bioihbjkbjnl/mcl2 huggingface dataset:
Efficacy and Safety of HyQvia (Immunoglobulin 10% With Recombinant Hyaluronidase) in Multifocal Motor Neuropathy (MMN)
Condition: Multifocal Motor Neuropathy
MeSH terms: Neuritis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of HyQvia (Immunoglobulin
      10% with recombinant hyaluronidase) with conventional subcutaneous immunoglobulin treatment
      in patients with Multifocal Motor Neuropathy (MMN).
    

Detailed description: 
      Subcutaneous immunoglobulin (SCIG) therapy for MMN is equally efficacious to intravenous
      immunoglobulin (IGIV), may be self-induced and may induce fewer systemic adverse reactions.
      Limited SC infusion volumes and reduced bioavailability, however, necessitate multiple
      infusion sites, more frequent treatment, and dose adjustment to achieve pharmacokinetic
      equivalence. This is an issue in particular in MMN where relatively high and frequent doses
      are necessary to maintain long-term improvement of muscle strength. Recombinant human
      hyaluronidase (rHuPH20) increases subcutaneous tissue permeability and facilitates dispersion
      and absorption, enabling subcutaneous administration of higher (monthly) doses of Ig. If
      treatment with HyQvia is at least equally effective and safe as compared with conventional Ig
      treatment, HyQvia could become the preferred treatment option for patients with MMN as it may
      have attractive benefits for patients by its mode of administration.
    

Intervention name(s): HyQvia; Subcuvia
Intervention type(s): Drug; Drug
Intervention description(s): Human immunoglobulin 10% with recombinant hyaluronidase for subcutaneous injection; Human immunoglobulin 16% for subcutaneous injection
Other intervention name(s): Human immunoglobulin; Human immunoglobulin
Intervention MeSH terms: Immunoglobulins; Immunoglobulins, Intravenous; Antibodies
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Subcutaneous immunoglobulin; MMN
Indirect Calorimeter Based Study in Patients With Liver Cirrhosis
Condition: Liver Cirrhoses
MeSH terms: Liver Cirrhosis; Fibrosis
Study type: Interventional

Summary: 
      Part I- Observational study In the first part , investigator would investigate and compare
      the energy requirements and substrate utilization in healthy subjects and in patients with
      liver cirrhosis of various etiologies across the disease severity state viz compensated,
      stable decompensated, critically ill cirrhotics. The investigator would also enroll patients
      with chronic kidney disease, critically ill patients of acute liver failure or acute on
      chronic liver failure as disease controls.

      Part II- Randomized Controlled Study All the eligible, critically ill cirrhotic patients on
      mechanical ventilator support would be randomized to a control group (receiving the
      nutritional therapy as per the standard enteral nutritional practice in a critical care
      setting) or the intervention group (receiving enteral nutrition based on proposed measured
      requirements by Indirect calorimetry (IC) given till the patient is in ICU(Intensive care
      unit). The IC would be done thrice a week in both groups.
    


Intervention name(s): Indirect calorimetry based nutritional intervention till patient in ICU(Intensive care unit); Standard and fixed nutritional intervention till patient in ICU
Intervention type(s): Other; Other
Intervention description(s): Nutrition therapy based on measured energy expenditure by indirect calorimetry (IC) done alternate day till patient on ventilatory support and protein intake 1.5 g/kg IBW/day; Fixed standard nutritional therapy 35-40 Kcal/Kg IBW/day and 1.5 g protein /Kg IBW/Day till patient on ventilator
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Indirect calorimeter; Resting energy expenditure; substrate utilization; nitrogen balance
Working Memory Performance Among Childhood Brain Tumor Survivors
Condition: Brain Tumors
MeSH terms: Brain Neoplasms
Study type: Observational

Summary: 
      Children treated with radiation therapy for brain tumors are at risk for cognitive problems.
      These problems have typically been demonstrated on global cognitive measures including
      measures of intellectual functioning (IQ). Identification of specific areas of impairment can
      assist in isolating vulnerable brain areas and developing targeted interventions.

      In this study, we assess brain tumor survivors, solid tumor controls and healthy sibling
      controls using measures of working memory (online maintenance and manipulation of
      information) in order to identify a specific cognitive process that may underlie the observed
      decline in IQ. We are also exploring relationships among working memory performance with IQ,
      clinical characteristics and a specific genetic factor of interest.
    

Detailed description: 
      This is a cross-sectional controlled study of brain tumor survivors treated at St. Jude with
      conformal radiation therapy. Brain tumor survivors (n= 50, solid tumor survivors (n=40), and
      healthy sibling controls (n= 40) are evaluated once only with laboratory measures of
      cognitive skills (working memory, episodic memory and estimated IQ) and parental
      questionnaires (executive and adaptive functions). We also use buccal (cheek) swabs to gather
      samples for DNA extraction. We hypothesize: brain tumor survivors will perform significantly
      worse than solid tumor and healthy controls on measures of working memory, working memory
      will correlate significantly with IQ, working memory will be associated with parent report of
      executive functions and a specified genotype related to dopamine metabolism will be
      associated with working memory impairment.
    

Intervention name(s): Series of tests/questionnaires
Intervention type(s): Behavioral
Intervention description(s): Developmental and Demographic, KINDL Health-Related Quality of Life, Adaptive Behavior Assessment System (ABAS-II),Behavior Rating Inventory of Executive Function (BRIEF), Wechsler Digit Span Task, Wide Range Achievement Test 3rd Edition (WRAT3),Wechsler Abbreviated Scale of Intelligence (WASI), Pediatric Immediate Post-Concussion Assessment and Cognitive Testing (ImPACT), Recognition Memory Task: Face Stimuli, Recognition Memory Task: Verbal Stimuli, Self Ordered Search: Object, Self Order Search: Verbal
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Both the patient group and sibling group will be accrued using a broad stratification
        process for gender (Male, Female) and age (8-12 years of age, 13-18 years of age).
      
Keywords: Brain Tumor; Cognitive Late Effects; Radiation Therapy; Working Memory
The Effect of Rectus Muscle Approximation at Cesarean Delivery on Pain Perceived After Operation
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This is a prospective randomized controlled study to determine the clinical outcome of rectus
      muscle re-approximation at Cesarean delivery.
    

Detailed description: 
      This is a prospective randomized controlled study to determine the clinical outcome of rectus
      muscle re-approximation at Cesarean delivery. Postoperative pain will be assessed in 2
      groups. Rectus muscle approximation will be done to the first group. The second group will be
      the control group.
    

Intervention name(s): Rectus muscle approximation
Intervention type(s): Procedure
Intervention description(s): The surgeon will take sutures to approximate rectus muscles at the end of cesarean delivery.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Safety and Efficacy of NNC-0156-0000-0009 After Long-Term Exposure in Patients With Haemophilia B: An Extension to Trials NN7999-3747 and NN7999-3773
Condition: Congenital Bleeding Disorder; Haemophilia B
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Asia, Europe, Japan, North America and South Africa. The aim is to
      evaluate the safety and efficacy of nonacog beta pegol (NNC-0156-0000-0009) after long-term
      exposure in patients with haemophilia B.

      This trial is an extension to trials NN7999-3747 (NCT01333111/paradigm™ 2) and NN7999-3773
      (NCT01386528/paradigm™ 3).
    


Intervention name(s): nonacog beta pegol; nonacog beta pegol; nonacog beta pegol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): One single dose administered intravenously (into the vein) once weekly. Patients will receive instruction on how to treat any bleeding episode they may experience.; One single dose administered intravenously (into the vein). Patients will treat themselves with either a low or a high dose dependent on the severity of the bleeding episode.; One single dose administered intravenously (into the vein) every second week. Patients will receive instruction on how to treat any bleeding episode they may experience.
Other intervention name(s): NNC-0156-0000-0009; NNC-0156-0000-0009; NNC-0156-0000-0009
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Low Dose Buprenorphine on Recovery After Hip or Knee Arthroplasty
Condition: Pain; Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      Buprenorphine is a highly lipophilic thebaine derivative that appears to have high affinity
      for mu-, kappa-, and delta-opioid receptors and low affinity for opioid receptors like 1
      -receptors. It acts as a partial agonist at the mu-opioid and as a partial agonist/antagonist
      at the kappa-opioid, and as an antagonist at the delta opioid receptors. Buprenorphine has up
      to two-fold duration of action and it is approximately 30-fold more potent when compared to
      morphine.

      Pain is a common problem in patients coming to joint arthroplastic surgery. Buprenorphine low
      dose patches are recommended for treatment of moderate pain for example osteoarthritis pain.
      It is known that well treated pain even preoperatively may prevent prolonged postsurgical
      pain.

      In the present study the effects of low dose buprenorphine on postoperative pain and recovery
      were assessed.
    


Intervention name(s): Buprenorphine; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Buprenorphine 5 microg/h/7 days; Placebo patch
Intervention MeSH terms: Buprenorphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pain; Arthroplasty; Buprenorphine
Combination Chemotherapy in Treating Patients With Advanced Non-small Cell Lung Cancer
Condition: Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells. It is not
      yet known which combination chemotherapy regimen is more effective in treating advanced
      non-small cell lung cancer.

      PURPOSE: Randomized phase III trial to compare the effectiveness of three different
      combination chemotherapy regimens in treating patients who have advanced non-small cell lung
      cancer.
    

Detailed description: 
      OBJECTIVES: I. Compare the overall survival between paclitaxel/cisplatin (arm I),
      gemcitabine/cisplatin (arm II), and paclitaxel/gemcitabine (arm III) in patients with
      advanced non-small cell lung cancer. II. Determine the response rate, duration of response,
      progression-free survival, toxicity, and quality of life of these patients randomized in
      these three treatment arms.

      OUTLINE: This is randomized, multicenter study. Patients are stratified according to
      performance status (0-1 vs 2) and stage of disease (locally advanced vs metastatic). Patients
      are randomized to receive paclitaxel IV over 3 hours on day 1 followed by cisplatin IV on day
      1 every 3 weeks (arm I), gemcitabine IV over 30-60 minutes on days 1 and 8 and cisplatin IV
      on day 1 every 3 weeks (arm II), or paclitaxel IV over 3 hours on day 1 followed by
      gemcitabine IV over 30-60 minutes on days 1 and 8 every 3 weeks (arm III). Patients receive
      at least 2 courses of treatment. In the absence of unacceptable toxicity and disease
      progression, patients may receive up to 6 courses of treatment. Quality of life is assessed
      before, during, and at the end of treatment, then every 6 weeks until disease progression,
      and then every 3 months until death. Patients are followed every 6 weeks until disease
      progression, then every 3 months until death.

      PROJECTED ACCRUAL: A total of 450 patients (150 patients per arm) will be accrued into this
      study over 36 months.
    

Intervention name(s): cisplatin; gemcitabine hydrochloride; paclitaxel
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Paclitaxel; Gemcitabine
Allocation: Randomized
Primary purpose: Treatment
Keywords: recurrent small cell lung cancer; stage IIIB non-small cell lung cancer; stage IV non-small cell lung cancer
Rapid Eating Is Linked to Emotional Eating in Obese Women Relieving From Bariatric Surgery
Condition: Obesity
Study type: Observational

Summary: 
      The aim of the study was to analyse eating rate in comparison to other aspects of eating
      habits in women suffering from severe/massive obesity.
    

Detailed description: 
      Eating rate is associated with BMI and weight gain in various populations and is a factor
      modulating the risk of complications after bariatric surgery. The aim of the present study is
      to determine whether common difficulties to change eating rate in subjects with obesity
      candidate to bariatric surgery could be due to more extensive abnormalities in eating
      behaviour.
    

Intervention name(s): Data collection
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women suffering from obesity and their eating habits
      
Keywords: Obese; Food behaviour; Eating rate
Safety Study of the Rapid System for Acute Ischemic Stroke
Condition: Acute Ischemic Stroke
MeSH terms: Ischemic Stroke; Ischemia
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a safety study of the Rapid System for acute ischemic stroke.
    


Intervention name(s): Rapid System
Intervention type(s): Device
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Realtime Detection for Prediction of Opioid Analgesic
Condition: Surgery; Individuality
Study type: Observational

Summary: 
      This study aimed to find a quick and timely way to predict the individual variation of
      efficacy of opioid analgesic during the operation and postoperative analgesia in Chinese
      patients undergoing elective surgeries. Methods: female patients receiving elective surgery
      under general anesthesia were recruited into this study. At the time of routine intravenous
      anesthetic induction we observe the efficacy of opioid analgesic including analgesic effect,
      effects on Narcotrend index, sedative effect, effects on respiratory system, and aslo effects
      on cardiovascular system. Then we record the consumption of of opioid analgesic during the
      operation and postoperative analgesia. Also we record the side effect of the opioid
      analgesic.
    

Detailed description: 
      Patients with the following diseases were excluded: known history of chronic pain,
      psychiatric diseases or communication disorders, diabetes mellitus, severe cardiovascular
      diseases, kidney or liver diseases with poor hepatic function, alcohol or drug abuse, heavy
      smoker, pregnancy or at the lactation period.
    

Observational model: Cohort
Sampling method: Probability Sample
Study population: 
        Chinese female patients receiving elective surgery under general anesthesia
      
Keywords: sufentanil; individual variation; pain threshold; narcotrend index
Comparison of the Effect of A-PRF and L-PRF on Outcomes After Removal of Impacted Mandibular Third Molar
Condition: Pain, Postoperative; Trismus; Swelling
MeSH terms: Tooth, Impacted; Trismus; Pain, Postoperative
Study type: Interventional

Summary: 
      In this study, it was aimed to investigating and comparing the postoperative effects of
      leukocyte- and platelet-rich fibrin (L-PRF) and advanced platelet-rich fibrin (A-PRF) in
      terms of pain, swelling on the cheek, and trismus after mandibular third molar surgery. The
      study included a total of 27 patients with bilateral impacted mandibular third molar which
      surgically operated at different times. Patients were evaluated in two randomly separated
      groups. For the first group; A-PRF and for the second group; L-PRF was applied into the tooth
      socket. The outcomes variables were; pain, swelling, the number of analgesics taken, and
      trismus. These variables were also assessed on the basis of; 1st, 2nd, 3rd and 7th days
      following the operation.
    


Intervention name(s): Advanced Platelet Rich Fibrin (A-PRF); Leukocyte- and platelet-rich fibrin (L-PRF)
Intervention type(s): Genetic; Genetic
Intervention description(s): blood samples collected in 10 ml of vacuumed plain glass tubes were centrifuged for 14 minutes at 1500 rpm without anticoagulant agents in order to obtain A-PRF; blood samples collected in 10 ml of glass coated plastic tubes were centrifuged without anticoagulant agents for 10 minutes in order to obtain L-PRF
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: patients with bilateral impacted mandibular third molar which surgically operated at different times
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Leukocyte- and platelet rich fibrin; Advanced platelet rich fibrin; Impacted mandibular third molar surgery
Cervical Cancer Screening in HIV Positive and Negative Women in Cambodia
Condition: Cervical Neoplasia; Cervical Cancer
MeSH terms: Uterine Cervical Neoplasms; Neoplasms
Study type: Observational

Summary: 
      The prevalence of cervical neoplasia in Cambodia is not known. There are no screening
      programs in place. The investigators plan on introducing a screening program based on WHO
      criteria and utilizing visualization with acetic acid. Patients who are positive will be
      offered same-day cryotherapy if indicated or will be referred for biopsy, LEEP and
      hysterectomy as indicated. The planned patient pool for this study is 1000 women, half of
      whom will be HIV positive (and thus have a presumed higher incidence of cervical neoplasia).
    


Intervention name(s): cryotherapy, further biopsy, LEEP, surgery as indicated
Intervention type(s): Procedure
Intervention description(s): These interventions and their outcomes are not part of this study. However, we will be offering at no charge appropriate treatment for neoplasia or cancer that is diagnosed.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The 1000 women will be recruited from the current patient base of Sihanouk hospital and the
        surrounding community.
      
Keywords: cervical neoplasia; cervical cancer'; visual inspection acetic acid; cryotherapy
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GSK2849466 in Healthy Male Subjects
Condition: Cachexia
MeSH terms: Cachexia
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is the first administration of GSK2849466 in humans. This will be a single centre,
      randomized, double-blind, placebo-controlled study, to investigate the safety, tolerability,
      pharmacokinetics (PK), and pharmacodynamics (PD) of GSK2849466, given as single and repeat
      oral doses up to 14 days to healthy male subjects. Part A will be a randomized placebo
      controlled and 4-way crossover study. It will include two cohorts of 8 subjects each. In each
      cohort there will be 4 study periods each approximately of 1 week including 6 days of
      washout. Each subject will receive a total of 3 active doses as ascending single oral dose of
      GSK2849466 and 1 placebo dose during the course of their participation in the study. The
      first ("bridging dose") dose provided to subjects in Cohort 2 will be the same as the last
      dose provided to subjects in Cohort 1. The single doses of GSK2849466 planned in Part A of
      this study are: 0.01, 0.03, 0.1, and 0.3 milligram (mg) in Cohort 1 and 0.3, 1, 3, and 10 mg
      in Cohort 2. In cohorts 1 and 2 all available safety, tolerability, and PK data will be
      reviewed prior to each dose escalation. The dosing schedule in Part A may be adjusted to
      expand a cohort or to add an additional cohort(s) in order to further evaluate additional
      doses or repeat evaluation of a dose level already studied. Part B will be a randomized
      placebo controlled, parallel group study. It will include three cohorts of 12 subjects each.
      Each subject will receive repeat doses of GSK2849466 over 14 days. The doses chosen for Part
      B will be based on the safety, tolerability, and PK data from Part A. Subjects in Cohort 4
      (and/or an another cohort [s] as determined based on Part A PK data) will be dosed in the
      fasted state on Days 1 and 14 and in the fed state on Day 7 when subjects will receive a
      standard meal 30 minutes prior to dosing. Part B will provide sufficient safety and
      tolerability data to bridge to longer duration studies. The study duration, including
      screening and follow-up, is not expected to exceed 70 days for subjects in the study.
    


Intervention name(s): GSK2849466; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GSK2849466 will be available as capsules of dose strengths 0.01, 0.1, 1.0, and 2.5 mg.; Matching placebo capsules will be available.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: safety; pharmacokinetics; FTIH; SARM
Disposition of 14C-LY3009104 Following Oral Administration in Healthy Human Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single dose study of radiolabeled [14C]-LY3009104 in healthy male volunteers to
      study the absorption, distribution, metabolism, and elimination of LY3009104. This study
      requires minimum of 7 days and maximum of 22 days stay. This study is for research purposes
      only and is not intended to treat any medical condition.
    


Intervention name(s): LY3009104
Intervention type(s): Drug
Intervention description(s): Administered orally
Other intervention name(s): Baricitinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Absorption; Distribution; Metabolism; Excretion; Mass balance; Metabolic profile; Radiolabeled study; 14C