bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Vitamin A in the Treatment of Neonatal Sepsis and Necrotizing Enterocolitis
Condition: Sepsis; Necrotizing Enterocolitis; Meningitis; Pneumonia
MeSH terms: Pneumonia; Sepsis; Toxemia; Enterocolitis; Enterocolitis, Necrotizing; Meningitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to determine whether vitamin A can improve survival and
      facilitate recovery from sepsis and necrotizing enterocolitis in hospitalized neonates.
    

Detailed description: 
      Sepsis and necrotizing enterocolitis (NEC) are leading causes of morbidity and mortality in
      neonates. Studies have shown that early reversal of the signs associated with severe disease
      is an important prognostic factor during acute illness. Vitamin A deficiency is widespread
      among children, including neonates, in developing countries. Vitamin A plays an important
      role in mediating immune responses and in maintaining epithelial integrity. For this reason
      vitamin A supplementation during the acute phase of neonatal infection could work
      synergistically with present antibiotic regimens in promoting early reversal of signs
      associated with adverse outcome and shorten the total duration of clinical illness. The
      purpose of the proposed hospital-based clinical trial is to evaluate the efficacy of vitamin
      A supplementation on reducing the morbidity and mortality among neonates hospitalized with
      sepsis (n=366) and NEC(n=150). Enrolled subjects will be randomized at the time of
      hospitalization to receive one dose of either 50,000 IU of vitamin A or placebo at
      enrollment, in addition to standard antibiotic therapy. We will compare the proportion of
      treatment failures in sepsis patients, the frequency of disease progression and mortality in
      NEC patients, and the time to clinical recovery and discharge between treatment groups. In
      addition, the study will determine whether vitamin A reduces pro-inflammatory cytokine
      levels; elevated host inflammatory cytokines are thought to contribute to the severity of
      both conditions. If vitamin A is found to be efficacious in the treatment of sepsis and NEC
      it could present a needed cost-effective approach to decreasing the global morbidity,
      mortality and the economic cost associated with neonatal sepsis and NEC in the developing
      world.
    

Intervention name(s): Vitamin A
Intervention type(s): Dietary Supplement
Intervention description(s): 50,000 IU of Vitamin A 50,000 IU of vegetable oil
Other intervention name(s): Retinol
Intervention MeSH terms: Vitamin A
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: vitamin A; Treatment; neonates; newborn; sepsis; necrotizing enterocolitis; meningitis; pneumonia
Efficacy Study of a Bioelectric Dressing to Treat Wounds Caused by Curettage and Electrodesiccation
Condition: Wound Healing; Wound Infection
MeSH terms: Wound Infection; Wounds and Injuries
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether a bioelectric wound dressing, a
      silver-coated dressing, or a silver-foam dressing are effective in the treatment of wounds
      resulting from curettage and electrodesiccation of skin lesions.
    


Intervention name(s): Procellera™ Antimicrobial Wound Dressing; ACTICOAT™ Antimicrobial Barrier Dressing; Mepilex® Ag Silver Foam Dressing
Intervention type(s): Device; Drug; Drug
Intervention description(s): Dressing indicated for partial and full-thickness wounds. Dressing changes every 2-3 days, more frequently if needed; Dressing changes every 2-3 days, more frequently if needed; Dressing changes every 2-3 days, more frequently if needed
Other intervention name(s): PROCELLERA™, PROSIT™, Bioelectric Wound Dressing; ACTICOAT™; Mepilex® Ag
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Wound; Skin lesion; Antimicrobial; Bioelectric
A Study of Imlunestrant (LY3484356) in Female Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate the effect of imlunestrant on repaglinide,
      omeprazole and dextromethorphan, and rosuvastatin and digoxin. The study will also
      investigate the effect of quinidine on imlunestrant in female healthy participants of
      non-childbearing potential. The safety and tolerability of imlunestrant will be investigated
      in female healthy participants of non-childbearing potential. The study will last
      approximately up to 32 days for each participant excluding the screening period.
    


Intervention name(s): Imlunestrant; Repaglinide; Omeprazole; Dextromethorphan; Quinidine; Rosuvastatin; Digoxin
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Administered orally.; Administered orally.; Administered orally.; Administered orally.; Administered orally.; Administered orally.; Administered orally.
Other intervention name(s): LY3484356
Intervention MeSH terms: Repaglinide; Quinidine; Digoxin; Dextromethorphan; Omeprazole; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Randomized Trial to Evaluate Ampyra for Gait Impairment in Parkinson's Disease
Condition: Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this study is to evaluate the effect of AMPYRA on a number of symptoms in
      Parkinson's disease. AMPYRA is a medication approved by FDA for gait dysfunction in multiple
      sclerosis. There are multiple studies to suggest that persons with multiple sclerosis benefit
      from this medication and have major improvements in gait after taking this medication.
      However, this medication was never studied in Parkinson's disease. This study aims to learn
      about possible benefits of AMPYRA in Parkinson's disease (PD).
    

Detailed description: 
      Subjects with Parkinson's disease will be randomly assigned to two groups. One group will
      receive Ampyra first for 4 weeks, followed by 2 weeks break and than 4 weeks placebo while
      the second group will first receive placebo and then Ampyra.
    

Intervention name(s): Ampyra first, then Placebo; placebo first, then Ampyra
Intervention type(s): Drug; Drug
Intervention description(s): 10 mg po bid for 4 weeks followed by placebo 4 weeks.; placebo
Other intervention name(s): first intervention; second intervention
Intervention MeSH terms: 4-Aminopyridine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: parkinson's; gait dysfunction; ampyra; 4-aminopyridine
MIRs03: Paravertebral Block With Ropivacaine Before Breast Cancer Surgery
Condition: Malignant Neoplasm of Breast
MeSH terms: Neoplasms; Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      Compare the effect of paravertebral block (PVB) with Ropivacaine or placebo on the incidence
      of chronic pain 3 months after breast cancer surgery.
    

Detailed description: 
      Before anesthesia, the second or third intercostal space is located. After an aspiration,
      0.35 mL/kg of solution (ropivacaine 7.5 mg/mL or saline, maximum 30 mL) are injected into the
      paravertebral space. After 30 minutes, spread of PVB is evaluated by cold test on skin. Then,
      general anesthesia is induced.

      Evaluation of the frequency of chronic pain at 3, 6 and 12 months by the Brief Pain Inventory
      (BPI) questionnaire and Neuropathic Pain Diagnostic (DN4) and Anxiety and depression
      evaluation by the Hospital Anxiety and Depression questionnaire (HAD) will be done.
    

Intervention name(s): Saline; Ropivacaine
Intervention type(s): Drug; Drug
Other intervention name(s): NA Cl 0.9%; Naropeine
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Surgery; Paravertebral block; Chronic pain
Acupressure Versus Ischemic Release in Non-specific Neck Pain
Condition: Manual Therapy; Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Chronic neck pain (CNP) attributed to myofascial pain syndrome (MFPS) which is one of the
      particularly common skeletal muscle disorder associated with the hyperirritable zone in the
      taut band of muscle. Myofascial trigger points (MTrP) are one of the most overlooked and
      ignored causes of musculoskeletal pain. This study aims to compare the clinical efficacy of
      acupressure of cervical acupoints versus ischemic compression release (ICR) of MTrPs in CNP.
    

Detailed description: 
      Nonspecific neck pain (NSNP) is the commonest cause of neck symptoms and results from
      postural and mechanical causes.Chronic neck pain (CNP) attributed to myofascial pain syndrome
      (MFPS) which is one of the particularly common skeletal muscle disorder associated with the
      hyperirritable zone in the taut band of muscle. Myofascial trigger points (MTrP) are one of
      the most overlooked and ignored causes of musculoskeletal pain.The objectives of this study
      is to compare the clinical efficacy of acupressure of cervical acupoints versus ischemic
      compression release (ICR) of MTrPs in CNP. This single blind randomized trial involves
      patients with NSNP were randomly assigned into three groups: the acupressure group (ACG), and
      the ischemic compression release group (ICRG) and the control group (CG). Patients in all
      groups received hot packs and post-isometric relaxation. Patients in ACG received acupressure
      at local acupuncture points, Gall bladder 21 (GB 21), small intestine 14 (SI 14) and SI 15,
      and the ICRG received pressure on MTrPs of trapezius muscle on both sides. VAS sores,
      pressure pain threshold (PPT), neck lateral flexion range of motion, and neck disability
      index (NDI) were assessed before and after 4 weeks of treatment.
    

Intervention name(s): Manual therapy
Intervention type(s): Procedure
Intervention description(s): Acupressure of acupoints is manipulation of classic acupoints by pressure.
Ischemic compression release is applying pressure to the myofascial trigger points until release of these points.
Other intervention name(s): Acupressure; Ischemic compression release
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Acupressure; Ischemic Compression Release; Neck Pain.
A Long Term Follow up Administration Study of L059 (Levetiracetam) in Epilepsy Patients With Partial Onset Seizures
Condition: Epilepsies; Partial
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is planned to evaluate the safety and efficacy of L059 (levetiracetam) in
      long-term administration in patients who completed N01020 [NCT00160165] or N01221
      [NCT00280696].
    


Intervention name(s): Levetiracetam
Intervention type(s): Drug
Intervention description(s): Levetiracetam 500 mg/day to 3000 mg/day , tablets twice daily (morning and evening orally) during the study period (until the time of approval granted).
Other intervention name(s): Keppra
Intervention MeSH terms: Levetiracetam
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsies; Partial; Keppra; levetiracetam
A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of JNJ-42721458 in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (what the
      body does to the medication), potential immunogenicity (ability to induce an immune
      response), and pharmacodynamics (what the drug does to the body) after administration of
      JNJ-42721458 in healthy adult male participants.
    

Detailed description: 
      This is a randomized (the study medication is assigned by chance), double-blind (neither
      physician nor participant knows the identity of the assigned treatment), placebo-controlled
      (an inactive substance that is compared with a medication to test whether the medication has
      a real effect in a clinical study), single-ascending (increasing) dose and multiple-ascending
      dose study of JNJ-42721458 compound in healthy males. The study is divided in two parts. Part
      1 is a single-ascending dose (SAD) study which will include up to 10 panels (using ascending
      doses starting from 0.1 mg) in which a single dose of the study medication will be
      administered on Day 1. Part 2 is a multiple-ascending dose (MAD) study which will include
      approximately 6 panels (using ascending doses starting from 5.0 mg) in which multiple doses
      of study medication will be administered once daily for 10 days.

      Part 2 will be initiated after completion of dosing and all relevant evaluations from Part 1.
      In each panel of Part 1 and 2, 6 participants will be randomly assigned to receive
      JNJ-42721458 and 2 participants randomly assigned to placebo. Safety evaluations will include
      assessment of adverse events, physical examinations, laboratory tests, vital signs,
      electrocardiograms, cardiac telemetry and evaluation of injection sites which will be
      monitored throughout the study. The total study duration for each participant will be
      approximately 6-7 weeks in Part 1 and 7-8 weeks for each participant in Part 2.
    

Intervention name(s): JNJ-42721458 (single dose); JNJ-42721458 (multiple doses); Placebo (single dose); Placebo (multiple doses)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): JNJ-42721458 will be administered subcutaneously (an injection under the skin) as single doses, starting from 0.1 mg.; JNJ-42721458 will be administered subcutaneously (an injection under the skin) once daily, starting with a dose of 5.0 mg.; Matching placebo will be administered subcutaneously (an injection under the skin) as a single dose in Part 1.; Matching placebo will be administered subcutaneously (an injection under the skin) once daily for 10 days in Part 2.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy; JNJ-42721458; Male; Safety; Tolerability; Pharmacokinetics; Pharmacodynamics; Immunogenicity
Aromatherapy Massage in Migraine Attacks
Condition: Pain; Head Pain; Quality of Life
MeSH terms: Headache
Study type: Interventional

Summary: 
      The aim of the study was to determine the effect of aromatherapy massage on the pain severity
      and quality of life in patients diagnosed with migraine in addition to medical treatment
      during an acute migraine attack.

      In addition to medical treatments, complementary and supportive therapies are commonly used
      to cope with pain during a migraine attack. In recent years, aromatherapy through massage has
      become more common to reduce the severity of pain, make the patient painless and improve the
      quality of life. Aromatherapy applications are the application of pain relief oil mixtures
      through massage. Lavender and peppermint essential oils are mostly used in aromatherapy
      applications to reduce pain. Therefore, a mixture of mint and lavender oil was used in the
      study.
    

Detailed description: 
      The study was planned and conducted as a randomized controlled experiment. The sample of the
      randomized controlled trial consisted of 70 patients who applied to the emergency department
      with a migraine attack and met the study criteria. Data were collected via Patient
      Information Form, 24-Hour Migraine Quality of Life Scale, Visual Analogue Scale,
      Sphygmomanometer, and Pulse oximeter. Along with the medical treatment, patients of
      experimental group were massaged for 15 minutes with an aromatic oil mixture (lavender and
      peppermint) applied on the temple and root of the neck, and this application continued for
      three weeks. Control group patients, however, received only medical treatment. Descriptive
      statistics methods, Shapiro Wilks test, Wilcoxon Signed Ranks Test, Mann Whitney U Test,
      Kruskal Wallis Test, Fisher's Exact Test and Chi-Square Test were used for data evaluation.
    

Intervention name(s): aromatherapy massage
Intervention type(s): Other
Intervention description(s): aromatherapy massage
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled experiment.
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: aromatherapy; massage
RELAX Anaesthetics: the Effect of a Bespoke Relaxation App on Stress Levels in Children Undergoing Anaesthesia
Condition: Surgery
Study type: Interventional

Summary: 
      RELAX Anaesthetics is a randomised clinical trial assessing the effectiveness of using an
      iPad app with art, music and games to relax and distract children, reduce anaesthetic
      induction time and make drug cost savings prior to surgery.
    

Detailed description: 
      The most distressing part of a parent's experience in hospital is watching a child undergo
      intravenous cannulation.1 This is commonly performed in the anaesthetic room prior to
      induction of anaesthesia. At Chelsea and Westminster Foundation Trust (CWFT) over 5000
      children undergo operations every year. Traditional methods of distracting the child during
      have included blowing bubbles, storybooks, and a variety of toys and games. These methods are
      not always effective and may present an infection risk due to inability to clean between
      uses.

      The use of an android/iPad provides a platform for effectively distracting the child with a
      choice of games, video and music, with the advantage of being cleaned between uses. Users of
      this platform are required to select the application that is most appropriate for the age,
      sex, method of anaesthesia, and compliance level of the child. To assist with this, the
      investigators have developed an application system that will select a range of entertainment
      applications appropriate for each child based on these four variables and hopefully help to
      keep children calm before their operations.
    

Intervention name(s): iPad app containing art, music and games; Toys, books and games
Intervention type(s): Other; Other
Intervention description(s): An iPad app that takes demographic information on a child and suggests suitable art, music and games for use by the anaesthetist and nurse to distract them during anaesthetics; Games, books and toys used to distract
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Narrative Therapy for Treatment-Resistant Obsessive-Compulsive Disorder
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      This is a prospective exploratory study using narrative therapy in group format, over 20
      sessions, 2 hours per session, weekly, to determine whether this modality can provide any
      benefit to OCD symptoms, mood, sense of social connectedness, sense of identity, and/or
      quality of life in individuals living with treatment-resistant OCD. NOTE: an amendment is now
      in place so that the group can occur virtually given the COVID pandemic; Zoom will be used as
      our platform.
    

Detailed description: 
      Many patients referred to the Thompson Centre at Sunnybrook have severe OCD, and have
      significant and disabling symptoms even after completing our treatment protocols, including
      our intensive and residential programs. These patients have already undergone traditional
      cognitive behavioural therapy (CBT) and exposure and response prevention (ERP), as well as
      pharmacotherapy. Patients voice distress at their poor quality of life and high symptom
      burden, and can feel hopeless, if they have exhausted numerous evidence-based treatment
      options without significant improvement. Narrative therapy is a unique approach, based on the
      premise that language reflects a social construction of reality. Individuals with severe
      mental illness hold within themselves life narratives that reinforce their painful beliefs
      about themselves, the world, and others. Evidence indicates that narrative therapy can help
      to create a more cohesive identity and a more flexible view of the self and the future.

      Our primary goal is to determine whether narrative therapy could improve OCD symptom burden
      and quality of life in a highly treatment-resistant population. Domains such as mood,
      identity, and interpersonal connectedness are secondary measures. The research questions are:
      could narrative therapy lead to symptomatic improvement in treatment-resistant OCD? And could
      narrative therapy improve the domains of mood, interpersonal connectedness, and/or identity
      in patients with treatment-resistant OCD?
    

Intervention name(s): Psychotherapy
Intervention type(s): Other
Intervention description(s): Group psychotherapy
Intervention model: Single Group Assignment
Intervention model description: A group consisting of 12-15 participants will be recruited for this initial exploratory study.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Narrative therapy; Group therapy
Parecoxib for Pain Management After Total Knee Arthroplasty and Total Hip Arthroplasty
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      Evaluated the effect of perioperative parecoxib administration on postoperative pain,
      analgesic use, function recovery, inflammatory response and bleeding risk.
    

Detailed description: 
      Non-steroid anti-inflammatory drugs are recommended for multimodal postoperative pain
      management.

      We evaluated the effect of perioperative parecoxib administration on postoperative pain,
      analgesic use, function recovery, inflammatory response and bleeding risk.
    

Intervention name(s): Parecoxib sodium; Normal saline injection
Intervention type(s): Drug; Drug
Intervention description(s): The patients in the parecoxib group received a single 40mg dose of parecoxib sodium 30 minutes before incision, 9:00 pm on the operation day as well as 9:00 am and 9:00 pm for the next two days after the operation, along with PCIA morphine.; The patients in the control group received 2 mL normal saline injection 30 minutes before Normal saline injection incision, 9:00 pm on the operation day as well as 9:00 am and 9:00 pm for the next two days after the operation, along with PCIA morphine.
Other intervention name(s): Dynastat; Physiological saline
Intervention MeSH terms: Parecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: preemptive analgesia; parecoxib sodium; total knee arthroplasty; total hip arthroplasty