bioihbjkbjnl/mcl2 huggingface dataset:
A Study in Healthy Men to Test How BI 764198 is Processed in the Body
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objective of this trial is to investigate the basic pharmacokinetics of BI 764198
      and its metabolites, total radioactivity including mass balance, excretion pathways and
      metabolism following oral administration to healthy male volunteers of a single oral dose of
      BI 764198 (C-14) in i) a classical hADME approach and ii) a hADME microtracer approach.
    


Intervention name(s): BI 764198 (C-14) (approach 1); BI 764198 (C-14) (approach 2)
Intervention type(s): Drug; Drug
Intervention description(s): BI 764198 (C-14) (approach 1); BI 764198 (C-14) (approach 2)
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparing Validity of Non-Invasive Hemoglobin Monitoring to Laboratory Results in Critically Ill Children
Condition: Hemoglobin Results
MeSH terms: Critical Illness
Study type: Observational

Summary: 
      This is a prospective study to determine the accuracy of the Masimo Pronto Non-Invasive
      Hemoglobin Monitor and associated Rainbow® probes in the detection of hemoglobin
      concentration in critically ill children.
    

Detailed description: 
      This is a prospective study to determine the accuracy of the Masimo Pronto Non-Invasive
      Hemoglobin Monitor and associated Rainbow® probes in the detection of hemoglobin
      concentration in critically ill children. Data from at least 30 patients admitted to the
      Pediatric Intensive Care Unit (PICU) over a period of 2 months will be collected and analyzed
      for this study.

      Note, that this device would not lead to deviations in routine patient care; specifically,
      the non-invasive monitor placed on the patient's finger is FDA approved. The proposed
      monitors are identical macroscopically to monitors, which are currently used to measure
      oxygen saturation at this institution. Clinical decisions, additional blood draws or
      alterations to the plan of care will not be made based on study data. The objective is to
      compare the validity of the hemoglobin values determined from non-invasive technology with
      measured laboratory values for hemoglobin utilized as standard of care.
    

Intervention name(s): Masimo Pronto Rad 7 Non-Invasive hemoglobin monitor; Standard Laboratory Blood Draw and Hemoglobin Analysis
Intervention type(s): Other; Other
Intervention description(s): Patients admitted to PICU requiring hemoglobin monitoring will have a total hemoglobin (SpHb) assessment from Masimo non-invasive monitor, prior to standard, required blood draw and laboratory analysis.; Patients admitted to PICU requiring hemoglobin monitoring will have a reading from Masimo non-invasive monitor, prior to standard, required blood draw and laboratory analysis.
Other intervention name(s): Rainbow adhesive sonsor R1 20L; Rainbow reusable spot check sensor DCIP SC-200; Rainbow reusable spot check sensor DCI SC-200
Intervention MeSH terms: Chrysarobin
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        pediatric patients admitted to the PICU requiring hemoglobin monitoring
      
Keywords: Pediatric critically ill; Masimo; hemoglobin; monitoring; UNC; PICU
The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese Healthy Subjects
Condition: Healthy
Study type: Interventional

Summary: 
      The Effect of Ethnic on Moxifloxacin Induced QT Interval Prolongation in Korean and Japanese
      Healthy Subjects
    

Detailed description: 
      The purpose of this study is to explore the ethnic and gender difference in the Moxifloxacin
      induced QT interval prolongation between Japanese and Korean subjects.
    

Intervention name(s): Moxifloxacin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): single oral administration of 400mg of moxifloxacin; single oral administration of 400mg of placebo
Other intervention name(s): Avelox; Lactose
Intervention MeSH terms: Moxifloxacin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Health Services Research
Keywords: Moxifloxacin; QT interval prolongation; Korean; Japanese
A Study of Adalimumab for the Induction of Clinical Remission in Japanese Subjects With Crohn's Disease
Condition: Crohn's Disease
MeSH terms: Crohn Disease
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to demonstrate the efficacy and safety of adalimumab for the
      induction of clinical remission in Japanese subjects with Crohn's disease.
    


Intervention name(s): adalimumab; adalimumab; placebo
Intervention type(s): Biological; Biological; Biological
Intervention description(s): 160 mg at Week 0, 80 mg at Week 2; 80 mg at Week 0, 40 mg at Week 2; Placebo at Week 0 and Week 2
Other intervention name(s): ABT-D2E7; Humira; ABT-D2E7; Humira
Intervention MeSH terms: Adalimumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Optical Coherence Tomography (OCT) Trial in Multiple Sclerosis
Condition: Multiple Sclerosis; RRMS
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      This is a 3-year, pharmacologically non-interventional study to evaluate OCT as an outcome
      measure in patients with relapsing remitting multiple sclerosis (RRMS).

      Approximately 350 RRMS patients, either untreated or treated with an approved MS
      disease-modifying therapy and approximately 70 reference subjects without ophthalmologic or
      neurologic disease are enrolled. No study medications are provided. Patients on
      disease-modifying therapy are treated according to the local prescribing information. For
      each MS patient and each reference subject, the study consists of Screening (up to 1 month),
      Baseline, and a 36-month longitudinal data collection phase. Eligibility will be confirmed
      during Screening.
    


Intervention name(s): Observational
Intervention type(s): Other
Intervention description(s): Observational
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Multiple Sclerosis patients and healthy volunteers
      
Keywords: Multiple sclerosis,; MS,; Optical coherence tomography; OCT,; RRMS
A Study to Evaluate the Pharmacokinetics of VI-0521 in Subjects With Hepatic Impairment
Condition: Hepatic Impairment
MeSH terms: Liver Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is designed to determine the effects of a single dose of the study medication in
      subjects with and without hepatic impairment. 18 to 24 subjects will participate by having
      multiple blood draws taken to measure the level of study medication in their blood over time.
    

Detailed description: 
      This study will look at the effect of a single does of study medication in three groups. Each
      group will have 6 - 8 subjects with similar levels of hepatic impairment. Group 1 will have
      normal hepatic function. Groups 2 and 3 will be made up of subjects with mild to moderate
      hepatic impairment. Subjects will have blood taken at specific intervals to measure study
      medication levels. Subject participation will last approximately 7 to 9 days.
    

Intervention name(s): Phentermine and Topiramate
Intervention type(s): Drug
Intervention description(s): Each subject will be dosed with a single oral dose of VI-0521 (PHEN/TPM 15/92 mg).
Intervention MeSH terms: Topiramate; Phentermine
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pharmacokinetics
The Effects of Attention Retraining in MS
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational

Summary: 
      The purpose of this study is to determine whether neuropsychological rehabilitation focused
      on attention retraining and teaching compensatory strategies has positive effects on
      cognitive performance, quality of life (QoL)and perceived cognitive deficits in patients with
      MS. The hypothesis is that the neuropsychological intervention shows positive effects on
      cognitive performance, QoL and perceived cognitive deficits.
    

Detailed description: 
      Background: Cognitive impairments are a typical manifestation of multiple sclerosis (MS).
      According to previous studies, neuropsychological rehabilitation may improve cognitive
      performance in MS. However, the quality of previous studies is low and, accordingly, the
      evidence on the effects of neuropsychological rehabilitation is low to modest.

      Objective: To study whether neuropsychological rehabilitation improves cognitive performance,
      QoL and perceived cognitive deficits in patients with MS.

      Methods: Altogether 100 patients with MS are randomised either to intervention or to control
      group in three different study sites. All the study subjects are assessed with
      neuropsychological tests as well as self-rating questionnaires evaluating mood, QoL,
      cognitive deficits, fatigue and impact of the disease at baseline, after three months
      (immediately after intervention) and after six months. Patients in the intervention group are
      offered with neuropsychological rehabilitation conducted once a week during thirteen weeks.
      Patients in the control group do not receive any intervention.

      Results: The effects of intervention on cognitive performance, QoL and perceived cognitive
      impairments are evaluated using appropriate statistical procedures and comparing the
      differences between the intervention and the control group.

      The present status: The baseline assessments have been performed and the intervention will be
      conducted between September and December, 2011.
    

Intervention name(s): neuropsychological rehabilitation
Intervention type(s): Behavioral
Intervention description(s): attention retraining and teaching compensatory strategies as well as offering psychological support to better cope with cognitive impairments (13 times 60 minutes, once per week during 13 weeks)
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with MS are collected from community by informing about the study via information
        letters send to the members of local MS Associations
      
Biospecimen description: 
      A randomised, controlled, single-blind study
    
Keywords: neuropsychological; rehabilitation; multiple sclerosis; RCT study
Coronary Artery Calcium and Cardiovascular Risk Factors Analysis After RT or Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This is a no-profit, national, monocenter, retrospective, and prospective low-intervention
      study. It is a low-intervention study in terms of diagnostic additional procedure (CT scan).
      It is planned to recruit a maximum of 100 women diagnosed with early-stage breast cancer and
      treated with adjuvant breast radiotherapy from 2010 to 2017 at the European Institute of
      Oncology who meet all the inclusion and exclusion criteria. The aim of the Study is to
      analyze a population of breast cancer patients treated by adjuvant whole breast radiotherapy
      to identify the most important cardiovascular (CV) risk factors linked to coronary artery
      disease (CAD) development, in a cure-without-complications oncology strategy.
    

Detailed description: 
      In the present study a pre-screening activity is planned, that will be conducted by the
      European Institute of Oncology (IEO) at the Division of Radiotherapy. It will be done to
      identify and select from the IEO's database about 100 women diagnosed with early-stage breast
      cancer and treated with adjuvant breast radiotherapy, from 2010 to 2017, and with a > 5 years
      clinical Follow up (FU). All patients, who present pre-specified RT treatment, in terms of
      radiation exposure, and radiation protocol (IORT excluded as well as previous RT treatments),
      will be proposed to participate in the Study. The researcher of the IEO will contact by phone
      each identified patient (eligible patients) to request her interest in participating in the
      present study and to obtain her availability to be contacted by the Investigator of Centro
      Cardiologico Monzino (CCM) to define all aspects and activities planned in the protocol.

      Patients who meet all eligibility criteria, after signing the informed consent form, at
      Centro Cardioogico Monzino, will be enrolled in the study. After execution of the CT scan the
      patient will be contacted to discuss the CT scan result. In case of high calcium score
      values, patients will be performing a cardiological medical examination, ECG, and further
      diagnostic investigations, as clinically indicated.
    

Intervention name(s): CT scan and blood sample collection
Intervention type(s): Diagnostic Test
Intervention description(s): Each enrolled patient performs:
preventive clinical cardiology assessment visit, addressed to individualized risk profile assessment and addressed to chest CT scan.
a blood sampling (1 citrate tube of 5 ml) will be done the same day just the chest CT scan and analyzed locally also for future research of biomarker discovery (single sample, for those patients who agree in ICF)
CT scan
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Keywords: Breast cancer; Coronary Artery Disease; Calcium Score; Radiotherapy; Cardiovascular events; CV risk factors; Cardio-oncology
A Study of EDP1066 in Healthy Participants and Participants With Mild to Moderate Psoriasis and Atopic Dermatitis
Condition: Psoriasis; Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Psoriasis; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 1

Summary: 
      Evelo will investigate the safety and tolerability of EDP1066 and its potential to be a
      medicinal product in healthy volunteers and individuals with mild to moderate psoriasis and
      atopic dermatitis.
    

Detailed description: 
      This will be a randomized, double-blind, placebo-controlled clinical study with dose
      escalations to assess safety, tolerability, and pharmacodynamic effect of EDP1066. Since this
      clinical study is the first study in humans, the participants will be healthy volunteers or
      subjects with mild to moderate psoriasis or atopic dermatitis who are otherwise well.
      Investigation of EDP1066 in this patient population provides an opportunity to gain
      pharmacodynamic information using a range of tissue biopsies and composite clinical
      endpoints.
    

Intervention name(s): EDP1066; Placebo oral capsule
Intervention type(s): Other; Drug
Intervention description(s): EDP1066 is an orally administered monoclonal microbial; placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Intervention model description: The study is a double-blind dose escalation cohort study in healthy volunteers and participants with either mild to moderate psoriasis or mild to moderate atopic dermatitis. The study consists of 9 cohorts and will test doses of EDP1066 versus placebo. The safety and tolerability of EDP1066 will be tested in participants with psoriasis and atopic dermatitis alongside pharmacodynamic effects on the systemic immune system and observation of any clinical effects.
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Assessment of the Antiviral Effect of Atorvastatin on Hepatitis C Virus
Condition: Hepatitis C
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      We hypothesize that atorvastatin will decrease HCV viral load in patients taking the
      medication.

      Cholesterol is needed for HCV virion production. Cell culture studies have shown that
      atorvastatin (an HMG-CoA reductase inhibitor) decreases HCV viral replication. As
      atorvastatin has been proven to decrease heart attack and stroke in patients with high
      cholesterol, this medication is indicated for the treatment of elevated cholesterol in at
      risk individuals. Therefore we propose to study the effect atorvastatin has on the viral load
      of patients initiated on atorvastatin therapy for their elevated cholesterol.
    

Detailed description: 
      Men and women ages 30 to 80 infected with HCV viremia whose physician has determined need
      cholesterol lowering medication will be recruited by the study investigators from
      Massachusetts General Hospital.

      The study investigators will approach the potential subject after the referring doctor has
      ascertained that the potential subject is interested in meeting with the investigator.

      Each subject who consents will undergo phlebotomy of 10 cc of blood three times. Once prior
      to the initiation of atorvastatin to measure the patients viral load. In addition, patients
      will undergo phlebotomy 4 and 12 weeks after the initiation of atorvastatin. The week 12
      phlebotomy is required in all patients started on atorvastatin to monitor for side effects.
      Therefore patients who enroll in this study will undergo one additional phlebotomy. As part
      of our study an extra 10 cc of blood will be taken at these times to measure the patients HCV
      viral load.
    

Intervention name(s): 20 mg of atorvastatin daily
Intervention type(s): Drug
Intervention MeSH terms: Atorvastatin
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Hepatitis C; viral load; antiviral therapy; cholesterol; atorvastatin
Can Passive Leg Raise Prevent Spinal Anesthesia-induced Hypotension During Cesarean Section?
Condition: Hypotension
MeSH terms: Hypotension
Study type: Interventional

Summary: 
      All over the world, spinal anesthesia is widely used in cesarean sections due to its
      superiority over general anesthesia. Due to reasons such as increased sensitivity to local
      anesthetics and increased intra-abdominal pressure in pregnant women, the frequency of
      hypotension increases by up to 70%. As a result of the blockage of sympathetic
      vasoconstrictor fibers originating from T1-L2 segments, loss of peripheral resistance, venous
      ponding occurs, and cardiac output decreases. Also, the level required for cesarean operation
      is T4 or T5, and the possibility of affecting the cardiac accelerator fibers, so bradycardia
      due to the increase in parasympathetic activity may deepen the hypotension. If postspinal
      hypotension is not managed correctly, it may lead to maternal and fetal complications. In
      addition to classical methods such as fluid loading and prophylactic vasoconstrictor
      application to prevent hypotension in pregnant women after spinal anesthesia, techniques such
      as wrapping the lower extremity, lifting, or applying both together have been in question.

      Passive leg raise application is an easy method that allows the blood collected in the lower
      part of the body to participate in the central circulation with the effect of gravity. An
      increase in venous return occurs with the passage of blood from the lower extremities to the
      thorax. Thus, it leads to an increase in stroke volume and an increase in cardiac output. In
      this study, we aimed to determine the effectiveness of passive leg raising in preventing or
      reducing the depth of hypotension after spinal anesthesia in pregnant women who underwent
      cesarean section under spinal anesthesia.
    


Intervention name(s): Passive leg Raise; control
Intervention type(s): Other; Other
Intervention description(s): The intervention will be performed immediately after spinal anesthesia, and passive leg raise will be performed using two standard pillows placed under the heel so that the leg is approximately 30 cm above the horizontal plane of the table. The passive leg raising position will continue until the cord is clamped.; The controlled group was positioned in the normal supine position.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: cesarean section; hypotension; spinal anesthesia; passive leg raise
Research of Biomarkers in Duchenne Muscular Dystrophy Patients
Condition: Duchenne Muscular Dystrophy (DMD)
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne
Study type: Observational

Summary: 
      The purpose of this study is to identify potential biomarkers for the diagnosis, disease
      progression assessment and response to treatment in patients with Duchenne Muscular
      Dystrophy.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        patients with Duchenne Muscular Dystrophy controls (healthy or patients with a non-related
        disease)
      
Biospecimen description: 
      DNA, serum, t lymphocytes, urine
    
Keywords: Duchenne Muscular Dystrophy; biomarkers; transcriptomics; mironics; proteomics
This Study Will Evaluate The Relationship Between Plasma Drug Levels And Receptor Binding In Brain Using PET (Positron Emission Tomography) In Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the relationship between plasma drug levels and
      receptor binding in brain using PET; and to evaluate safety and tolerability after a single
      administration of PF-05212377 in healthy volunteers
    


Intervention name(s): PF-05212377
Intervention type(s): Drug
Intervention description(s): Single dose of up to 70 mg PF-05212377, delivered as .25 mg, 5 mg and/or 15 mg on study day 1
Other intervention name(s): SAM-760
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Healthy Volunteers