bioihbjkbjnl/mcl2 huggingface dataset:
Nasal Prep for Nasendoscopy in Children
Condition: Flexible Nasendoscopy
Study type: Interventional
Phase: Phase 4

Summary: 
      Flexible nasendoscopy involves passing a soft, thin, endoscope through the nose. This
      diagnostic procedure is often essential for assessment of a child by an Otolaryngologist in
      outpatients. The purpose of this randomized controlled double-blind study is to determine
      whether there is a difference in the degree of discomfort experienced by children undergoing
      flexible nasendoscopy, after receiving one of three different intranasal sprays: (A) placebo
      (isotonic saline solution), (B) decongestant (0.05% xylometazoline hydrochloride), or (C)
      decongestant with local anesthetic (0.05% xylometazoline hydrochloride with 1% lidocaine
      hydrochloride).

      Null hypothesis: There is no difference in the degree of reported discomfort experienced
      (using a validated pediatric pain score) by children undergoing flexible nasendoscopy, after
      receiving either intra-nasal topical placebo, decongestant, or decongestant with local
      anesthetic.
    


Intervention name(s): 0.05% xylometazoline hydrochloride with 1% lidocaine hydrochloride; 0.05% xylometazoline hydrochloride; Isotonic normal saline
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Decongestant with local anesthetic; Decongestant; Placebo
Intervention MeSH terms: Lidocaine; Xylometazoline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Comparison of the Effect of Remimazolam and Propofol on Perioperative Hypothermia Under Spinal Anesthesia
Condition: Lower Extremity Problem; Gynecologic Disease; Urinary Tract Disease
MeSH terms: Genital Diseases, Female; Urologic Diseases; Hypothermia
Study type: Interventional

Summary: 
      After dividing the patients into two groups, sedation is performed with propofol and
      remimazolam, respectively, after spinal anesthesia. Compare the patient's body temperature
      change after surgery.
    

Detailed description: 
      Patients in the study were randomly assigned to the propofol group (Group P) and the
      remimazolam group (Group R) in a 1:1 ratio. Study drugs are prepared in the same 50 ml
      syringe, double-blind to group assignment. All patients are not given pre-anesthetic
      medication, and body temperature, blood pressure, and heart rate are measured in the recovery
      room after surgery at 10-minute intervals from just before anesthesia induction to surgery.
      If hypotension or bradycardia occurs during surgery and is not corrected even after rapid
      fluid infusion, ephedrine is increased by 10 mg or glycopyrrolate 0.2 mg or atropine 0.5 mg
      is administered.

      If spinal anesthesia is successfully performed, check the patient's anesthesia height. When
      the appropriate level of anesthesia is confirmed, Group P receives propofol at
      25-100ug/kg/min and maintains the BIS at 70-80. Group R receives remimazolam at 1-20ug/kg/min
      and maintains BIS between 70-80. Both groups apply a conventionally used air heating device,
      and the operating room temperature is kept at 20 °C. If shivering occurs during surgery, the
      elapsed time from induction and the shivering grades are recorded.

      At the end of the surgery, record total anesthesia time and surgery time, fluid dose, and
      drug use. After moving to the recovery room, the patient's body temperature, systolic blood
      pressure, diastolic pressure, heart rate, the incidence of shivering, and the grade of
      shivering are checked. When shivering occurs, a forced air-warming device is applied first,
      and if shivering continues, administer meperidine in 5mg increments until the patient is
      comfortable and record the total dose.
    

Intervention name(s): Propofol; Remimazolam
Intervention type(s): Drug; Drug
Intervention description(s): Propofol is injected at 25-100ug/kg/min (immediately after spinal anesthesia to the end of surgery) to maintain the BIS at 70-80.; Remimazolam is injected at 1-20ug/kg/min (immediately after spinal anesthesia to the end of surgery) to maintain the BIS at 70-80.
Other intervention name(s): Fresofol®; Byfavo®
Intervention MeSH terms: Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Study of Long-term Safety, Efficacy Tolerability of BYM338 in Patients With Sporadic Inclusion Body Myositis
Condition: Sporadic Inclusion Body Myositis (sIBM)
MeSH terms: Myositis; Myositis, Inclusion Body
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This study is an open-label, long-term study for those patients who participated in the prior
      proof-of-concept protocol, in which the preliminary efficacy for BYM338 in patients with sIBM
      was demonstrated after a single 30 mg/kg i.v. dose of BYM338. This study is designed to
      confirm the efficacy, safety and tolerability of BYM338 in sIBM with long-term dosing.
      However due to lack of efficacy in patients with sIBM, the study was terminated early.
    

Detailed description: 
      This is a non-confirmatory, multicenter, open-label, non-randomized trial which will extend
      active treatment to those patients that participated in the preceding proof-of-concept study
      (CBYM338X2205) in order to collect long-term safety and tolerability data. Up to 14 patients
      with sIBM will be invited to enroll into the study to receive BYM338 open-label for a period
      of approximately 3 years or until BYM338 is commercially available, whichever comes first.
      The study consists of a maximum 28-day screening period, a 5-day baseline period, and a
      treatment period consisting of the site visits at 4-week intervals for treatment
      administration, safety and pharmacokinetic follow-up. All patients will be administered a
      medium level i.v. BYM338 dose regardless of their treatment allocation in the prior study.
    

Intervention name(s): BYM338 (Bimagrumab)
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Inclusion Body Myositis (IBM)
LevetIracetam in Patients Being Treated for Epilepsy
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Observational

Summary: 
      Epilepsy is one of the most common neurological diseases.Approximately 53 million people
      suffering from chronic recurrent epilepsy in 1990 and that number increased about 58 million
      in 2005.

      The annual incidence of epilepsy varies considerably in different epidemiological studies,
      ranging from 11 cases per 100,000 general population to 230 cases per 100,000 people.

      To date there has been discovered the ideal Antiepileptic Drugs. The drug, ie, that are safe
      and effective, it has good daily administration frequency, easily administered from all
      roads, which has high bioavailability, which is not highly bound to proteins, and not holding
      inductive or inhibitory effect.
    

Detailed description: 
      There are broad-spectrum anticonvulsant, which means that a drug can be very effective for a
      patient, but may or may not regulate and increase the frequency of another crisis. Thus there
      remains now only to choose one among a number of drugs, the most appropriate.This study
      intends to register within 12 months clinical practice in Greek reality as regards the
      elements of diagnosis and management of patients with epilepsy and those who already are, or
      are part of treatment with levetiracetam.

      The aims of this clinical study is to record data on

        -  the diagnosis

        -  The management of epilepsy in daily clinical practice in a sample of Greek population

        -  The monitoring of patients entering or already undergoing treatment with levetiracetam.

        -  The assessment of quality of life between visits of the study by using quality of life
           QOLIE-31 questionnaire

        -  The economic evaluation of the change in treatment from original to generic
           levetiracetam This is a data recording study and evaluation of treatment with
           levetiracetam. The study will take place in 15 antiepileptic centers throughout Greece.
           Researchers will have to successively record all incidents of patients (30 per center)
           with epilepsy, which are new diagnoses or already diagnosed and are treated with
           levetiracetam.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study will recruit outpatients who are new epilepsy diagnoses or diagnosed prior to
        enrollment in the study and treated with levetiracetam for the management of their disease.
        All patients will be included from 15 research centers nationwide. Each center will include
        ≥30 patients to be monitored (1: 1 newly diagnosed / older diagnoses).
      
Keywords: seizures,; quality of life
The Effect of Codeine on Driving Abilities
Condition: Healthy
Study type: Observational

Summary: 
      20 chronic pain patients using codeine are compared with 20 chronic patients not using
      opioids and 20 healthy volunteers with respect to driving ability measured by
      neurophysiological tests and driving in a car simulator.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        chronic pain patients driving more than 50,000 km/yr
      
Keywords: possible problems using codeine when driving
OTL38 Injection for Intraoperative Imaging of Folate Receptor Positive Lung Nodules
Condition: Lung Neoplasms; Lung Cancer
MeSH terms: Lung Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a phase 2, multi-center, single dose, open-label, exploratory study in suspected lung
      cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/positron emission
      tomography imaging based on standard of care. This study aims to assess the efficacy of OTL38
      and Near Infrared Imaging (NIR) at identifying pulmonary nodules within the operating
      theater, and to assess the safety and tolerability of single intravenous doses of OTL38.
    

Detailed description: 
      This is a phase 2, multi-center, single dose, open-label, exploratory study in suspected lung
      cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/positron emission
      tomography (PET) imaging based on standard of care.

      Two to three hours prior to surgery, patients will be infused with OTL38. After the patient
      is intubated and surgical site incised, the surgeon will locate and document all nodules
      identifiable by white light, manual palpation, and Near-Infrared Imaging (NIR). This will be
      documented and recorded. Surgery will be completed per surgeon's standard of care, afterwards
      the area will be reviewed under standard and infrared light. All samples will be sent for
      pathology and immunohistochemistry (IHC) evaluation.
    

Intervention name(s): OTL38 for Injection; Near infrared camera imaging system; Endoscopic or Thoracic Surgery
Intervention type(s): Drug; Device; Procedure
Intervention description(s): Folate analog ligand conjugated with an indole cyanine-like green dye as a solution in vials containing 3 mL at 2 mg/mL; Near infrared camera imaging system; Endoscopic or Thoracic Surgery
Other intervention name(s): OTL38
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
BlueWind Medical System for the Treatment of Patients With OAB
Condition: Over Active Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional

Summary: 
      BlueWind system safety and performance in treatment of patients diagnosed with overactive
      bladder (OAB)
    

Detailed description: 
      BlueWind Medical system safety and performance in treatment of patients diagnosed with
      overactive bladder (OAB)
    

Intervention name(s): BlueWind Medical system
Intervention type(s): Device
Intervention description(s): The BlueWind Medical System is intended for the treatment of patients with overactive bladder (OAB) including urinary urgency frequency and urge incontinence.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Bioavailability of Select Nutrients From Two Formulations of a Multivitamin/Mineral Supplement
Condition: Bioavailability
Study type: Interventional

Summary: 
      The objective of this study is to assess the relative bioavailability of select nutrients
      from two formulations of a multivitamin/mineral supplement in healthy adults.
    


Intervention name(s): Formulation #1; Formulation #2
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subject will receive a single dose of formulation #1 of a multivitamin/mineral supplement; Subject will receive a single dose of formulation #2 of a multivitamin/mineral supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Physical Activity in Youth: Implications for Reversing Risk Factors for Type 2 Diabetes
Condition: Abdominal Obesity
MeSH terms: Obesity; Obesity, Abdominal
Study type: Interventional

Summary: 
      In this randomized controlled trial, we will examine the effect of a 3-month exercise
      training (aerobic exercise versus resistance exercise) without calorie restriction on total
      and regional adiposity, and risk of type 2 diabetes in overweight children and adolescents.
    


Intervention name(s): Control; Resistance Exercise; Aerobic exercise
Intervention type(s): Other; Other; Other
Intervention description(s): Standard care control (no exercise); Supervised resistance exercise using stack weight equipments.; Supervised aerobic exercise using treadmills, bikes, and ellipticals
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Childhood obesity; Abdominal obesity; Visceral fat; Insulin resistance; Liver fat; Skeletal muscle lipid; Fitness
Placebo-controlled Study to Determine the Safety and Tolerability of Subcutaneous Doses of Sevuparin
Condition: Safety and Tolerability
Study type: Interventional
Phase: Phase 1

Summary: 
      A Double-blind, Placebo-controlled study in Healthy Volunteers to Determine the Safety and
      Tolerability of Single, Ascending Subcutaneous Doses of Sevuparin
    

Detailed description: 
      This is a randomized, double-blind, placebo-controlled, sequential cohort, single escalating
      dose study to explore the safety, tolerability, pharmacokinetics and pharmacodynamics of
      sevuparin in healthy volunteer adult male and female subjects. The study will consist of
      three subcutaneous dose cohorts (3, 6 and 9 mg/kg sevuparin). Each dosing cohort will consist
      of 8 subjects who will be randomized to receive either a single dose of sevuparin or matching
      placebo in a 3:1 ratio (6 active/2 placebo).
    

Intervention name(s): Sevuparin
Intervention type(s): Drug
Intervention description(s): The study will consist of three dose cohorts (3, 6 and 9 mg/kg sevuparin). Subjects in each cohort will receive a single dose of sevuparin or placebo subcutaneously on Day 1.
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: The study will consist of three dose cohorts (3, 6 and 9 mg/kg sevuparin). Subjects in each cohort will receive a single dose of sevuparin or placebo subcutaneously on Day 1.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cervical Ripening Before Induction of Labour at Term: a Randomised Comparison of Prostin vs Propess
Condition: Cervical Ripening; Labor, Induced
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to compare two different preparation
    


Intervention name(s): Prostaglandin E2
Intervention type(s): Drug
Intervention MeSH terms: Dinoprostone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Prostaglandin E2; Intravaginal gel; Bishop score; Induction of labor; randomized trial; Vaginal insert
Multiple Dose Safety, Tolerability, PK，PD and Food Effect Study of HEC96719 in Healthy Adult Subjects
Condition: Nonalcoholic Steatohepatitis (NASH)
MeSH terms: Fatty Liver; Non-alcoholic Fatty Liver Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The Safety, Tolerability, Pharmacokinetic, Pharmacodynamics and Food Effect Study of HEC96719
      in Healthy Subjects
    


Intervention name(s): HEC96719
Intervention type(s): Drug
Intervention description(s): Part 2：Mulltiple doses up to 10 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Internet-delivered ACT for Treating the Psychological Effects of Hearing Loss
Condition: Hearing Loss
MeSH terms: Hearing Loss; Deafness
Study type: Interventional

Summary: 
      Randomized trial comparing internet-delivered ACT with therapist support against waiting list
      for persons with hearing loss and comorbid psychological distress
    

Detailed description: 
      Hearing loss is the most common sensory disability in the world. Hearing loss is an auditory
      disability which affects not only speech recognition, but also the ability to recognize,
      locate and identify sounds in one's environment. Today there are a variety of studies
      investigating the relationship between hearing loss and mental health. For example, there are
      studies showing that hearing loss can lead to depression, somatization, social isolation,
      worrying or anxiety, loneliness, smaller social networks, lower self-efficacy, sensitivity to
      stress, burnout, and impaired sleep quality and quality of life in comparison with people
      with normal hearing. Initial results from other studies indicate that acceptance may be of
      importance, as it in turn can lead to increased help-seeking.To avoid prolonged stress and a
      healthy self-efficacy could contribute to greater well-being of people with hearing loss.
      This is the first study to use ACT to improve psychological health in people with hearing
      loss through the process of psychological flexibility. The treatment is eight weeks long and
      internet delivered through self-help texts with weekly therapist support.
    

Intervention name(s): Internet-delivered ACT
Intervention type(s): Behavioral
Intervention description(s): Therapist-guided Internet-delivered ACT (acceptance and commitment therapy) for 8 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: psychological effects
Effects of Sex Steroid Hormones on Human Brain Function, Structure and Connectivity
Condition: Gender Identity Disorder
MeSH terms: Gender Dysphoria
Study type: Observational

Summary: 
      This ultrahigh-field MRI study gives us the unique opportunity to measure changes in brain
      function and structure induced by long-term opposite-sex steroid hormone administration in
      transsexual subjects. Our aim is 1. to prove the influence of high-dose, long-term
      opposite-sex steroid hormone treatment on functional brain response in transsexuals. 2. to
      investigate the influence of hormone treatment on resting state functional connectivity and
      brain morphology. 3. to investigate differences between transsexuals and healthy control
      subjects in brain function and functional connectivity, brain morphology and structural
      connectivity. In this longitudinal study, transsexuals and healthy control subjects will
      undergo three 7 Tesla ultrahigh-field MRI scan sessions: 1. baseline (before hormone
      treatment), 2. after 4 weeks of treatment and 3. after 4 months of treatment.
    


Intervention name(s): Hormones
Intervention type(s): Drug
Intervention description(s): FtM will receive
1000mg testosterone undecanoate every 12 weeks (Nebido® 4ml i.m.), or alternatively 50mg testosterone transdermally (Testogel® 5g-bag per day) and
if menstruation still occurs, additionally either lynestrenol Orgametril® (2-3 tablets/day) or in some cases 0.075mg desogestrel (Cerazette®, 1 tablet/day).
MtF will receive
50mg cyproterone acetate daily (Androcur®)
estradiol 100µg transdermal therapeutic system (TTS) twice a week (Estradot®, Estramon®), especially if subjects age is > 40 years, or p.o. estradiol 2x2mg (Estrofem®) if subjects age is < 40 years; alternatively estradiol 0,75-1,5mg (1-2 hubs) transdermally (Estrogel-Gel®) and
2,5mg alpha-5-reductase-inhibitor every 2nd day (Finasterid Actavis/ Arcana/ Aurobindo®) in case of extensive hair loss.
Intervention MeSH terms: Hormones
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Transsexuals urging sex reassignment in a clinical setting will be enrolled at the Unit for
        Gender Identity Disorder at the General Hospital in Vienna. 20 female-to-male (FtM) and 20
        male-to-female (MtF) transsexuals will be asked to undergo this fMRI, MRI, DTI and
        resting-state functional connectivity study. Transsexual subjects are aged between 18 and
        50 years old and free from hormone-treatment at baseline.

        40 healthy control subjects, matched for age, sex and sexual orientation to transsexual
        subjects will be recruited.
Uptake and Adherence to Daily Oral PrEP as a Primary Prevention Strategy for Young African Women: A Vanguard Study
Condition: HIV
Study type: Interventional
Phase: Phase 4

Summary: 
      To assess the acceptance rate, adherence, acceptability, and continuation of oral
      pre-exposure prophylaxis (PrEP) among young southern African women.
    

Detailed description: 
      A Phase IV randomized multi-site prospective study to assess PrEP acceptance and adherence
      among HIV-uninfected young women. All women who accept open-label daily oral PrEP will be
      randomized 1:1 to receive enhanced adherence counselling based on feedback from observed drug
      levels or standard adherence support. A subset of up to ~25 women per site (maximum 75), will
      participate in qualitative assessments of facilitators and barriers for PrEP acceptance,
      adherence and continuation.
    

Intervention name(s): Truvada
Intervention type(s): Drug
Intervention description(s): 400 women who accept to initiate PrEP
Other intervention name(s): PrEP Acceptor
Intervention MeSH terms: Emtricitabine, Tenofovir Disoproxil Fumarate Drug Combination
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: ART (Antir-retroviral therapy); PrEP (Pre-Exposure Prophylaxis); DAIDS (Division of AIDS); HPTN (HIV Prevention Trials Network)