bioihbjkbjnl/mcl2 huggingface dataset:
Docetaxel in Node Positive Adjuvant Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study was to compare disease-free survival after treatment with docetaxel
      in combination with doxorubicin and cyclophosphamide to 5-fluorouracil in combination with
      doxorubicin and cyclophosphamide in operable breast cancer patients with positive axillary
      lymph nodes.
    

Detailed description: 
      In addition to the 5-year analysis conducted in September 2003, two other analyses were
      planned when 590 and 700 Disease Free Survival events occurred. However, due to the lower
      than predicted DFS event rate, and in agreement with FDA and EMA, a time-based final analysis
      at 10 years was considered more appropriate than an event-based (700 Disease Free Survival
      events) analysis.
    

Intervention name(s): Docetaxel; 5-fluorouracil; Doxorubicin; Cyclophosphamide
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): intravenous; intravenous; intravenous; intravenous
Other intervention name(s): Taxotere®; 5-FU
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Doxorubicin; Fluorouracil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: adjuvant treatment
Safety Study of Immune System Modulator for Autoimmune Diseases
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the toxicity, tolerability and safety of single
      ascending doses of AX-024.HCl in healthy male subjects.
    


Intervention name(s): AX-024.HCl; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Premedication With Nebulized Ketamine,Dexmedetomidine Versus Midazolam in Oncologic Preschool Children
Condition: Oncological Children
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Evaluate the efficacy of nebulized dexmedetomidine, nebulized ketamine, and nebulized
      midazolam a premedication prior to general anesthesia (GA) in oncologic preschool children
      undergo bone marrow aspirate and biopsy.
    

Detailed description: 
      The preoperative period can be a traumatic time for young children undergoing surgery.
      Pediatric anesthesiologists strive to minimize distress for children in the operating room
      (OR) environment and to provide a smooth induction of anesthesia. Preoperative anxiety
      stimulates the sympathetic, parasympathetic, and endocrine systems, leading to an increase in
      heart rate (HR), blood pressure, and cardiac excitability. Various drugs have been advocated
      as premedication to allay anxiety and facilitate the smooth separation of children from
      parents. The ideal premedicant in children should be readily acceptable and should have a
      rapid and reliable onset with minimal side effects. Dexmedetomidine is a tasteless,
      colorless, and odorless drug that acts as a selective α-2 adrenergic agonist with both
      sedative and analgesic effects via actions in the central nervous system. Ketamine is an
      N-methyl-d-aspartate receptor antagonist that produces a state of sedation, anesthesia,
      immobility, analgesia, amnesia, and dissociation from the environment. Midazolam is a
      water-soluble benzodiazepine known to have a rapid onset and short duration of action, as
      well as properties of amnesia and anxiolysis. Administered intranasally, midazolam is an
      effective option for conscious sedation.
    

Intervention name(s): nebulized ketamine; nebulized Dexmedetomidine; nebulized midazolam
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Drugs will be prepared in 3 mL of saline 0.9% before administration by a standard hospital jet nebulizer via a mouthpiece, with a continuous flow of 100% oxygen at 6 L/min for 10 to 15 minutes (30 minutes before GA). Treatment will be stopped when the nebulizer began to sputter.
Intervention MeSH terms: Midazolam; Dexmedetomidine; Ketamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Safety Study of OPC-1085EL Ophthalmic Solution in Subjects With Glaucoma or Ocular Hypertension
Condition: Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine the efficacy and safety of OPC-1085EL ophthalmic
      solution in comparison with carteolol long-acting ophthalmic solution in subjects who are
      insufficiently responsive to carteolol long-acting ophthalmic solution.
    


Intervention name(s): OPC-1085EL ophthalmic solution; Carteolol long-acting ophthalmic solution
Intervention type(s): Drug; Drug
Intervention MeSH terms: Carteolol; Pharmaceutical Solutions; Ophthalmic Solutions
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Role of Percutaneous Angioplasty in Ischemic Leg Ulcer Healing
Condition: Ischemic Foot Ulcers
MeSH terms: Foot Ulcer; Leg Ulcer; Ischemia; Ulcer
Study type: Interventional

Summary: 
      The aim of our study was to evaluate the technical and clinical effectiveness of PTA in the
      management of ischemic foot ulcers. All consecutive patients presenting with a foot ulcer at
      the outpatient Vascular surgery clinic of our hospital were evaluated. If non-invasive
      parameters suggested peripheral arterial disease (PAD) anatomic imaging (CTA and/or DSA) was
      performed and a PTA was carried out when feasible during the same session. All patients were
      followed until healing, amputation, death, or for at least two years. Short-term and
      long-term clinical success of PTA was evaluated based on ulcer size and appearance. Patients
      with worsening ulcers after PTA underwent bypass grafting or amputation.
    

Detailed description: 
      The aim of our study was to evaluate the technical and clinical effectiveness of PTA in the
      management of ischemic foot ulcers.

      Methods: All consecutive patients presenting with a foot ulcer at the outpatient Vascular
      surgery clinic of our hospital were evaluated. Preoperative evaluation included foot pulse
      assessment, ankle-brachial-index (ABI) and duplex scanning. If non-invasive parameters
      suggested peripheral arterial disease (PAD) anatomic imaging (CTA and/or DSA) was performed
      and a PTA was carried out when feasible during the same session. All patients were followed
      until healing, amputation, death, or for at least two years. Short-term and long-term
      clinical success of PTA was evaluated based on ulcer size and appearance. Patients with
      worsening ulcers after PTA underwent bypass grafting or amputation.
    

Intervention name(s): Percutaneous transluminal angioplasty (PTA)
Intervention type(s): Procedure
Intervention description(s): The main goal of the angioplasty (which was also the definition of technical success) was to achieve straight-line flow (SLF) from the aorta down to either a patent dorsalis pedis or plantar arch.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety and Pharmacokinetics of Kovacaine Nasal Spray (24 Hour Blood Collection)
Condition: Anesthesia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the pharmacokinetics/pharmacodynamics and safety of
      a nasal spray containing the anesthetic drug tetracaine in combination with oxymetazoline
      with blood draws over 24 hours.
    

Detailed description: 
      The purpose of this study is to determine the pharmacokinetics and safety of tetracaine,
      para- butylaminobenzoic acid (PBBA), and oxymetazoline after intranasal administration of the
      highest Phase 3 dose of Kovacaine Mist (Tetracaine Hydrochloride with Oxymetazoline
      Hydrochloride) to healthy volunteers.

      This is an open-label, single-treatment, single-dose study in healthy volunteers in which all
      subjects will receive the highest Phase 3 dose of Kovacaine Mist on one occasion. No
      randomization is necessary for this single treatment, single dose study. A single study
      center will participate.

      Each subject will receive a single dose of Kovacaine Mist (3% tetracaine HCl with 0.05%
      oxymetazoline HCl) consisting of 3 sprays (each 0.2 mL) in one nostril not taking longer than
      8 minutes, for a total 0.6 mL dose containing 18 mg tetracaine HCl and 0.3 mg oxymetazoline
      HCl.

      The total dosing period will be 8 minutes. Subjects will be required to fast 10 hours prior
      to dosing and for four (4) hours after dosing. Water will be allowed ad lib during the study
      except for one (1) hour prior through one (1) hour after dose administration. Subjects will
      be admitted to the study unit no later than 2100 hours of the evening prior to drug
      administration and will remain in the unit until the 24 hour blood sample is collected and
      discharge procedures are completed.
    

Intervention name(s): Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Intervention type(s): Drug
Intervention description(s): 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl (para-butylaminobenzoic acid or PABA is active metabolite)
Other intervention name(s): Kovacaine Nasal Spray
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Tetracaine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetic
V260 Registration Study (V260-013)(COMPLETED)
Condition: Rotavirus
Study type: Interventional
Phase: Phase 3

Summary: 
      Immunogenicity and Safety of V260 in Healthy Infants in Korea
    


Intervention name(s): Rotavirus Vaccine, Live, Oral, Pentavalent; Comparator: Placebo
Intervention type(s): Biological; Biological
Intervention description(s): 3 doses of rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 70 days post Dose 1, and 28 to 70 days post Dose 2; 3 doses of placebo to rotavirus vaccine live, oral, pentavalent on Day 1, 28 to 70 days post Dose 1, and 28 to 70 days post Dose 2
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Gastrointestinal Rotavirus
Efficacy of inControl Advice: A Decision Support System (DSS) for Diabetes
Condition: Type1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The purpose of this study is to reduce the frequency of hypoglycemia and severe hypoglycemic
      events in subjects who use insulin pens to treat their Type 1 Diabetes Mellitus (T1DM).
      Hypoglycemia is the number one fear of many individuals and families with someone who has
      type 1 diabetes, and this fear often prevents optimal glycemic control. It is expected that
      this protocol will yield increased knowledge about using a decision support system to help
      control the glucose level.
    

Detailed description: 
      This study is a 12-week parallel group multi-center randomized trial designed to compare
      CGM+DSS with CGM alone. The DSS to be implemented contains a "smart" bolus advisor that
      adjusts the size of correction insulin boluses based on short term blood glucose predictions.
      It is able to complete this function by evaluating CGM values, insulin usage and carbohydrate
      intake record. It also contains an exercise advisor, a bedtime advisor, hypoglycemia risk and
      long-term tracker of HbA1c.

      inControl-Advice, a smart-phone based medical software platform, is designed to provide
      advice to users. It receives data from an insulin pen and then adjustments the insulin
      delivery every 5 minutes. The system provides a series of real-time alerts and on-demand
      advice, for both dosing of insulin and ingestion of carbohydrates, based on data collected
      from T1DM patients (i.e. carbohydrate consumption, insulin injected, CGM) and inConrol Cloud
      analytics.
    

Intervention name(s): Continuous Glucose Monitor (CGM)+Decision Support System (DSS); Continuous Glucose Monitor (CGM) alone
Intervention type(s): Device; Other
Intervention description(s): Continuous Glucose Monitor (CGM)+Decision Support System (DSS) study participants will use the inControl Advice App and a study CGM at home for 12 weeks. The DSS contains a "smart" bolus advisor that adjusts the size of the correction insulin boluses based on short-term blood glucose predictions. It is able to complete this function by evaluating CGM values, insulin usage and carbohydrate intake record. It also contains an exercise advisor, a bedtime advisor, hypoglycemia risk and long-term tracker of HbA1c. Subjects will use study basal and bolus insulin during the study.; Continuous Glucose Monitor (CGM) alone study participants will use a study CGM at home for 12 weeks. Subjects will use study basal and bolus insulin during the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes Mellitus (T1DM); Continuous Glucose Monitor (CGM); Multiple Daily Injections (MDI); Insulin Pen; inControl Advice; Decision Support System (DSS)
Non-pharmacological Treatment and Pharmacological Treatment for Non-acute Lumbar Disc Herniation
Condition: Lumbar Disc Herniation; Radiculopathy Lumbar
MeSH terms: Intervertebral Disc Displacement; Radiculopathy; Hernia
Study type: Interventional

Summary: 
      This study is a 2-armed parallel, multi-centered, pragmatic clinical trial that compares the
      comparative effectiveness of non-pharmacological treatment and pharmacological treatment for
      non-acute lumbar disc herniation.
    

Detailed description: 
      This study is a multi-centered, pragmatic clinical trial that compares the comparative
      effectiveness of non-pharmacological treatment and pharmacological treatment for non-acute
      lumbar disc herniation. The participants who voluntarily signed informed consent will be
      randomly assigned in 1:2 ratio to non-pharmacological group and pharmacological group and
      will receive the 8 weeks of intervention.
    

Intervention name(s): non-pharmacological treatment; pharmacological treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): This is a pragmatic setting, and specific intervention is not determined prior to the study. Non-pharmacological treatment including Korean medicine, such as acupuncture, electroacupuncture and chuna, etc, will be chosen by professional physician according to the medical condition of each subject.; This is a pragmatic setting, and specific intervention is not determined prior to the study. The pharmacological treatment will be chosen by professional physician according to the medical condition of each subject.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Efficacy and Tolerability of Propiverine Hydrochloride in Patients With Neurogenic Detrusor Overactivity
Condition: Neurogenic Urinary Bladder Disorder; Urinary Bladder, Neurogenic; Bladder Disorder, Neurogenic; Urinary Bladder Disorder, Neurogenic; Neurogenic Bladder Disorder; Urinary Bladder Neurogenic Dysfunction; Urologic Diseases; Overactive Detrusor Function; Urinary Incontinence
MeSH terms: Urinary Bladder, Neurogenic; Urinary Incontinence; Urologic Diseases; Urinary Bladder, Overactive; Urinary Bladder Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this clinical study is to compare efficacy and safety of propiverine
      hydrochloride extended and immediate release formulations in patients suffering from
      neurogenic detrusor overactivity.
    


Intervention name(s): Propiverine hydrochloride ER (extended release); Propiverine hydrochloride IR (immediate release)
Intervention type(s): Drug; Drug
Intervention description(s): 45 mg capsule (1x1/d); 15 mg tablet (3x1/d)
Other intervention name(s): Mictonorm UNO 45; Detrunorm XL 45; Mictonorm; Detrunorm
Intervention MeSH terms: Propiverine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Antimuscarinics; Neurogenic bladder; Propiverine; Urodynamics
Emotional Freedom Liberation Technique, Surgical Fear and Anxiety
Condition: Emotional Distress
Study type: Interventional

Summary: 
      Aim: In this study, the effect of Emotional Freedom Technique applied to patients before
      Laparoscopic Cholecystectomy on surgical fear and anxiety was investigated.

      Design: This is a randomized controlled study. Method: A total of 112 patients who were going
      to have Laparoscopic Cholecystectomy were randomly divided into two groups each including 56
      participants. The intervention group was provided with Emotional Freedom Technique. The
      control group received routine face-to-face education. Surgical fear and anxiety were
      examined.
    


Intervention name(s): Emotional Freedom Liberation Technique
Intervention type(s): Behavioral
Intervention description(s): The investigators will apply Emotional Freedom Liberation Technique
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: surgery; anxiety
Rebif New Formulation (RNF) in Relapsing Forms of Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to compare the immunogenicity of the new fetal bovine
      serum (FBS)-free/human serum albumin (HSA)-free Rebif® formulation (RNF) to historical data.
    

Detailed description: 
      As has been seen with other recombinant protein molecules, the use of injectable recombinant
      proteins may result in the development of neutralising antibodies (NAbs). Antibodies are
      considered neutralising by their ability to inhibit the biological effect of interferon in a
      bioassay system. EMD Serono has actively pursued improvements in the formulation of
      interferon (IFN) beta-1a to reduce aggregate levels and to develop a formulation that is
      HSA-free. Reducing aggregates should reduce antigenicity of the product while removal of HSA
      may have an unpredictable effect on antigenicity. EMD Serono will conduct a study to assess
      the immunogenicity and safety of the new HSA-free formulation, manufactured using IFN-ß-1a
      drug substance produced by a new clone from the FBS-free process.
    

Intervention name(s): Interferon-beta-1a FBS-free/HSA-free
Intervention type(s): Biological
Intervention description(s): Pre-filled syringes 44mcg/injected subcutaneous 3x per week. Total study period is 96 weeks.
Intervention MeSH terms: Interferons; Interferon-beta; Interferon beta-1a
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Relapsing forms of multiple sclerosis
Evaluation of Prevent in Underserved Populations
Condition: Prediabetes; Overweight; Obesity
MeSH terms: Overweight; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The goal of this study is to evaluate an online Diabetes Prevention Program adapted for
      patients with prediabetes in safety net health care settings.
    

Detailed description: 
      The Diabetes Prevention Program (DPP) demonstrated that intensive behavioral counseling is a
      successful approach to reduce the risk of developing diabetes in patients with prediabetes.
      While the DPP lifestyle intervention was successful and group based adaptations of the DPP
      have positive results, scalable alternatives that allow for even broader reach are necessary.
      Omada Health has developed an online, group-based, recognized DPP program (Prevent). The goal
      of this study is to evaluate a literacy-adapted version of Prevent for patients with
      prediabetes in safety net health care settings.
    

Intervention name(s): Prevent
Intervention type(s): Behavioral
Intervention description(s): Intensive behavioral counseling for diabetes prevention and healthy lifestyle management. Recipients have access to online curriculum, a live health coach, group-based communication forums, and connected technology to track weight and physical activity.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: prediabetes, weight loss, behavior modification
Safety and Efficacy Dose of Artesunate Used in Combination With LAPDAP Treatment of Uncomplicated Falciparum Malaria
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 2

Summary: 
      Drug resistance to a range of antimalarial treatments has become widespread in Africa, South
      East Asia and South America. Because the rapid spread of drug resistance threatens a public
      health disaster in these areas of the world and to comply with the WHO-Roll Back Malaria
      policy of using Artemisinin-based combination therapies (ACT), there is a need to develop
      new, safe, effective and affordable ACT.

      Chlorproguanil-dapsone-artesunate (CDA)is a new ACT that is being developed for the treatment
      of uncomplicated falciparum malaria in Africa.
    


Intervention name(s): Chlorproguanil-dapsone-artesunate (CDA)
Intervention type(s): Drug
Intervention MeSH terms: Artesunate; Dapsone; Chlorproguanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: dose-ranging study; SB-714703; artesunate,; malaria; CDA,; chlorproguanil,; dapsone,
The Effects of Exercise of Secreted Factors From Muscle and Adipose Tissue
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to find out whether exercise leads to changes in the blood that
      are produced by exercised muscles and if these changes produce new hormones that affect the
      body's regulation of sugar and body weight.
    

Detailed description: 
      Recent work in the laboratory at the Joslin Diabetes Center and elsewhere has shown that when
      small animals exercise they improve their muscles and improve their blood sugar levels. Also,
      these animals show changes in their abdominal fat tissue, compared to animals that did not
      exercise. Our data suggest that factors released from exercised muscle and fat tissue from
      exercised mice also has a positive effect on other tissues in the same animal. Therefore,
      there could be new factors or hormones, which come from the trained animals' muscles or fat
      tissue and which exert a positive effect on the animals' blood sugar levels. Large studies
      with human volunteers have shown that exercise can improve blood sugar uptake into skeletal
      muscle and lower blood sugar levels, thereby preventing type 2 diabetes. The purpose if this
      study is to evaluate if a single exercise bout leads to changes in circulating factors in the
      blood. We plan to detect if there are hormones being produced in the body that have a
      beneficial effect elsewhere in the body.
    

Intervention name(s): Exercise bout
Intervention type(s): Other
Intervention description(s): Participants will exercise for 45min at 75% of VO2peak
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Exercise