bioihbjkbjnl/mcl2 huggingface dataset:
Vasopressin Versus Epinephrine in Myomectomy
Condition: Uterine Myomas
MeSH terms: Leiomyoma; Myofibroma
Study type: Interventional
Phase: Phase 3

Summary: 
      Uterine myomas (fibroids or leiomyomas) are the most common benign tumor of the female
      genital tract and the leading indication for hysterectomy. Although hysterectomy is the
      definitive treatment of myomas, myomectomy remains the gold standard treatment for women
      desiring future fertility and uterine conservation3. However, bleeding is often a problem in
      myomectomy and can results in intraoperative hypovolemic shock, postoperative anemia, pelvic
      infection, and adhesions with infertility.

      A number of interventions have been introduced to reduce hemorrhage during myomectomy. Two
      categories of interventions can be identified: (a) Vascular interventions on uterine and/or
      ovarian arteries such as artery clamping, tying, or embolization; (b) pharmacologic
      interventions such as vasopressin, epinephrine, oxytocin, ergometrine, misoprostol,
      sulprostone, and gonadotropin-releasing hormone (GnRH) agonist4-11. Of these, intraoperative
      local injection of vasopressin causing vasospasm is most commonly used. However, there is not
      a wide consensus on the use of this agent because of serious side effects reported in
      literature. In addition, in several countries, including France and Italy, vasopressin has
      not been commercialized because of its potential adverse effects on cardiovascular system.

      Epinephrine also induces a vasoconstrictive effect on tissue that lasts longer than that of
      vasopressin (5-6 hours versus 7-35 minutes) and is used during various gynecological
      surgeries, endoscopic resection, and dermatologic procedures to reduce blood loss. However,
      there are a few studies for the use of epinephrine to reduce hemorrhage during myomectomy.
      Furthermore, a randomized comparison of epinephrine and vasopressin as hemostatic agents
      during myomectomy has never been conducted. To test the hypothesis that the injections of
      epinephrine and vasopressin during myomectomy are equivalent in reducing blood loss, the
      investigators performed this randomized controlled study.
    


Intervention name(s): Epinephrine; Vasopressin
Intervention type(s): Drug; Drug
Intervention MeSH terms: Vasopressins; Arginine Vasopressin; Epinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Apomorphine Effects on Experimental Pain
Condition: Healthy
Study type: Interventional
Phase: Early Phase 1

Summary: 
      The aims of this study were to assess the effects of the dopamine agonist apomorphine on
      experimental pain models in healthy subjects and to explore the possible association between
      these effects and a common polymorphism within the dopamine transporter gene.
    

Detailed description: 
      Healthy volunteers (n=105) participated in this randomized double-blind, placebo-controlled,
      cross-over trial. Heat pain threshold and intensity, cold pain threshold, and the response to
      tonic cold pain (latency, intensity, and tolerance) were evaluated before and for up to 120
      min after the administration of 1.5 mg apomorphine/placebo. A polymorphism (DAT-1) within the
      dopamine transporter gene (SLC6A3) was investigated.
    

Intervention name(s): Apomorphine
Intervention type(s): Drug
Intervention description(s): 1.5 mg Apomorphine
Other intervention name(s): Active Comparator: Apomorphine
Intervention MeSH terms: Apomorphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: apomorphine; dopamine transporter gene; SLC6A3; cold pressor test; tolerance; experimental pain; dopamine agonist
Epidural Analgesia During Labour
Condition: Anesthesia, Obstetrical; Analgesia, Epidural
MeSH terms: Agnosia
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized single blind trial based on comparing the way the local anesthetic is dosificated
      during labour. The pain control is evaluated and compared with both dosage techniques (PCEA
      vs PIEB)using levobupivacaine and fentanyl. The primary objective is to see no differences in
      pain control(VAS, Visual Analog Scale). The secondary goals are the differences in motor
      block(Bromage Scale), satisfaction (Likert Scale), the outcome (eutocic, instrumental o
      cesarean section), second stage of labour time, newborn´s Apgar and pH and total dosis and
      secondary effects of local anesthetic.
    

Detailed description: 
      There is a protocol where every healthy primiparous women have the chance to join the study
      after the explanation and the informed consent is signed. There are blind envelopes with the
      two kinds of treatment and the investigator only has to follow the protocol.
    

Intervention name(s): PIEB: Patient Intermittent Epidural Boluses; PCEA: Patient Controlled Epidural Analgesia
Intervention type(s): Drug; Drug
Intervention description(s): Each patient were randomized to PIEB (7 ml bolus every 30 minutes, with extra boluses (PCEA) of 6 ml every 20 minutes) or PCEA (5 ml in continuous perfussion + PCEA of 5 ml every 15 minutes).; Each patient were randomized to PIEB (7 ml bolus every 30 minutes, with extra boluses (PCEA) of 6 ml every 20 minutes) or PCEA (5 ml in continuous perfussion + PCEA of 5 ml every 15 minutes).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PIEB; PCEA; LEVOBUPIVACAINE
Ten-year Practice of Labor Pain Control in China
Condition: Labor Pain
MeSH terms: Labor Pain
Study type: Observational

Summary: 
      Since 1999, labor pain control has being performed in China, and the initial time of
      analgesia is at the cervix >= 2 cm. Meanwhile, American Society of Obstetrics & Gynecology
      recommended that the labor analgesia with neuraxial block should be performed at the cervix
      >= 4 cm in 2002. After that, the threshold has been revised to at least >= 2 cm in 2006 by
      the Society. However, in China, the practice of labor analgesia with neuraxial block has
      being performed for over seven years. Up until now, the practice has being experienced during
      this ten-year period at the cervix around 1 cm. The investigators hypothesized that labor
      pain control in different stages had different characteristics and had different influence on
      patients short- and long-lasting outcomes. This study is mainly investigating different labor
      analgesia procedures in different stages since the initiation of the practice in 1999, and
      assessing their influence on the outcomes to display the trajectory of development of labor
      analgesia in China of which might fit to the the whole process of the study of labor
      analgesia throughout the world. All these were done by analyzing the data records since from
      January 1999 to December 2008.
    


Intervention name(s): CSEA with PCA; CSEA with IBI; EA with PCA; EA with IBI
Intervention type(s): Procedure; Procedure; Procedure; Procedure
Intervention description(s): Records regarding combined spinal-epidural analgesia with patient-controlled pump; Records regarding combined spinal-epidural analgesia with intermittent bolus injection; Records regarding epidural analgesia with patient-controlled pump; Records regarding epidural analgesia with intermittent bolus injection
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All parturients delivered in the investigator's institution since from January 1999 to
        December 2008
      
Keywords: Combined spinal-epidural analgesia; Patient-controlled analgesia; Epidural analgesia
Effect of Repeated Doses of DS-8500a on Pharmacokinetics of Rosuvastatin in Healthy Volunteers
Condition: Drug Pharmacokinetics in Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to assess the effect of repeated doses of DS-8500a on
      the single dose pharmacokinetics (PK) of rosuvastatin.

      The total length of time (from screening to follow-up) for each participant is approximately
      7 weeks.

      It is expected that repeated oral doses of DS-8500a will not have a significant effect on the
      pharmacokinetics of a single dose of rosuvastatin.
    


Intervention name(s): DS-8500a; Rosuvastatin
Intervention type(s): Drug; Drug
Intervention description(s): DS-8500a is provided as three 25-mg tablets for oral administration; Rosuvastatin is provided as a 10-mg tablet for oral administration
Other intervention name(s): Experimental product; Crestor
Intervention MeSH terms: Firuglipel; Rosuvastatin Calcium
Intervention model: Sequential Assignment
Intervention model description: Fixed sequence
Masking: None (Open Label)
Primary purpose: Basic Science
Effects of 2 Different Broccoli Sprout Containing Supplements on Nasal Cells in Healthy Volunteers
Condition: Healthy Adult Volunteers
Study type: Interventional

Summary: 
      Purpose: To compare the change in nasal cell HO-1 expression induced by two different
      preparations of sulforaphane (SFN)-containing nutritional supplements Participants: Healthy
      nonsmoking young adults, age 18-35 Procedures (methods): This pilot study will use a
      randomized crossover design. Subjects will be randomized to receive either the equivalent of
      4 ounces/day of fresh broccoli sprouts (FBS) in food and tea, or the equivalent amount as
      broccoli sprout homogenates (BSH), for 3 consecutive days. Nasal lavage and blood samples
      will be obtained before, during and after this 3-day period. After at least a 2-week washout
      interval, the protocol will be repeated with the alternate supplement. The primary analysis
      will test the hypothesis that broccoli sprouts in food will increase HO-1 expression to a
      similar degree as the equivalent amount of sprouts in BSH
    

Detailed description: 
      Broccoli sprouts are a concentrated source of the potent phase 2 enzyme (antioxidant)
      potentiator, sulforaphane (SFN) in the form of its natural precursor, sulforaphane
      glucosinolate (SGS™). SFN is an isothiocyanate which has generated interest recently as a
      chemopreventive agent in cancer research, and as an antioxidant in inflammation research.
      Recently published data show that 3 days intake of broccoli sprouts in homogenate form is
      followed by significant upregulation of several phase 2 enzymes in nasal cells. Our group's
      research at the UNC Center for Environmental Medicine, Asthma and Lung Biology (CEMALB)
      focuses on the effects of oxidant pollutants on inflammatory and host defense responses to
      viral infections. One of the aims of our grant is to measure the effects of pre-treatment
      with SFN supplements, on nasal responses to live attenuated influenza virus vaccines. In
      preparation for this larger study, we here propose a pilot study comparing the effects of the
      published BSH supplement, vs. supplementation with foods containing fresh broccoli sprouts,
      on relevant nasal endpoints and serum SFN levels.
    

Intervention name(s): Supplement A followed by Supplement B; Supplement B followed by Supplement A
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Supplement A (3 days of Broccosprout homogenate) will be followed at least 2 weeks later by Supplement B (3 days of Broccosprout sandwich and SFN rich tea); Supplement B (Broccosprout sandwich and SFN rich tea for 3 days) followed at least 2 weeks later by 3 days of Supplement A (Broccosprout homogenate)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Effects of Sitagliptin on Gastric Emptying in Healthy Subjects
Condition: Gastroparesis; Diabetes Mellitus
MeSH terms: Gastroparesis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effects of the drug, sitagliptin, on the rate
      at which the stomach empties, and the release of gut hormones and blood glucose
      concentrations, after a mashed potato meal in healthy subjects. Sitagliptin has been shown to
      reduce the blood glucose (sugar) response to a meal and this may potentially be due to
      slowing of stomach emptying. This is particularly relevant to people who have diabetes, in
      whom normalization of elevated blood glucose levels is important to maintain health.
    

Detailed description: 
      The purpose of this study is to evaluate the effect of sitagliptin on gastric emptying,
      intragastric meal distribution, postprandial glycemia and insulinemia in healthy subjects.
      Glucagon-like peptide-1 (GLP-1) inhibits gastric emptying, thereby slowing the delivery of
      nutrients, and their absorption, across the small intestine. The rate of entry of
      carbohydrate into the small intestine is especially important in patients with diabetes
      mellitus. Sitagliptin is an orally administered inhibitor of dipeptidyl-peptidase-IV
      (DPP-IV), the enzyme responsible for the degradation of GLP-1. It is hypothesized that
      sitagliptin will increase the GLP-1 response to, and thereby slow gastric emptying and
      diminish the glycemic response to, a carbohydrate-containing meal.

      Fifteen healthy subjects (male and female) will be studied. Each subject will be studied on
      two occasions following treatment for 2 days with sitagliptin (100mg once daily) or matching
      placebo in a randomized, double blind, crossover design. Measurements of gastric emptying,
      intragastric meal distribution, blood glucose concentrations, gut hormones and appetite will
      be measured for 4 hours following ingestion of a mashed potato meal.
    

Intervention name(s): Sitagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 100mg mane for 2 days; 100mg mane for 2 days
Other intervention name(s): MK-0431-075; Januvia
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: gastric emptying; glycemia; appetite; incretin hormones
Men's Beliefs About Associations Between HPV, Cancers, and HPV Vaccination
Condition: Anus Neoplasms
MeSH terms: Anus Neoplasms
Study type: Observational

Summary: 
      This research focuses on men who have sex with men (MSM) who are at higher risk of anal
      cancer. The survey will evaluate their beliefs about anal and oral cancer, their knowledge
      about role of human papillomavirus (HPV) infection in these cancers, and their knowledge of
      HPV vaccination and anal Pap smears. Approximately 12% of subjects will be HIV-positive.
    

Detailed description: 
      Little research has examined men's understanding of what causes anal and oral cancers and
      whether HPV vaccination can play a potential protective role. This research focuses on men
      who have sex with men (MSM) who are at notably elevated risk of anal cancer, and seeks to
      characterize their beliefs about anal and oral cancer, knowledge about the etiological role
      of HPV infection in these cancers, as well as their knowledge of HPV vaccination and anal Pap
      smears. We will also study heterosexual men.
    

Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Approximately 600 men (ages 18-59) who have agreed to participate in a periodic panel
        through the private survey company, Knowledge Networks.
A Trial of PTS Via Intratumoral Injection in Patients With Central Air Way NSCLC Severe Obstruction
Condition: Nsclc
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial was to evaluate the efficacy of intratumoral PTS injection in alleviating airway
      obstruction and dyspnea by improving the percentage of lumen patency of patients with central
      air way NSCLC tumor severe obstruction.
    

Detailed description: 
      1. Local intratumoral injection of para toluenesulfonamide (PTS) via bronchoscopy could
           alleviate airway obstruction for patients with central air way NSCLC tumor severe
           obstruction, which contributed to the shrinkage of target tumor lesions in a short
           period, with an objective response rate of 66% and an improvement rate of luminal tumor
           obstruction of 70% in the end-of-treatment period.

        2. Patient's pulmonary function, atelectasis and quality of life were improved
           significantly after treatment, indicating that PTS treatment cuold relieve the symptoms
           of air way obstruction and provide clinical benefits to the patients.

        3. Adverse events were mainly blood streaked sputum, injection site haemorrhage, cough,
           pyrexia and oropharyngeal pain, without reporting of potential risks. Common study drug
           related adverse events included injection site haemorrhage, cough, and blood streaked
           sputum and oropharyngeal pain. The multi-center clinical study conducted strictly in
           accordance with Standard Operation Procedures for the Use of a Standard Bronchoscope in
           Local Intratumoral PTS Injection showed that PTS had good safety and tolerability and
           that the procedural risks of intratumoral PTS injection via bronchoscopy could be
           controlled.

        4. The advantages of PTS for treatment of airway lung cancer obstruction included
           significant efficacy, good safety, large applicable population; relatively simple
           equipment conditions and operation, thus it could be spread easily. PTS is also expected
           to be used in the treatment of central lung cancer with acute airway obstruction in
           combination with other treatments (such as stent implantation), which provides a new
           drug treatment to patients with airway lung cancer obstruction. PTS can complement with
           other treatments, which is expected to improve the treatment efficacy significantly.
    

Intervention name(s): Para-Toluenesulfonamide
Intervention type(s): Drug
Other intervention name(s): PTS
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Comparison Of Study Drug Blood Levels After One Dose Of GSK189075 In Subjects With Normal And Reduced Kidney Function
Condition: Type 2 Diabetes Mellitus; Diabetes Mellitus, Type 2; Renal Insufficiency
MeSH terms: Renal Insufficiency; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label study that will measure blood levels of different parts of a drug
      called GKS189075. People participating in this study will receive a single dose of 250mg
      GSK189075 by mouth. About 20 people with mild to moderate decrease in renal (kidney) function
      will be asked to participate in this study. They will be compared to about 20 healthy
      participants who are close to the same age and body size. People participating in this study
      will stay at a clinical research unit beginning 2 days before they receive their single dose
      of GSK189075 and will remain there until approximately one day after receiving the study
      drug. During this study urine will be collected beginning the day before receiving study drug
      until the day after, just prior to leaving the clinical research unit. Blood samples will
      also be collected at various times beginning immediately before until 24 hours after
      receiving the study drug.
    


Intervention name(s): GSK189075
Intervention type(s): Drug
Intervention description(s): single 250 mg dose of drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 2 Diabetes Mellitus; renal insufficiency
Effectiveness of Theta-burst Stimulation (TBS) in Patients With Major Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional

Summary: 
      Repetitive Transcranial Magnetic Stimulation (rTMS) as well as Theta- Burst Stimulation of
      the frontal cortex are used to modulate the neuronal excitability in patients with
      depression. In the proposed study we investigate whether high frequent rTMS or Theta-Burst
      Stimulation of the DLPFC is more effective in patients with a depressive episode.
    

Detailed description: 
      Depression is a common mental disorder that presents with depressed mood, loss of interest,
      feelings of guilt or low self-worth, disturbed sleep or appetite, low energy, and poor
      concentration. These problems can become chronic or recurrent and lead to substantial
      impairments in an individual's ability to take care of his or her everyday responsibilities,
      at its worst, depression can lead to suicide.Depression can be reliably diagnosed in primary
      care. Antidepressant medications and brief, structured forms of psychotherapy are effective
      for 60-80 % of those affected and can be delivered in primary care.

      In patients with depression the cerebral metabolism is deranged in some specific areas such
      as hypoexcitability in frontal cortical areas. High-frequency rTMS of the dorsolateral
      prefrontal cortex (DLPFC) has been investigated for the treatment of hypoexcitability
      disorders. Pilot data indicate that the mild effects of the rTMS could be increased by a
      special kind of TMS, the Theta-burst stimulation. In the proposed study we investigate
      whether high frequent rTMS or Theta-Burst Stimulation of the DLPFC is more effective in
      patients with a depressive episode.
    

Intervention name(s): Thetaburst Stimulation; High frequency rTMS; Placebo Stimulation
Intervention type(s): Device; Device; Device
Intervention description(s): Thetaburst stimulation: continuous TBS over the right DLPFC, followed by intermitted TBS over the left DLPFC, each with 50 Hz, together 1200 stimuli (80% motorthreshold); Experimental high frequency rTMS ( Alpine Biomed Mag Pro Option) : 1000 stimuli of 1 Hz over the right DLPFC (110% motor threshold)followed by 1000 stimuli of 10 Hz over the left DLPFC (110% motorthreshold); Sham Stimulation (Sham coil):right DLPFC continuous TBS, followed by left DLPFC intermitted TBS each with 50 Hz, together 1200 Stimuli, 80% motorthreshold
Other intervention name(s): Transcranial Magnetic Stimulation; Theta-burst; Transcranial Magnetic Stimulation,; High frequency repetitive TMS; Transcranial Magnetic Stimulation; Sham Stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Depression; Transcranial magnetic stimulation; Thetaburst Stimulation; Alternative treatment methods