bioihbjkbjnl/mcl2 huggingface dataset:
Validation of the Turkish Translation of the London Speech Evaluation Scale
Condition: Speech Intelligibility; Speech Disorders; Head and Neck Cancer; Speech Dysfunction; Speech
MeSH terms: Speech Disorders
Study type: Observational

Summary: 
      Purpose of the study is the validation and cultual adaptation of the Turkish translation of
      the London Speech Evaluation Scale (LSE-T), so that it would be used as an assessment tool
      for Turkish head and neck cancer patients. There is no validated Turkish version of LSE to
      measure severity of perceptual speech in head and neck cancer patients.
    

Detailed description: 
      The speech function is a multidirectional process that depends on complex neuro-muscular
      network. The function can be evaluated using instrumental, such as voice analysis computer
      programmes, scales, or well structured questionnaires. There are many scales for assessment
      of perceptual speech but there is no validated for head and neck patients. The study will
      assess the construct validity and adaptation of the Turkish translation of Speech Specific
      Perceptual Speech Evaluation as known as London Speech Evaluation Scale. The investigators
      developed the Turkish translation of this scale (LSE-T), according to the cross-cultural
      adaptation guidelines. Two translators translated the LSE into Turkish and a native English
      language speaker reverse-translated it into English. The back translation was sent to the
      original author for proofreading. The LSE scale consisted of 6 parameters and 4 scores
      related with perceptual speech in head and neck cancer patients.
    

Intervention name(s): The speech records related to the reading document
Intervention type(s): Other
Intervention description(s): The document consists "bit, bet, but" words and Diyet passage. Volunteers will read the document in front of the microphone and also the speech will recorded by a computer.
Observational model: Other
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Adults with oral, oropharyngeal cancer and healthy adults
      
Keywords: Perceptual; speech; articulation; neck; cancer
MBI for Psychological Distress, SI and NSSI Among Young Adults
Condition: Psychological Distress; Suicidal Ideation; Non-Suicidal Self Injury
MeSH terms: Suicidal Ideation; Self-Injurious Behavior
Study type: Interventional

Summary: 
      Designed to measure the impact of Mindfulness Based Intervention on depression, anxiety,
      stress, psychological distress, Suicidal Ideation, Non-Suicidal Self Injury urge and
      Mindfulness in young adults. Those individuals who agree to participate in the trial and
      identified with high levels of psychological distress and Suicidal Ideation, randomly divided
      into interventional (n=30) and control (n=30) groups. The Mindfulness Based Stress Reduction
      intervention then administered to the interventional group for eight weeks and pre and post
      intervention assessment done for both the groups.
    

Detailed description: 
      Study assessment measures:

        -  Informed consent form

        -  Demographic questionnaire

        -  Screener questions form

        -  Assessment instruments:

        -  Depression Anxiety and Stress Scale (DASS-21)

        -  Suicide Ideation Scale (SIS)

        -  Alexian Brothers Urge to Self Injure Scale (ABUSI)

        -  Mindfulness Attention Awareness Scale
    

Intervention name(s): Mindfulness Based Stress Reduction Intervention
Intervention type(s): Other
Intervention description(s): During an eight-week intervention period, clients were to engage in mindfulness practices lasting between 45 minutes to an hour each session. The intervention would incorporate various components of the Mindfulness-Based Stress Reduction (MBSR) program, including mindfulness of the present moment, body scans, mindful eating, walking meditation, yoga exercises, and discussions on applying mindfulness to everyday experiences and stress management. Sessions would typically range from 30 to 90 minutes per week, with an additional full-day retreat session towards the end of the program. In addition to mindfulness practice, participants were to receive teachings on stress management and its application to interpersonal and daily life situations.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Mindfulness Based Intervention; Psychological Distress; Suicidal Ideation; Non-Suicidal Self Injury
Metabolic Effects of Choline and Docosahexaenoic Acid Supplementation in Preterm Infants
Condition: Infant, Premature
Study type: Interventional

Summary: 
      To explore the effects of enteral choline and DHA supplementation on plasma choline and
      DHA-PC concentrations and metabolism, this randomized controlled study will assign 40 preterm
      infants to 1 of 4 groups: standard care, choline supplementation, DHA supplementation, and
      choline and DHA supplementation.

      After 7 days of supplementation, a single dose of stable isotope labelled choline will be
      administered and the kinetics of newly synthesized DHA-PC determined to assess plasma levels,
      uptake and distribution of choline and DHA.

      This study is designed to inform larger studies evaluating this approach of enteral
      co-application of choline and DHA on clinical important outcomes.
    

Detailed description: 
      In utero, there is a constant high supply of choline to the fetus. Preterm delivery disrupts
      this maternal-fetal choline-transfer. We have shown that choline plasma levels rapidly half
      after preterm delivery. We also demonstrated that plasma DHA-PC rapidly falls after preterm
      delivery. DHA supplementation has been evaluated and found safe, however the clinical
      benefits have been smaller than expected. We speculate that choline deficiency may have
      contributed to the smaller than expected benefit of DHA supplementation in the past.

      This study verifies the hypothesis that concomitant supply of choline and DHA will improve
      DHA-PC availability and turn-over. This is important because DHA-PC is the transport molecule
      for the DHA transport to the brain and the retina.

      To explore the effects of enteral choline and DHA supplementation on plasma choline and
      DHA-PC concentrations, this randomized controlled study will assign 40 preterm infants to 1
      of 4 groups: standard care, choline supplementation, DHA supplementation, and choline and DHA
      supplementation.

      After 7 days of supplementation, a single dose of stable isotope labelled choline will be
      administered and the kinetics of newly synthesized DHA-PC determined to assess plasma levels,
      uptake and distribution of choline and DHA.

      This study is designed to inform future larger studies evaluating this approach of enteral
      co-application of choline and DHA on important clinical outcomes.
    

Intervention name(s): choline supplementation; DHA supplementation; standard nutrition
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): in addition to standard nutrition: enteral supplementation with 30mg/kg choline chloride for 10 days; in addition to standard nutrition: enteral supplementation with 60mg/kg DHA for 10 days; standard nutrition
Intervention MeSH terms: Choline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: choline; docosahexaenoic acid
Three-times-weekly Versus Daily Growth Hormone (GH) Treatment in naïve GH-deficient Children
Condition: Growth Hormone Treatment
Study type: Interventional
Phase: Phase 3

Summary: 
      Growth hormone (GH) treatment in patients with GH deficiency (GHD) is commonly administered
      daily, although the pulsatile GH secretion is unlikely to be achieved and this regimen is
      often not complied. The auxological effect of three injections per week (TIW) regimen is
      controversial, while the metabolic effects were never evaluated in children. The objective of
      this study was to evaluate whether two different regimens of weekly injections could lead to
      similar auxological and metabolic effects in children with GHD.
    

Detailed description: 
      Thirty-two children with growth hormone (GH) deficiency (25 males, mean age 10.5 ± 2.2 yr)
      were randomly assigned to receive daily (group A, No 16) or three injections per week (group
      B, No 16) GH therapy for 12 months.

      Auxological parameters, insulin-like growth factor-I (IGF-I), glucose and insulin during an
      oral glucose tolerance test, glycosylated hemoglobin, lipid profile, the oral disposition
      index (DIo), the homeostasis model assessment estimate of insulin resistance (Homa-IR), the
      quantitative insulin sensitivity check index (QUICKI) and the insulin sensitivity index (ISI)
      were evaluated in the two groups of patients.
    

Intervention name(s): Growth Hormone
Intervention type(s): Drug
Intervention MeSH terms: Hormones
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: growth hormone; children; metabolism
Prevalence, Predictors and Management of Gastroesophageal Reflux After Laparoscopic Sleeve Gastrectomy
Condition: Gastroesophageal Reflux
MeSH terms: Gastroesophageal Reflux; Esophagitis, Peptic
Study type: Interventional

Summary: 
      From January 2017 to January 2022, we looked at patients who had primary LSG and developed
      GERD. Before and after surgery, patients for LSG performed barium meal in Trendelenburg
      position and upper GIT endoscopy. Esophageal manometry and 24 h PH metery for patients who
      developed GERD.
    

Detailed description: 
      Patients with morbid obesity who had LSG between January 2017 to January 2022were included in
      the trial, which was a multicenter cohort study. Patients with morbid obesity, defined as a
      BMI of more than 40 or less than 35 with at least one comorbidity and ages ranging from 16 to
      65, were patients' eligibility criteria for LSG. Patients under the age of 16 or over 65, as
      well as those with severe GERD, pregnancy, or inflammatory bowel disease, were excluded from
      the trial.

      The data were recorded in a prospective manner in a computerized file, all patients signed
      the informed consent form after the description of the technique and possible postoperative
      morbidities.

      Before and after surgery, patients for LSG performed barium meal in Trendelenburg position
      and upper GIT endoscopy. Esophageal manometry and 24 h PH metery for patients who developed
      GERD.

      The study's purpose was to determine the prevalence of GERD symptoms, as well as potential
      predictors of GERD symptoms following LSG and how GERD symptoms were managed after LSG.
    

Intervention name(s): patients with GERD after LSG
Intervention type(s): Procedure
Intervention description(s): patients with GERD after LSG
Other intervention name(s): GERD after LSG
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients with morbid obesity who had LSG between January 2017 to January 2022were included in the trial, which was a multicenter cohort study.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: laparoscopic sleeve gastrectomy; morbid obesity; GERD
An Open-Label Phase II Study to Evaluate Immunogenicity and Safety of a Single IMVAMUNE Booster Vaccination Two Years After the Last IMVAMUNE Vaccination in Former POX-MVA-005 Vaccinees
Condition: Smallpox
MeSH terms: Smallpox
Study type: Interventional
Phase: Phase 2

Summary: 
      The study was preformed to evaluate the persistence of antibodies following vaccination with
      MVA-BN and to assess the immunological memory response induced by a booster vaccination with
      MVA-BN in subjects two years after their participation in trial POX-MVA-005 (NCT00316524) in
      which they had received one or two doses of MVA-BN.
    


Intervention name(s): IMVAMUNE; IMVAMUNE; Blood Draw Only
Intervention type(s): Biological; Biological; Procedure
Intervention description(s): 1x 10E8_TCID50; 1x 10E8_TCID50
Intervention MeSH terms: Smallpox and monkeypox vaccine modified vaccinia ankara-bavarian nordic
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Quadratus Lumborum Block : Effect on Acute Pain and Quality of Recovery After Laparoscopic Renal Surgery
Condition: Laparoscopic Renal Surgery; Pain Management; Nerve Block
Study type: Interventional

Summary: 
      This prospective, randomized study,control study aims to compare the analgesic effect,opioids
      consumption,quality of recovery,length of hospital stay and incidence of chronic pain,et al.
      between single-injection QLB(quadratus lumborum block)+ intravenous patient-controlled
      analgesia (IPCA) and intravenous patient-controlled analgesia (IPCA) alone in patients
      undergoing laparoscopic renal surgeries.
    


Intervention name(s): single-injection QLB(quadratus lumborum block); Philip CX50 Ultrasound Scanner; PAJUNK StimuLong; single dose ropivacaine; Morphine given as IPCA(intravenous patient controlled analgesia)
Intervention type(s): Procedure; Device; Device; Drug; Drug
Intervention description(s): Inject local anesthetics in between quadratus lumborum and psoas major without continuous local infusion; The curved (C1-5) probe of Philip CX 50 Ultrasound Scanner is used for scan; 0.6ml/kg 0.5% ropivacaine with 1:200,000 adrenaline.
given immediately after the correct position of the tip of the needle has been verified.; bolus: 1.5~2mg, lock time: 10min, 1h limitation: 6~8mg
Intervention MeSH terms: Morphine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
A Study of Imatinib With Reinduction Chemotherapy Using Mitoxantrone, Etoposide and Cytarabine in Patients With Relapsed/Refractory C-kit Positive (AML) Acute Myeloid Leukemia
Condition: Leukemia
MeSH terms: Leukemia; Leukemia, Myeloid, Acute
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Phase I-II study evaluating the toxicity and efficacy of imatinib combined with
      mitoxantrone, etoposide and high-dose cytarabine reinduction therapy in relapsed and
      refractory AML. Patients will be treated initially at a 200 mg dose of imatinib; if
      tolerated, the imatinib dose will be escalated in subsequent cohorts to 300 mg and 400 mg.
      Once the recommended dose is determined, the remaining patients will be treated at that dose,
      to evaluate the antileukemic activity of the regimen. Patients achieving complete remission
      will receive consolidation therapy with imatinib combined with high-dose cytarabine and
      mitoxantrone, followed by maintenance imatinib.
    

Detailed description: 
      Induction therapy:

        -  Imatinib 200-400 mg p.o. daily x 10 days, Days 1-10 (see dose escalation scheme in
           Section 5.4 below).

        -  Mitoxantrone 10 mg/m2 daily x 5 days, Days 4-8.

        -  Etoposide 100 mg/m2 daily x 5 days, Days 4-8.

        -  Cytarabine 1.5 grams/m2 q12h x 4 doses, Days 9-10 (for patients aged 60 years and over,
           1.0 gram/m2).

      Only one induction course will be permitted. Only patients achieving CR will proceed to
      consolidation and maintenance.

      Consolidation therapy, maximum 2 cycles (for patients achieving CR):

        -  Imatinib 200-400 mg p.o. daily x 8 days, Days 1-8 (see dose escalation scheme in Section
           5.4 below).

        -  Mitoxantrone 12 mg/m2 daily x 2 days, Days 4-5.

        -  Cytarabine 3 grams/m2 q12h x 6 doses, Days 4,6,8. For patients aged 60 years and over,
           the dose will be reduced to 1.5 grams/m2.

      Maintenance therapy (for patients still in CR at end of consolidation):

      Imatinib 600 mg p.o. daily, until relapse or toxicity (see dose modification criteria in
      Section 5.6.6 below). Patients must receive at least one consolidation cycle before being
      permitted to proceed to maintenance therapy (see Section 5.6 for details). Maintenance
      therapy with imatinib will be provided for a maximum period of 1 year.

      Dose escalation scheme:

      Imatinib will be used during induction and consolidation at one of the following dose levels:

      Level -1 100 mg daily Level 1 200 mg daily Level 2 300 mg daily Level 3 400 mg daily
    

Intervention name(s): Imatinib (Gleevec)
Intervention type(s): Drug
Intervention MeSH terms: Imatinib Mesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Gleevec; c-kit; aml
Yoga for Abdominal Obesity
Condition: Obesity, Abdominal
MeSH terms: Obesity; Obesity, Abdominal
Study type: Interventional

Summary: 
      The aim of this randomized trial is to investigate the effects of a 12-week yoga intervention
      compared to no specific intervention on weight-related outcomes, well-being, and health
      behaviour in 60 females with abdominal obesity.
    


Intervention name(s): Yoga
Intervention type(s): Behavioral
Intervention description(s): 12 weeks of yoga, twice weekly for 90 minutes plus a whole-day workshop
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment
Effectiveness of Selected Physical Therapy Exercise Program and Transcutaneous Electrical Nerve Stimulation on Patients With Pudendal Neuralgia
Condition: Pudendal Neuralgia
MeSH terms: Neuralgia; Pudendal Neuralgia
Study type: Interventional

Summary: 
      To study the efficacy of adding Transcutaneous Electrical Nerve Stimulation (TENS) to
      selected physical therapy exercise program on pain in patients with pudendal neuralgia.

      Fifty-two male participants with chronic pudendal neuralgia (30-50 years) shared in this
      study.

      Methods: patients were assigned randomly into two groups equal in number; study and control
      groups with 26 patients in each. All patients were receiving the same physical therapy
      exercise program, in addition to the same prescribed analgesic medication. Patients in the
      study group received additional TENS therapy and those in the control group received sham
      TENS. Treatment was provided three sessions per week for twelve successive weeks. The
      participants underwent baseline and post treatment assessment for pain level as measured by
      three methods; Serum Cortisol Level (SCL), Daily Etodolac intake dose (DEID), and Numerical
      Pain Rating Scale (NPRS).
    


Intervention name(s): Exercise therapy program plus TENS therapy
Intervention type(s): Other
Intervention description(s): All patients were receiving the same physical therapy exercise program, 3 times per week for 12 weeks in the form of pelvic floor relaxation exercises, diastasis correction exercises , myofascial trigger points release, connective tissue manipulation and progressive abdominal strengthening exercises. Pelvic floor relaxation exercises included pelvic floor release stretches, Proprioceptive Neuromuscular Facilitation technique, and pelvic floor drop exercises in addition to TENS therapy The standard protocol for TENS therapy in this group was 20 minutes of 100 Hz frequency, pulse duration of 200 µsec, three times a week for successive 12 weeks
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Nitrite, Isoquercetin and Endothelial Dysfunction (NICE) Trial
Condition: Chronic Kidney Disease
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      The proposed randomized controlled trial will test the safety and efficacy of combination
      therapy with sodium nitrite and isoquercetin on endothelial function and inflammation among
      patients with chronic kidney disease.
    

Detailed description: 
      The proposed randomized controlled trial will test the safety and efficacy of combination
      therapy with sodium nitrite and isoquercetin on endothelial function and inflammation among
      patients with chronic kidney disease. Investigators will recruit 70 albuminuric CKD patients
      and randomly assign participants to combination therapy with sodium nitrite and isoquercetin
      or placebo for three months.
    

Intervention name(s): Immediate release sodium nitrite; Isoquercetin; placebos
Intervention type(s): Drug; Dietary Supplement; Other
Intervention description(s): Immediate release sodium nitrite 40 mg by mouth twice per day; Isoquercetin 225 mg by mouth once per day; placebos
Other intervention name(s): TV1001; 3-O-glucoside
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Endothelial Dysfunction; Inflammation; Oxidative Stress; eGFR; Urine Albumin
Pharmacokinetic Study of Levosulpiride
Condition: Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 1

Summary: 
      The aim of this study was to characterise the pharmacokinetic properties and assess the
      safety of different formulations of levosulpiride in healthy Chinese volunteers.
    

Detailed description: 
      Levosulpiride was administered to 42 healthy male and female (1:1) subjects as tablet
      (orally) and injection (intramuscularly and intravenously) formulations. Blood samples were
      collected at regular intervals after single and multiple drug administration. The
      concentration of levosulpiride in plasma was determined using a validated high performance
      liquid chromatography-tandem mass spectrometry method. Non-compartmental analysis was
      performed to estimate pharmacokinetic parameters. The analysis of variance was used to test
      for linearity and assess the effect of gender on the pharmacokinetic properties of the study
      drug. Adverse effects were monitored using investigators' questionnaires and subjects'
      spontaneous reports, vital sign measurements, hematology, clinical chemistry, and
      electrocardiogram.
    

Intervention name(s): Levosulpiride
Intervention type(s): Drug
Intervention description(s): different formulations of levosulpiride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: levosulpiride; pharmacokinetics; adverse effects; bioavailability