bioihbjkbjnl/mcl2 huggingface dataset:
Comparison of Blood Pressure Medications on Metabolism
Condition: Diabetes
MeSH terms: Diabetes Mellitus
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine if there are differences, (benefits) between
      carvedilol and metoprolol in the treatment of HTN in patients with type 2 diabetes.
      Specifically we will be looking at differences in blood pressure and blood sugar control,
      endothelial function, inflammation, oxidative stress and coagulation.

      Subjects will be randomized to one of the two beta-blockers and followed for 5 months. Each
      subject will undergo 4 inpatient studies where an oral glucose tolerance test will be done,
      Inflammatory and oxidative stress markers will be measured. Endothelial function will be
      measured using brachial artery ultrasound and laser skin Doppler
    

Detailed description: 
      The purpose of this study is to determine if there are differences, (benefits) between
      carvedilol and metoprolol in the treatment of HTN in patients with type 2 diabetes.
      Specifically we will be looking at differences in blood pressure and blood sugar control,
      endothelial function, inflammation, oxidative stress and coagulation.

      Subjects will be randomized to one of the two beta-blockers and followed for 5 months. Each
      subject will undergo 4 inpatient studies where an oral glucose tolerance test will be done,
      Inflammatory and oxidative stress markers will be measured. Endothelial function will be
      measured using brachial artery ultrasound and laser skin Doppler. Baseline visit will be done
      when subjects are off all antihypertension medications except ACEI/ARB. Following the
      baseline study subjects will be randomized to study drug. The dose will be titrated until
      goal blood pressure is reached. Add on medication will be used if needed.

      Subjects will then undergo a second study. The third study will take place after 5 months on
      treatment. Stud drug will then be stoppped and subjects will be restudied 2 weeks later
    

Intervention name(s): carvedilol; metoprolol
Intervention type(s): Drug; Drug
Intervention description(s): variable; variable
Other intervention name(s): coreg; toprol
Intervention MeSH terms: Metoprolol; Carvedilol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Diagnostic
Keywords: diabetes blood pressure oxidative stress
Neural Mechanisms in Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Observational

Summary: 
      Asthma is a chronic disease that affects nearly 13% of adults in the U.S., causing
      substantial impairment that is reflected in the tens of millions of missed days of work, and
      doctors' and emergency room visits it leads to annually. Those who have asthma are twice as
      likely to develop depression and anxiety, which are associated with more frequent and severe
      asthma symptoms, especially in those under chronic stress. The project proposed here seeks to
      understand the role of the brain in these associations and to evaluate the neural mechanisms
      through which a safe, low-cost intervention, that influences the function of body via the
      mind, may diminish the expression of asthma symptoms.
    


Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Community sample
Incubator Temperature for Culturing Human Embryos
Condition: Embryo Culture
Study type: Interventional

Summary: 
      Incubator temperature is one of the most precious variables in IVF labs. When the IVF
      started, almost all incubator temperatures were set at 37 degrees which mimic in vivo
      conditions. Some authors speculated that gametes and early embryos might need low
      temperatures that provide quieter metabolism. We decide to compare Embryo culture at 37
      degree or slightly lower 36.5 degree and extensively investigate to find which is better to
      crucially introduce a solid evidence through this RCT.
    

Detailed description: 
      Since the first IVF birth in 1978, the field of assisted reproductive technology has evolved
      dramatically. The evolution includes both the ovarian stimulation protocols and the
      laboratory techniques. Optimization of the laboratory procedures is of great interest to the
      scientists in the field of IVF.

      Incubator temperature is one of the most precious variables in IVF labs. When the IVF
      started, almost all incubator temperatures were set at 37 degrees which mimic in vivo
      conditions.

      Some authors speculated that gametes and early embryos might need low temperatures that
      provide quieter metabolism. another group found increase in pregnancy rate for embryos
      cultured below 37 degree compared to those cultured at 37 degree. Nevertheless; the majority
      of embryologists still consider culture at 37 degrees is the back bone for the incubators.

      The paucity of well designed studies makes it difficult to achieve a satisfactory answer
      whether lower temperature will improve the pregnancy rate. This encourage us to study the
      effect of lower temperature (36.5 degrees) on the pregnancy rate compared to conventional
      temperature (37 degrees).
    

Intervention name(s): Incubator Temp set to 36.5 degree; Incubator Temp 37 degree
Intervention type(s): Other; Other
Intervention description(s): We will set incubator Temp to 36.5 so we can assess the outcome and compare the results with the placebo group.; We will set incubator Temp to 37 degree as the routine embryo culture Temp since 1978 as the placebo arm.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Health Services Research
Effectiveness of 12 Clips in Maternal and Neoanatal Health Through Applied Neuroscience Tools (Neuromarketing Strategy)
Condition: Pregnancy
Study type: Interventional

Summary: 
      Objective: To evaluate the effectiveness of 12 knowledge transfer clips of maternal and
      neonatal health in order to generate knowledge appropriation. Methodology: Randomized
      cross-over clinical trial with a non-probabilistic sample of intentional feature of 150
      subjects: pregnant women, non-pregnant women and men. Participants will be evaluated during
      the observation of 13 clips (one of them is the control clip) in which sequence will be
      assigned randomly. The level of attention will be assessed by means of eye tracking, to see
      the ocular gaze and fixation in relation to the content of clips, and emotional reaction
      through the psychophysiological record (galvanic skin response). In addition, recall of
      information will be assessed through the application of questionnaires at the end of each
      video. The analysis will focus on identifying differences in the three outcomes between
      intervention clips and the control clip, and between the three groups, and determine the
      clips and segments that generate greater emotional response, attention and recall.
    


Intervention name(s): Twelve clips regarding maternal and neonatal health topics; Control Clip
Intervention type(s): Other; Other
Intervention description(s): Twelve clips regarding maternal and neonatal health topics, designed with mixed 2D and 3D elements, each one about 45 seconds long (prepared based on the best available evidence and validated by clinical experts).; Control clip with 2D elements about 45 seconds long, containing information on prenatal control and presented in conventional format (narration, static images and on screen text).
Intervention MeSH terms: Adrenocorticotropic Hormone; Melanocyte-Stimulating Hormones; beta-Endorphin
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Crossover randomized clinical trial
Masking: None (Open Label)
Primary purpose: Other
A Within Subject Comparison of Opioid Withdrawal in Opioid Dependent Individuals
Condition: Opioid Abuse; Opioid Dependence
MeSH terms: Opioid-Related Disorders
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Buprenorphine is an approved medication for the treatment of opioid dependence. It is
      typically administered once daily as a sublingual tablet combined with naloxone (i.e.,
      Suboxone). Evidence suggests buprenorphine produces relatively low levels of physical
      dependence. In addition, some research suggests there is relatively little withdrawal
      following cessation of chronically administered buprenorphine. This study will examine the
      spontaneous withdrawal associated with abrupt cessation of buprenorphine compared to morphine
      in opioid dependent individuals. This study will assess the characteristics and time course
      of withdrawal using subject-rated and observer-rated measures of opioid withdrawal.
      Physiologic measures and psychomotor performance will be collected during chronic opioid
      administration and during placebo administration (i.e., during spontaneous withdrawal).
      Particular attention will be paid to the differences (if any) in sleep disturbances and
      withdrawal associated hyperalgesia.
    


Intervention name(s): buprenorphine; morphine
Intervention type(s): Drug; Drug
Intervention description(s): parenteral buprenorphine may be administered at multiple times each day; parenteral morphine may be administered multiple times each day
Intervention MeSH terms: Morphine; Buprenorphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: opioid pharmacology; buprenorphine; morphine; withdrawal; human research
HPV Vaccine Immunity in High-risk Women
Condition: HPV Infection
MeSH terms: Papillomavirus Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      This is a single arm immunological study based in Vietnam. The study will examine human
      papillomavirus (HPV) vaccine responses in high-risk women (female-sex-worker; FSW). We aim to
      recruit 60 women (aged 18-25 years old) and provide them with a standard 3-dose schedule of
      licensed 4vHPV vaccine (Gardasil®, Merck). Blood and cervical swab samples will be collected
      for immunology and virology testing, respectively.
    

Detailed description: 
      Multiple sexual partners (>4) is a risk factor for human papillomavirus (HPV) infection and
      cervical cancer. Due to the nature of their work, female sex workers (FSW) are at a
      particular high risk of HPV infection and developing cervical cancer. These groups are also
      likely to be reservoirs for HPV transmission since they are less likely to clear the
      infection and are known to be infected with multiple HPV types simultaneously. Benefits in
      vaccinating HPV-infected individuals, includes protecting them against HPV vaccine types that
      the person is not currently infected with as well as re-infection with the same HPV type.
      Therefore, immunising FSW with HPV vaccine is a novel strategy to reduce their risk of
      cervical cancer as well as downstream effects on HPV transmission. FSW is common in low-and
      middle-income countries (LMICs) of Asia (i.e. Vietnam), but the use of HPV vaccine in LMICs
      is very low often due to high costs and logistical difficulties in vaccine delivery.
      Furthermore, available data on the immunogenicity of HPV vaccine in FSW are limited. The aim
      of this study is to determine the immunogenicity of HPV vaccine in FSW and compare their
      antibody responses among young women (non-FSW) of the same age group by comparison with
      published data.
    

Intervention name(s): Gardasil®, Merck
Intervention type(s): Biological
Intervention description(s): Gardasil® (4vHPV) is a recombinant protein particulate (VLP) vaccine. Each 0.5 mL monodose pre-filled syringe or vial contains approximately 20 μg of HPV 6 L1 protein, 40 μg of HPV 11 L1 protein, 40 μg of HPV 16 L1 protein, and 20 μg of HPV 18 L1 protein as well as approximately 225 mcg of aluminum (as Amorphous Aluminum Hydroxyphosphate Sulfate adjuvant). It has completed phase III trials and is licensed for use in over 100 countries around the world including the United States, Australia and countries in the European Union (EU) for girls aged 9-26 years. Vietnam currently offer this vaccine in private health clinics, as a 3-dose schedule (0, 2 and 6 months).
Intervention model: Single Group Assignment
Intervention model description: All subjects will be given Gardasil (Merck) HPV vaccine
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: HPV vaccine
Comparison of a Blood Clotting Drug (Recombinant Factor XIII) Produced by Two Different Manufacturers in Healthy Male Subjects
Condition: Congenital Bleeding Disorder; Congenital FXIII Deficiency; Healthy
MeSH terms: Hemostatic Disorders; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this clinical trial is to compare the
      metabolism of a blood-clotting drug (recombinant Factor XIII)) produced by two different
      manufacturers (Novo Nordisk and Avecia) in healthy male volunteers.
    


Intervention name(s): catridecacog; recombinant factor XIII
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 35 IU/kg body weight recombinant factor XIII (catridecacog) (Novo Nordisk) administered iv (into the vein) followed by a single dose of 35 IU/kg body weight recombinant factor XIII (Avecia) administered iv.; Single dose of 35 IU/kg body weight recombinant factor XIII (Avecia) to be administered iv (into the vein) followed by a single dose of 35 IU/kg body weight recombinant factor XIII (catridecacog) (Novo Nordisk) administered iv.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Morphological and Functional Evaluation of Adult Flat Foot Before and After Corrective Surgery
Condition: Flat Feet
MeSH terms: Flatfoot
Study type: Interventional

Summary: 
      Morphological weight bearing computed tomography parameters and gait analysis can implement
      the evaluation of the flat foot. Weight bearing CT is useful to verify the severity of the 3D
      deformities typical of flat foot, while kinematic and kinetic variables of gait is able to
      quantify the functional improvements of the foot after surgery.
    


Intervention name(s): morphological and functional evaluation of adult flat foot
Intervention type(s): Procedure
Intervention description(s): Evaluations are realized by weight bearing computed tomography and by Gait analysis in the pre-operative phase and at a 6-months follow-up from the surgery with Grice technique
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
G6PD (Glucose-6-phosphate Dehydrogenase) Study to Evaluate Hemolysis Potential of TFQ (Tafenoquine)
Condition: Malaria
MeSH terms: Malaria
Study type: Interventional
Phase: Phase 1

Summary: 
      SB-252263 (Tafenoquine, TQ) is an 8-aminoquinoline (8-AQ) antimalarial drug being developed
      by GlaxoSmithKline (GSK), the U.S. Army Medical Research and Materiel Command (USAMRMC) and
      Medicines for Malaria Venture (MMV). TQ is currently being developed for the radical cure of
      acute P. vivax malaria in combination with standard doses of CQ, which is 1500 mg over 3
      days.

      The current gold standard for radical cure of P. vivax malaria in many areas of the world is
      chloroquine (CQ) for clearance of the acute parasitemia immediately followed by primaquine
      (PQ) to clear the liver stages of the parasite and prevent disease relapse. The 8-AQ class of
      drugs, including PQ, is hemolytic in subjects with glucose-6-phosphate dehydrogenase (G6PD)
      deficiency. The current study will identify a dose of TQ within the target efficacious dose
      range that has a hemolytic effect similar to or less than PQ 15 mg OD x 14 days (i.e. ≤
      25-30% hemoglobin decline in WHO class III G6PD-deficient subjects).
    


Intervention name(s): Chloroquine; Primaquine; Tafenoquine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): The current gold standard for radical cure of P. vivax malaria in many areas of the world is chloroquine (CQ); typically 600 mg day 1, 600 mg day 2, 300 mg day 3 for clearance of the acute parasitemia. After this Tafenoquine will be given and subject will be followed up.; Primaquine (PQ) is another 8 aminoquinoline drug available for Malaria treatment; Once daily on Day 1 only. For Part B and C of this study Chloroquine will be given to treat Malaria
Intervention MeSH terms: Chloroquine; Primaquine; Tafenoquine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Impact of Combined Behavioral Interventions on Cognitive Outcomes in MCI
Condition: Mild Cognitive Impairment
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      Vast evidence supports use of physical exercise and cognitive stimulation for lowering risk
      for cognitive decline and dementia, with combinations of non-pharmacological interventions
      providing greatest promise for impacting cognitive aging. This, paired with limited cognitive
      benefits from pharmacological interventions in dementia, has shifted focus to
      non-pharmacological interventions administered earlier in the disease course. This
      application, therefore, proposes a randomized controlled trial (RCT; 12-week active
      intervention, 3- and 6-month follow-up) comparing 3 conditions: walking program (guided
      progressive increases in weekly step counts), computer-based cognitive training program
      (Brain HQ, Posit Science), and combination of the exercise and cognitive program, on
      cognitive, functional, and diagnostic outcomes in 60 sedentary, community-dwelling adults
      with mild cognitive impairment (MCI).
    


Intervention name(s): Walking Intervention; Cognitive Training Intervention; Combined Intervention
Intervention type(s): Behavioral; Behavioral; Behavioral
Intervention description(s): The walking intervention will begin following baseline assessments and will be continued for 12 weeks. Participants will be given a pedometer to use daily and log their daily steps, with an identified goal of increasing step counts by 3000 steps a day over the course of the intervention. After obtaining a week long baseline step count, individuals in the intervention group will progressively increase their step counts by 100 steps daily each week for the first three weeks, by 200 steps daily for weeks four through six, by 300 steps daily for weeks seven through nine, and by 400 steps daily for weeks ten through twelve. Mean baseline step counts for sedentary older adults in our pilot work were 4150 per day; therefore, most participants will almost double their daily activity by the end of the intervention.; In the CT condition, participants will use Brain HQ, a computer cognitive training program (Posit Science Corporation, San Francisco, CA), shown to be well tolerated by older adults with positive short- and long-term cognitive outcomes. Participants will use the program 60 minutes/day, 5 days/week for 12 weeks. If participants do not have a home computer/internet access, they can complete the modules at another location such as a public library, senior center, or at the MARC, but training will still be self-directed.; The combined condition will concurrently follow both the walking and the CT programs as described above.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Efficacy and Safety of Basic Triple Therapy Including Ilaprazole on the First Line Eradication Treatment of H.Pylori
Condition: Helicobacter Infections
MeSH terms: Helicobacter Infections
Study type: Observational

Summary: 
      This study compared efficacy and safety of basic triple therapy including Ilaprazole 10mg,
      Levofloxacin 500mg and Amoxicillin 1000mg BID for 10 days on the first line eradication
      treatment of H.pylori
    

Detailed description: 
      This study compared efficacy and safety of basic triple therapy including Noltec(Ilaprazole)
      10mg, Cravit(Levofloxacin) 500mg and Chongkundang Amoxicillin Cap(Amoxicillin) 1000mg BID on
      the first line eradication treatment of H.pylori.

      Participants are defined as persons who have endoscopically confirmed on gastric or duodenal
      ulcer(including scar stage) and gastritis confirmed to be H.pylori positive patients in the
      biopsy and UBT test. For 10 days, Participants treated as basic triple therapy including
      Noltec(Ilaprazole) 10mg, Cravit(Levofloxacin) 500mg and Chongkundang Amoxicillin
      Cap(Amoxicillin) 1000mg BID. After treatment, The healing rate was evaluated in the UBT test
      and Biopsy at 49±5days from the first day dosing.
    

Intervention name(s): Noltec tab. 10mg; Chongkundang Amoxicillin Cap. 500mg; Cravit Tab. 500mg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ilaprazole 10mg BID dosage form : delayed release tablet; Amoxicillin 1000mg, BID dosage form : capsule; Levofloxacin 500mg, BID dosage form : film coated tablet
Other intervention name(s): Ilaprazole; Amoxicillin; Levofloxacin
Intervention MeSH terms: Amoxicillin; Levofloxacin
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who visited the hospital
      
Keywords: helicobacter pylori; ilaprazole; eradication; triple therapy
Spinal Anesthesia Magnesium Infusion
Condition: Operation
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study was to investigate the effect of i.v. infusion of magnesium sulphate
      during spinal anesthesia on duration of spinal block and postoperative pain.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        18 and 65 female patients undergoing abdominal hysterectomy