bioihbjkbjnl/mcl2 huggingface dataset:
Study of Atomoxetine in Children With ADHD to Assess Symptomatic and Functional Outcomes
Condition: Attention-Deficit/Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to assess whether changes in the symptoms of ADHD show a
      relationship with changes in functioning in children with ADHD treated with atomoxetine over
      a 3-month period.
    


Intervention name(s): Atomoxetine
Intervention type(s): Drug
Intervention MeSH terms: Atomoxetine Hydrochloride
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Step-Up Intervention for Self-Management of Fatigue in Young Adults Receiving Chemotherapy
Condition: Young Adult, Cancer, Physical Activity
MeSH terms: Fatigue
Study type: Interventional

Summary: 
      The purpose of the study is to determine the impact of a physical activity intervention on
      the self-management of fatigue in young adults receiving chemotherapy. Half of the
      participants will receive an intervention which includes education and resources to set
      physical activity goals and monitor progress toward goals.
    

Detailed description: 
      Interventions to increase physical activity have been shown to relieve fatigue in patients
      receiving chemotherapy, but no studies have tested a physical activity intervention to
      improve fatigue in young adults receiving chemotherapy. This study will determine the impact
      of a physical activity intervention on the self-management process variables of self-efficacy
      and self-regulation and their relationships to physical activity and fatigue severity in
      young adults receiving chemotherapy.
    

Intervention name(s): Step-Up Intervention
Intervention type(s): Behavioral
Intervention description(s): Intervention group participants will meet with a study facilitator during 5 regularly scheduled visits for chemotherapy. The facilitator will provide education about the benefits of physical activity and strategies to overcome barriers to physical activity, help the participants to set physical activity goals based on ability and preferences, and educate the participant on using a physical activity tracker.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Should I Have an Elective Induction?
Condition: Labor, Induced; Patient Preference
Study type: Interventional

Summary: 
      The goal of the proposed study is to perform a pilot test of a patient-centered decision
      support tool to help pregnant people and providers work together in making informed, shared
      decisions regarding whether or not to opt for elective IOL at 39 weeks gestation
    

Detailed description: 
      60 nulliparous pregnant people with singleton, vertex pregnancies at 36-38 weeks who do not
      have an indication for induction of labor (IOL) will be enrolled and will view a decision
      support tool (DST) regarding induction without medical indication. During the enrollment
      face-to-face interview, participants will interact with the DST and complete pre- and
      post-DST viewing questionnaires. The investigators will conduct telephone interviews a few
      days later but before 39+0 weeks, and again 2-4 weeks postpartum and will review the medical
      record for delivery events and outcomes.
    

Intervention name(s): Elective Induction of Labor Decision Support Tool
Intervention type(s): Behavioral
Intervention description(s): Decision support tool for people having their first baby and planning vaginal delivery without a medical indication for induction of labor
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Shared Decision Making
Efficacy of Dead Sea Peloid Gel in Chronic Endometritis
Condition: Chronic Endometritis
MeSH terms: Endometritis
Study type: Interventional

Summary: 
      This study evaluates the effect of Dead Sea Peloid Gel in the treatment of Chronic
      Endometritis in women with reproductive disorders. Half of participants will receive Dead Sea
      Peloid Gel and antibiotics, while the other half will receive Placebo Gel and antibiotics.

      Patients with reproductive disorders who visited Research Medical Center of Family Health
      Problems and Human Reproduction were recruited.
    

Detailed description: 
      Dead Sea Peloid Gel achieves improvement of blood circulation and receptor sensitivity of
      endometrium.
    

Intervention name(s): Dead Sea Peloid Gel
Intervention type(s): Drug
Intervention description(s): intravaginally
Other intervention name(s): Placebo Gel
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic endometritis; Miscarriage; Infertility
The Plecanatide Chronic Idiopathic Constipation (CIC) Study
Condition: Chronic Idiopathic Constipation
MeSH terms: Constipation
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      This is a randomized, double-blind, placebo controlled, 12 week repeat oral dose, dose
      ranging study to determine the efficacy and safety of 3 doses of plecanatide compared to
      placebo in patients with Chronic Idiopathic Constipation (CIC).
    

Detailed description: 
      This is a Phase IIb/III, randomized, double-blind, placebo-controlled, 12-Week, Repeat, Oral
      Dose Ranging, study to determine the safety and efficacy of plecanatide in patients with
      chronic idiopathic constipation (CIC). Subjects diagnosed with CIC via modified Rome III
      criteria will be screened against the inclusion and exclusion criteria for the study and
      enter a 2 Week pre treatment screening. During this phase patients will be required to call
      in their bowel movements (BM diary) as they occur, and call at least once daily to complete a
      patient diary of questions on their symptoms (Symptom Diary) associated with CC, as they will
      throughout the trial. Patients who complete at least 5 days of dosing per week, 6 of each 7
      day period of BM diary calls, and continue to have less than 3 complete spontaneous movements
      per week (as well as meeting other inclusion and exclusion criteria) will be enrolled and
      randomized to one of three plecanatide doses 0.3 mg, 1.0 mg, and 3.0 mg or placebo. 880
      patients will be randomized with the intent of having 200 patients per treatment group (each
      group the same size) included in efficacy analyses. All subjects receiving at least one dose
      of plecanatide or matching placebo will be included in the safety analyses.
    

Intervention name(s): plecanatide; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Subjects receive experimental study drug for 12 weeks.; Subjects receive experimental study drug for 12 weeks.
Other intervention name(s): Trulance
Intervention MeSH terms: Plecanatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Chronic Idiopathic Constipation; Constipation; Sign and Symptoms: Digestive
Clinical Feasibility of a Conformal Ultrasound Blood Pressure Sensor
Condition: Feasibility Study; Medical Device
Study type: Observational

Summary: 
      Blood pressure (BP) monitoring is essential for managing cardiovascular diseases. Arterial
      line (A-line), the clinical gold standard for BP monitoring, is too invasive for routine
      measurements. The sphygmomanometer, on the other hand, is non-invasive but captures only
      discrete values. The recently introduced conformal ultrasound sensor oﬀers non-invasive and
      continuous monitoring of BP, which can potentially improve the quality of patient care, but
      its accuracy has yet to be thoroughly validated. Here the investigators are working to
      validate the accuracy of a redesigned ultrasound sensor with enhanced reliability in BP
      measurements at-home and in clinics even under different interventions.
    


Intervention name(s): sphygmomanometer; Arterial Line
Intervention type(s): Device; Device
Intervention description(s): Comparison to the ultrasound sensor; Comparison to the ultrasound sensor
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants without any severe cardiac anomalies
Paracetamol Versus Dipyrone After Pediatric Lower Abdominal Surgery in Children With Spinal Anesthesia
Condition: Other Acute Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 2

Summary: 
      We conducted a prospective, randomized double-blind study to compare the effectiveness of
      intravenous paracetamol and dipyrone for preventing pain during early postoperative period in
      school-age children undergoing lower abdominal surgery with spinal anesthesia.
    

Detailed description: 
      The intensity of postoperative pain was assessed using a visual analog scale (VAS) (0
      represented no pain and 10 the worst pain ever experienced) at 15, 30, 60th minutes, and 2nd,
      4th, 6th hours postoperatively.
    

Intervention name(s): Paracetamol; Dipyrone
Intervention type(s): Drug; Drug
Intervention description(s): 15 mg/kg IV (premixed with 0.9% sodium chloride to a total of 50 ml), preoperative single dose; 15 mg/kg IV (premixed with 0.9% sodium chloride to a total of 50 ml), preoperative single dose
Other intervention name(s): Parol; Metamizole
Intervention MeSH terms: Acetaminophen; Dipyrone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Pediatric spinal anesthesia, paracetamol, dipyrone
Acceptability of Human Papillomavirus (HPV) Vaccine in Female Sex Workers
Condition: Human Papillomavirus Infection
MeSH terms: Infections; Papillomavirus Infections
Study type: Interventional
Phase: Phase 4

Summary: 
      The primary objectives of this study are to determine the acceptance and potential for the
      effective use of HPV vaccine in the standard and a modified schedule in female sex workers.
      Secondary objectives include ascertaining the prevalence of HPV types among female sex
      workers by age and sexual experience.
    

Detailed description: 
      FSWs are at higher risk of HPV infection and presumably cervical cancer, and the recently
      available vaccine has been shown to protect against persistent infection from these types. If
      this study gives evidence showing the vaccine is acceptable in preventing cervical HPV
      infection by types 16 and 18 in this population, then the burden of cervical cancer and
      cancer precursors could be drastically decreased through widespread vaccination of this
      target group. Vaccination at the point of entry of brothel based sex work may become a
      requirement to lower the burden of cervical cancer among FSWs and also among all other sex
      partners of clients of FSWs. A modified schedule may prove beneficial for FSWs in Peru to
      complete the vaccine regimen.
    

Intervention name(s): Gardasil
Intervention type(s): Biological
Intervention description(s): Dosage Form: 0.5 ml intramuscular injection Dosage: Gardasil 0.5ml suspension Frequency: 3 doses
Other intervention name(s): Human Papillomavirus Quadrivalent Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Female sex worker; Peru; Cervical infection; Cervical abnormality; Serum antibody; Vaccine acceptance; Alternative schedule; Viral infections; Human papillomavirus vaccine; Human papillomavirus (HPV); non inferiority
Pharmacokinetic Study of Spironolactone 25 mg, 50 mg and 100 mg Tablets
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      Objective is to investigate pharmacokinetics and to estimate the level of dose linearity of
      spironolactone and its metabolites canrenone and 7α-thiomethylspirolactone from
      Spironolactone 25 mg, 50 mg and 100 mg Tablets
    


Intervention name(s): Spironolactone; Spironolactone; Spironolactone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): single dose of one tablet; 25 mg tablet; single dose of one tablet; 50 mg tablet; single dose of one tablet; 100 mg tablet
Intervention MeSH terms: Spironolactone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: spironolactone; linearity of pharmacokinetics; Healthy volunteers
Use of a Compliant Balloon for Large Bore Catheter Navigation in Mechanical Thrombectomy for Stroke: a Retrospective Study
Condition: Ischemic Stroke
MeSH terms: Stroke; Ischemic Stroke
Study type: Observational

Summary: 
      The superiority of mechanical thrombectomy (MT) in patients with acute ischemic stroke from
      large vessel occlusion compared to standard medical therapy alone has been demonstrated by
      several randomized clinical trials and become the standard of care for these patients. A
      direct aspiration first pass technique (ADAPT) for the endovascular treatment of stroke using
      a large-bore catheter has been reported to be an effective method of achieving MT. Recent
      studies reported that ADAPT is as efficient and safe as stent retrievers, with a similar
      successful recanalization rate, but may have better functional outcomes, fewer procedure
      related-adverse events, and a tendency for faster revascularization compared to the
      stent-retriever thrombectomy.

      However, navigation of a large-bore aspiration catheter is not always possible due to
      unsuccessful passage of the ophthalmic artery origin ("ledge effect") or tortuous vascular
      anatomy. The coaxial technique comprises guiding the large-bore catheter with a smaller inner
      catheter and can facilitate distal access. However, there is a gap between the inner catheter
      and the distal tip of the large-bore outer catheter that creates a risk of damaging the
      vessel wall and causing dissection or subarachnoid hemorrhage. Even with this coaxial
      technique, it is not always possible to reach the clot site with the large-bore catheter. To
      decrease the gap between the two catheters, several authors have used, in place of the inner
      microcatheter, a compliant balloon catheter positioned and inflated at the distal tip of the
      large-bore catheter. The aim of the present study was to evaluate the safety and efficacy of
      ADAPT assisted by a compliant balloon (ADAPT-AB) when ADAPT using the coaxial technique fails
      to reach the clot site.
    


Intervention name(s): Compliant balloon
Intervention type(s): Device
Intervention description(s): Use of a compliant balloon when ADAPT fails to reach the clot site
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All patients who underwent an endovascular procedure for acute stroke in a single center
        from November 2018 to February 2020 were included in the study
CORE: A Study of OPC-6535 With Asacol® in Maintaining Ulcerative Colitis (UC) Remission
Condition: Ulcerative Colitis
MeSH terms: Colitis; Colitis, Ulcerative; Ulcer
Study type: Interventional
Phase: Phase 3

Summary: 
      This dose comparison study, taking place at over 200 sites worldwide, will compare the
      dosing, safety and efficacy of an investigational medicine OPC-6535 to the dosing, safety and
      efficacy of Asacol ® in the maintenance of remission in subjects with ulcerative colitis.
    

Detailed description: 
      Objective(s):

      This study will compare the safety and efficacy of 25 mg per day (QD) and 50 mg QD of
      OPC-6535 to 800 mg twice a day (BID) of Asacol® in the maintenance of remission in subjects
      with ulcerative colitis.

      Subject Population:

        -  Subjects with ulcerative colitis currently in remission defined as rectal bleeding (RB)
           and flexible sigmoidoscopy (FS) scores of 0, on or off a stable dose of sulfasalazine or
           5-ASA products for at least 6 weeks.

        -  Subjects must have had the diagnosis of ulcerative colitis established by prior
           colonoscopy or undergo colonoscopy in lieu of flexible sigmoidoscopy during the
           Screening Period.

        -  Subjects must have had treatment for a flare of ulcerative colitis, with symptomatic
           onset of remission occurring no more than 52 weeks from the Screening Period.

        -  Subjects may not have used corticosteroids, topical agents (corticosteroid or 5-ASA
           enemas, suppositories, foams), azathioprine, 6-mercaptopurine, or methotrexate within 6
           weeks of the Screening Period. Upon entry, sulfasalazine and 5-ASA containing products
           will be discontinued.

      Safety: Vital signs, ECGs, laboratory studies (including hematology, clinical chemistry, and
      urinalysis), and adverse events.
    

Intervention name(s): OPC-6535; Asacol®
Intervention type(s): Drug; Drug
Intervention MeSH terms: Mesalamine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Ulcerative Colitis Remission; ulcerative; colitis; remission; relapse; Asacol®; maintain; maintenance; flare; rectal; bleeding; bowel
Aztreonam for Inhalation Solution (AZLI) for the Treatment of Exacerbations of Cystic Fibrosis
Condition: Cystic Fibrosis; Infection; Pseudomonas
MeSH terms: Cystic Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study evaluates the role of AZLI in the treatment of acute pulmonary exacerbations of
      CF. For consecutive exacerbations patients will receive AZLI + IV Colistin, or two IV
      anti-pseudomonals.
    

Detailed description: 
      AZLI, marketed as Cayston, is an inhaled beta-lactam antibiotic. It has a license for the
      chronic suppression of Pseudomonas aeruginosa (PA). Current standard practice dictates the
      use of two IV antipseudomonal antibiotics for the treatment of acute pulmonary exacerbations.
      The increasing survival, and hence population, in CF means that newer antimicrobial
      strategies are required in order to manage antimicrobial resistance, minimise adverse
      systemic effects of heavy antimicrobial exposure and also make effective use of resources.
      Inhaled antibiotics are commonly used in the chronic suppression of PA yet their use has not
      been thoroughly investigated in acute pulmonary exacerbation. Inhaled antibiotics deliver
      their drugs directly to the target-site with minimal systemic absorbance, making them an
      attractive candidate for treatment of acute exacerbations.

      Recently, it has become apparent that the bacterial community is much more complex than
      initially thought. The microbiome, a term used to describe the polymicrobial community in the
      lungs, has become apparent due to the use of modern culture-independent methods to detect
      bacteria. The microbiome changes in composition and structure around the time of
      exacerbations and in response to treatment, although these changes have not been
      prospectively characterised.

      We have designed an open-label randomised, controlled cross-over trial to investigate the
      clinical effectiveness of of AZLI in the treatment of acute pulmonary exacerbation, whilst
      simultaneously comparing the effect inhaled and intravenous antibiotics have on the
      microbiome.
    

Intervention name(s): Aztreonam; Standard Care
Intervention type(s): Drug; Drug
Intervention description(s): 14 days of AZLI: 75mg TDS PLUS IV Colistin; 14 days of IV Colistin plus one of Tazocin/Ceftazidime/Meropenem/Aztreonam/Fosfomycin
Other intervention name(s): Cayston; AZLI
Intervention MeSH terms: Aztreonam
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Mood and Subthalamic Nucleus (STN) Deep Brain Stimulation
Condition: Movement Disorders
MeSH terms: Movement Disorders
Study type: Observational

Summary: 
      The purpose of this research study is to investigate any changes seen in mood or behavior
      following deep brain stimulation for movement disorders.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Parkinson's patients who undergo STN DBS
      
Keywords: Staged versus Simultaneous Bilateral DBS
Effect of Varied Outreach Methods on Appointment Scheduling, Appointment Completion, and Receipt of MMR Vaccination
Condition: Preventable Disease, Vaccine; Health Care Utilization
MeSH terms: Vaccine-Preventable Diseases
Study type: Interventional

Summary: 
      Our objective is to determine the effectiveness of varied outreach methods (e.g. automated
      reminder calls/text messages with or without personalized calls/texts) to children age 12-14
      months or 4 years old who are due for a WCC visit and don't have one scheduled in the next 45
      days on the outcomes of appointment scheduling, appointment completion, and receipt of the
      MMR vaccination.
    


Intervention name(s): 1 automated message; 2 automated messages; No personal contact attempt; 1 personal contact attempt
Intervention type(s): Other; Other; Other; Other
Intervention description(s): Parents of eligible patients will receive 1 HIPAA compliant automated call or text reminder (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment.; Parents of eligible patients will receive 2 HIPAA compliant automated call or text reminders (based on preference recorded in EHR) that their child is due for a checkup and information on how to schedule an appointment.; No personal contact attempts will be made.; Parents of eligible patients will receive a text from a medical assistant informing them that their child is due for a check up. This will be followed by personal call from the medical assistant to assist the parent with scheduling an appointment.
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Efficacy and Safety of Different Concentrations of Mapracorat Ointment Over 4 Weeks in Atopic Dermatitis (AD)
Condition: Atopic Dermatitis; Eczema
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of three concentrations of a
      development drug compared to ointment base (vehicle) in subjects with Atopic Dermatitis (AD).
    


Intervention name(s): Mapracorat; Vehicle without active
Intervention type(s): Drug; Drug
Intervention description(s): Daily topical application; Daily topical application
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment