bioihbjkbjnl/mcl2 huggingface dataset:
Laparoscopic vs Robotic-Assisted Radical Prostatectomy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      This randomized trial was designed to address the lack of high-quality literature comparing
      robotic-assisted (RARP) and laparoscopic (LRP) radical prostatectomy (RP).

      Purpose: The LAP-01 trial compares outcomes between RARP and LRP.
    

Detailed description: 
      LAP-01 is the first multicenter, prospective randomized, patient-blinded controlled trial
      comparing robotic-assisted and conventional laparoscopic radical prostatectomy.

      The investigation include an extensive evaluation of clinical, oncological, functional and
      quality of life related data by means of validated patient-reported outcome measures.

      The primary outcome is the assessment of time to continence restoration at 3 months. This is
      evaluated by an assessment of a pad diary completed daily by each patient from the time of
      catheter removal until restoration of continence. Secondary endpoints include continence and
      erectile function, as well as quality of life (EORTC-QLQ-C30, EORTC-QLQ-PR25), patient
      satisfaction and Hospital Anxiety and Depression Scale (HADS) at 1, 3, 6 and 12 months after
      surgery in addition to oncological outcomes up to 3 years follow-up.

      With 782 enrolled patients it is the largest trial carried out till date on this topic.
    

Intervention name(s): Prostatectomy
Intervention type(s): Procedure
Intervention description(s): Comparison of robotic-assisted and conventional laparoscopic radical prostatectomy
Other intervention name(s): robotic-assisted laparoscopic radical prostatectomy; conventional laparoscopic radical prostatectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: DaVinci; Robotic-Assisted; Prostatectomy; Laparoscopy; Continence
Flupentixol and Melitracen Tablets in the Treatment of Emotional Disorder
Condition: Emotional Disorder; Neurologic Disorder
MeSH terms: Nervous System Diseases; Mood Disorders
Study type: Interventional
Phase: Phase 4

Summary: 
      To evaluate the efficacy and safety of Flupentixol melitracen tablets in the treatment of
      different types of non random emotional disorders
    

Detailed description: 
      Involuntary emotional expression disorder (ieed) is a kind of disorder of emotion control.
      Its main clinical feature is frequent short and violent uncontrollable crying and (or)
      laughing, which is different from mood disorder and self emotional expression.

      The mixture of Flupentixol and melitracen is used for antidepressant. Melitracen is a
      tricyclic antidepressant, while Flupentixol is a neurodepressant in structure, but its dose
      in Deanxit has antidepressant properties.

      The active components of Deanxit are Flupentixol dihydrochloride (Flupentixol) and melitracen
      (melitracen). Flupentixol is a thiazolyl (thioanthracene) antipsychotic, and melitracen is a
      tricyclic antidepressant. Low dose Flupentixol (0.5mg-3mg) has antidepressant and antianxiety
      effects, while melitracen has antidepressant effect. The mixture of the two components is
      used to treat mild to moderate mental disorders.

      The purpose of this study was to evaluate the efficacy and safety of Flupentixol melitracen
      tablets in the treatment of different types of non random emotional disorders.
    

Intervention name(s): Flupentixol melitracen tablets
Intervention type(s): Drug
Intervention description(s): Patients were treated with Flupentixol and melitracen tablets for 12 weeks
Intervention MeSH terms: Flupenthixol; Flupenthixol decanoate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Speech Perception for Children With Cochlear Implants
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether speech recognition in noise can be improved
      by the addition of a special listening program to the sound processor. Thus we propose to
      assess speech perception in noise for pediatric cochlear implant patients using both their
      everyday listening program as well an ASC program.
    

Detailed description: 
      The purpose of this study is to determine whether speech recognition in noise can be improved
      by the addition of a special listening program to the sound processor. Thus we propose to
      assess speech perception in noise for pediatric cochlear implant patients using both their
      everyday listening program as well an ASC program.

      You will be asked to listen to sentences in quiet and in noise and repeat the sentences. You
      will be seated in a comfortable chair inside the sound booth with 8 loudspeakers placed in a
      circular pattern around your head. We will test your sentence recognition abilities in your
      listening program as well as in the new listening program. The sentences and noise will be
      presented through loudspeakers at levels typically encountered in everyday communication
      environments. Your participation would involve approximately 20 minutes of testing plus 10
      minutes to add the new listening program to their processor.
    

Intervention name(s): sentence recognition
Intervention type(s): Behavioral
Intervention description(s): testing the ability for sentence recognition in quiet and in noise.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: pediatrics; cochlear implant
Very Low Dose Caudal Morphine for Postoperative Pain Management
Condition: Caudal Anesthesia
MeSH terms: Pain, Postoperative
Study type: Observational

Summary: 
      This is a chart review. The aim of this study is to investigate the effectiveness and side
      effects of very low dose morphine administered caudally to children that went to surgical
      procedures that used caudal anesthesia. The study compares caudal block with Bupivacaine (1
      ml kg_1 of bupivacaine 0.25% and saline 0.02 ml kg_10) with very low dose morphine (a mix of
      1 ml kg_-1 of ropivacaine 0.2% and preservative-free morphine: 10 µg kg-1).
    

Detailed description: 
      Caudal anesthesia is the most common technique of epidural anesthesia in children. Caudal
      anesthesia is recommended for most surgical procedures of the lower part of the body,
      including herniorrhaphies; operations on the urinary tract, anus, and rectum; and orthopedic
      procedures on the pelvic girdle and lower extremities. Many anesthetic agents have been used
      for caudal anesthesia in pediatric patients, with lidocaine and Bupivacaine being most
      common. The major problems associated with this technique are the limited duration of
      analgesia and unwanted motor blockade.

      Addition of medications that prolong analgesia after a single shot caudal block has been
      investigated. Several authors have mentioned a special interest in using an opioid like
      morphine in caudal block for postoperative analgesia. When low dose morphine is used, the
      side effects are lower than when higher dose of morphine are used. A larger and definitive
      study is needed to compare very low dose morphine via caudal administration and caudal block
      without Opioid with regard to duration of analgesia and frequency of side effects. We plan to
      conduct a chart review in our center on pediatric patients that went to urological,
      orthopedic, and general surgery procedures for which caudal block were given and compare the
      effectiveness and side effects of very low dose morphine and caudal block without Opioid.
    

Intervention name(s): Caudal block
Intervention type(s): Procedure
Intervention description(s): Chart review of patients that received very low dose morphine administered caudally (M) and plain caudal block with Ropivacaine or Marcaine (B)from October 2008 to October 2009.
Other intervention name(s): Postoperative pain; Morphine; Bupivacaine
Intervention MeSH terms: Morphine; Bupivacaine
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        This is a chart review from October 2008 to October 2009 of children from 1 month of age to
        10 years old that went to elective Urological procedures such us circumcision, orchidopexy
        and inguinal hernia repair, orthopedic and general surgery procedures for which caudal
        block are usually administered for pain management
12-Week Study of DS-8500a in Subjects With Type 2 Diabetes Mellitus on Metformin
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The hypothesis of this Phase 2, 12-week study, is that DS-8500a will improve glycemic control
      relative to placebo, based on changes in HbA1c, with acceptable safety and tolerability, in
      patients with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin.
    


Intervention name(s): Sitagliptin 100 mg; DS-8500a 25mg; Placebo Tablet; Placebo Capsule
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Two sitagliptin 50 mg tablets, over-encapsulated to provide a once-daily dose of 100 mg, for oral administration; DS-8500a 25mg tablet for oral administration; Placebo matching DS-8500a tablet for oral administration; Placebo matching sitagliptin over-capsule for oral administration
Other intervention name(s): Januvia; Investigational product; Placebo; Placebo
Intervention MeSH terms: Sitagliptin Phosphate; Firuglipel
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: type 2 diabetes mellitus; interventional; double blind; phase 2
Cognitive and Blood Flow Effects of Mountain Tea
Condition: Cognitive Change; Affect; Blood Pressure; Neuroimaging
Study type: Interventional

Summary: 
      Two doses (475 mg and 950 mg) of Sideritis Scardica (SS or 'mountain tea') are investigated
      for cognitive, mood, blood pressure and cerebral blood flow effects in a healthy group of
      50-70 yr olds, both acutely and following 28 days of consumption.
    

Detailed description: 
      The presence of polyphenols such as ferulic acid, chlorogenic acid and apigenin in Sideritis
      Scardica (SS or 'mountain tea') are likely responsible for the cognitive and mood effects of
      its consumption and this could be underpinned by the ability of such polyphenols to prevent
      monoamine neurotransmitter reuptake and to increase cerebral blood flow (CBF).

      The current randomised, placebo controlled, parallel groups study extends on the
      abovementioned small amount of literature; assessing both cognitive and mood outcomes in a
      sample of older (50-70 yrs) adults, as well as blood pressure (BP) and CBF, in a sub-sample,
      utilizing near-infrared spectroscopy (NIRS). The above will be assessed acutely (pre-dose and
      90- and 310-mins post dose) on day 1 and following 28 days consumption of either a placebo
      control, and active control of 240 mg ginkgo biloba, 475 mg SS or 950 mg SS.
    

Intervention name(s): Sideritis Scardica; Ginkgo biloba; Placebo control
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Sideritis Scardica is a popular, naturally un-caffeinated Eastern European tea extract derived from the ironwort plant; Ginkgo biloba is an extract from the ginkgo tree comprising ginkgolides and bilobalide. In this trial Ginkgo acted as an active control.; An inert encapsulated powder provided by Finzelberg.
Other intervention name(s): Shepherd's tea; Olympus tea; Mountain tea
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Other
A Study of LY3556050 in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to learn more about the safety of LY3556050 after it is
      given by mouth to healthy participants. Blood tests will be performed to check how much
      LY3556050 gets into the bloodstream and how long the body takes to get rid of it. Each
      enrolled participant will receive multiple doses of LY3556050 or placebo and will remain in
      the study for up to 31 days.
    


Intervention name(s): LY3556050; Placebo; Iohexol; Metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Administered orally.; Administered orally.; Administered IV.; Administered orally.
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Part A - Parallel design. Part B - Open label design.
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Treatment and Rehabilitation of Patients With Hip Arthroplasty to Regain Walk and Work Efficiency and Quality of Life
Condition: Osteoarthritis, Hip
MeSH terms: Osteoarthritis, Hip
Study type: Interventional

Summary: 
      The aim of the study is to improve hospital treatment and rehabilitation of patients with hip
      arthroplasty to help the patients to regain functional ability in the shortest possible time,
      and reduce hospital and rehabilitation time to save costs for the patient and society.

      Optimal reconstruction of the hip joint and the effect of an intensive physical training
      programme are compared to conventional rehabilitation programmes.
    


Intervention name(s): Maximal strength training; conventional rehabilitation
Intervention type(s): Behavioral; Behavioral
Intervention description(s): maximal dynamic strength training from 1 week after the operation, 5 training bouts a week for 4 weeks. The regimen consisted of 2 exercises, leg press and hip abduction, that included 4 series of 5RM involving the operated leg only. 5RM corresponds to approximately 85% of 1RM. When the patients managed to perform 6RM, the load was increased by 5kg. The series were separated by resting periods of 2 minutes.; conventional rehabilitation program: inpatient treatment in a rehabilitation center. Individual sling exercise therapy in hip abduction/adduction, hip flexion/extension, exercises with low resistance (>12-15 repetitions37), or no resistance and exercises performed in water when sutures had been removed. Each session lasted 1 hour and was performed 5 days a week for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Double-Blind, Randomized Study Of The Analgesic Efficacy And Safety Of Valdecoxib 20 Mg Daily And Valdecoxib 20 Mg Twice Daily Compared To Placebo For Management Of Acute Postsurgical Pain In Anterior Cruciate Ligament (ACL) Reconstruction
Condition: Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective was to evaluate the analgesic efficacy of valdecoxib 20 mg daily and
      valdecoxib 20 mg twice daily compared with placebo in outpatients with moderate-severe pain
      after arthroscopic anterior cruciate ligament (ACL) reconstruction surgery. Secondary
      objectives were to compare each valdecoxib dose with placebo on additional measures of pain
      intensity, health outcomes, the use of rescue medication, and the occurrence of
      opioid-related symptoms, and to evaluate their safety.
    


Intervention name(s): placebo; valdecoxib; valdecoxib
Intervention type(s): Drug; Drug; Drug
Intervention description(s): valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, placebo BID by mouth on Days 2 to 5.; valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, valdecoxib 20 mg once daily (QD) by mouth on Days 2 to 5.; valdecoxib 40 mg (two 20-mg tablets) by mouth followed by valdecoxib 20 mg 1 to 12 hours after the first dose or 12 hours after the first dose, but no later than midnight on Day 1; then, valdecoxib 20 mg twice daily (BID) by mouth on Days 2 to 5.
Intervention MeSH terms: Valdecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Post surgical pain; Anterior Cruciate ligament reconstruction; Arthroscopy; Perioperative pain
Effect of a Fixed Pramlintide: Insulin Dose Ratio on Postprandial Glucose in Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to investigate the clinical efficacy and safety of pramlintide
      co-administered as a fixed-dose ratio with basal-bolus SC insulin, delivered simultaneously
      via 2 separate pumps, in subjects with type 1 diabetes who are failing to achieve the desired
      level of glycemic control using insulin therapy.
    

Detailed description: 
      Potentially eligible subjects with Type 1 diabetes mellitus who are treated with with a
      basal-bolus insulin regimen through multiple daily injections or insulin pump at a total
      daily insulin dose ≤60 U, will be eligible. Visit 1 is approximately 3-6 weeks prior to
      randomization. Given some variability in HbA1c and C-peptide assays, re-testing for HbA1c and
      C-peptide can be performed within 18 days from the initial visit. Visit 2 is approximately
      2-5 weeks prior to randomization. Subjects are on lispro insulin throughout study except
      during Visit 4 and Visit 5, the domicile 24 hr treatment period, when they are switched to
      regular insulin U-100.

      Screen failed patients may be re-screened for inclusion in the study, as long as re-screening
      takes place at least 3 months after the original screening visit. If a subject is
      re-screened, he/she must continue to meet all inclusion/exclusion criteria. All study
      procedures of initial Visit 1 must be repeated at the re-screening visit.
    

Intervention name(s): Pramlintide acetate; Placebo; Lispro insulin U-100; Regular insulin U-100
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Pramlintide acetate administered by a separate pump; Placebo administered by separate pump; Subjects will be stabilized on a separate insulin pump and administered lispro insulin throughout the study, except during both inpatient treatment periods (Visit 4 and Visit 5); Use during two in-patient treatment periods (visits 4 and 5) and administered by separate pump
Other intervention name(s): Pramlintide: SYMLIN; Humalog insulin lispro U-100; Humulin R; U-100
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro; Pramlintide; Islet Amyloid Polypeptide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Type 1 Diabetes Mellitus; Pramlintide
The Effect of CORT118335 on Olanzapine-Induced Weight Gain
Condition: Antipsychotic-induced Weight Gain
MeSH terms: Body Weight; Weight Gain
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will investigate if there is any difference in the amount of weight gained by
      participants taking olanzapine with CORT118335 compared with olanzapine with placebo (a dummy
      test medicine which looks like CORT118335 but contains no active medicine). Safety and
      tolerability of CORT118335 when taken with olanzapine will also be evaluated.
    


Intervention name(s): Olanzapine; CORT118335; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Olanzapine 10 mg oral tablet; CORT118335 600 mg oral tablets administered as 2 X 300 mg or 6 X 100 mg tablets; Placebo matching CORT118335, 2 or 6 oral tablets, depending on the CORT118335 tablet strength available
Intervention MeSH terms: Olanzapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A Study to Assess the Efficacy, Safety and Pharmacokinetics of Nusinersen (ISIS 396443) in Infants With Spinal Muscular Atrophy (SMA)
Condition: Spinal Muscular Atrophy
MeSH terms: Muscular Atrophy; Muscular Atrophy, Spinal; Atrophy
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective is to examine the clinical efficacy of multiple doses of nusinersen
      (ISIS 396443) administered intrathecally to participants with Infantile-Onset Spinal Muscular
      Atrophy (SMA). The secondary objectives are to examine the safety and tolerability of
      multiple doses of nusinersen administered intrathecally to participants with infantile-onset
      SMA and to examine the cerebral spinal fluid (CSF) and plasma Pharmacokinetics (PK) of
      multiple doses of nusinersen administered intrathecally to participants with infantile-onset
      SMA.
    

Detailed description: 
      This study was conducted and the protocol was registered by Ionis Pharmaceuticals, Inc.. In
      August 2016, sponsorship of the trial was transferred to Biogen.
    

Intervention name(s): nusinersen
Intervention type(s): Drug
Intervention description(s): Administered by intrathecal (IT) injection
Other intervention name(s): ISIS 396443; Spinraza; BIIB058; IONIS SMN Rx; ISIS SMNRx
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Spinal Muscular Atrophy; SMA; SMN; SMNRx; ISIS-SMNRx; ISIS 396443; IONIS-SMNRx; Spinraza; Nusinersen