bioihbjkbjnl/mcl2 huggingface dataset:
A Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy Study of TPI-287 in Alzheimer's Disease
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine the highest dose of TPI-287 that is safe and
      tolerable when administered as an intravenous infusion to participants with mild to moderate
      Alzheimer's disease (AD), to measure pharmacokinetic properties of the drug as well as to
      gauge preliminary efficacy of TPI-287 on disease progression.
    

Detailed description: 
      The maximum tolerated dose of TPI-287 will be determined through a planned dose escalation
      over 3 sequential cohorts, each comprising of 11 participants randomized to either TPI-287 or
      placebo. TPI-287 or placebo will be administered as an intravenous infusion once every 3
      weeks for 9 weeks, for a total of 4 infusions. Participants who successfully complete this
      phase will have the option of entering into the open label extension phase during which
      TPI-287 will be administered once every 3 weeks for an additional 6 weeks, for a total of 3
      extra infusions.

      Pre-medication of diphenhyramine 25 mg (Benadryl) will be given IV within 30 to 60 minutes
      prior to each study infusion in the study.

      Safety and tolerability will be assessed through reporting of adverse events, physical and
      neurological testing, ECGs, as well as blood and urine analyses. Baseline and end-point
      measures of cognition and function, MRI brain scans, and cerebrospinal fluid (CSF) biomarker
      analyses will be used to determine preliminary efficacy of TPI-287 in mild-moderate AD.
      Pharmacokinetic and pharmacodynamic properties of TPI-287 will be calculated from blood
      plasma collected after the first infusion, and from CSF collected on the last visit of the
      placebo-controlled phase.
    

Intervention name(s): TPI-287 2 mg/m2; TPI-287 6.3 mg/m2; TPI-287 20 mg/m2; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 mg/m2 of TPI-287 diluted with 500mL 0.9% sodium chloride. TPI-287 is a microtubule inhibitor belonging to the taxane diterpenoid (taxoid) family, and specifically to the abeotaxane class.; 6.3 mg/m2 of TPI-287 diluted with 500mL 0.9% sodium chloride. TPI-287 is a microtubule inhibitor belonging to the taxane diterpenoid (taxoid) family, and specifically to the abeotaxane class.; 20 mg/m2 of TPI-287 diluted with 500mL 0.9% sodium chloride. TPI-287 is a microtubule inhibitor belonging to the taxane diterpenoid (taxoid) family, and specifically to the abeotaxane class.; 500mL 0.9% sodium chloride.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Other
Keywords: Alzheimer's disease; mild to moderate
Safety, Tolerability, and Antiviral Activity of ANA598 in Patients With Genotype-1 Chronic HCV Infection
Condition: Chronic Hepatitis C
MeSH terms: Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to investigate the safety, tolerability, and antiviral activity
      of ANA598 in patients with genotype-1 chronic hepatitis C infection.
    

Detailed description: 
      The safety, tolerability and antiviral activity of ANA598, administered orally twice daily
      for 3 days, will be compared to placebo in treatment-naïve subjects chronically infected with
      HCV genotype 1 infection. Thirty (30) subjects will be randomized to one of three cohorts
      described above. The ten patients in each cohort will be randomized 8 active: 2 placebo. At
      least 5 subjects with genotype 1a and 5 subjects with genotype 1b will be enrolled within
      each cohort.
    

Intervention name(s): ANA598 200 mg bid or placebo; ANA598 400 mg bid or placebo; ANA598 800 mg bid or placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): ANA598 200 mg bid or placebo; ANA598 400 mg bid or placebo; ANA598 800 mg bid or placebo
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: HCV
Soy Protein Intake and the Metabolic Syndrome
Condition: Metabolic Syndrome X
MeSH terms: Metabolic Syndrome; Syndrome
Study type: Interventional

Summary: 
      Soy protein has a high biological value, and contains several potential health-related
      nutritional factors, i.e. its amino acids pattern, biological active peptides and non-protein
      compounds such as isoflavones. In the field of obesity and blood lipids soy protein is
      well-studied and appreciated; it improves circulating blood lipids and is associated with
      weight reduction. The effect of soy on insulin resistance, glucose homeostasis and the
      metabolic syndrome is less frequently studied. However, several molecular mechanisms of
      action of soy protein make it a promising approach.
    

Detailed description: 
      Objective: The primary objective of the present study is to evaluate the effect of a high soy
      protein diet on insulin resistance and glycemic control in participants with characteristics
      of the metabolic syndrome. Secondly, the present study will evaluate whether reduced
      low-grade inflammation is a possible mechanism underlying the improvement in insulin
      resistance and glucose homeostasis. Finally, it will be assessed whether soy protein has
      beneficial effects on components of the metabolic syndrome, such as cardio-metabolic risk
      factors, blood lipid profile, blood pressure and endothelial function, fat storage in the
      liver and gene-expression in subcutaneous abdominal adipose tissue.

      Study design: Single-blind, cross-over strictly-controlled dietary intervention.
    

Intervention name(s): Soy protein diet; Control diet
Intervention type(s): Other; Other
Intervention description(s): 4 weeks high protein diet (20 en%) with 25gr of soy protein per day; 4 weeks high mixed protein diet (20 en%)
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Prevention
Azilsartan in Chinese Patients With Mild and Moderate Hypertension
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      A phase 3 clinical study to evaluate the safety and efficacy of Azilsartan in Chinese
      hypertension patients
    


Intervention name(s): Azilsartan tablets; Azilsartan placebo tablets; Olmesartan medoxomil tablets; olmesartan medoxomil placebo tablets
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 20mg/tablet; placebo tablet; 20mg/tablet; placebo tablet
Intervention MeSH terms: Olmesartan; Olmesartan Medoxomil; Azilsartan medoxomil
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Neurotrack Virtual Cognitive Health Study
Condition: Subjective Cognitive Decline
MeSH terms: Cognitive Dysfunction
Study type: Interventional

Summary: 
      The Neurotrack Virtual Cognitive Health Study is a 12-month long, prospective study that aims
      to evaluate the impact of the Neurotrack Virtual Cognitive Health Coaching Program on
      cognitive ability, anxiety and depression, and lifestyle behaviors for individuals who show
      signs of subjective cognitive decline.
    


Intervention name(s): Neurotrack Virtual Cognitive Health Program
Intervention type(s): Behavioral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Norepinephrine Versus Phenylephrine Continuous Variable Infusion in Cesarean Delivery
Condition: Cesarean Section Complications; Spinal Anesthesia
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison will be conducted between continuous variable infusions of Phenylephrine with
      starting dose of 0.75 mcg/Kg/min and Norepinephrine Bitartrate with starting dose of 0.1
      mcg/Kg/min (with norepinephrine base of 0.05 mcg/Kg/min) for prophylaxis against Post-spinal
      hypotension during cesarean delivery
    

Detailed description: 
      Maternal hypotension is a common complication after spinal anesthesia for cesarean delivery
      (CD). Many vasopressors have been used for prevention of post-spinal hypotension (PSH) during
      CD; however, the optimum protocol for prophylaxis is not established yet. Phenylephrine (PE)
      is a popular vasopressor used in obstetric anesthesia; however, its use is limited by its
      marked cardiac depressant nature. Norepinephrine (NE) is a potent vasopressor characterized
      by both α adrenergic agonistic activity in addition to a weak β adrenergic agonistic
      activity; thus, NE is considered a vasopressor with minimal cardiac depressant effect; these
      pharmacological properties would make NE an attractive alternative to PE. In this study, the
      investigators will compare continuous variable infusion of both drugs (PE and NE) with doses
      of 0.75 mcg/Kg/min and 0.05 mcg/Kg/min respectively for prophylaxis against PSH during CD. We
      used Norepinephrine Bitartrate 8 mg ampules which contains norepinephrine base of 4 mg.
    

Intervention name(s): Phenylephrine; Norepinephrine; Bupivacaine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Phenylephrine variable infusion with a starting rate of 0.75 mcg/Kg/min.; Norepinephrine bitartrate variable infusion with a starting rate of 0.1 mcg/Kg/min (equivalent to norepinephrine base of 0.05 mcg/Kg/min).; Bupivacaine will be injected in the subarachnoid space with a dose of 10 mg.
Other intervention name(s): Levophed; Marcaine
Intervention MeSH terms: Phenylephrine; Oxymetazoline; Norepinephrine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Prevention
Phase I Study of INO-1800 With or Without INO-9112 + EP in Chronic Hepatitis B Subjects
Condition: Hepatitis B
MeSH terms: Hepatitis A; Hepatitis B; Hepatitis B, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 1

Summary: 
      This was an open-label study that evaluated the safety, tolerability, and immunogenicity of
      dose combinations of INO-1800 (DNA plasmids encoding Hepatitis B surface antigen [HBsAg] and
      Hepatitis B core antigen [HBcAg]) and INO-9112 (DNA plasmid encoding human interleukin 12)
      delivered by electroporation (EP) in 90 (ninety) nucleos(t)ide analogue treated participants.
    


Intervention name(s): INO-1800; INO-9112; Nucleos(t)ide Analogue Treatment
Intervention type(s): Biological; Biological; Drug
Intervention description(s): INO-1800 delivered by EP; INO-9112 delivered by EP; Continued treatment with nucleos(t)ide analogue
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Chronic HBV; immunotherapy; DNA vaccine; electroporation
A Study of Response-Guided Duration of Combination Therapy With GS-9190, GS-9256, Pegasys® and Copegus® in Previously Untreated Subjects With Genotype 1 Chronic Hepatitis C
Condition: Chronic Hepatitis C Infection
MeSH terms: Infections; Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis; Hepatitis, Chronic
Study type: Interventional
Phase: Phase 2

Summary: 
      This phase 2b study will evaluate the efficacy and safety of 16 and 24 weeks of
      response-guided duration of therapy with GS-9190 and GS-9256 in combination with
      Peginterferon Alfa-2a (Pegasys®) and Ribavirin (Copegus®). Additionally, the efficacy and
      safety of 24 weeks of GS-9256 in combination with Peginterferon Alfa-2a (Pegasys®) and
      Ribavirin (Copegus®) will be evaluated.
    


Intervention name(s): GS-9190; GS-9256; Pegasys®; Copegus®; GS-9190 placebo; GS-9256; Pegasys®; Copegus®; GS-9190 placebo; GS-9256 placebo; Pegasys®; Copegus®
Intervention type(s): Drug; Drug; Biological; Drug; Drug; Drug; Biological; Drug; Drug; Drug; Biological; Drug
Intervention description(s): GS-9190 capsule, 20 mg BID, 16 or 24 weeks; GS-9256 capsule, 150 mg BID, 16 or 24 weeks; peginterferon alfa-2a, (solution for injection) 180 µg/week, up to 48 weeks; ribavirin 200 mg tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day >/= 75 kg) divided twice daily (BID), up to 48 weeks; placebo matching GS-9190 capsule BID, 24 weeks; GS-9256 capsule, 150 mg BID, 24 weeks; peginterferon alfa-2a (solution for injection) 180 µg/week, up to 48 weeks; ribavirin 200 mg tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day >/= 75 kg) divided twice daily (BID), up to 48 weeks; placebo matching GS-9190 capsule BID, 24 weeks; placebo matching GS-9256 capsule BID, 24 weeks; peginterferon alfa-2a (solution for injection) 180 µg/week, 48 weeks; ribavirin 200 mg tablet (weight based: 1000 mg/day <75 kg; 1200 mg/day >/= 75 kg) divided twice daily (BID), 48 weeks
Intervention MeSH terms: Peginterferon alfa-2a; Interferon-alpha; Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hepatitis C; HCV; Rapid Virologic Response; Sustained Virologic Response; Direct Acting Antiviral; Combination Therapy; HCV RNA; Polymerase inhibitor; Protease inhibitor; Treatment naïve; GS-9190; GS-9256
Optical Nerve Sheath Changes During Head Down Laparoscopy
Condition: Intracranial Hypertension; Brain Edema; Pneumoperitoneum; Surgery, Laparoscopic
MeSH terms: Pneumoperitoneum; Intracranial Hypertension; Brain Edema
Study type: Observational

Summary: 
      Patient undergoing laparoscopic radical prostatectomy in steep trendelenburg position are at
      risk to develop complication from brain edema.

      Ultrasound assessment of optical nerve sheath diameter is a simply, non-invasive method to
      estimate the increase of intracranial pressure. It is unknown how optical nerve sheath
      diameter changes after prolonged head down position.
    


Intervention name(s): Optical nerve sheath diameter ultrasound measurement
Intervention type(s): Diagnostic Test
Intervention description(s): In cases: ultrasound measurement of the diameter of the optical nerve sheath at (T1) baseline before the induction of general anesthesia (5 min after the beginning of mechanical ventilation in supine position); (T2) after 10 min from 25 degrees head down positioning and with pneumoperitoneum insufflation; (T3) after 60 min from T2, in head down position; (T4) after 10 min from tracheal tube removal, in supine position.
In healthy controls: ultrasound measurement of the diameter of the optical nerve sheath at (T1) baseline in supine position; (T2) after 10 min from 25 degrees head down positioning; (T3) after 60 min from T2, in a head down position; (T4) after 10 min from positioning supine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients undergoing elective laparoscopic radical prostatectomy
Gender Differences in the Tolerance to Stretch
Condition: Range of Motion, Articular; Muscle Stretching Exercises
Study type: Observational

Summary: 
      The effect of stretching on range of motion is believed to rely upon an increased tolerance
      to stretch. This suggests, that pain modulation has significance in regards to the effect of
      stretching.
    

Detailed description: 
      Given that there may be differences in the way men and women perceive a painful stimulus,
      this suggests that there may be potential gender differences in the tolerance to stretch
      following stretching.
    

Intervention name(s): Muscle stretching exercises
Intervention type(s): Other
Intervention description(s): Muscle stretching exercises consisting of static stretching exercises of the knee flexors
Observational model: Case-Control
Time perspective: Cross-Sectional
Sampling method: Probability Sample
Study population: 
        Healthy male and female volunteers between the ages of 18 to 45 are eligible for
        participation.
Effects of a Resistance Training Period on Blood Pressure of Hypertensive Elderlies: Influence of the Polymorphism of the Angiotensin Converting Enzyme
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional

Summary: 
      The study aimed to evaluate the chronic effects of resistance training on blood pressure and
      biochemical exams in hypertensive elderlies and the influence of the polymorphism of the
      angiotensin converting enzyme in these response.
    

Detailed description: 
      To investigate the chronic effects of resistance training on blood pressure and biochemical
      exams in elderly, 135 hypertensive elderlies were divided into 2 groups: trained and control.
      The trained group was submitted to a resistance training period. Before the 16 weeks ACE gene
      was genotyped (PCR). Before and after 16 weeks, blood pressure (ambulatory), HDL-cholesterol,
      Total cholesterol, Glycemia, Triacylglycerol (colorimetric assay) and plasminogen activator
      inhibition (PAI-1), intercellular adhesion molecule (ICAM-1), vascular endothelial cell
      adhesion molecule (VCAM-1), Adiponectin, tumor necrosis factor alpha (TNF-alpha), C Reactive
      Protein, Angiotensin II, Angiotensin Converting Enzyme, Angiotensin 1-7, (ELISA assay) were
      measured.
    

Intervention name(s): Resistance training
Intervention type(s): Behavioral
Intervention description(s): Resistance training performed three times at week for 16 weeks, in 8 exercises for the main muscles, the protocol of 3 sets of 10 repetitions with intensity of 50% of 1 maximum repetition (MR).
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Observational Program of Zemplar in Patients With End Stage Chronic Kidney Disease and Parathyroid Disorder on Hemodialysis in the Russian Federation
Condition: Secondary Hyperparathyroidism
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Study type: Observational

Summary: 
      Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at
      thirteen sites in Russia. Planned therapy will be six months. Participants with Stage 5
      Chronic Kidney Disease and with hyperparathyroidism on hemodialysis will be included into the
      study. Ability of Zemplar, (paricalcitol) to lower intact Parathyroid Hormone level will be
      assessed during the study.
    

Detailed description: 
      Eighty-six eligible participants with secondary hyperparathyroidism will be enrolled at
      thirteen sites in Russia. Study drug will be administered per local prescribing guidelines.
      Planned therapy is six months. Intact Parathyroid Hormone will be measured at the Screening
      visit. All participants who meet the inclusion criteria and fail to meet the exclusion
      criteria will be included in the study.

      Adverse events will be monitored throughout the observation period (and up to 30 days after
      the last dose of Zemplar).

      Ability of Zemplar to lower intact Parathyroid Hormone level will be assessed throughout the
      study. Proportion of participants with the level of intact Parathyroid Hormone 150 - 300
      pg/mL was stated as primary endpoint. Calcium and Phosphorus elevation will be also measured
      throughout the study.

      The selected population is representative in relation to those who will take Zemplar in
      routine practice. Participants with contraindications to Zemplar therapy (as per the local
      label) will not be included in the study.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hemodialysis centers
      
Keywords: Secondary Hyperparathyroidism; Chronic Renal Insufficiency
ANAVEX2-73 Study in Parkinson's Disease Dementia
Condition: Parkinsons Disease With Dementia
MeSH terms: Parkinson Disease; Dementia
Study type: Interventional
Phase: Phase 2

Summary: 
      A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Safety,
      Tolerability, and Efficacy of ANAVEX2-73 for Cognitive Impairment in Patients with
      Parkinson's Disease with Dementia (PDD)
    

Detailed description: 
      This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group,
      three-arm, 14-week study in PD patients with dementia. The study includes a 2 week Screening
      / Baseline Observation Period and a 14-week Treatment Period (including a 2 week Titration
      Period), and a 2-week Safety Follow-Up Period
    

Intervention name(s): High dose ANAVEX2-73; Mid dose ANAVEX2-73; Placebo oral capsule
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Active oral capsule; Active oral capsule; Placebo oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Femoral Remodeling Following Total Hip Arthroplasty With OMNI Apex Modular™ and OMNI Apex ARC™ Stem Compared to Competitive Designs
Condition: Osteoarthritis, Hip
MeSH terms: Osteoarthritis, Hip
Study type: Observational

Summary: 
      This study compares the change in bone density which occurs after hip replacement with
      different femoral stem devices.
    


Intervention name(s): OMNI Apex Modular™ Hip Device; OMNI Apex ARC™ Hip Device
Intervention type(s): Device; Device
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adult patients undergoing elective total hip arthroplasty
      
Keywords: Total Hip Arthroplasty; Bone Loss; Femoral Remodeling; Bone mineral density; THA; DXA; DEXA; Dual Energy X-Ray Absorptiometry