bioihbjkbjnl/mcl2 huggingface dataset:
Safety, Tolerability, Pharmacokinetics & Pharmacodynamics Study of Ropeginterferon Alfa-2b in Healthy Japanese and Caucasian Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1 single center, parallel group study to assess and compare the safety,
      tolerability, PK and PD of 4 single ascending doses of P1101 (100, 200, 300, and 450 μg)
      following subcutaneous administration in healthy Japanese and Caucasian subjects.
    

Detailed description: 
      Twenty-four healthy eligible Japanese male subjects and 24 healthy eligible Caucasian male
      subjects, each divided into 4 cohorts of 6 subjects, will participate in this study. No
      subject will participate in more than 1 cohort and all subjects will receive a single dose of
      P1101. Caucasian subjects will be body weight- and height-matched to Japanese subjects.

      Dosing will be initiated with the lowest dose of 100 μg in both Japanese and Caucasian
      subjects.
    

Intervention name(s): ropeginterferon alfa-2b
Intervention type(s): Drug
Intervention description(s): 6 subjects in each cohort will receive a single dose by subcutaneous injection
Other intervention name(s): P1101
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect Of Static And Dynamic Stretching On Muscle Tendon Unit
Condition: Healthy
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the acute effects of two different types of
      muscle stretching (static and dynamic) on muscle-tendon unit of gastrocnemius muscle by
      ultrasound and to follow how long the stretching effects are sustained.
    

Detailed description: 
      Muscle stretching is a very common practice applied in warm-up process in order to enhance
      performance in sports and to prevent or decrease the risk of sports injury. Muscle stretching
      is also used for therapeutic purposes in many clinical conditions.

      It is generally performed in either static or dynamic manner. Muscle is brought to its
      lengthened position and is held at that point for a certain period of time in static
      stretching (SS). In dynamic stretching (DS), however, active movements of muscle take the
      joint through the range of motion and creates a stretch, but the muscle is not held in the
      end position.

      Although recent studies suggest that static stretching has adverse effects on performance,
      reduces maximal muscle force and is not successful in preventing non-contact injuries, as
      believed so; and the dynamic type therefore gaining popularity; it is reported that
      flexibility and range of motion can be improved by stretching as a consequence of the
      decrement in muscle stiffness. However, the effects of stretching depend on the type,
      duration and timing of stretching and there is still debate over which prescription provides
      the best results in terms of flexibility, power, performance or injury protection. And what
      happens to the viscoelastic properties of a muscle when it is stretched statically or
      dynamically is still not well documented. Ultrasound seems to be a good option as it offers
      an objective and a non-invasive way to expose the alteration in muscles and tendons due to
      stretching.
    

Intervention name(s): stretching exercises
Intervention type(s): Other
Intervention description(s): static stretching exercise of 5 repetitions, with a duration of 45 seconds to the right gastrocnemius muscle and dynamic stretching exercise of 5 repetitions, with a duration of 45 seconds to the cases' left gastrocnemius muscles
Other intervention name(s): static stretching exercise; dynamic stretching exercise
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: static stretching; dynamic stretching; muscle-tendon unit; ultrasound; Subjects
Connected Health to Decrease Opioid Use in Patients With Chronic Pain
Condition: Chronic Pain
MeSH terms: Chronic Pain
Study type: Interventional

Summary: 
      The objective of this pilot study to evaluate if behavioral incentives applied at the VA
      Medical Center can appreciably increase participation in activities that promote mobility,
      and subsequently reduce pain severity and opioid use.
    

Detailed description: 
      Chronic pain is a highly prevalent and costly condition in the US. An estimated 88.5 million
      adults suffer from daily pain, resulting in estimated cost of $500- 635 biJlion due to lost
      productivity, and $261-300 billion in health care expenditures. To manage their chronic pain,
      5 to 8 million Americans take an opioid medication daily. Yet , the risks associated with
      ongoing opioid prescription , including overdose, abuse and diversion, temper their analgesic
      effects.

      Opioids are not more effective in the treatment of chronic pain compared with non-opioid
      approaches. Current guidelines have adapted to the evidence, recommending opioid-sparing
      approaches for treating patients with chronic pain, and tapering for those on higher doses to
      safer levels of use. Tapering opioids, however, requires replacing them with effective
      non-opioid strategies. Improving mobility has been shown to improve pain and decrease
      medication use among patients chronically prescribed opiates. Concurrently, financial
      incentives and the use of behavioral incentives have been shown to promote mobility.

      Appreciating the gains in health outcomes that can be made with "connected health"
      approaches, we propose a novel pilot study designed to evaluate if technology enabled care
      (TEC) strategies and financial incentives can improve patient mobility in our chronic pain
      population, reduce pain and decrease opioid use . Our primary aim is to determine if chronic
      pain patients who receive TEC-enhanced treatment with financial incentives demonstrate
      increased participation in activities that promote mobility (physical therapy, yoga, tai chi)
      in comparison to patients receiving usual care. Secondary outcomes will include whether
      increased activity participation also reduces pain severity and opioid use, and improves
      function and increases the number of daily steps taken. The results of this pilot will enable
      us to determine what strategies are effective at increasing mobility and if these gains
      translate into reduced pain and decreased opioid use.
    

Intervention name(s): Regret lottery; Way to Health technology enhanced care
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Subjects who achieve step goals are entered into a lottery in which they can win a financial incentive of $30 or $100.; Subjects receive text reminders to reach activity goals.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Pharmacokinetic and Safety of Dexlansoprazole in Adolescents With Gastroesophageal Reflux Disease
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to asses the pharmacokinetics and safety of dexlansoprazole
      modified release (MR), once daily (QD), in adolescent subjects (age 12-17 years old) with
      Symptomatic Gastroesophageal Reflux Disease.
    

Detailed description: 
      Gastroesophageal reflux disease is a condition of multifactorial etiology resulting in the
      reflux of gastric contents into the esophagus through the lower esophageal sphincter. The
      prevalence of Gastroesophageal reflux disease in the pediatric population is becoming
      increasingly recognized and documented. It is a chronic disease that can persist through
      adulthood with symptoms in older children and adolescents being similar to those seen in
      adults. The prevalence of gastroesophageal reflux disease increases with age, from 2.5% of
      children between the ages of 3 and 9 years, to 8.5% of those between the ages of 10 and 17
      years.

      Younger children generally present with extra-esophageal manifestations, regurgitation, and
      epigastric pain, while older children and adolescents typically present with adult-type
      gastroesophageal reflux disease symptoms of heartburn and regurgitation. Treatment for
      gastroesophageal reflux disease is aimed at alleviating symptoms and healing the esophageal
      inflammation.

      This study evaluated the pharmacokinetics and safety of dexlansoprazole MR in the pediatric
      population (ages 12-17) and determined if the pharmacokinetic profile is similar to that in
      adults given the same dose.
    

Intervention name(s): Dexlansoprazole MR; Dexlansoprazole MR
Intervention type(s): Drug; Drug
Intervention description(s): Dexlansoprazole MR 30 mg, capsules, orally, once daily for up to 7 days.; Dexlansoprazole MR 60 mg, capsules, orally, once daily for up to 7 days.
Other intervention name(s): TAK-390MR; Kapidex; Dexilant; TAK-390MR; Kapidex; Dexilant
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Esophageal Reflux; Gastro-Esophageal Reflux; Gastroesophageal Reflux Disease; GERD; Regurgitation, Gastric; Heartburn; Drug Therapy; Adolescent
The Effectiveness of a Stress Incontinence Care Protocol
Condition: Stress Incontinence, Female; Nursing
MeSH terms: Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      This study seeks to contribute to nursing practices by developing and stress incontinence
      care protocol with the help of the Star model and implementing this care protocol for the
      purpose of standardizing patient care outcomes.
    

Detailed description: 
      To identify the effectiveness of a care protocol developed using the Star model on outcomes
      in female patients with stress incontinence.

      Information and evidence needs to be translated into nursing practice and applied to clinical
      decision-making in stress incontinence cases. Evidence-based study models such as the Star
      model provide guidance on using evidence to develop clinical guidelines and care protocols.
      The Star model is designed to improve patient outcomes by creating a bridge between research
      and clinical practice. There is currently no published stress incontinence care protocol
      based on the Star model. Although there is one published study of a care protocol for urinary
      incontinence, this protocol was not drawn up on the basis of an evidence-based model.

      Women that matched the sample criteria were recruited into the study. After their consent was
      obtained, the women were randomized into an intervention and a control group. The women in
      the intervention group were provided care according to stress incontinence care protocol. The
      control group received no intervention during the eight-week intervention period.
    

Intervention name(s): intervention group
Intervention type(s): Behavioral
Intervention description(s): The women in the intervention group were provided care according to SICP
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: Nursing; evidence-based practice; Star model; stress incontinence; nursing care protocol; female
Efficacy and Safety of Grazax in Children
Condition: Allergy
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to investigate if immunotherapy with Grazax is safe and reduces
      the hayfever symptoms and the use of symptom relieving medications in children during the
      grass pollen season
    


Intervention name(s): Grazax-R; Grazax Placebo
Intervention type(s): Biological; Biological
Intervention description(s): Grass tablet, 75.000 SQ per day for one year; Grazax Placebo, 0 SQ tablet per day for one year
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Intrathecal Dexmedetomidine With Bupivacaine for Spinal Anesthesia in Cesarean Section
Condition: Anesthesia, Spinal
Study type: Interventional
Phase: Phase 4

Summary: 
      A Randomized, Controlled, Double blind study aiming to evaluate the analgesic potentials and
      side effect profile of different dose levels of Dexmedetomidine added to subarachnoid
      bupivacaine in full-term pregnant women undergoing elective cesarean section using spinal
      anesthesia. The investigators ultimate goal is to find out the least effective dose which
      will be associated with minimal or no side effects. The primary outcome will be the time to
      two sensory block segment regression.
    

Detailed description: 
      Alpha 2-agonists are non-opioid adjuvants with a significant role in extending the analgesic
      duration of subarachnoid block. When clonidine or Dexmedetomidine was added to intrathecal
      local anesthetics, the regression of sensory and motor blocks increased dose-dependently.
      Further, a recent meta-analysis including seven randomized controlled studies reported an
      increase in the duration of analgesia and reduced morphine requirement after the concomitant
      subarachnoid administration of clonidine.

      Animal studies demonstrated that Dexmedetomidine added to bupivacaine significantly enhanced
      the duration of sensory and motor blockade of sciatic nerve block. Histo-pathological
      examination proved that all of the nerves analyzed had normal axons and myelin at 24 h and 14
      days after the peri-neural administration of Dexmedetomidine. Several clinical studies
      confirmed the analgesic potentials and safe neurological outcome of neuraxially administered
      Dexmedetomidine in the non-obstetric settings while intrathecal clonidine proved to be a
      useful analgesic adjunct for spinal anesthesia in patients undergoing cesarean section. But
      to the best of the investigator knowledge the effects of intrathecal Dexmedetomidine on the
      perioperative clinical profile of bupivacaine-induced spinal anesthesia were not studied
      before in the obstetric patient population.
    

Intervention name(s): Dexmedetomidine & Bupivacaine.; Bupivacaine Only.
Intervention type(s): Drug; Drug
Intervention description(s): Intrathecal injection of Dexmedetomidine & Bupivacaine.; Intrathecal injection of Bupivacaine only.
Intervention MeSH terms: Dexmedetomidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: spinal anesthesia; caesarian section; Dexmedetomidine
Paracervical Block for Pain Associated With Laminaria Insertion
Condition: Pain
Study type: Interventional

Summary: 
      To assess if paracervical block is effective at reducing discomfort during placement of
      intracervical laminaria for pre-operative cervical preparation.
    

Detailed description: 
      Pre-operative dilation of the cervix with use of osmotic dilators (e.g. laminaria, dilapan-S)
      is commonly done prior to pregnancy termination to make the procedure safer. This study seeks
      to assess whether paracervical blocks are effective at reducing pain associated with
      placement of laminaria. Secondarily, this study will evaluate if paracervical blocks are
      effective at reducing overall procedural pain and increasing overall patient satisfaction for
      the intracervical laminaria placement procedure.
    

Intervention name(s): Paracervical Block with lidocaine; Sham paracervical block
Intervention type(s): Drug; Drug
Intervention description(s): Performance of paracervical block, using 18 mL of 1% lidocaine buffered with 2 mL 8.4% sodium bicarbonate, prior to laminaria insertion; A capped needle will be placed on the cervix prior to laminaria insertion for purposes of blinding both the participant and research staff assessing outcomes
Other intervention name(s): Paracervical block; Sham block; placebo
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Laminaria
Endoscopic Variceal Ligation (EVL)+ Drugs Versus Endoscopic Variceal Ligation (EVL) Alone For Secondary Prophylaxis
Condition: Portal Hypertension
MeSH terms: Hypertension, Portal
Study type: Interventional

Summary: 
      Background: Both endoscopic variceal ligation (EVL) and propranolol are valuable methods for
      secondary prophylaxis of variceal bleeding. Addition of ISMN to propranolol improves the
      efficacy of drug therapy. It is hypothesized that a combination of EVL and portal pressure
      reducing drugs should significantly be better than EVL alone.

      Patients and Methods: Patients with history of variceal bleed were randomized to EVL plus
      drugs (propranolol and ISMN) or EVL alone. EVL was repeated every 3-4 weeks until variceal
      eradication. Propranolol dose was adjusted to reduce the resting heart rate to 55 bpm. Dose
      of ISMN was 40 mg/d. Primary end points were rebleed or death. Secondary end points included
      complications of portal hypertension and the development of serious adverse effects to
      therapy.
    


Intervention name(s): EVL + Propranolol + Isosorbide 5 mononitrate; EVL alone
Intervention type(s): Drug; Other
Intervention description(s): Treatment was started with propranolol at a dose of 40 mg twice a day. The heart rate and blood pressure were checked after 12 to 24 hours. The dose of propranolol was increased at increments of 20 to 40 mg per day until the patient achieved a heart rate of 55 bpm, or a maximum dose of 320 mg/day was achieved.ISMN was added at a dose of 10 mg twice a day. The dose was escalated at increments of 10-20 mg/day till a maximum dose of 40 mg/day was reached.
Intervention MeSH terms: Propranolol; Isosorbide; Isosorbide Dinitrate; Isosorbide-5-mononitrate
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Prevention
To Investigate the Multiple Dose Safety, Tolerability and Pharmacokinetics of WCK 4282 (FEP-TAZ)
Condition: Antibiotics Causing Adverse Effects in Therapeutic Use
Study type: Interventional
Phase: Phase 1

Summary: 
      To evaluate the safety, tolerability and pharmacokinetics (PK) of multiple IV doses of
      FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) administered every 8 hours (q8h) in healthy adult
      volunteers for 10 days.
    


Intervention name(s): FEP-TAZ 4 g; Placebo
Intervention type(s): Drug; Other
Intervention description(s): FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) IV treatments as a q8h infusion (90 min) regimen for 10 days; Placebo IV
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Subjects will receive one of the following IV treatments as a q8h infusion (90 min) regimen for 10 days:
FEP-TAZ 4 g (2 g cefepime + 2 g tazobactam) (n=16)
Placebo (n=4)
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Comparison Between a Telerehabilitation Program for Urinary Incontinence Versus a Conventional Face-to-face Program
Condition: Stress Urinary Incontinence; Incontinence, Urinary; Covid19; Pelvic Floor Muscle Weakness
MeSH terms: Muscle Weakness; Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      Urinary incontinence (UI) is defined as any involuntary loss of urine. It affects a
      significant percentage of the population, mainly female, with a prevalence of 21.4% in
      Portuguese women, having a negative impact on quality of life and sexual function.

      About half presents with stress UI (SUI), followed by mixed UI (MUI), with isolated urgency
      UI being less common.

      Pelvic floor rehabilitiation is a first line treatment for SUI and MUI, however, it is not
      yet defined which is the best treatment program or the ideal strategies to improve adherence
      to it.

      Telerehabilitation assumed a leading role in the covid pandemic phase, although there are few
      studies on pelvic floor rehabilitation for UI, none in Portugal to date.

      The authors aim to evaluate the effectiveness of a hybrid program of pelvic floor
      rehabilitation in female patients with SUI and MUI with a predominance of SUI, including
      consultation and face-to-face sessions complemented with telerehabilitation.
    

Detailed description: 
      Randomized longitudinal study including consecutively admitted patients on pelvic floor
      rehabilitation consultation of the Physical Medicine and Rehabilitation Department of Centro
      Hospitalar São João for conservative treatment of UI.

      Patients who meet the inclusion criteria and do not meet any of the exclusion criteria will
      be randomized one to one between the intervention group and the control group.

      The intervention group includes a hybrid program of face-to-face sessions followed by
      sessions of video, while the control group develops the entire program in face-to-face
      sessions.

      The effectiveness of the program will be assessed by the results in the UI-related quality of
      life (primary outcome); UI severity, patient's overall perception of improvement, sexual
      function, depression/anxiety symptoms and satisfaction and adherence to treatment (secondary
      outcomes).
    

Intervention name(s): Pelvic Floor Telerehabilitation Program; Pelvic Floor Face-to-Face Program
Intervention type(s): Other; Other
Intervention description(s): See experimental and active comparator arms.; See experimental and active comparator arms.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pelvic floor; Physical therapy; Urinary incontinence; Quality of life; Telerehabilitation; Training; Pelvic floor musculature; Female; Pelvic Floor Muscle Training
The Impact and Benefit of Physical Activity on Premature Ejaculation
Condition: Premature Ejaculation
MeSH terms: Premature Birth; Premature Ejaculation
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the relationship between physical activity and
      PE, and determine whether moderate physical activity might delay ejaculation time or be an
      alternative treatment for PE.
    


Intervention name(s): physical activity; dapoxetine 30 mg on demand
Intervention type(s): Behavioral; Drug
Intervention description(s): patients will do moderate running which make them breathe somewhat harder than normal for at least 30 minutes for 5 days in a week; Dapoxetine, a short-acting selective serotonin reuptake inhibitors, has been utilized for the treatment of premature ejaculation in various countries
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: intravaginal ejaculatory latency time; international physical activity questionnaire; premature ejaculation diagnostic tool