bioihbjkbjnl/mcl2 huggingface dataset:
Study to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in Healthy Volunteers
Condition: Pediculosis
MeSH terms: Lice Infestations
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to Evaluate the Effect of Ha44 Gel on the Electrocardiogram in
      Healthy Volunteers.
    

Detailed description: 
      This study was a randomized, double-blind, placebo- and active-controlled, crossover study
      that evaluated the potential of Abametapir to prolong cardiac repolarization in healthy adult
      subjects (total of 57 subjects).
    

Intervention name(s): Ha44; Ha44 Placebo; Moxifloxacin Placebo; Moxifloxacin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Abametapir Lotion 0.74%; Ha44 Vehicle Gel without Abametapir; Moxifloxacin Placebo; Moxifloxacin 400mg
Other intervention name(s): Abametapir Lotion; Abametapir Placebo; Moxifloxacin Active
Intervention MeSH terms: Moxifloxacin; Norgestimate, ethinyl estradiol drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Acupuncture Analgesia in Relation to Psychiatric Comorbidity
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional
Phase: Phase 3

Summary: 
      It is our hypothesis that patient's expectations concerning treatment outcome will be
      influenced by their psychiatric symptoms, and that this expectancy will have a strong
      influence on the efficacy of acupuncture treatment to suppress experimentally induced pain.
      We will conduct a study, monitoring expectations but not manipulating them, in a cohort of
      patients with chronic low back pain.
    

Detailed description: 
      Specific Aim: To characterize subjective analgesia (behavioral effect) of different
      expectancy levels on verum and sham acupuncture treatment and the relative contribution of
      acupuncture treatment and expectancy to the resultant analgesia in healthy normals and in
      those with low back pain, controlling for psychiatric comorbidity.

      Hypothesis 1: Patients with low back pain, low psychiatric comorbidity, and high expectations
      for acupuncture treatment will experience the same magnitude of acupuncture analgesia to
      thermal pain stimuli as healthy volunteers with high expectations for treatment.

      Hypothesis 2: Patients with low back pain and high psychiatric comorbidity will experience
      less acupuncture analgesia compared to patients with low back pain and low psychiatric
      comorbidity, regardless of the level of expectations for acupuncture treatment.

      Hypothesis 3: Patients with low back pain and high psychiatric comorbidity will have
      increased acupuncture placebo analgesia to thermal pain stimuli than both other groups.
    

Intervention name(s): acupuncture
Intervention type(s): Procedure
Intervention description(s): acupuncture
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Psychiatric Comorbidity; Acupuncture; expectancy
To Evaluate the Efficacy and Safety of Multifocal Soft Contact Lens in Myopia Control
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The objective of this study is to investigate the efficacy and safety of soft lens in myopia
      control.
    

Detailed description: 
      This is a prospective, randomized, paired eye comparison, double-blind study aims to evaluate
      the efficacy and safety of "Soft Lens" in myopia control among schoolchildren. A total of 118
      eyes are planned to be enrolled and the expect duration of subject participation will be 48
      weeks not including two weeks of screening period. Data such as refractive error, axial
      length, visual acuity, average wearing hours, self-assessment, adverse events etc. will be
      collected during the study. A total of 10 visits, i.e. a screening visit, a randomization
      visit, and 8 treatment visits are planned. Subjects will be encouraged to complete all
      planned visits.
    

Intervention name(s): soft contact lens
Intervention type(s): Device
Intervention description(s): Group A
Group B
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Paired-eye comparison
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Myopia control
A Study of Alirocumab in Participants With Autosomal Dominant Hypercholesterolemia (ADH) and Gain-of-Function Mutations (GOFm) of the Proprotein Convertase Subtilisin Kexin 9 (PCSK9) Gene or Loss-of-Function Mutations (LOFm) of the Apolipoprotein (Apo) B Gene
Condition: Hypercholesterolemia
MeSH terms: Hyperlipoproteinemia Type II; Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of the study is to assess the pharmacodynamic (PD) effect of alirocumab
      on serum low density lipoprotein cholesterol (LDL-C) during 14 weeks of subcutaneous (SC)
      administered alirocumab in patients with autosomal dominant hypercholesterolemia (ADH) and
      gain-of-function mutation (GOFm) in 1 or both alleles of the proprotein convertase
      subtilisin/kexin type 9 (PCSK9) gene or with loss-of-function mutation (LOFm) in 1 or more
      alleles of the apolipoprotein (ApoB) gene.
    


Intervention name(s): Alirocumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): SC injection in the abdomen; SC injection in the abdomen
Other intervention name(s): Praluent®; REGN727; SAR236553
Intervention MeSH terms: Alirocumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Sigma CR150 Versus Sigma CR Knee RCT
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will compare two very similar designs of knee replacement device. One device
      (Sigma CR150) is a slightly modified version of the original (Sigma CR) and has been modified
      to enhance/accommodate higher flexion. The original device has been in widespread clinical
      use with excellent results since 1996 and this study will determine whether the design
      modifications of the newer device add further value. The newer device has been in clinical
      use with good short-term(unpublished) outcomes since becoming commercially available in
      January 2009.

      Achieving higher knee flexion may be required for cultural reasons or by the increasingly
      younger, more active patient population undergoing knee replacement today. In addition to
      promoting flexion, it is also possible that this design change may help the knee replacement
      to last longer than traditional implants in patients who achieve higher flexion. Therefore,
      the study will compare the two devices in terms of survivorship, flexion and other measures
      of the success of a total knee replacement (range of motion, knee-related quality of life,
      activity and generic quality of life) over the short-term.

      A minimum of one hundred and forty subjects (minimum 70 per group) with osteoarthritis and
      aged 50-75 years will be included at UK/international hospitals.

      Study duration is 2 years and patients will complete standard knee outcome scores plus
      radiological evaluation.

      Subjects would receive one of the study devices regardless of their involvement in the study,
      and apart from (possible)additional visits, x-rays and/or questionnaires, treatment and
      follow-up care will be as per the care they would receive outside of the study.
    


Intervention name(s): Sigma CR150; Sigma CR
Intervention type(s): Device; Device
Intervention description(s): Sigma CR150 femoral component used in combination with the Highly Polished Cobalt Chrome fixed bearing tibial tray and the Curved (XLK) polyethylene bearing (cemented, no patellar resurfacing).; Sigma CR femoral component used in combination with the Highly Polished Cobalt Chrome fixed bearing tibial tray and the Curved (XLK) polyethylene bearing (cemented, no patellar resurfacing).
Other intervention name(s): PFC Sigma CR150; PFC Sigma CR
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Sigma; cruciate; retaining; fixed; primary; total; knee; arthroplasty; cemented; osteoarthritis
A Study of the Efficacy and Safety of Adalimumab in Pediatric Subjects With Enthesitis Related Arthritis
Condition: Enthesitis Related Arthritis (ERA)
MeSH terms: Arthritis; Enthesopathy; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of adalimumab given
      subcutaneously every other week (eow) as compared to placebo in pediatric subjects with
      Enthesitis Related Arthritis (ERA).
    


Intervention name(s): adalimumab; placebo for adalimumab
Intervention type(s): Biological; Biological
Intervention description(s): Adalimumab solution for subcutaneous injection.; Placebo for adalimumab solution for subcutaneous injection.
Other intervention name(s): ABT-D2E7; Humira
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: inflammatory back pain; ankylosing spondylitis; sacroiliitis; Juvenile Idiopathic Arthritis; enthesitis; arthritis
Processed Meat and Colon Carcinogenesis
Condition: Colorectal Cancer
MeSH terms: Colorectal Neoplasms; Carcinogenesis
Study type: Interventional

Summary: 
      Colorectal cancer kills forty five people in France every day. Epidemiological studies
      suggest that two cases out of three could be prevented and show that processed meat intake is
      a consistent risk factor. The aim of this study is to understand how meat promotes cancer, to
      find protective strategies, and to make compelling dietary recommendations.
    

Detailed description: 
      18 healthy volunteers will be randomized and will start the study. The study will last 4
      weeks for each subject. The first week will be a week of adaptation (or run-in period) to the
      diet which they will have to follow for the duration of study. During this period, they will
      collect 2 samples of stools and urine. Then subjects will alternate 4 days of diet either
      with ham, or with ham and calcium, or with ham enriched with vitamin E. At least, 3 days will
      separate every period (wash-out) of nutritional intervention. Urines and stools will be
      collected last 3 days of every interventional period and also last day of every wash out
      period.
    

Intervention name(s): Ham; Ham + calcium; Ham + vitamin E
Intervention type(s): Other; Other; Other
Intervention description(s): Ham : 180 g per day during 4 days; Ham : 160g/d during 4 days calcium : 1000mg/d during 4 days; Ham : 160g/d during 4 days Vitamin E : 80 mg/d during 4 days
Intervention MeSH terms: Vitamin E; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Colorectal cancer; Processed meat; Calcium; Vitamin E; Preventive strategies
Vitamin D3 Treatment and Homocysteine Concentrations Among Overweight Reproductive Women
Condition: Homocystinaemia; Vitamin D Deficiency
MeSH terms: Overweight; Vitamin D Deficiency
Study type: Interventional
Phase: Phase 2

Summary: 
      100 overweight reproductive vitamin D deficient women were divided into two groups; vitamin D
      (n = 50) and placebo (n = 50). Vitamin D group received treatment dose of 50,000 IU of
      vitamin D3 per week for 2 consecutive months and placebo group received placebo tablets
      similar in size, shape and color to vitamin D3 for 2 months also. Total homocysteine
      concentrations were measured before intervention (basal), on 30 days (one month) and on 60
      days (2 months) of intervention. Changes in means of homocysteine concentrations for placebo
      and vitamin D group over time showed significant difference on 30 and 60 days of
      intervention. Mean comparisons of homocysteine concentrations and standard error of the means
      before and after intervention showed statistical significant decrease in homocysteine
      concentrations among vitamin D group.
    


Intervention name(s): Vit D; Placebo
Intervention type(s): Drug; Other
Intervention description(s): 50,000 IU
Other intervention name(s): Biodal
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment
Keywords: Homocysteine; Overweight; vitamin D3; Reproductive women; RCT
To Assess the Safety, Efficacy and Tolerability of CKD-519, Administered With HMG-CoA Reductase Inhibitors
Condition: Dyslipidemias
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      A multicenter, double-blind, parallel-group, active-controlled, dose-ranging study to assess
      the safety and efficacy of the novel cholesteryl ester transfer protein (CETP) inhibitor
      CKD-519 in combination with atorvastatin or rosuvastatin in subjects with dyslipidemia.
    

Detailed description: 
      The purpose of this study is to assess the safety, efficacy, and tolerability of CKD-519,
      administered with HMG-CoA reductase inhibitors in subjects with dyslipidemia
    

Intervention name(s): Atorvastatin 20mg; Atorvastatin 20 mg + CKD-519 50 mg; Atorvastatin 20 mg + CKD-519 100 mg; Atorvastatin 20 mg + CKD-519 200 mg; Rosuvastatin 10 mg; Rosuvastatin 10 mg + CKD-519 100 mg
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): PO daily for 4weeks; PO daily for 4weeks; PO daily for 4weeks; PO daily for 4weeks; PO daily for 4weeks; PO daily for 4weeks
Other intervention name(s): Lipitor 20mg; Lipitor 20mg; Lipitor 20mg; Lipitor 20mg; Crestor 10mg; Crestor 10mg
Intervention MeSH terms: Atorvastatin; Rosuvastatin Calcium
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Dyslipidemia; CETP Inhibitors; Hyperlipidemia
Prevention of Cardiac Dysfunction During Adjuvant Breast Cancer Therapy
Condition: Breast Cancer; Heart Failure
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      Women treated for breast cancer are at increased risk for cardiovascular disease, including
      heart failure. In this study, by using magnetic resonance imaging (MRI), the investigators
      want to assess if heart failure medications such as beta blockers and angiotensin receptor
      blockers can prevent cardiac dysfunction during early breast cancer therapy.
    

Detailed description: 
      Breast cancer is one of the most common malignancies in women. Recent progress in the
      detection and treatment of breast cancer has resulted in survival gains, but a consequence of
      therapeutic advances is an increasing number of long-term survivors who may be at risk for
      development of cardiovascular disease. Several studies suggest that women treated for breast
      cancer may be at increased risk for cardiovascular disease, the probable causes being
      multi-factorial. Importantly, therapies for breast cancer, including radiotherapy, anti-HER-2
      regimens and certain chemotherapeutic regimens, may increase the risk of subsequent
      cardiovascular disease, including atherosclerotic disease, left ventricular dysfunction, and
      heart failure.

      In the current study we propose to undertake a randomized, placebo-controlled, 2x2 factorial,
      double-blind trial to assess whether left ventricular dysfunction and/or injury is
      preventable, completely or partly, by the concomitant administration of the angiotensin
      receptor blocker (ARB), candesartan, and the beta blocker, metoprolol, during postoperative
      chemotherapy and radiotherapy.

      The proposed study addresses an important clinical problem in a large patient group. Thus,
      the possibility of preventing cardiovascular side effects of contemporary therapy for breast
      cancer is important both clinically and scientifically.
    

Intervention name(s): Metoprolol; Placebo; Candesartan; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Tablet, target dose 100 mg once daily; Tablet, target dose 100 mg once daily; Tablet, target dose 32 mg once daily; Tablet, 32 mg once daily
Intervention MeSH terms: Metoprolol; Candesartan; Candesartan cilexetil
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Anthracyclines; Trastuzumab
Comparison of Optic Nerve Sheath Diameter in Children Receiving Caudal Block According to Anesthetic Agents: Total Intravenous Anesthesia vs. Volatile Anesthesia
Condition: Caudal Block for Postoperative Analgesia
Study type: Interventional

Summary: 
      Caudal block is commonly used for postoperative analgesia in paediatric patients. A higher
      volume (1.5 ml/kg) of local anaesthetic for caudal block has been reported to not only
      increase the level of cranial spread but also provide better quality and longer duration of
      analgesia in comparison with the conventional volume (1.0 ml/kg). However, caudal block with
      a high volume of local anaesthetic can increase intracranial pressure (ICP). Previous studies
      have shown that propofol anesthesia lowers ICP when compared with volatile anesthesia.
      Therefore, this study was designed to test if propofol can reduce the magnitude of ICP
      increase following caudal block when compared with a volatile anesthetic, sevoflurane. There
      is increasing evidence that optic nerve sheath diameter (ONSD) measured by ultrasonography
      correlates with degree of ICP and is able to detect intracranial hypertension. Therefore,
      ONSD will be measured as a surrogate of ICP.
    

Detailed description: 
      Equal number of patients are randomly assigned to the P or S group. The participants in the P
      and S group are anesthetized with propofol and sevoflurane, respectively. Irrespective of
      assigned group, all participants receive caudal block with 1.5 ml/kg of 0.15% ropivacaine (up
      to 30 ml per individual participant). All anesthetic procedures except for main anesthetic
      agent are the same in all participants. ONSD is measured at the following time points: before
      (T0), immediately after (T1), and 10 min (T2) and 30 min(T3) after caudal block. Two
      measurements of each optic nerve sheath are acquired in each eye. The mean value of the four
      measurements is considered as the ONSD at each time point.
    

Intervention name(s): Propofol; Sevoflurane
Intervention type(s): Drug; Drug
Intervention description(s): The participants in the group P are anesthetized with propofol; The participants in the group S are anesthetized with sevoflurane.
Intervention MeSH terms: Propofol; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: There are 2 groups according to the type of main anesthetic agent. P group are anesthetized with propofol, so are S group with sevoflurane.
Masking: Single (Outcomes Assessor)
Primary purpose: Other
Keywords: Caudal block; Intracranial pressure; Propofol; Sevoflurane; Ultrasound
Magnesium Associated With Morphine for Cancer Pain Relief
Condition: Cancer-related Problem/Condition
MeSH terms: Cancer Pain
Study type: Interventional

Summary: 
      This study is an evaluation of the analgesic effect of magnesium associated with morphine in
      patients with cancer pain.
    

Detailed description: 
      The study is prospective, randomized, double-blind. The patients will be allocated into two
      groups. After approval by the Ethics Committee and signed informed consent, 40 patients, aged
      > 18 years of both genders with cancer pain, will be studied.

      The patients in group 1 (n = 20) will receive a dose of magnesium sulfate (65 mg) po twice
      daily. Patients in Group 2 (n = 20) will receive placebo twice a day. The Mg and placebo
      capsules are identical. Everyone will receive morphine as needed.

      Will be recorded: tumor location, factors which worsen the pain, quality of pain. Pain
      intensity will be assessed by numerical scale from zero to 10 at T0 (first visit) and after
      1, 2, 3. and 4wk.

      The patient will note the intensity of pain and side effects at home. Functional performance
      assessment will bes done by the Karnofsky Performance Status Scale. Quality of life will be
      assessed by the QLQ-c30.
    

Intervention name(s): Magnesiun
Intervention type(s): Drug
Intervention description(s): 75mg pills; each 12h; 12wk
Other intervention name(s): NMDA receptor antagonist
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cancer pain; Magnesiun
Pharmacokinetics of IAsp Following CSII in Patients With T1DM
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objective of the study is to compare SSPIAsp during CSII giving one bolus per
      hour compared with multiple boluses per hour.

      The secondary objective is to compare SSPIAsp during continuous subcutaneous insulin infusion
      (CSII) versus continuous intravenous insulin infusion (CIII).
    

Detailed description: 
      Rapid acting insulin, like insulin aspart, can be administered as CSII. The insulin can be
      administered as a basal rate with additional insulin administration from the pump related to
      mealtimes.

      Insulin is physiologically secreted in a pulsate manner from the pancreatic β-cells with a
      period of 5-10 minutes, and this is responsible for plasma insulin oscillations with similar
      frequency. The oscillatory pattern is believed to optimize control mechanisms of insulin to
      enhance its action on metabolism.
    

Intervention name(s): Insulin Aspart (IAsp); Insulin Aspart (IAsp).; Insulin Aspart (IAsp)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): IAsp 100 U.
≈ bolus protocol: From 6 pm until 6 am
• 50 % of habitual 24 hour insulin need/24 hours = basal rate (per hour)
From 8 am until 6 pm
1 dose/h + 50 % s.c. (≈ bolus).; IAsp 100 U From 6 pm until 8 am
• 50 % of habitual 24 hour insulin need/24 hours = basal rate (per hour)
From 8 am until 6 pm 50 % increase of basal rate; IAsp 100 U From 6 pm until 8 am
• 50 % of habitual 24 hour insulin need/24 hours = basal rate (per hour)
From 8 am until 6 pm 50 % increase of basal rate
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Aspart; Insulin, Long-Acting; Insulin degludec, insulin aspart drug combination
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes Mellitus; Continuous Subcutaneous Insulin Infusion (CSII)