bioihbjkbjnl/mcl2 huggingface dataset:
Effect of Tamoxifen on Breast Density in Premenopausal Women With Breast Cancer or High Risk for Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Observational

Summary: 
      RATIONALE: High estrogen levels may be associated with dense breast tissue and an increased
      risk of developing breast cancer. Tamoxifen may be effective in reducing breast density by
      decreasing estrogen levels.

      PURPOSE: This phase I trial is studying how well tamoxifen works in reducing breast density
      in premenopausal women with breast cancer or at high risk of developing breast cancer.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  Determine whether breast density, as measured by digital mammography, decreases in
           premenopausal women receiving tamoxifen for breast cancer or for breast cancer risk
           reduction.

        -  Determine whether breast density, as determined by a trained mammographer, decreases in
           patients treated with this drug.

        -  Correlate tamoxifen-induced symptoms in estrogen target tissue with change in salivary
           steroids in patients treated with this drug.

      Secondary

        -  Determine the effect of this drug on salivary steroids in regularly cycling and
           amenorrheic patients.

        -  Correlate changes in breast density with tamoxifen-induced alterations in sex steroid
           levels, as measured in the saliva, of patients treated with this drug.

      OUTLINE: Patients receive oral tamoxifen once daily. Treatment continues for 5 years in the
      absence of disease metastasis (patients with known breast cancer) or a diagnosis of breast
      cancer (patients undergoing risk reduction).

      Patients undergo mammography to determine breast density at baseline, at 6 and 12 months, and
      then annually for 4 years. Patients also collect daily salivary samples during the 30-day
      periods surrounding the imaging studies to measure salivary estradiol and progesterone
      levels. The results of the salivary hormone studies are correlated with density changes at
      study completion.

      PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Women who are initiating tamoxifen on the advice of their treating physician as the sole
        systemic treatment for breast carcinoma or breast cancer risk reduction
      
Keywords: breast cancer; stage I breast cancer; stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer
Transdermal Patch to Monitor Inflammatory Biomarkers of GVHD
Condition: Graft Versus Host Disease
MeSH terms: Graft vs Host Disease
Study type: Interventional

Summary: 
      The aim of this study is to measure local inflammatory responses in patients undergoing an
      allogeneic stem cell transplant and attempt to define any set of biomarkers that are
      significantly altered in acute or chronic skin graft versus host disease.
    

Detailed description: 
      Acute skin graft versus host disease is a significant complication following allogeneic stem
      cell transplant. To date, there are no specific dermal biomarkers that predict or define the
      onset of acute skin graft versus host disease. The primary objective of this study is to
      observe the changes in the inflammatory environment of the skin during the process of acute
      and chronic skin graft versus host disease. This will be accomplished by using a non-invasive
      transdermal patch called D-Squame to analyze inflammatory cytokines and key epidermal
      proteins. Patients will be enrolled prior to receiving a stem cell transplant and followed
      weekly after stem cell infusion until day 99. If acute skin graft versus host disease
      develops, they will be followed weekly until resolution of acute graft versus host disease or
      development of chronic graft versus host disease, whichever occurs first. Patients with a
      diagnosis of chronic skin graft versus host disease will be enrolled and followed weekly
      until 4 weeks, irrespective of clinical course. In addition, healthy controls will be
      enrolled and used as comparators. The relevance of this study is to provide a better
      understanding of the local inflammatory environment induced by acute or chronic skin graft
      versus host disease. This is likely to enable the investigators to define a biomarker panel
      that predicts the onset of acute graft versus host disease rapidly and non-invasively.
    

Intervention name(s): D-SQUAME Skin Sampling Discs
Intervention type(s): Device
Intervention description(s): A D-SQUAME Skin Sampling Disc is a noninvasive patch that collects skin cell samples when affixed to the superficial stratum corneum (top layer of skin). The patch is applied with gentle pressure to the desired quadrant of the forearm and removed 2 minutes after application.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: children; bone marrow transplant; GVHD
A Comparison of the Drug Therapy Versus Re-Ablation
Condition: Paroxysmal Atrial Fibrillation; Failed First Radiofrequency Ablation Procedure
MeSH terms: Atrial Fibrillation
Study type: Interventional
Phase: Phase 2

Summary: 
      The hypothesis of this study was that early re-ablation (test) was superior to AAD therapy
      (control) in patients with previous failed PVI ablation for paroxysmal AF.
    


Intervention name(s): Anti-Arrhythmia Agents (propafenone, flecainide, and/or sotalol, or amiodarone); re-ablation procedure; ILR implantation
Intervention type(s): Drug; Procedure; Procedure
Intervention description(s): propafenone, flecainide, and/or sotalol as first-line drugs in patients without structural heart disease or amiodarone as a single drug or in combination in patients with structural heart disease or in case of first-line drug failure; Reisolation of the PVs was performed by identifying the breakthrough site on the mapping catheter (NaviStar ThermoCool, Biosense-Webster Inc., Diamond Bar, CA). RF energy was delivered at 43°C, 35 W, 0.5 cm away from the PV ostia at the anterior wall, and was reduced to 43°C, 30 W, 1 cm away from the PV ostia at the posterior wall, with a saline irrigation rate of 17 mL/min. Each lesion was ablated continuously until the local potential amplitude decreased by >80% or RF energy deliveries exceeded 40 s. The endpoint of ablation was complete PVI; this was confirmed when Lasso catheter mapping showed the disappearance of all PV potentials or the dissociation of PV potentials from LA activity.; The Reveal XT was implanted in the parasternal area of the chest. The requirement for defining the exact final position was an R-wave amplitude ≥0.4 mV assessed through the Vector Check.
Patients were provided with the Patient Assistant, a tool that allows each patient to store the ECG through the implanted device during symptoms; data were collected in order to analyze heart rhythm during symptomatic events.
Intervention MeSH terms: Amiodarone; Flecainide; Sotalol; Propafenone; Anti-Arrhythmia Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: atrial fibrillation; arrhythmias; anti-arrhythmic agents
Double-Blind, Multicenter, Sham Surgery Controlled Study of CERE-120 in Subjects With Idiopathic Parkinson's Disease
Condition: Idiopathic Parkinson's Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this double blind study is to determine whether CERE-120 (adeno-associated
      virus serotype 2 [AAV2]-neurturin [NTN]) is effective and safe in the treatment of patients
      with idiopathic Parkinson's Disease. CERE-120 is administered via bilateral stereotactic
      injections targeting the putaminal region of the brain. The design of this study involves
      approximately 34 patients receiving CERE-120 treatment via stereotactic surgery and
      approximately 17 patients receiving sham stereotactic surgery (no CERE-120 administered).
    


Intervention name(s): CERE-120 (Adeno-Associated Virus Serotype 2 [AAV2]-Neurturin [NTN]); Sham Surgery
Intervention type(s): Drug; Procedure
Intervention description(s): CERE-120 5.4 x 10^11 vg; Bilateral partial thickness burr holes placed, no intraparenchymal injections
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
A Bioequivalence Study of Mirikizumab (LY3074828) Solution in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to evaluate amount of mirikizumab (test) that gets into the
      blood stream and how long it takes the body to get rid of it, when given via pre-filled
      syringe compared to mirikizumab (reference) solution given via pre-filled syringe. The
      information about any adverse effects experienced will be collected and the tolerability of
      mirikizumab will also be evaluated.

      Screening is required within 35 days prior to enrolment. For each participant, the total
      duration of the clinical trial will be about 17 weeks including screening.
    


Intervention name(s): Mirikizumab
Intervention type(s): Drug
Intervention description(s): Administered SC.
Other intervention name(s): LY3074828
Intervention MeSH terms: Mirikizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Efficacy and Safety of Pramipexole (PPX) in Moderate to Severe Idiopathic Restless Legs Syndrome (RLS) Patients
Condition: Restless Legs Syndrome
MeSH terms: Psychomotor Agitation; Restless Legs Syndrome; Syndrome
Study type: Interventional
Phase: Phase 3

Summary: 
      To evaluate safety and efficacy of pramipexole in the treatment of patients suffering from
      moderate to severe RLS over 6 weeks under double blinded conditions followed by a 46 week
      open label or double blind extension.
    

Detailed description: 
      To evaluate safety and efficacy of pramipexole in the treatment of patients suffering from
      moderate to severe RLS over 6 weeks under double blinded conditions followed by a 46 weeks
      open label or double blind extension

      Study Hypotheses:

      Null hypothesis: No difference between pramipexole and placebo in RLSRS total score from
      baseline and no difference in the CGI-I responder rates at the end of the 6 weeks
      double-blind treatment.

      Comparison(s):

      Pramipexole vs. Placebo
    

Intervention name(s): pramipexole
Intervention type(s): Drug
Intervention MeSH terms: Pramipexole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Pharmacokinetics of Levetiracetam (Keppra) in Neonates
Condition: Seizures; Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Observational

Summary: 
      The primary objective of this study is to determine the pharmacokinetic profile of a loading
      dose of intravenous levetiracetam, given for clinical reasons, in term and late preterm
      infants with seizures. Secondary objectives are to evaluate the safety and efficacy of
      levetiracetam in term and preterm infants with seizures.
    


Intervention name(s): levetiracetam
Intervention type(s): Drug
Intervention description(s): Patients will receive levetiracetam as needed for clinical and/or electrographic seizures. Need for levetiracetam will be determined by the clinical team and will NOT determined by the study protocol.
Intervention MeSH terms: Levetiracetam
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Infants ≥ 32 weeks gestation and ≤ 30 days of age requiring treatment with levetiracetam
        for clinical and/or electrographic seizures or seizure prophylaxis.
      
Keywords: seizures; epilepsy; neonatal; levetiracetam
Plasma Exchange Therapy for Post- COVID-19 Condition: A Pilot, Randomized Double-Blind Study
Condition: Post-COVID19 Condition
MeSH terms: COVID-19; Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      PAX is a prospective, randomized (1:1), double-blind, placebo-controlled study, that have as
      a objective to evaluate the safety and tolerability of plasma exchange (PE) in patients with
      Post Acute Covid-19 Syndrome (PCC) comparing to sham plasma exchange. The participants will
      be randomized in two arms: (1) 6 sessions of PE (Plasma Exchange) with human serum albumin 5%
      or (2) 6 sessions with placebo (infusion of of sterile saline solution 0.9%) on days 1, 3, 8,
      10, 15 and 17.
    

Detailed description: 
      Randomized participants will receive plasma exchange (PE) or sham PE (placebo) (6 sessions:
      V2, V3, V4, V5, V6 and V7) and will continue their follow-up visits(V8d22, V9d45, V10d90).
      Plasma volumes will be replaced, which will vary depending on sex, height, weight and
      hematocrit.
    

Intervention name(s): Plasma Exchange Procedure; Sham Plasma Exchange Procedure
Intervention type(s): Combination Product; Other
Intervention description(s): Plasma exchanges will be performed with 5% albumin as the replacement fluid. The typical schedule prescribed will be an exchange of 1 volemia. Blood will be separated into cells and plasma; the cells will be combined with reconstituted 5% human serum albumin and reinfused into the patient with normal saline; For sham plasma exchange procedures, a sound behind the curtain will be performed imitating the sound of the cell processing platform. In these cases, only one infusion of 200 to 250ml of sterile saline solution 0.9% will be performed during the time stablished for all procedures. Albumin will not be necessary for those patients in the Sham plasma exchange arm
Other intervention name(s): Plasmapheresis
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized (1:1), double-blind, placebo-controlled study
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: SARS-CoV-2; COVID-19; Long COVID19; Plasma exchange (PE); Plasmapheresis
RHODOS Follow-up Single-visit Study
Condition: Leber's Hereditary Optic Neuropathy
MeSH terms: Optic Nerve Diseases; Optic Atrophy, Hereditary, Leber
Study type: Observational

Summary: 
      This study aims to evaluate the current visual acuity of SNT-II-003 participants and compare
      this with the last visit from the SNT-II-003 study.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients who participated in study SNT-II-003
      
Keywords: leber's hereditary optic neuropathy; idebenone
Safety, Tolerability and Pharmacokinetics Study of EGT0001474 in Subjects With Type 2 Diabetes
Condition: Diabetes Mellitus Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety, tolerability and pharmacokinetics (how
      much of the drug gets into the blood and how long it takes the body to get rid of it) of
      single doses of EGT0001474 given to patients with Type 2 diabetes. The study will also
      evaluate how EGT0001474 affects the amount of glucose produced by the body in the urine.
    

Detailed description: 
      EGT0001474 is a compound that may inhibit the effect of other compounds in the body known as
      sugar transporters. The use of EGT0001474 may enhance the elimination of glucose from the
      blood by increasing the amount of urine produced. This would help prevent an abnormal
      decrease in blood sugar (hypoglycemia) both during fasting and after meals without increasing
      insulin secretion (which may result in weight gain or an abnormal increase in blood sugar
      known as Type 2 diabetes).
    

Intervention name(s): EGT0001474; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Cohort 1: single dose of 25 mg EGT0001474 given as an oral capsule; Cohort 2: single dose of 75 mg EGT0001474 given as 3 oral capsules; Cohort 3: single dose of 150 mg EGT0001474 given as 6 oral capsules.; Placebo capsules to match EGT0001474
Other intervention name(s): Human SGLT2 inhibitor; Human SGLT2 inhibitor
Intervention MeSH terms: Sodium-Glucose Transporter 2 Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Diabetes Mellitus Type 2
A Study to Investigate the Regional Brain Kinetics of the Positron Emission Tomography Ligand [18F]-JNJ-70099731 in Healthy Male Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purposes of this study are to measure the whole-body distribution and radiation dosimetry
      of [18F]-JNJ-70099731 (Part A), to measure the uptake, distribution, and clearance (CL) of
      [18F]-JNJ-70099731 by Positron Emission Tomography (PET) and to model tissue specific
      kinetics of [18F]-JNJ-70099731 with the appropriate input function (IF) (Part B), and to
      measure participant test-retest variability in the distribution of [18F]-JNJ-70099731 by
      comparing PET scans obtained at least 1 week apart (Part C) in the brain of healthy male
      participants.
    


Intervention name(s): [18F]-JNJ-70099731
Intervention type(s): Drug
Intervention description(s): [18F]JNJ-70099731 injection will be administered intravenously.
Allocation: Non-Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Evaluation of N1539 Following Bunionectomy Surgery
Condition: Pain, Post-operative
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study is to evaluate the analgesic efficacy of N1539 in
      subjects with acute moderate to severe pain following unilateral bunionectomy.
    


Intervention name(s): N1539; Intravenous Placebo
Intervention type(s): Drug; Drug
Other intervention name(s): Intravenous meloxicam
Intervention MeSH terms: Meloxicam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Bunion; Bunionectomy; Pain; Analgesia; N1539; Phase 3
Bioequivalence Study of Torrent Pharmaceuticals Ltd.'s Rosuvastatin Calcium Tablets Under Fed Conditions
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      Subjects to compare the single dose bioavailability of Torrent's Rosuvastatin Calcium Tablets
      40 mg and Crestor® 40 mg Tablets of AstraZeneca Pharmaceuticals LP, USA. Dosing periods of
      studies were separated by a washout period of 7 days.
    

Detailed description: 
      An Open Label, Randomized, 2-period, 2- Treatment, 2-Sequence, Crossover, Single-dose
      Bioequivalence Study of Rosuvastatin Calcium Tablets containing Rosuvastatin Calcium 40 mg (
      Test Formulation, Torrent Pharmaceutical Ltd., India) Versus Crestor® 40 mg Tablets
      containing Rosuvastatin Calcium 40 mg (Reference , AstraZeneca Pharmaceuticals LP, USA) in
      Healthy Human Volunteers Under Fed Condition.
    

Intervention name(s): Torrent's Rosuvastatin Calcium Tablets 40 mg; Crestor 40 mg Tablets of AstraZeneca Pharmaceuticals LP, USA
Intervention type(s): Drug; Drug
Intervention description(s): Oral, crossover; Oral, crossover
Intervention MeSH terms: Rosuvastatin Calcium; Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional

Summary: 
      In this study the researchers want to investigate the effects of long-term transcutaneous
      electrical nerve stimulation on the cortical excitability of persons with multiple sclerosis.
    


Intervention name(s): Transcutaneous electrical nerve stimulation
Intervention type(s): Device
Intervention description(s): 3 weeks, 5 times a week, 60 minutes a day.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Transcutaneous electrical nerve stimulation; Cortical Excitability
Cognitive Behavioral Suicide Prevention for Psychosis: Aim 1
Condition: Suicide; Psychosis
MeSH terms: Suicide; Psychotic Disorders; Mental Disorders; Suicide Prevention
Study type: Interventional

Summary: 
      The investigators are modifying and testing the preliminary effectiveness and implementation
      of a Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) intervention. In this
      phase of the study, CBSPp will be tested in an initial open trial (n = 10) to examine its
      feasibility and acceptability. Investigators will recruit clients receiving services at a
      community mental health setting who have a schizophrenia spectrum disorder and recent
      suicidal thoughts and behaviors to receive the behavioral intervention for 10-weeks.
      Providers will be recruited and trained to deliver the intervention. Both clients and
      providers will be assessed at baseline to test our approach to measurement prior to the Aim 2
      RCT (registered separately). Clients will be assessed at three additional timepoints (middle
      of treatment, end of treatment, and 2 months after treatment ends.
    


Intervention name(s): Cognitive Behavioral Suicide Prevention for psychosis CBSPp)
Intervention type(s): Behavioral
Intervention description(s): Cognitive and behavioral approach to suicide prevention among individuals with psychosis
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cognitive behavioral therapy; suicide prevention; community mental health
An Study of Efficacy and Safety of Clevudine
Condition: Chronic Hepatitis B
MeSH terms: Hepatitis B; Hepatitis B, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 3

Summary: 
      Randomized, double blind parallel group, positive control, multi-center trial. Patients will
      be randomized at 1:1 ratio in group A or group B
    


Intervention name(s): Clevudine; Adefovir
Intervention type(s): Drug; Drug
Intervention description(s): Clevudine flexible dosages of 30 mg/day; Adefovir flexible dosages of 10 mg/day
Intervention MeSH terms: Adefovir; Clevudine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Clevudine; efficacy; safety; chronic hepatitis B