bioihbjkbjnl/mcl2 huggingface dataset:
NAS Treatment - Opiate Versus Non-Opiate
Condition: Neonatal Abstinence Syndrome
MeSH terms: Neonatal Abstinence Syndrome; Syndrome
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to compare two different medicines to treat babies with opiate
      withdrawal. The treatment medicines are morphine, which is an opiate, and clonidine, a
      non-opiate. Morphine is a narcotic medicine, with is included in most pain killers. Clonidine
      is another drug, but is different from morphine. It is also used for babies, and even adults
      for withdrawal symptoms. Both drugs are effective, but the purpose of this study is to see if
      one may be better than the other.
    

Detailed description: 
      Withdrawal from drugs, called Neonatal abstinence syndrome (NAS), is a group of symptoms that
      occurs to babies whose mother took or used drugs (prescription, addicting, illegal, pain
      pills, or drugs for addiction treatment) during pregnancy. Medicines the mother takes while
      pregnant, the baby also takes. Babies may experience withdrawal after delivery, and may need
      treatment. There are different ways to treat babies with withdrawal - about 50% of doctors
      use morphine, an opiate, to treat these babies, the rest uses other drugs, like clonidine and
      phenobarbitol.
    

Intervention name(s): Morphine; Clonidine
Intervention type(s): Drug; Drug
Intervention description(s): Start at 0.4mg/kg/day (divided every 3-4 hours, given with feeds. Dose may be increased 25% of initial dose until symptoms are stable, up to 1 mg/kg/day.
Once stable for 72 hrs, weaning may begin (decrease 10% of max dose, every other day). When total dose is <0.1mg/kg/day, may discontinue.; Initial dose is 5 mcg/kg/day (divided every 3-4 hrs, given with feeds). Will increase 25% of initial dose every 12-24 hrs until stable, up to 12 mcg/kg/day. Dose is unchanged for 72 hours once stable, then may decrease by 10% every other day. If re-escalation is required, the previous dose may be used with 72 hours for stabilizing.
Other intervention name(s): Morphine sulfate; clonidine hydrochloride
Intervention MeSH terms: Clonidine; Morphine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Prenatal opiate exposure; neonatal withdrawal; Pharmacologic treatment
Comparison of Dexmedetomidin and Remifentanil for the Effect on Airway Reflex and Hemodynamic Response During Emergence in Patients Undergoing Craniotomy
Condition: Open Craniotomy
Study type: Interventional
Phase: Phase 4

Summary: 
      During recovery from general anesthesia the stimuli of endotracheal tube lead to the
      coughing, hypertension, tachycardia, which can cause a serious complication. Especially the
      postoperative course of patients emerging from general anesthesia after intracranial surgery
      is frequently complicated by the occurrence of hypertension and coughing event.

      It has been demonstrated that opioid, intravenous or topical lidocaine administration can
      attenuate the coughing reflex. Administered the opioid before emergence, it is effective to
      prevent cough reflex but the recovery is delayed, it was difficult to predict emergence.

      However, remifentanil is an opioid widely used because of rapid context-sensitive half-life,
      target-controled infusion method to adequately maintain the effect site concentration could
      help to predict the recovery time to the alert state from the general anesthesia. It is
      considered proper method of continuous infusion of remifentanil for reducing emergence cough.

      Dexmedetomidine , a potent alpha adrenoceptor agonist which dose-dependently reduces arterial
      blood pressure and heart rate, decreases the hemodynamic and and catecholamine response to
      intubation and extubation. It is thus theologically appropriate for reducing airway and
      circulatory reflexes during emergence from anesthesia.

      In this study, the investigators used bolus dexmedetomidine immediately before extubation,
      and compared the effects on coughing, hemodynamic response and recovery profile to a
      continuous infusion of remifentanil.
    


Intervention name(s): remifentanil; dexmedetomidine with remifentanil
Intervention type(s): Drug; Drug
Intervention description(s): remifentanil effect site-TCI 2-4ng/ml; remifentanil effect site-TCI 2-4ng/ml with dexmedetomidine 0.5mcg/kg
Intervention MeSH terms: Dexmedetomidine; Remifentanil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Study Of The Effects Of A New Antidepressant Therapy In Patients With Major Depressive Disorder (MDD)
Condition: Depressive Disorder, Major
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy, safety and tolerability of GW679769
      patients with Major depressive Disorder (MDD).
    


Intervention name(s): GW679769
Intervention type(s): Drug
Intervention MeSH terms: Casopitant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: depression; major depressive disorder; MDD
24-Hour Intraocular Pressure (IOP) Control With Travoprost/Timolol Fixed Combination
Condition: Primary Open Angle Glaucoma; Exfoliation Syndrome
MeSH terms: Glaucoma, Open-Angle; Exfoliation Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to compare the short-term (8 week) mean 24-hour intraocular
      pressure control and safety of TravTim fixed combination given once in the evening with
      placebo once in the morning versus TravTim given once in the morning with placebo once in the
      evening in patients with open-angle glaucoma.
    


Intervention name(s): travoprost/timolol fixed combination; placebo (artificial tears)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Timolol; Travoprost; Lubricant Eye Drops
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Improving Neuroprotective Strategy for Ischemic Stroke With Sufficient Recanalization After Thrombectomy by Edaravone Dexborneol
Condition: Stroke; Endovascular Thrombectomy
MeSH terms: Stroke; Ischemic Stroke
Study type: Interventional
Phase: Phase 2

Summary: 
      To explore the safety and efficacy of edaravone dexborneol for the treatment of acute
      ischemic stroke patients who received endovascular thrombectomy.
    


Intervention name(s): edaravone dexborneol
Intervention type(s): Drug
Intervention description(s): Intravenous injections of edaravone dexborneol (37.5mg, dissolved in 100ml saline) twice a day for 12 ±2 days.
Other intervention name(s): edaravone deborbeol placebo
Intervention MeSH terms: Edaravone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Bioequivalence Study of BAY77-1931 Granule
Condition: Hyperphosphatemia
MeSH terms: Hyperphosphatemia
Study type: Interventional
Phase: Phase 1

Summary: 
      The study is conducted as a randomized, non-blinded, 2-way crossover study. Target population
      is 60 Japanese healthy male adult subjects selected by screening examination which will be
      conducted within 4 weeks before the first drug administration of period 1 (before the
      hospitalization of period 1). Subjects will admit in the clinical institute on Day -3 and be
      discharged on Day 6 in each period. During hospitalization, standardized phosphate diet from
      Day -2 to Day 4 will start approximately 20 minutes before dosing. Subject will take about
      1300 mg of phosphate evenly at breakfast lunch and dinner for each day. Subject should
      consume at least 95% of a meal. Distilled water not to include phosphate will be used for
      drinking water and meal. Subjects are to drink at least 1 L of distilled water every day in
      clinic to make sure enough urine volume. The 24 hours urine collection will be conducted
      between Day -2 and Day 4 to investigate the urinary phosphate excretion.BAY77-1931 granule
      500 mg or Fosrenol chewable tablet 500 mg will be administered three times daily after each
      meal from Day 1 to Day 4. On day 4 single dose after breakfast will be administered. Study
      drugs will be administered immediately after each meal, that is within 20 minutes after start
      of each meal with 240 mL of distilled water. A Fosrenol chewable tablet 500 mg will be taken
      after chewing completely.
    


Intervention name(s): Lanthanum Carbonate (Fosrenol, BAY77-1931) Granule; Lanthanum Carbonate (Fosrenol, BAY77-1931) Chewable tablet
Intervention type(s): Drug; Drug
Intervention description(s): BAY77-1931 Granule TID for 4 days; BAY77-1931 Chewable tablet TID for 4 days
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hyperphosphatemia; BE; Granule; Healthy volunteers
Assessment of Long-term Safety in Patients With Non-cancer-related Pain and Opioid-induced Constipation
Condition: Opioid-Induced Constipation (OIC)
MeSH terms: Constipation; Opioid-Induced Constipation
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to evaluate the long-term safety and tolerability of NKTR-118
      treatment of opioid-induced constipation (OIC) in patients with non-cancer-related pain.
    


Intervention name(s): NKTR-118; Usual care
Intervention type(s): Drug; Drug
Intervention description(s): 25 mg oral tablet once daily; As prescribed by the investigator
Intervention MeSH terms: Naloxegol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Non-Cancer-Related Pain; Opioid-Induced Constipation
A Study to Evaluate the Different Doses of VAC52416 (ExPEC10V) in Japanese Adults
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and reactogenicity of different doses of
      extraintestinal pathogenic Escherichia coli 10 valent (ExPEC10V) in Japanese participants
      greater than or equal to (>=) 60 to less than or equal to (<=) 85 years of age.
    


Intervention name(s): ExPEC10V; Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Participants will receive a single IM injection of ExPEC10V.; Participants will receive single IM injection of matching placebo.
Other intervention name(s): VAC52416
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
A National School-based Health Lifestyles Interventions Among Chinese Children and Adolescents Against Obesity
Condition: Pediatric Obesity
MeSH terms: Obesity; Pediatric Obesity
Study type: Interventional

Summary: 
      The study was designed as a national multi-centered cluster randomized controlled trial
      involving more than 70,000 children and adolescents aged 7-18 years from 7 provinces in
      China. In each center, about 12-16 primary and secondary schools, with totally at least 10000
      participants were randomly selected (Primary: Secondary=1:1). All of the selected schools
      were randomly allocated to either intervention or control group (Intervention:
      Control=1:1).The multi-components school-based and family-involved scheme was conducted
      within the intervention group for 9 month, while students in the control group followed their
      usual health practice. The intervention consisted of four components: a) Create supportive
      school and family environment, b) Health lifestyles education and related compulsory physical
      activities, c) Instruct and promote school physical education, d) Self-monitor obesity
      related behaviors. Four types of outcomes including anthropometric, behavioral, blood
      chemical and physical fitness were measured to assess the effectiveness of the intervention
      program.
    


Intervention name(s): The Health Lifestyles Interventions
Intervention type(s): Behavioral
Intervention description(s): Creating supportive school and family environment, whole intervention periods;
Health lifestyles educational strategies, 30min/week for education lessons and six times education activities;
Instruct and promote school physical education, whole intervention periods;
The monitoring and instruction of obesity related behaviors, once a week for physical activity and dietary behavioral log and once a month for parental monitor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Chinese multi-centered school based obesity intervention
L.Fermentum CECT5716 in Treatment of Breast Pain
Condition: Breast Pain
MeSH terms: Mastodynia
Study type: Interventional

Summary: 
      The main objective of this intervention study is to evaluate the efficacy of Lactobacillus
      fermentum CECT5716 to reduce the presence in the milk of genera Staphylococcus and
      Streptococcus as risk factors for mastitis in women with breast pain
    

Detailed description: 
      1. Type of study Nutritional intervention study, multicenter, randomized, blinded, parallel
           group included 25 women per group

             -  Group 1: 3x109 cfu / day (n = 25)

             -  Group 2: 6x109 cfu / day (n = 25)

             -  Group 3: 9x109 cfu / day (n = 25)

             -  Group 4: placebo (n = 25)

        2. Statistical calculation of sample size. The calculation of sample size was calculated by
           the company SEPLIN Solutions Statistics. The primary endpoint was the bacterial count of
           in milk. The sample size obtained to observe a difference of 1 log10, with a power of
           0.80 and a significance level of 0.05 was 20 volunteers per group.

        3. Randomization Randomization was performed using a list of random numbers generated by
           computer. Subjects will be randomized in a strictly sequential.

           If a subject is removed from the test, the number that was assigned randomization not be
           reused again.

        4. Overall design and outline of the study At visit 1 we require the informed consent of
           the patient. It will take the milk sample, we will review the implementation of the
           inclusion and exclusion criteria. Be randomized and explain the treatment guidelines to
           be followed, the data to be collected and medical appointments that must go (2 and 3
           weeks). It will complete the pain assessment questionnaire (MQP) and nutrition survey.

           On visits 2, 3 and 4 corresponding to 1, 2 and 3 weeks of intervention will collect milk
           sample pain assessment survey and nutrition survey.

           Milk samples (5 mL) were collected aseptically in sterile tubes to be frozen immediately
           until analysis to be carried out within seven days.

        5. Intervention duration The intervention will last three weeks.
    

Intervention name(s): Lactobacillus fermentum CECT5716; Placebo Comparator: maltodextrin
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: breast pain; probiotic; mastitis; lactobacillus fermentun; Staphylococcus
Long-term Open-label Trial in Idiopathic Restless Legs Syndrome (RLS)
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a multi-center, open-label extension trial conducted at the same European sites that
      participated in trial SP 709 (NCT00243217). The trial is designed to collect long-term safety
      and tolerability, efficacy correlates, and quality of life data in subjects with idiopathic
      Restless Leg Syndrome (RLS). The duration of treatment is approximately 5 years. Subject will
      be up-titrated to their optimal dose (administration of 1 patch per day, 5 different doses
      and patch sizes).
    


Intervention name(s): Rotigotine
Intervention type(s): Drug
Intervention description(s): Rotigotine transdermal patches once daily:
2.5cm2 (0.5mg/24 hours) 5cm2 (1mg/24 hours) 10cm2 (2mg/24 hours) 15cm2 (3mg/24 hours) 20cm2 (4mg/24 hours)
Other intervention name(s): Neupro®
Intervention MeSH terms: Rotigotine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Rotigotine; Neupro®
High Dose Rate Prostate Brachytherapy as Salvage for Locally Recurrent Prostate Cancer Previously Treated With External Beam Radiotherapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      High dose rate (HDR) brachytherapy is a form of radiation treatment using temporary
      radioactive seeds. This is done by placing very tiny catheters or tubes into the prostate and
      then inserting temporary radioactive seeds, called Iridium 192, through these catheters. HDR
      brachytherapy gives precise radiation to the prostate with less radiation given to the normal
      tissues near the prostate. For patients who have been treated with external beam radiation to
      the prostate before, HDR brachytherapy can give radiation again to the prostate without
      exposing the normal tissues around the prostate to significantly more radiation. This may be
      safer than giving external beam radiation again. The purpose of this study is to test the
      safety of high dose rate temporary brachytherapy (HDR) for prostate cancer that has come back
      after external beam radiation. We want to find out what effects, good and/or bad, the
      treatment has on you and your recurrent prostate cancer.
    


Intervention name(s): High dose rate (HDR) brachytherapy using Iridium 192 radioactive seeds
Intervention type(s): Radiation
Intervention description(s): Pre-tx Sexual function questionnaire Quality of Life baseline, Treatment with HDR (Two days) Treatment: Iridium 192 radioactive seeds temporarily inserted into patient. Post treatment (after HDR) Month 1 (+/- 2 weeks), 3 (+/- 1 month), 6 (+/- 1 month), 9 (+/-1 month), 12 (+/- 1 month)* NCI CTC GU and GI assessment,IPSS, IIEF, PSA lab test, Prostate HRQOL
*After 1 year, will follow up with doctor about every 6 months.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: recurrent
Sodium Oxybate in Idiopathic Hypersomnia
Condition: Idiopathic Hypersomnia
MeSH terms: Disorders of Excessive Somnolence; Idiopathic Hypersomnia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      this study evaluates of the efficacy of sodium oxybate on excessive daytime sleepiness using
      Epworth sleepiness scale over 8 weeks compared to placebo
    

Detailed description: 
      Bicentric, randomized, double-blind controlled study Outpatients aged from 18 to 60 years,
      suffering from current idiopathic hypersomnia (ICSD-3), recruited via medical consultations
      in the investigation centers Randomization in Xyrem or placebo arms after the inclusion
      visit,

      1.Screening Period (up to 15 days), 2.Titration Period (up to 45 days), 3.Maintenance Period
      (minimum 15 days), 4.Safety Follow-Up Period (14 days)
    

Intervention name(s): Sodium Oxybate Oral Solution 500 MG/ML; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): First night after V1: Dose prescribed at 4.5 g per night (2.25 g x 2) for 2 weeks First night after V2: Dose increased to 6 g per night (3 g x 2) for 2 weeks, according to investigator's opinion, tolerance of drug and CGI-S First night after V3: Dose either maintained stable at 6 g or increased to 9 g per night (4.5 g x 2) with dose increments of 1.5 g per night (0.75 g x 2) every week, based on benefit-risk ratio, for 2 weeks.
First night after V4: Dose maintained at 9 g or reduced at 6 g per night according to benefit-risk ratio for 2 weeks. No dose adjustment during the Maintenance period.
First night after V5: Taper period. Dose decrease by 2.25 g x 2 every two days until complete withdrawal; Xyrem Placebo: sodium citrate solution in equimolar concentration of sodium in the 500 mg/mL Xyrem oral solution, PH adjusted with malic acid
Intervention MeSH terms: Sodium Oxybate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Idiopathic Hypersomnia
Safety of the CO-rebreathing Method in Stable Coronary Artery Disease and COPD Patients
Condition: Cardiovascular Disease; Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Cardiovascular Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Observational

Summary: 
      The primary objective is to establish the safety of the CO-rebreathing method for measuring
      total blood and plasma volume in CAD patients. The working hypothesis is that the
      CO-rebreathing method is safe in use with coronary artery disease patients and that it does
      not cause myocardial ischemia or cardiovascular damage.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Stable, optimally medicated coronary artery disease and COPD patients with LVEF ≥ 0.40 will
        be recruited
      
Biospecimen description: 
      Blood samples
    
Keywords: Blood volume; CO-rebreathing; COPD; CVD
24 Hour Plasma Glucose Profiles Comparing Lispro Mix 75/25 vs. Glargine
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if twice-daily Lispro low mixture (75/25) will
      result in lower post prandial blood glucose readings versus once-daily glargine plus oral
      diabetic medications.
    

Detailed description: 
      The primary objective of this study is to test the hypothesis that a twice daily insulin
      regimen consisting of insulin lispro (mix 75/25)plus OAMs will result in a lower 2 hour
      postprandial plasma glucose, averaged across the morning and evening meals, compared with
      once daily insulin glargine plus OAMs at bedtime following 12 weeks of treatment.
    

Intervention name(s): Lispro mix 75/25; Glargine
Intervention type(s): Drug; Drug
Intervention description(s): Lispro mix 75/25 twice-daily, SC injection, given in conjunction with oral antidiabetic medications.; SC injection, once-daily, given in conjunction with oral antidiabetic medications.
Intervention MeSH terms: Insulin Glargine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Diabetes; Diabetic; Insulin; Glargine; Lispro