2006, the investigators conducted an exploratory, prospective and
      comparative research study, taking each person as their own control, to evaluate the benefits
      of the type of emotional regulation developed by the Tipi association on a population
      suffering from phobias.

      - Participants Phobias can be categorized by type, as defined in the DSM IV, the standard
      reference during the study period (American Psychiatriy Association, 2000) : agoraphobias,
      social phobias, specific situational phobias (claustrophobia, transport phobia), phobias
      linked to the natural environment (heights, water, fire), to animals (spiders, snakes,
      amphibians, tentacled shellfish) and other types of specific phobias (fear of physical
      contact, being dirtied, contaminated, vomiting), phobia of blood - injections - medical
      techniques - accidents.

      The investigators aim to conduct a prior and systematic verification with each person to
      confirm that their fears were phobias as defined in the DSM IV (American Psychiatriy
      Association, 2000). The phobia must be diagnosed by a doctor or psychiatrist. Each people
      must provide a medical certificate that evidenced the diagnosis in writing.

      All people must read an information form on "Understanding your emotions" All participants
      must have suffered from their phobias for a long time. They have to describe their treatment.

      Everybody in the study population have to provide a short-written report on the effects of
      the session(s) 1 week, 1 month, 3 months and 12 months after the session.

        -  Intervention (see below)

        -  Follow-up During the one-year follow-up period, the patient was requested to send a
           written self-assessment of his situation and the change and/or disappearance of his
           phobia. If the investigators didn't receive the person's assessment, the investigators
           followed-up with a mail and a phone call.
    

Observational model: Other
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        People with a phobic fear listed in the DSM IV classification
Acarbose and Secondary Prevention After Coronary Stenting
Condition: Glucose Metabolism Disorders; Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Metabolic Diseases; Glucose Metabolism Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether the intervention for newly diagnosed
      abnormal glucose tolerance after coronary stenting will improve the long-term clinical
      outcome.
    

Detailed description: 
      Recent studies have demonstrated that newly diagnosed abnormal glucose tolerance (AGT;
      diabetes mellitus and impaired glucose tolerance) are common among the patients with ischemic
      heart disease. Several large cohort studies indicate that people with prediabetic conditions,
      such as impaired glucose tolerance, have a raised risk of future cardiovascular disease.
      Intervention with acarbose can prevent myocardial infarction and cardiovascular disease in
      type 2 diabetic and IGT patients. However, the effect of acarbose to secondary prevention of
      myocardial infarction or cardiovascular events in patients with newly diagnosed AGT after
      coronary stenting remains unclear. The purpose of the present study is to determine whether
      the intervention to such abnormalities after coronary stenting will improve the long-term
      clinical outcome. This is a opened, randomized study to compare acarbose versus a standard
      lifestyle modification. Patients will have a 1:1 chance of receiving acarbose versus the
      standard lifestyle modification. There is some research evidence that suggests acarbose may
      improve clinical outcome in patients with type 2 diabetes and in IGT patients.
    

Intervention name(s): Acarbose
Intervention type(s): Drug
Intervention MeSH terms: Acarbose
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Abnormal Glucose Tolerance; coronary artery disease; diabetes mellitus; clinical outcome
2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy
Condition: Thyroid Nodule
MeSH terms: Thyroid Nodule
Study type: Interventional

Summary: 
      In transoral thyroidectomy via vestibular approach (TOETVA), prophylactic antibiotic for 5~7
      days is recommended for the clean-contaminated wound. In this study, the investigators design
      a 2-day versus 7-day antibiotic prophylaxis to compare the surgical result and infection
      rate.
    

Detailed description: 
      Remote-access thyroid surgery has gained popularity and has advanced significantly over the
      past two decades, given the patient desire to avoid cosmetically displeasing scarring. The
      mostly recently introduced remote thyroid surgery is the transoral endoscopic thyroid surgery
      via vestibular approach (TOETVA). Because of the several advantages comparing with other
      removeaccess thyroid surgery, making it nowadays growing in popularity since 2016. However,
      TOETVA carry some inherent risks, including mental nerve injury, tumor seeding and local
      recurrence, fibrosis-induced long-lasting pulling sensation below the lower jaws, and
      surgical site infection coming from the clean-contaminated environment of oral incision.

      Comparing with clean wound via the traditional open surgery, TOETVA carry the potential risk
      of infection. Based on the author's recommendation, prophylactic antibiotic (augmentin) will
      be administered 30 minutes before incision at operative room, followed by 2-day course of
      intravenous antibiotic, then shift to 5-day course of oral antibiotic finally. Up to date,
      only few case complicating postoperative infection were reported with extremely low infection
      rate (<1%). Therefore, the investigators want to study the short-course (2 days) of
      antibiotic coverage is also effective to prevent surgical site infection. It was proved in
      the preliminary study, comprising 5 patients in each group (2-day course in the study group
      and 7-day course in the control group). Later, the investigators will recruit more patients
      (n=100) to confirm this study.
    

Intervention name(s): Amoxicillin Clavulanate
Intervention type(s): Drug
Intervention description(s): compare the duration of antbiotic use: 2 day versus 7 day
Other intervention name(s): Augmentin
Intervention MeSH terms: Amoxicillin; Clavulanic Acid; Clavulanic Acids; Amoxicillin-Potassium Clavulanate Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: thyroid nodules, plan for transoral thyroidectomy
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: transoral surgery
Determination of Remifentanil's ED50 for Rapid Sequence Intubation Avoiding Bradycardia and Hypotension in Adults
Condition: Bradycardia; Hypotension
MeSH terms: Hypotension; Bradycardia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will find the median effective dose of remifentanil for rapid sequence intubation
      which avoids bradycardia and hypotension
    

Detailed description: 
      Remifentanil is becoming popular for rapid sequence intubation because it has a fast onset
      and ultra-short half-life.

      Remifentanil a potent opioid associated to bradycardia and hypotension at high doses.
    

Intervention name(s): Remifentanil
Intervention type(s): Drug
Intervention description(s): bolus dose
Intervention MeSH terms: Remifentanil
Intervention model: Sequential Assignment
Intervention model description: Adaptative clinical trial, Dixon's Up-And-Down Method
Masking: None (Open Label)
Primary purpose: Supportive Care
Psychophysical Correlates of Pain Reduction by Topical Analgesic Compounds
Condition: Healthy Volunteers
Study type: Observational

Summary: 
      Background:

      - Researchers are studying a topical (skin) cream that reduces pain. This is called an
      analgesic cream. They want to try a new test to better measure how well it works. Heat will
      be applied to the participants arms and they will judge the intensity of the temperatures.
      Researchers will compare the pain reduction from this cream to other pain relief treatments.

      Objective:

      - To better measure the effects of a pain-relieving (analgesic) cream.

      Eligibility:

      - Healthy volunteers ages 18 50.

      Design:

        -  There will be 2 study sessions.

        -  Session 1 will be about 1.5 hours.

             -  Participants will be screened with physical exam and urine drug test. They will
                answer medical and psychological questions.

             -  Participants will have sensory testing.

        -  A moisturizer will be put on their arms. A heating device will be placed on their arms.
           It gives heat pulses of about 2 seconds each. Some are warm and some are very hot.
           Participants will say how strong each pulse is. They can move away if it gets painful.

        -  Then the pain-relieving cream will be put on one arm. The moisturizer will be put on the
           other. Participants will get more pulses and rate them. They will also get pairs of
           pulses and compare them.

        -  Some participants will return for session 2 for 1 hour. They will receive similar
           sensory testing as in session 1.
    

Detailed description: 
      This study uses a new testing design to evaluate pain reduction from a pain-relieving cream.
      Sequences of heat stimuli will be applied to the participants arms and participants will be
      asked to judge the intensity of the temperatures they perceive. There are two study sessions.
      Session 1 involves eligibility screening and baseline sensory testing with and without the
      analgesic (pain-relieving) cream. Session 2 involves more sensory testing with the analgesic
      cream. The study population is 40 healthy volunteers aged 18 to 50.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Keywords: Skin; TEMPERATURE; Placebo
Study of Antenatal Thyrotropin-Releasing Hormone in Women in Premature Labor to Prevent Lung Disease in Preterm Infants
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Interventional

Summary: 
      OBJECTIVES:

      I. Assess the efficacy and safety of antenatal administration of thyrotropin-releasing
      hormone to women in premature labor to improve pulmonary outcomes in preterm infants.
    

Detailed description: 
      PROTOCOL OUTLINE: This is a randomized, double blind, multicenter study. Patients are
      randomized to receive antenatal thyrotropin-releasing hormone or placebo.

      Patients receive thyrotropin-releasing hormone or placebo intravenously over 20 minutes every
      8 hours for 4 doses.

      Infants are assessed for survival and chronic lung disease until day 28 after birth, and
      again at 36 postmenstrual weeks.
    

Intervention name(s): thyrotropin-releasing hormone
Intervention type(s): Drug
Intervention MeSH terms: Hormones; Thyrotropin-Releasing Hormone
Allocation: Randomized
Masking: Double
Primary purpose: Treatment
Keywords: cardiovascular and respiratory diseases; neonatal disorders; rare disease; respiratory distress syndrome
Dysport® In Migraine Without Aura Prophylaxis : DIMWAP Study
Condition: Migraine Without Aura Prophylaxis
MeSH terms: Migraine Disorders; Migraine without Aura
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether 120 Unit, and 240 unit of botulinum toxin A
      are effective in the treatment of migraine without aura prophylaxis.
    

Detailed description: 
      This is a 12-week, prospective double-blinded, randomized, multicenter study of placebo, 120
      Unit, and 240 unit of botulinum toxin A ( Dysport ® ) injection for patient with a diagnosis
      of Migraine without aura according to International Headache Society criteria. It is designed
      to evaluate the efficacy, safety, tolerability and optimum dose of Botulinum toxin type A
      (Dysport ®)injection for migraine without aura prophylaxis.
    

Intervention name(s): Botulinum Toxin type A (Dysport ® ) IM/SC 6-sites pericranial injection
Intervention type(s): Drug
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Botulinum toxin type A,; Dysport®,Dysport; Migraine without aura,; Migraine prophylaxis.
Safety and Efficacy of Oral Fampridine-Sustained Release (SR) for the Treatment of Spasticity Resulting From Spinal Cord Injury
Condition: Spinal Cord Injury; Muscle Spasticity
MeSH terms: Muscle Spasticity; Spinal Cord Injuries; Wounds and Injuries
Study type: Interventional
Phase: Phase 3

Summary: 
      Normally, nerve fibers carry electrical impulses through the spinal cord, providing
      communication between the brain and the arms and legs. In people with spinal cord injury,
      some fibers may be destroyed at the site of injury, while others remain connected but do not
      work correctly to carry electrical impulses. As a result, subjects with an incomplete spinal
      cord injury may have spasticity which is muscle spasms or muscle stiffness that makes
      movement difficult. Fampridine-SR is an experimental drug that increases the ability of the
      nerve to conduct electrical impulses. This study will examine the effects of Fampridine-SR on
      moderate to severe lower-limb spasticity, as well as the effects on bodily functions such as
      bladder control, bowel function and sexual function. The study will also examine the possible
      risks of taking Fampridine-SR.
    


Intervention name(s): Fampridine-SR; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 25mg bid (twice daily); Placebo
Intervention MeSH terms: 4-Aminopyridine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: spinal cord injury; muscle spasticity
Effects of Pimecrolimus on Skin Biopsy Ex-plants From Patients With Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Observational

Summary: 
      THe study seeks to determine if pimecrolimus has a positive effect on increasing
      antimicrobial peptide expression and reducing vaccinia virus growth in the skin explants from
      patients with atopic dermatitis.
    

Detailed description: 
      AMP play an important role in the innate immune response against infections. Two major
      classes of AMP have been identified: the beta defensins (HBD) (Harder 1997) and cathelicidins
      (LL-37) (Gallo 2002). AMP have been shown to have antibacterial activities against S. aureus
      (Ong 2002) and antiviral activity against vaccinia virus (VV) (Howell 2004).

      The skin of AD patients is characterized by a deficiency in AMP, which may account for their
      propensity to skin infections (Ong 2002). This AMP deficiency is believed to be due to an
      increase in Th2 cytokines, IL-4 and IL-13, expression (Ong 2002), as well as an increase of
      IL-10 expression (Howell 2005). Other cytokines known to affect AMP expression are TNF-alpha
      (TNFa), IL-6, IL-1 and interferon-gamma (IFN-g). These cytokines induce the expression of AMP
      (Erdag 2002, Liu 2002, Ong 2002, Nomura 2003). However, negligible levels of TNF-a and IFN-g
      have been shown in AD skin possibly due to their downregulation by Th2 cytokines (Nomura
      2003). Therefore, the neutralization of IL-4, IL-13 and IL-10 in AD patients may correct the
      AMP deficiency of AD patients and decrease their propensity to recurrent skin infections.
      Interestingly, the addition of anti-IL10 to skin explants from AD patients augmented HBD-2
      and LL-37 expression (Howell 2005). In addition, IL-4 and IL-13 were found to enhance VV
      replication and down-regulate LL-37 in VV-stimulated keratinocytes and neutralization of
      IL-4/IL-13 in AD skin augmented LL-37 and inhibited VV replication (Howell 2006a). LL-37 and
      HBD-3 have been found to kill VV(Howell 2004; Howell 2006b). Thus a deficiency of these AMP
      may contribute to increased propensity to viral infection. Therapeutic strategies are needed
      to augment AMP expression in AD skin to reduce skin infection.

      Pimecrolimus is a calcineurin inhibitor that binds with high affinity to macrophilin-12. The
      complex pimecrolimus-macrophilin inhibits calcineurin, a phosphatase required for the
      dephosphorylation of the cytosolic form of the nuclear factor of activated T cells (NF-AT).
      As a consequence, pimecrolimus prevents the nuclear translocation of NFAT and thereby the
      transcription and release of both Th1 and Th2 cytokines such as IL-2, IFN-g, IL-4, IL-5,
      IL-10, TNF-a and GM-CSF (Grassberger 1999).

      As the most common topical corticosteroid treatment used by AD patients, triamcinolone
      diacetate is included in this study as an active comparator.
    

Time perspective: Prospective
Keywords: atopic dermatitis
Kettlebell Swings and Paraspinal Muscle Function
Condition: Exercise Training
Study type: Interventional

Summary: 
      The purpose of this randomized control trial is to determine the extent of muscle fatigue in
      the lumbar erector spinae musculature secondary to a high-intensity interval kettlebell swing
      protocol utilizing TMG previously published by Jay et. al in 2011.
    

Detailed description: 
      Background: Kettlebell swings are commonly utilized to target the lumbar erector spinae and
      lower body musculature. This exercise exhibits distinct loading properties that requires
      cyclical contraction of the trunk extensors and posterior chain, potentially explaining its
      novel influence on muscle contractility. Tensiomyography (TMG) is a reliable, noninvasive,
      passive technique that may be used to examine muscular fatigue produced by kettlebell swings.
      Purpose: The purpose of this randomized control trial is to determine the extent of muscle
      fatigue in the lumbar erector spinae musculature secondary to a high-intensity interval
      kettlebell swing protocol utilizing TMG previously published by Jay et. al in 2011. Subjects:
      Forty-one adults between the ages of 18 and 45 were recruited. Inclusion criteria included
      subjects with no recent history of low back pain and clearance by the physical activity
      readiness questionnaire. Methods: Participants were randomly allocated to either a kettlebell
      swing group (KBS; n=21) or a control group (CON; n=20) who only performed the unloaded warm
      up. Participants were assessed at baseline, post-intervention, and 24-hours post-intervention
      for bilateral erector spinae fatigue, measured by five TMG parameters (Dm, Tc, Tr, Td, Ts).
    

Intervention name(s): Kettlebell swing
Intervention type(s): Other
Intervention description(s): The intervention group completed two-handed Russian KBSs using an interval training protocol outlined by Jay et al.10 involving 30 seconds of work followed by 30 seconds of rest for 10 total intervals. Prior to completing the intervention, participants completed a general warmup consisting of 10 non-weighted squats, 10 non-weighted dead-lifts, and 10 dowel rod shoulder flexion repetitions. Participants were instructed to perform all warm-up activities at an intensity of 70% of maximal effort using a Rate of Perceived Exertion scale(RPE).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized Control Trial
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Pharmacokinetic Interaction of Oral Treprostinil and Ethanol in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      A study to assess the interaction of acohol and oral treprostinil.
    

Detailed description: 
      This study will compare the effects of ethanol on the PKs of a 1 mg dose of UT-15C in healthy
      volunteers to determine the in vivo effects of ethanol, including the timing of ethanol
      consumption in relation to UT-15C ingestion.

      This is an open-label, randomized, single-center, four-way (period), crossover study in which
      28 healthy volunteers will receive a single 1 mg oral dose of UT-15C and/or ethanol. Eligible
      subjects will be randomly assigned to one of four treatment sequences such that all subjects
      will receive all four sequences in a pre-specified order.
    

Intervention name(s): UT-15C; ethanol
Intervention type(s): Drug; Other
Intervention description(s): sustained release oral treprostinil; Absolut 100 vodka
Other intervention name(s): Oral treprostinil; alcohol
Intervention MeSH terms: Ethanol; Treprostinil
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: This is a healthy volunteer study.
In Vitro Maturation (IVM) for Polycystic Ovary Syndrome (PCOS)
Condition: Polycystic Ovarian Syndrome
MeSH terms: Polycystic Ovary Syndrome; Syndrome
Study type: Interventional

Summary: 
      This pilot study will be a prospective investigation to study the efficacy and safety of
      In-Vitro Maturation (IVM) for women with Polycystic Ovarian Syndrome (PCOS). There will be 10
      subjects total in this Study. There will be no blinding to treatment.

      In-Vitro Maturation will provide a viable, safe option for women with PCOS attempting
      pregnancy through the use of Assisted Reproductive Technology (ART).
    


Intervention name(s): IVM
Intervention type(s): Other
Intervention description(s): all patients in this pilot study will undergo IVM. IVM involves immature eggs being retrieved and matured in the laboratory.After maturation they are fertilized like is done in a typical IVF cycle.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PCOS; IVM; Polycystic ovarian syndrome; In Vitro Maturation; IVF