bioihbjkbjnl/mcl2 huggingface dataset:
Safety and Feasibility Evaluation of the APS APP
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This clinical trial is a safety and feasibility study to assess the performance of artificial
      pancreas (AP) system using the Zone Model Predictive control (Zone-MPC) and Health Monitoring
      System (HMS) algorithms embedded into the APS APP platform.
    

Detailed description: 
      The system will be evaluated on up to 10 adult subjects with type 1 diabetes age 18-75 years
      old at a single clinical site (Sansum Diabetes Research Institute), who will complete a
      48-hour closed-loop (CL) session in an observed CRC environment with medical staff present.
      During the session subjects will bolus for all meals and snacks and perform a 45-minute
      walking session while supervised by medical staff. The AP system used consists of an insulin
      pump, a CGM sensor, and a phone app (the Artificial Pancreas System [APS] phone app).
    

Intervention name(s): Artificial Pancreas App
Intervention type(s): Device
Intervention description(s): The portable Artificial Pancreas System App (APS APP) is an artificial pancreas system comprised primarily of an insulin pump, a continuous glucose monitor (CGM), and a cellular phone device to connect the components.
Intervention MeSH terms: Pancrelipase
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: artificial pancreas; hyperglycemia; hypoglycemia
Tranexamic Acid in Functional Endoscopic Sinus Surgery
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of the study is to compare the effect of oral tranexamic acid vs. intravenous in
      decreasing bleeding and improving the field during FESS.
    

Detailed description: 
      The use of tranexamic acid during Intraoperative bleeding in functional endoscopic sinus
      surgery (FESS) improves the outcome. Bleeding is one of the most devastating complications
      during fess. Tranexamic acid is used in open heart surgery to improve the surgical field.

      Using oral vs. intravenous forms of the drug will add to our knowledge and improve outcomes.
    

Intervention name(s): Oral tranexamic acid; Intravenous tranexamic acid
Intervention type(s): Drug; Drug
Intervention description(s): 4 tablets of tranexamic acid 500mg (equal 2gm) 2 hours before surgery in the ward.; 15mg/kg of tranexamic acid in a 20ml syringe slowly intravenous during induction.
Intervention MeSH terms: Tranexamic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Evaluation of Impact of Nitrous Oxide on PONV in Breast Surgeries
Condition: Breast Cancer
Study type: Interventional

Summary: 
      Postoperative nausea and vomiting (PONV) is considered one of the most unpleasant
      postoperative discomforts and lead to serious complications of aspiration of gastric
      contents, suture dehiscence, esophageal rupture, subcutaneous emphysema, or pneumothorax. The
      incidence of PONV is 30-40% in normal population and touches a peak of 75-80% in certain
      high-risk groups. PONV is associated with delayed recovery and prolonged hospital stay and is
      associated with significant morbidity. It may also result in delayed discharge, which is
      particularly significant after potentially ambulatory surgery. Women are 2 to 3 times more
      susceptible to PONV than men and breast surgery, which is primarily done in an outpatient
      setting, is associated with high incidence of PONV, ranging between 15% and 84% in the
      absence of prophylactic treatment.

      Nitrous oxide (N2O) has analgesic and sedative properties but may potentially increase the
      incidence of PONV. N2O might increase the incidence of PONV by several potential mechanisms:
      (1) increase in middle ear pressure (2) bowel distension, (3) activation of the dopaminergic
      system in the chemoreceptor trigger zone and (4) interaction with opioid receptors. N2O has
      been demonstrated to increase the incidence of PONV in some studies but not in others. The
      present study is undertaken to evaluate the effect of nitrous oxide- free general anesthesia
      on the undesirable clinical outcome of PONV.
    


Intervention name(s): nitrous oxide anesthesia; air anesthesia; laryngeal mask airway (LMA Supreme Size 3/4; sevoflurane
Intervention type(s): Drug; Drug; Device; Drug
Intervention description(s): General anesthesia will be maintained by 40% oxygen (FiO2 0.4) with Nitrous Oxide and volatile anesthetic sevoflurane through laryngeal mask airway (LMA Supreme Size 3/4) or endotracheal tube (Size 7.0-7.5). All patients will receive standard anesthetic care and monitoring; General anesthesia will be maintained by 40% oxygen (FiO2 0.4) with air and volatile anesthetic sevoflurane through laryngeal mask airway (LMA Supreme Size 3/4) or endotracheal tube (Size 7.0-7.5). All patients will receive standard anesthetic care and monitoring
Intervention MeSH terms: Nitrous Oxide; Anesthetics; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Prevention
Immunogenicity and Safety of Two Different Commercial EV71 Vaccines
Condition: Hand, Foot and Mouth Disease
MeSH terms: Foot-and-Mouth Disease; Hand, Foot and Mouth Disease; Mouth Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate the immunogenicity and safety of sequential
      vaccination of two EV71 inactived vaccines in healthy infants aged 6-35 months.
    

Detailed description: 
      This study is a opened,randomized and controlled phase Ⅳ clinical trial. The purpose of this
      study is to evaluate the immunogenicity and safety of sequential vaccination of two EV71
      inactived vaccines in healthy infants aged 6-35 months. EV71 inactived vaccines(Vero
      cells）was manufactured by Sinovac Biotech Co., Ltd and EV71 inactived vaccines(Human diploid
      cells）was manufactured by Institute of Medical Biology Chinese Academy of Medical
      Sciences.300 infants aged between 6-35 months will be randomly assigned into experimental
      group in the ratio 1:1:1:1.The experimental group 1 received two doses EV71 inactived
      vaccines(Vero cells）on day 0 and 30. The experimental group 2 received two doses EV71
      inactived vaccines (Human diploid cells）on day 0 and 30. The experimental group 3 received
      one dose EV71 inactived vaccines (Vero cells）on day 0 and one dose EV71 inactived vaccines
      (Human diploid cells）on day 30.The experimental group 4 received one dose EV71 inactived
      vaccines (Human diploid cells）on day 0 and one dose EV71 inactived vaccines (Vero cells）on
      day 30. To evaluate the immunogenicity of the vaccine, venous blood will be collected for the
      EV71 neutralizing antibody detection prior to vaccination and 30 days after the 2nd dose
      vaccination.
    

Intervention name(s): EV71 inactived vaccine（Vero cells）; EV71 inactived vaccine（Human diploid cells）
Intervention type(s): Biological; Biological
Intervention description(s): The EV71 inactived vaccine（Vero cells） was manufactured by Sinovac Biotech Co., Ltd.; The EV71 inactived vaccine（Human diploid cells） was manufactured by Institute of Medical Biology Chinese Academy of Medical Sciences.
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Inactivated Enterovirus Type 71 (EV71) Vaccine; Sequential vaccination; Immunity; Safety
Study Evaluating Bifeprunox in Bipolar Depression
Condition: Depression Bipolar
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of the study is to investigate whether eight weeks of treatment with flexible
      doses of Bifeprunox is superior to treatment with placebo in depressed patients with bipolar
      disorder.
    


Intervention name(s): Bifeprunox
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Sex Differences, Hormones & Smoking Cessation
Condition: Tobacco Cessation
Study type: Interventional

Summary: 
      Data suggest that progesterone may improve smoking cessation outcomes perhaps by reducing
      impulsive behavior. However, the clinical literature on this topic is lacking. Therefore, in
      Project I we are proposing a double-blind randomized controlled trial to assess the role of
      exogenous progesterone on impulsivity and smoking cessation in a sample of males and females
      who are motivated to quit smoking.
    

Detailed description: 
      Subjects will be stratified by sex and then randomly assigned to active progesterone (PRO) or
      placebo (PBO).

      Telephone screening and visit invitation leads to the consent process and in-person screening
      including medical-psychiatric evaluation for inclusion/exclusion, then randomization and
      medication induction, stable medication with medication reduction and final evaluation for
      secondary outcomes.
    

Intervention name(s): Placebo; Progesterone; Smoking Cessation Behavioral Counseling
Intervention type(s): Other; Drug; Other
Intervention description(s): Placebo - subjects will take 200 mg twice daily orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date.; The progesterone will be given in the form of an active micronized natural progesterone (Prometrium). All subjects will take 200 mg twice daily orally (approximately 8am and 8pm) for twelve weeks starting seven days prior to the assigned quit date.; Subjects will receive weekly smoking cessation behavioral counseling.
Other intervention name(s): Prometrium
Intervention MeSH terms: Progesterone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Exercise Interventions of Eye Muscles Post Strabismus Surgery
Condition: Strabismus; Amblyopia
MeSH terms: Amblyopia; Strabismus
Study type: Interventional

Summary: 
      It will be hypothesized that:

        -  Eye exercises have a positive effect on correction of remaining ocular deviation post
           strabismus surgery.

        -  Eye exercises have a positive effect on improving amplyobia.
    

Detailed description: 
      This study applied to determine the effect of physiotherapy exercises on correction the
      remaining ocular deviation which still present following the strabismus surgery and also its
      effect on amplyobia.

      Different type of physiotherapy exercises was applied to experimental group for 12 weeks
      beside the medical treatment applied post-surgery while the control group received
      traditional treatment only.

      The near and far angles of ocular deviation were measured before and after the treatment for
      evaluation of strabismus and measuring visual acuity for evaluation of amplyobia.
    

Intervention name(s): eye exercises; eye glasses
Intervention type(s): Other; Device
Intervention description(s): Eye exercises for correcting eye deviation; Eye glasses for correcting eye deviation
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Strabismus and amplyobia and physiotherapy eye exercise
Biological Age Applied at Ubberup
Condition: Healthy Aging; Lifestyle Risk Reduction
Study type: Observational [Patient Registry]

Summary: 
      In a previous study the investigators have developed a novel biological age model. Assessing
      biological age is the assessment of the present health status and functional
      capacity/physiological reserve of that person in comparison with people of the same age and
      sex.

      The aim of this study is to investigate the utility and validity of this novel biological age
      model designed for health promotion in real world conditions.
    

Detailed description: 
      Study design: This is a longitudinal study, where biological age assessment is conducted in
      the first and final week of an 11-14 week lifestyle intervention course. These courses take
      place at a Danish folk high school (Ubberup), which is specialized in performing intensive
      lifestyle interventions targeting a 10% weight loss. The intention is to include 80 adult men
      and women.

      Data collection: This will take place at the facilities at Ubberup folk high school,
      participants being overnight fasted and without having exercised for the previous 24 hours.
      All analysis will be performed in investigators lab (Xlab) at the Department of Biomedical
      Sciences, Copenhagen University. When all samples are analysed Biological age will be
      calculated for each particpant.
    

Intervention name(s): Lifestyle intervention
Intervention type(s): Behavioral
Intervention description(s): The 14 week courses takes place at a Danish folk high school (Ubberup), specialized in lifestyle interventions targeting a 10% weight loss. Adult individuals with obesity sign up for the course. They stay at the School for the whole course period and the total cost amounts to 300-400 Euros per week plus loss of income.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        adults participating and finishing the 12-14 week intensive lifestyle intervention at
        Ubberup folk high school.
      
Biospecimen description: 
      Blood sample will be drawn from a vein in the elbow
    
Keywords: Individualised Health; Prediction; Risk Assessment
Folic Acid vs 5-methyltetrahydrofolate (5MTHF) in Recurrent Abortion
Condition: Recurrent Abortion
MeSH terms: Abortion, Habitual; Recurrence
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Recent data indicates that 5 methyltetrahydrofolate (5MTHF) can reduce serum homocystein
      level more efficiently than folic acid. On the other hand, folic acid is currently an
      important part of treatment in idiopathic recurrent abortion. There is no study comparing the
      effectiveness of these supplements in the treatment of recurrent abortion. The aim of this
      study is to compare the efficiency of these two agents in the treatment of recurrent
      abortion. In this study, patients with idiopathic recurrent abortion, referring to Avicenna
      clinic will be randomly allocated into two groups of those taking either folic acid (5 mg) or
      5 MTHF (5mg) from 8 weeks prior to conception until the 20th week of pregnancy. The serum
      level of folate, homocystein, and ongoing pregnancy will be analysed and compared in the two
      groups.
    


Intervention name(s): 5-methyltetrahydrofolate; folic Acid
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Folic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Study of PF-05221304 in Subjects With Varying Degrees of Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      Hepatic impairment PK study
    

Detailed description: 
      This is a non randomized, open label, single dose, parallel cohort, multisite study to
      investigate the effect of varying degrees of hepatic impairment on the plasma
      pharmacokinetics (total and unbound) of PF-05221304 after a single oral dose administered in
      the fed state.
    

Intervention name(s): PF-05221304
Intervention type(s): Drug
Intervention description(s): 25 mg dose
Other intervention name(s): experimental drug
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Oral Mucositis in Patients Undergoing Antineoplastic Chemotherapy
Condition: Oral Mucositis
MeSH terms: Mucositis; Stomatitis
Study type: Observational

Summary: 
      The purpose of this study was to:

        1. To investigate the feasibility of using infrared (IR) thermometer to grade the severity
           of oral mucositis in patients with multiple myeloma undergoing chemotherapy.

        2. To obtain preliminary data on the most optimal method of scoring the severity of oral
           mucositis by comparing the results obtained using the IR thermometer to the World Health
           Organization (WHO) mucositis grading system and the patient self-assessment
           questionnaire.

        3. To Investigate the correlation between the quantitative readings obtained from oral
           mucosa with the IR thermometer.
    

Detailed description: 
      Several grading systems for oral mucositis are available including those of the World Health
      Organization (WHO), Radiation Therapy Oncology Group (RTOG), Western Consortium for Cancer
      Nursing Research WCCNR, and the National Cancer Institute Common Toxicity Criteria (NCICTC)
      and others However, all of these oral mucositis grading systems rely on visual examination
      and are therefore subjective and operator-dependent tools and suffer from significant
      interpersonal variability (6). With the current improvements in medicine and technology,
      there is definitely a need for a more objective, easy to perform, non-invasive, affordable,
      quantitative and reproducible tool that is operator-independent to assess the severity of
      oral mucositis. The introduction of such a tool would greatly improve our ability to compare
      the oral mucosal toxicity of antineoplastic therapies and the efficacy of various
      mucoprotective therapies. Furthermore, the use of such a tool can be extended to patients
      undergoing radiation treatment with or without chemotherapy for various malignancies
      including head and neck cancers.
    

Intervention name(s): Infrared Thermometer
Intervention type(s): Device
Intervention description(s): The infrared thermometer will be used to grade the severity of oral mucositis in patients undergoing antineoplastic chemotherapy for multiple myeloma. The photothermal camera will be used to take intraoral digital images of the mouth.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients receiving Chemotherapy for Multiple Myeloma and suffering with mucositis
      
Keywords: mucositis
Nociceptive Gain Processing After Physical Therapy in Carpal Tunnel Syndrome
Condition: Carpal Tunnel Syndrome
MeSH terms: Carpal Tunnel Syndrome; Syndrome
Study type: Interventional

Summary: 
      This randomized clinical trial will investigate changes in pain intensity and nociceptive
      gain processing after the application of either physical therapy or surgery in women with
      carpal tunnel syndrome (CTS). The purpose of this study will be to determine changes in pain
      intensity, widespread pressure pain sensitivity and segmental thermal changes after the
      application of a physical therapy program based on desensitization maneuvers of the central
      nervous system or endoscopic surgery in women with CTS at medium and long-term follow-up
      periods. We hypothesize that the physical therapy intervention targeted to desensitization of
      the central nervous system is more effective than surgical intervention for modulating
      altered nociceptive gain processing in women with CTS.
    

Detailed description: 
      There is increasing evidence suggesting that carpal tunnel syndrome (CTS) represents a
      complex pain syndrome including both peripheral and central sensitization mechanisms. In
      fact, patients with unilateral CTS exhibit bilateral widespread pressure hyperalgesia and
      bilateral pain hypersensitivity suggesting the presence of altered nociceptive gain
      processing. In addition, these sensitization processes seem to be independent of
      electro-diagnostic findings. Previous studies support the use of physical therapy and
      surgical interventions for the management of pain and disability in these patients. However,
      there is no evidence related to changes in nociceptive gain process after the application of
      any therapeutic intervention. Preliminary evidence suggests that manual therapies can
      modulate sensitization mechanisms. Therefore, our objective is to conduct a randomized
      clinical trial to determine if manual therapies including desensitization maneuvers of the
      central nervous system are effective to decrease widespread pressure pain and thermal pain
      hypersensitivity in women with CTS.
    

Intervention name(s): Surgical Group; Physical Therapy Group
Intervention type(s): Other; Other
Intervention description(s): The surgical group will receive a surgical procedure consisting of the decompression and release of the median nerve at the carpal tunnel performed by an experienced surgeon according to standardized protocols.; The physical therapy group will receive 3 treatment sessions of manual therapy including desensitization maneuvers of the central nervous system of 30 minutes of duration, once per week.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Carpal Tunnel Syndrome; Pain; Sensitivity; Pain Thresholds; Sensitization; Physical Therapy
A Study Of PF-03882845 Absorption In Healthy Volunteers Given Orally As Tablet Versus Suspension Formulations And Effect Of Food On Its Absorption
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to estimate the relative bioavailability and food effect
      of a PF-03882845 tablet as compared to a suspension formulation used in previous clinical
      studies.
    


Intervention name(s): PF-03882845; PF-03882845; PF-03882845
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 25 mg of PF-03882845 suspension (75% SDD) will be given as a single oral dose under fasted condition; 25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fasted condition; 25 mg PF-03882845 Tablet (75% SDD) will be given as a single oral dose under fed condition
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Relative bioavailability; food effect; tablet; suspension; single dose; crossover; healthy subjects