bioihbjkbjnl/mcl2 huggingface dataset:
Opioid Prescribing After Cesarean Delivery
Condition: Surgery; Opioid Use
Study type: Interventional

Summary: 
      The number of opioid overdose deaths in the United States has quadrupled in 15 years, a
      dramatic manifestation of the current opioid abuse epidemic. This rise parallels a sharp
      increase in the amount of legal prescription opioids dispensed. The abundance of prescription
      opioids available is a primary pathway for opioid abuse and diversion. Adjusting post-
      cesarean delivery opioid prescribing practices to better match actual patient need has the
      potential to reduce unused opioids available for diversion, nonmedical use, and development
      of chronic dependence, as well as reduce wasted resources.
    

Detailed description: 
      Preliminary data from a quality improvement project performed in our department found that
      most women are prescribed opioids after discharge that were significantly in excess of the
      actual opioids used. However there is a subset of women (~25%) who use all opioids and
      complain that they were not prescribed enough. The only variable predictive of post-
      discharge opioid use was Inpatient opioid use. These data were used to develop a formula for
      estimating outpatient use based on inpatient use. Currently there are no guidelines for
      outpatient prescribing either at our institution or on a national level. On average, most
      patients at our institution received 30 tablets of 5mg oxycodone at discharge. In surveying
      providers, very few looked at inpatient use and most had a standard prescription that they
      gave everyone.
    

Intervention name(s): Tailored prescription; Control
Intervention type(s): Other; Other
Intervention description(s): Participants will be prescribed an opioid tablet number based on a formula derived from inpatient opioid use; Participants will be prescribed 30 tablets of oxycodone 5mg
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants were randomized to either a personalized prescribing algorithm based off of inpatient opioid use versus standard discharge opioid prescribing.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: safe opioid prescribing
Nicotine Lozenge to Reduce Smokeless Tobacco Use
Condition: Tobacco Use Disorder
MeSH terms: Tobacco Use Disorder
Study type: Interventional
Phase: Phase 2

Summary: 
      Smokeless tobacco (ST), which includes both chewing tobacco and snuff, has as many health
      risks associated with its use as cigarettes. While there are many treatment programs that
      focus on stopping tobacco use, there are no interventions that specifically focus on reducing
      tobacco use. This study will evaluate the effectiveness of nicotine lozenge at reducing
      tobacco use in ST users.
    

Detailed description: 
      Individuals who use ST are at risk for developing heart disease, stroke, high blood pressure,
      and cancer. Other long-term effects include tooth abrasion, gum recession, and loss of bone
      in the jaw. Many individuals who use ST recognize the health risks associated with ST, but
      either do not want to quit or feel that it is impossible to quit. For these individuals,
      tobacco reduction may be an important transitional goal, either prior to quitting or as a
      treatment endpoint. The need exists for a program specifically aimed towards reducing, rather
      than quitting, tobacco use. The purpose of this study is to evaluate the effectiveness of
      nicotine gum at reducing ST use, as well as assessing the motivation to either quit or
      sustain lower levels of ST use.

      This 8-week study will enroll frequent users of ST. Participants will be randomly assigned to
      receive either nicotine lozenge plus behavioral counseling or behavioral counseling alone.
      All participants will be asked to alternate use of their usual ST brand with nicotine lozenge
      or placebo in order to reduce nicotine intake by 50% during the first 4 weeks and by 75% the
      following 4 weeks. Participants will be required to maintain a daily tobacco use diary. Study
      visits will occur once a week. Tobacco levels will be monitored with urine tests, and
      questionnaires will be completed to assess tobacco use. Follow-up evaluations will occur 12
      and 26 weeks following the end of treatment.
    

Intervention name(s): Nicotine Lozenge; Behavioral Counseling
Intervention type(s): Drug; Behavioral
Intervention description(s): Oral Nicotine replacement product; Use of behavioral counseling to reduce tobacco use.
Other intervention name(s): Commite Nicotine lozenge
Intervention MeSH terms: Nicotine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Nicotine Dependence; Tobacco Dependence
The Effect of Anesthesia on Pain in Percutaneous Nephrolithotomy
Condition: Percutaneous Nephrolithotomy
Study type: Observational

Summary: 
      It is aimed to determine the ideal application by determining the effect of different
      anesthesia methods applied in percutaneous nephrolithotomy surgeries on analgesic consumption
      and pain level.
    

Detailed description: 
      Different anesthesia methods are used in percutaneous nephrolithotomy.In addition to
      traditional analgesia methods such as intravenous paracetamol, NSAIDs, opioids, various
      methods such as epidiural analgesia or blocks added to general anesthesia are used.In this
      study, it was aimed to investigate whether central or peripheral block applications are
      preferred in percutaneous nephrolithotomy, and the need for intraoperative and postoperative
      analgesics in patients.In addition, it was aimed to investigate whether there was a change in
      analgesic consumption, recovery and pain level, and hospital stay in patients who were given
      general anesthesia or regional anesthesia, in a multicentric observational manner.
    

Intervention name(s): The anesthesia and analgesia technique preferred by the anesthetist will be recorded.
Intervention type(s): Other
Intervention description(s): In the study, the anesthesia method applied by blind anesthesiologists in the peroperative period, the drugs or techniques used for analgesia will be recorded and their effects on the postoperative period and hospital stay will be examined.There will be no intervention in the perioperative and postoperative process.
Intervention MeSH terms: Anesthetics
Observational model: Case-Control
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        600 patients
      
Keywords: general anesthesia; postoperative pain
A Dose Escalation Study of Bradanicline in Refractory Chronic Cough
Condition: Chronic Cough
MeSH terms: Cough
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, double-blind, placebo-controlled, crossover, dose escalation study of
      bradanicline in subjects with chronic cough
    

Detailed description: 
      This study will have two 21-day treatment periods separated by a 14-day washout period. There
      will be a 14-day follow-up period.
    

Intervention name(s): Bradanicline; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Three different doses over the course of the study; Matching placebo for Bradanicline
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Melatonin and Hyaluronic Acid in Maxillary Sinus Augmentation
Condition: Edentulous; Alveolar Process, Atrophy
MeSH terms: Atrophy
Study type: Interventional

Summary: 
      melatonin proved an ability to repair bone defects and enhance osseointegration of dental
      implants. Also, hyaluronic acid has osteopromoting properties.

      the effect of melatonin and hyaluronic acid on the newly formed bone in maxillary sinus
      augmentation was evaluated
    

Detailed description: 
      16 participants with missing maxillary posterior teeth and residual alveolar ridge of at
      least 5 mm will be equally and randomly divided into two groups.

      The study group will receive melatonin and hyaluronic acid after sinus membrane elevation and
      simultaneous implant placement while the control group will not receive any materials after
      sinus membrane elevation and simultaneous implant placement.
    

Intervention name(s): Melatonin and hyaluronic acid and sinus membrane elevation; sinus membrane elevation without any materials
Intervention type(s): Other; Procedure
Intervention description(s): 3 mg melatonin powder mixed with 0.2% hyaluronic acid gel will be placed to fill the sinus space and around the implant apex.; No materials will be placed at the sinus space.
Intervention MeSH terms: Melatonin; Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Pulmonary Vein Ablation of Atrial Fibrillation Using Magnetic Navigation: Single Ring Versus Circumferential Techniques
Condition: Pulmonary Vein Isolation, Ablation Time, Procedure Time, Freedom Form Atrial Fibrillation
MeSH terms: Atrial Fibrillation
Study type: Interventional

Summary: 
      The single-ring ablation method aims for isolation of the posterior LA wall including the
      pulmonary veins. If avoiding ablation on the posterior LA wall esophageal injury is unlikely.

      Aim of this prospective study was to evaluate the safety and efficacy of an RMN-guided
      single-ring ablation method as compared to standard RMN-guided circumferential PVA.
    


Intervention name(s): Circumferential pulmonary vein ablation; single ring pulmonary vein ablation
Intervention type(s): Procedure; Procedure
Intervention description(s): Circumferential pulmonary vein ablation; single ring pulmonary vein ablation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
The Effects of Transversus Abdominis Plane Block in Patients Undergoing Total Abdominal Hysterectomy
Condition: Abdominal Hysterectomy (& Wertheim); Intraoperative Complications
MeSH terms: Intraoperative Complications
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine the effects of Transversus Abdominis Plane Block on
      hemodynamic variables, anaesthetic and analgesic requirement, and quality of recovery in
      patients undergoing total abdominal hysterectomy
    

Detailed description: 
      Pain is one of the main causes of the poor perioperative outcomes and pain management is the
      important part of perioperative period. Neuraxial blocks could provide adequate analgesia
      during and after abdominal surgery. However,neuraxial blocks have a lot of contraindicated
      situations and neuraxial anesthesia can easily induce hemodynamic abnormalities. Therefore,
      in most cases, the choice of anaesthetic management may be the general anesthesia. In
      addition to reduce the blood pressure and heart rate changes due to surgical stimulations,
      the large amount of opioids and anaesthetics may be required. Opioid related side effects can
      affect perioperative complications and postoperative quality of recovery. Transversus
      abdominis plane block is a new choice to reduce postoperative pain in abdominal surgery.
      Although its postoperative analgesic efficacy is well known, its effects on hemodynamic
      variables, anaesthetic and analgesic requirement is not clear. The main objective of this
      study is to estimate the effect of Transversus abdominis plane block on hemodynamic
      variables, anaesthetic and analgesic requirement and quality of recovery in patients
      undergoing total abdominal hysterectomy.
    

Intervention name(s): TAP block; Control
Intervention type(s): Procedure; Procedure
Intervention description(s): Using real time ultrasound imaging, bilateral, 20 ml 0,25% bupivacaine inject into the area between the internal oblique and transverse abdominis muscle; A sham band-aid will be applied to the abdomen of subjects
Other intervention name(s): Transversus abdominis plane block; sham group
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Maintenance Gabapentin to Prolong Pregnancy.
Condition: Preterm Labor, Premature Birth
MeSH terms: Premature Birth; Obstetric Labor, Premature
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a pilot study to evaluate the tolerability and effects of maintenance gabapentin
      therapy on the rate of premature birth in women who have had preterm labor.
    


Intervention name(s): Gabapentin
Intervention type(s): Drug
Other intervention name(s): Neurontin
Intervention MeSH terms: Gabapentin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Preterm labor, premature birth, gabapentin
The Use of Warmed Saline in Vaso-occlusive Episodes
Condition: Sickle Cell Disease; Sickle Cell Crisis
MeSH terms: Anemia, Sickle Cell
Study type: Interventional

Summary: 
      The purpose of this study is to determine if warming the intravenous (IV) fluid given to
      patients with Sickle Cell Disease who are experiencing painful episodes known as
      Vaso-Occlusive Episodes; will decrease rates of hospital admission, decrease amounts of IV
      pain medications given, improve pain and improve global comfort.
    

Detailed description: 
      Vaso-occlusive crisis (VOC) is a common painful complication of Sickle Cell Disease and is
      the primary reason that these patients seek medical care in the acute care setting. This
      complication arises when blood vessels are obstructed by sickled red blood cells resulting in
      ischemic injury.

      The standard management of these painful episodes comprises the administration of opioid
      analgesics, the infusion of intravenous (IV) fluids at room temperature and rest. These
      episodes often last five to seven days and many patients require inpatient management for
      continued administration of intravenous analgesics.

      The public health impact of the disease is large as admissions frequently result in school or
      work absences and can be financially and emotionally taxing.

      It is well established that exposure to cold precipitates VOC. For this reason, management of
      the pain of VOC in some centers includes the use of warming blankets as an adjunct for pain
      relief. It is conceptually appealing to conjecture that warm fluids might have similar
      salutary effects on VOC. This conjecture is bolstered by the physiologic effect of
      temperature on vascular tone. Specifically, it is well established that cold temperatures
      cause vasoconstriction whereas warm temperatures cause vasodilation. We expect that warmed
      fluids will similarly induce vasodilation, improving blood flow to vaso-occluded ischemic
      areas.
    

Intervention name(s): Astoflo Plus fluid warmer
Intervention type(s): Device
Intervention description(s): A fluid warmer (the Astoflo Plus warmer) was used to warm fluid to body temperature 37.5 degrees Celsius
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
TDM of Asparaginase in ALL2008
Condition: Acute Lymphoblastic Leukemia
MeSH terms: Precursor Cell Lymphoblastic Leukemia-Lymphoma
Study type: Observational

Summary: 
      Asparaginase is a cornerstone in the treatment of ALL. In most contemporary protocols like in
      NOPHO ALL2008 prolonged asparaginase treatment has been implemented.

      Publish data from NOPHO ALL2008 show sufficient treatment of the majority of patients
      (analysing trough levels of asparaginase after 2 weeks) but 13% of the patients experience an
      allergic reaction to this foreign protein (85% of them after the 2nd or 3rd dose) and they
      have no enzyme activity even before the reaction, meaning that they don't benefit from the
      treatment at all. In addition 4-5% of the patients have no enzyme activity through the whole
      treatment without hypersensitivity symptoms. So in reality approximately 20% of the patients
      don't receive any asparaginase treatment. Therapeutic Drug Monitoring (TDM) of asparaginase
      has been established in Aarhus, Denmark, under the leadership of Birgitte Klug Albertsen
      (BKA). From February 2017 the centers have been invited to send samples (extended sampling)
      in order to gain more knowledge about the pharmacokinetics, to identify patients without
      activity and to establish the logistics for TDM of asparaginase, which will be mandatory in
      the next protocol ALLTogether, presumably opening in 2018.

      From February 2016 an extended sampling for enzyme activity measurements was started and will
      continue until NOPHO ALL2008 closes. These samples will make it possible to do more in depth
      pharmacokinetic studies as well as identify the optimal sampling time points for identifying
      no-activity patients in the future.

      A database is being developed for TDM in ALLTogether, but it will also include all the
      asparaginase measurements in ALL2008.
    


Observational model: Cohort
Time perspective: Retrospective
Sampling method: Probability Sample
Study population: 
        Alle patients in the NOPHO countries aged 1-45 years treated for ALL on the NOPHO ALL2008
        protocol and have asparaginase-activity-samples sent to Aarhus.
Overweighed Children´s Health - Studies of the Effect of Lifestyle and Food Habits
Condition: Overweight; Obesity
MeSH terms: Overweight
Study type: Interventional

Summary: 
      The aim is to investigate the development of overweight and obesity from infancy to school
      age, and to evaluate an intervention to prevent further development of overweight and obesity
      among children.

      A follow-up study will be conducted on 267 children and will allow comparison between
      children that developed overweight with the ones who did not. Subjects will be requited at 10
      years of age from a previous project. These children have been studied when they were 6-18
      months old and a follow-up was conducted at 4 years of age. Sixteen percent of the children
      were overweight at 4 years of age and retrospective data of e.g. food intake, blood lipids
      and anthropometric measurements exists. In the present follow-up data regarding food and
      physical activity habits, anthropometric measurements and blood samples of e.g. blood lipids,
      IGF1 will be collected.

      An intervention study will be conducted on 80-120 overweight children that will be randomized
      into one intervention and one control group. An intervention during two years will encourage
      long term healthy habits regarding diet and physical activity through group meetings and
      supervision. Information about food habits will be collected through questionnaires,
      interviews and diaries. Measurement of physical activity and energy expenditure will be made
      with Sense Wear and double labeled water, and will be used to validate reported food intake.
      Further, anthropometric measurements and blood samples will be collected.
    


Intervention name(s): Intervention regarding food habits and physical activity.
Intervention type(s): Behavioral
Intervention description(s): Children in the intervention group participated in an intervention program regarding food habits and physical activity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Children; Overweight; Obesity; Food habits; Dietary assessment; Physical activity
A Study of the Drug Interactions Between a Hormonal Emergency Contraception and an HIV Medication
Condition: HIV Infections; Contraception; Pharmacokinetics
MeSH terms: HIV Infections; Emergencies
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine if blood levels of the hormonal emergency
      contraceptive agent, Plan B, are altered by concomitant use with the HIV medication,
      efavirenz.
    

Detailed description: 
      The use of hormonal contraceptive pills in women with HIV is complex due to potential
      interactions between these agents and HIV medications. HIV-infected women taking efavirenz
      have an even greater need for effective birth control as this medication may cause severe
      brain damage to a developing fetus. The use of an emergency contraceptive agent in cases of
      unprotected sex or condom failure can prevent pregnancy. This study seeks to establish that
      Plan B can be used effectively and safely in women taking efavirenz.
    

Intervention name(s): levonorgestrel, efavirenz
Intervention type(s): Drug
Intervention MeSH terms: Efavirenz; Levonorgestrel
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV; Contraception; Antiretroviral agents; Pharmacokinetics
Comparison of Rigid Annuloplasty Ring With a Band in the Correction of Secondary Tricuspid Insufficiency
Condition: Tricuspid Regurgitation
MeSH terms: Tricuspid Valve Insufficiency
Study type: Interventional

Summary: 
      randomized study which include comparison rigid ring and band devices in treatment tricuspid
      regurgitation.
    

Detailed description: 
      study include 308 patients. Patient will be randomized and 154 patient will receive band for
      treatment tricuspid regurgitation, rest patient will receive rigid ring. Follow up will be 1
      year. Primary outcome - freedom of moderate or severe regurgitation. Secondary outcome - RV
      function, quality of life.
    

Intervention name(s): band implantation; rigid ring implantation
Intervention type(s): Device; Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Tricuspid Regurgitation; Insufficiency, Tricuspid Valve; Valvular Annuloplasty; Cardiac Valve Annulus Repair
Study Evaluating the Pharmacokinetics of HCV-796 in Healthy Japanese Men
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to assess the safety and tolerability of ascending multiple oral
      doses of HCV-796 in healthy Japanese male subjects.
    


Intervention name(s): HCV-796
Intervention type(s): Drug
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: SAD