bioihbjkbjnl/mcl2 huggingface dataset:
PET/CT (Positron Emission Tomography / Computed Tomography) Investigations With BAY86-9596 (18F) (300 MBq) Following Single Intravenous Administration in Patients With Cancer or Inflammations.
Condition: Diagnostic Imaging
MeSH terms: Inflammation
Study type: Interventional
Phase: Phase 1

Summary: 
      The study will be conducted as an open label, single-center, single dose and biodistribution
      study in patients with cancer or inflammation. 56 patients will be selected among the
      patients undergoing the screening examination conducted within 3 weeks before drug
      administration. Single dose of the study drug will be administrated in a dose of 300 MBq to
      these patients. The follow-up period contains the end-of-study telephone interview 5-8 days
      following the treatment. Key measurements are the PET/CT image acquisitions within a time
      frame of about 2 hours after the single injection of BAY86-9596.
    


Intervention name(s): BAY86-9596
Intervention type(s): Drug
Intervention description(s): One single dose administration of a diagnostic agent
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Proof of Mechanism; Phase I; Neoplasm; Inflammation
Effect of Pumpkin Seed Oil on Hair Growth in Men With Androgenetic Alopecia
Condition: Androgenic Alopecia
MeSH terms: Alopecia; Alopecia Areata
Study type: Interventional

Summary: 
      Androgenic alopecia is the most common cause of hair loss in men. Finasteride and minoxidil
      are available in treatment of androgenetic alopecia, although the former causes decreased
      libido or ejaculate volume, erectile dysfunction, the latter causes scaling, itching of the
      scalp. Recently, Pulpkin Seed Oil shows some improved clinical efficacy on scalp hair growth
      in men with androgenetic alopecia, but there is no evidence to support this.

      The investigators conducted a randomized, double-blind, placebo-controlled efficacy and
      tolerability trial of Pumpkin seed oil (400mg/day)therapy in male patients with androgenetic
      alopecia.
    


Intervention name(s): 400mg /day during 6 months
Intervention type(s): Dietary Supplement
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Pumpkin seed oil; Hair growth; Men
Six vs 12 Months of Trastuzumab With Docetaxel Following FEC as Adjuvant Treatment in N+ Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      This trial will compare 6 versus 12 months of trastuzumab in combination with dose dense
      docetaxel following FE75C as adjuvant chemotherapy in women with axillary lymph node positive
      breast cancer overexpressing HER2
    

Detailed description: 
      Anthracycline-containing regimens are recommended as adjuvant treatment for women with node
      positive breast cancer. In at least three large randomized clinical trials the addition or
      sequential administration of a taxane (paclitaxel or docetaxel) to an antracycline-based
      regimen resulted in superior clinical outcome for women with node positive early breast
      cancer. In two large randomized studies the dose dense administration with G-CSF support of
      anthracycline-based and paclitaxel combination was superior to the same regimen administered
      every three weeks without growth factors as adjuvant therapy in women with axillary node
      positive breast cancer. In one randomized trial, docetaxel was proved superior to paclitaxel
      in women with metastatic breast cancer. Trastuzumab (anti-HER2 monoclonal antibody) in
      combination with paclitaxel was superior to paclitaxel alone in women with metastatic breast
      cancer overexpressing HER2
    

Intervention name(s): Docetaxel; Trastuzumab; Epirubicin; Cyclophosphamide; 5-fluoruracil; Granulocyte-colony stimulating growth factor; Trastuzumab
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Docetaxel 75 mg/m2 as an IV infusion over 1h every two weeks for 4 cycles; Trastuzumab 6 mg/Kg IV over 30 min every two weeks for 4 cycles. Subsequently,trastuzumab 6 mg/Kg IV over 30 min for 12 months; Epirubicin 75 mg/m2 IV push on day 1 every 2 weeks for 4 cycles; Cyclophosphamide 700 mg/m2 IV push on day 1 every 4 weeks; 5-fluoruracil 700 mg/m2 IV push on day 1 every 4 weeks; rhG-CSF 5 μg/kg/d on days 3-10 after each cycle; Trastuzumab 6mg/Kg IV over 30 min every 2 weeks for 4 cycles. Subsequently, trastuzumab 6mg/Kg IV over 30 min for 6 months
Other intervention name(s): Taxotere; Herceptin; Farmorubicin; Endoxan; 5-FU; Granocyte; Neulasta; Herceptin
Intervention MeSH terms: Cyclophosphamide; Docetaxel; Trastuzumab; Epirubicin; Fluorouracil; Lenograstim; Mitogens
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Early breast cancer; Axillary node positive; HER2 overexpression; Adjuvant chemotherapy; Dose dense; Docetaxel; Trastuzumab; FEC
The PK/PD of Deoxycholic Acid Amphotericin B in Invasive Fungal Infection Patients With Sepsis/Septic Shock
Condition: Fungal Infection
MeSH terms: Infections; Communicable Diseases; Mycoses; Invasive Fungal Infections
Study type: Observational

Summary: 
      To explore the PK/PD of deoxycholic amphotericin B in invasive fungal infection patients with
      sepsis/septic shock;To compare the PK/PD of deoxycholic amphotericin B in invasive fungal
      infection patients with sepsis and septic shock.
    

Detailed description: 
      This was a single-center study.Patients who were diagnosed with in invasive fungal infection
      receieved deoxycholic acid amphotericin B during the study period.The information was recored
      including the general condition, infection index, PK/PD index and drug-related side effects.
    

Intervention name(s): Deoxycholic acid amphotericin B
Intervention type(s): Drug
Intervention description(s): Starting with 1mg and increasing by 5-25mg daily until the maintenance dose is 50mg/d.
Other intervention name(s): amphotericin B
Intervention MeSH terms: Amphotericin B; Liposomal amphotericin B; Deoxycholic Acid
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients with Sepsis admitted to ICU of Zhongda hospital
      
Keywords: Blood Concentration; Deoxycholic Acid Amphotericin B; Fungal Infection
PEG-Intron Plus Rebetol Treatment of Chronic Hepatitis C Subjects Who Failed Response to Alpha-Interferon Plus Ribavirin (Study P02370)
Condition: Hepatitis; Hepatitis C, Chronic; Fibrosis; Liver Cirrhosis
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Liver Cirrhosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this study is to determine the effectiveness of PEG-Intron 1.5 ug/kg/wk plus
      REBETOL (ribavirin) 800-1400 mg/day in adults with chronic hepatitis C with moderate to
      severe liver fibrosis or cirrhosis who failed to respond to previous treatment with an alpha
      interferon in combination with ribavirin. Patients who do not respond to PEG-Intron plus
      REBETOL (ribavirin) will be enrolled in a long-term maintenance study to evaluate the
      effectiveness of PEG-Intron monotherapy versus no treatment for the prevention of disease
      progression (Protocols P02569 and P02570).
    


Intervention name(s): PegIntron (peginterferon alfa-2b; SCH 54031); REBETOL (ribavirin; SCH 18908)
Intervention type(s): Biological; Drug
Intervention description(s): PegIntron (peginterferon alfa-2b) administered at a dose of 1.5 mcg/kg subcutaneously (SC) once a week (QW) for up to 48 weeks; REBETOL (ribavirin) administered on a weight basis: 800-1400 mg/day orally (PO) for up to 48 weeks
Other intervention name(s): SCH 54031
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2b; Interferon-alpha
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Transcranial Direct Current Stimulation (tDCS) for Treatment-Resistant Obsessive-Compulsive Disorder (FRONT)
Condition: Obsessive-Compulsive Disorder
MeSH terms: Compulsive Personality Disorder; Obsessive-Compulsive Disorder
Study type: Interventional

Summary: 
      Neuromodulation techniques for the treatment of Obsessive-Compulsive Disorder (OCD) have
      expanded with the greater understanding of the brain circuits involved in this disorder.
      Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique
      that has been studied as an alternative for strategy for treatment-resistant OCD. The main
      study is a randomized, sham-controlled, double-blinded trial tDCS for OCD patients
      unresponsive to cognitive-behavioral therapy and/or selective serotonin reuptake inhibitors.
      Forty-four patients will be randomized to two groups: active or simulated intervention. The
      intervention consisted of delivering an electric current of 2mA to the cathode, positioned
      bilaterally in the cranial region corresponding to the supplementary motor cortex, and the
      anode positioned in the deltoid (neutral region), during 30-minutes, for four consecutive
      weeks. The primary outcome was the reduction in baseline YBOCS scores before and after of
      tDCS treatment. Secondary outcomes include measures of depressive and anxiety symptoms,
      genetic markers, motor cortical excitability and performance in neurocognitive tests.
    


Intervention name(s): Active tDCS (transcranial direct current stimulation); Sham tDCS
Intervention type(s): Device; Device
Intervention description(s): An electrical current of 2mA is delivered to the cathode, positioned bilaterally in the cranial region corresponding to the supplementary motor cortex, with the anode positioned in the deltoid (neutral region), in 30-minute sessions, 5 days a week (Mondays through Fridays) for four consecutive weeks.; The cathode is positioned bilaterally in the cranial region corresponding to the supplementary motor cortex, with the anode positioned in the deltoid (neutral region), in a 30-minute session, 5 days a week (Mondays through Fridays) for four consecutive weeks, without delivery of the electric current.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: randomized, sham-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obsessive-Compulsive Disorder; Transcranial direct current stimulation; Neuromodulation
Evaluation of a Walking School Bus Program
Condition: Obesity; Physical Activity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      Just two generations ago, walking or bicycling to school was the norm for a substantial
      number of US children, e.g. 48% of children walked or biked to school in 1969 versus only 13%
      in 2009. This decline occurred in the same timeframe as the childhood obesity epidemic, which
      is at record high levels in the US and affects low-income and ethnic minority children the
      most. This project will test "the walking school bus" (WSB) program, in which children walk
      to and from school with adults, and its impact on low-income, ethnic minority children's
      walking to school, physical activity, and risk for obesity. Ultimately, this line of research
      has the potential to provide a low-cost, easy to disseminate program to reduce risk of
      obesity and cancer for at-risk children.

      The investigators Specific Aims among 3rd-5th grade children include:

      SA1) To recruit 770 child-parent dyads from 22 elementary schools over 4 years and conduct a
      cluster randomized controlled trial to assess the efficacy of a WSB program on children's
      walking to school, physical activity, and BMI z-score over a school-year SA2) To collect and
      analyze data on individual-, school-, and macro-level influences on changes to children's
      walking to school resulting from the WSB program

      The Primary Hypotheses to be tested, in comparison to control children, include:

      H1) The WSB program will increase children's walking to school over a school-year.

      H1a) Parents' outcome expectations and self-efficacy will mediate the relationship between
      the WSB and changes to children's walking to school.

      H1b) Walkability, safety, and acculturation will moderate changes to children's walking to
      school.

      H2) The WSB program will increase children's physical activity and decrease BMI z-scores over
      a school-year.

      H3) The WSB program will increase school-level pedestrian safety behaviors over a
      school-year.
    


Intervention name(s): Walking School Bus
Intervention type(s): Behavioral
Intervention description(s): Children will have the option of walking to and/or from school with study staff who are trained in Safe Routes to School methods.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Safe Routes to School; Walking School Bus; Cluster Randomized Controlled Trial; Physical Activity; Obesity; Overweight
Study to Evaluate a 13-valent Pneumococcal Conjugate Vaccine in Infants
Condition: Vaccines, Pneumococcal
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to assess the safety, tolerability and immunogenicity of a
      13-valent pneumococcal conjugate (13vPnC) vaccine compared to Prevenar (7vPnC), when given
      concomitantly with routine pediatric vaccines in France.
    


Intervention name(s): 13-valent pneumococcal conjugate vaccine; 7-valent pneumococcal conjugate vaccine; Pentavac
Intervention type(s): Biological; Biological; Drug
Intervention description(s): Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.; Single 0.5 mL dose given at 2, 3, 4, and 12 months of age.; The Pentavac was administered by intramuscular injection 0.5 ml into the anterolateral thigh muscle of the right leg at 2, 3, and 4 months (infant series) and 12 months of age (toddler dose).
Intervention MeSH terms: Vaccines; Heptavalent Pneumococcal Conjugate Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Safety; Vaccine
Neural Injury in Adolescents With Concussion
Condition: Mild Traumatic Brain Injury; Concussion, Mild; Acute Brain Injury
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Brain Concussion; Wounds and Injuries
Study type: Observational

Summary: 
      This study utilizes multimodal brain imaging to obtain quantitative biomarkers of brain
      injury and to improve understanding of the biological basis of brain pathology in adolescents
      with concussion. Adolescents with a concussion will undergo neuroimaging and neuropsychology
      assessments acutely and four months after injury.
    

Detailed description: 
      Concussion is a highly prevalent condition in adolescence, but it remains a clinical
      diagnosis that largely relies on subjective patient report with no reliable objective
      biomarkers for diagnosis. Traditional clinical brain imaging has not been found useful for
      concussion as the pathology is generally not visible on conventional acute MRI or CT. The
      proposed study addresses this gap in concussion diagnosis and management by examining the
      sensitivity of magnetoencephalography (MEG) for identifying areas of brain injury through
      detection of abnormal neural activity (slowing) in adolescents with concussion compared to
      healthy controls. Adolescents with a concussion will complete neuroimaging (MEG and MRI) and
      neuropsychology assessments at two time points within ten days and then again 4 months
      post-injury. Healthy controls will complete neuroimaging and neuropsychology assessments at a
      single time point.
    

Intervention name(s): MEG; MRI; Neuropsychology assessment
Intervention type(s): Device; Device; Behavioral
Intervention description(s): MEG is a non-invasive functional imaging technique that can measure slow-wave neural activity.; MRI is a non-invasive imaging modality that provides measures of brain structure.; A battery of tests will be administered by a neuropsychologist to evaluate the cognitive function of adolescents with concussion compared to healthy controls.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescents with a recent concussion will be recruited from outpatient clinics in
        orthopedics and trauma surgery. Healthy controls will be obtained via volunteers and
        previous brain imaging research studies.
      
Keywords: Magnetoencephalography (MEG); Magnetic resonance imaging (MRI)
Phase 3 Trial of NCX 470 vs. Latanoprost in Subjects With Open-Angle Glaucoma or Ocular Hypertension
Condition: Open Angle Glaucoma; Ocular Hypertension
MeSH terms: Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The objective of this clinical study is to evaluate the safety and efficacy of NCX 470
      Ophthalmic Solution in lowering intraocular pressure (IOP) in patients with ocular
      hypertension or open-angle glaucoma. In the adaptive dose selection phase of the trial,
      subjects will be randomized in a 1:1:1 ratio to one of two doses of NCX 470 (0.065% or 0.1%)
      or to latanoprost 0.005%. Following the selection of one dose of NCX 470, subjects will be
      randomized in a 1:1 ratio to the chosen dose of NCX 470 or to latanoprost 0.005%.
    


Intervention name(s): NCX 470 0.065% (initial phase of trial); Latanoprost 0.005% (initial phase of trial); NCX 470 0.1% (initial phase of trial); NCX 470 0.1% (remainder of trial); Latanoprost 0.005% (remainder of trial)
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): NCX 470 Ophthalmic Solution, 0.065% (initial phase of trial); Latanoprost Ophthalmic Solution, 0.005%; NCX 470 Ophthalmic Solution, 0.1%; NCX 470 Ophthalmic Solution, 0.1%; Latanoprost Ophthalmic Solution, 0.005%
Other intervention name(s): Latanoprost
Intervention MeSH terms: Latanoprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
University of Alabama at Birmingham (UAB) Adult CBD Program
Condition: Epilepsy; Seizures
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of Epidiolex at various
      doses between 5 mg/kg/day and 50 mg/kg/day as an additional (add-on) drug for treating
      debilitating, drug-resistant epilepsy.
    

Detailed description: 
      The specific goals of this phase 1 dose finding study, conducted in consecutively enrolled
      patients 18 years of age and older, are to prospectively and longitudinally assess the safety
      and tolerability, including cognitive effects, of Cannabidiol (CBD) at various doses between
      5 mg/kg/day and 25 mg/kg/day, with additional titration in some cases up to 50 mg/kg/day. In
      order to participate in the study, participants will need to fulfill the inclusion and
      exclusion criteria.

      The goal of the study is to fulfill the mandate of "Carly's Law" and to provide patients with
      debilitating epileptic conditions with access to CBD as an add-on treatment. Other care
      including routine neurological care unrelated to participation in the CBD study will need to
      be provided by patients' primary/current treating neurologist.
    

Intervention name(s): Epidiolex
Intervention type(s): Drug
Intervention description(s): Epidiolex oral solution (100 mg/mL CBD concentration) with inactive ingredients including anhydrous ethanol, sesame seed oil, strawberry flavor, and sucralose).
Other intervention name(s): Cannabidiol; CBD
Intervention MeSH terms: Cannabidiol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Trial of Postoperative Whole Brain Radiation Therapy vs. Salvage Stereotactic Radiosurgery Therapy for Metastasis
Condition: Brain Neoplasms; Neoplasm Metastasis
MeSH terms: Neoplasms; Neoplasm Metastasis; Brain Neoplasms
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of this study is to evaluate non-inferiority of salvage stereotactic radiosurgery
      (SRS) in the patients who received surgical resection for brain metastases in comparison with
      postoperative whole brain radiation therapy (WBRT).
    

Detailed description: 
      A randomized phase III study is started in Japan to compare postoperative whole brain
      radiation therapy with salvage stereotactic radiosurgery in patient with one to four brain
      metastases from lung, breast, and colorectal cancer.

      Total of 270 patients will be accrued for this study from 21 institutions within three years.
      The primary endpoint is overall survival. The secondary endpoints are proportion of
      performance status (PS) preservation, proportion of mini-mental status examination (MMSE)
      preservation, and adverse events.
    

Intervention name(s): Whole brain radiation therapy arm; Salvage stereotactic radiosurgery arm
Intervention type(s): Device; Device
Intervention description(s): Whole brain radiation therapy arm; Salvage stereotactic radiosurgery arm
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Randomized Controlled Trials; Brain Neoplasms/Secondary; Brain Neoplasms/Radiotherapy; Radiosurgery
Trivalent rHA Dose Escalation Study in Elderly Subjects
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare the safety and immunogenicity of three different dose levels of an
      experimental recombinant influenza HA protein vaccine to a standard inactivated influenza
      vaccine in heallthy elderly subjects ages 65-80. Blood and nasal secretions for assessment of
      antibody responses will be obtained from all subjects prior to and one month after
      vaccination.
    

Detailed description: 
      Approximately 400 healthy, ambulatory adults ages 65-80 will be randomized into one of four
      study groups to receive a single immunization of a licensed trivalent inactivated influenza
      vaccine or one of three dose levels of an investigatioanl trivalent recombinant influenza HA
      protein vaccine. The study will be conducted in 2 stages. In the first stage, 80 subjects
      will be randomized (20 per group) and receive one vaccination on Day 0. Safety will be
      evaluated after Stage 1 subjects have completed a 7 day follow-up. Enrollment of Stage 2
      subjects will begin after the safety data for Stage 1 has been reviewed. In Stage 2, 320
      subjects will be randomized (80 per group) and receive one vaccination on Day 0. Blood and
      nasal secretions will be collected prior to an approximately one month after vaccination to
      assess antibody responses.
    

Intervention name(s): rHAO Trivalent Influenza Vaccine
Intervention type(s): Biological
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Prevention
Keywords: Influenza, Baculovirus, Immunogenicity, Geriatrics