bioihbjkbjnl/mcl2 huggingface dataset:
Bevacizumab Plus Modified FOLFOX6 Regimen as the Salvage Treatment in Metastatic Breast Cancer (MBC) Patients
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of this phase II study is to evaluate efficacy and safety of avastin plus
      modified FOLFOX6 regimen in HER-2 negative metastatic breast cancer patients. Fifty-five
      patients will be enrolled into this study.
    

Detailed description: 
      Anthracyclines and taxanes are the most frequently used agents for breast cancer,both in
      adjuvant and in first-line metastatic settings.For the patients who do not respond or relapse
      early after the administration of a taxane or anthracycline regimen,it is clearly needed to
      explore new combinations and schedules of drugs.Oxaliplatin has shown very promising activity
      in MBC either in monotherapy or in combination with 5-fluorouracil(5-FU) with or without
      leucovorin (LV). Avastin is a target therapy with proven efficacy in the treatment of MBC.
      Avastin plus FOLFOX regimen showed synergetic effet and been used as the standard trial in
      metastatic colorectal cancer patients. Based on the above reason, we initiate this phase II
      study to evaluate efficacy and safety of avastin plus modified FOLFOX6 regimen in HER-2
      negative metastatic breast cancer patients.
    

Intervention name(s): Avastin + mFOLFOX6
Intervention type(s): Drug
Intervention description(s): mFOLFOX6 regimen, repeated every 2 weeks: Oxaliplatin 85 mg/m2，ivgtt； Leucovorin 400 mg/m2,ivgtt； 5-FU 400 mg/m2，iv，and then 2400 mg/m2，civ46h；
Avastin: Avastin 5mg/kg q2w or 7.5mg/kg q3w
Other intervention name(s): Avastin; Oxaliplatin; Leucovorin; 5-FU
Intervention MeSH terms: Leucovorin; Oxaliplatin; Bevacizumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic Breast Cancer, Her-2 negative Breast Cancer; Avastin, FOLFOX regimen
Study of Efficacy and Safety of Xolair® (Omalizumab) in Chinese Patients With Chronic Spontaneous Urticaria
Condition: Chronic Spontaneous Urticaria
MeSH terms: Urticaria; Chronic Urticaria
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to demonstrate the efficacy and safety of omalizumab, compared
      with placebo, as an add-on to H1 antihistamines (H1AH) therapy in adult patients suffering
      from Chronic Spontaneous Urticaria (CSU) who remained symptomatic despite H1AH therapy.
    

Detailed description: 
      This was a randomized, multicenteric, double-blinded, placebo-controlled, parallel-group
      study to evaluate the efficacy and safety of omalizumab as an add-on therapy for the
      treatment of patients of refractory CSU who remained symptomatic despite approved-dosed H1AH
      treatment.

      The study consisted of three distinct epochs over 24 weeks: Screening epoch (Day -28 to Day
      -1), Randomized treatment epoch (Day 1 to Week 12) and Post-treatment follow-up epoch (Week
      12 to Week 20). Patients were randomized into three treatment groups (omalizumab 300 mg s.c.
      omalizumab 150 mg s.c. and placebo) in a 2:2:1 ratio, stratified by latent tuberculosis (TB)
      status at Baseline (Yes/No).

      On Day 1, eligible patients were randomly assigned to receive omalizumab (150 mg or 300 mg)
      or placebo by subcutaneous (s.c.) injection every 4 weeks (on Day 1, Week 4, and Week 8)
      during the 12-week double-blind randomized-treatment epoch. Patients visited the study center
      at 4-week intervals. Patients were instructed to stay on the same CSU H1AH treatment at
      stable dose that they were using during the pre-randomization period during the randomized
      treatment epoch. They were allowed to use diphenhydramine as rescue medication during all
      epochs. The last dose of the study drug during the randomized-treatment epoch was
      administered at Week 8 study visit, however, the last assessment was done at Week 12.

      After the completion of the 12-week randomized-treatment epoch, all patients entered an
      8-week post-treatment follow-up epoch.
    

Intervention name(s): Omalizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): injection of 150mg or 300 mg; Injection of placebo
Other intervention name(s): IGE025
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic spontaneous urticaria; ISS7; UAS7; omalizumab; China
RISE Pediatric Medication Study
Condition: Prediabetes; Type 2 Diabetes
MeSH terms: Prediabetic State
Study type: Interventional
Phase: Phase 3

Summary: 
      The RISE Pediatric Medication Study is a 2-arm, 4-center, clinical trial of children with
      prediabetes and early type 2 diabetes to address the hypothesis that aggressive glucose
      lowering will lead to recovery of beta-cell function that will be sustained after withdrawal
      of treatment. Pediatric participants (ages 10-19) will be randomized to one of the following
      treatment regimens: (1) metformin alone or (2) early intensive treatment with basal insulin
      glargine followed by metformin.

      The primary clinical question RISE will address is: Are improvements in ß-cell function
      following 12 months of active treatment maintained for 3 months following the withdrawal of
      therapy? Secondary outcomes will assess durability of glucose tolerance following withdrawal
      of therapy, and whether biomarkers obtained in the fasting state predict parameters of ß-cell
      function, insulin sensitivity and glucose tolerance and the response to an intervention.
    


Intervention name(s): Metformin; Glargine
Intervention type(s): Drug; Drug
Other intervention name(s): Glucophage; Insulin glargine, Lantus
Intervention MeSH terms: Metformin; Insulin Glargine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Children; Pediatric
Open Label Safety/Efficacy Study of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Gout Patients
Condition: Hyperuricemia; Gout
MeSH terms: Gout; Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether arhalofenate is safe and effective when
      dosed in combination with febuxostat in lowering serum uric acid in patients with gout.
    


Intervention name(s): Arhalofenate; Febuxostat; Colchicine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 400 mg once daily orally for two weeks then up-titrated to 600 mg once daily orally for an additional two weeks; 80 mg once daily orally for 5 weeks; Colchicine 0.6 mg daily as prophylaxis to prevent gout flares
Other intervention name(s): MBX-102; Uloric; Colcrys
Intervention MeSH terms: Colchicine; Febuxostat
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyperuricemia; gout; serum uric acid
A Within-subject Study to Evaluate the Efficacy and Safety of Diclofenac Sodium Topical Gel 1% Compared to Placebo in Subjects Experiencing Delayed Onset Muscle Soreness
Condition: Muscle Soreness
MeSH terms: Myalgia
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will assess the analgesic efficacy of DSG 1% compared to placebo in the reduction
      of the pain associated with DOMS
    


Intervention name(s): Diclofenac sodium gel 1%; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Diclofenac sodium gel 1% four times daily (This study is a within-subject design i.e. active drug applied to one leg and placebo to the other leg at the same time. Therefore the study design is not a cross-over).; Placebo gel four times daily (This study is a within-subject design i.e. active drug applied to one leg and placebo to the other leg at the same time. Therefore the study design is not a cross-over).
Intervention MeSH terms: Diclofenac
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Over-the-Counter Medication Usage
Condition: Drugs, Non-Prescription; Medication Systems
Study type: Interventional

Summary: 
      There are several benefits of over-the-counter medications, yet there is little research
      evaluating how to increase patient compliance when a health care provider suggests an
      over-the-counter (OTC) medication. We are evaluating two types of physician directions to see
      which increases patient compliance with OTC medications.
    

Detailed description: 
      Researchers will identify a cohort of gynecologic patients presenting for annual examinations
      and offer participation in the study. Physician researchers will randomize patients to 2
      types of physician directions about OTC medications, then follow compliance over the course
      of the next 7 months. A total of 123 participants in each arm will undergo recruitment, until
      a total of 246 participants are recruited.

      Inclusion criteria include: female, non-pregnant patients presenting for annual gynecologic
      examinations between the ages of 19-50.

      Exclusion criteria include: outside of study age range, patient taking thyroid medication,
      history of kidney stones, history of hypercalcemia, non-English speaking.
    

Intervention name(s): Verbal advice; Prescription
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Patients receive verbal advice regarding specific over-the-counter medications.; Patients receive a prescription for a specific over-the-counter medication.
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Calcium; Compliance; Medication compliance; electronic prescription; over-the-counter medications; OTC medications
Comparison of a Basal Plus One Insulin Regimen With a Biphasic Insulin Regimen in Type 2 Diabetes Patients
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective is to demonstrate the non-inferiority at six months of a basal plus one
      insulin regimen (Lantus plus one injection of Apidra) compared with a biphasic insulin
      regimen (NovoMix 30) at controlling glycosylated haemoglobin (HbA1c) in type 2 diabetes.

      The secondary objective are:

        -  To compare the proportion of patients in each treatment group reaching HbA1c target (<
           7%) at the end of the treatment period

        -  To compare the rates of hypoglycaemia (total, severe, nocturnal)

        -  To compare the change in body weight from visit 10 to visit 24

        -  To compare the change in diabetes specific quality of life and other patient reported
           outcomes from visit 10 to visit 24

             -  Diabetes Treatment Satisfaction Questionnaire - status and change (DTSQs+c)

             -  Audit of Diabetes-Dependent Quality of Life (ADDQoL) questionnaire

             -  Insulin Treatment Satisfaction Questionnaire (ITSQ)

             -  EuroQoL 5 Dimensions (EQ5D) questionnaire

        -  To record the change in the daily dose of insulin from visit 2 to visit 10 and visit 10
           to visit 24
    


Intervention name(s): INSULIN GLARGINE (HOE901); Insulin aspart; Insulin Glulisine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): LANTUS®: Solution for injection. 100U/mL in a prefilled pen (SoloStar®); NovoMix® 30: Suspension for injection. 100U/mL in a prefilled pen (FlexPen®); APIDRA®: Solution for injection. 100U/mL in a prefilled pen (SoloStar®)
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Glargine; Insulin Aspart; Insulin glulisine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Repeatability and Feasibility of Infant Spirometry
Condition: Prematurity
MeSH terms: Premature Birth
Study type: Observational

Summary: 
      This is a study examining repeatability and feasibility of a new method for measurement of
      lung function in babies. A flexible vest is placed around the torso of the baby, and changes
      in tidal volume and flow is measured. The study will enable a better understanding of the
      usefulness of this equipment in a neonatal intensive care unit. The equipment is made by
      VOLUSENSE Norway AS, and marketed under the name FloRight. The equipment is owned by
      Volusense Norway AS during the study period.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Term born and preterm born babies
      
Keywords: Repeatability of measurements
Study to Assess if ABP 798 is Safe & Effective in Treating Moderate to Severe Rheumatoid Arthritis (RA) Compared to Rituximab
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is designed to determine what effects the human body has on the investigational
      medicine, ABP 798, and what effects the body has on the investigational medicine after you
      have been given it, and if this is comparable to what is seen for the licensed medicine,
      rituximab, in patients with moderate or severe RA.

      This study will also assess if the investigational medicine is safe and effective in treating
      moderate or severe RA compared to the licensed medicine.
    


Intervention name(s): ABP 798; Rituximab (US); Rituximab (EU)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Supplied as a 10 mg/mL liquid concentrate for intravenous (IV) administration.; Supplied as a 10 mg/mL liquid concentrate for IV administration.; Supplied as a 10 mg/mL liquid concentrate for IV administration.
Other intervention name(s): Rituxan®; MabThera®
Intervention MeSH terms: Rituximab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study of the Bronchodilator Effect of Formoterol Fumarate Used in Combination With Mometasone Furoate Metered Dose Inhaler in Children With Persistent Asthma (P06476 AM2)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      A study to compare the bronchodilatory effect of a single dose of Mometasone
      Furoate/Formoterol Fumarate (MF/F) pressurized metered dose inhaler (MDI) delivered with and
      without an AeroChamber Plus® with Flow-Vu® Anti-Static Valved Holding Chamber (spacer) versus
      Placebo MDI (combined with and without spacer) and formoterol fumarate (F) dry powder inhaler
      (DPI). Participants were randomly assigned to 1 of 6 treatment sequences and each participant
      was to receive a single dose of each of 4 treatments in each period. Each treatment period
      was separated by a 5 to 7 day washout period. It assumed that a single dose MF/F MDI 100/10
      microgram (mcg) delivered with a spacer would produce bronchodilation, defined as a
      significant increase in forced expiratory volume in one second (FEV1) area under the curve
      from 0 to 12 hours (AUC[0-12 hr]) when compared to placebo.
    


Intervention name(s): Formoterol Fumarate DPI; Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) without spacer; Mometasone Furoate/Formoterol Fumarate MDI (ex-actuator) with spacer; Placebo MDI with spacer; Placebo MDI without spacer; Mometasone Furoate DPI
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Two inhalations of Formoterol Fumarate DPI 10 mcg administered as a single dose; Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer); Two inhalations of Mometasone Furoate/Formoterol Fumarate MDI 50/5 mcg administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer); Two inhalations of placebo MDI administered as a single dose with an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer); Two inhalations of placebo MDI administered as a single dose without an AeroChamber Plus® Flow-Vu® Anti-Static Valved Holding Chamber (spacer); Two inhalations of MF DPI 100 mcg administered as a single dose once daily at night. Used as maintenance therapy during screening and in between single doses of study drug.
Other intervention name(s): SCH 045571; MK-5571; Foradil® Aerolizer®; SCH 418131; MK-0877A; SCH 418131; MK-0877A; SCH 032088; MK-0887; Asmanex® Twisthaler®
Intervention MeSH terms: Mometasone Furoate; Formoterol Fumarate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: asthma; children; persistent
Ethyl Chloride Vapocoolant as Anesthesia for Arterial Punctures
Condition: Anesthesia; Pain
Study type: Interventional

Summary: 
      Ethyl chloride vapocoolant sprays provide transient skin anesthesia within seconds of
      application. The current investigation aim is to compare the effect of ethyl chloride based
      vapocoolant spray to placebo in reducing pain associated with arterial puncture for gasometry
      determinations.

      The investigators will conduce a double-blind randomized placebo-controlled trial at
      Emergency Department.

      We will enroll patients who come to Emergency Department who need an arterial gasometry
      determination. Patients will be randomized to intervention-group (ethyl chloride vapocoolant
      sprays will be usad before arterial puncture) or to placebo-group (alcohol spray as placebo
      will be used before arterial puncture.) and after the puncture they will rate their pain
      using a 10 points visual analogue scale.
    

Detailed description: 
      Single-blind, randomized placebo-controlled trial in an emergency department of Hospital de
      Basurto in Bilbao, Spain. Patients for whom arterial blood gas analysis had been ordered will
      be included. They will be randomly assigned to receive application of the experimental ethyl
      chloride spray or a placebo aerosol spray of a solution of alcohol in water. The assigned
      spray will be applied just before arterial puncture. The main outcome variable is pain
      intensity reported on an 11-point numeric rating scale.
    

Intervention name(s): Ethyl chloride; Alcohol
Intervention type(s): Drug; Drug
Intervention description(s): Nurses will administrate ethyl chloride vapocoolant spray on patient's skin a few seconds before arterial puncture (of cubital arteria).; Nurses will use an alcohol-based spray as placebo on patient's skin a few seconds before arterial puncture (of cubital arteria).
Other intervention name(s): Intervention; Placebo
Intervention MeSH terms: Ethyl Chloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Efficiency Study to Investigate Blonanserin in Treatment of Schizophrenia When Compared With Risperidone
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical
      trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone
    

Detailed description: 
      A Randomized, Double-blinded, Double-dummy, Parallel-controlled and Multicenter Clinical
      trial to Investigate Blonanserin in Treatment of Schizophrenia when compared with Risperidone

      Trial drugs:

        -  Blonanserin group: Blonanserin tablets+Risperidone mimetic tablets

        -  Risperidone group: Risperidone tablets+Blonanserin mimetic tablets

      Objectives of Study :

      To evaluate the efficacy and safety of Blonanserin in treating schizophrenia
    

Intervention name(s): Blonanserin; Risperidone
Intervention type(s): Drug; Drug
Intervention description(s): Blonanserin tablets: 8 - 24mg/day; twice daily after breakfast and dinner; in the meantime, the placebo and positive drug were taken in whole tablets. When the morning and evening doses could not be administered equally, the evening dose should be greater than the morning dose. The interval between 2 dose escalations should not be shorter than 3 days.; Risperidone tablets: 2 - 6mg/day; twice daily after breakfast and dinner; in the meantime, the placebo and positive drug were taken in whole tablets. When the morning and evening doses could not be administered equally, the evening dose should be greater than the morning dose. The interval between 2 dose escalations should not be shorter than 3 days.
Other intervention name(s): Lonasen; Risperdal
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Blonanserin
Is Aminophylline More Effective Than Neostigmine/Atropine Mixture in the Treatment of Post-dural Puncture Headache
Condition: Post-Dural Puncture Headache
MeSH terms: Post-Dural Puncture Headache; Headache; Wounds and Injuries
Study type: Interventional
Phase: Phase 4

Summary: 
      Objectives: To compare the safety and efficacy of IV aminophylline versus IV
      neostigmine/atropine mixture in the treatment of post-dural puncture headache (PDPH).

      Background: PDPH is the most frequent complication of procedures associated with dural
      puncture for spinal anesthesia or following accidental dural puncture during epidural
      anesthesia. Since invasive treatments have known complications, pharmacologic management may
      be preferable.

      Patients and Methods: This was a prospective, randomized, double-blind, phase four clinical
      trial; carried out on 60 patients presented with PDPH at our hospital. Patients were randomly
      allocated into two equal groups (30 patients each); group A, received IV aminophylline, and
      group NA, received IV neostigmine/atropine mixture.
    


Intervention name(s): IV Aminophylline; IV Neostigmine Methylsulfate + Atropine Sulphate
Intervention type(s): Drug; Drug
Intervention description(s): IV Aminophylline (100 mg/8h); IV Neostigmine/Atropine mixture (20 μg/kg Neostigmine + 10 μg/kg Atropine)/8h
Other intervention name(s): Minophylline-N ampoule; Neostigmine ampoule, Atropine ampoule
Intervention MeSH terms: Atropine; Aminophylline; Neostigmine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Aminophylline; Atropine; Neostigmine; Post-dural puncture headache; Spinal anesthesia