bioihbjkbjnl/mcl2 huggingface dataset:
A Novel Treatment for Aphasia and Apraxia of Speech : Measurement of Outcomes
Condition: Apraxia of Speech; Aphasia
MeSH terms: Aphasia; Apraxias
Study type: Interventional

Summary: 
      In order to determine if speech-language therapy has positive effect, reliable measurement
      tools are required to document outcomes. Currently, there is very limited information
      concerning the measurement of changes in speech production as a result of treatment for
      acquired apraxia of speech and aphasia. This study will obtain information concerning the
      reliability of several speech production measures over time. Thirty persons with chronic
      aphasia and apraxia of speech will be asked to provide speech samples in response to commonly
      used assessment tools on three sampling occasions so that the stability of measurements may
      be examined.

      After establishment of appropriate outcome measures, a small, pilot treatment study will be
      conducted with four participants. The participants will receive a new treatment for aphasia
      and acquired apraxia of speech and outcomes will be measured relative to speech and language
      production.
    

Detailed description: 
      A single group, repeated measures design will be used to obtain repeated speech samples from
      30 persons with chronic acquired apraxia of speech and aphasia. Speech samples will be
      elicited using commonly employed motor speech assessment protocols; an initial sample, a
      sample one week following the initial sample, and a sample at four weeks following the
      initial sample. The following measures will be obtained from the samples: percent consonants
      correct, percent fluent utterances, and duration of utterance. Stability of the measures will
      be examined.

      After the preceding measures have been analyzed, a series of four, single-subject
      experimental designs will be conducted. Four participants with chronic aphasia and apraxia of
      speech will receive a new treatment for aphasia and apraxia of speech applied sequentially to
      two sets of experimental picture picture stimuli. Outcomes will be measured in terms of
      speech production (measures described above) as well as in terms of language production.
    

Intervention name(s): Combined Aphasia and Apraxia of Speech Treatment (CAAST)
Intervention type(s): Behavioral
Intervention description(s): Therapy is delivered in a face-to-face format. The therapist uses picture stimuli, verbal modeling, feedback, reinforcement, forward-chaining to increase verbal production. For speech errors that occur, the therapist uses modeling, feedback, reinforcement, simultaneous production, articulatory instruction, and repeated practice to improve articulation.
Other intervention name(s): CAAST
Intervention model: Single Group Assignment
Intervention model description: Single-case experimental design; multiple baseline design across behaviors and participants
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: aphasia; apraxia of speech; outcomes
Ultrasound-guided Selective Supraclavicular Nerve Block for Postoperative Pain Control in Pediatric Patients.
Condition: Cancer Pediatric
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      This prospective randomized controlled trial aims to investigate the effect of
      ultrasound-guided selective supraclavicular nerve block on pain control after Hickman
      catheter, chemoport, or Perm cath insertion in children.
    

Detailed description: 
      Pediatric patients undergoing surgical insertion of a Hickman catheter, chemoport, or
      Permcath are randomly assigned to a test group (Ultrasound-guided selective supraclavicular
      nerve block with Ropivacaine) and a control group (Nerve block is not performed).

      Immediately after induction of general anesthesia, in the test group, the supraclavicular
      nerve block was selectively performed using ultrasound using 0.1mL/kg of 0.5% Ropivacaine
      (Maximum dose: 5mL), and the nerve block was not completed in the control group. After that,
      a Hickman catheter, chemoport, or Permcath is surgically inserted in the usual way and
      allowed to recover from anesthesia.

      The pain score is evaluated between 10 and 30 minutes of entering the recovery room (1 hour
      after the procedure) and 1 hour, 3 hours, and 24 hours after leaving the recovery room by
      another research team who is unaware of the group assignment. In addition, the use of
      additional analgesic drugs and related side effects were collected before discharge.
    

Intervention name(s): Ropivacaine; Control (without intervention)
Intervention type(s): Drug; Other
Intervention description(s): The nerve involved in the operation of Hickman catheter, chemoport, and Perm cath is the supraclavicular nerve. Therefore, it is judged that if only this nerve is selectively blocked, pain control can be effectively performed with a small amount of local anesthetic, and relatively few side effects occur.; No intervention
Intervention MeSH terms: Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: selective supraclavicular nerve block; postoperative pain control; Hickman catheter; chemoport; Perm cath
Rehabilitation of Patients With Modic Changes in the Lumbar Spine
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to compare patients with low back pain (LBP) and Modic Changes
      from The Backcenter Funen, Ringe:

        1. To compare the effect of two types of non-operative treatments:

           A. exercise and advice to be physically active

           B. restitution and advice not to overload the spine

        2. To investigate if the results of the treatment are influenced by gender, age, smoking,
           and physical load.
    

Detailed description: 
      The clinical experience is that many patients with Modic changes have relatively severe and
      persistent LBP, which typically appears to be resistant to treatment. Furthermore, a
      retrospective study at The Backcenter Funen, Ringe, shows that patients with MC fail to
      improve engaging physical activity. This is unfortunate, because the typical rehabilitation
      for patients with persistent LBP is back exercises and information about keeping physically
      active. This means that this relatively large subgroup of patients with Modic changes
      probably does not improve with the rehabilitation tools used today.

      A randomised controlled trial has therefore been designed to study the specific subgroup of
      patients with Modic changes. In this study we will compare the present "state-of-the art"
      rehabilitation approach to persistent LBP (namely to exercise and keep active) with a new
      concept (restitution). The justification for this is that restitution reduces mechanical
      stress on the vertebrae and therefore would allow heeling of the possible micro fractures in
      Modic changes.
    

Intervention name(s): Exercise; Restitution
Intervention type(s): Other; Other
Intervention description(s): Back exercise: At home every day. In groups once a week. Duration 10 weeks.; Restitution: At home 2 times one hour. Meetings every 2 weeks. Duration 10 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Low back pain; Modic changes
Anaerobic Power and Salbutamol
Condition: Ergogenic Athletic Performance
Study type: Interventional

Summary: 
      Athletes using inhaled β2-adrenoreceptor agonists (IBAs) win a disproportionate number of
      medals. However, most previous research has shown that β2 agonists do not improve exercise
      performance in either asthmatic or non-asthmatic athletes. Although the majority of these
      studies do not show an ergogenic effect, the small number of studies with extended exercise
      bouts (~60 minutes) do show an advantage. The investigators believe that a controlled yet
      sport-specific exercise protocol will elucidate this ergogenic effect. Because IBAs may have
      different effects on these two groups of athletes, the investigators will measure exercise
      performance in both female and male elite cyclists. The investigators hypothesize that
      athletes will perform better during a combination steady-state/sprint exercise task following
      salbutamol administration.
    


Intervention name(s): Cycling Exercise
Intervention type(s): Other
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
Keywords: salbutamol; exercise-induced bronchoconstriction; anaerobic power
Examining the Influence of Guided Meditation on Diabetes-related Distress and Glycemic Control
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional

Summary: 
      The study aims to investigate the effects of Guided Meditation on diabetes-related distress
      and glycemic control in hospitalized Type 1 adolescent diabetic patients. The study will
      employ a randomized controlled trial design, with participants randomly assigned to either
      the intervention group (receiving Guided Meditation sessions) or the control group (receiving
      standard care). The primary outcomes measured will be diabetes-related distress levels and
      glycemic control (HbA1c levels).
    

Detailed description: 
      The researchers hypothesize that the intervention group will experience a reduction in
      diabetes-related distress and an improvement in glycemic control compared to the control
      group. The study's findings could suggest how guided meditation could help manage the
      emotional distress and enhance diabetes management in hospitalized Type 1 adolescent diabetic
      patients.
    

Intervention name(s): Guided meditation
Intervention type(s): Behavioral
Intervention description(s): Meditation with guidance
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Randomized controlled trial
Masking: Single (Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: Type 1 diabetes mellitus; Guided meditation; Adolescents
Intravenous Pantoloc In Aspirin-Induced Ulcer Bleeding
Condition: Cardiovascular Disease; Cerebrovascular Disorders
MeSH terms: Cerebrovascular Disorders; Cardiovascular Diseases
Study type: Interventional

Summary: 
      The aim of the study is to investigate whether intravenous infusion of pantoprazole
      (Pantoloc) is effective in preventing recurrent bleeding in patients who present with acute
      ulcer bleeding and continue to use aspirin
    

Detailed description: 
      Aspirin is an effective treatment for acute stroke and heart attack. However, aspirin also
      induces ulcer and provokes acute ulcer bleeding. Thus, aspirin is often withheld in acute
      ulcer bleeding but this precipitate recurrent stroke or heart attack. We previously showed
      that intravenous infusion of a potent acid suppressant substantially reduced the incidence of
      recurrent ulcer bleeding in patients who withheld aspirin. The aim of this study is to
      investigate whether intravenous infusion of an acid suppressant (Pantoprazole) is effective
      in preventing recurrent ulcer bleeding with continuous use of aspirin.
    

Intervention name(s): Aspirin and Pantoloc
Intervention type(s): Drug
Intervention MeSH terms: Aspirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Predictive Validity of Lumbopelvic Stress Tests to Determine Those Who Will Benefit From Lumbar Traction: A Pilot Study
Condition: Low Back Pain
MeSH terms: Low Back Pain
Study type: Interventional

Summary: 
      The objective in this study is to determine the predictive validity of a set of special
      clinical tests in identifying those who will respond to lumbar traction
    

Detailed description: 
      The objective in this study is to determine the predictive validity of a set of special
      clinical tests in identifying those who will respond to lumbar traction. The central
      hypothesis of this pilot study is that a cluster of lumbopelvic stress tests will be able to
      identify a subgroup of patients with low back pain who will respond favorably to mechanical
      lumbar traction. If these clinical tests can identify a subgroup of patients with low back
      pain who respond favorably to lumbar traction, additional studies, including randomized
      clinical trials will be necessary to further test and validate the use of this cluster of
      clinical tests. The rationale for this research is to examine the connection between
      provocative lumbar compression testing and lumbar traction as a means of decompression
    

Intervention name(s): Lumbar traction
Intervention type(s): Other
Intervention description(s): Lumbar traction is used to decompress the spinal structures and relieve pressure and may stretch the spine.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Erector Spina Plane Block for Multilevel Major Spinal Surgery
Condition: Pain; Post Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Erector spinae plane (ESP) block is an interfacial plane block with visceral and somatic
      analgesic activity at paraspinal muscles. This study aims to examine the postoperative
      analgesic efficacy of ESP block in patients undergoing posterior spinal instrumentation
    

Detailed description: 
      Postoperative patient-controlled analgesia in the ESP group and control group will be
      compared with 24-hour morphine consumption and NRS scores at different time points. In
      addition, the need for rescue analgesics and patient satisfaction will be evaluated.
    

Intervention name(s): Erector spinae plane block; Control
Intervention type(s): Procedure; Procedure
Intervention description(s): Erector spinae plane block was performed; Erector spinae plane block was not applied.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pain; postoperative analgesia; Erector spinae plane block; posterior spinal instrumentation
OlmeSartan and Calcium Antagonists Randomized (OSCAR) Study
Condition: Hypertension; Cardiovascular Diseases
MeSH terms: Hypertension; Cardiovascular Diseases
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to investigate whether high-dose angiotensin II receptor blocker
      (ARB) monotherapy or combination therapy with ARB and calcium channel blockers is more
      effective in reducing the incidence of cardiovascular events in Japanese elderly high-risk
      hypertensive patients not adequately controlled by standard dose ARB alone.
    

Detailed description: 
      Hypertension is one of the major risk factors of cardiovascular diseases. It is also
      important for elderly hypertensive patients to strictly reduce their blood pressures to
      prevent cardiovascular events. Although angiotensin II receptor blockers (ARBs) are
      increasingly used in antihypertensive treatment recently, few studies have been performed in
      Japan to assess the difference between high-dose ARB monotherapy and combination therapy of
      ARB with calcium channel blocker (CCB) in prevention of cardiovascular diseases for patients
      whose blood pressure is not well controlled by ARB monotherapy. OSCAR-study is a multicenter,
      active-controlled, 2-arm parallel group comparison, prospective randomized open blinded
      end-point (PROBE) design study. The dose administered is olmesartan medoxomil 20mg/day as ARB
      monotherapy in the 'Step 1' period. If the blood pressure is not adequately controlled and
      treatment is well tolerated then the dose is changed to olmesartan medoxomil 40mg/day in the
      high-dose ARB monotherapy group, or olmesartan medoxomil 20mg/day and a CCB in the
      combination therapy group in the 'Step 2' period. At least 500 patients will be enrolled in
      each group, and the follow-up duration will be 3 years. The primary objective is to compare
      the incidence of a composite of fatal and non-fatal cardiovascular events, and all cause
      mortality between the two treatment groups.
    

Intervention name(s): Olmesartan medoxomil; Calcium channel blockers (amlodipine, azelnidipine)
Intervention type(s): Drug; Drug
Intervention description(s): Olmesartan medoxomil 40mg/Day; Olmesartan medoxomil 20mg/Day with Calcium channel blockers (amlodipine or azelnidipine)
Intervention MeSH terms: Amlodipine; Olmesartan; Olmesartan Medoxomil; Calcium Channel Blockers; Calcium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Aged; Hypertension; Cardiovascular Diseases; Angiotensin II Type 1 Receptor Blockers; Calcium Channel Blockers; Combination Drug Therapy; Diabetes Mellitus Type 2
Redox State in the Course of Chronic Renal Insufficiency and Hemodialysis: Implications in Morbimortality
Condition: Chronic Renal Insufficiency
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic
Study type: Interventional

Summary: 
      The influence of hemodialysis on oxidative stress, endothelial activation, inflammation and
      on the redox state of lymphocytes should be clarified as well as the putative relationships
      between all these parameters.
    

Detailed description: 
      Up to now, no anti-oxydative treatment has been able to reduce the mortality of the patients
      with Kidney Failure. Thus it is necessary to have a better knowledge of oxydative stress
      mechanisms in patients with KF in order to find more efficacious treatments. The influence of
      hemodialysis upon oxidative stress is not well known.
    

Intervention name(s): Sampling of blood; Sampling of blood; Sampling of blood
Intervention type(s): Other; Other; Other
Intervention description(s): A sampling of blood will be made; A sampling of bood will be made before the dialysis; A sampling of blood will be made.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Redox state in the course of chronic renal insufficiency and hemodialysis.
The Use of Statically Determinate Force System in Closure of Anterior Open Bite in Adults.
Condition: Anterior Openbite
MeSH terms: Open Bite
Study type: Interventional

Summary: 
      The aim of the current study was to evaluate and quantify the cephalometric changes produced
      by maxillary and mandibular extrusion arches in closure of anterior open bite in non-growing
      patients.
    


Intervention name(s): Extrusion arch
Intervention type(s): Device
Intervention description(s): one couple force system is applied; a custom-made extrusion wire from 0.016x0.022 stainless steel wire with helical bends placed 2-5 mm mesial to the molar tube placed in the upper and lower arches and tied distal to the lateral incisors
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study of Paliperidone Palmitate 6-Month Formulation
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 3

Summary: 
      The main purpose of this study is to assess the long-term safety and tolerability of
      paliperidone 6-month PP6M (Dose 1 or Dose 2 [milligram] mg eq.) and to provide access to PP6M
      in participants with schizophrenia completing the R092670PSY3015 study without relapse.
    


Intervention name(s): PP6M injection Dose 1; PP6M injection Dose 2
Intervention type(s): Drug; Drug
Intervention description(s): Participants will receive Dose 1 PP6M intramuscular (IM) injection at Visit 1 (Day) then once every 6 month up to 24 months.; Participants will receive Dose 2 PP6M IM injection at Visit 1 (Day) then once every 6 month up to 24 months.
Other intervention name(s): R092670; R092670
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Metoclopramide Versus Sumatriptan for Emergency Department Treatment of Migraine Headache
Condition: Migraine Disorders
MeSH terms: Migraine Disorders; Headache
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine which drug makes lower migraine headache
    

Detailed description: 
      There are different options to manage benign headache in emergency department.The
      investigators compared Intravenous metoclopramide with Subcutaneous sumatriptan to relieve
      pain in emergency department.
    

Intervention name(s): metoclopramide, injection,20mg, one time; Sumatriptan, injection, 6 mg, one time
Intervention type(s): Drug; Drug
Intervention description(s): metoclopramide, intravenous injection,20mg, one time; Sumatriptan, subcutaneous injection, 6 mg, one time
Other intervention name(s): plasil
Intervention MeSH terms: Sumatriptan; Metoclopramide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Metoclopramide; Sumatriptan; migraine; headache
Juvenile Rheumatoid Arthritis
Condition: Juvenile Chronic Arthritis
MeSH terms: Arthritis; Arthritis, Juvenile
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the safety of anakinra in patients with
      Polyarticular-Course Juvenile Rheumatoid Arthritis, a form of rheumatoid arthritis affecting
      children.
    


Intervention name(s): Anakinra; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): anakinra; placebo
Intervention MeSH terms: Interleukin 1 Receptor Antagonist Protein
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment