bioihbjkbjnl/mcl2 huggingface dataset:
Monoclonal Antibody Against PCSK9 to Reduce Elevated Low-density Lipoprotein Cholesterol (LDL-C) in Adults Currently Not Receiving Drug Therapy for Easing Lipid Levels
Condition: Hyperlipidemia
MeSH terms: Hyperlipidemias
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG
      145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change
      from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia.
    


Intervention name(s): Evolocumab; Ezetimibe; Placebo to Evolocumab
Intervention type(s): Biological; Drug; Other
Intervention description(s): Administered by subcutaneous injection; Administered orally once a day; Administered by subcutaneous injection
Other intervention name(s): AMG 145; Repatha; Zetia
Intervention MeSH terms: Ezetimibe; Evolocumab; Antibodies, Monoclonal
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: High cholesterol; Proprotein convertase subtilisin/kexin type 9 (PCSK9); Treatment for high cholesterol; Lowering cholesterol; Lowering high cholesterol; Hypercholesterolemia
Neoadjuvant Chemotherapy Versus Radiochemotherapy for Cancer of the Esophagus or Cardia
Condition: Carcinoma, Squamous Cell; Adenocarcinoma of the Esophagus and Gastric Cardia
MeSH terms: Adenocarcinoma; Carcinoma, Squamous Cell; Esophageal Neoplasms
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this randomized study is to clarify if neoadjuvant radiochemotherapy gives a
      higher degree of complete histological response than neoadjuvant chemotherapy before surgery
      in patients undergoing treatment for cancer of the esophagus or cardia.
    


Intervention name(s): Chemotherapy; Radiochemotherapy
Intervention type(s): Drug; Radiation
Intervention description(s): Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values.; Cisplantin 100 mg/m2 day 1. 5-fluoracil 750 mg/m2/24 hours infusion day 1-5. Three cycles. In the chemoradiation arm the radiotherapy start week 4 and continuing until week 7. Dose adjustet according to current LPK and TPK values.
Other intervention name(s): Suffering moderate/severe hearing impairment and/or tinnitus cisplatin can be replaced. If adenocarcinoma oxaliplatin.If squamos cell carcinoma carboplatin.; Suffering moderate/severe hearing impairment and/or tinnitus cisplatin can be replaced. If adenocarcinoma oxaliplatin.If squamos cell carcinoma carboplatin.
Intervention MeSH terms: Cisplatin; Carboplatin; Oxaliplatin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Histologically confirmed squamos cell carcinoma or adenocarcinoma of the esophagus and gastric cardia.Suitable for surgery.
Safety, Tolerability, and Pharmacokinetics of a Subcutaneous and Intravenous Dose of BI 655130 in Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary objective of this trial is to investigate the relative bioavailability of BI
      655130 following subcutaneous administration (Test, T) compared to BI 655130 following
      intravenous infusion (Reference, R).

      The secondary objective is the evaluation and comparison of several pharmacokinetic
      parameters between all tested treatments.
    


Intervention name(s): BI 655130
Intervention type(s): Drug
Intervention description(s): single dose
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Popliteal Block for Postoperative Pain in Knee-ankle Soft Tissue Surgery in Cerebral Palsy
Condition: Postoperative Pain; Cerebral Palsy
MeSH terms: Cerebral Palsy; Pain, Postoperative
Study type: Interventional

Summary: 
      Popliteal block is a technique for providing postoperative pain management in children. In
      this randomized double-blinded study, the investigators evaluated the effects of preoperative
      popliteal nerve block on postoperative pain and analgesic requirement in children with
      cerebral palsy (CP) undergoing knee-anckle soft tissue surgery. The Wong Baker faces scale
      and skin conductance fluctuations will be assessed.
    

Detailed description: 
      Sevoflurane will be used for anesthesia induction and maintance. Laryngeal mask airway will
      be placed without neuromuscular blocking agent. In group P (popliteal block), a single dose
      of 0.3ml.kg(-1) of 0.25% bupivacaine will be performed for popiteal nerve block (with
      ultrasound guidence). In group C ( control), only plaster cover will be applied without nerve
      block for sham procedure to provide double-blinded study. Intraoperative heart rate, mean
      arterial pressure, BIS (bispectral index) values, sevoflurane consumption will be recorded
      ten minutes interval. Wong Baker faces scale and skin conductance fluctuations will be
      recorded at postoperative 0, 10th min, 20th min , 1st h, 4th h, 12th h qnd 24th h. Total
      analgesic consumption (paracetamol orally ) will be recorded.
    

Intervention name(s): Popliteal block; Sevoflurane; Ultrasound; Plaster cover; bupivacaine; Laryngeal mask airway
Intervention type(s): Procedure; Drug; Device; Other; Drug; Other
Intervention description(s): In group P, popliteal block will be performed with ultrasound guidence.; Sevoflurane will be used to all patient's for anesthesia induction and maintenance; For recognize the nerve (sciatic nerve), ultrasound will be used in group P.; Plaster cover will be used to control group for sham procedure; Bupivacaine 0.25% will be performed for popliteal block to group P.; After anesthesia induction, laryngeal mask airway will be inserted to all patients
Intervention MeSH terms: Bupivacaine; Sevoflurane
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: nerve block
Regadenoson and Adenosine
Condition: Coronary Artery Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the study is to test the accuracy of Regadenoson to induce maximal and steady
      state hyperemia as compared to central venous infusion of adenosine for assessing fractional
      flow reserve. (adenosine is considered to be the gold standard)and to investigate the time
      intervals of maximum hyperemia induced by centrally and peripherally administered
      Regadenoson.
    


Intervention name(s): Regadenoson central -central; Regadenoson peripheral - peripheral; Regadenoson central - peripheral; Regadenoson peripheral - central; Adenosine
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention description(s): To test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the golden standard).; To test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the golden standard).; To test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the golden standard).; To test the accuracy of Regadenoson to induce maximal and steady state hyperemia as compared to central venous infusion of adenosine for assessing fractional flow reserve. (adenosine is considered to be the golden standard).; Fractional flow reserve is measured by inducing hyperaemia using central adenosine infusion.
Intervention MeSH terms: Adenosine; Regadenoson
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Coronary artery disease; Regadenoson; Adenosine; Maximal hyperemia; Fractional flow reserve; FFR
Study to Evaluate the Safety and Preliminary Efficacy of IDCT, a Treatment for Symptomatic Lumbar Intervertebral Disc Degeneration
Condition: Degenerative Disc Disease
MeSH terms: Intervertebral Disc Degeneration
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare the safety and preliminary efficacy of intradiscal
      injections of two doses of IDCT (Discogenic Cells + Sodium Hyaluronate vehicle) and two
      controls (saline, Sodium Hyaluronate vehicle) in subjects with chronic low back pain due to
      Degenerative Disc Disease (DDD) at one lumbar level from L3 to S1.
    

Detailed description: 
      This is a Phase I, first-in-human, randomized, double-blind, vehicle and placebo-controlled,
      parallel-group, multi-center study in subjects with single-level, symptomatic lumbar
      intervertebral disc degeneration (>6 months) and unresponsive to conservative therapy for at
      least 3 months. The study will compare single intradiscal injections of high and low dose
      IDCT with two control groups (saline, Sodium Hyaluronate).

      8 study visits will be completed by all subjects; screening, day 1 (injection day), week 4,
      week 12, week 26, week 52, week 72 and week 104. The subject will be assessed for safety and
      efficacy utilizing VAS and ODI questionnaires alongside radiographic evaluations. The study
      will have a 1 year follow-up and a 1 year extension period (total 2 years).
    

Intervention name(s): IDCT; Saline Solution; Sodium Hyaluronate
Intervention type(s): Biological; Drug; Drug
Intervention description(s): Discogenic Cells + Sodium Hyaluronate Vehicle; Sodium Chloride Solution; Sodium Hyaluronate Vehicle
Other intervention name(s): Progenitor Cells, Stem Cells, Allogeneic Cell Therapy; Saline injection, Placebo control; Sodium Hyaluronate injection, Hyaluronate Acid, Sodium Hyaluronate Solution Vehicle control
Intervention MeSH terms: Pharmaceutical Solutions; Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Lumbar disc degeneration; Low back pain; Intervertebral disc degeneration
Blood Flow Restriction Exercise Study
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis, Knee
Study type: Interventional

Summary: 
      This pilot study will investigate the effects of blood flow restriction (BFR) exercise for up
      to 4-6 weeks prior to total knee arthroplasty (TKA) surgery in older patients to measure
      clinical outcomes such as strength, lower extremity function, and pain.
    

Detailed description: 
      The purpose of this study is to test the feasibility and efficacy of a low-resistance
      exercise protocol with blood flow restriction (BFR) using a tourniquet in the preoperative
      period of patients awaiting TKA. BFR exercise is a new exercise method that has not been
      studied in the perioperative period. The investigators will compare our intervention to a
      no-exercise group up to 4 - 6 weeks prior to surgery to determine if this type of exercise is
      feasible in the preoperative period and if BFR exercise will improve functional,
      physiological, and molecular outcomes when compared to patients without exercise.
    

Intervention name(s): Strength testing; Short Physical Performance Battery (SPPB); Six-minute walk (SMW); Numerical pain scale; Self-assessed function; Muscle biopsies; Determination of 1 Repetition Maximum (1-RM); Blood flow restriction exercise; Borg CR10 scale
Intervention type(s): Device; Behavioral; Behavioral; Behavioral; Behavioral; Procedure; Device; Device; Behavioral
Intervention description(s): Test the strength of subject's lower extremity muscles on the dynamometer system; The SPPB is a timed short distance walk, repeated chair stands, and balance test that measures lower extremity function.; Subjects walk back and forth along a 100-ft hallway for six minutes after instructions to complete as many laps as possible.; Measure pain using an 11-point numerical pain scale.; Using the Late Life Function and Disability Instrument.; During the course of the surgery two small muscle biopsies from the quadriceps muscle of the operative leg will be collected.; Following the warm-up, subjects will attempt to complete one repetition of the leg press exercise at progressively greater resistance until a full repetition can no longer be performed. The weight of the last complete unassisted repetition will be recorded as the 1-RM.; Perform lower-extremity exercises (leg press, leg extension, leg curl, and calf extension) at an intensity of 30% of 1-RM with external compression applied to the proximal thigh of each leg.; Following each exercise session, participants will provide a rating of perceived exertion (RPE) for the session according to the Borg CR10 scale.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
Keywords: Elderly; Exercise
Dashboards for Clinician Monitoring of Patients Through a Mobile Sensing Platform
Condition: Behavioral Health With Medical Comorbidities
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the use of a mobile sensing platform in a
      primary care setting has an effect on provider workflows, patient outcomes, patient
      engagement, patient self-help behavior, health research, and total cost of care.
    


Intervention name(s): Cogito Companion Intervention; mobile phone application
Intervention type(s): Other; Device
Other intervention name(s): Cogito Mobile Sensing Platform
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Health Services Research
A Study to Assess the Effect of Intragastric pH and Fasting on the Pharmacokinetics of Gefapixant (AF-219/MK-7264)
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to: determine the effect of stomach pH on the multiple dose
      pharmacokinetics (PK) of gefapixant (AF-219); assess the effect of multiple doses of
      gefapixant on various sensory assessments; and, assess the safety and tolerability of
      gefapixant.
    


Intervention name(s): Omeprazole; Gefapixant; Gefapixant; Gefapixant
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 40 mg oral capsules administered twice daily for 8.5 days; Gefapixant oral tablet (25 mg administered as a divided 50 mg tablet) administered twice daily for 2 days; Gefapixant oral tablet (50 mg tablet) administered twice daily for 8 days; Gefapixant oral tablet (150 mg administered as three 50 mg tablets) administered twice daily for 8 days
Other intervention name(s): Prilosec; AF-219; MK-7264; AF-219; MK-7264; AF-219; MK-7264
Intervention MeSH terms: Omeprazole
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Staccato Loxapine Pulmonary Safety in Patients With COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pulmonary safety of 2 doses of Staccato Loxapine
      within a day in patients with COPD.
    

Detailed description: 
      To address the possibility that inhalation of loxapine may have adverse pulmonary effects, we
      studied two 10-mg inhaled doses of loxapine or placebo were given 10 hr apart to subjects
      with chronic obstructive pulmonary disease (COPD). The objective was to determine the time
      course and reversibility of pulmonary effects for inhaled loxapine compared with placebo.
    

Intervention name(s): Inhaled Loxapine; Inhaled Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Staccato Loxapine, 10 mg x 2 doses, 10 hours apart; Staccato Placebo, inhalations x 2 , 10 hours apart
Intervention MeSH terms: Loxapine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
Keywords: Staccato Loxapine; COPD; pulmonary safety
Efficacy and Safety Study of Ultrasound Bone Strength Device to Measure Calcaneal Bone Strength Index of Human Subjects
Condition: Clinical Trial; Comparative Effectiveness Research; Equipment Safety
Study type: Interventional

Summary: 
      The purpose of this study is to examine whether ultrasound bone strength device (Model
      Number: Oste-scan 500A) is effective and safe in measuring calcaneal bone strength index of
      human subjects, compared with a listed, similar device (Model Number: SONOST3000).
    

Detailed description: 
      This study adopt a method of multicenter, open-labeled, self-paired design. Each subject will
      be randomly assigned to two different detective sequence groups. In one group, the
      investigators will detect the same calcaneus of each subject by experimental ultrasound bone
      strength device firstly and then by control device. In another group, the investigators will
      detect the same calcaneus of each subject by control ultrasound bone strength device firstly
      and then by experimental device. Experimental ultrasound bone strength device is developed by
      Wuxi Huajian Hengchuang Medical Equipment Science and Technology Co., Ltd.. This device's
      model number is Oste-scan 500A and report number is Z-Y-2009-2014, Z-E-0530-2014(G). Control
      ultrasound bone strength device which has same clinical indications and action mechanism with
      the experimental one, is manufactured by Osteosys Co., Ltd.. This device's model number is
      SONOST3000.
    

Intervention name(s): Oste-scan 500A; SONOST3000
Intervention type(s): Device; Device
Intervention description(s): The investigators will detect the same calcaneus of each subject by experimental ultrasound bone strength device. Experimental ultrasound bone strength device's model number is Oste-scan 500A and report number is Z-Y-2009-2014, Z-E-0530-2014(G).; The investigators will detect the same calcaneus of each subject by control ultrasound bone strength device. Control ultrasound bone strength device's model number is SONOST3000.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
Antiretroviral Activity and Pharmacokinetics of Deferiprone in Healthy Volunteers and Asymptomatic HIV-infected Subjects
Condition: HIV Infection
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study was to examine the safety, efficacy, and pharmacokinetics of
      different dosages of deferiprone in subjects with or without HIV infection.
    

Detailed description: 
      Three cohorts were enrolled: two of individuals who were asymptomatically infected with HIV
      and one of healthy volunteers. Dosages were as follows:

        -  Cohort 1 (asymptomatic HIV infected subjects): 33 mg/kg deferiprone three times daily
           for a total of 99 mg/kg/day

        -  Cohort 2 (healthy volunteers): 50 mg/kg deferiprone three times daily for a total of 150
           mg/kg/day

        -  Cohort 3 (asymptomatic HIV infected subjects): 50 mg/kg deferiprone three times daily
           for a total of 150 mg/kg/day
    

Intervention name(s): Deferiprone
Intervention type(s): Drug
Intervention description(s): Oral iron chelator
Other intervention name(s): Ferriprox; L1
Intervention MeSH terms: Deferiprone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Keywords: HIV; deferiprone; iron chelation
Evaluating Serum Sex Steroid Hormones
Condition: Validation
Study type: Observational

Summary: 
      The purpose of this study is to evaluate the reproducibility of measurements of sex hormone
      levels in serum samples. Researchers will collect blood from 60 healthy adults, including 20
      men, 20 premenopausal women, and 20 postmenopausal women. Blood samples will be collected
      after study participants have fasted overnight.
    

Detailed description: 
      This evaluation of the reproducibility of serum sex steroid measurements has two components.
      The first is the evaluation of reproducibility of laboratory measurements of steroid sex
      hormones in men. This is an ancillary study to serve as a quality control (QC) measure for
      the ongoing DCEG Prostate Tissue Study (ORSH#: OH99-C-N025; principal investigator: Dr. Ann
      Hsing) so that high-quality assays can be chosen to quantify steroids in tissue. Pending
      satisfactory performance in serum, we will then evaluate the reproducibility of tissue
      hormone measurements by Gas Chromatography-Mass Spectrometry (GC-MS) or by Liquid
      Chromatography - Mass Spectrometry-(GC-MS) or by Liquid Chromatography- Mass Spectrometry-
      Mass Spectrometry (LC-MS-MS) before incorporating them into the Prostate Tissue Study. The
      second component of this study involves evaluation of the reproducibility of sex steroid
      hormone measurements in pre- and postmenopausal women. This component, although not part of
      the Prostate Tissue Study, is included in this summary because the laboratory, assay methods,
      and blood collection procedures used in the female component are identical to those in the
      male component and these two components will run in parallel.

      The present study will evaluate the reproducibility of serum sex steroid assays using two
      different assay methods in different laboratories. Specifically, the study will investigate
      assay reproducibility at Dr. Fernand Labrie's laboratory using GC-MS and LC-MSMS and at Dr.
      Frank Stanczyk's laboratory using radioimmunoassay (RIA). We propose to collect overnight
      fasting blood from 60 healthy subjects (20 men aged 50-65, 20 premonopausal women, and 20
      postmenopausal women). Once collected, the blood will be separated and aliquotted into
      multiple vials. Serum from each subject will be sent to Dr. Labrie, who will perform CG-MS or
      LC-MSMS assays, and to Dr. Stanczyk, who will perform RIA, at four different time intervals.
      Subject recruitment and blood collection will be performed by Westat. BBI Biotech will ship
      and store the specimens after they have been collected.
    

Keywords: GCMS; LCMS-MS