bioihbjkbjnl/mcl2 huggingface dataset:
Pharmacokinetic Study on Raltegravir and Lamotrigine
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine whether interactions between raltegravir and
      lamotrigine take place and to study the safety of the combination raltegravir/lamotrigine
      before used in HIV patients.
    

Detailed description: 
      Lamotrigine is an anticonvulsive drug that is used both for the treatment of HIV-associated
      neuropathic pain and the treatment of epilepsy in HIV-infected individuals. Lamotrigine is
      metabolized via glucuronidation.

      Raltegravir is a newly developed integrase inhibitor that is also metabolized via
      glucuronidation.

      Since both agents are metabolized via glucuronidation, there is a possibility of competition
      for glucuronidation, leading to drug-drug interactions between raltegravir and lamotrigine.

      This primary objective of this study is to determine the effect of raltegravir on the
      pharmacokinetics of single dose lamotrigine (by intrasubject comparison). A secondary
      objective is to determine the effect of single dose lamotrigine on the pharmacokinetics of
      raltegravir when compared to historical controls. Another secondary objective is to evaluate
      the safety of combined use of single dose lamotrigine and raltegravir.
    

Intervention name(s): lamotrigine; Raltegravir
Intervention type(s): Drug; Drug
Intervention description(s): 100 mg; 400 mg BD
Other intervention name(s): Lamictal
Intervention MeSH terms: Raltegravir Potassium; Lamotrigine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: interactions; neuropathic pain; pharmacokinetics
Magic Camp for Children With Hemiplegic Cerebral Palsy
Condition: Cerebral Palsy
MeSH terms: Paralysis; Cerebral Palsy
Study type: Interventional

Summary: 
      The proposed study will test the feasibility and effectiveness of a "Magic Camp" in children
      with spastic hemiplegic cerebral palsy (CP). A single group pretest-posttest design (n=10)
      will be used to investigate the immediate (2 weeks) and longer-term effect (3 months) of a
      "Magic Camp" on improving upper limb motor function and health-related quality of life
      (HRQoL) in children with hemiplegic CP.
    

Detailed description: 
      This project will employ a single group pretest-posttest design to investigate the impact of
      a "Magic Camp" on the improvement in upper limb motor function, health-related quality of
      life, and emotional stress among children with spastic hemiplegic CP. After the baseline
      evaluation, eligible participants will complete one-on-one "magic trick" training 3-hours per
      day for 2 consecutive weeks. The primary outcome measures will be unimanual function as
      measured by the Jebsen Taylor Test of Hand Function, bimanual coordination as measured by
      kinematic parameters using motion analysis, and spontaneous use of the more affected limb in
      real-life activities that demand the use of both hands as measured by the Children's Hand
      Experience Questionnaire. Secondary outcome measures will include HRQoL as measured by the
      Cerebral Palsy Quality of Life Questionnaire, in-depth dyad qualitative interviews of the
      caregivers and children, and emotional stress as measured by the fingernail cortisol levels.
    

Intervention name(s): Magic camp intervention
Intervention type(s): Behavioral
Intervention description(s): Hand-arm bimanual motor skills training
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: motor training for cerebral palsy
Bioequivalence Study Comparing Calcium Acetate Oral Solution Versus Calcium Acetate Gelcaps in Healthy Volunteers
Condition: Hyperphosphatemia
MeSH terms: Hyperphosphatemia
Study type: Interventional
Phase: Phase 1

Summary: 
      To compare the bioequivalence of calcium acetate oral solution vs. calcium acetate gelcaps in
      healthy volunteers with calcium citrate as a positive control.
    


Intervention name(s): Calcium Acetate Oral Solution 667 mg per 5 mL; Calcium Acetate 667 mg GelCaps; Calcium Citrate 950 mg Caplets
Intervention type(s): Drug; Drug; Dietary Supplement
Intervention description(s): Drug: Calcium acetate oral solution 667 mg calcium acetate, USP per 5 mL (169 mg of elemental calcium per 5 mL); Dosage: 30 mL of calcium acetate oral solution; Dosage frequency: three times per day with meals; Duration: 3 days and the morning of day 4, in total ten doses; Drug: PhosLo GelCaps (calcium acetate) 667 mg (169 mg of elemental calcium per gelcap); Dosage: 6 gelcaps; Dosage frequency: three times per day with meals; Duration: 3 days and the morning of day 4, in total ten doses.; Drug: Calcium Citrate 950 mg Caplets (200 mg of elemental calcium per caplet); Dosage: 5 caplets; Dosage frequency: three times per day with meals; Duration: 3 days and the morning of day 4, in total ten doses
Intervention MeSH terms: Calcium, Dietary; Calcium; Calcium acetate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bioequivalence
Efficacy and Safety of Artemisinin-based Combination Treatments in the Democratic Republic of the Congo
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 4

Summary: 
      The Democratic Republic of the Congo (DRC) is among the countries most affected by malaria in
      Sub-Saharan Africa. Condidering its size and the geographic position, the DRC is meant to
      play a major role in the malaria control in the region. The National Malaria Control program
      recommends artemisinin-based combination treatments (ACTs), in particular
      artesunate-amodiaquine or artemether-lumefrantrine for the treatment of uncomplicated
      malaria. Previous studies indicated that ACTs are still effective, with efficacy above the
      required threshold of 90%. It is required to assess regularly the efficacy of antimalarial
      drugs, in order to ascertain the relevance of treatment guidelines such that, in case of
      increasing failure rates, alternative options can be decided ontime.

      The purpose of this trial is to assess efficacy and safety of artesunate-amodiaquine (ASAQ
      Winthrop®), artemether-lumefantrine (Coartem Dispersible®) and
      dihydro-artemisinin-piperaquine (Eurartesim®) at day 42 in the treatment of uncomplicated
      Plasmodium falciparum malaria in six surveillance sites around DRC.
    

Detailed description: 
      This is a phase 4, randomized, open labelled clinical trial, aiming to assess efficacy and
      safety of 3 ACTs in the treatment of uncomplicated malaria in the Democratic Republic of the
      Congo. Children diagnosed with uncomplicated Plasmodium falciparum uncomplicated malaria will
      be randomized and followed-up during 42 days.
    

Intervention name(s): artesunate-amodiaquine; artemether-lumefantrine; Dihydroartemisinine-piperaquine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Tablets containing 25 mg of artesunate and 67.5 mg of amodiaquine: one tablet daily for three days children weighing 4.5 to 8 kg, and tablets containing 50 mg of artesunate and 135 mg of amodiaquine: one tablet daily for three days for children weighing 9 to 17 kg.; Tablets containing 20 mg of Artemether and 120 mg of Lumefantrine. Each dose to be taken with high-fat food or drinks (for example milk).
One tablet twice daily for children weighing 5 to <15 kg, two tablets twice daily for those weighing 15 to <25 kg and three tablets twice daily for those weighing 25 to < 35 kg, for three days.; Tablets containing 20 mg of dihydroartemisinine and 160 mg of piperaquine. Half a tablet once daily for children weighing 5 to <7 kg, one tablet once daily for those weighing 7 to <13 kg, and two tablets once daily for those weighing 13 to <24 kg, for three days.
Other intervention name(s): artesunate-amodiaquine Winthrop®; Coartem®; Eurartesim®
Intervention MeSH terms: Artesunate; Lumefantrine; Artemether; Piperaquine; Artemether, Lumefantrine Drug Combination; Amodiaquine; Artenimol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Malaria, efficacy, safety, ACT, DR Congo
Immediate Effects Of Alliance Therapy In Modulation Of Pain And Disability In Subjects With Knee Osteoarthritis
Condition: Arthritis; Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional

Summary: 
      INTRODUCTION: The Osteoarthritis (OA) is the most common type of joint disease, its features
      include joint space narrowing, osteophytes formation of the joint margins, motor deficit,
      reduced strength, and persistent pain. As a treatment option physiotherapy has several
      resources for the patient approach. However, the effect of treatment is not only the
      application of therapeutic techniques and resources but also to existing contextual factors
      such as the therapeutic alliance. OBJECTIVE: To assess the effects of an intervention with
      the focus on positive therapeutic alliance in subjects OA knee on pain and disability.
      METHODS: This is a randomized study of two arms with a blind evaluator. 40 subjects were
      randomized into 2 groups: group 1 "Kinesio Taping® KT" group 2 " Kinesio Taping® with
      therapeutic alliance KT+AT". Both groups received the application of Kinesio Taping® method
      as the concepts of the original method. The group "KT+AT" session was conducted in order to
      increase the relationship between the therapist and the patient.
    


Intervention name(s): Kinesio Taping and therapeutic alliance
Intervention type(s): Other
Intervention description(s): bandage used in the treatment of orthopedic diseases and the technique of therapeutic approach in the known patient with therapeutic alliance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Heliox in Preterm Infants With Respiratory Distress Syndrome
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Syndrome
Study type: Interventional

Summary: 
      Heliox can lower respiratory resistance, improve the oxygenation, reduce respiratory distress
      and lung injury caused by mechanical ventilation.
    

Detailed description: 
      Heliox can improve the oxygenation, reduce respiratory distress and lung injury caused by
      mechanical ventilation.

      Heliox has not been widely used. More studies on the effects and safety of Heliox in addition
      to NIPPV and mechanical ventilation should be tried.
    

Intervention name(s): heliox
Intervention type(s): Other
Intervention description(s): heliox or oxygen is used in the two groups respectively
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Study of LY2951742 in Participants With Migraine
Condition: Migraine Headache
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the efficacy and safety of LY2951742 in the prevention of migraine headache in
      migraineurs with or without aura during 3 months of treatment.
    

Detailed description: 
      The study is comprised of 4 trial periods:

        1. Screening and washout (5-45 days)

        2. Baseline for assessment of the type, frequency, and severity of headaches (28-38 days)

        3. Treatment (12 weeks)

        4. Follow-up (12 weeks)
    

Intervention name(s): LY2951742; Placebo
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effects of Medium Chain Triglyceride Oil, Versus Olive Oil, for Weight Loss
Condition: Overweight
MeSH terms: Overweight; Weight Loss
Study type: Interventional

Summary: 
      The primary aim of this research project is to determine whether the incorporation of food
      products containing medium chain triglyceride (MCT) oil in a weight-loss program results in a
      different degree of weight-loss and total and regional fat mass loss than the incorporation
      of extra light olive oil. The secondary goals are to test whether there are differences in in
      metabolic risk profile changes between the 2 diets. We hypothesize that men and women who
      consumed MCT oil as part of their weight loss program will lose more weight and body fat than
      those who consume olive oil in their weight loss diet.
    


Intervention name(s): Weight loss
Intervention type(s): Dietary Supplement
Intervention description(s): Weight loss study including consumption of either 22-25 g of medium chain triglyceride oil or olive oil
Other intervention name(s): MCT oil, Neobee 1053, Stepan Company
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Overweight; Obesity; Weight loss; Medium chain triglycerides; Cardiovascular disease risk
Effect of Homogenization and Pasteurization of Milk on the Stomach Problems in Adults
Condition: Unidentified Stomach Discomfort Following Dairy Consumption
Study type: Interventional

Summary: 
      This study aims to investigate differences in digestion rates and stomach problems caused by
      pasteurized and homogenized milk compared with raw milk in healthy adults by ingestible
      capsule that measures pH and pressure, diary of symptoms, blood glucose and triacylglycerol
      levels and plasma cytokine levels.
    


Intervention name(s): Dietary intervention
Intervention type(s): Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Safety and Immunogenicity Study of a Booster Dose of GSK Biologicals' 10-valent Pneumococcal Conjugate Vaccine.
Condition: Infections, Streptococcal
MeSH terms: Streptococcal Infections
Study type: Interventional
Phase: Phase 3

Summary: 
      This study will evaluate the safety, reactogenicity and immunogenicity of a booster dose of
      GSK Biologicals' pneumococcal conjugate vaccine compared to Prevenar™ given at 12-18 mo of
      age to children primed with either pneumococcal vaccine or Prevenar™ in study 105553.
      Antibody persistence will be evaluated at 8-14 mo after completion of the 3-dose immunization
      course in study 105553 (NCT00307554). The immune response to a booster dose of GSK
      Biologicals' pneumococcal conjugate vaccine will also be evaluated when given at 12-18 mo to
      subjects not primed with GSK Biologicals' vaccine but with Prevenar™.

      The study has 3 groups. 1 group of children primed with GSK Biologicals' pneumococcal
      conjugate vaccine will receive a booster dose of the same vaccine. 2nd group of children
      primed with Prevenar™ will receive a booster dose of Prevenar™ (control group). 3rd group of
      children primed with Prevenar™ will receive a booster dose of GSK Biologicals' pneumococcal
      conjugate vaccine. All children will receive concomitantly a booster dose of DTPa-HBV-IPV/Hib
      vaccine.
    


Intervention name(s): Synflorix; Prevenar; Infanrix hexa
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 1 dose injected IM in the right thigh or deltoid.; 1 dose injected IM in the right thigh or deltoid.; 1 dose injected IM in the right thigh or deltoid.
Other intervention name(s): 10 valent pneumococcal conjugate (vaccine)
Intervention MeSH terms: Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Primary purpose: Prevention
Keywords: Streptococcus pneumonia, pneumococcal conjugate vaccine
The Use of TrIple Fixed-dose Combination in the Treatment of Arterial Hypertension
Condition: Arterial Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      The use of TRIple fixed-dose COmbination in the treatment of arteriaL hypertension:
      opportunity for effective BP control with cOmbined antihypertensive therapy.

      The main aim of this study to assess the antihypertensive effectiveness effect on the 24-hour
      BP profile, as well as tolerability of and compliance to the treatment with a triple FDC of
      amlodipine / indapamide / perindopril arginine in hypertensive patients in the real clinical
      practice.

      Type of program: Multicenter, observational, non-controlled, open-label program.

      Investigators: Cardiologists and outpatient (primary care) physicians (general
      practitioners).

      Number of patients: 1,300 hypertensive patients.
    

Detailed description: 
      It is multicenter, observational, non-controlled, open-label program. The baseline
      characteristics will be analyzed in all the patients who started the treatment
      (intention-to-treat [ITT] population). In case of significant differences between two
      treatment groups, the baseline characteristics will be provided for both of them.

      Changes in the SBP and DBP (with the corresponding confidence intervals) will be assessed in
      the patients who completed the program without major deviations from protocol (per-protocol
      population [PPP]).

      The analysis of parameters with normal distribution will be performed using the Student's
      t-test for paired measurements; otherwise the non-parametric Wilcoxon test will be used. The
      percentage of patients with normalized BP, as well as the percentage of patients who
      responded to treatment (with 95% confidence intervals), will be calculated.

      Questionnaires: The score for each scale will be calculated as the sum of scores for
      questions constituting the scale.

      Assessment of the AEs will be carried out in all the patients who started the treatment (ITT
      population).
    

Intervention name(s): amlodipine / indapamide / perindopril arginine FDC
Intervention type(s): Drug
Intervention description(s): CCB / diuretic / ACE inhibitor
Other intervention name(s): CCB / diuretic / ACE inhibitor
Intervention MeSH terms: Amlodipine; Perindopril; Indapamide; Indapamide, perindopril drug combination; Diuretics; Angiotensin-Converting Enzyme Inhibitors
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with uncontrolled arterial hypertension who needs triple antihypertensive
        combinations in a single tablet
Metabolic Effects of Egg Protein and Unsaturated Fat Intakes in Subjects With Hypertriglyceridemia
Condition: Hypertriglyceridemia
MeSH terms: Hypertriglyceridemia
Study type: Interventional

Summary: 
      The goal of this study is to evaluate the effects of replacing some refined starches and
      added sugars with a combination of egg protein and unsaturated fatty acids on markers of
      cardiometabolic health in men and women with hypertriglyceridemia.
    

Detailed description: 
      The objective of this study is to evaluate the effects of a combination of egg protein and
      unsaturated fatty acids acting as substitutes for ~16% of energy from refined carbohydrate on
      the metabolic profile of men and women with elevated triglycerides. This is a randomized,
      controlled feeding, crossover trial that includes two screening/baseline visits, two 3-week
      treatment conditions, and a 2-week washout phase. Subjects consume a standardized background
      diet (7-day rotating menu) that incorporates at least 3 servings/day of study test foods,
      providing 40-60% of subjects' daily energy needs. Study test foods consist of yogurt,
      muffins, waffles, and cookies. The test foods account for 8% higher protein energy (from egg
      protein) and 8% higher fat energy (from unsaturated fatty acids) in the Active Condition
      compared to the Control Condition. In the Control Condition, the study foods account for 16%
      higher carbohydrate energy. The overall macronutrient composition of each condition is as
      follows: Active Condition, approximately 42/23/35% kcal from carbohydrate/protein/fat,
      respectively, and Control Condition, approximately 58/15/27% kcal from
      carbohydrate/protein/fat, respectively. Blood samples will be collected at baseline and end
      of treatment for measurement of metabolic parameters, and a liquid meal tolerance test (LMTT)
      will be conducted at baseline and the end of each treatment period.
    

Intervention name(s): Egg protein/unsaturated fatty acid; Control
Intervention type(s): Other; Other
Intervention description(s): Study test foods (yogurt, muffins, waffles, and cookies) containing 8% higher protein energy (egg protein) and 8% higher fat energy (unsaturated fatty acids) than Control; Study test foods (yogurt, muffins, waffles, and cookies) containing 16% higher carbohydrate energy than Egg protein/unsaturated fatty acid
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Egg; Protein; Unsaturated fatty acids; Triglycerides; Insulin sensitivity; Lipid triad
Standard Antibiotic Versus Enhanced Prophylactic Measures on Rate of Urinary Tract Infection After Flexible Ureteroscopy
Condition: Urinary Tract Infections
MeSH terms: Infections; Communicable Diseases; Urinary Tract Infections
Study type: Interventional

Summary: 
      Background and aim: Urinary tract infections (UTIs) are commonly seen after flexible
      ureteroscopy. Prevention of UTIs remains controversial. The present randomized study aimed to
      compare the rate of post-procedural UTI in patients subjected to the standard antibiotic
      prophylaxis alone versus enhanced prophylactic measures.

      Patients and methods: The study included 100 patients subjected to fURS for management of
      ureteral and/or renal stones. Patients were equally and randomly allocated into one of the
      two treatment groups using randomly computer-generated allocation tables and concealed
      envelope technique. Treatment groups included standard antibiotic prophylaxis group and
      enhanced prophylaxis group. Patients in the standard antibiotic prophylaxis group IV
      fluoroquinolone 1 hour preoperatively and oral antibiotics were used for 24h postoperatively.
      In the enhanced prophylaxis group, patients had urine culture 10 days before the procedure.
      In addition to the antibiotic prophylaxis, hydrophilic-coated ureteral access sheaths were
      systematically used.
    


Intervention name(s): IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively.; Urine culture, antibiotic prophylaxis and hydrophilic-coated ureteral access sheaths
Intervention type(s): Drug; Other
Intervention description(s): IV fluoroquinolone 1 hour preoperatively and oral antibiotics for 24h postoperatively.; Patients had urine culture 10 days before the procedure. In addition to the antibiotic prophylaxis, hydrophilic-coated ureteral access sheaths were systematically used.
Intervention MeSH terms: Anti-Bacterial Agents; Fluoroquinolones; Antibiotics, Antitubercular
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention