bioihbjkbjnl/mcl2 huggingface dataset:
Cervical Ripening With Cook Catheter Plus Low Dose Oxytocin
Condition: Cervical Ripening
Study type: Interventional

Summary: 
      The purpose of this study is to compare if using a Cook Cervical Ripening Balloon in
      conjunction with low dose oxytocin is more effective at shortening labor induction times than
      the Cook Cervical Ripening Balloon alone. After obtaining consent, patients will be randomly
      divided into a Balloon with oxytocin or Balloon only group. The Balloon will be placed by
      either Resident or Attending Physicians and left in place for 12 hours (protocol) in both
      groups or until it falls out. After either 12 hours or the Balloon falls out, oxytocin will
      be used for the remainder of the induction per current hospital protocol. Time to delivery,
      mode of delivery, average number of hours Balloon remained in place, non-reassuring fetal
      heart tracings, adverse outcomes (ie fetal malpresentation, postpartum hemorrhage) will be
      recorded.
    


Intervention name(s): Cook catheter; Oxytocin
Intervention type(s): Device; Drug
Intervention MeSH terms: Oxytocin
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Stryker Triathlon® Cruciate Substituting vs. Posterior Stabilized Outcomes Study
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Observational

Summary: 
      This study compares the clinical and radiographic outcomes obtained with the use of the
      Stryker Triathalon® Cruciate Substituting (CS) and Posterior Stabilized (PS) tibial inserts.
    


Intervention name(s): Stryker Triathlon® CS Tibial Insert; Stryker Triathlon® PS Tibial Insert
Intervention type(s): Device; Device
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adult patients undergoing total knee arthroplasty
      
Keywords: Osteoarthritis; Total Knee Replacement; TKA; Knee; PS; CS
The HEADWIND Study - Part 2
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Hypoglycemia; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      To analyse driving behavior of individuals with type 1 diabetes in eu- and progressive
      hypoglycaemia while driving in a real car. Based on the driving variables provided by the car
      the investigators aim at establishing algorithms capable of discriminating eu- and
      hypoglycemic driving patterns using machine learning neural networks (deep machine learning
      classifiers).
    

Detailed description: 
      Hypoglycaemia is among the most relevant acute complications of diabetes mellitus. During
      hypoglycaemia physical, psychomotor, executive and cognitive function significantly
      deteriorate. These are important prerequisites for safe driving. Accordingly, hypoglycaemia
      has consistently been shown to be associated with an increased risk of driving accidents and
      is, therefore, regarded as one of the relevant factors in traffic safety. Despite important
      developments in the field of diabetes technology, the problem of hypoglycaemia during driving
      persists. Automotive technology is highly dynamic, and fully autonomous driving might, in the
      end, resolve the issue of hypoglycemia-induced accidents. However, autonomous driving (level
      4 or 5) is likely to be broadly available only to a substantially later time point than
      previously thought due to increasing concerns of safety associated with this technology.
      Therefore, solutions bridging the upcoming period by more rapidly and directly addressing the
      problem of hypoglycemia-associated traffic incidents are urgently needed.

      On the supposition that driving behaviour differs significantly between euglycaemic state and
      hypoglycaemic state, the investigators assume that different driving patterns in hypoglycemia
      compared to euglycemia can be used to generate hypoglycemia detection models using machine
      learning neural networks (deep machine learning classifiers).
    

Intervention name(s): Controlled hypoglycaemic state while driving
Intervention type(s): Other
Intervention description(s): Participants will drive on a designated circuit with a real car on a test track accompanied by a driving instructor. Driving data will be recorded in 4 subsequent glycemic states using an adapted hypoglycemic clamp protocol: euglycemia (d1, 5-8 mmol/l), progressive hypoglycaemia (d2, declining from 4.5 to 2.5 mmol/l), stable hypoglycemia (d3, 2.0-2.5 mmol/l), and again in euglycaemia (d4, 5-8 mmol/l). Patients will be blinded to their glucose levels.
Intervention MeSH terms: Hypoglycemic Agents
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Automotive Technology; Hypoglycemia; Hypoglycaemia; Driving; Car
Effect of Liraglutide on Heart Frequency in Healthy Volunteers
Condition: Diabetes; Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in the United States of America (USA). The aim of this trial is to
      investigate if liraglutide effects the QTc interval. Moxifloxacin (Avelox®) is administered
      as positive control.
    


Intervention name(s): liraglutide; placebo; moxifloxacin; placebo; electrocardiogram (ECG); electrocardiogram (ECG)
Intervention type(s): Drug; Drug; Drug; Drug; Procedure; Procedure
Intervention description(s): 0.6 mg daily for 7 days followed by 1.2 mg daily for 7 days followed by 1.8 mg daily for 7 days. Injected subcutaneously. Subjects are randomly allocated to two treatment sequences; Injected subcutaneously. Subjects are randomly allocated to two treatment sequences; Following the double-blinded period and a wash-out period of 7 days, subjects are re-randomised to an open-label, parallel period where a single dose of 400 mg moxifloxacin (tablets) is administered as positive control; Following the double-blinded period and a wash-out period of 7 days, subjects are re-randomised to an open-label, parallel period where single dose of oral placebo is administered; 24 hours serial ECG is collected before initial dose of 0.6 mg liraglutide, on the last dosing day of 1.2 mg liraglutide and on the last dosing day of 1.8 mg liraglutide; Six hours after moxifloxacin or placebo single dose, 1 hour serial ECG is collected
Intervention MeSH terms: Liraglutide; Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Comparative Study of the Efficacy and Safety of Muscarinic M3 Receptors Antagonists in the Treatment of Neurogenic Detrusor Overactivity
Condition: Spinal Cord Injury; Neurogenic Detrusor Overactivity
MeSH terms: Spinal Cord Injuries; Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a phase IV, double-blind, multicenter, randomized trial evaluating the efficacy and
      safety of two M3 receptors antagonists (Trospium Chloride and Darifenacin Hydrobromide) with
      one standard drug (Oxybutynin Chloride) for treatment of overactive bladder in individuals
      with spinal cord injury.
    


Intervention name(s): Oxybutynin Cl; Trospium Cl; Darifenacin Hydrogen Bromide (HBr)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 15 mg qd for 3 months; 20mg bid for 3 months; 15 mg qd for 3 months
Other intervention name(s): Uromax; Trosec; Enablex
Intervention MeSH terms: Bromides; Oxybutynin; Darifenacin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
n-3 and n-6 Fatty Acids in Rheumatoid Arthritis
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 2

Summary: 
      Purpose: To investigate into the differential effects of polyunsaturated fatty acids as
      compared to standard control therapy (olive oil) on disease activity and biochemical
      parameters in patients with rheumatoid arthritis (RA), resp. psoriasis arthritis (PA).
    

Detailed description: 
      Methods: Double-blinded, four-armed randomised controlled trial with 3.0 g/d of either n-3
      long chain polyunsaturated fatty acids (LC-PUFA) or gamma linolenic acid (GLA), resp. the
      combination of 1.5 g/d of each, resp. 3.0 g/d of olive oil over 12 weeks. Outcome parameters
      disease activity score (DAS28), C-reactive protein, concentrations of n-3 LC-PUFA, resp. GLA
      in plasma lipids (PL), cholesterol esters (CE), and erythrocyte membranes (EM), and serum
      concentrations of arachidonic acid (AA). Conventional antirheumatic and immunosuppressive
      therapies could be changed only within defined limits.
    

Intervention name(s): Fish oil, gamma-linolenic acid
Intervention type(s): Dietary Supplement
Intervention description(s): 3 g/d DHA + EPA
Other intervention name(s): Fish oil, omega-6 fatty acids
Intervention MeSH terms: Evening primrose oil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: n-3 fatty acids; n-6 fatty acids; anti-inflammatory action; clinical trial; randomized double-blinded; incorporation of fatty acids
Lack of Antenatal Care in Primiparas
Condition: Antenatal Care
Study type: Observational

Summary: 
      Antenatal care is a key strategy for reducing maternal and neonatal morbidity and mortality
      rate because adequate utilization of antenatal health care services is associated with
      improved maternal and neonatal health outcomes. The trend of maternal mortality in developing
      countries has been increasing and various international organizations have reported that an
      important factor related to maternal and infant mortality has been linked to lack of
      antenatal care. According to Federal Ministry of Health, some of the dangers of pregnancy and
      childbirth can be avoided if the pregnant woman attends antenatal regularly. In order to
      decrease these mortality rates, regular antenatal care has to be instituted or reinforced
      which can only be achieved through identifying factors causing poor utilization of antenatal
      care services
    


Observational model: Cohort
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        primiparas who will be delivered in Assiut Women Health Hospital
Randomized Crossover Study to Test the Impact of Using a Software for Smartphones and Tablets in Treating Type 1 Diabetes
Condition: Type 1 Diabetes; Quality of Life; Hypoglycaemia
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the impact of a software for smartphones and tablets
      on type 1 diabetes control and quality of life
    

Detailed description: 
      The hypothesis underlying this project, is that most calculations necessary for flexible
      intensive insulin therapy for type 1 diabetes in children can be performed using software
      installed on a smartphone or tablet that nowadays is carried by most parents and children.
      Smartphones and tablets can easily communicate with each other and with a desktop computer
      via the Internet, thereby permitting the exchange of information such as blood glucose values
      or types of meals among family members and physicians. Finally, software collecting blood
      glucose values and merging values obtained on different devices easily permits reviewing
      these values by the patient and sending them to the physician's office, thereby avoiding
      consultations during which no blood glucose values are brought by the patient.

      We hypothesize that the Webdia software, that will be tested in this randomized crossover
      study, will increase treatment compliance and therefore will improve diabetes
      self-management. We believe, the software will facilitate the adaptation of insulin schemes
      by physicians and therefore will lead to improved HbA1C values. We also think that this
      software will improve the patient's quality of life.
    

Intervention name(s): Webdia Software
Intervention type(s): Device
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 diabetes; HbA1C; Quality of Life; Hypoglycaemia; Self-management; Telemedicine
Samatasvir (IDX719) in Combinations With Simeprevir and/or TMC647055/Ritonavir With or Without Ribavirin for 12 Weeks in Participants With Chronic Hepatitis C Infection (MK-1894-005)
Condition: Chronic Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      Parts A and B of this study are designed to evaluate the safety, tolerability, efficacy and
      pharmacokinetic profiles of samatasvir and simeprevir when administered in combination with
      ribavirin (RBV) for 12 weeks in treatment-naïve, Genotype (GT) 1b, 4 and 6 hepatitic C virus
      (HCV)-infected participants.

      Part C of this study is designed to evaluate the safety, tolerability, efficacy and
      pharmacokinetic profiles of samatasvir, simeprevir, TMC647055 and ritonavir (RTV) when
      administered in combination with or without RBV for 12 weeks in treatment-naïve or
      interferon/RBV-treatment relapsed, GT 1a and 1b HCV-infected participants.
    

Detailed description: 
      Part A of this study is randomized and double-blind. Parts B and C are randomized and
      open-label.
    

Intervention name(s): Samatasvir; Simeprevir; Ribavirin (RBV); TMC647055; Ritonavir (RTV); Pegylated interferon (Peg-IFN); Samatasvir matching placebo
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Biological; Other
Intervention description(s): Samatasvir (IDX719) will be supplied as 25 mg and 50 mg oral tablets.; Simeprevir will be supplied as 75 and 150 mg oral capsules.; Ribavirin will be supplied as 200 mg oral tablets. Participants in the RBV-free arms experiencing non-response or virologic breakthrough during the treatment period will be offered RBV dosed according to the product label as an add-on to the participant's randomized treatment assignment.; TMC647055 will be supplied as 150 mg oral capsules.; Ritonavir will be supplied as 80 mg/mL oral solution.; Participants experiencing non-response or virologic breakthrough during the treatment period will be offered Peg-IFN (subcutaneous injection) dosed according to the product label as an add-on to the participant's randomized treatment assignment.; Samatasvir matching placebo will be supplied for the 50 mg tablets used in Part A.
Intervention MeSH terms: Interferons; Ritonavir; Ribavirin; Simeprevir
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: HCV; Hepatitis C; chronic hepatitis C; antiviral
Early Signs of Altitude Illness in Patients With COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Observational

Summary: 
      This study evaluates whether structured self-monitoring (SSM) by a symptom checklist in
      combination with a pulse oximeter worn at the wrist allows lowlanders with COPD to accurately
      identify whether or not they will experience an altitude-related illness during altitude
      travel.
    

Detailed description: 
      This study evaluates whether structured self-monitoring (SSM) by a symptom checklist in
      combination with a pulse oximeter worn at the wrist allows lowlanders with COPD to accurately
      identify whether or not they will experience an altitude-related illness during altitude
      travel. After baseline evaluation at 760 m, patients will travel by bus within 3-5 h to the
      Tuja Ashu high altitude clinic at 3'100 m and stay there for 2 days. During this period,
      participants will perform SSM. They are instructed to report to study personnel if they
      fulfill predefined criteria for impeding altitude-related illness.

      A planned interim analysis will be performed after the first year of the study or after
      completion of study by 80 participants, whichever comes first to allow any necessary
      adaptations of the sample size or terminate the study early for futility or high accuracy of
      the index test.
    

Intervention name(s): Structured self-monitoring during an altitude ascent and stay at high altitude
Intervention type(s): Diagnostic Test
Intervention description(s): Structured self-monitoring by a symptom checklist in combination with a pulse oximeter worn at the wrist in lowlanders with COPD ascending from low altitude (760m) to high altitude (3100m).
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with COPD, FEV1 40-80% predicted living at low altitude.
      
Keywords: Altitude; Hypobaric hypoxia; Altitude-related illness; Prevention
Phase II Study to Evaluate the Efficacy and Safety of Glassia® in Type-1 Diabetes
Condition: New Onset Type-1 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase II, Double-Blind, Randomized, Placebo-Controlled, Multicenter, Study Evaluating the
      Efficacy and Safety of Human, Alpha-1 Antitrypsin (AAT) [Glassia®] in the Treatment of New
      Onset Type-1 Diabetes.

      The study objectives are:

        -  To assess the efficacy of intravenous AAT in treatment of new onset Type 1 Diabetes

        -  To assess the safety and tolerability of intravenous AAT in new onset Type 1 Diabetes
           pediatric and young adult population.
    


Intervention name(s): Alpha-1 Antitrypsin; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Placebo
Other intervention name(s): Humman Alpha-1 Antitrypsin; Alpha-1 Proteinase Inhibitor; API; AAT
Intervention MeSH terms: Protease Inhibitors; Alpha 1-Antitrypsin; Protein C Inhibitor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Type-1 Diabetes; T1D; Diabetes Mellitus
Efficacy and Safety of Monotherapy With Noradrenaline and Terlipressin in Patients of Cirrhosis With Septic Shock Admitted to Intensive Care Unit
Condition: Cirrhosis With Septic Shock
MeSH terms: Shock, Septic; Liver Cirrhosis; Shock; Fibrosis
Study type: Interventional

Summary: 
      The Patient evaluated in Emergency room since admission and detailed history and clinical
      examination done .The in hospital cases where sepsis is the culprit and shifted to Intensive
      Care Unit (ICU) in view of septic shock were included since onset of shock.

      Initial fluid resuscitation done and if the patient were no fluid responsive they were
      randomized into arms noradrenaline or terlipressin and the dose escalated to achieve the
      primary objectives. At the same time the strict vitals monitoring and standard medical
      therapy for sepsis including antibiotics and other supportive therapy continued. The patients
      were followed up till discharge, death or up to 28days after enrollment into the protocol
      (whichever the longest). The detail methodology has been explained in column 14 later.
    


Intervention name(s): Terlipressin; Noradrenaline
Intervention type(s): Drug; Drug
Intervention description(s): Terlipressin (1.3mcg/min i.e 2mg over 24 hr to max of terlipressin 5.2mcg/min i.e. up to 8mg over 24hr) .The dose to be increased every 15min from start dose by 1ml and to decrease by 0.5ml every 15min keeping MAP (Mean Arterial Pressure) >65 .Terlipressin 2mg in 48ml,1ml=42mcg=0.67mg/min, max dose 8mg/day- 8ml/hr of infusion.; Noradrenaline 2amp (4000mcg in 50ml) at 6ml/hr = 7.5mcg/min and dose maximum 60mcg/min 24ml/hr double strength. The dose to be increased every 15min from start dose by 1ml and to decrease by 0.5ml every 15min keeping MAP (Mean Arterial Pressure)>65
Intervention MeSH terms: Terlipressin; Norepinephrine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Clinical Efficacy and Safety of T1225 Versus Tobramycin 0.3 % Eye Drops in the Treatment of Purulent Bacterial Conjunctivitis of Children.
Condition: Purulent Bacterial Conjunctivitis
MeSH terms: Conjunctivitis, Bacterial; Conjunctivitis
Study type: Interventional
Phase: Phase 3

Summary: 
      Efficacy/Safety of T1225, in comparison to reference product, for the treatment of purulent
      bacterial conjunctivitis of children.
    


Intervention name(s): T1225; Tobramycin
Intervention type(s): Drug; Drug
Intervention description(s): one drop twice daily (morning and evening) in each eye from Day 0 to Day 2; 1 to 2 drops every two hours while awake on Days 0-1, up to 8×/day, then 1 to 2 drops 4 times daily on Days 2-6
Intervention MeSH terms: Tobramycin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Pharmacokinetic and Pharmacodynamic Profile of Insulin Lispro Using Needle-Free Jet Injection Technology
Condition: Healthy
Study type: Interventional
Phase: Phase 4

Summary: 
      Needle-free jet injector provides an alternative for patients with diabetes treated by
      insulin. This study aimed at evaluating pharmacokinetics and pharmacodynamics (PK-PD)
      profiles of lispro administered by jet injector and conventional pen.
    

Detailed description: 
      This is a randomized, double-blind, double-dummy, crossover study. Eighteen healthy
      volunteers will be recruited. Lispro (0.2 units/kg) will be administered by jet injector or
      by conventional pen and a seven-hour euglycemic clamp test will be performed. PK-PD profiles
      of lispro will be calculated.
    

Intervention name(s): Needle-free jet injection with insulin lispro; Conventional pen injection with insulin lispro
Intervention type(s): Device; Device
Intervention description(s): Subjects injected by jet injectors which deliver insulin lispro; Subjects injected by conventional insulin pens which deliver insulin lispro
Intervention MeSH terms: Insulin; Insulin, Globin Zinc; Insulin Lispro
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: Needle-Free Jet Injection; Insulin Lispro; pharmacokinetics; pharmacodynamics