bioihbjkbjnl/mcl2 huggingface dataset:
Brief Intervention for Drug Misuse in the Emergency Department
Condition: Substance Abuse Detection; HIV; Hepatitis B; Hepatitis C; Brief Intervention; HIV Infections
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis B; Hepatitis; Emergencies; Substance-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      Although screening, brief intervention, and referral to treatment (SBIRT) approaches are
      effective in reducing alcohol misuse and its associated risk-taking behaviors and negative
      consequences, there is little research demonstrating the effectiveness of SBIRT for illicit
      and/or prescription drug misuse. Misusers of illicit and/or prescription drugs frequently
      seek medical care in emergency departments (EDs), particularly for reasons related to their
      misuse. As a result, the ED is well suited as a site to conduct an analysis of the
      effectiveness of SBIRT for this population.

      The Brief Intervention for Drug Misuse for the Emergency Department (BIDMED) study is a
      randomized, controlled, trial that will include adult ED patients at a large, academic,
      trauma center (Rhode Island Hospital) and a community hospital (The Miriam Hospital) who have
      a subcritical illness or injury and whose screening indicates illicit and/or prescription
      drug misuse. BIDMED participants will be randomized to receive screening only (SO) or brief
      intervention (BI) with appropriate referral to treatment. Participants will complete a
      battery of blinded baseline assessments using standardized instruments as well as adapted
      instruments specific to the aims of this study. All participants will undergo blinded
      follow-up assessments at three, six, and twelve months post-randomization. The primary
      hypotheses addressed in the BIDMED study are that, compared to participants in the SO arm,
      participants in the BI arm will show a significantly greater reduction in: (1) drug misuse
      within the prior 30 days at three months post-randomization, (2) behaviors associated with
      drug misuse at six months post-randomization; and (3) negative physical health, psychosocial
      health, and socioeconomic consequences at twelve months post-randomization. As a secondary
      aim, the impact of BI compared to SO will be assessed on participants contacting, enrolling
      in, and completing a drug treatment program. In addition, the impact of BI compared to SO on
      increasing uptake of HIV and hepatitis B/C screening will be measured. A mechanisms of change
      model that addresses the expected mediators and moderators of change to explain the effects
      of SBIRT in this setting will also be developed and tested. Further, the epidemiology of
      illicit and/or prescription drug misuse will be assessed in a random sample of ED patients.
    


Intervention name(s): Brief motivational intervention
Intervention type(s): Behavioral
Intervention description(s): two session delivered two weeks apart
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Trial on Safety and Pharmacokinetics of Intravaginal Curcumin
Condition: Uterine Cervical Dysplasia
MeSH terms: Uterine Cervical Dysplasia
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this study is to determine the maximum tolerable dose and safety of
      intravaginal curcumin in a normal population of women (women with no evidence of cervical
      cytological abnormalities by pap testing).
    


Intervention name(s): Curcumin; curcumin
Intervention type(s): Drug; Drug
Intervention description(s): Curcumin 500 mg capsules will be inserted intravaginally once daily for 14 days for a maximum daily dosage of 2000 mg; all patients received the drug
Other intervention name(s): Sabinsa Curcumin Capsules
Intervention MeSH terms: Curcumin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: chemoprevention; curcumin; pharmacokinetics; safety
Aromatherapy for Prevention of Intrathecal Morphine Induced Nausea and Vomiting
Condition: Post Operative Nausea and Vomiting
MeSH terms: Nausea; Vomiting; Postoperative Nausea and Vomiting
Study type: Interventional

Summary: 
      This study evaluates the effect of combining non pharmacological anti emetic prophylaxis,
      namely peppermint essential oil to granisetron and dexamethasone in patient who receive
      intrathecal morphine for lower segment cesarean section. Half of the patient will receive
      nasal strip containing peppermint essential oil in addition to granisetron and dexamethasone
      while the other half will only receive granisetron and dexamethasone.
    

Detailed description: 
      It is not uncommon to use different group of anti emetic in order to achieve high successful
      rate in the prevention of opioid induced nausea and vomiting. This study evaluates the effect
      of combining non pharmacological and pharmacological method to prevent such condition.

      Aromatherapy has been used since many years to treat nausea and vomiting. One of the proposed
      mechanism is by the activation of olfactory receptor when the molecules of essential oil
      absorb in the mucus lining olfactory epithelium. The signal is then carried by olfactory
      sensory neuron to the olfactory bulb which filters and send signal to olfactory cortex as
      well as limbic system to give the feeling of well being.

      Granisetron is a serotonin 3 receptor antagonist prevent or treat nausea and vomiting by
      competitively blocks the action of serotonin at 5-hydroxytryptamine 3 (5HT3) receptors while
      the mechanism of action of dexamethasone; which is a glucocorticoids is not fully understood.
    

Intervention name(s): Peppermint essential oil; Granisetron; Dexamethasone
Intervention type(s): Biological; Drug; Drug
Intervention description(s): 2 drops applied on a nasal strip; 1mg intravenous injection; 4mg intravenous injection
Other intervention name(s): YoungLiving®, 100% pure Peppermint essential oil
Intervention MeSH terms: Dexamethasone; Granisetron
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: peppermint oil; intrathecal morphine; PONV; lower segment cesarean section; dexamethasone; granisetron
Dose-response Study of Efficacy and Safety of Botulinum Toxin Type A to Treat Spasticity of the Leg(s) in Cerebral Palsy
Condition: Lower Limb Spasticity Due to Cerebral Palsy
MeSH terms: Muscle Spasticity; Cerebral Palsy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether injections of Botulinum toxin type A into
      muscles of the leg(s) are effective in treating children/adolescents (age 2-17 years) with
      increased muscle tension/uncontrollable muscle stiffness (spasticity) due to cerebral palsy.
    


Intervention name(s): IncobotulinumtoxinA (16 Units per kg body weight); IncobotulinumtoxinA (12 Units per kg body weight); IncobotulinumtoxinA (4 Units per kg body weight)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Total volume 8.0 mL; 400 units; Mode of administration: intramuscular injection into spastic muscles.; Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Total volume 8.0 mL; 300 units; Mode of administration: intramuscular injection into spastic muscles.; Active ingredient: Clostridium Botulinum neurotoxin Type A free from complexing proteins. Solution for injection prepared by reconstitution of powder with 0.9% Sodium Chloride (NaCl); Total volume 8.0 mL; 100 units; Mode of administration: intramuscular injection into spastic muscles.
Other intervention name(s): Xeomin; NT 201; Botulinum toxin type A (150 kiloDalton), free from complexing proteins; Xeomin; NT 201; Botulinum toxin type A (150 kiloDalton), free from complexing proteins; Xeomin; NT 201; Botulinum toxin type A (150 kiloDalton), free from complexing proteins
Intervention MeSH terms: Botulinum Toxins; Botulinum Toxins, Type A; abobotulinumtoxinA; incobotulinumtoxinA
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Gastric Plication in Mexican Patients
Condition: Bariatric Surgery Candidate; Weight Loss; Obesity, Morbid
MeSH terms: Obesity, Morbid; Weight Loss
Study type: Observational

Summary: 
      Between January and December 2012, a total of 40 patients underwent GLP. The study will
      assess subject excess weight loss (%EWL) following the study procedure at 3, 6, 12, 36 and 60
      months.
    

Detailed description: 
      The patient characteristics extracted from the medical records included age and gender. A
      detailed height and weight history was collected to reflect BMI, excess weight, %EWL, and
      %BMI before LGP and after 3, 6, 12, 36 and 60 months.

      The institutional review board approved the present study.
    

Intervention name(s): GASTROPLICATURE
Intervention type(s): Procedure
Intervention description(s): All procedures were performed by a single surgeon. All patients underwent 2-row gastric plication. Dissection was started at the greater curvature of the stomach in contact to the gastric wall from prepyloric area to 2-cm proximal to the Hiss angle preserving the anatomy of Hiss angle. All vessels along the greater curvature were separated using LigaSure (Covidien, Mansfield, MA, USA). The greater curvature (from the perimeter) was invaginated using 2 rows of 00 prolene or 00 nylon sutures. Two layers of plication were performed with continuous sutures with 1 surgical sting in all patients to prevent any displacement of inverted folds such as eversion outside or intussusception into esophagus or pylorus. All sutures were extramucusal to avoid their absorption by gastric acid. Finally, a tube shaped stomach was achieved in which the greater curvature was inverted in to the stomach.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Mexican patients who underwent Gastroplicature
The Effect of Mindfulness Meditation During Dental Implant Surgery
Condition: Mindfulness; Dental Implant
Study type: Interventional

Summary: 
      The aim of this pioneer study was to evaluate the efficacy (heart rate value, blood pressure,
      oxygen saturation, cortisol levels, BIS monitoring, patients' anxiety) of Mindfulness
      Meditation as a sedative technique during dental implant surgery.
    

Detailed description: 
      Since anxiety is a form of psychological stress, an increase in anxiety results in a surge in
      stress levels. The role of sedation in dental surgery cannot be overemphasised. The reduction
      in pain and anxiety eventually causes better cooperation and patients' satisfaction.
      Therefore, balancing anxiety and/or stress levels in patients would be useful to ensure
      patient safety during treatment.Therefore, the aim of this pioneer study was to evaluate the
      efficacy (heart rate value, blood pressure, oxygen saturation, cortisol levels, BIS
      monitoring, patients' anxiety) of Mindfulness Meditation as a sedative technique during
      dental implant surgery.
    

Intervention name(s): Mindfulness Meditation
Intervention type(s): Other
Intervention description(s): Mindfulness meditation has been reported to produce beneficial effects on a number of psychiatric, functional somatic, and stress-related symptoms and has therefore increasingly been incorporated into psychotherapeutic programs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Uridine Adolescent Bipolar Depression Randomized Controlled Trial
Condition: Bipolar Disorder; Bipolar Depression; Manic Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional

Summary: 
      This is a randomized, double-blind, placebo-controlled study of the investigational drug
      uridine as a treatment for depressed adolescents with bipolar disorder (i.e. "bipolar
      depression"). Participants initially randomized to placebo who complete the 6-week protocol
      will be offered 6 months of open-label uridine treatment and follow-up. Participants
      initially randomized to uridine will be offered the open-label treatment as well.
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled study of the investigational drug
      uridine as a treatment for depressed adolescents with bipolar disorder (i.e. "bipolar
      depression").

      In addition to treatment with the investigational drug versus placebo, the study includes a
      translational neuroimaging component: magnetic resonance spectroscopy (1H-MRS) brain scans
      are performed at baseline, and then repeated following 6 weeks of treatment with uridine or
      placebo. The scans do not use radiation, and are performed on a 3 Tesla MRI system that is
      approved for clinical use. The scans allow researchers to measure the concentrations of
      several chemicals in the brain that are believed to be involved in bipolar disorder and
      depression.

      The primary hypothesis is that uridine treatment will be associated with a significant
      decrease in GLX (i.e. glutamate + glutamine) levels, compared to placebo, in a part of the
      brain known as the anterior cingulate cortex.

      The secondary hypothesis is that decreased depressive symptoms measured with the Children
      Depression Rating Scale-Revised (CDRS-R) and Montgomery-Asberg Depression Rating Scale
      (MADRS) will be correlated with reductions in GLX.

      All participants who complete the initial 6-week protocol, including two brain scans, will be
      offered 6 months of open-label treatment with uridine.
    

Intervention name(s): Uridine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Uridine is the active treatment in this clinical trial.; Pill placebo is the inactive treatment comparator in this clinical trial.
Other intervention name(s): Pill Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Adolescent; Bipolar Disorder; Bipolar Depression; Manic Depression; Neuroimaging; Magnetic Resonance Spectroscopy; Uridine; Pyrimidines
PREEMPTİVE PARA-CERVİCAL BLOCK FOR POSTOPERATİVE PAIN AFTER LAPAROSCOPIC HYSTERECTOMY
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Total hysterectomy is one of the most common surgical procedure in gynecology. The
      laparoscopic route for the performance of hysterectomies are on the rise [1]. The
      laparoscopic hysterectomy (TLH) procedure has several advantages over open surgery such as
      better cosmetic outcomes, faster recovery earlier return to normal activities and work [1-3].
      Nonetheless, postoperative pain (PP) remains an issue that scuppers these advantages [1-3].

      The incidence of PP after TLH has been reported to vary from 35% to 63% [4,5]. The origin of
      PP after laparoscopy is multifactorial and complex such as perioperative predicaments,
      including pneumoperitoneum, stretching of the intraabdominal cavity, the blood left in the
      abdomen, and dissection of the pelvic region [6-7]. A randomized controlled trial has
      demonstrated that there may be more intense pain and greater analgesia requirements in the
      immediate postoperative period after laparoscopic surgery than after laparotomy [8]. Further
      inquiry to intercept the advancement and decrease the severity of PP is prominent to further
      improve TLH.

      Women undergoing TLH experience two different pain characteristics including incisional pain
      and visceral pain in the first hour after the operation [6]. These pains were most intense 30
      min after TLH, gradually decreasing thereafter for postoperative 72 hr [6]. High levels of
      acute postoperative pain (APP) are pertain with an increment risk of chronic postsurgical
      pain so control of these acute pains in the urgent postoperative period is vital for faster
      amelioration.

      Many attempts have been tried to control APP after THL, such as transverse abdominal plane
      blocks, superior hypogastric plexus block, local anesthetic injection to the port side, and
      reduced port caliber [9-12]. Para-cervical bloc (PCB) is believed to block the Frankenhouser
      nerve plexus that supplies the visceral sensory fibers to the uterus, cervix, and top of the
      vagina. Only two randomized studies have assessed the effect of PCB in THL, but several
      limitations such as the small sample size preclude drawing conclusions on PP after TLH. Thus,
      the primary goal of this randomized clinical trial was to investigate if PCB at the onset of
      surgery, as a part of enhanced recovery protocol, could improve patient recovery after THL.
    


Intervention name(s): Para-cervical block
Intervention type(s): Procedure
Intervention description(s): Block of inferior hypogastric plexus with local anesthetic
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Cediranib in Combination With Lomustine Chemotherapy in Recurrent Glioblastoma
Condition: Recurrent Glioblastoma
MeSH terms: Glioblastoma; Recurrence
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to see how effective cediranib is in treating a brain tumour
      called recurrent glioblastoma. Two drugs are being tested in this study. Lomustine is an
      approved oral chemotherapy that belongs to the class of drugs called alkylating agents.
      Cediranib is a new drug that has not yet been approved for this disease. This study will
      compare the use of lomustine with cediranib, cediranib alone or lomustine with placebo
      ("inactive substance") to see whether the combination or cediranib alone will be more
      effective than the chemotherapy alone (lomustine) in preventing the growth of cancer cells.
    


Intervention name(s): Cediranib; Cediranib; Lomustine Chemotherapy; Placebo Cediranib
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 30 mg/day, oral, until progression; 20 mg/day, oral, until progression; 110 mg/m2 / Q6W, oral, until progression; Oral, until progression
Intervention MeSH terms: Cediranib; Lomustine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cancer; Tumour; Advanced Solid Tumour; GBM; Glioblastoma
Safety, Tolerability, Pharmacokinetics of Intravenous FL058 and Meropenem in Healthy Subjects(SAD/MAD)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Phase 1 Study of the Safety, Tolerability, and Pharmacokinetics of FL058 and Meropenem Alone
      and in Combination following Single and Multiple Doses in Healthy Adult Subjects.
    


Intervention name(s): FL058 500mg and Meropenem 1000mg（ IV 120min）; FL058 Placebo and Meropenem 1000mg（ IV 120min）; FL058 1000mg（ IV 120min）; FL058 Placebo （ IV 120min）; Meropenem 1000 mg （ IV 120min）; Meropenem Placebo （ IV 120min）; FL058 1000mg and Meropenem 1000mg （ IV 120min）; FL058 Placebo and Meropenem 1000mg （ IV 120min）; FL058 1000mg and Meropenem 2000mg （ IV 120min）; FL058 Placebo and Meropenem 2000m（ IV 120min）; FL058 1000mg and Meropenem 2000mg （ IV 180min）; FL058 Placebo and Meropenem 2000m（ IV 180min）; FL058 2000mg and Meropenem 2000mg（ IV 180min）; FL058 Placebo and Meropenem 2000mg（ IV 180min）
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): D1 qd;
D2~ D8 q8h;
D9 qd; D1 qd;
D2~ D8 q8h;
D9 qd; D1 qd;; D1 qd;; D4 qd;; D4 qd;; D7 qd;
D8~ D14 q8h;
D15 qd;; D7 qd;
D8~ D14 q8h;
D15 qd;; D1 qd;
D2~ D8 q8h;
D9 qd; D1 qd;
D2~ D8 q8h;
D9 qd; D1 qd;
D2~ D8 q8h;
D9 qd; D1 qd;
D2~ D8 q8h;
D9 qd; D1 qd;
D2~ D8 q8h;
D9 qd; D1 qd;
D2~ D8 q8h;
D9 qd
Intervention MeSH terms: Meropenem
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Fractionated Carbon Dioxide Laser and Burn Scar Contractures: Evaluation of Post-Treatment Scar Function and Appearance
Condition: Burn Scars
MeSH terms: Contracture; Cicatrix; Burns
Study type: Interventional

Summary: 
      The investigators are studying the appearance and function of burn scars after treatment with
      fractionated carbon dioxide laser. The investigators hypothesize that the cosmetic appearance
      and range of motion will improve with treatment.
    

Detailed description: 
      The primary goal of the study will analyze whether the fractionated carbon dioxide laser can
      improve other subjective and objective qualities of hypertrophic and/or contracted burn scars
      with or without involvement of nearby mobile joints.

      The investigators hypothesize that fractionated carbon dioxide laser therapy will increase
      range of motion and improve tissue compliance in all scars overlying a mobile joint that has
      been limited due to burn scar contracture. In addition, the investigators will evaluate the
      effect of fractionated carbon dioxide laser therapy on common sequelae of hypertrophic and/or
      contracted burn scars.
    

Intervention name(s): fractionated carbon dioxide laser
Intervention type(s): Device
Intervention description(s): patients will have serial laser treatments
Other intervention name(s): UltraPulse, Lumenis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: burn; scar
Tamoxifen to Reduce Unscheduled Bleeding in New Users of the Levonorgestrel-releasing Intrauterine System (LNG-IUS)
Condition: Menorrhagia; Metrorrhagia; Medicated Intrauterine Devices
MeSH terms: Menorrhagia; Metrorrhagia; Hemorrhage
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the ability of tamoxifen to improve frequent or prolonged bleeding in
      new users of the 52mg levonorgestrel-releasing intrauterine device (IUD). Half of
      participants will receive a course of tamoxifen three weeks after insertion of the IUD, while
      the other half of participants will receive a course of placebo.
    

Detailed description: 
      New users of the LNG IUD will be eligible. Subjects will be randomized to receive tamoxifen
      10 mg twice daily for 7 days or placebo. Study drug will be started 3 weeks after placement
      of the IUD. Subjects will maintain a record of daily bleeding and spotting using an
      electronic text messaging diary.
    

Intervention name(s): Tamoxifen; Placebo (for Tamoxifen)
Intervention type(s): Drug; Drug
Intervention description(s): 10mg PO (by mouth) twice daily for 7 days starting on day 21 after IUD insertion for one course; Sugar pill manufactured to mimic the tamoxifen 10mg tablet
Other intervention name(s): Nolvadex
Intervention MeSH terms: Tamoxifen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: levonorgestrel; breakthrough bleeding