bioihbjkbjnl/mcl2 huggingface dataset:
Morning Light Treatment for Traumatic Stress: The Role of Amygdala Reactivity
Condition: Stress
Study type: Interventional

Summary: 
      The purpose of this study is to determine the effect of different amounts of time of morning
      light on brain emotional processing.
    


Intervention name(s): Light therapy A via the Re-Timer®; Light therapy B via the Re-Timer®; Light therapy C via the Re-Timer®
Intervention type(s): Device; Device; Device
Intervention description(s): Subjects will conduct light treatment in the mornings at home.; Subjects will conduct light treatment in the mornings at home.; Subjects will conduct light treatment in the mornings at home.
Other intervention name(s): Re-Timer®; Re-Timer®; Re-Timer®
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Circadian timing; Mood; Light
Combination Chemotherapy of Gemcitabine and Paclitaxel for Metastatic Breast Cancer
Condition: Metastatic Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate efficacy, safety and PK of gemcitabine and paclitaxel combination in patients
      with metastatic breast cancer after adjuvant/neo-adjuvant chemotherapy with anthracycline
      regimen
    


Intervention name(s): gemcitabine; paclitaxel
Intervention type(s): Drug; Drug
Intervention description(s): Phase 1: 1000 mg/m2, intravenous (IV), day 1 and day 8 x 2 cycles (dose escalation)
Phase 2: dose determined by phase 1; Phase 1: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
Phase 2: 175 mg/m2, intravenous (IV), every 21 days x 2 cycles
Other intervention name(s): LY188011; Gemzar
Intervention MeSH terms: Paclitaxel; Gemcitabine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Safety, Tolerability, and Immunogenicity of mRNA-1325 in Healthy Adult Subjects
Condition: Zika Virus
MeSH terms: Zika Virus Infection
Study type: Interventional
Phase: Phase 1

Summary: 
      The clinical study will assess the safety, tolerability, and immunogenicity of mRNA-1325 in
      healthy adult subjects.
    


Intervention name(s): mRNA-1325; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Escalating dose levels
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: mRNA-1325; Zika vaccine
Lamotrigine for the Treatment of Mania in Youth Ages 6-17 With Bipolar Disorder
Condition: Bipolar Disorder; Mania
MeSH terms: Mania; Bipolar Disorder
Study type: Interventional
Phase: Phase 4

Summary: 
      The main objective of this study is to assess the effectiveness and safety of lamotrigine in
      the treatment of youth with bipolar and bipolar spectrum disorder. This is an exploratory,
      12-week, open-label treatment period, pilot study, of youth ages 6-17, who meet the DSM-IV
      diagnostic criteria for bipolar I, bipolar II, or bipolar spectrum disorder. The study
      results will be used to generate hypotheses for a larger randomized controlled clinical
      trial. Based on the available literature in adults with bipolar disorder, we hypothesized
      that lamotrigine will be efficacious and well tolerated in youth with pediatric bipolar and
      bipolar spectrum disorders.
    

Detailed description: 
      Lamotrigine is a new generation antiepileptic drug, approved by the FDA in 2003 for the
      maintenance treatment of adults with Bipolar I disorder to delay the time to occurrence of
      mood episodes (depression, mania, hypomania,& mixed episodes) in patients treated for acute
      mood episodes with standard therapy. Recent studies have shown that Lamotrigine maintenance
      treatment was more robust in bipolar depression.

      The study includes 1) use of a 12-week design to document the response rate 2) assessment of
      the impact of Lamotrigine on functional capacities and cognition, 3) careful assessment of
      safety and tolerability.
    

Intervention name(s): lamotrigine
Intervention type(s): Drug
Intervention description(s): Open-label, flexible-dose, BID treatment of lamotrigine (Lamictal). For children <12 years, dosing began at 0.35 mg/kg/day, divided in 2 doses, rounded down to nearest 5mg, to be increased weekly depending on response and tolerability to maintenance dose of 5-15 mg/kg/day (maximum 400 mg/day in 2 divided doses). For children ≥12 years, dose began at 25 mg/day in 1 dose, to be increased weekly depending on response and tolerability to maintenance dose of 300-500 mg/day in 2 divided doses.
Other intervention name(s): Lamictal
Intervention MeSH terms: Lamotrigine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bipolar disorder; lamotrigine; children; mania
Efficacy and Safety of a Herbal Medicinal Product (Dry Extract BNO 1016) in Patients With Acute Rhinosinusitis
Condition: Acute Rhinosinusitis
MeSH terms: Sinusitis
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether the dry extract BNO 1016 is effective and
      safe in the treatment of acute rhinosinusitis in adults.
    

Detailed description: 
      The aim of this clinical study is to investigate the efficacy of a 15-days treatment with the
      herbal medicinal product BNO 1016 for therapy of acute rhinosinusitis in adult patients. Due
      to the considerable morbidity and the diminished quality of life experienced by people
      afflicted with acute rhinosinusitis an important aim of the treatment is to reduce the
      severity of rhinosinusitis symptoms and the duration of the disease. By grading the severity
      of the disease on the basis of the 5 main rhinosinusitis symptoms the investigator will
      assess the efficacy of the treatment.
    

Intervention name(s): BNO 1016; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): sugar coated tablets with dry extract (80 mg) of 5 herbal drugs; dosage: 480 mg per day (2 tablets t.i.d.) duration: 15 days; sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration 15 days
Other intervention name(s): Sinupret extract; Placebo to BNO 1016
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: BNO 1016, acute rhinosinusitis
A STUDY OF A RSV VACCINE WHEN GIVEN TOGETHER WITH TDAP IN HEALTHY NONPREGNANT WOMEN AGED BETWEEN 18 TO 49 YEARS
Condition: Respiratory Tract Infection
MeSH terms: Respiratory Tract Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase 2b study will evaluate safety, tolerability, and immunogenicity of an RSV vaccine
      when given together with Tdap in approximately 710 healthy nonpregnant women 18 through 49
      years of age. This study will evaluate non-inferiority of RSV vaccine when given with Tdap
      and vice-versa.
    

Detailed description: 
      This Phase 2b study will evaluate safety, tolerability, and immunogenicity of an RSV vaccine
      when given together with Tdap in approximately 710 healthy nonpregnant women 18 through 49
      years of age.

      The participants will be equally split into 5 treatment groups: One of a possible two dose
      levels of RSV vaccine (the higher dose level will be formulated with an aluminum hydroxide
      adjuvant) with either the Tdap or Placebo, or a Tdap and placebo combination.

      This study will evaluate non-inferiority of the Tdap when co-administered with RSV vaccine
      candidate and vice-versa by measuring participants' immune response through appropriate
      antibody and component levels 1 month after vaccination.
    

Intervention name(s): RSV Vaccine; Tdap; Placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): RSV vaccine; Tetanus, Diphtheria, and Acellular Pertussis Vaccine; Normal saline solution for injection (0.9% sodium chloride injection)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Respiratory tract infection; Respiratory Syncytial Virus; RSV; Tdap; Tetanus; Diphtheria; Acellular Pertussis; Vaccine
Antimicrobial Prophylaxis in Thyroid and Parathyroid Surgery
Condition: Thyroid Disease; Parathyroid Disease
MeSH terms: Thyroid Diseases; Parathyroid Diseases
Study type: Interventional

Summary: 
      The effectiveness of antimicrobial prophylaxis (AMP) for prevention of surgical site
      infection (SSI) following thyroid and parathyroid surgery remains uncertain. Present
      prospective randomized control study (Ito-RCT1) assessed the effectiveness of AMP in clean
      neck surgery associated with thyroid and parathyroid disease.
    

Detailed description: 
      Between November 2010 and April 2012, 2164 consecutive patients who agreed to attend the
      randomized control study were enrolled. All the participants received surgery for thyroid and
      parathyroid disease at Ito Hospital and randomized in three groups; Group A (n=541):
      operation with AMP (PIPC, piperacillin sodium), Group B (n=541): operation with AMP (CEZ,
      cefazolin sodium), and Group C (n=1082): operation without AMP.

      Exclusion criteria

        -  Patients who did not agree to attend the randomized control study.

        -  Patients who received the operation including mediastinum with sternotomy.

        -  Patients who received the operation including additional resection of trachea, esophagus
           and larynx.

        -  Patients who received the re-operation for post-operative bleedings.

        -  Patients who had known allergy to cephem or penicillin.
    

Intervention name(s): PIPC piperacillin sodium; CEZ, cefazolin sodium
Intervention type(s): Drug; Drug
Other intervention name(s): PIPC, piperacillin sodium
Intervention MeSH terms: Cefazolin; Piperacillin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: antimicrobial prophylaxis; AMP; surgical site infection; SSI; thyroid; thyroidectomy; parathyroid; surgery
Pediatric Bipolar Depression
Condition: Bipolar Depression
MeSH terms: Depression; Depressive Disorder; Bipolar Disorder
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if quetiapine fumarate extended-release (quetiapine
      XR or SEROQUEL® XR) 150 to 300 mg/day taken by itself is effective and safe in treating
      children or adolescents aged 10 to 17 with bipolar depression and if so, how it compares with
      placebo (a non-active tablet, like a sugar pill, that looks like quetiapine).
    


Intervention name(s): Quetiapine XR; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral treatment with 150 up to 300 mg/day once daily in the evening; Oral treatment once daily in the evening
Other intervention name(s): Seroquel XR
Intervention MeSH terms: Quetiapine Fumarate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bipolar Depression; Depression; Children; Adolescents; Seroquel; Bipolar Depression in Children and Adolescents
Treatment of Hand and Foot Syndrome With Traditional Chinese Medicine Formula LC09 in Patients Who Are Receiving Capecitabine for Colorectal and/or Breast Cancer
Condition: Hand Foot Syndrome
MeSH terms: Hand-Foot Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      RATIONALE: Hand foot syndrome may be treated or reduced by soaking Traditional Chinese
      Medicine Formula LC09 in patients receiving capecitabine for colorectal and/or breast cancer.

      PURPOSE: This randomized phase III trial is studying soaking Traditional Chinese Medicine
      Formula LC09 to see how well they work compared to placebos in preventing hand-foot syndrome
      in patients who are receiving capecitabine for colorectal or breast cancer.
    

Detailed description: 
      OBJECTIVES:

      OBJECTIVES: Determine whether Traditional Chinese Medicine Formula LC09 can treat or reduce
      the severity of capecitabine-caused hand foot syndrome.

      Evaluate the potential toxicity of Traditional Chinese Medicine Formula LC09. OUTLINE: This
      is a multicenter, randomized, double-blind, placebo-controlled study. Patients are randomized
      to 2 treatment arms.

      Arm I: Patients receive Traditional Chinese Medicine Formula LC09 by soaking their affected
      hand and feet 20 min twice daily.

      Arm II: Patients receive placebo by soaking their affected hand and feet 20 min twice daily.
    

Intervention name(s): Traditional Chinese Medicine Formula LC09; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Thromboaspiration in Patients With High Thrombotic Burden Undergoing Primary Percutaneous Coronary Intervention (PCI)
Condition: Primary PCI for STEMI
Study type: Interventional
Phase: Phase 4

Summary: 
      200 consecutive patients presenting with STEMI within 12 hours from the onset of symptoms and
      having a high thrombotic burden at coronary angiography, defined as the presence of a
      thrombus size ≥ 2 times the diameter of the vessel, according to a visual estimate. The main
      objective of the study is to evaluate the effectiveness of thrombectomy (either rheolytic or
      manual aspiration) as an adjunct to primary or rescue angioplasty, in patients with
      angiographic evidence high thrombotic burden in the culprit artery. Primary end points: (1)
      rate of complete ST-segment elevation resolution at 60 minutes after the end of the
      procedure; (2) infarct size as assessed by delayed-enhancement cardiac magnetic resonance
      imaging (DE-MRI) at 3 months after the index procedure.

      Secondary endpoints: post-procedural TIMI flow grade; post-procedural MBG; infarct
      transmurality at 3 months; MVO at 3 months; 1-year actuarial freedom from MACEs.
    


Intervention name(s): coronary thrombectomy; standard primary PCI (with stenting, as required)
Intervention type(s): Device; Device
Intervention description(s): coronary thrombectomy with either Angiojet device (rhelytic thrombectomy) or Export device (manual aspiration); standard primary PCI (usually with stenting) for STEMI, without use of thrombectomy or distal protection devices
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Evaluation of the Presence and Effects of Kinesiophobia in Multiple Sclerosis
Condition: Multiple Sclerosis; Kinesiophobia
MeSH terms: Multiple Sclerosis; Sclerosis; Kinesiophobia
Study type: Observational

Summary: 
      The aim of this study was to evaluate the presence of kinesiophobia in multiple sclerosis and
      to investigate the effect of kinesiophobia on physical activity, functional status, quality
      of life and depression.
    

Detailed description: 
      90 people, including 45 patients and 45 healthy control groups, were included in the study.
      Demographic data of all participants were recorded. Tampa Scale of Kinesiophobia (TSK), Beck
      Depression Inventory (BDI), Quality of Life Scale Short Form-36 (SF-36), International
      Physical Activity Questionnaire Short Form (IPAQ-SF), Functional Ambulation Classification
      (FAS), in addition to Multiple Sclerosis group, Functional Independence Measure (FIM),
      Expanded Disability Status Scale (EDSS) were implemented.
    

Intervention name(s): questionnaire and examination
Intervention type(s): Other
Intervention description(s): Demographic data of all participants, height, weight, body mass index, occupation, marriage status, education level, comorbidities, medications used, duration of illness and subtype will be recorded by the researcher. Questionnaires to be filled by patients. On the same day, the musculoskeletal system and neurological examination of the participants will be evaluated by the researcher.
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        A total of 90 people, 45 patients and 45 healthy controls, who applied to the Gazi
        University Medical School PM&R and Neurology multiple sclerosis outpatient clinic between
        the ages of 18-65, were included in the study.
      
Keywords: Multiple sclerosis; kinesiophobia; fear of movement
Arsenic Trioxide and Radiation Therapy in Treating Young Patients With Newly Diagnosed Gliomas
Condition: Brain and Central Nervous System Tumors
MeSH terms: Glioma; Nervous System Neoplasms; Central Nervous System Neoplasms
Study type: Interventional
Phase: Phase 1

Summary: 
      RATIONALE: Drugs used in chemotherapy, such as arsenic trioxide, work in different ways to
      stop tumor cells from dividing so they stop growing or die. Radiation therapy uses
      high-energy x-rays to damage tumor cells and may be an effective treatment for patients with
      glioma. Drugs such as arsenic trioxide may also make the tumor cells more sensitive to
      radiation therapy. Combining arsenic trioxide with radiation therapy may kill more tumor
      cells.

      PURPOSE: Phase I trial to study the effectiveness of combining arsenic trioxide with
      radiation therapy in treating patients who have newly diagnosed gliomas.
    

Detailed description: 
      OBJECTIVES:

        -  Determine the maximum tolerated dose of arsenic trioxide when administered with
           radiotherapy in pediatric patients with newly diagnosed anaplastic astrocytoma,
           glioblastoma multiforme, gliosarcoma, or intrinsic pontine glioma.

        -  Determine the toxicity of this regimen in these patients.

      OUTLINE: This is a dose-escalation study of arsenic trioxide (ATO).

      Patients undergo radiotherapy once daily, 5 days a week, for approximately 6 weeks. Patients
      concurrently receive ATO IV over 1 hour, 1-5 times weekly, for approximately 6 weeks in the
      absence of disease progression or unacceptable toxicity.

      Cohorts of 3-6 patients receive escalating doses of ATO until the maximum tolerated dose
      (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6
      patients experience dose-limiting toxicity.

      Patients are followed every 2 months.

      PROJECTED ACCRUAL: A total of 3-36 patients will be accrued for this study within 3-36
      months.
    

Intervention name(s): arsenic trioxide; radiation therapy
Intervention type(s): Drug; Radiation
Intervention MeSH terms: Arsenic Trioxide
Primary purpose: Treatment
Keywords: untreated childhood brain stem glioma; childhood high-grade cerebral astrocytoma
Metabolic Availability of Lysine From Rice
Condition: Healthy Adults
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the digestibility of the amino acid lysine in
      cooked rice in adult men using stable isotope technique.
    

Detailed description: 
      The investigators objective is to determine the metabolic availability (MA) of lysine in
      cooked white rice protein using the indicator amino acid oxidation (IAAO) technique. Five men
      will receive graded levels (20, 40, and 60, and 70%) of the lysine requirement of 35 mg/kg/d
      as a crystalline AA mixture,and cooked rice protein (20, 40 and 60%), respectively.
    

Intervention name(s): Amino Acid Crystalline Lysine Amino Acid Mix; Cooked Rice containing Lysine
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): crystalline lysine from AA MIX (20, 40, and 60% of the mean lysine requirement of 35 mg/kg/d) Lysine will be given in the form of L-Lysine-HCl, Sigma-Aldrich Brand.; Lysine (20,40 and 60 % of the mean lysine requirement) from Cooked Rice
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: lysine; rice; bioavailability
Correlation Analysis Between Brain Lesions and Sensorimotor Impairments in Individuals With Stroke (Preliminary Study)
Condition: Stroke
MeSH terms: Stroke
Study type: Observational

Summary: 
      The objective of the preliminary study is:

        1. To identify correlations between brain lesions and sensorimotor impairments in stroke.

        2. To identify possible patterns between brain lesions and sensorimotor impairments that
           might increase our understanding in stroke recovery and guide further tailor-based
           neuro-rehabilitation
    

Detailed description: 
      The purpose of this study is to investigate arm and hand function after stroke and how the
      location of the brain lesion affects arm and hand function. We are hoping to collect data in
      the form of assessments what you feel and how your arm moves, surveys about activities in
      daily life and well-being, and we will perform 1 Magnetic Resonance Imaging (MRI) scan. MRI
      scans are loud but painless; nothing is injected. With MRI, we collect images from the brain.
    

Intervention name(s): Device: 3T scanner with MRI-compatible robot
Intervention type(s): Other
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Healthy Control Group Stroke patient subjects
Does Duloxetine Reduce Sub-Acute Pain After Knee Arthroplasty?
Condition: Total Knee Arthroplasty
MeSH terms: Acute Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      We are investigating the impact of duloxetine ("Cymbalta"), a serotonin and norepinephrine
      reuptake inhibitor, on pain after total knee arthroplasty (TKA). Specifically, the
      investigators will determine whether duloxetine, 60 mg daily for 2 weeks, reduces pain scores
      2 weeks after TKA.
    


Intervention name(s): Placebo; Duloxetine 60mg
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive placebo drug with no active ingredients per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.; Patients will receive 60mg of duloxetine per dose. 1 capsule will be taken pre-operatively. One capsule once a day until end of POD14.
Other intervention name(s): Cymbalta
Intervention MeSH terms: Duloxetine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment