bioihbjkbjnl/mcl2 huggingface dataset:
Compensatory Strategies Applied to Cognitive Impairment in Schizophrenia
Condition: Schizophrenia
MeSH terms: Schizophrenia; Cognitive Dysfunction
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether Cognitive Adaptation Training are effective
      in comparison with conventional treatment, focusing on social functions, symptoms, relapse,
      re-hospitalisation, and quality of life in outpatients with schizophrenia.
    

Detailed description: 
      It is estimated that approximately 80% of patients with schizophrenia have reduced cognitive
      functions, representing problems with attention, verbal memory, short-term memory and
      executive functions (1-3). These impairments might have an impact on the patients ability to
      complete rehabilitation programmes, apply learned strategies to social problems, develop work
      skills and manage daily life (4,5). The effect of Cognitive Adaptation Training has been
      tested as a psychosocial treatment including training of compensatory strategies in order to
      sequence patient's adaptive behaviour, showing promising results concerning improved social
      functions (6). There are however no solid evidence for these statements. The existing few
      studies investigating the effect of Cognitive Adaptation Training (6-8) are underpowered
      (small sample sizes) and have a lack of younger patients, which limits the conclusions that
      can be drawn from the results of the improvement. The present trial employs a prospective
      design of 26 weeks with a follow-up period of 9 months after inclusion. The study will enroll
      164 consecutively recruited participants from three Danish out-patient teams for young adults
      with a first episode of psychosis.
    

Intervention name(s): Cognitive Adaptation Training
Intervention type(s): Behavioral
Intervention description(s): All patients receive treatment as usual. Additionally, patients in the intervention arm receives training concerning solving concrete problems related to the patient's daily life using tools such as schedules, schemes and signs. Additional the patient can receive SMS messages or instructions for the use of schedules in cell-phones to prompt for activities. The intervention is conducted in the patients homes every 14th day in a period of six months.
Other intervention name(s): Memory disorders; Adaptation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Social Adjustment; Quality of life; Recurrence; Hospitalization
Standard Versus High-Dose Trivalent Inactivated Flu Vaccine in Pediatric Acute Lymphoblastic Leukemia Patients
Condition: Pediatric Patients With Acute Lymphoblastic Leukemia
MeSH terms: Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase I safety and immunogenicity trial comparing high-dose (HD)trivalent
      inactivated influenza vaccine (TIV) to standard dose (SD) TIV in pediatric patients with
      Acute Lymphoblastic Leukemia.
    


Intervention name(s): High-dose trivalent inactivated influenza vaccine; Standard dose trivalent inactivated influenza vaccine
Intervention type(s): Drug; Drug
Intervention description(s): 0.5 mL of high-dose trivalent inactivated influenza vaccine, either one dose or 2 based on whether the patient has previously received standard dose trivalent inactivated influenza vaccine.; 0.5 mL standard dose trivalent inactivated influenza vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia (MyStromalCell Trial)
Condition: Chronic Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      Coronary artery disease (CAD) is the most common cause of death and a major cause of hospital
      admissions for acute chest pain. In spite of improved treatments still many patients with CAD
      have daily attacks of severe chest pain and severely reduced life quality.

      The investigators have established a double-blind placebo-controlled trial in patients with
      CAD to test efficacy and safety of treatment with adipose derived stem cells to improve
      perfusion in the heart muscle and exercise capacity, and reduce the patient's symptoms.
    

Detailed description: 
      In an open single centre pilot study we have evaluated the safety and efficacy of MSC
      treatment to improve heart muscle perfusion in patients with chronic CAD. Patients treated
      with MSCs had significant increased exercise capacity, reduction in angina, angina attacks
      and medication and in life quality at 6 months follow-up. For all the parameters there was a
      tendency towards improved outcome with increasing number of cells. The treatment with MSCs
      was safe.

      The investigators have now established a double-blind placebo-controlled trial in patients
      with CAD to test efficacy and safety of treatment with MSCs to improve perfusion in the heart
      muscle and exercise capacity, and reduce the patient's symptoms.
    

Intervention name(s): MSC; Saline
Intervention type(s): Biological; Biological
Intervention description(s): No of cells after culture expansion; 3 cc saline
Other intervention name(s): Adipose derived stem cells; Mesenchymal stromal cells; Mesenchymal stem cells
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Patients
Measuring and Reducing Excessive Infant Crying
Condition: Infant Colic; Postpartum Depression
MeSH terms: Depression, Postpartum; Colic
Study type: Interventional

Summary: 
      Excessive infant crying (EIC) is likely to increase the risk of child abuse. The
      investigators propose a randomized trial using an intervention based on recommendations of
      Karp. The investigators will systematically identify 170 term infants with EIC and conduct
      assessments in the home at 6-8 weeks age to test the hypothesis that the intervention reduces
      mean infant hours of night-time crying, increases maternal soothing behaviors and improves
      parental anxiety and depression.
    

Detailed description: 
      Hypotheses: The soothing techniques taught to study parents 2-3 wks after birth augment
      parental soothing skills and reduces infant crying at night (primary outcome) and parental
      sleep loss, distress, & depression assessed in the home by a masked nurse at 8 wks.

      Methods: Term singleton infants with EIC (> 3 hrs/24h) recruited through a program offered to
      parents at our hospital (4,700 births/yr) will be seen in our clinic 2-3 wks after birth.
      Consenting families (n=178) will be randomized to standard colic counseling (American Academy
      of Pediatrics) or to the intervention (adding nurse instruction plus a video and pamphlets).
      At 8 wks a study nurse will assess parental sleep and distress (Brief Symptom Inventory-18),
      place dosimeters in rooms where the infant sleeps and spends most time, and apply the
      actigraph at the ankle. She will collect the devices 5 days later, perform a physical exam at
      a usual feeding time (when EIC is likely), record infant & maternal behaviors during
      crying/feeding for the next 15 minutes using unobtrusive, validated methods (Tyson, 1992),
      and provide maternal support if desired. Standard statistical tests will be used (alpha=0.05;
      beta = 0.20; effect size =0.5 SD, power = .90).
    

Intervention name(s): The Happiest Baby on The Block; AAP Infant Colic counseling
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Those receiving the intervention will be trained in the infant soothing techniques outlined in "The Happiest Baby on the Block".; Those receiving the control group allocation will be counseled using the American Academy of Pediatrics material for Infant Colic.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Randomized Trial; Infant Colic; Abusive Head Trauma; Shaken Baby Syndrome
Hyaluronan in the Treatment of Painful Tendinopathy
Condition: Tendinopathy
MeSH terms: Tendinopathy
Study type: Interventional

Summary: 
      The primary objective of this study is to evaluate the efficacy and safety of TCHY106 (2%
      hyaluronan) in the treatment of painful tendinopathy.
    


Intervention name(s): hyaluronic acid sodium salt
Intervention type(s): Device
Intervention description(s): Two injections of 2 % (40 milligrams (mg) / 2 millilitres (ml)) hyaluronan in weekly interval.
Intervention MeSH terms: Hyaluronic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: tendinopathy; hyaluronan; tendon; hyaluronic acid
Impact of 3D Intraoral Scanning on Postsurgical Evaluation of Mandibular Third Molar Surgery
Condition: Third Molar Surgery; Impacted Third Molar Tooth
MeSH terms: Tooth, Impacted
Study type: Interventional

Summary: 
      The aim of this study was to analyze the effectiveness of piezoelectric surgery and
      traditional rotating device in reducing perioperative sequelae after impacted mandibular
      third molar surgery in 56 subjects. Ni All subjects were randomly allocated to receive one
      treatment.
    

Detailed description: 
      The aim of this study was to analyze the effectiveness of piezoelectric surgery and
      traditional rotating device in reducing perioperative sequelae after impacted mandibular
      third molar surgery. Fifty-six patients who needed surgical extraction of an impacted
      mandibular third molar were selected for the study. All subjects were randomly allocated to
      receive one of the following surgical treatments piezoelectric surgery (n = 28), traditional
      surgery with rotating device (n = 28). The primary outcome was postoperative pain, evaluated
      using the visual analogue scale (VAS) score at baseline, 1, 2, 5, 7, 10 and 14 and 28 days
      following surgery. The secondary outcomes chosen were changes in postoperative swelling and
      maximum mouth opening values compared to preoperative ones.
    

Intervention name(s): Third molar surgery
Intervention type(s): Device
Intervention description(s): It was extracted one impacted mandibular third molar per patient with piezoelectric or rotating drills device
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Thee primary outcome was postoperative pain, evaluated using the visual analogue scale (VAS) score at Baseline, 1, 2, 5, 7, 10, 14 and 28 days following surgery in subject treated for third molar surgery with piezoelectric surgery or rotating drills. The secondary outcomes chosen were changes in postoperative swelling and maximum mouth opening values compared to preoperative ones.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Evaluation of the Safety, Tolerability, Pharmacokinetics, and Activity of GS-9450 in Subjects With Chronic HCV
Condition: HCV Infection
MeSH terms: Hepatitis C
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to examine the safety, tolerability, pharmacokinetics (studies
      how the body processes a drug), and initial activity of GS-9450 in preventing liver damage
      due to scarring, or fibrosis, caused by Hepatitis C Virus (HCV) infection.
    

Detailed description: 
      Approximately 32 subjects will receive GS 9450 or placebo for 14 consecutive days. Eight
      subjects will receive treatment within each of four dosing cohorts; 6 randomized to receive
      GS 9450 and two randomized to placebo:

      Cohort 1: GS 9450 10 mg or placebo given daily x 14 days Cohort 2: GS 9450 40 mg or placebo
      given daily x 14 days Cohort 3: GS 9450 80 mg or placebo given daily x 14 days

      If further characterization of the activity profile is deemed necessary, an additional cohort
      at a lower dose (5 mg) may be enrolled:

      Cohort 4: GS 9450 5 mg or placebo given daily x 14 days

      Each cohort will be conducted sequentially. Advancement to higher dose cohorts is dependent
      upon satisfactory safety and tolerability profiles of the preceding cohort as determined by
      Sponsor review (conducted in consultation with the Lead Investigator[s]). Progression to
      Cohort 4 (5 mg dose strength) will not require a safety review of Cohort 3 (80 mg dose
      strength); screening and randomization for Cohort 4 may begin immediately after fully
      enrolling Cohort 3. Alternatively, if a dose-response relationship is apparent in review of
      the blinded activity data from the first three cohorts, the final 5 mg cohort may be omitted.
    

Intervention name(s): GS-9450; GS-9450 Placebo
Intervention type(s): Drug; Drug
Intervention description(s): GS-9450 capsules administered orally once daily; Placebo to match GS-9450 administered orally once daily
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatitis C; HCV; Fibrosis; Apoptosis; GS-9450
Effect of Prednisone onTregs and TH17
Condition: Chronic Rhinosinusitis
MeSH terms: Sinusitis
Study type: Observational

Summary: 
      The primary objective of this study is to see whether systemic corticosteroids (such as
      Prednisone) have an effect on the peripheral blood Treg and Th17 function in patients with
      CRS. Patients are taking prednisone as part of their routine medical care.
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with seasonal allergies taking prednisone and normal controls form the community.
Memory Inhibition and Delayed Onset Post-traumatic Stress Disorder in Older Subjects
Condition: Post-Traumatic Stress Disorder in Old Age
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      In the elderly, we can see a post-traumatic syndrome associated with an event that occurred
      before old age that had not previously manifested or not fully manifested.

      This little-known pathology and notable psychiatric co-morbidities (depression, anxiety) can
      take in elderly subjects different masks that interfere with diagnosis and treatment.

      The data in the literature suggest that this Post-Traumatic Stress Disorder with Delayed
      Expression (TSPT-R) may be related to a deficiency of the executive functions of inhibition,
      and more particularly a deficit of mental memory inhibition and therefore the removal of
      unwanted memories.
    


Intervention name(s): Post Traumatic Stress Disorder
Intervention type(s): Other
Intervention description(s): The test "Think / No-Think"
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
123-I mIBG (AdreView) Heart-to-Mediastinal (H/M) Ratio and SPECT Imaging on a Small Field of View-High Efficiency Cardiac SPECT System
Condition: Heart Failure; Cardiomyopathy
MeSH terms: Cardiomyopathies
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to demonstrate correlation of the H/M ratio of AdreView when
      derived from a large field of view Anger SPECT system and from a small field of view high
      sensitivity (CZT) SPECT system.
    


Intervention name(s): AdreView; Single Photon Emission Computed Tomography
Intervention type(s): Drug; Other
Intervention description(s): 10 millicurie of AdreView (123I-mIBG)
Other intervention name(s): SPECT
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: 123I-mIBG; AdreView; SPECT; Heart to Mediastinal Ratio
Effectiveness of Zoledronic Acid in the Prevention of Osteoporosis in Early Breast Cancer Patients Receiving Letrozole
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Osteoporosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether zoledronic acid given intravenously every 6
      months can prevent reduction in bone mineral density in women with early stage breast cancer
      receiving adjuvant therapy with the aromatase inhibitor drug letrozole, after having received
      adjuvant tamoxifen.
    

Detailed description: 
      Letrozole is an aromatase inhibitor used in the treatment of hormone receptor positive
      metastatic breast cancer in postmenopausal women.It has more recently been approved for use
      in many countries as adjuvant therapy for early breast cancer; and is often used in an
      adjuvant regimen following 2-3 years of tamoxifen treatment or as an extended adjuvant
      therapy after up to 5 years of tamoxifen. Letrozole inhibits the conversion of androgens to
      estrogens in vitro and in vivo. Plasma levels of estradiol and related estrogen compounds in
      postmenopausal patients receiving letrozole are suppressed up to 95% from baseline and are
      often undetectable.The estrogen deprivation in women receiving letrozole may cause increased
      bone resorption and bone loss.Studies comparing tamoxifen and aromatase inhibitors, in
      adjuvant therapy have shown an increase fracture rate, and decreased bone mineral density in
      patients receiving aromatase inhibitors. Zoledronic acid is an intravenously administered
      bisphosphonate that inhibits osteoclastic bone resorption. Intravenous bisphosphonates are
      effective in reducing the rate of skeletal complications, including fractures, in patients
      with metastatic breast cancer and other tumors when given every few weeks. Small clinical
      trials have given some evidence that osteoporosis can be effectively treated by one or two
      doses of intravenous zoledronic acid per year. This study will determine the effect of giving
      zoledronic acid every 6 months on the bone mineral density of patients receiving letrozole as
      adjuvant therapy for early breast cancer after having received adjuvant tamoxifen for at
      least 2.5 years. Patients will be randomized to receive zoledronic acid either at the start
      of letrozole therapy or when bone mineral density T score drops below - 2 standard deviation
      or at the occurrence of a non-trauma related fracture.
    

Intervention name(s): zoledronic acid
Intervention type(s): Drug
Intervention description(s): Zoledronic acid 4 mg IV every 6 months up to 2.5 years after the start of letrozole treatment.
Other intervention name(s): Zomera, zolendronate
Intervention MeSH terms: Zoledronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: breast cancer, postmenopausal, letrozole, zoledronic acid, adjuvant,bone mineral density
Study of Seasonal Influenza Vaccine Against H5N1 Avian Influenza Virus
Condition: Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional

Summary: 
      This will be a randomized, open-label, pilot feasibility study of four 2-dose vaccine
      regimens in healthy volunteers using two commercially available seasonal influenza vaccines
      to compare immune responses and in vitro cross-reactivity against H5N1. Vaccine doses will be
      spaced by approximately 8 weeks to allow for optimal prime boost conditions. Humoral,
      cellular and secretory immune responses will be measured 2 and 4 weeks after each vaccine
      dose and compared with baseline values.
    


Intervention name(s): FluMist® live, attenuated, intranasal seasonal influenza vaccine; Fluzone® inactivated influenza virus vaccine
Intervention type(s): Biological; Biological
Intervention description(s): FluMist® live, attenuated, intranasal seasonal influenza vaccine 0.2mL (0.1mL per nostril); Fluzone® inactivated influenza virus vaccine 0.5mL intramuscularly
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: seasonal influenza vaccine; avian influenza H5N1; cross reactivity; prime boost
ACT34-CMI -- Adult Autologous CD34+ Cells
Condition: Myocardial Ischemia
MeSH terms: Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate the efficacy and safety of intramyocardial
      injections of CLBS14 in patients with refractory chronic myocardial ischemia.
    

Detailed description: 
      This is a double-blind, prospective, randomized, placebo-controlled trial to determine the
      tolerability, efficacy, safety and dose range of intramyocardial injections of adult
      autologous CD34+ cells mobilized with granulocyte colony stimulating factor (G-CSF) for the
      reduction of angina episodes in patients with refractory chronic myocardial ischemia.
    

Intervention name(s): CLBS14 (low-dose); CLBS14 (high-dose); placebo injection
Intervention type(s): Biological; Biological; Biological
Intervention description(s): Eligible subjects will receive subcutaneous injections of 5 µg/kg/day G-CSF for 5 days to mobilize CD34+ cells from the bone marrow to the peripheral blood. Mononuclear cells (MNCs) will be collected via apheresis on day 5. On the day of the cell/placebo injection (day 6), the apheresis product will be enriched for CD34+ cells using the Isolex 300i Magnetic Cell Selection System (Baxter Healthcare). Autologous CD34+ cells will be delivered in 10 intramyocardial injections of 0.2 mL at a dose of 1 x 10^5 (=100000) cells/kg bodyweight each using the MyoStar injection catheter (Biosense Webster, Inc.) into the target areas of myocardial ischemia.; Eligible subjects will receive subcutaneous injections of 5 µg/kg/day G-CSF for 5 days to mobilize CD34+cells from the bone marrow to the peripheral blood. Mononuclear cells (MNCs) will be collected via apheresis on day 5. On the day of the cell/placebo injection (day 6), the apheresis product will be enriched for CD34+ cells using the Isolex 300i Magnetic Cell Selection System (Baxter Healthcare). Autologous CD34+ cells will be delivered in 10 intramyocardial injections of 0.2 mL at a dose of 5 x 10^5 (=500000) cells/kg bodyweight each using the MyoStar injection catheter (Biosense Webster, Inc.) into the target areas of myocardial ischemia.; Eligible subjects will receive subcutaneous injections of 5 µg/kg/day G-CSF for 5 days to mobilize CD34+ cells from the bone marrow to the peripheral blood. Mononuclear cells (MNCs) will be collected via apheresis on day 5. On the day of the cell/placebo injection (day 6), the apheresis product will be enriched for CD34+ cells using the Isolex 300i Magnetic Cell Selection System (Baxter Healthcare). Placebo will be delivered in 10 intramyocardial injections of 0.2 mL each of 0.9% NaCl (saline) in 5% autologous plasma into the target areas of myocardial ischemia.
Other intervention name(s): G-CSF mobilized, autologous CD34+ cells; G-CSF mobilized, autologous CD34+ cells; 0.9% NaCl (saline) in 5% autologous plasma
Intervention MeSH terms: Lenograstim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: angina