bioihbjkbjnl/mcl2 huggingface dataset:
Study of Efficacy, Safety and Tolerability of ACZ885 (Canakinumab) in Pediatric and Young Adult Patients With Sickle Cell Anemia
Condition: Sickle Cell Anemia
MeSH terms: Anemia; Anemia, Sickle Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      The study assesses the efficacy, safety and tolerability of ACZ885 (canakinumab) in pediatric
      and young adult patients with sickle cell anemia (SCA).
    

Detailed description: 
      This was an ambulatory-based 24-week study followed by an additional 24-week open label
      phase. It was a subject- and investigator-blinded, randomized, placebo-controlled, parallel
      group, non-confirmatory study to assess the clinical efficacy of ACZ885 administered s.c. in
      six injections given 28 days apart (in each phase of the study).

      Pediatric and young adult subjects diagnosed with sickle cell anemia (SCA) were planned to be
      randomized to either ACZ885 treatment or placebo treatment in a 1:1 ratio,.

      For each subject, there was a maximum 28-day screening period that included recording of
      daily pain frequency and intensity by e-diary for at least 1 week. Subjects who met the
      eligibility criteria at screening underwent evaluation of baseline clinical and biomarker
      assessments prior to first dose administration.

      On Day 1, monthly s.c. dosing with ACZ885 started at 4 mg/kg for subjects weighing ≤40 kg and
      300 mg for all other subjects. Subjects in the placebo treatment arm were injected with
      placebo in a like manner. All subjects returned to the study centers for safety checks on a
      monthly basis when they received treatment with either ACZ885 or placebo.

      The final blinded dosing was given on Week 20, followed by blinded clinical assessments at
      Week 24. Subjects from both study arms were then offered optional, open label monthly dosing
      of ACZ885 for an additional 24 weeks (Weeks 24-48) with clinical outcome assessment.

      Subjects returned for the end of study (EOS) visit at Week 56. For subjects who chose not to
      participate in the optional, open label portion of the study, or for those stopping treatment
      early for any other reason, an EOS visit occurred approximately 8 weeks after last dose
      received.

      After enrollment of 49 subjects, Novartis decided to terminate the study early due to
      strategic reasons not related to safety and decided that no additional enrollment was needed
      in order to interpret the study objectives.
    

Intervention name(s): ACZ885; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Monthly doses of 4 mg/kg for subjects weighing ≤40 kg and 300 mg for all other subjects; Monthly doses of placebo to match the administered dose of canakinumab s.c.
Other intervention name(s): Canakinumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sickle cell disease; hemoglobinopathy; pediatric
Safety Study of Intravenous Hydromorphone Using Incremental 1mg Doses up to 2mg for Adult ED Patients
Condition: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      We wish to examine the safety and speed of onset of giving a dose of 1mg hydromorphone
      followed by an additional 1mg. Eligible patients will be given 1 mg intravenous (IV)
      hydromorphone. At 15 minutes, these patients will be asked the question, "Do you need more
      pain medication?" Those that answer "yes" will receive an additional 1mg IV hydromorphone.
      Those that answer "no" will not receive additional pain medications at that time period (15
      minutes). Thus, we wish to give up to 2 mg IV hydromorphone titrated to patients' pain, which
      we believe will result in less incidence of oxygen desaturation.

      If our study shows that this regimen is safe, its efficacy can be assessed in future trials.
      Positive results of those trials may lead to the use of this regimen to improve pain
      management in the emergency department.
    

Detailed description: 
      Prospective interventional study at an urban academic emergency department (ED). One
      milligram of IV hydromorphone was administered to adults 21 to 64 years of age who had acute
      severe pain. Fifteen minutes later, patients were asked whether they wanted more pain
      medication. If they answered yes, they received another 1 mg of IV hydromorphone and were
      again asked 15 minutes later whether they wanted more pain medication. The primary efficacy
      outcome was the proportion of patients who had adequate analgesia, defined as declining
      additional hydromorphone within 1 hour of entering the protocol. The primary safety outcome
      was incidence of oxygen desaturation less than 95%. Secondary outcomes included numeric
      rating scale pain scores and adverse events.
    

Intervention name(s): Hydromorphone
Intervention type(s): Drug
Intervention description(s): 1mg IV hydromorphone, followed by an optional dose of 1mg IV hydromorphone 15 minutes later if the patient answers "yes" to the question, "Do you want more pain medication?"
Other intervention name(s): Dilaudid
Intervention MeSH terms: Hydromorphone
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nonelderly patients with acute moderate to severe pain
Study Evaluating Changes In Mammographic Breast Density
Condition: Osteoporosis
MeSH terms: Osteoporosis
Study type: Observational

Summary: 
      The objective of the study is to evaluate quantitative changes in mammographic breast density
      from baseline to 24 months in postmenopausal women receiving daily doses of either BZA 20
      mg/CE 0.45 mg, BZA 20 mg/CE 0.625 mg, Raloxifene or placebo. The primary endpoint in this
      study is the change in mammographic breast density between baseline and month 24 for each
      group.
    


Intervention name(s): BZA 20 mg/CE 0.45 mg; BZA 20 mg/CE 0.625 mg; Raloxifene 60 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as baxedoxifene/CE tablets in capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.; There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as baxedoxifene/CE tablets in capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.; There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as raloxifene tablets in capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.; There was no drug taken during study 3115A1-4000. During the 3115A1-303 study the test article was supplied as placebo capsules. Subjects took one capsule orally, once daily at approximately the same time each day on a continuous regimen for 2 years or until early termination from the study.
Intervention MeSH terms: Raloxifene Hydrochloride
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Women with osteoporosis risk factors who were participants in a phase 3 trial for
        osteoporosis prevention (study 3115A1-303-WW)
Kidney Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Rapamune (Sirolimus) in Kidney Transplant Recipients
Condition: Kidney Transplantation
Study type: Interventional
Phase: Phase 4

Summary: 
      This 2-arm study recruited kidney transplant patients who were receiving standard care of
      calcineurin inhibitors (CNIs, tacrolimus or cyclosporine), CellCept (1.0-1.5 g twice daily)
      and corticosteroids. They were either randomized to continue this regimen, or CNI therapy was
      discontinued and replaced by sirolimus therapy (in combination with CellCept and
      corticosteroids). The effect of these 2 regimens on efficacy, safety and kidney function was
      evaluated. The anticipated time on study treatment was 1-2 years, and the target sample size
      was 100-500 individuals.
    


Intervention name(s): mycophenolate mofetil [CellCept]; Corticosteroids; Calcineurin inhibitors; Sirolimus
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 1.0-1.5 g oral dose twice daily; As prescribed; As prescribed; As prescribed
Intervention MeSH terms: Mycophenolic Acid; Sirolimus; Calcineurin Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Postoperative Sleep Quality of Patients Anesthesia With Propofol or Sevoflurane Undergoing Thyroidectomy
Condition: Postoperative Sleep Quality
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigators designed a study to determine whether Propofol or Sevoflurane would provide
      same postoperative sleep quality in patients undergoing thyroidectomy.
    

Detailed description: 
      The investigators designed a study to determine whether Propofol or Sevoflurane would provide
      same postoperative sleep quality in patients undergoing thyroidectomy.The bispectral index
      score (BIS) was monitored during the operation and the first postoperative night.
    

Intervention name(s): propofol; sevoflurane
Intervention type(s): Drug; Drug
Intervention description(s): introvenious infusion of propofol; sevoflurane (1.0-1.3 Minimum Alveolar Concentration)
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: postoperative; sleep quality; propofol; sevoflurane
The Effect of Physical Training and the Omega 3 Consumption on Attention Deficit Hyperactivity Disorder in Children
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      The attention deficit hyperactivity disorder (ADHD) usually occurs in preschool and may cause
      disabilities through whole life.
    

Detailed description: 
      The attention deficit hyperactivity disorder (ADHD) usually occurs in preschool and may cause
      disabilities through whole life. The treatment of this disease is expensive and difficult.
      Moreover, physical exercise and omegas consumption may improve the cognitive functions and
      behavior, so it could be an interesting strategy to improve this disorder. The aim of the
      present study is to verify the effects of multiple components physical training and the
      consumption of omega 3 on behavior, cognitive functions and the serum levels of BDNF and
      IGF-1 in ADHD children. Thus, 68 ADHD children, between seven and fourteen years old will be
      selected. The volunteers will be randomly divided into four groups: Physical Training Group
      (PTG), Omega Group (OG), Omega and Physical Training Group (OPTG) and Control Group (CG). The
      protocol of the experiment will last three months in which the OPTG will make physical
      training and receive fish oil capsules, and the PTG will make only the physical training and
      receive a placebo of fish oil. The others groups will be oriented not to make any type of
      physical training, but the OG will receive fish oil capsule, and the CG will receive a
      placebo of fish oil. Behavioral and cognitive functions evaluations and blood analysis will
      be made at the beginning and at the end of the protocol.
    

Intervention name(s): Omega 3; Physical Training
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Capsules of omega 3, 1000mg / capsules. Administered 3 times a day.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Physical Training; ADHD-Attention deficit hyperactivity disorder; Omega 3
A Study to Demonstrate the Bioequivalence of Lacosamide Tablets and Dry Syrup in Healthy Male Japanese Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study designed to demonstrate the Bioequivalence between Lacosamide (LCM) Tablet
      and Dry Syrup in Healthy Male Japanese Subjects
    


Intervention name(s): Lacosamide (LCM) tablet; Lacosamide (LCM) dry syrup
Intervention type(s): Drug; Drug
Intervention description(s): Treatment A: Single dose of Lacosamide (LCM) 100 mg tablet; Treatment B: Single dose of Lacosamide (LCM) 100 mg given as dry syrup
Intervention MeSH terms: Lacosamide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Lacosamide; Bioequivalence; Dry Syrup
A Study Assessing the Safety and Ocular Hypotensive Efficacy of AR-12286 in Patients With Elevated Intraocular Pressure for 3 Months
Condition: Ocular Hypertension; Open-angle Glaucoma
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      A double-masked, parallel study of AR-12286 Ophthalmic Solution 0.5%, or 0.7% (q.d., PM) or
      timolol maleate Ophthalmic Solution, 0.5% (b.i.d.), O.U. for 3 months.
    


Intervention name(s): AR-12286 Ophthalmic Solution 0.7%; AR-12286 Ophthalmic Solution 0.5%; Timolol maleate ophthalmic solution 0.5%
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ophthalmic Solution; Ophthalmic Solution; Ophthalmic Solution
Intervention MeSH terms: Timolol; Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Glaucoma
Memantine in the Treatment of Kleptomania
Condition: Kleptomania
MeSH terms: Disruptive, Impulse Control, and Conduct Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The goal of the proposed study is to evaluate the efficacy and safety of memantine in
      kleptomania.
    

Detailed description: 
      The proposed study will consist of 8 weeks of treatment with memantine in 10 subjects with
      kleptomania. The hypothesis to be tested is that memantine will be effective in reducing the
      urges to steal in patients with kleptomania. The proposed study will provide needed data on
      the treatment of a disabling disorder that currently lacks a clearly effective treatment.
    

Intervention name(s): Memantine
Intervention type(s): Drug
Intervention description(s): 10-30mg, daily for 8 weeks
Other intervention name(s): Namenda
Intervention MeSH terms: Memantine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Compulsive Stealing; Compulsive Shoplifting
Comparing Treatments for HIV-Infected Opioid and Alcohol Users in an Integrated Care Effectiveness Study
Condition: Opioid Use Disorder; Alcohol Use Disorder
MeSH terms: Alcoholism; Opioid-Related Disorders
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to learn how best to treat substance use disorders in an HIV
      clinic setting. Specifically, the purpose of this pilot study is to learn if extended-release
      naltrexone (XR-NTX) would be a feasible and acceptable treatment for HIV-infected individuals
      with opioid or alcohol use disorders.
    


Intervention name(s): Extended Release Naltrexone; Treatment As usual
Intervention type(s): Drug; Other
Other intervention name(s): Vivitrol
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Substance related disorders; HIV; naltrexone
Maintenance of Platelet Inhibition With Cangrelor
Condition: Acute Coronary Syndrome (ACS)
MeSH terms: Acute Coronary Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to demonstrate that patients receiving cangrelor infusion before
      coronary artery bypass grafting have an acceptable safety profile and can undergo surgery
      without excessive bleeding peri-operatively.
    


Intervention name(s): cangrelor; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Placebo IV infusion administered in the same fashion as the active study drug in order to maintain the blind in the study.
Intervention MeSH terms: Cangrelor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
to Assess the Efficacy and Safety of the Probiotic E. Coli Strain M17 on Patients With GERD
Condition: GERD
MeSH terms: Gastroesophageal Reflux
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is an Open Label, Prospective, Non Comparative, Pilot, clinical trial design.
      Patients with inadequate relief in GI symptoms associated with GERD despite PPI treatment
      will be screened and those who meet the inclusion and exclusion criteria will perform a
      glucose breath test for bacterial overgrowth . Each patient will then complete a
      questionnaire to record their GERD related symptoms. Each patient will then receive a daily
      intake of 30 mL two times daily, 30 minutes before meals for a period of 4 weeks. During the
      course of the trial, they will have 4 visits with the study physician to assess treatment
      compliance and occurrence of adverse events, and will complete periodic daily diaries to
      record compliance.
    


Intervention name(s): ProBactrix
Intervention type(s): Drug
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Phase II Trial of Combined Modality Treatment in Primary Central Nervous System Lymphoma
Condition: Lymphoma, B Cell
MeSH terms: Lymphoma; Lymphoma, B-Cell
Study type: Interventional
Phase: Phase 2

Summary: 
      Aim of the study is to establish in a prospective, randomized clinical trial the activity of
      primary chemotherapy containing high dose-methotrexate, alone or combined with high dose
      cytarabine, in patients with primary central nervous system lymphoma
    


Intervention name(s): high dose methotrexate; high dose cytarabine; radiotherapy
Intervention type(s): Drug; Drug; Radiation
Intervention MeSH terms: Cytarabine; Methotrexate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Diaphragmmatic Muscle Strength and Balance in Women With Dysmenorhea
Condition: Dysmenorrhea Primary
MeSH terms: Dysmenorrhea
Study type: Observational

Summary: 
      Analysis of stabilometric and respiratory variables in patients with dysmenorrhea during the
      first day of the menstrual cycle and any other day outside the cycle.
    

Detailed description: 
      Sociodemographic variables such as age, height, body mass index.

      Respiratory variables such as maximum inspiratory pressure (MIP), MIP reference %, and MIP
      predictive value.

      Stabilometric variables we will measure the balance in condition of eyes open and eyes closed
      bipodal support and eyes open in monopodal support
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women with primary dysmenorrhea
      
Keywords: dysmenorrhea; diaphragm; balance; muscular strength
The Effects of a Polyphenol-enriched Fruit Drink on Metabolic Health
Condition: Healthy Men and Women
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether consumption of the active product affects
      postprandial changes in metabolic indices, in comparison to the control product.
    


Intervention name(s): Polyphenol-enriched fruit-based drink - low; Polyphenol-enriched fruit-based drink - medium; Polyphenol-enriched fruit-based drink - high; Very low polyphenol fruit based drink (control)
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Polyphenol; Fruit; Metabolic; Healthy
Acupuncture in Patients With Carpal Tunnel Syndrome ~ A Randomized Controlled Trial
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      To investigate the efficacy of acupuncture compared with steroid treatment in patients with
      mild-to-moderate carpal tunnel syndrome (CTS) as measured by objective changes in nerve
      conduction studies (NCS) and subjective symptoms assessment in a randomized, controlled
      study.
    

Detailed description: 
      A total of 77 consecutive and prospective CTS patients confirmed by NCS were enrolled in the
      study. Those who had fixed sensory complaint over the median nerve and thenar muscle atrophy
      were excluded. The CTS patients were randomly divided into 2 treatment arms: (1) 2 weeks of
      prednisolone 20 mg daily followed by 2 weeks of prednisolone 10 mg daily (n =39), and
      (2)acupuncture administered in 8 sessions over 4 weeks (n=38). A validated standard
      questionnaire as a subjective measurement was used to rate the 5 major symptoms (pain,
      numbness, paresthesia,weakness/clumsiness, and nocturnal awakening) on a scale from 0 (no
      symptoms) to 10 (very severe). The total score in each of the 5 categories was termed the
      global symptom score (GSS). Patients completed standard questionnaires at baseline and 2 and
      4 weeks later. The changes in GSS were analyzed to evaluate the statistical significance. NCS
      were performed at baseline and repeated at the end of the study to assess improvement. All
      main analyses used intent-to-treat.
    

Intervention name(s): Acupuncture; Prednisolone
Intervention type(s): Other; Drug
Intervention description(s): acupuncture administered in 8 sessions over 4 weeks; 2 weeks of prednisolone 20 mg daily followed by 2 weeks of prednisolone 10 mg daily
Intervention MeSH terms: Prednisolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: acupuncture; carpal tunnel syndrome; CTS; steroid; global symptom score (GSS)