bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Evaluate the Effect of Antacid and Multivitamin and Mineral Tablet on the Study Drug GSK1349572
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose is to study the effect of Maalox® and One A Day® on the pharmacokinetics of
      GSK1349572, and also to compare the safety of GSK1349572 when administered alone and when
      administered with Maalox® and One A Day®. There are four dosing periods in this study, each
      period requires a 4 night stay. A follow-up visit is also required at approximately 7 days
      after the last dose administration. Starting from the first period to the follow-up, it will
      take about 1 month. Screening visit is required to be completed within 30 days prior to the
      first dose.

      MAALOX® is a registered trademark of Novartic Consumer Health, LLC. ONE A DAY® is a
      registered trademark of Bayer Healthcare LLC.
    


Intervention name(s): GSK1349572 and MaaloxAdvanced Maximum Strength; GSK1349572 and Maalox Advanced Maximum Strength; GSK1349572 and One A Day; GSK1349572
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): A single dose of GSK1349572 co-administered with a single dose of 20 mL of Maalox Advanced Maximum Strength; A single dose of GSK1349572 administered 2 hours prior to administration of a single dose of 20 mL of Maalox Advanced Maximum Strength; A single dose of GSK1349572 50 mg co-administered with a single dose of a One A Day Maximum multivitamin; A single dose of GSK1349572
Intervention MeSH terms: Dolutegravir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Healthy Volunteers; Drug interation, Pharmacokinetics
Extension Study to Assess Long Term Safety, Tolerability, and Efficacy of Valsartan and Enalapril Combined and Alone in Children With Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this extension study is to compare the long-term safety of valsartan versus
      enalapril, and the effectiveness of the combination of valsartan and enalapril versus
      enalapril alone in children with hypertension.
    


Intervention name(s): Valsartan; Enalapril; placebo matched to enalapril; placebo matched to valsartan
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Valsartan (80, 160, and 320 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.; Enalapril (10, 20, and 40 mg, weight stratified). All study medications were taken orally once daily, at approximately the same time each day, with or without food.; Placebo matched to enalapril. All study medications were taken orally once daily, at approximately the same time each day, with or without food.; placebo matched to valsartan. All study medications were taken orally once daily, at approximately the same time each day, with or without food.
Intervention MeSH terms: Valsartan; Enalapril; Enalaprilat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: children; pediatrics; high blood pressure; hypertension; valsartan; enalapril
Cutaneous Remote Ischemic Preconditioning in Plastic Surgery
Condition: Ischemic Preconditioning
MeSH terms: Ischemia
Study type: Interventional

Summary: 
      Background: In plastic and reconstructive surgery, free flaps are routinely used for
      treatment of soft tissue defects. Treatment strategies aim at reducing or preventing flap
      necrosis by conditioning tissue tolerance against ischemia. Although previous studies
      indicate that remote ischemic preconditioning (RIPC) is a systemic phenomenon, only a few
      studies have focused on the elucidation of its mechanisms of action. Therefore, the aim of
      this study is to evaluate the microcirculatory effects of remote ischemic preconditioning on
      a potential free flap location in a human in-vivo setting for the first time.

      Conclusion: Remote ischemic preconditioning improves cutaneous tissue oxygen saturation,
      arterial capillary blood flow and postcapillary venous flow in a remote free flap donor
      location. To what extent remote preconditioning might ameliorate the reperfusion injury of
      free flap transplantation, further clinical trials have to evaluate both in the means of
      microcirculatory assessment and partial or total flap loss as end points of these studies.
    


Intervention name(s): remote ischemic preconditioning
Intervention type(s): Procedure
Intervention description(s): A standardized location for microcirculatory assessment was determined on the left leg of each participant between the proximal and distal third of a drawn line between the anterior superior iliac spine and the lateral aspect of the Patella.
The healthy subjects had to rest before starting data assessment in a horizontal position for 15 minutes. The probe was taped on the left upper leg in a standardized manner after localizing the measuring point. A blood pressure cuff was applied on the contralateral upper arm. Baseline data was assessed over 5 minutes before starting remote ischemia. Three circles of a five minute ischemia were applied at the contralateral right upper arm at suprasystolic levels. Parameters of microcirculation were assessed continuously over time. Microcirculation during the reperfusion phase was ascertained over 10 minutes after first and second remote ischemia and 15 minutes after the third remote ischemia.
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: remote ischemic preconditioning, free flap, microcirculation
Relation Between Renin-Angiotensin Gene Polymorphisms, Plasma Adiponectin and Arterial Stiffness in Renal Transplant Recipients
Condition: Vascular Diseases; Arterial Stiffness
MeSH terms: Vascular Diseases
Study type: Observational

Summary: 
      Relation between Renin-Angiotensin Gene Polymorphisms, Plasma Adiponectin and Arterial
      Stiffness in Renal Transplant Recipients
    


Time perspective: Prospective
Bilevel Versus Servoventilation in Complex Sleep Apnea
Condition: Complex Sleep Apnea; CPAP Induced Central Sleep Apnea
MeSH terms: Apnea; Sleep Apnea Syndromes; Sleep Apnea, Central
Study type: Interventional

Summary: 
      Randomized trial to evaluate the performance of Bilevel vs. Servoventilation in patients with
      complex sleep apnea during continuous positive airway pressure (CPAP) treatment.
    

Detailed description: 
      Patients with primary obstructive sleep apnea, who develop complex sleep apnea after CPAP
      treatment of 4-6 weeks duration were randomized to either receive Bilevel of Servoventilation
      treatment. Parameters of sleep as well as apnea-hypopnea indices are to be compared.
    

Intervention name(s): Bilevel therapy (somnovent ST 22, Weinmann, Hamburg, Germany); servoventilation (Somnovent CR, Weinmann, Hamburg, Germany)
Intervention type(s): Device; Device
Intervention description(s): nighttime positive airway therapy for 6 weeks; nighttime positive airway therapy for 6 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Sleep apnea; central sleep apnea; bilevel; servoventilation; CPAP
A Study of Safety, PK, & PD of ISIS 416858 Administered Subcutaneously to Patients With End-Stage Renal Disease on Hemodialysis
Condition: End-stage Renal Disease (ESRD)
MeSH terms: Kidney Diseases; Kidney Failure, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      Evaluation of safety, tolerability, PK and PD of ISIS 416858 in patients with end-stage renal
      disease (ESRD) receiving chronic hemodialysis.
    

Detailed description: 
      Evaluation of Safety, PK and PD of ISIS 416858 in patients with end-stage renal disease
      (ESRD) receiving chronic hemodialysis.

      The overall objectives are to evaluate the safety, tolerability, pharmacokinetics, and
      pharmacodynamics of ISIS 416858 in ESRD patients on hemodialysis.
    

Intervention name(s): ISIS 416858; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): subcutaneous injection; subcutaneous injection
Other intervention name(s): ISIS-FXI Rx; BAY2306001; IONIS-FXI Rx; 0.9% sterile saline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Hearing Preservation Using Dexamethasone and Hyaluronic Acid for Cochlear Implantation
Condition: Hearing Loss
MeSH terms: Hearing Loss
Study type: Interventional
Phase: Phase 2

Summary: 
      The objective of the present study is to investigate the effect dexamethasone and hyaluronic
      acid have on hearing preservation
    

Detailed description: 
      Many efforts have been made to prevent residual hearing loss after cochlear implantation,
      such as the development of soft surgical techniques and pharmacological protection.

      In this study we investigate whether the topical application of dexamethasone and hyaluronic
      acid prevents residual hearing loss.
    

Intervention name(s): Cochlear Implantation; Cochlear Implantation+dexamethasone; Cochlear Implantation+dexamethasone+hyaluronic acid
Intervention type(s): Device; Drug; Drug
Intervention description(s): Cochlear implantation using Hybrid L24 Implant; Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window; Cochlear implantation using Hybrid L24 Implant,dexamethasone (4mg/ml) in the round window and hyaluronic acid (10mg/ml) in the electrode array
Other intervention name(s): Hybrid L24 Implant; Hybrid L24 Implant; Dexamethasone (4mg/ml); Hybrid L24 Implant; Dexamethasone (4mg/ml); Hyaluronic acid (10mg/ml)
Intervention MeSH terms: Dexamethasone; Dexamethasone acetate; BB 1101; Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cochlear implantation; Dexamethasone; Acid, Hyaluronic
Superiority of Omega-3 Versus Placebo on the Improvement of ADHD in Children
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      This study aims to evaluate the efficacy of an Omega-3 Fatty Acid Supplement on improving the
      Attention Deficit Hyperactivity Disorder (ADHD) clinical symptoms.
    

Detailed description: 
      This is a multicenter, controlled, randomized, prospective, parallel-group, double-blind
      study to evaluate the effect of an Omega-3 Fatty Acid Supplement with EPA, DHA, vitamins E
      and D on ADHD clinical symptoms (according to Diagnostic and Statistical Manual for Mental
      Disorders, 4th. edition (DSM-IV-TR) criteria) in children between 6 and 11 years. Patients
      will be randomized to receive either the new omega-3 supplement or a placebo during 6 months.
    

Intervention name(s): Omega-3 Fatty Acids; Medium Chain Triglycerides
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Patients will receive a daily dose calculated based on the child weight (≤28 kg=4ml; 29-40 kg= 6ml and ≥41 kg=8ml) and will be provided once a day for 6 months.; Patients will receive a daily dose calculated based on the child weight (≤28 kg=4ml; 29-40 kg= 6ml and ≥41 kg=8ml) and will be provided once a day for 6 months.
Other intervention name(s): EPA/DHA; Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Omega-3; ADHD; Quality of Life; Inattention; Hyperactivity
Effect of Sevoflurane on the Onset Characteristics and Intubating Conditions of Rocuronium
Condition: Muscle Relaxation Caused by Sevoflurane
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the potentiation of muscle relaxation caused by rocuronium by
      inhalational agent sevoflurane. Half the patients will be ventilated with oxygen ,nitrous
      oxide and sevoflurane during induction of anaesthesia and half will be ventilated only with
      oxygen and nitrous oxide.
    

Detailed description: 
      Rocuronium is a non depolarizing muscle relaxant. Inhalational general anaesthetic agents
      like Sevoflurane have some muscle relaxation effect by depressing the spinal motor neurons.
      Inhalational anaesthetics also alter the tonic input received from descending modulatory
      systems from the brain. Deep anaesthesia with inhalational agents may cause some degree of
      neuromuscular blockade.
    

Intervention name(s): Sevoflurane; Rocuronium
Intervention type(s): Drug; Drug
Intervention description(s): Patients were ventilated with 2 % inspired concentration of sevoflurane in a fresh gas flow of 5 litres containing 66.6% nitrous oxide and 33.3% percent of oxygen; rocuronium 0.6mg per kg body weight was given intravenously after induction of anaesthesia
Other intervention name(s): Sevorane; Esmeron
Intervention MeSH terms: Sevoflurane; Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: sevoflurane; rocuronium; intubation
The Effect of Virtual Reality Glasses Used During Burn Dressing in Children on Pain, Anxiety and Fear
Condition: Randomized
Study type: Observational [Patient Registry]

Summary: 
      This work; It was planned as a randomized controlled study to determine the effect of
      watching cartoons with virtual reality glasses during burn dressing of children aged 5-10
      years who applied to the Training and Research Hospital Burn Unit Polyclinic on the feeling
      of pain, anxiety and fear in children.
    

Detailed description: 
      The study will be applied to children in the 5-10 group who will undergo burn dressing.
      During the dressing, children will be watched cartoons with virtual reality glasses and pain,
      anxiety and fear will be looked at before and after the dressing. The children in the control
      group will be given routine applications of the clinic.
    

Intervention name(s): Experimental group
Intervention type(s): Other
Intervention description(s): Experimental group: 26 control group group: 26
Other intervention name(s): control group
Observational model: Other
Time perspective: Other
Sampling method: Probability Sample
Study population: 
        In order to determine the number of samples, power analysis was performed using the G*power
        program. The effect size coefficient was calculated by using the Newcastle satisfaction
        scale averages in source 1 (thesis), and the effect size = 0.76, and it was decided to
        recruit at least 26 people in each group in order to obtain 80% power at the ɑ=0.05 level,
        a total of 52 people in the two groups.
Antimanic Drug Use in Pregnancy
Condition: Bipolar Disorder; Pregnancy
MeSH terms: Bipolar Disorder
Study type: Observational

Summary: 
      The purpose of this study is to learn about the effects of bipolar disorder or the use of
      antimanic medications on the mother's health and wellbeing during pregnancy and for the first
      postpartum year. Infant health and development are also assessed during the first year.
      Participation in the study includes 7 study visits, three in pregnancy and four postpartum.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Age 18 or older Pregnant at 20 weeks or more English-speaking DSM-IV diagnosis of BP, any
        subtype
      
Keywords: Bipolar Disorder; Pregnancy; Infant Development
Food Supplement Physiomanna® Baby in Pediatric Patients
Condition: Irritable Bowel Syndrome Characterized by Constipation
MeSH terms: Irritable Bowel Syndrome; Constipation
Study type: Interventional

Summary: 
      The primary objective is to assess the efficacy and safety of the Food Supplement
      Physiomanna® Baby in pediatric patients with a history of functional constipation

      The secondary objective of the trial is to evaluate the adherence to product's administration
      in the enrolled children.
    

Detailed description: 
      This is an interventional, non-controlled, multicenter trial with a prospective design in one
      cohort of patients. This clinical investigation will be performed in 3 centers in Romania.

      The tested hypothesis is that Physiomanna® Baby administration for 3 weeks, increases the SBM
      to be more than 2 times per week.
    

Intervention name(s): Physiomanna® Baby
Intervention type(s): Dietary Supplement
Intervention description(s): Dosage 1g/kg body, 2 cycles (if applicable)
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: childhod constipation
Surveillance of Cardiovascular Risk Factors in Cameroonian Garrison
Condition: Cardiovascular Risk Factor
Study type: Observational [Patient Registry]

Summary: 
      Purpose: The objective of our study was to assess the cardiovascular risk of a Cameroonian
      military population and compare it to the cardiovascular risk of the neighboring civilian
      population.

      Patients and methods: We will conduct a cross-sectional study that involved subjects aged
      from 18 to 58 years, recruited from October 2017 to November 2018 at the Fifth Military
      Sector Health Center in Ngaoundéré. Data collection and assessment was done according to
      World Health Organization STEPS manual for surveillance of risk factors of Non-communicable
      chronic diseases; and the Alcohol Use Disorders Identification Test. Five cardiovascular risk
      factors were assessed, smoking, harmful alcohol consumption, obesity/overweight, hypertension
      and diabetes. Cardiovascular risk was considered high in subjects with three or more
      cardiovascular risk factors. Univariates analysis and multivariate logistic regression were
      carried out according to their indications.
    


Intervention name(s): STEPS and AUDIT questionnaires
Intervention type(s): Diagnostic Test
Intervention description(s): assessment was done according to World Health Organization STEPS manual for surveillance of risk factors of Non-communicable chronic diseases; and the Alcohol Use Disorders Identification Test. Five cardiovascular risk factors were assessed, smoking, harmful alcohol consumption, obesity/overweight, hypertension and diabetes. Cardiovascular risk was considered high in subjects with three or more cardiovascular risk factors.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The subjects of our study were recruited according to two methods at the Military Medical
        Center of Sector N°5 in Ngaoundere.

        Participation in the study was proposed to any soldier who attended the Military Medical
        Center of Sector N°5 for the annual re-engagement medical visit during the period from
        January 1, 2017 to November 13, 2018.

        The civilian populations were recruited from two free cardiovascular risk factors screening
        campaigns carried out from January 04, 2017 to January 10, 2017 and from November 12, 2018
        to November 18, 2018. These campaigns were open to soldiers wishing to participate.
      
Keywords: prevention; non-communicable disease; cardiovascular diseases; cardiovascular risk; soldiers
S1 Plus Anlotinib in Treating Patients With Refractory or Relapsed Small-cell Lung Cancer
Condition: Small Cell Lung Cancer Recurrent
MeSH terms: Lung Neoplasms; Small Cell Lung Carcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy and safety of S1 combination with
      Anlotinib in patients with small cell lung cancer whose cancer has progression or recurrence
      after at least one standard chemotherapy.
    

Detailed description: 
      Although SCLC is very responsive to initial treatment, most patients relapse with relatively
      resistant disease.These patients have a median survival of only 4 to 5 months when treated
      with further systemic therapy. Improvements in therapy for relapsed SCLC are much needed.The
      purpose of this study is to assess the efficacy and safety of S1 combination with Anlotinib
      in patients with small cell lung cancer whose cancer has progression or recurrence after at
      least one standard chemotherapy.
    

Intervention name(s): S1/Anlotinib
Intervention type(s): Drug
Intervention description(s): Anlotinib 12mg qd, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until maximum 6 cycles； S1 60mg bid, day 1 to day 14 followed by 7 days off treatment in a 21-day cycle until it can not tolerate, or disease progression.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparing Weaning of Nasal Continuous Positive Airway Pressure (CPAP) From Preterm Infants
Condition: Respiratory Distress Syndrome
MeSH terms: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn
Study type: Interventional

Summary: 
      To compare the 2 methods of weaning of nasal continuous positive airway pressure (CPAP) in
      premature babies born between 26 and 32 weeks
    

Detailed description: 
      To study the weight and the post menstrual age (PMA) at the time of NCPAP wean utilizing the
      method of sudden wean as compared to gradual wean.

      Methods: A prospective randomized trial was conducted comparing sudden weaning with gradual
      weaning from NCPAP in neonates with gestational age between 26 and 32 weeks. The patients
      were randomized to one of the two methods of weaning from NCPAP and their success was
      compared
    

Intervention name(s): Gradual pressure wean
Intervention type(s): Other
Intervention description(s): NCPAP will be removed by gradually decreasing pressure over 24 hours once the weaning is decided
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: weaning; NCPAP; Preterm; sudden wean; gradual pressure off wean
Evaluation of Changes in Bowel Movement Frequency Following the Consumption of PHGG in Adults With Constipation
Condition: Constipation - Functional
MeSH terms: Constipation
Study type: Interventional

Summary: 
      Evaluation of Changes in Bowel Movement Frequency Following the Consumption of Partially
      Hydrolyzed Guar Gum (PHGG) in Adults with Constipation
    


Intervention name(s): PHGG; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): PHGG; Maltodextrin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Other