bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Pharmacogenetic Factors Affecting Fentanyl Requirements for Postoperative Pain Control
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      Fentanyl is a widely used opioid analgesic. There are big interindividual variabilities in
      dose requirements of fentanyl for postoperative pain control. This study aims to reveal the
      genetic factors affecting the variable requirements of fentanyl during postoperative period.
    

Detailed description: 
      The candidate genes are OPRM1, ABCB1,CYP3A4 and CYP3A5.
    

Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Gynecologic patients undergoing total abdominal hysterectomy or laparoscpy assisted vaginal
        hysterectomy under general anesthesia
      
Biospecimen description: 
      whole blood
    
Keywords: pharmacogenetics
Study of Efficacy of Ramelteon in Adults With Chronic Insomnia
Condition: Chronic Insomnia
MeSH terms: Sleep Initiation and Maintenance Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the safety and efficacy of Ramelteon, once daily
      (QD), in the treatment of chronic insomnia using polysomnography and subjective measures of
      sleep
    

Detailed description: 
      Insomnia is characterized by difficulties initiating and maintaining sleep or of
      nonrestorative and non-refreshing sleep. Transient insomnia affects approximately one-third
      to one-half of the US population, based on the results of 2 surveys of representative samples
      of the adult US population conducted by the Gallup Organization in which respondents were
      asked if they had "ever had difficulty sleeping." Based on reports of "regular" or "frequent"
      sleep difficulty, results from the same studies suggest that approximately one-tenth of the
      US population experiences chronic insomnia. The ideal treatment for insomnia would reduce the
      latency to onset of sleep and increase total sleep time, without a negative impact on sleep
      architecture and without safety concerns or next-day effects.

      Ramelteon is a selective melatonin-1 receptor agonist under global development by Takeda
      Chemical Industries, Ltd., for the treatment of transient and chronic insomnia and for the
      treatment of Circadian Rhythm Sleep Disorders.

      This study will determine the safety and efficacy of 35-day treatment of chronic insomnia
      with Ramelteon using polysomnography and subjective measures of sleep. Participation in this
      study is anticipated to be about 2 months.
    

Intervention name(s): Ramelteon; Ramelteon; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ramelteon 8 mg, tablets, orally, once nightly for up to 5 weeks.; Ramelteon 16 mg, tablets, orally, once nightly for up to 5 weeks.; Ramelteon placebo-matching tablets, orally, once nightly for up to 5 weeks.
Other intervention name(s): Rozerem™; TAK-375; Rozerem™; TAK-375
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sleep Disorder; Insomnia; Drug Therapy
Physiotherapy Intervention in Climacteric Women With Dyspareunia
Condition: Dyspareunia
MeSH terms: Dyspareunia
Study type: Interventional

Summary: 
      Aim: To evaluate the effectiveness of physical therapy intervention techniques in the
      improvement of dyspareunia in climacteric women.

      Study design: This is a randomized controlled trial.
    

Detailed description: 
      Search location: Menopause and Sexuality Clinic of the department of obstetrics and
      Gynecology and Clinical Research Center, Hospital de Clínicas de Porto Alegre (HCPA).

      Patients or participants: The recruited patients may not be vaginal atrophy (cytology-hormone
      test) and must provide the diagnosis of dyspareunia for more than six months being confirmed
      by one of the investigators through the pain score above grade 3 (visual analog pain scale)
      visual inspection, palpation and a questionnaire about the duration and location of pain.

      Intervention and measures: consist of evaluation of the pelvic floor muscles (Oxford Scale
      and Perfect), myoelectric assessment (Electromyography), quality of life (Cervantes Scale),
      sexual function (FSFI), level of depression (Beck Scale) and pain (visual analog pain scale)
      before and after physical therapy intervention.

      Expected results: To estimate the effectiveness of pelvic floor training techniques with
      physical therapy in women with dyspareunia.
    

Intervention name(s): superficial heat pelvic floor muscle; superficial heat low back; Pelvic Floor Muscle Training; Manual therapy in iliopsoas, diaphragm and piriformis; Intra Vaginal Manual therapy; Electromyographic biofeedback
Intervention type(s): Other; Other; Other; Other; Other; Other
Intervention description(s): Superficial heat application in the pelvic floor muscle; Superficial heat application in the low back; Pelvic floor muscle training exercises; Manual therapy in iliopsoas, diaphragm and piriformis for 10 minutes; Intra Vaginal Manual therapy in the pelvic floor muscles; Electromyographic biofeedback in the pelvic floor muscles
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Dyspareunia; Pelvic floor muscles; Women
VR-based Remote Rehabilitation for Pediatric ABI
Condition: Acquired Brain Injury
MeSH terms: Brain Injuries
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the feasibility and effectiveness of an
      at-home program of VR-based vestibular and oculomotor rehabilitation on improving postural
      stability, ocular motility and activities of daily living for children with mild to severe
      ABI
    


Intervention name(s): LibraVR
Intervention type(s): Device
Intervention description(s): LibraVR is a standalone VR-based rehabilitation software for use in physiotherapy. It is designed to work with standard off-the-shelf hardware that is tested and approved for use in conjunction with the software.
LibraVR system consists of the software (LibraVR Clinic) running on a PC (database of patients, creation of protocols, uploading protocols to mobile), and the LibraVR Mobile APP that runs on commercial mobile smartphones embedded in a lightweight cardboard or plastic VR viewer that the child wears as they would eyeglasses. The software displays a range of immersive VR exercises.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pediatric
Studying the Effects of 7 Days of Gonadotropin Releasing Hormone (GnRH) Treatment in Men With Hypogonadism
Condition: Kallmann Syndrome; Idiopathic Hypogonadotropic Hypogonadism; GnRH Deficiency
MeSH terms: Kallmann Syndrome; Hypogonadism
Study type: Interventional
Phase: Phase 1

Summary: 
      Men with Idiopathic Hypogonadotropic Hypogonadism (IHH) lack a hormone called gonadotropin
      releasing hormone (GnRH). This hormone is important for starting puberty, maintaining
      testosterone levels, and fertility. The purpose of this study is to research the effects of
      treating IHH men with GnRH for 7 days.
    

Detailed description: 
      Despite variability in the triggers, timing, and pace of sexual maturity between species, all
      species utilize the final pathway of hypothalamic secretion of gonadotropin releasing hormone
      (GnRH) to initiate and maintain the reproductive axis. Thus, GnRH is required for
      reproductive competence in the human. The classic studies from the 1970s clearly demonstrate
      that pulsatile release of GnRH from the hypothalamus is a prerequisite for physiologic
      gonadotrope function. Absence, decreased frequency or decreased amplitude of pulsatile GnRH
      release results in the clinical syndrome of hypogonadotropic hypogonadism (HH). The
      phenotypic expression of GnRH deficiency in the human demonstrates considerable
      heterogeneity. Defining the physiology of GnRH is critical to understanding the clinical
      heterogeneity of isolated GnRH deficiency and its comparison to other conditions resulting in
      hypogonadotropic hypogonadism (HH). The overall goal of this protocol is to investigate the
      neuroendocrine control of reproduction and specifically the physiology and pathophysiology of
      GnRH secretion and action in the human male.

      Subjects will be selected from a group of adult men (18-65 years)based on the demonstration
      of a low testosterone level (<100 ng/dL) in association with low or inappropriately normal
      gonadotropin levels. All patients will undergo an initial assessment that includes an
      overnight 12-hour frequent blood sampling study to determine their degree of endogenous GnRH
      secretion. Following the overnight evaluation, subjects will have daily outpatient visits for
      7 consecutive days when they will receive a GnRH bolus followed by 2hrs of blood sampling.
    

Intervention name(s): gonadotropin releasing hormone (GnRH)
Intervention type(s): Drug
Intervention description(s): Pulsatile GnRH (25 ng/kg per bolus every two hours via microinfusion pump)
Intervention MeSH terms: Hormones
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Kallmann Syndrome; Idiopathic Hypogonadotropic Hypogonadism; GnRH deficiency
PET in Guiding Cervical Lymphadenectomy (ECTOP-2003)
Condition: Esophageal Cancer
MeSH terms: Lymphatic Metastasis
Study type: Observational

Summary: 
      Esophageal cancer is the eighth most common cancer around the world, with more than 450000
      new cases per year. Esophagectomy with radical lymphadenectomy (2-field lymphadenectomy) is
      the mainstay of treatment in many countries for patients with esophageal cancer. To improve
      the survival, 3-field lymphadenectomy combined with cervical lymphadenectomy was started in
      1980s. More potential positive lymph nodes were found during more extended lymphadenectomy,
      offering more accurate TNM staging, affecting consequent treatment.
      However，3-field-lymphadenectomy was associated with increased surgical morbidity and
      mortality. Positron emission tomography (PET) is used for detecting distant metastases and
      lymphatic involvement. The aim of the study is to evaluate the role of PET in predicting
      cervical lymph metastases of patients with thoracic esophageal squamous cell carcinoma, and
      to determine if investigators can use PET to guide future cervical lymphadenectomy. (Eastern
      Cooperative Thoracic Oncology Projects 2003, ECTOP-2003)
    

Detailed description: 
      From June, 2018, a total of 110 patients with thoracic esophageal carcinoma will be recruited
      in 4 hospital in China. Participants with resectable esophageal cancer will have PET/CT scan
      before three-field lymphadenectomy. Lymph nodes will be recored according to the anatomy
      site. Lymph nodes metastasis diagnosed by PET/CT and by postoperation pathological
      examination will be compared to evaluate the role of PET/CT in guiding the extent of
      lymphadenecomy and surgical approach.
    

Intervention name(s): positron emission tomography
Intervention type(s): Diagnostic Test
Intervention description(s): patients who had esophagectomy with 3-field lymphadenectomy underwent examination of positron emission tomography prior to surgery within 2 weeks.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients had resectable thoracic esophageal squamous cell carcinoma.
      
Keywords: positron emission tomography; cervical lymphatic metastasis
Dose Study in Healthy Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083 Compared to Norditropin® SimpleXx®
Condition: Growth Hormone Disorder; Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this trial is to investigate the safety,
      tolerability, pharmacokinetics (exposure of drug) and pharmacodynamics (effect) of
      NNC126-0083 compared to Norditropin® SimpleXx® and placebo in healthy volunteers
    


Intervention name(s): NNC126-0083; Norditropin® SimpleXx®; placebo; NNC126-0083; Norditropin® SimpleXx®
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): One of five dose levels administered subcutaneously (under the skin); One of two dose levels, followed by NNC126-0083, administered subcutaneously (under the skin); Placebo comparator; One of three dose levels administered subcutaneously (under the skin); One of two dose levels, followed by placebo, administered subcutaneously (under the skin)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Nicotinic Modulation of Schizophrenia-like Information Processing Deficits in Healthy Subjects
Condition: Healthy Subjects
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study examines the interactive effects of ketamine and nicotine.
    


Intervention name(s): Ketamine; Nicotine; Placebo; Ketamine and Nicotine
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Ketamine: 0.23 mg/kg bolus over one minute followed by maintenance infusion at 0.58mg/kg/hour x 30 minutes, followed by 0.29 mg/kg/hour x 64 minutes; Nicotine: 13.5 µg/kg given over 10 min (1.35 µg/min/kg),IV (in the arm) followed by a constant infusion of 31.02 µg/kg given over 85 min (0.365 µg/min/kg) Placebo: Normal saline (sodium chloride 0.9%)IV (in the arm); Normal saline (sodium chloride 0.9%)administered via IV (in the arm) over 95 minutes; 0.23 mg/kg of ketamine bolus IV (in the arm) over one minute followed by maintenance infusion at 0.58mg/kg/hour x 30 minutes, followed by 0.29 mg/kg/hour x 64 minutes.
13.5 µg/kg of nicotineIV (in the arm) given over 10 min (1.35 µg/min/kg), followed by a constant infusion of 31.02 µg/kg given over 85 min (0.365 µg/min/kg)
Other intervention name(s): K; Special K
Intervention MeSH terms: Ketamine; Nicotine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Keywords: ketamine; nicotine; schizophrenia; cognitive deficits; P300 oddball paradigm; Mismatch Negativity; P50 gating
Concurrent Involved-field Radiotherapy and Intrathecal Chemotherapy for Leptomeningeal Metastases From Solid Tumors
Condition: Leptomeningeal Metastasis
MeSH terms: Neoplasm Metastasis; Meningeal Carcinomatosis
Study type: Interventional
Phase: Phase 2

Summary: 
      It has been proved that concurrent radiotherapy (RT) and intrathecal methotrexate (MTX) for
      leptomeningeal metastases (LM) from solid tumors with adverse prognostic factors showed great
      effectiveness and safety. Cytarabine(Ara-C) is another agent which is commonly used for
      intrathecal chemotherapy. The purpose of the study is to observe the effectiveness and safety
      of concurrent RT and intrathecal chemotherapy for LM from solid tumors. In addition, the
      effectiveness of these two types of agents (MTX and Ara-C) in the concurrent
      chemo-radiotherapy will be compared in this study. This is a randomized controlled, parallel
      group, and phase II clinical trial. The object of this study is newly diagnosis patients with
      leptomeningeal metastases from solid tumors, who will accept the treatment of involved-field
      RT combined with concurrent intrathecal-MTX or intrathecal-Ara-C, respectively. Major
      endpoint is clinical response rate. Secondary endpoints are time to progression,severe
      adverse events and overall survival.
    

Detailed description: 
      The patients were randomly divided into two groups, who will accept the treatment of
      involved-field RT combined with concurrent intrathecal-MTX or intrathecal-Ara-C,
      respectively. Concomitant regimen consisted of intrathecal chemotherapy (via lumbar puncture,
      MTX 15 mg, plus dexamethasone 5 mg, or Ara-C 50mg, plus dexamethasone 5 mg, once per week, 4
      weeks in total) and RT. RT consisted of fractionated, conformal radiation given at a daily
      dose of 2 Gy. The planning volume consisted of sites of symptomatic disease, bulky disease
      observed on MRI, including the whole brain and basis cranii received 40 Gy in 20 fractions
      and/or segment of spinal canal received 40-50 Gy. The RANO proposal for response criteria of
      LM disease was used to assess the clinical response in this study.
    

Intervention name(s): MTX; Ara-C; Radiotherapy
Intervention type(s): Drug; Drug; Radiation
Intervention description(s): MTX 15 mg,via lumbar puncture,once per week, 4 weeks in total; Ara-C 50mg,via lumbar puncture,once per week, 4 weeks in total; The sites of symptomatic disease, bulky disease observed on MRI, including the whole brain and basis cranii, 40 Gy in 20 fractions;and/or segment of spinal canal received 40-50 Gy in 20-25 fractions.
Other intervention name(s): Intrathecal chemotherapy; Intrathecal chemotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect Of Core Stability Training In Temporomandibular Disorders
Condition: Temporomandibular Disorder
MeSH terms: Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome
Study type: Interventional

Summary: 
      This study is to investigate the effect of Core stability training on pain, function, quality
      of life, sleep quality, body posture, foot posture, oral habits and kinesiophobia in
      individuals with temporomandibular disorder.

      Materials and Methods: The study included 40 people over the age of 18, who were diagnosed
      with temporomandibular disorder from the dentist.
    


Intervention name(s): Core stability training; Rocabado Exercises
Intervention type(s): Other; Other
Intervention description(s): Core stability exercises; Exercises for Temporomandibular Disorders
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomised Controlled Trial
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: core stability; pain; quality of life; function; temporomandibular disorder
A Clinical Trial of an Inactivated Quadrivalent Influenza Vaccine in Chinese Children Aged 3 to 8 Years
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 4

Summary: 
      Routine annual influenza vaccination is recommended for all persons aged≥6 months who do not
      have contraindications. For those aged 6 monthsthrough 8 years who have previously received
      ≥2 total doses of trivalent orquadrivalent influenza vaccine ≥4 weeks apart, they require
      only 1 dose ofinfluenza vaccine. For those who have not previously received ≥2 doses
      oftrivalent or quadrivalent influenza vaccine, they require 2 dose of influenzavaccine. but
      the evidence on how to select vaccine doses for quadrivalentinfluenza vaccine is limited in
      China. The study is a prospective, open-labelcomparison of the immunogenicity and
      reactogenicity of 1 versus 2 doses ofan inactivated quadrivalent influenza vaccine in
      subjects of 3-8 years old withdifferent history of influenza vaccination.
    

Detailed description: 
      Subjects receive 2 dosed of quadrivalent influenza vaccine 4 weeks apart.Blood samples were
      obtained from children at 3 time points-before receiptof dose 1, 4 weeks after receipt of
      dose 1 and before dose 2, and 4 weeksafter dose 2. Hemagglutination inhibition (HAI) antibody
      titers to the A/H3N2,A/H1N1, and B antigens included in the vaccine were measured at each
      timepoint
    

Intervention name(s): Quadrivalent influenza vaccine
Intervention type(s): Biological
Intervention description(s): Subjects receive two doses of quadrivalent influenzavaccine administered 4 weeks apart by intramuscularinjection. Each 0.5-ml dosecontained 15 μg of hemagglutinin per strain.
Intervention model: Single Group Assignment
Intervention model description: Subjects received 2 doses of an inactivated quadrivalent influenza vaccine,4 weeks apart. Blood samples were obtained from children at 3 time points-before receipt of dose 1, 4 weeks after receipt of dose 1 and before dose 2, and4 weeks after dose 2.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Safety; Immunogenicity; Quadrivalent influenza vaccine
Evaluation of Two Positions for Free Floating Tracheal Intubation in Weightlessness
Condition: Intubation; Difficult or Failed; Intubation Complication
Study type: Interventional

Summary: 
      In a non-randomized, controlled, cross-over simulation study, the investigators evaluated and
      compared intubation performance of trained operators, using either a conventional
      laryngoscope in an ice-pick position or a video laryngoscope in a free-floating classic
      position, in weightlessness and in normogravity.

      Data were analyzed with the generalized linear mixed-effects models.

      Primary endpoint was the success rate of tracheal intubation. Time to intubation and the
      confidence score into the success of tube placement were also recorded as secondary
      endpoints.
    


Intervention name(s): Videolaryngoscopy / Direct Laryngoscopy
Intervention type(s): Device
Intervention description(s): First pass success analysis
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Intervention model description: A simulation study, in which participants alternatively perform oro-tracheal intubation on a manikin, either using a videolaryngoscope (McGrath model, Medtronic TM) or a direct laryngoscope
Masking: None (Open Label)
Primary purpose: Other