bioihbjkbjnl/mcl2 huggingface dataset:
A Pilot Study of Mitoxantrone for the Treatment of Recurrent Neuromyelitis Optica (Devic's Disease)
Condition: Neuromyelitis Optica; Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System
MeSH terms: Myelitis; Myelitis, Transverse; Neuromyelitis Optica; Nervous System Diseases; Autoimmune Diseases of the Nervous System; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      Neuromyelitis optica (NMO) is a severe demyelinating disease that selectively involves the
      optic nerves and the spinal cord but usually spares the brain. NMO is considered to have a B
      cell induced pathogenesis. Mitoxantrone (MITO, Novantrone®), a synthetic anthracenedione
      approved for worsening relapsing-remitting multiple sclerosis (MS) and secondary progressive
      MS, has been shown to primarily suppress the humoral response. We conducted a prospective
      2-year study to evaluate the benefit of MITO in five relapsing NMO patients.
    

Detailed description: 
      The treatment protocol consisted of monthly 12 mg/m2 MITO intravenous infusions for 6 months
      followed by 3 additional treatments every 3 months. Neurological assessment including the
      determination of the Expanded Disability Status Scale (EDSS) score was performed every 3
      months and during relapses. Orbital, brain and spinal cord MRI was performed at baseline, 3,
      6, 12, 18, and 24 months. Visual evoked potentials and ophthalmologic evaluations were
      performed at baseline and annually.
    

Intervention name(s): Mitoxantrone
Intervention type(s): Drug
Intervention MeSH terms: Mitoxantrone
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Novantrone
IRIS Hook Assisted Phacoemulsification in Vitrectomized Eyes
Condition: Cataract; Vitrectomy
MeSH terms: Cataract
Study type: Interventional

Summary: 
      Although phacoemulsification in previously vitrectomized eyes is a relatively safe procedure
      comparing with extracapsular cataract surgery, it is still more challenging than in eyes
      without previous vitrectomy because of the anatomical differences after PPV. Intraoperative
      difficulties such as abnormal anterior chamber deepening, unstable posterior capsules, and
      weakened zonules have been reported.

      The investigators aim to evaluate the efficacy and safety of a new simple iris hook assisted
      maneuver in phacoemulsification, then compare the incidence of intraoperative and
      postoperative complications of this technique with traditional phacoemulsification and
      phacoemulsification with 25-gauge vitreous irrigation. The latter two surgery methods are
      currently popular for cataract in vitrectomized eyes.
    

Detailed description: 
      With the continuous evolution in vitrectomy techniques and instrumentation, an increasing
      number of vitreorential disorders are being successfully managed with pars plana vitrectomy
      (PPV). Cataract is one of the most common complications seen in phakic patients following
      PPV, and the incidence of it ranges from 4 to 80%, even up to 100% in various studies.

      Although phacoemulsification in previously vitrectomized eyes is a relatively safe procedure
      comparing with extracapsular cataract surgery, it is still more challenging than in eyes
      without previous vitrectomy because of the anatomical differences after PPV. Intraoperative
      difficulties such as abnormal anterior chamber deepening, unstable posterior capsules, and
      weakened zonules have been reported.

      The investigators aim to evaluate the efficacy and safety of a new simple iris hook assisted
      maneuver in phacoemulsification, then compare the incidence of intraoperative and
      postoperative complications of this technique with traditional phacoemulsification and
      phacoemulsification with 25-gauge vitreous irrigation. The latter two surgery methods are
      currently popular for cataract in vitrectomized eyes.
    

Intervention name(s): IRIS HOOK; TRADITION
Intervention type(s): Device; Device
Intervention description(s): iris hook assisted maneuver in phacoemulsification; traditional phacoemulsification or phacoemulsification with 25-gauge vitreous irrigation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Health Assessment, Patient Treatment Satisfaction and Quality-of-Life in Insulin-Naive Type 2 Diabetes Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary Objective:

      To investigate the impact of insulin glargine versus Neutral Protamine Hagedorn basal insulin
      on a composite diabetes related quality of life score (DRQoL).

      Secondary Objective:

      A comparison of combination therapy with insulin glargine versus Neutral Protamine Hagedorn
      basal insulin from baseline to endpoint in terms of:

        -  Glycaemic parameters: 7 blood glucose profiles

        -  Incidence of confirmed symptomatic hypoglycemia as well as confirmed severe hypoglycemia

        -  Change in lipid status
    


Intervention name(s): Insulin Glargine (HOE901)/NPH Insulin
Intervention type(s): Drug
Intervention description(s): Arm 1: Subcutaneous injection of Insulin Glargine with the TactiPen® injector pen once daily at any time, but each day at the same time
Arm 2: Subcutaneous injection of Protamine Hagedorn basal insulin with the TactiPen® injector pen once or twice daily at the discretion of the treating physician
The starting dose is 10 I.U. (NPH basal insulin) resp. 10 U (insulin glargine) per day.
The dose adjustments will be based on the results of self-monitoring.
Intervention MeSH terms: Insulin; Insulin Glargine; Insulin, Isophane; Isophane Insulin, Human; Isophane insulin, beef
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Electrical Synchronization of Slow Oscillations to Enhance Deep Sleep
Condition: Sleep; Sleep Hygiene
Study type: Interventional
Phase: Early Phase 1

Summary: 
      This study applied slowly oscillating (0.5 hz) transcranial electrical stimulation (TES;
      frontopolar and lateral frontal electrodes versus mastoid and occipital electrode returns) to
      synchronize the endogenous slow oscillations (SOs) of deep sleep (N3 or stage 3 Non-REM). A
      double-blind placebo control provided no stimulation. The primary endpoint was duration of N3
      sleep during the night. Thirteen normal adults completed the study (before the study was
      terminated because of COVID-19), and usable data were obtained from ten. The synchronizing
      stimulation resulted in significantly longer N3 sleep compared to placebo.
    

Detailed description: 
      Previous studies have demonstrated successful synchronization of SOs with slow TES pulses.
      However, the stimulation in those studies used electrodes in dorsolateral frontal areas (F3,
      F4 versus contralateral mastoids), consistent with the assumption that human SOs emanate from
      frontal neocortex. In the present study, we hypothesized that transcranial electrical
      stimulation (TES) could be applied to frontopolar and inferior frontal head sites in order to
      synchronize the limbic sources of SOs specifically and thereby enhance the duration of N3
      sleep. Furthermore, based on our computational modeling with this more optimal targeting of
      the limbic sites, we hypothesized that we could use lower TES current levels (0.5 mA versus 1
      or 2 mA in previous studies) that would be unlikely to disrupt sleep and that may still be
      successful in synchronizing SOs to enhance the adaptive neurophysiology of deep sleep.
    

Intervention name(s): Transcranial Electrical Stimulation
Intervention type(s): Device
Intervention description(s): Oscillating electrical current
Other intervention name(s): Sleep WISP (Wireless Interface Sensor Pod)
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention model description: First night adaptation sleep; second and third nights (one week apart) stimulation or placebo control (order randomized).
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Safety, Tolerability, Pharmacokinetic and Absolute Bioavailability Study of JNJ-63623872 Administered as an Intravenous Infusion and a 600-Milligram (mg) Oral Dose in Healthy Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to characterize the single-dose pharmacokinetic (PK) of single
      escalating intravenous (IV) doses of JNJ-63623872 administered as a continuous infusion; to
      evaluate the safety and tolerability of single escalating IV doses of JNJ-63623872
      administered as a continuous infusion; to characterize the single-dose PK of JNJ-63623872 of
      one selected dose administered as a continuous IV infusion at various durations and to
      characterize the single- and repeat-dose PK of JNJ-63623872 administered as a continuous
      infusion.
    


Intervention name(s): JNJ-63623872; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 3 mg/mL solution as intravenous (IV) infusion or a single oral 600 mg dose (2 tablets of 300 mg) under fasted conditions will be administered.; Intravenous infusion of matching placebo.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Effect of Primer Application on the Lingual Retainer
Condition: Dental Bonding; Orthodontic Retainers
Study type: Interventional

Summary: 
      Background: The aim of this study was to examine the effect of self-etch primer (SEP)
      application on the bond failure rate of a mandibular bonded lingual retainer over 24 months.

      Materials and Methods: After the removal of the orthodontic appliances, the lingual
      retainers, which were made of six-stranded stainless steel wire 0.0215 inches in diameter,
      wiil bent and bond onto the lingual surface of all mandibular anterior teeth. The study will
      performed using a split-mouth design. In the study group, the SEP will be administired to the
      teeth's lingual surfaces. In the control group, they will etch using 37% phosphoric etchant
      liquid gel. After etching, the primer wiil be applied. The adhesive resin was applied and the
      lingual retainer was fitted. The patients will be re-valuated over 24 months. The first bond
      failures and the amount of adhesive remaining on the tooth will be recorded as the adhesive
      remnant index (ARI) scores.

      The chi-square test will be used to compare the bond failure rates and ARI scores between the
      groups. The survival rates of the retainers will be estimated using the Kaplan-Meier test.
      The significance level will P < 0.05.
    


Intervention name(s): Orthodontic retainer bonding
Intervention type(s): Other
Intervention description(s): Self-etch primer (Transbond XT Primer; 3M Unitek, California) was administered to the teeth's lingual surfaces.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Reactivation of Inactive Blood Donors
Condition: Blood Donor
Study type: Interventional

Summary: 
      Blood donor retention is a critical strategy to ensure the safety and sufficiency of clinical
      blood supply. An effective strategy can prevent donors from lapsing and eventually becoming
      inactive.
    


Intervention name(s): Telephone call; SMS
Intervention type(s): Other; Other
Intervention description(s): From 20 October to 10 November 2016, telephone calls were given to the donors in the phone call group; Text messages were sent to an equal number of donors in the SMS group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Prevention of Traumatic Brain Injury in Youth and Adolescents
Condition: Focus of Study: Bicycle Helmet Wearing Compliance
MeSH terms: Brain Injuries; Brain Injuries, Traumatic
Study type: Interventional
Phase: Phase 1

Summary: 
      The hypothesis was that the implementation of a Safe Kids East Central brain injury
      prevention program targeting children and caregivers admitted to the Georgia Health Sciences
      University Children's Medical Center is feasible and that short-term treatment effects of
      injury prevention education on the child or adolescent and the caregiver will increase
      bicycle helmet use.
    

Detailed description: 
      The overarching goal of this project is to reduce traumatic brain injury in children and
      adolescents by promoting bicycle helmet use via an inpatient educational program. The Safe
      Kids East Central injury prevention educational program was customized for hospitalized
      subjects and their caregivers. The investigators hypothesized that this program would
      increase bicycle helmet use.
    

Intervention name(s): education intervention
Intervention type(s): Behavioral
Intervention description(s): The brain injury prevention education intervention included case scenarios as well as education about the benefits of bicycle helmet use. The intervention was designed to be sensitive to the age and educational level of the study participant and his or her parents. Educational materials were chosen to provide use of the five senses to enhance the learning experience. The intervention took place in the privacy of the patient's hospital room. The study was designed so as not to interfere with the hospital standard of care.
The proper way to fit the bicycle helmet was demonstrated.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Implication of Cardiac Shock Wave Therapy on Coronary Artery Disease
Condition: Cardiac Ischemia
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Ischemia
Study type: Interventional

Summary: 
      Coronary heart disease (CHD) is a public health care challenge. There are three types of
      treatment for CHD, medication, percutaneous coronary intervention (PCI) and coronary artery
      bypass graft (CABG). However, some end-stage CHD patients lost the chance to get those
      treatment. Cardiac shock wave therapy (CSWT) is a new developed therapy for these patients,
      which is used in tens of countries all over the world. Safety, invasiveness, effectiveness is
      its advantage. Ischemia condition can be improved after CSWT. There are only three cities in
      China run the program of CSWT, which are Kunming, Beijing and Shanghai. The investigators
      designed a randomized double-blind study to evaluate the effectiveness and safety of CSWT.
    

Detailed description: 
      Coronary heart disease (CHD) is a public health care challenge, which lead to 3.5 millions of
      people died in China every year. There are three types of treatment for CHD, medication,
      percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG). However,
      some end-stage CHD patients with severe cardiac ischemia lost the chance to get those
      treatment. Their quality of life is influenced by recurrent angina. Cardiac shock wave
      therapy (CSWT) is a new developed therapy for these patients, which is used in tens of
      countries all over the world. German and Japan are the countries earliest used CSWT. Safety,
      invasiveness, effectiveness is its advantage. Ischemia condition can be improved after CSWT
      by objective examination. New small vessels generation on ischemia area was found on mice and
      pig model. There are only three cities in China run the program of CSWT, that are Kunming,
      Beijing and Shanghai. Beijing hospital has the only CSWT machine in Beijing. The
      investigators designed a randomized double-blind study to evaluate the effectiveness and
      safety of CSWT.
    

Intervention name(s): Cardiac shock wave therapy; Sham cardiac shock wave (Control group)
Intervention type(s): Device; Other
Intervention description(s): Patients in CSWT group will receive CSWT for a 3-month therapy, located in their ischemia area with a energy of 0.09mJ/mm2. Patients will get therapy on every first week of the month and rest for following three weeks.; Patients in sham CSWT group will receive sham cardiac shock wave, which is segregated by an air cushion.
Other intervention name(s): CSWT group; Sham CSWT group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: cardiac ischemia
Addition of Ondansetron to Ongoing Antipsychotic Treatment for Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will examine the effects of ondansetron on auditory nerve activity in people with
      schizophrenia who are being treated with new antipsychotics.
    

Detailed description: 
      Schizophrenia is a devastating brain disorder. Most people with schizophrenia have difficulty
      filtering out unimportant auditory information. They have an inability to appropriately
      inhibit, or gate, sensory information that enters the ear. Standard treatments do not address
      this problem. When the drug ondansetron is taken in addition to typical antipsychotic drugs,
      P50 auditory gating improves. However, ondansetron has not been used with some of the newer,
      atypical antipsychotic drugs. This study will evaluate the effect of combining ondansetron
      with newer, atypical antipsychotic drugs on P50 auditory gating.

      Participants in this double-blind study will be randomly assigned to receive either
      ondansetron or placebo for 3 months. Upon completion of the first 3 months, participants will
      be crossed over to receive the other treatment for an additional 3 months. All participants
      will also take an atypical antipsychotic drug, including olanzapine, quetiapine, or
      aripiprazole. Auditory gating will be assessed using computerized cognitive testing and
      functional magnetic resonance imaging (fMRI) at baseline and Months 3 and 6. Vital signs and
      evoked potentials will be assessed at Weeks 1, 3, and 6. Clinical symptoms and cognitive
      abilities will also be evaluated to determine the effectiveness of ondansetron.
    

Intervention name(s): Ondansetron followed by placebo; Placebo followed by Ondansetron
Intervention type(s): Drug; Drug
Intervention description(s): Participants will take 16mg of ondansetron daily for the first three months followed by 3 months of placebo. An atypical antipsychotic drug (olanzapine,quetiapine, or aripiprazole) will also be taken throughout the 6 months treatment period.; Participants will take placebo daily for the first three months followed by 3 months of 16mg of ondansetron daily. An atypical antipsychotic drug (olanzapine,quetiapine, or aripiprazole) will also be taken throughout the 6 months treatment period.
Other intervention name(s): Zofran, Zuplenz; Zofran, Zuplenz
Intervention MeSH terms: Ondansetron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Ondansetron; P50 sensory gating; Evoked potentials; 5-HT3 receptors; Atypical antipsychotics
Revisional Versus Primary Roux-en-Y Gastric Bypass: a Case Matched Analysis
Condition: Effect of Revisional Surgery for Failed Gastric Banding
Study type: Observational

Summary: 
      This study compared revisional malabsorptive laparoscopic very very long limb gastric bypass
      (VVLL RYGB) with primary VVLL RYGB and tested the hypothesis that one staged revisional
      laparoscopic VVLL RYGB is a safe and effective procedure after failed restrictive gastric
      banding.
    


Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        morbidly obese patients
Effect During Pregnancy and Intrapartum Health
Condition: Pregnancy
Study type: Interventional

Summary: 
      Assessing the role of moderate exercise in newborn intrapartum variables have showed to be
      crucial not only on prescribing exercise safely, but also on understanding its impact on the
      prevention of some cardio-metabolic diseases after labor. Clarify this concept will be
      essential on reducing human risk for some chronic diseases through implementing supervised
      exercise programs during such a critical period.
    

Detailed description: 
      The aim of this randomized controlled trial was to evaluate the effect of combined exercise
      (aerobic and strength exercise) on maternal and newborn intrapartum variables.
    

Intervention name(s): Exercise pregnant women
Intervention type(s): Behavioral
Intervention description(s): A supervised physical conditioning program of three 55-60 minute sessions per week during whole pregnancy (from week 10 to 39) was conducted. Each session consisted of 25-30 minutes of cardiovascular exercise,10 minutes of specific exercises (strength and balance exercises), and 10 minutes of pelvic floor muscles training. Aerobic activity was prescribed at light to moderate intensity, aiming for 55-60 of maximal heart rate. All subjects wore a heart rate (HR) monitor during the training sessions to control the intensity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: exercise; intrapartum; aerobic exercise; resistance exercise; wellbeing
Effect of 10mg Domperidone on Gastric Emptying of a High-fat Meal and Appetite Sensations in Healthy Adults
Condition: Diabetes Mellitus
MeSH terms: Diabetes Mellitus
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether domperidone was sufficient to accelerate
      gastric emptying of a high-fat solid meal and reduce satiety responses in a healthy adult
      population.
    

Detailed description: 
      This study aims to investigate the effect of domperidone on gastric emptying and appetite
      sensations in healthy subjects. Domperidone is a dopamine 2 (D2) receptor antagonist with
      claims of gastrointestinal tract pro-kinetic activity. Accelerated gastric emptying (GE) may
      lead to reduced satiation, increased food intake and is associated with obesity and diabetes
      mellitus. It is hypothesized that domperidone will increase gastric emptying rate and reduce
      satiety responses to a high-fat meal.

      The effect of acute oral administration of 10 mg domperidone on gastric emptying of a
      high-fat pancake test meal, and subjective appetite sensations by visual analogue scale will
      be measured for six hours postprandially in a randomized, placebo-controlled, single-blinded
      manner in 13 healthy subjects.
    

Intervention name(s): Domperidone 10mg; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 10mg domperidone tablet 30 minutes before a test-meal.; Homeopathic (Sugar) pill-Placebo
Other intervention name(s): Motilium; Homeopathic medicine; Silicea, 6c, Weleda, Derbyshire, UK
Intervention MeSH terms: Domperidone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Domperidone; gastric emptying; obesity; diabetes mellitus; Domperidone/pharmacology; Pharmacologic Actions; Physiological Effects of Drugs; Gastrointestinal Agents; Humans