bioihbjkbjnl/mcl2 huggingface dataset:
Prediction and Prevention of Preeclampsia by First Trimester Ultrasound
Condition: Preeclampsia
MeSH terms: Pre-Eclampsia
Study type: Observational

Summary: 
      The purpose of this study is to determine whether the Fetal Medicine Foundation algorithm for
      individual risk calculation for preeclampsia (PE) and pregnancy induced hypertension (PIH) is
      suitable to identify women in high risk of developing these diseases in a Norwegian
      population.
    

Detailed description: 
      It has been shown that low dose acetylsalicylic acid (ASA) in pregnancy reduces adverse
      outcome of pregnancy in women that have high risk of developing preeclampsia (PE). It is a
      challenge for the clinician to identify the high risk women. Doppler blood flow measurements
      in uterine arteries in second trimester have been shown useful to predict the development of
      the disease but prophylactic treatment with ASA from this point in pregnancy has not been
      proven effective. Fetal Medical Foundation has developed an algorithm that calculates
      individual risks for PE/ PIH based on Doppler blood flow measurements and anamnestic
      information.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Pregnant women
      
Biospecimen description: 
      Blood samples Urine
    
Keywords: Preeclampsia; Doppler ultrasound; First trimester; Acetylsalicylic acid
Safety, Tolerability and Efficacy of 28-day Inhaled CHF 6001 DPI in COPD Patients
Condition: COPD
Study type: Interventional
Phase: Phase 2

Summary: 
      Phase IIa study in COPD patients aimed to evaluate the safety, tolerability ,pharmacodynamics
      (effect on biological markers of inflammation in induced sputum and in blood, and on
      pulmonary function) and on pharmacokinetics of CHF 6001 (a PDE4 inhibitor) after 28-days of
      daily inhaled dosing.
    


Intervention name(s): CHF6001 DPI; Roflumilast; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Preference Methotrexate (MTX) Pre-filled Syringe Versus Pre-filled Pen in Rheumatoid Arthritis (RA)
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to assess the number of patients preferring the
      methotrexate pre-filled pen to the methotrexate pre-filled syringe after 6 weeks of treatment
      based on a questionnaire
    


Intervention name(s): methotrexate prefilled pen; methotrexate prefilled syringe
Intervention type(s): Drug; Drug
Intervention MeSH terms: Methotrexate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Pharmacokinetics of IDX719 in Participants With Normal and Impaired Hepatic Function (MK-1894-008)
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetics (PK) and safety and
      tolerability of single-dose administration of IDX719 in participants with normal hepatic
      function and participants with varying degrees of hepatic impairment.
    


Intervention name(s): IDX719
Intervention type(s): Drug
Intervention description(s): IDX719 supplied as 50 mg tablets.
Other intervention name(s): Samatasvir
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic hepatitis C; Hepatitis C virus; HCV
Safety and Efficacy of Olopatadine HCl Nasal Spray in 6-11 Year Old Patients
Condition: Seasonal Allergic Rhinitis
MeSH terms: Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
Study type: Interventional
Phase: Phase 3

Summary: 
      A study to demonstrate the superiority of test article nasal spray relative to vehicle nasal
      spray for the treatment of seasonal allergic rhinitis for a 2 week period in patients aged 6
      to 11 years with a history of seasonal allergic rhinitis.
    


Intervention name(s): Olopatadine Hydrochloride Nasal Spray 0.6%; Vehicle
Intervention type(s): Drug; Drug
Intervention description(s): Olopatadine HCl 1 or 2 sprays per nostril twice daily; Vehicle 1 or 2 sprays per nostril twice daily
Intervention MeSH terms: Olopatadine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: allergic rhinitis; allergies; seasonal allergies
Meningococcal B Vaccination in University Students
Condition: Neisseria Meningitidis Serogroup B
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is the third in a series using the MenB vaccine from the National Institute of
      Public Health in Norway (NIPH). The vaccine was first made in response to a high incidence of
      disease using the 44/76 strain which was resopnsible for most of the disease there. The VEC
      did the first study, MNB1, using this vaccine. Since then the NIPH has formed a commercial
      partnership with Chiron Vaccines and has reformulated the vaccine using the NZ98/254 MenB
      strain for use in New Zealand.

      The vaccine was first produced at NIPH facilties and it was this vaccine that was used in our
      second study, MNB2. The current study, MNB3, will use the NZ98/254 MenB vaccine but from
      Chiron facilities where production has been scaled up in order to provide enough doses for
      the national immunisation campaign that is ongoing in New Zealand.
    


Intervention name(s): Meningococcal B Vaccine NZ
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: meningococcal B vaccine
Vitamin D Levels in Residents in Medicine
Condition: Vitamin D Deficiency
MeSH terms: Vitamin D Deficiency
Study type: Observational

Summary: 
      the study aims to messure the vitamin D levels in medical staff in the hospital. The
      physicians in the course of their internship who work indoors and work many night shifts have
      limited sun exposure in all seasons. Nursing staff who work shifts and work indoors are at
      the same risk of liltle sun exposure. The study addresses the amount of sun exposure,
      assessed by a sun exposure questioner, age, gender,work load related to number of shifts in
      the physicien group and in nursing group the job percentile we also adress religion (clothing
      cover)as a factor.
    

Detailed description: 
      The population in Israel is heterogeneous in the aspect of skin exposure to the sun. Women in
      the Moslem community with traditional long sleeve dress code whose sun exposure to the sun
      even in the summer months is limited.

      The physicians in the course of their internship who work indoors and work many night shifts
      and nurses with their shift work have limited sun exposure in all seasons.

      The study addresses the amount of sun exposure, assessed by a sun exposure questioner, age,
      gender,number of shifts in the physicien group and in nursing group the job percentile
      religion (clothing cover).

      The standard for measuring vitamin D status is 25(OH) D levels in the serum. The staff
      members from which blood will be drawn will be have an explanation about the aim of the study
      and will sign an informed consent.
    

Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        medical staff, interns doing night shifts. nursing staff.
Accelerated rTMS for Treatment-Resistant Major Depression
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      High frequency repetitive transcranial magnetic stimulation (HF-rTMS) has shown safety and
      efficacy for treatment-resistant depression, but requires daily treatment for 4-6 weeks.
      Accelerated HF-TMS (aHF-rTMS), in which all treatments are delivered in less time, would have
      significant advantages in terms of access, patient acceptance and costs. In the present open
      label trial the investigators intend to assess the effectiveness and acceptability of a novel
      aHF-rTMS protocol (i.e., 2 daily sessions over 2 consecutive weeks; 6,000 pulses per day).
      For this, depressed outpatients will receive the aHF-rTMS protocol and will be assessed at
      baseline and at weeks 3 and 9 with several clinician- and patient- reported measures as well
      as with computerized neurocognitive tests.
    


Intervention name(s): Accelerated HF-rTMS (Magstim Rapid 2 stimulator)
Intervention type(s): Device
Intervention description(s): Twice daily rTMS sessions involving 10 Hz in 75 trains of 4 seconds duration, with 26 seconds intertrain intervals (6,000 pulses per day) at 120% of the resting motor threshold.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Momordica Charantia Supplementation on Blood Glucose Levels
Condition: Glucose Intolerance
MeSH terms: Glucose Intolerance
Study type: Interventional

Summary: 
      The study is a randomized, cross-over, double blind, controlled trial in which study
      participants will receive two 4-week interventions with a washout period of 4 weeks between
      interventions. Study subjects will visit the research facility before and after each
      intervention period for a test day. In the third intervention week participants are provided
      with a 3-day controlled diet and glucose responses will be monitored via a continuous glucose
      monitoring device.
    

Detailed description: 
      Bitter gourd (BG) (Momordica charantia), is a highly nutritive vegetable from the cucumber
      family. The objective is to assess the impact of 4-week BG supplementation on blood glucose
      levels and glucose tolerance in subjects with an impaired fasting glucose or with an impaired
      glucose tolerance and to evaluate how BG supplements modulate glucose response curves during
      meal intake. The study is a randomized, cross-over, double blind, controlled trial in which
      study participants will receive two 4-week interventions with a washout period of 4 weeks
      between interventions. Study subjects will visit the research facility before and after each
      intervention period for a test day. In the third intervention week participants are provided
      with a 3-day controlled diet and glucose responses will be monitored via a continuous glucose
      monitoring device. The intervention will be a 4-week intervention with 2.4g/d dried
      bitter-gourd supplements and a reference intervention with 2.4g/d dried cucumber supplements.
      The main study parameter is fasting levels of plasma glucose and 2hour plasma glucose after a
      75-gram OGTT.
    

Intervention name(s): dried bitter-gourd supplements; dried cucumber supplements
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): intervention with 2.4g/d dried bitter-gourd supplements; reference intervention with 2.4g/d dried cucumber supplements
Other intervention name(s): Momordica charantia
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Care Provider)
Primary purpose: Treatment
Keywords: bitter gourd; pre-diabetics; glucose response
Drug-Drug Interaction Study in Healthy Subjects
Condition: Hepatitis C
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics and safety of BMS-790052 and
      BMS-650032 when co-administered and when administered alone
    

Detailed description: 
      Pharmacokinetics and Safety in Healthy Subjects
    

Intervention name(s): BMS-650032; BMS-790052; BMS-650032; BMS-790052
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Capsules, Oral, 600 mg, Q12h, Days 1-7; Capsules, Oral, 60 mg, Q24h, Days 1-7; Capsules, Oral, 200 mg, Q12h, Days 8-21; Capsules, Oral, 30 mg, Q24h, Days 8-21
Intervention MeSH terms: Asunaprevir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
The Effect of Diabetes Education Digital Games and Video Animation on Quality of Life
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      This research will be conducted to evaluate the effect of digital game and video
      animation-based diabetes education on the quality of life of children with Type 1 Diabetes.
      HbA1c, diabetes knowledge and Quality of Life Scale in Children with Diabetes (PedsQL 3.0)
      score will be taken into consideration when evaluating the quality of life of children with
      type 1 diabetes.
    

Detailed description: 
      This research was conducted to examine the effects of diabetes education given to children
      with Type 1 Diabetes Mellitus with digital game and video animation on quality of life and
      metabolic control. The study is a single-blind, randomized controlled trial. It was conducted
      with a total of 55 children with Type 1 Diabetes Mellitus, including the experimental (n=27)
      and control group (n=28). Diabetes education was given to the experimental group with digital
      games and video animations. Data were collected before the training, at the 3rd and 6th
      months after the training. Research data were collected with "Descriptive Information Form",
      "Quality of Life Scale in Children with Diabetes Mellitus" and "Metabolic Control Parameters
      Follow-up Form". Children in the control group received routine outpatient
      examination/check-up and diabetes education by a diabetes nurse. Children in the intervention
      group were given digital game and video animation-based training, as well as routine
      outpatient examination/check-up and training given by a diabetes nurse.
    

Intervention name(s): digital game and video animation based diabetes education
Intervention type(s): Behavioral
Intervention description(s): While creating the digital game and video animation, an agreement was made with a software company and this company was responsible for the software and repair of the game. Digital games and video animations cover the basic educational topics of Type 1 diabetes. Expert opinions were received from experts in the field of Child Health and Disease Nursing to ensure the suitability of the content of the educational material. The name of the game site and how to use it were explained to the children in the intervention group by the researcher. In addition, children in the intervention group were given usernames and passwords to log in to the site. Game Sections; What is Diabetes? Medical Nutrition Treatment in Diabetes, Insulin Treatment and Application, Exercise and Physical Activity in Diabetes, Complications of Type 1 Diabetes Mellitus, Diabetes Management at School.
Other intervention name(s): digital game, video animation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is a parallel group randomized controlled study
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: diabetes education; digital game; video animation
Hamstrings X Patellar Tendon for ACL Reconstruction in Soccer Players - RCT
Condition: Anterior Cruciate Ligament Injuries
MeSH terms: Anterior Cruciate Ligament Injuries
Study type: Interventional

Summary: 
      The purpose of this study is to specifically evaluate outcomes of bone-patellar tendon-bone
      autograft versus hamstring autograft ACL reconstruction in soccer players.
    

Detailed description: 
      A number of techniques for ACL reconstruction have been proposed and tested, and most
      surgeons now prefer autografts with the patellar tendon or semitendinosus tendon. The
      functional outcome after ACL reconstruction with the patellar or semitendinosus tendon has
      been a recent area of interest. Soccer is the most popular sport worldwide with more than 260
      million active players, and it is hard to say if patellar tendon or semitendinosus grafts
      have different outcomes.

      The purpose of this study was to specifically evaluate outcomes of bone-patellar tendon-bone
      autograft versus hamstring autograft ACL reconstruction in soccer players. The hypothesis of
      this study was that hamstring autograft ACL reconstruction would provide no statistically
      significant differences in patient-reported outcome scores, postoperative level of sports
      function, and harvest-site morbidity when compared with patellar tendon autograft .The
      Cincinnati Knee Rating System (CKRS) was chosen as the primary outcome. As secondary outcome,
      reruptures.

      Between march 2016 and march 2017, 60 soccer players will be operated. The investigators
      consider as soccer players those who play more than 4 times a week. Once included in the
      study, they will be randomized in two groups: "hamstring group" and "patellar tendon group".

      The final clinical evaluation with two years. For both groups, the technique is the same, the
      fixation of the grafts with metal interference screws. Femoral tunnel will be drilled with
      outside-in technique. The tibial tunnel with conventional 55 degrees guide.

      Both groups of patients will receive the same physical therapy protocol. Data will be
      evaluated with the SPSS software for Windows (version 13.0).
    

Intervention name(s): Patellar Tendon graft; Hamstring Graft
Intervention type(s): Procedure; Procedure
Intervention description(s): Acl reconstruction with patellar tendon graft; Acl reconstruction with hamstring graft
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: ACL reconstruction; Single bundle; Clinical results; Soccer players
Comparison of Insulin Detemir and Insulin Semilente®MC in Type 1 Diabetes
Condition: Diabetes; Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial is conducted in Europe.

      A 32-week efficacy and safety comparison of insulin detemir and insulin semilente MC in
      children between 6 and 21 years with type 1 diabetes.
    


Intervention name(s): insulin detemir
Intervention type(s): Drug
Intervention MeSH terms: Insulin Detemir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dose-ranging Study of Vilanterol (VI) Inhalation Powder in Children
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase IIb, multi-centre, randomised, double-blind, parallel-group,
      placebo-controlled study in children aged 5-11 years with persistent uncontrolled asthma.
      Subjects entering the run-in period will stop their current asthma medication and be given
      open label fluticasone propionate (FP) 100mcg twice daily via DISKUS/ACCUHALER and
      salbutamol/albuterol as required to use throughout the run-in and double-blind treatment
      period. At Visit 3 subjects meeting the randomization eligibility criteria will receive
      vilanterol (6.25mcg, 12.5mcg, or 25mcg,) or placebo via the Novel Dry Powder Inhaler (NDPI)
      once daily for 4 weeks in addition to open-label fluticasone propionate twice daily
      throughout the treatment period. Primary endpoints consist of change from baseline in clinic
      visit trough (pre-bronchodilator and pre-dose) PEF at the end of the 28-day treatment period
      in all subjects. Safety assessments include adverse events, oropharyngeal examinations,
      clinical chemistry, 12-lead ECG, and vital signs. Blood samples will be taken from all
      subjects for pharmacokinetic analysis to determine plasma concentrations of vilanterol at
      specific time intervals relative to the dose of study drug.
    


Intervention name(s): Fluticasone propionate 100mcg; Placebo; Vilanterol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): all subjects recieve open-label Flovent twice daily duirng the run in and treatment period; Placebo inhalation powder during treatment period; subjects will recieve 4 weeks via NDPI during treament period
Intervention MeSH terms: Fluticasone; Xhance
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Study to Evaluate the Bioequivalence of Over-encapsulated Oseltamivir Capsules to Marketed Oseltamivir Capsules in Healthy Volunteers
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a study in healthy adult volunteers to assess the bioequivalence of over-encapsulated
      oseltamivir capsules to commercially available oseltamivir capsules. Both formulations will
      be administered in the fasting state.
    


Intervention name(s): over-encapsulated oseltamivir; oseltamivir
Intervention type(s): Drug; Drug
Intervention description(s): 75 mg once; 75 mg once
Intervention MeSH terms: Oseltamivir
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: influenza, bioequivalence, oseltamivir, Tamiflu, over-encapsulation
Clinical Presentations Before AMI Onset and Coronary Atherosclerosis
Condition: Acute Myocardial Infarction
MeSH terms: Myocardial Infarction; Infarction
Study type: Observational

Summary: 
      This study aimed to evaluate the incidence of preinfarction angina in AMI patients and test
      the hypothesis that different clinical presentations before AMI onset can affect coronary
      plaque morphologies in AMI patients .
    

Detailed description: 
      Patients with AMI who underwent primary percutaneous coronary intervention（PCI） and optical
      coherence tomography (OCT) examination is expected to be included in this study.Data about
      history were prospectively collected by a standard questionaire ,especially regarding the
      detail information about preinfarction angina.The basic clinical characteristics,angiographic
      and OCT findings are compared between patients with and without preinfarction angina.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        AMI patients
Effect of Quetiapine on Negative Symptoms and Cognition
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to investigate the outcome on negative symptoms of schizophrenic
      patients during therapy with quetiapine or risperidone.
    


Intervention name(s): Quetiapine fumarate; Risperidone
Intervention type(s): Drug; Drug
Intervention MeSH terms: Risperidone; Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment