bioihbjkbjnl/mcl2 huggingface dataset:
Study of Modified Constraint-Induced Aphasia Therapy Schedule to Treat Patients Following Sub-acute Stroke
Condition: Aphasia
MeSH terms: Aphasia; Stroke
Study type: Interventional

Summary: 
      The purpose of this study is to assess the feasibility of modified Constraint-Induced Aphasia
      Therapy (CIAT) in the early sub-acute stage and to examine the efficacy of modified CIAT
      versus standard treatment with the same intensity of intervention.
    


Intervention name(s): Investigate efficacy of modified ciat schedule; examine the efficacy of standard treatment versus modified ciat schedule
Intervention type(s): Other; Other
Intervention description(s): 2 hours of training over 15 days; 2 hours of training over 15 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Aphasia; Rehabilitation of Speech and Language Disorders
Aromatherapy for Anxiety and Self-esteem: Clinical Trial
Condition: Anxiety; Self Esteem
MeSH terms: Anxiety Disorders
Study type: Interventional

Summary: 
      The aim of this study was to determine whether the use of Ylang Ylang essential oil through
      dermal application or inhalation alters the perception of anxiety and self-esteem and
      physiological parameters such us blood pressure and temperature.
    

Detailed description: 
      34 nurses from the University Hospital participated in this study and were randomized into
      three groups: one that received the Ylang Ylang Essential Oil cutaneous route, the second
      received the Essential Oil inhalation and the third (placebo) received the essence of Ylang
      ylang cutaneous route.
    

Intervention name(s): Intervention Group 2; Intervention Group 1; Intervention Group 3
Intervention type(s): Other; Other; Other
Intervention description(s): Massage with Ylang Ylang Essence was applied for 30 seconds on the handle and the sternum area; Massage with Ylang Ylang essential oil in the wrist and in the region of the sternum; Put a drop of essential oil of ylang ylang in cotton located within the freshener and inhale throughout their work shift
Other intervention name(s): Massage; Aromatherapy; Massage; Aromatherapy; Aromatherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Anxiety; Self-Esteem
GB002 in Adult Subjects With Pulmonary Arterial Hypertension (PAH)
Condition: Pulmonary Artery Hypertension
MeSH terms: Pulmonary Arterial Hypertension; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective for this trial is to determine the effect of GB002 (seralutinib) on
      improving pulmonary hemodynamics in subjects with World Health Organization (WHO) Group 1 PAH
      who are Functional Class (FC) II and III. The secondary objective for this trial is to
      determine the effect of GB002 (seralutinib) on improving exercise capacity in this
      population.
    


Intervention name(s): GB002 (seralutinib); Placebo; Generic Dry Powder Inhaler
Intervention type(s): Drug; Drug; Device
Intervention description(s): Capsule containing GB002 (seralutinib); Matching capsule containing placebo; Generic dry powder inhaler for GB002 (seralutinib) or placebo delivery
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: seralutinib
Hepatitis B Vaccine Clinical Trial
Condition: Hepatitis B; Hepatitis, Viral, Human; Liver Diseases
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis, Viral, Human; Hepatitis; Liver Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the efficacy of a hepatitis vaccine in preventing hepatitis B.
    

Detailed description: 
      BACKGROUND:

      Although most carriers of HBsAg are asymptomatic, a substantial proportion eventually develop
      chronic active hepatitis and cirrhosis. There is also overwhelming evidence that the
      hepatitis B virus is the single most important causative factor of hepatocellular carcinoma.
      Thus, mass immunization programs against HBV infection may ultimately affect not only the
      incidence of acute hepatitis B and the pool of chronic carriers but may also reduce the
      morbidity and mortality from chronic active hepatitis, cirrhosis, and hepatocellular
      carcinoma.

      Krugman and his co-workers laid the groundwork for active immunization against hepatitis B in
      1970 to 1973. They discovered that a 1:10 dilution of hepatitis B infective serum lost its
      infectivity when boiled for one minute but retained its antigenicity and prevented hepatitis
      B in 70 percent of vaccinated subjects. Hilleman and his colleagues at the Merck Institute of
      Therapeutic Research developed a more sophisticated vaccine consisting of highly purified,
      formalin-inactivated HBsAg particles derived from the plasma of chronic carriers of the
      antigen. By 1978, data were sufficient to permit testing in a clinical trial.

      The first subject was inoculated in November 1978, and by October 1979, recruitment had
      ended. In May 1980, all trial events were reviewed and classified by an expert panel. In June
      1980 the code of vaccine and placebo allocation was broken.

      DESIGN NARRATIVE:

      Randomized, double blind, fixed-sample. A total of 549 subjects were allocated to the vaccine
      group in which they were treated with highly purified formalin-inactivated virus subunits
      derived from the plasma of chronic carriers of hepatitis B. A total of 534 were allocated to
      the placebo group. Both groups received injections at 0, 1 month, and 6 months unless
      evidence of infection developed before the series was completed.
    

Intervention name(s): hepatitis B vaccines
Intervention type(s): Biological
Allocation: Randomized
Masking: Double
Primary purpose: Prevention
Measuring Head Control Change With 2D Video Analysis After Utilization of Headpod in Children With Poor Head Control
Condition: To Determine Efficacy of the Headpod; Cerebral Palsy
MeSH terms: Cerebral Palsy
Study type: Interventional

Summary: 
      Inclusion Criteria: children ages 2 to 14 years with poor head control and non progressive
      diagnoses. Exclusion criteria: significant change of status i.e. prolonged hospitalization,
      surgery; inability to tolerate using Headpod. Requires use of Headpod 3x per day for minimum
      of 15 minutes each time over a 6 month period. Log must be kept documenting usage of the
      Headpod. Video will be taken to document changes.
    

Detailed description: 
      Requires usage of the Headpod 3x per day for a minimum of 15 minutes each time. Usage
      required for 6 month period. Log must be kept documenting usage of the Headpod. Video will be
      taken on initial trial use, 1 week post trial use, at 3 months post utilization of the
      Headpod and at 6 months post utilization of the Headpod.
    

Intervention name(s): Headpod
Intervention type(s): Device
Intervention description(s): Adaptive equipment to assist with active head movements
Intervention model: Single Group Assignment
Intervention model description: Quasi-experimental, one-way repeated measures design
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Assess the Effect of Ketoconazole on the Metabolism of ABT-199
Condition: Non-Hodgkin's Lymphoma
MeSH terms: Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label multicenter, study to assess the pharmacokinetic interaction of
      ketoconazole with ABT-199 in up to 12 subjects with relapsed or refractory non-Hodgkin's
      lymphoma.
    

Detailed description: 
      This is a Phase 1 study designed to assess how the body processes the study drug ABT-199 when
      taken alone and in combination with ketoconazole and to assess the safety of ABT-199 in
      combination with ketoconazole. Subjects may enroll in a separate extension study to continue
      receiving ABT-199 after completion of this study.
    

Intervention name(s): ABT-199; Ketoconazole
Intervention type(s): Drug; Drug
Intervention description(s): Subjects will be dosed with ABT-199, then dosed with ABT-199 in combination with ketoconazole; Subjects will be dosed with ABT-199, then dosed with ABT-199 in combination with ketoconazole
Other intervention name(s): GDC-0199
Intervention MeSH terms: Ketoconazole; Venetoclax
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: non-Hodgkin's lymphoma; GDC-0199; Safety; Relapsed; Refractory; ABT-199; Pharmacokinetics; Cancer
Multi-Centre Clinical Evaluation Of Two Daily Disposable Contact Lenses
Condition: Myopia
MeSH terms: Myopia
Study type: Interventional

Summary: 
      The purpose of this study is to compare the subjective performance for handling of two daily
      disposable contact lenses, stenfilcon A and etafilcon A.
    

Detailed description: 
      The study is to compare the subjective performance for handling of two daily disposable
      contact lenses, stenfilcon A and etafilcon A in this cross-over study.
    

Intervention name(s): etafilcon A; stenfilcon A
Intervention type(s): Device; Device
Intervention description(s): Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.; Participants wear a first pair of lenses for two weeks and then crossover and wear an alternate second pair of lenses for two weeks.
Other intervention name(s): etafilcon A (Daily Disposable Contact Lens); stenfilcon A (Daily Disposable Contact Lens)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
The ISLAND Study: InSuLa Assessed Needs for Depression
Condition: Depression
MeSH terms: Depression; Depressive Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      While there are many effective options for treating a major depressive episode, there are no
      clinical markers that predict the likelihood of remission with an initial trial of either an
      antidepressant medication or psychotherapy. The goal of this study is to test how brain
      function changes in depress patients treated with cognitive behavioral therapy (CBT) compared
      to patients treated with a selective serotonin reuptake inhibitor (SSRI, either escitalopram
      or sertraline), which are FDA approved antidepressants. The study aims to determine if bran
      scan findings might help physicians to select the most effective antidepressant treatment for
      an individual patient.

      Up to 100 male and female outpatients who are between 21-55 years old will be enrolled.
      Participation in the study will last from 14-26 weeks.

      Subjects will be randomized to receive either escitalopram (s-CIT) or CBT for 12 weeks.
      Resting-state positron emission tomography (PET) and BOLD functional magnetic resonance
      imaging (fMRI) scans will be done before the treatment begins, and again at the end of
      treatment (week 12). Non-responders to s-cIT or CBT will be crossed over to receive an
      additional 12 weeks of treatment with the alternative intervention.
    


Intervention name(s): Selective serotonin re-uptake inhibitor; Cognitive Behavioral Therapy; Combination treatment (SSRI + CBT)
Intervention type(s): Drug; Behavioral; Other
Intervention description(s): Escitalopram, 20mg-40mg daily or Sertraline 50-150 mg daily for 12 weeks; Cognitive Behavioral Therapy, standardized, 16 sessions over 12 weeks.; study participants who do not remit in the first 12 weeks will be offered combination treatment of both treatments for 12 more weeks.
Other intervention name(s): Escitalopram or Sertraline; SSRI; Antidepressant medication; Depression treatment; CBT; Depression Treatment; Talk therapy; Crossover treatment; escitalopram; depression treatment; antidepressant; talk therapy; depression trial
Intervention MeSH terms: Dexetimide; Citalopram; Sertraline; Antidepressive Agents; Escitalopram; Selective Serotonin Reuptake Inhibitors; Serotonin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: MDD; Major Depressive Disorder; Treatment; Antidepressants; Lexapro; Talk therapy
Comaprison Between QLB and ESPB in Patients for PCNL Operation
Condition: Pain, Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      comparing the subcostal oblique Quadratus Lumborum block and the Erector Spinae plane block
      in patients undergoing percutaneous nephrolithotomy operation to get the best and longest
      postoperative analgesic effect.
    

Detailed description: 
      Here the investigators are going to compare between the Anterior approach for the subcostal
      oblique Quadratus Lumborum block (QLB) and the Erector Spinae Plane Block (ESPB) to determine
      their level of spread and their value in controlling postoperative pain in patients scheduled
      for Percutaneous Nephrolithotomy surgery. We hypothesized that quadratus lumborum is not
      inferior regarding the duration of analgesia when compared to erector spinae in patients
      undergoing percutaneous nephrolithotomy under general anesthesia.
    

Intervention name(s): Subcostal Oblique Quadratus Lumborum Block and Erector Spinae Plain Block.
Intervention type(s): Procedure
Intervention description(s): patients undergo general anesthesia,will be put in prone position.In case of Quadratus Lumborum block 1-3 mL of normal saline is injected to produce hydro-dissection and spread cranially between the QL and kidney. The corresponding ultrasonographic sign is a lunar-shaped hypo-echoic fluid collection observed between the long axis of the kidney and QL muscle. 20 ml Bupivacaine 0.5%, 10 ml Lidocaine 2%, and 10 ml normal saline is administered. In case of the ESPB The location of the needle tip is confirmed by hydro-dissection and after visualizing the fluid spread lifting the Erector Spinae off the transverse process, 20 ml bupivacaine 0.5%, 10 ml Lidocaine 2%, and 10 ml normal saline is injected.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Supportive Care
Keywords: pain management; Nephrolithotomy; QLB; ESPB; Erector Spinae; Quadratus Lumborum; Anesthesia; ultrasound; regional anethesia
Comparison of 3 Different Density Levobupivacaine Solutions + Fentanyl for Spinal Anaesthesia for Caesarean Delivery.
Condition: Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      The investigator's aim is to compare the efficacy of 3 levobupivacaine solutions with
      different density on spinal anesthesia for caesarean delivery.
    

Detailed description: 
      Patients scheduled for elective caesarean delivery were separated into 4 groups. Spinal
      anesthesia was performed with one of the following regimens.

      Group 1: Levobupivacaine 8 mg + 20 mcg Fentanyl Group 2: Levobupivacaine 8 mg + 20 mcg
      Fentanyl + 40 mg Dextrose Group 3: Levobupivacaine 8 mg + 20 mcg Fentanyl + 60 mg Dextrose
      Group 4: Levobupivacaine 8 mg + 20 mcg Fentanyl + 80 mg Dextrose After anesthesia induction
      motor block was evaluated via bromage scale and sensory block via pinprick test every 3
      minutes for the first 15 minutes, and every 5 minutes up to 60 minutes. Maximum sensory block
      level, time to reach maximum block level, time needed to achieve T10 sensory level were
      recorded.

      Baby delivery time, and operation duration were also recorded. Time to two segment regression
      of maximum sensory block, motor block recovery time and time to S2 regression of sensory
      block will be recorded.

      Hemodynamic data, nausea vomiting, were also recorded throughout surgery at the same
      evaluation periods and postoperative period.

      The surgeon will also evaluate the abdominal relaxation surgical block quality as good,
      medium and poor.

      The patient will evaluate spinal block analgesia quality as good, medium or poor.

      Pain scores are going to be evaluated by VAS at the beginning, uterine incision and during
      abdominal closure. Time for first analgesic requirement and postoperative pain is also going
      to be evaluated by VAS.
    

Intervention name(s): Chirocaine %0.5; Chirocaine Heavy 40; Chirocaine Heavy 60; Chirocaine Heavy 80
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Levobupivacaine 8 mg Chirocaine (% 0.5) +20 mcg fentanyl; Chirocaine (%0.75) + Dextrose 40 mg+20 mcg fentanyl; Chirocaine (%0.75) + Dextrose 60 mg+20 mcg fentanyl; Chirocaine (%0.75) + Dextrose 80 mg+20 mcg fentanyl
Other intervention name(s): Plain levobupivacaine; Group 1; levobupivacaine heavy 40; Group 2; levobupivacaine heavy 60; Group 3; levobupivacaine heavy 80; Group 4
Intervention MeSH terms: Levobupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Anesthesia, Spinal; Cesarean Section; Levobupivacaine
Prediction of Femoral Revascularization Quality Using the Somatic NIRS Signal
Condition: Lower Limb Vascular Surgery - Femoral Artery Endarteriectomy
Study type: Observational

Summary: 
      Despite effective femoral artery endarteriectomy, patients with occlusive arteritis may need
      complementary stenting of revascularization procedures within the 2 years after the primary
      surgery because of a poor blood supply in their lower limb extremity. The Near infrared
      spectrophotometry (NIRS) is a non-invasive monitoring of the brain or tissue oxygenation and
      provide information on the quality of the local oxygen supply. The aim of our observational
      study is to correlate the intraoperative NIRS variations at the calf and the soles and the
      one-year evolution of the arteritis.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing unilateral femoral endarteriectomy
Ultrasound Guided Quadratus Lumborum Block Versus Caudal Block in Pediatric Patient
Condition: Postoperative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      The purpose of this research study is to find the best way to decrease pain in children whom
      have had low abdominal surgery. Investigators will perform two technique;Caudal block or
      Quadratus lumborum block .The method used is often chosen by which one the doctor has more
      experience using. The Investigator plans to find out if one of the methods is more effective
      and/or safer than the other method.

      The results of this study will help learn how to best control pain in children having surgery
      low abdominal surgery.
    

Detailed description: 
      Children aged 1-9 years undergoing lower abdominal surgeries would be recruited in this
      randomized study.

      Children would be monitored by electrocardiogram, pulse oximeter and non-invasive blood
      pressure.

      After preoxygenation for three minutes, anesthesia would be induced with 8% sevoflurane
      inhalation in 50% oxygen and % 50 air ; 1ug/kg fentanyl and 3 mg/kg propofol is administered
      intravenously. Then laryngeal mask is inserted when conditions are satisfactory (jaw relaxed,
      lash reflex disappeared, no coughing, gagging, swallowing).After ethical committee approval,
      informed written consent will be obtained from all patients.

      Consenting patients scheduled to have unilaterally low abdominal surgery(inguinal
      hernia,hydrocele,undescended testicles surgery will be randomised to unilateral Quadratus
      lumborum block or caudal block at the begin of surgery.

      All patients heart rate,MAP and Oxygen saturation record intraoperatively. All patients will
      receive paracetamol if requirement for postoperative analgesia.All patient will transfer from
      PACU to day-surgery unit (DSU) if they achieved Modified Aldrete Score of ten.

      All patients will be assessed postoperatively by a blinded investigator: in the
      postanesthesia care unit and at 30 min 1,2, 4, 6, 12, 24, hour postoperatively.FLACC and
      Modified Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score will be used.
    

Intervention name(s): Quadratus lumborum block; Caudal block
Intervention type(s): Procedure; Procedure
Intervention description(s): Postoperative pain procedure; Postoperative pain procedure
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: All Children will be randomly assigned to one of 2 groups of 25 patients each using a computer-generated number table.
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Sulfonylurea Effects on Glucagon Regulation During Hypoglycemia in Type 1 DM
Condition: Diabetes Mellitus, Type 1
MeSH terms: Diabetes Mellitus; Hypoglycemia; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      We aim to demonstrate that oral administration of glibenclamide stimulates pancreatic
      glucagon secretion during hypoglycemia in insulin-deficient (C-peptide negative) patients
      with type 1 diabetes when compared to type 1 diabetic patients with residual insulin
      secretion (C-peptide positive).
    

Detailed description: 
      The glucagon response during insulin induced hypoglycemia and rate of glucose recovery will
      be monitored in 10 C-peptide positive and 10 C-Peptide negative patients with type 1 DM
      following the application of glibenclamide and placebo in a randomized, single-blind,
      cross-over study.

      Cognitive function during hypoglycemia with and without glibenclamide pretreatment will be a
      secondary outcome.
    

Intervention name(s): glibenclamide; placebo
Intervention type(s): Drug; Drug
Intervention description(s): glibenclamide 15 mg single dose; placebo capsules, single dose
Other intervention name(s): Daonil 5 mg pills
Intervention MeSH terms: Glyburide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: diabetes mellitus type 1; hypoglycemia; sulfonylurea; glucagon
A Study to Examine the Effects of Low and High-fat Meals on Orally Administered Lapatinib in Metastatic ErbB2 Positive Breast Cancer Patients
Condition: Neoplasms, Breast
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will be a randomized 3-treatment, cross-over study to evaluate the bioavailability
      of lapatinib administered after a high or low-fat meal.
    


Intervention name(s): Lapatinib
Intervention type(s): Drug
Intervention description(s): Treatment A: one dose of 1250mg lapatinib 1 hour before starting a low-fat breakfast; Treatment B: one dose of 1250mg lapatinib 1 hour after finishing a low fat breakfast; or Treatment C: one dose of 1250mg lapatinib 1 hour after finishing a high-fat breakfast.
Other intervention name(s): TYKERB - US; TYVERB - UK
Intervention MeSH terms: Lapatinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Phase I Food Effect