bioihbjkbjnl/mcl2 huggingface dataset:
Long-Term, Open Label Atomoxetine Study
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 3

Summary: 
      To learn about the safety and any side effects of atomoxetine when given to children and
      adolescents for about 5 years (long-term) and to learn whether atomoxetine can help children
      and adolescents with attention-deficit/hyperactivity disorder (ADHD) who take the drug for
      about 5 years (long-term).

      Study participants can be atomoxetine naive, atomoxetine experienced whose therapy has been
      interrupted or, atomoxetine experienced on a known stable dose.
    


Intervention name(s): atomoxetine
Intervention type(s): Drug
Intervention description(s): 0.5-1.8 mg/kg/day, by mouth (PO), for up to 5 years
Other intervention name(s): LY139603; Strattera
Intervention MeSH terms: Atomoxetine Hydrochloride
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Study to Evaluate Pharmacokinetics, Safety and Tolerability of Dolutegravir and Rilpivirine (JULUCA™) 50 Milligram (mg)/25 mg Tablets in Healthy Subjects of Japanese Descent
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Dolutegravir (DTG), a human immunodeficiency virus (HIV)-1 integrase inhibitor (INI), and
      Rilpivirine (RPV), a non-nucleoside HIV-1 reverse transcriptase inhibitor (NNRTI), are each
      approved in the United States (US), European Union, and other countries for the treatment of
      HIV-1 infection. JULUCA is a combination of Dolutegravir and Rilpivirine indicated for the
      treatment of HIV-1 infection in antiretroviral (ARV) experienced adult subjects who are
      switching from their current antiretroviral treatment to the 2-drug combination. Although,
      the pharmacokinetics (PK), safety and tolerability of DTG/RPV (50 milligram [mg]/25mg)
      fixed-dose combination (FDC) tablets have been extensively studied, these parameters have not
      been assessed exclusively in Japanese subjects. This study will evaluate the
      pharmacokinetics, safety and tolerability of a single dose DTG/RPV 50 mg/25 mg FDC in a
      healthy adult Japanese population to support a post-approval commitment for DTG/RPV 50 mg/25
      mg FDC in Japan.
    


Intervention name(s): JULUCA (Dolutegravir and Rilpivirine) 50mg/25mg FDC tablet
Intervention type(s): Drug
Intervention description(s): JULUCA tablets will be administered orally once daily with a meal. It will be available as a fixed dose combination of Dolutegravir 50mg and Rilpivirine 25mg.
Intervention MeSH terms: Dolutegravir; Rilpivirine; Dolutegravir, rilpivirine drug combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Dolutegravir, Rilpivirine, HIV infection, Fixed-dose combination, Japanese, Pharmacokinetics
A Study to Evaluate the Impact of Omeprazole on the Pharmacokinetics of Sotorasib Co-administered With an Acidic Beverage in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of the study is to evaluate the effects of omeprazole (a proton-pump
      inhibitor) and an acidic beverage (Coca-Cola) on sotorasib pharmacokinetics (PK) when
      administered orally in healthy volunteers.
    


Intervention name(s): Omeprazole; Sotorasib
Intervention type(s): Drug; Drug
Intervention description(s): Omeprazole will be administered as an oral capsule.; Sotorasib will be administered as an oral tablet.
Other intervention name(s): AMG 510
Intervention MeSH terms: Sotorasib; Omeprazole
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy volunteers; Sotorasib; AMG 510; Omeprazole
Cefazolin Dosing in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass
Condition: Cardiopulmonary Bypass
Study type: Observational

Summary: 
      Pharmacokinetics of cefazolin in children undergoing cardiac surgery.
    


Intervention name(s): blood and tissue sampling
Intervention type(s): Procedure
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        children undergoing cardiac surgery with cardiopulmonary bypass
      
Biospecimen description: 
      blood and tissue samples
In-use Study of Four Different Tampons
Condition: Menstruation
Study type: Interventional

Summary: 
      This study will evaluate the impact on vaginal health of four different tampons using
      gynecologic assessment and subjective assessment of comfort during in-use conditions
    


Intervention name(s): tampon D; tampon M; tampon T; tampon V
Intervention type(s): Device; Device; Device; Device
Intervention description(s): regular absorbency tampon; regular absorbency tampon; regular absorbency tampon; regular absorbency tampon
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: tampon
A Dose-Finding Study of RO4998452 in Patients With Diabetes Mellitus
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      This 6 arm study will evaluate the efficacy, safety and pharmacokinetics of 5 doses of
      RO4998452 compared to placebo in patients with type 2 diabetes mellitus. Patients will be
      randomized to one of 6 groups to receive RO4998452 at doses of 2.5mg, 5mg, 10mg, 20mg or 40mg
      po daily, or placebo daily. Patients pre-treated with stable metformin will continue to take
      their usual dose of metformin throughout the study.The anticipated time on study treatment is
      <=3 months
    


Intervention name(s): Placebo; RO4998452; RO4998452; RO4998452; RO4998452; RO4998452
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): po daily for 12 weeks; 2.5mg po daily for 12 weeks; 5mg po daily for 12 weeks; 10mg po daily for 12 weeks; 20mg po daily for 12 weeks; 40mg po daily for 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Aneurysm Wall Histology Registry
Condition: Brain Aneurysm
MeSH terms: Intracranial Aneurysm; Aneurysm
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this prospective registry is to determine if patients harboring intracranial
      aneurysms have any predictive markers between aneurysm wall tissue, cerebrospinal fluid and
      blood plasma.
    

Detailed description: 
      To design a registry to evaluate the wall of intracranial aneurysms during open surgical
      clipping by direct photographic appearance, wall biopsy samples, CSF and blood plasma fluid
      collection (Interleukins; IL-8/ Matrix Metalloproteinase; MMP-9) for complete evaluation and
      comparison.

      The focus of the registry will be to determine the presence of aneurysmal wall defects, mural
      clot, atherosclerotic and atheroma, wall permeability and delamination. These findings will
      then be correlated to the collected CSF and blood values to determine if there is any direct
      features of the aneurysm wall that would predict any of the reported post embolic syndromes.
      The collected data can also be correlated to the peroperative imaging, (MRI, CT and
      Angiogram).
    

Intervention name(s): Surgical Clipping of Aneurysm
Intervention type(s): Procedure
Intervention description(s): Surgical clipping of intracranial aneurysm
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Postoperative Environment on Pain Following Pelvic Reconstructive Surgery
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This study is to determine if patients following prolapse repair including vaginal vault
      suspension have decreased pain measured via a visual analog scale (VAS) on postoperative day
      one and just prior to discharge when exposed to the diad of music and positive images
      compared to patients receiving standard care.
    

Detailed description: 
      Over the past decade, interest has grown in improving the patient experience. As part of this
      movement, studies have sought to evaluate the mechanisms by which the postoperative
      environment affects a patient's outcome and perception of healing.

      Literature review reveals efforts by both medical and design teams towards improving the
      experience of the patient and developing an environment that promotes healing. Changes to the
      physical environment have been shown to have an impact on satisfaction. These parameters have
      included music and art. Considering the effort that is now going into improving the patient
      experience and developing this theory of healing spaces, there has yet to be a randomized
      controlled trial evaluating these alternative therapies in the urogynecologic patient
      population. Although each of these modalities appears beneficial, we believe that a
      combination of these would be even more useful. Indeed, these treatments are also relatively
      easy to implement without undue cost or burden to the hospital. This study seeks to determine
      the influence of applying music and art to the post operative environment for patients
      recovering from major urogynecologic surgery on pain.
    

Intervention name(s): music and positive images
Intervention type(s): Other
Intervention description(s): The diad of misic and positive image will be administered to the standard care by adding a Bluetooth capable speaker with selections of music and a soothing nature landscape into the hospital room.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
The Effect of TENS Application for Pain
Condition: Appendicitis Surgery; Inguinal Surgery
MeSH terms: Appendicitis
Study type: Interventional

Summary: 
      The aim of the study which was planned in a randomized controlled experimental design, it was
      aimed to determine the effect of Transcutaneous Electrical Nerve Stimulation (TENS)
      application on pain level before mobilization in the postoperative period in children.
    

Detailed description: 
      Children can often experience chronic muscle, bone, joint pain, headache and abdominal pain,
      and acutely experience pain due to postoperative and procedural procedures. Effective
      management of childhood pain is emphasized as a health priority by the World Health
      Organization and pain communities. The findings of various epidemiological studies emphasized
      that a significant proportion (49% to 64%) of children receiving treatment in a hospital
      setting received inadequate pain management services despite the increase in available
      knowledge and treatments. One of the situations in which pediatric patients encounter acute
      pain is the postoperative period. Mobilization is delayed in patients who cannot provide
      adequate pain control, and accordingly, serious complications such as impaired tissue
      perfusion, atelectasis and deep vein thrombosis may develop. There are studies on the use of
      TENS, one of the methods used in non-pharmacological pain management, in postoperative pain
      management in adults. Studies on pain management in children for TENS application are very
      limited today. There was no evidence for the effectiveness of TENS application applied before
      mobilization in the postoperative period in children.
    

Intervention name(s): TENS application
Intervention type(s): Device
Intervention description(s): Assigned Interventions: In addition to the standard pain management applied in the clinic, TENS will be applied to children who have had surgery.
Other intervention name(s): Transcutaneous Electrical Nerve Stimulation
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Transcutaneous Electric Nerve Stimulation; Child; Surgery; Pain
Effects of Breaking Sitting on Human Behaviour and Metabolic Health
Condition: Energy Balance; Physical Activity Level; Cognition; Metabolic Health
Study type: Interventional

Summary: 
      This study primarily aimed to investigate effects of breaking up prolonged sitting with
      intermittent brisk walking in healthy young individuals on (1) post-trial human behaviours
      including energy intake and physical activity under free-living conditions and (2) cognitive
      performance in a simulated workplace environment.
    


Intervention name(s): Prolonged sitting; Breaking prolonged sitting
Intervention type(s): Behavioral; Behavioral
Intervention description(s): In the laboratory, after consuming 1st meal, participants sat on a chair for 180 min. After 180 min, the 2nd meal was provided. After finishing the 2nd meal, participants sat on a chair for another 120 min. After data collection was completed in the laboratory, participants were asked to keep wearing the same pedometer and to record any food and liquid consumption for the rest of the day (until midnight) under free-living conditions.; In the laboratory, after consuming 1st meal, participants walked 2 min on a treadmill every 20 minutes for the following 180 min. For the remainder of the time participants sat on the chair. After 180 min, the 2nd meal was provided. After finishing the 2nd meal, participants continued 2 min of walking every 20 min for the following 120 min. After data collection was completed in the laboratory, participants were asked to keep wearing the same pedometer and to record any food and liquid consumption for the rest of the day (until midnight) under free-living conditions.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Breaking up sitting; Eating behaviour; Spontaneous physical activity; Executive function; Energy balance
Efficacy of Repyflec Cognitive Remediation Group Training in Schizophrenia
Condition: Indication for Modification of Patient Cognitive Status
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study was to develop an integrative intervention for schizophrenia taking
      into account previous efficacious therapies. Thus, our aim was to evaluate the efficacy of
      our cognitive remediation group training: Problem Solving and Cognitive Flexibility training
      (REPYFLEC), focused to improve neurocognition and functioning in schizophrenia patients. We
      hypothesized that training executive function and metacognition would allow us to achieve
      improvements in neurocognition, functioning and psychiatric symptoms of patients with
      schizophrenia.
    


Intervention name(s): Repyflec cognitive remediation training
Intervention type(s): Behavioral
Intervention description(s): Comparison of 32 Repyflec group sessions among 32 leisure group sessions where we stimulated non-specific cognitive perform.
Other intervention name(s): Cognitive remediation therapy; Cognitive rehabilitation; Cognitive training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Cognitive remediation; Group training; Executive function; Social functioning
Capacity of Biofilm Removal and Gingival Abrasion After Utilization Medium and Soft Toothbrushes
Condition: Biofilm Removal; Gingival Abrasion
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This study compared the removal of dental biofilm between soft and medium toothbrushes. The
      patients refrained from performing mechanical or chemical plaque control for 96 hours to
      allow dental biofilm accumulation on the tooth surfaces. After the period of dental biofilm
      formation, the quadrants were randomized and the participants brushed different quadrants
      with soft and medium toothbrushes, with or without dentifrice. The plaque indices were
      analyzed by a blinded examiner before and after toothbrushing. The 2Tone was used for plaque
      disclosure and analysis was performed by the Quigley-Hein index modified by Turesky et al.
      (1970).
    


Intervention name(s): Two kind toothbrushes
Intervention type(s): Device
Intervention description(s): a randomization was performed in which the participants were allocated to the following experimental procedures: Two quadrants (1 and 3 or 2 and 4) with medium toothbrush Two quadrants with soft toothbrush. All procedures were performed using the same dentifrice. Each quadrant was brushed for 30 seconds by the participant without specific instructions on the technique, under supervision of the person in charge of the randomization.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Dental plaque; Gingival abrasion; toothbrushing
Alternate Day Fasting and Exercise in Overweight or Obese Adults
Condition: Overweight; Obesity; Diet Modification; Exercise
MeSH terms: Overweight
Study type: Interventional

Summary: 
      Alternate day fasting is known to be helpful to control weight and have a positive effect on
      insulin resistance and cardiovascular risk factors. However, there have been no studies on
      weight reduction program combining alternate day fasting with exercise which preserves lean
      mass in Korea. The purpose of this randomized clinical trial is to examine the effects of
      alternate day fasting and exercise on weight reduction, visceral fat, and metabolic
      parameters in overweight or obese adults.
    


Intervention name(s): Alternate Day Fasting; Exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): During the 8-week intervention, participants consumed 25% of their daily recommended energy intake (approximately 500 kcal) on each "fast day" (24 h), and consumed food ad libitum on each "feed day" (24 h). The "fast day" and "feed day" were repeated every other day, and the "fast day" occurred 3 days per week.; During the 8-week intervention, participants visited the research center gym at least three times per week and received exercise logs. Each exercise session began with 5 minutes of warm-up and ended with 5 minutes of cool-down. Resistance training was performed using weight training machines, barbells, and dumbbells for 40 minutes. Aerobic exercise was performed on motorized treadmills for 20 minutes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Efficacy and Safety of ETX-018810 for the Treatment of Diabetic Peripheral Neuropathic Pain
Condition: Diabetic Peripheral Neuropathic Pain; Diabetic Peripheral Neuropathy
MeSH terms: Neuralgia; Peripheral Nervous System Diseases; Diabetic Neuropathies
Study type: Interventional
Phase: Phase 2

Summary: 
      A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Parallel-Group Study to Evaluate
      the Efficacy and Safety of ETX 018810 in Subjects with Diabetic Peripheral Neuropathic Pain.
    

Detailed description: 
      ETX-018810 is a new chemical entity that is under development as a non-opioid treatment for
      chronic pain syndromes. ETX-018810 is a prodrug of palmitoylethanolamide (PEA), an endogenous
      bioactive lipid that has shown efficacy in a broad range of nonclinical inflammatory and
      neuropathic pain models and in clinical trials in chronic pain indications, including
      diabetic peripheral neuropathic pain (DPNP).
    

Intervention name(s): ETX-018810; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Study Drug; Matching Placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Placebo-Controlled, Parallel-Group
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Blood Collection Sub-Study for CRC Screening in Individuals 45-49 at Average Risk for CRC.
Condition: Colo-rectal Cancer
MeSH terms: Rectal Neoplasms
Study type: Observational

Summary: 
      The primary objective of this sub-study, 2018-10B, is to collect blood specimens to assess
      new biomarkers for the detection of Colorectal Cancer (CRC).
    

Detailed description: 
      Subjects who consent to enroll in Exact Sciences Protocol 2018-10, will be asked to
      participate in this sub-study. Subjects enrolled in the Exact Sciences Protocol 2018-10, who
      provide written informed consent to participate in this sub-study, will have a blood sample
      collected at enrollment.
    

Intervention name(s): Blood Sample Collection
Intervention type(s): Other
Intervention description(s): Subjects participating in the study will have blood drawn at enrollment.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects will be men and women, 45-49 years of age, who enroll in Exact Sciences Protocol
        2018-10. Up to 942 subjects will be enrolled.
      
Biospecimen description: 
      Residual blood samples may be used for evaluating performance of biomarkers for feasibility
      and assay development. Sample may be stored for up to 20 years. These blood samples will be
      de-identified.
    
Keywords: Blood Draw
Aerobic Exercise and Covid-19 Survivors With Post-Intensive Care Syndrome (Pics)
Condition: COVID-19; Post Intensive Care Syndrome
MeSH terms: COVID-19; Syndrome
Study type: Interventional

Summary: 
      To investigate the effects of aerobic exercise program on physical activity, aerobic
      capacity, anxiety& depression in Covid-19 survivors discharged from Intensive Care Unit.
      There is evidence in the literature that post-intensive case survivors who have been
      mechanically ventilated will likely experience short- and medium-term consequences in the
      form of Post Intensive Care Syndrome (PICS).
    

Detailed description: 
      The notion that patients surviving intensive care and mechanical ventilation for several
      weeks can be discharged home without further medical attention is a dangerous illusion.
      Post-Intensive Care Syndrome and other severe conditions will require not only adequate
      screening but early rehabilitation and other interventions. So, this focused control trial
      will contribute particularly to determining the Effects of the Aerobic Exercise Program in
      Covid-19 Survivors with Post-Intensive Care Syndrome.
    

Intervention name(s): Aerobic Exercise Training; Home Plan
Intervention type(s): Other; Other
Intervention description(s): Warm-up: 5 minutes Aerobic Training Treadmill/cycle ergometer Frequency:3 days a week Intensity:40-70% of HR max(Start from 40% than increment to as per patient tolerance) Total Duration:6 weeks. Duration of each session:15-30 mins. Cool-down: 5 minutes; Positions to ease breathlessness
Controlled breathing/Deep breathing*10 Reps* TD,s
Progressive Muscle Relaxation Exercises.
ROM & Flexibility Exercises. 3 days a week for 6 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Aerobic exercise; COVID-19 Survivors; Post Intensive Care Syndrome