bioihbjkbjnl/mcl2 huggingface dataset:
Mobile Technology Monitoring System to Assess a Web-based Intervention for Teen Risky Driving
Condition: Adolescent; Accidents, Traffic; Attention; Motor Vehicles
Study type: Interventional

Summary: 
      This research study examines the feasibility of using an in-vehicle mobile technology
      monitoring system to measure teen secondary task engagement during on-road driving as the
      outcome measure for a web-based intervention to prevent risky driving in novice teen drivers.
    

Detailed description: 
      This research study examines the feasibility of using an in-vehicle mobile technology
      monitoring system to measure teen secondary task engagement during on-road driving as the
      outcome measure for a web-based intervention to prevent risky driving in novice teen drivers.
      Approximately 20 teens who have been licensed for less than 90 days will be enrolled and
      evaluated at baseline, ~1 week and ~4 weeks. Participants will complete an intervention after
      the ~1 week assessment. This study will provide information on the feasibility of the
      web-based intervention to prevent risky driving and estimation of effect size of the
      intervention on cell phone use while driving.
    

Intervention name(s): Risky Driving Prevention; Teen Healthy Living
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The web-based intervention to prevent risky driving targets knowledge, attitudes, perceived control and norms about driver inattention, with strategies to keep attention on the roadway.; The control group will receive a web-based intervention for general health promotion and is designed to enhance participants' knowledge and ability to reduce their risk of adverse health conditions including, obesity and heart disease.
Other intervention name(s): Web-based intervention to prevent risky driving
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Traditional Chinese Medicine in the Treatment of Patients With Hyperuricemia.
Condition: Hyperuricemia
MeSH terms: Hyperuricemia
Study type: Interventional
Phase: Phase 2

Summary: 
      To testify the efficacy and safety of traditional Chinese formulae, "Wu-Ling San" and
      "Yin-Chen Wu-Ling San" for patients with hyperuricemia.
    

Detailed description: 
      The prevalence of hyperuricemia and gout is increasing in Taiwan. It is probably contributed
      by adapting to Western diet and lifestyle. Previous studies have demonstrated the
      relationship between hyperuricemia with hypertension, metabolic syndrome, cardiovascular
      disease and chronic renal disease. While Western medicine shows promising effects in treating
      hyperuricemia and gout, we are searching for an alternative in traditional Chinese medicine
      with both safety and efficacy in treating hyperuricemia.

      We conducted a randomized double-blinded placebo-controlled clinical trial in adults with
      hyperuricemia. Sixty patients with serum uric acid level more than 8 mg/dl were enrolled.
      Patients were then randomized into three arms: Traditional Chinese Medicine formulae:
      "Wu-Ling San", "Yin-Chen Wu-Ling San" or placebo for 4 weeks. Efficacy and safety were
      evaluated at Week 2, 4 and 8. Primary endpoint was the serum uric acid<6 mg/dL at Week 4.
      Secondary endpoints were the differences between groups in serum uric acid at Week 2 and 8,
      serum SGPT, SGOT, creatinine, total cholesterol, triglycerides, HDL, LDL, fasting blood
      glucose, body weight, blood pressures and frequency of gouty attack at Week 4.
    

Intervention name(s): Wu Ling San; Yin-Chen Wu Ling San; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): assigned to Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Wu Ling San for a period of 4 weeks.; assigned to Yin-Chen Wu Ling San (n =20) and were instructed to take 4.5 gm 2 times per day of Yin-Chen Wu Ling San for a period of 4 weeks.; 1/10 Wu Ling San assigned to Placebo (n =20) and were instructed to take 4.5 gm 2 times per day of Placebo for a period of 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
Magnetic-Targeted Doxorubicin in Treating Patients With Cancer Metastatic to the Liver
Condition: Metastases, Neoplasm; Colorectal Neoplasms; Esophageal Neoplasms; Stomach Neoplasms; Pancreatic Neoplasms; Breast Neoplasms; Melanoma; Sarcoma; Gastrointestinal Neoplasms; Lung Neoplasms; Liver Neoplasms; Cholangiocarcinoma
MeSH terms: Neoplasms; Melanoma; Neoplasm Metastasis; Sarcoma; Cholangiocarcinoma; Breast Neoplasms; Colorectal Neoplasms; Lung Neoplasms; Pancreatic Neoplasms; Stomach Neoplasms; Esophageal Neoplasms; Liver Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      MTC-DOX is Doxorubicin or DOX, a chemotherapy drug, that is adsorbed, or made to "stick", to
      magnetic beads (MTCs). MTCs are tiny, microscopic particles of iron and carbon. When DOX is
      added to MTCs, DOX attaches to the carbon part of the MTCs. MTC-DOX is directed to and
      deposited in the area of a tumor, where it is thought that it then "leaks" through the blood
      vessel walls. Once in the surrounding tissues, it is thought that Doxorubicin becomes "free
      from" the magnetic beads and will then be able to act against the tumor cells. The iron
      component of the particle has magnetic properties, making it possible to direct MTC-DOX to
      specific tumor sites in the liver by placing a magnet on the body surface. It is hoped that
      MTC-DOX used with the magnet may target the chemotherapy drug directly to liver tumors and
      provide a treatment to patients with cancers that have spread to the liver.
    


Intervention name(s): MTC-DOX for Injection; Chemotherapy
Intervention type(s): Drug; Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metastatic liver cancer; Cholangiocarcinoma; colorectal cancer; esophageal cancer; gastric cancer; pancreatic cancer; breast cancer; malignant melanoma; sarcoma; GIST; gastrointestinal stromal tumor; lung cancer; liver cancer
Disease Burden of Pneumonia, Meningitis and Bacteremia Among Children in Japan: Pneumonet Japan
Condition: Pneumococcal Disease
MeSH terms: Pneumonia; Pneumococcal Infections
Study type: Observational

Summary: 
      Streptococcus pneumoniae is a major cause of pneumonia, among infants and children in Japan
      and worldwideThis study plans to investigate the rate of invasive pneumococcal disease "IPD "
      and the rate of hospitalizations due to pneumonia in Okinawa and the Eastern half of Hokkaido
      Currently, only a limited information about pneumococcal disease burden is available in
      Japan.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants and children less than 5 years of age living in Okinawa and Eastern Hokkaido.
      
Keywords: PNEUMONET JAPAN STUDY
Efficacy and Safety of Duloxetine
Condition: Urinary Stress Incontinence
MeSH terms: Urinary Incontinence, Stress
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to monitor the long term safety and efficacy of duloxetine in
      the treatment of severe pure genuine stress incontinence.
    


Intervention name(s): Duloxetine; Placebo
Intervention type(s): Drug; Drug
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Elizabeth Glaser Pediatric AIDS Foundation Maternal Events and Pregnancy Outcomes (MEP Project)A Multi-site Protocol
Condition: HIV Infections; HIV Positive; Pregnant Women
MeSH terms: HIV Infections; HIV Seropositivity
Study type: Observational

Summary: 
      The purpose of this study is to find out if antiretroviral drugs are safe and well tolerated
      by HIV-positive pregnant women and their infants in South Africa and Zambia.
    

Detailed description: 
      Although the use of HAART in pregnancy has significantly reduced rates of vertical
      transmission of HIV-1, some questions remain regarding the safety of these therapies and
      their potential impact on the uninfected infant.

      The overall goal of the project is to establish a voluntary exposure-registry and perform
      observational surveillance on HIV - positive pregnant women who are exposed to antiretroviral
      products during the prenatal period, in order to evaluate the outcome of the pregnancy and
      safety of the products in HIV-positive pregnant women, and their infants.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        HIV positive pregnant women attending ART clinics
      
Keywords: HIV; Pregnancy; Antiretrovirals; HIV Seronegativity; Treatment Experienced
A Study of the Safety and Effectiveness of Topiramate on Insulin Sensitivity in Overweight or Obese Patients With Type 2 Diabetes
Condition: Obesity; Diabetes Mellitus, Type 2; Diabetes Mellitus, Adult-Onset
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Overweight; Insulin Resistance
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to investigate (1) the effect of topiramate on insulin
      sensitivity in overweight or obese patients with type 2 diabetes mellitus and (2) the safety
      of topiramate in type 2 diabetic patients. The study will also investigate the effect of
      topiramate on body weight, body fat, fat distribution, and metabolic control including both
      glucose and lipid levels.
    

Detailed description: 
      Topiramate is not approved for the treatment of obesity. This double-blind, placebo
      controlled study investigates the effect of topiramate on insulin sensitivity in overweight
      or obese patients with Type 2 Diabetes. After a screening phase, patients are randomized to
      receive either topiramate (96 milligrams[mg] twice daily) or placebo for 9 months in the
      double-blind phase. After 9 months, patients have the option to continue in the open-label
      phase and receive treatment with topiramate for 1 year. Patients in the placebo group then
      receive topiramate with dosage increasing gradually to 96 mg twice daily, with the option of
      increasing to 256 mg twice daily. Patients in the topiramate group continue with the
      maintenance dose received during the double-blind phase, with the option of increasing to 256
      mg twice daily. Assessments of effectiveness made monthly include insulin sensitivity, body
      composition (as measured by computed tomography [CT]), body weight and Body Mass Index (BMI),
      waist and hip circumferences, fasting lipid profile, fasting glucose and hemoglobin type A1c
      (HbA1c) levels, and blood pressure. Safety evaluations, including incidence of adverse
      events, clinical laboratory results, vital signs, and electrocardiograms [ECGs]), are
      performed throughout the study. The study hypothesis is that topiramate will improve insulin
      sensitivity in type 2 diabetic patients and will be well tolerated. Patients will be
      randomized to receive 192 mg/day (96mg twice daily) of topiramate, or placebo, per mouth for
      9 months, with an option of topiramate treatment increasing to 256mg/day both groups during
      the extension period of 1 year.
    

Intervention name(s): topiramate
Intervention type(s): Drug
Intervention MeSH terms: Topiramate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Type 2 Diabetes; Obesity; Insulin Resistance; Body Mass Index; Hypertension; Hyperlipidemia; Sulfonylurea; Topiramate; Adult-Onset Diabetes Mellitus; Metabolic Syndrome
Safety and Efficacy of Turoctocog Alfa in Haemophilia A Subjects
Condition: Congenital Bleeding Disorder; Haemophilia A
MeSH terms: Hemostatic Disorders; Hemophilia A; Blood Coagulation Disorders; Hemorrhage
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Asia, Europe, and North and South America. The trial consists of a
      main trial and a sub-trial. The main trial investigates safety and efficacy of turoctocog
      alfa (recombinant factor VIII, rFVIII (N8)) in haemophilia A subjects, while the sub-trial
      investigates safety and efficacy of turoctocog alfa in prevention and treatment of bleeding
      episodes during surgical procedures.
    


Intervention name(s): turoctocog alfa
Intervention type(s): Drug
Intervention description(s): Subjects will receive bleeding preventive treatment (home treatment with self-injection i.v.) with turoctocog alfa at a dose of 20-40 IU/kg body weight every second day or 20-50 IU/kg body weight three times per week at the investigator's discretion.
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pregabalin Reduce the Sevoflurane Requirement
Condition: Elective Laparoscopic Cholecystectomy; Sevoflurane Anesthesia
Study type: Interventional
Phase: Phase 2

Summary: 
      Preoperative administration of pregabalin would reduce the end tidal concentration of
      sevoflurane during laparoscopic cholecystectomy with added beneficial improving of the
      quality of postoperative analgesia.
    

Detailed description: 
      laparoscopic cholecystectomy is a painful and stressful surgical procedure. Pregabalin is a
      lipophilic structural analogue of the inhibitory γ-aminobutyric acid by binding to the
      presynaptic voltage-gated calcium channels that are widely distributed throughout the central
      and peripheral nervous system. Pregabalin has anticonvulsant, anxiolytic, sleep-modulating,
      anti-hyperalgesic, opioid-sparing6 and anti-allodynic properties through inhibition of the
      release of excitatory neurotransmitters such as glutamate, norepinephrine, serotonin,
      dopamine and substance P. These unique characteristics make pregabalin as a useful
      therapeutic for treating neuropathic pain and acute postoperative pain in several models of
      incisional injury and inflammatory conditions including laparoscopic cholecystectomy.
    

Intervention name(s): Placebo; pregabalin; pregabalin
Intervention type(s): Drug; Drug; Drug
Intervention description(s): to receive two identical placebo capsules 1 hr before surgery; one capsule of pregabalin 150 mg and one placebo capsule 1 hr before surgery; two capsules of pregabalin 150 mg 1 hr before surgery
Intervention MeSH terms: Pregabalin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anesthesia; pregabalin; sevoflurane; laparoscopic cholecystectomy
Bioavailability, Pharmacokinetics and Safety of ESR 1150 CL in Healthy Adult Male Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate the bioavailability of ESR 1150 CL by the time course determination of plasma
      concentration (pharmacokinetics) of no-transformed ESR 1150 after single administration to
      healthy adult male volunteers. Secondary objective is to investigate the safety of ESR 1150
      CL.
    


Intervention name(s): ESR 1150 CL, Capsule, oral; ESR 1150 CL, solution, intravenous
Intervention type(s): Drug; Drug
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fruquintinib Hepatic Impairment Study
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      An Open-label, Phase 1 Study to Assess the Effect of Hepatic Impairment on the
      Pharmacokinetics of Fruquintinib
    

Detailed description: 
      This is a multicenter open-label, single-dose, single-period, sequential study in subjects
      without cancer with the primary objective of determining the effect of moderate and mild
      hepatic impairment on the PK of fruquintinib. The secondary objective is to evaluate the
      safety in subjects with moderate and mild (if enrolled) hepatic impairment and subjects with
      normal hepatic function.

      Initially, subjects with moderate hepatic impairment will be enrolled. An interim
      pharmacokinetic (PK) analysis will be performed to evaluate the need to enroll subjects with
      mild hepatic impairment. Subjects with normal hepatic function will be enrolled after all
      other subjects have completed the study and will be matched for sex, age and body mass index.
      Subjects with hepatic impairment will be enrolled based on the hepatic function
      classification determined by Child-Pugh scoring.

      Subjects with moderate hepatic impairment will receive a single dose of 2 mg fruquintinib to
      account for potential increase in fruquintinib PK exposure. Subjects with mild hepatic
      impairment or normal hepatic function will receive a single dose of 5 mg fruquintinib.
    

Intervention name(s): Fruquintinib
Intervention type(s): Drug
Intervention description(s): Fruquintinib will be administered as a single oral dose on the morning of day 1 under fasting conditions
Other intervention name(s): HMPL-013
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Safety and Efficacy of a Metallic Cannula Versus A Standard Needle for Soft Tissue Augmentation of the Nasolabial Folds
Condition: Wrinkles
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study was to assess the safety and efficacy of a new metallic cannula to
      inject hyaluronic acid for dermal augmentation in the nasolabial folds compared to standard
      needle.
    

Detailed description: 
      This was a monocentric, prospective, randomized, phase II and double-blind study.

      At the baseline visits, one investigator rated the severity of nasolabial folds on both left
      and right sides according to the mentioned scale, and a standard set of six photographs of
      the face (frontal, left side and right side for both the whole face and the lower face) were
      taken.

      On the day of the injection, the main investigator injected 1ml of dermal filler - hyaluronic
      acid (Restylane®, Q-Med, Uppsala, Sweden) - for each subject. The injected amount was 0,5ml
      for the right nasolabial fold and 0,5ml for the left nasolabial fold. The sides will be
      randomized.
    

Intervention name(s): hyaluronic acid with metallic cannula or standard needle.; Hyaluronic acid injected with the new tool.
Intervention type(s): Procedure; Drug
Intervention description(s): The sides of injection were randomized and both the subject and the evaluator were blind to it. The injections were performed according through two different devices:
In one of the sides, the hyaluronic acid (Restylane®) was injected in its conventional pharmaceutical presentation, with a standard needle which is part of the product's kit;
In the other side, the hyaluronic acid (Restylane®) was injected through a metallic cannula, which replaced the needle of the product's kit.
Local analgesia was provided for both applications: topical analgesics 4% Lidocaine, for the application with the standard needle, and nerve block (Lidocaine 2%), where the application was performed with the metallic cannula.; hyaluronic acid with metallic cannula.
Other intervention name(s): Restylane; Restylane
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: metallic cannula; Hyaluronic acid
Hemodynamic Effects of Dexmedetomidine in Septic Shock
Condition: Septic Shock
MeSH terms: Shock, Septic; Shock
Study type: Interventional
Phase: Phase 3

Summary: 
      The current treatment regimen of patients with septic shock requires a sufficient hemodynamic
      support aiming to preserve tissue oxygen requirements and perfusion. Therefore, aggressive
      fluid challenge and vasopressor agents play a pivotal role. To increase total peripheral
      resistance and preserve organ perfusion, a continuous infusion of catecholamines is often
      needed. Because sepsis is usually associated with adrenergic receptor and post-receptor
      abnormalities, the efficacy of such treatment regimens often gradually decreases over time,
      thereby complicating hemodynamic support. Experimental evidence suggest that α-2 agonists
      increase pressor responsiveness following lipopolysaccharide administration. This study will
      assess the effects of the sedation with dexmedetomidine (α-2 agonist) on norepinephrine
      requirements in patients with septic shock.
    

Detailed description: 
      The present study was designed as a prospective study. All patients enrolled in the study
      will require norepinephrine to maintain MAP between 65 and 75 mmHg despite adequate volume
      resuscitation and will be sedated according to istitutional guidelines with propofol and
      remifentanyl. After 8 h had elapsed during stable hemodynamic conditions, an initial set of
      measurements will be obtained during the sedation with propofol and remifentanyl. This set of
      measurements will be considered as baseline. In the patients in which conventional sedation
      will be replaced by dexmedetomidine and remifentanyl, a second set of measurements will be
      obtained after 4 h had elapsed during stable conditions. A final set of mesurements will be
      obtained after another 8-h period in stable conditions after switcheing back again to
      propofol and remifentanyl, .

      During the observational period the dosage rate of norepinephrine will be adjusted to
      maintain the same threshold MAP of 65-75 mmHg All other medications were held constant.
    

Intervention name(s): Dexmedetomidine
Intervention type(s): Drug
Intervention description(s): Sedation with propofol and remifentanyl will be replaced by a sedation with dexmedetomidine and remifentanyl
Other intervention name(s): Dexdor
Intervention MeSH terms: Dexmedetomidine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment