bioihbjkbjnl/mcl2 huggingface dataset:
Abnormal Uterine Bleeding and Progestin-only Contraceptives
Condition: Contraception
MeSH terms: Uterine Hemorrhage
Study type: Observational

Summary: 
      The use of progestin-only methods of contraception has been increased obviously and
      progressively over the world in the last few years. Progestin-only contraception is an option
      for women in whom an estrogen-containing contraceptive is either contraindicated or causes
      additional health concerns.

      Progestogen-only pills are contraceptive pills that contain only synthetic progestogens
      (progestins) and do not contain estrogen . The progestin-only pill is recommended over
      regular birth control pills for women who are breastfeeding because the mini-pill does not
      affect milk production.

      The most common progestin-only method used is the injectable depot medroxy-progesterone
      acetate which had been approved by Food and Drug Administration since 1992 . depot
      medroxy-progesterone acetate provides reliable, private, long-acting (three months) and
      reversible contraception. Users of depot medroxy-progesterone acetate don't need daily taking
      as well as it doesn't affect the intercourse by any mean.

      The etonogestrel implant (Implanon) is a single-rod progestin contraceptive method placed
      subdermally in the inner aspect of upper non dependant arm for three years. Much evidence
      supports the safety, efficacy, reversibility and acceptability of this contraceptive method.

      A common reason women choose to discontinue progestin-only contraception is dissatisfaction
      with its effects on uterine bleeding which occurs in a significant number of users.
      Information revealed from many clinical trials shows that abnormal uterine bleeding with
      progestin-only contraception ranging from 10 to 25 % at first year of use.
    


Intervention name(s): Depot medroxy-progesterone acetate; Etonogestrel; Desogestrel 75 µg
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Injection every 3 months; 68 mg implant; one pill every day for 28 days without pill-free interval.
Intervention MeSH terms: Medroxyprogesterone Acetate; Etonogestrel; Desogestrel; Medroxyprogesterone; Progesterone
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        women who requested DMPA, etonogestrel subdermal implant or POPs for pregnancy prevention.
Food Effect Study of Anaprazole in Healthy Chinese Subjects
Condition: Healthy Male Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      A single-center, randomized, open-labeled, 2×2 crossover phase 1 study to evaluate the
      pharmakinetics effect of high fat food to single dose administration of Anaprazole in healthy
      Chinese male subjects. 14 health male subjects is divided to A group (n=7) and B group (n=7).
      2 periods (7 days) cross-over design, anaprazole 40mg single dose, one is fasting oral
      administration before breakfast, the other is oral administration 30 minutes after breakfast
      with high fat food.
    


Intervention name(s): Anaprazole; Anaprazole
Intervention type(s): Drug; Drug
Intervention description(s): single dose, oral administration 30 minutes after breakfast with high fat food.; single dose, oral administration before breakfast.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Randomised Controlled Trial Comparing Single Shot Adductor Canal Block With Local Infiltration Analgesia for Postoperative Analgesia After Total Knee Arthroplasty
Condition: Analgesia in Total Knee Arthroplasty
MeSH terms: Agnosia
Study type: Interventional

Summary: 
      Total knee arthroplasty or replacement (TKA), a commonly performed surgery for osteoarthritis
      of the knee, is a painful procedure and requires a multimodal analgesic approach. A method
      for analgesia is local infiltration analgesia (LIA), where a mixture of drugs is injected
      around the knee joint.

      Adductor canal block (ACB) is an alternative regional anaesthesia technique which has been
      shown to result in minimal thigh weakness.

      The investigators aim to study if the analgesia provided by ACB is superior to LIA while
      preserving quadriceps strength.
    


Intervention name(s): Adductor Canal Block
Intervention type(s): Procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Heart Rate Response to Regadenoson and Sudden Cardiac Death
Condition: Left Ventricular Systolic Dysfunction; Sudden Cardiac Death
MeSH terms: Death, Sudden, Cardiac; Ventricular Dysfunction, Left; Death
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether a blunted heart rate response to
      regadenoson is an independent predictor of sudden cardiac death.
    

Detailed description: 
      In patients with heart failure and in those with a history of sudden cardiac death, an
      Implantable Cardiac Defibrillator (ICD) reduces death rates. However, not all patients with
      an ICD receive appropriate therapy from it. Inappropriate ICD shocks are common and are
      associated with worse quality of life and increased death rate. We hope to establish a better
      predictor of risk of sudden cardiac death and of response to ICD. We are conducting a
      prospective observational study of 150 patients (18-80 years) with an indication for ICD
      implantation for primary prevention of sudden cardiac death. Prior to the implantation of a
      clinically indicated ICD, the heart rate response to regadenoson will be assessed.
      Regadenoson will be administered intravenously as a fixed intravenous bolus dose of 400 μg
      followed by a 5 mL saline flush.

      The main objectives of this proposal are to investigate whether:

        1. A blunted heart rate response to regadenoson is an independent predictor of sudden
           cardiac death.

        2. A blunted heart rate response to regadenoson can be used as a predictor of response to
           ICD on top of traditionally used indicators.

      We Hypothesize that:

        1. Patients with a blunted heart rate response to regadenoson are at higher risk of sudden
           cardiac death (death or appropriate cardiac defibrillation). This risk is maintained
           after controlling for age, gender, left ventricular ejection fraction, heart failure
           symptoms and medication use.

        2. Patients with a normal heart rate response to regadenoson have a low rate of events
           (death or appropriate cardiac defibrillation) despite meeting current indications for
           having an ICD.
    

Intervention name(s): regadenoson
Intervention type(s): Drug
Intervention description(s): Prior to the implantation of a clinically indicated ICD, the heart rate response to regadenoson will be assessed. Regadenoson will be administered intravenously as a fixed intravenous bolus dose of 400 μg followed by a 5 mL saline flush. Medications (including beta-blockers) will be withheld on the morning of the test. The heart rate and blood pressure will be measured at baseline and every minute after regadenoson bolus for at least 5 minutes and until the heart rate and blood pressure are clearly returning towards baseline.
Other intervention name(s): Lexiscan
Intervention MeSH terms: Regadenoson
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Implantable cardiac defibrillator; regadenoson; sudden cardiac death; heart rate response
Comparison of Simple Blood Lancet(Vitrex®)With DuoTip as Skin Prick Test Devices Among Mite-sensitized Subjects
Condition: Skin Prick Test
Study type: Observational

Summary: 
      The purpose of this study is to compare the results skin prick tests using simple blood
      lancet (Vitrex®) with DuoTips among mite-sensitized subjects.
    

Detailed description: 
      We intend to compare results of skin prick tests by using simple blood lancet(Vitrex®) and
      DuoTips in terms of wheal size, variability, transfer of allergen and pain level, among
      mite-sensitive subjects.
    

Intervention name(s): Simple blood lancet
Intervention type(s): Device
Intervention description(s): Skin prick testing with blood lancet and DuoTip is performed on the back of mite-sensitized person. Allergen(Der p)is placed in 1st and 2nd row whereas histamine is placed in 3rd row. Allergen and normal saline are placed alternately in 4th row. Block randomization were allocated subjects into 2 groups; Group1:blood lancet is performed in 1st row and DuoTip in 2nd row. Group2:DuoTip is performed in 1st row and blood lancet in 2nd row. Blood lancet is applied in 3rd and 4th row in all subjects. A technician performed device applications and another technician who is blinded to device performed all readings. Pain was assessed on a scale from 0 to 10 with 0 being no pain and 10 being the worst imaginable pain
Other intervention name(s): Vitrex®
Observational model: Case-Only
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Individuals who have positive skin prick testing to Der p 10,000 AU/ml (wheal size 3 mm at
        least)
      
Keywords: allergy; skin prick test; mite sensitivity
Effects of Filter Ventilation and Ventilation Information on Product Use Behaviors in Cigarette Smokers
Condition: Cigarette Smoking-Related Carcinoma
Study type: Interventional

Summary: 
      This clinical trial collects data to see how filter ventilation and ventilation information
      affects product use behaviors in cigarette smokers. Providing ventilation information on the
      cigarette package may affect smokers' rating of product appeal, perceptions of health risk,
      and changes in cigarette consumption.
    

Detailed description: 
      PRIMARY OBJECTIVE:

      I. To assess how adding messaging to cigarette packages about filter vents and filters
      influences respondents awareness of filter ventilation, beliefs about the function of filter
      vents and filters, smoking behavior, ratings of cigarette satisfaction, smoking topography,
      exposure to nicotine and carbon monoxide, perceptions about the risk of smoking, and
      intention to stop smoking.

      OUTLINE: Participants are randomized to 1 of 4 conditions.

      CONDITION I: Participants receive regular package cigarettes for 2 weeks. Participants attend
      3 video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data
      collection.

      CONDITION II: Participants receive cigarettes with neutral message "Nothing about this
      product's color or name means that it will protect a smoker from the health risks of smoking"
      on package for 2 weeks. Participants attend 3 video sessions over 0.5 hour each at baseline,
      1, and 2 weeks respectively for data collection.

      CONDITION III: Participants receive cigarettes with compensation message "This product has a
      ventilated filter. Filter vents increase how deeply a smoker inhales without them knowing,
      which can increase the health risks of smoking" on package for 2 weeks. Participants attend 3
      video sessions over 0.5 hour each at baseline, 1, and 2 weeks respectively for data
      collection.

      CONDITION IV: Participants receive cigarettes with blocking message "This product has a
      ventilated filter. Be sure not to block the vent holes with your fingers or lips, which can
      increase the health risks of smoking" for 2 weeks. Participants attend 3 video sessions over
      0.5 hour each at baseline, 1, and 2 weeks respectively for data collection.
    

Intervention name(s): Cigarette packaging; Data capture; Questionnaire administration
Intervention type(s): Other; Other; Other
Intervention description(s): receive normal packet cigarette; Attend video sessions; Ancillary studies
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Anesthesia for Dental Treatment in Cardiac Patients: Lidocaine Comparative Study
Condition: Arrhythmias; Anxiety
MeSH terms: Arrhythmias, Cardiac
Study type: Observational

Summary: 
      Prospective, randomized double-blinded study to investigate hemodynamic changes in valvular
      cardiac patients during dental treatment with the use of a local anesthesia containing
      epinephrine.
    

Detailed description: 
      Patients with valvular disease constitute a group in which local anesthesia must be effective
      to avoid higher release of endogenous catecholamines that could trigger hemodynamic. The
      study was conducted in the Dental Department of the Instituto do Coração do Hospital das
      Clínicas da Faculdade de Medicina da Universidade de São Paulo (Brazil). Patients were
      allocated into two groups through an aleatory numbered table: PL (plain 2% lidocaine, n= 31)
      and LE (2% lidocaine with 1:100.000 epinephrine, n= 28). The anesthetic amount was
      registered. DIXTAL monitor (São Paulo- Brazil) captured blood pressure, heart rate,
      oxygenation and electrocardiogram records.
    

Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with acquired valvular diseases participated in this study, aging between 18-65
        years in need of dental surgery (extractions) or restorative dentistry in mandible
      
Keywords: Anesthesia, Local; Lidocaine; Dental care; Arrhythmias, Cardiac; Anxiety
Safety and Efficacy of Risedronate in the Treatment of Osteogenesis Imperfecta in Children
Condition: Osteogenesis Imperfecta
MeSH terms: Osteogenesis Imperfecta
Study type: Interventional
Phase: Phase 3

Summary: 
      Children with Osteogenesis Imperfecta (OI) have bone pain, low bone mass and fractures. There
      are no approved drugs for the treatment of OI in children, even though some intravenous (IV)
      bisphosphonates are used off-label in some countries. In a single dose, pharmacokinetic
      study, data showed that risedronate was well tolerated in 28 children with OI. This three
      year study will test the safety and efficacy of risedronate in the treatment of children with
      OI. For the first year, patients will be randomized to the risedronate and placebo groups in
      a 2:1 ratio. For the second and third years of the study, all patients will receive
      risedronate.
    


Intervention name(s): risedronate sodium (Actonel); Placebo
Intervention type(s): Drug; Drug
Intervention description(s): risedronate tablet once a day for one year followed by risedronate once a day for two years; placebo tablet once a day for one year followed by risedronate once a day for two years
Intervention MeSH terms: Risedronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Primary disease: Osteogenesis Imperfecta
Neuromuscular Block and Anesthetic Depth Monitoring
Condition: Cholecystectomy, Laparoscopic
Study type: Interventional

Summary: 
      The purpose of this study is to evaluated whether the depth of neuromuscular block may affect
      the unicon value of anesthetic depth monitoring system (ADMS).
    


Intervention name(s): Rocuronium (MB group); Rocuronium (DB group)
Intervention type(s): Drug; Drug
Intervention description(s): Count of train-of-four: 1-2 Titration of rocuronium dose; Post-tetanic count: 1-2 Titration of rocuronium dose
Intervention MeSH terms: Rocuronium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Dose-escalation Study of Single Dose GHB04L1 in Healthy Adults
Condition: Influenza
Study type: Interventional
Phase: Phase 1

Summary: 
      It is the hypothesis of this study that intranasal vaccination with a single dose of GHB04L1
      is safe and induces an immune response against influenza A H5N1. This hypothesis will be
      tested in a randomized, double-blind, placebo-controlled, Phase I dose-escalation study
      assessing the safety and tolerability of single dose administration of GHB04L1 in healthy
      adults. Furthermore, the local and systemic immune response as well as the pharmacokinetic
      properties of a single dose of GHB04L1 will be studied as secondary objectives. GHB04L1 will
      be escalated according to a fixed dose escalation scheme comprising three dose levels.
    


Intervention name(s): GHB04L1; Placebo
Intervention type(s): Biological; Other
Intervention description(s): single dose intranasal administration of GHB04L1; SPGN buffer
Other intervention name(s): A/Vietnam/1203/04 (H5N1)-ΔNS1 virus reassortant
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: vaccination; avian
Laparoscopic Complete Mesocolic Excision on Colon Cancer
Condition: Operation Finding; Complications; Pathology; Quality of Life; Neoplasms Recurrence
MeSH terms: Recurrence
Study type: Interventional

Summary: 
      Laparoscopic complete mesocolic excision is a concept that using laparoscopic surgery
      technique to perform a resection for colon cancer. Besides, the segment of the colon
      containing the tumor, the resection area should include an intact mesocolon as an envelope to
      encase the possible route for metastasis. The routes include blood vessels, lymphatic drain
      and etc. Such hypothesis predicts better histopathological and higher oncological results
      which turns into better survival rate and better quality of life.
    


Intervention name(s): laparoscopic complete mesocolic excision; D3-laparoscopic colectomy
Intervention type(s): Procedure; Procedure
Intervention description(s): laparoscopic complete mesocolic excision would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications. Lap.CME facilitaes medial approach to complete the procedure. CME and HMA are the two arms of the medial approach utilized.; D3-laparoscopic colectomy would be applied on randomized group of patients suffering colon cancer and possessing no marked surgical anti-indications.
Other intervention name(s): laparoscopic CME; Complete Medial Approach (CMA); Hybrid Medial Approach (HMA); D3 laparoscopic colectomy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Whole Body Vibration on Autonomic Function in Healthy Young and Elderly
Condition: Healthy; Aging
Study type: Interventional

Summary: 
      Aging causes anatomical and physiological changes in the cardiovascular system and autonomic
      function with decline in its maximum function. This study aimed to evaluate the acute effects
      of whole body vibration on cardiovascular system, autonomic function and heart variability in
      healthy young and elderly. The investigators' hypothesis is that whole body vibration has
      different effects in young and elderly.
    


Intervention name(s): Whole Body Vibration
Intervention type(s): Other
Intervention description(s): A whole body vibration session will be performed through a vibrating platform with three axes and vibration frequency set at 35 Hz. The amplitude used will be 04 mm.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Youth mHealth Adherence Intervention for HIV+ YMSM
Condition: HIV
Study type: Interventional

Summary: 
      This study will help determine feasibility, acceptability, and preliminary efficacy of an app
      for HIV medication adherence over a 3-month period. Participation is 3 months consisting of
      two study visits: An initial study visit and a 3 month follow up visit with both visits
      lasting about 60-90 minutes. The participant must use the study application (app) at least
      once daily, and at study visits, must complete surveys.
    

Detailed description: 
      Young men who have sex with men (YMSM) are disproportionately affected by HIV in the US and
      fewer than half of youth who are prescribed antiretroviral therapy (ART) achieve viral
      suppression. Yet few interventions have been developed to address adherence in this
      population with unique developmental/psychosocial needs. Mobile technology, which is
      constantly consumed by youth, has the potential to deliver interventions that provide support
      and feedback in real time as youth go about their daily lives.

      This pilot study will test a theory-driven, patient-centered, mobile phone-based intervention
      (mHealth app) targeting medication adherence among HIV+ youth. It is a three-month
      prospective feasibility trial to test a medication adherence mobile application consisting of
      two study visits: baseline and 3-month follow up.

      Data collection consists of app usage, Computer Assisted Self-Interview (CASI) for
      participant satisfaction with the app, demographics, and mental health and risk behaviors, as
      well as medical chart abstraction of disease biomarkers (CD4, viral load) and pharmacy refill
      data.
    

Intervention name(s): HIV medication adherence app
Intervention type(s): Device
Intervention description(s): A medication adherence mobile application for HIV+ youth. It is a theory-driven, patient-centered, mobile phone-based intervention targeting medication adherence and engagement in care among HIV+ youth with features including, but not limited to: custom avatar, medication reminders, calendar tracking of medication adherence, and anonymous chat function for social support.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Men who have sex with men (MSM); mHealth; antiretroviral therapy (ART); native android app
Study to Evaluate the Efficacy and Safety of Reslizumab Treatment in Patients With Moderate to Severe Asthma
Condition: Eosinophilic Asthma
MeSH terms: Asthma; Pulmonary Eosinophilia
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of the study is to characterize the efficacy of reslizumab treatment,
      at a dosage of 3.0 milligrams per kilogram (mg/kg) every 4 weeks for a total of 4 doses, in
      improving pulmonary function in relation to baseline blood eosinophil levels in patients with
      moderate to severe asthma, as assessed by the change from baseline to week 16 in forced
      expiratory volume in 1 second (FEV1).
    


Intervention name(s): Reslizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Reslizumab administered at a dosage of 3.0 mg/kg by intravenous (iv) infusion by qualified study personnel every 4 weeks for 16 weeks (for a total of 4 doses).; Matching placebo administered by intravenous (iv) infusion by qualified study personnel every 4 weeks for 16 weeks (for a total of 4 doses).
Other intervention name(s): Cinquil; humanized monoclonal antibody; CEP-38072
Intervention MeSH terms: Reslizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment