bioihbjkbjnl/mcl2 huggingface dataset:
African American Study of Kidney Disease and Hypertension
Condition: Hypertensive Nephrosclerosis; Chronic Renal Insufficiency
MeSH terms: Kidney Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Nephrosclerosis; Hypertension
Study type: Interventional
Phase: Phase 3

Summary: 
      The AASK is a multicenter, randomized, controlled clinical trial using a 2 × 3 factorial
      design to evaluate the effects of level of blood pressure control and type of
      anti-hypertensive medication on progression of chronic renal disease among African American
      men and women with chronic renal insufficiency caused by hypertension (hypertensive
      nephrosclerosis).
    

Detailed description: 
      The AASK is a multicenter, randomized, controlled clinical trial using a 2 × 3 factorial
      design to evaluate the effects of level of blood pressure control and type of
      anti-hypertensive medication on progression of chronic renal disease among African American
      men and women with chronic renal insufficiency caused by hypertension (hypertensive
      nephrosclerosis). Two levels of blood pressure control were defined in terms of mean arterial
      pressure (MAP = 2/3 diastolic blood pressure + 1/3 systolic blood pressure). A usual goal is
      defined as an MAP of 102 to 107 mm Hg, and a low goal is defined as an MAP of 92 mm Hg or
      less. The three antihypertensive drug regimens contained either a calcium channel blocker
      (amlodipine), β-blocker (metoprolol; Toprol XL), or angiotensin-converting enzyme inhibitor
      (ramipril) as initial therapy. Progression of renal disease was measured as the rate of
      decline in glomerular filtration rate (GFR).
    

Intervention name(s): MAP goal less than or equal to 92 mm Hg; MAP goal 102-107 mm Hg; Ramipril; Amlodipine; Metoprolol
Intervention type(s): Other; Other; Drug; Drug; Drug
Intervention description(s): Lower Blood Pressure Goal (mean arterial pressure (MAP) less than or equal to 92 mm Hg) which corresponds to a BP of approximately 115/80 mmHg; Usual Blood Pressure Goal (mean arterial pressure (MAP) 102-107 mm Hg) which corresponds to a BP of approximately 135/85 to 140/90 mmHg; An angiotensin-converting enzyme inhibitor, (ACEI: ramipril) 2.5 to 10 mg/d; A dihydropyridine calcium channel blocker, (DHPCCB: amlodipine) 5 to 10 mg/d; A sustained release beta-blocker, (BB: metoprolol) 50 to 200 mg/d
Other intervention name(s): ACEI; DHPCCB; BB
Intervention MeSH terms: Metoprolol; Amlodipine; Ramipril
Allocation: Randomized
Intervention model: Factorial Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Fixed-Sequence, Two-Period, Open-Label Drug-Drug Interaction Study to Assess the Effect of an Inhibitor of Cytochrome P450 Isoenzyme 3A4 and Permeability Glycoprotein 1 on the Pharmacokinetics of TD-1211
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will examine the effect of an inhibitor of cytochrome P450 isoenzyme 3A4 (CYP3A4)
      and permeability glycoprotein 1 (P gp) (200 mg itraconazole) on the PK disposition of a 10 mg
      tablet of TD- 1211 administered orally to fasted subjects.
    


Intervention name(s): TD-1211; TD-1211+ itraconazole
Intervention type(s): Drug; Drug
Intervention description(s): Period 1; Period 2
Intervention MeSH terms: Itraconazole
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: None - normal volunteers
The Precision of Pulmonary Artery Cardiac Output-measurements in Spontaneously Breathing Patients
Condition: Heart Diseases
MeSH terms: Heart Diseases
Study type: Interventional

Summary: 
      The intention of this study is to determine whether the precision of the measure of cardiac
      output can be optimized by conducting the measurement while the participant is instructed to
      exhale slowly. This will be compared to measurements done at random to respiration and timed
      with the participant's spontaneous expiration.
    


Intervention name(s): Cardiac output measurement at random to respiration; Cardiac output measurement synchronised at start of expiration; Cardiac output measurement timed to instructed exhalation
Intervention type(s): Procedure; Procedure; Procedure
Intervention description(s): Cardiac output measurement obtained by pulmonary artery catheter thermodilution technique (PAC TD); Cardiac output measurement obtained by PAC TD; Cardiac output measurement obtained by PAC TD
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Keywords: Cardiac surgical procedures; Pulmonary Artery Catheterizations; Cardiac output; Swan Ganz Catheterization
Study of Excretion Balance and Pharmacokinetics of [14C]-SAR442168 in Healthy Male Subjects
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      Primary Objective:

      To determine the excretion balance and systemic exposure of radioactivity after oral
      administration of [14C]-SAR442168.

      To determine the pharmacokinetics of SAR442168 and its contribution to the overall exposure
      of radioactivity.

      To collect samples in order to determine the metabolic pathways of SAR442168 and identify the
      chemical structures and main excretion route of the main metabolites (samples will be
      analyzed according to metabolic analysis plan and results will be documented in a separate
      report).

      Secondary Objective:

      To assess the clinical and biological tolerability of an oral solution of SAR442168.
    

Detailed description: 
      Total study duration is 3 to 10 weeks, including a screening period of 27 days, treatment
      period of up to 15 days and a follow-up and end of study of up to 4 weeks.
    

Intervention name(s): SAR442168
Intervention type(s): Drug
Intervention description(s): Pharmaceutical form:oral solution Route of administration: Oral
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Antipsychotic Polypharmacy: Prevalence, Background and Consequences
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The primary purpose of the study is to investigate whether an intensive educational
      intervention can reduce the use of antipsychotic polypharmacy. It is hypothesised that the
      use of antipsychotic polypharmacy is, in some degree, dependent on non-patient related
      factors.
    

Detailed description: 
      Several surveys have shown a high prevalence of antipsychotic polypharmacy (concomitant
      prescription of at least 2 different antipsychotics) among patients with schizophrenia even
      though international guidelines recommend monotherapy.

      From register data areas with differences in the prevalence of antipsychotic polypharmacy
      will be identified. Two high prevalence areas will be randomized to either control or
      intervention area. In the intervention area an intensive educational intervention consisting
      of outreach visits with a multifaceted approach will be carried out with the duration of 1
      year.

      Differences in health staff related factors such as knowledge and attitude towards clinical
      guidelines will be assessed with a questionnaire before and after the intervention in the
      intervention area as well as in the low prevalence area at baseline.

      Medical records data describing the use of antipsychotic polypharmacy will be collected. With
      register data health economic issues will be assessed.
    

Intervention name(s): Implementation of guideline
Intervention type(s): Behavioral
Intervention description(s): Outreach visits with interactive education for health staff
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Antipsychotic polypharmacy; Schizophrenia; Implementation of clinical guidelines
Safety Study of Peptide Cancer Vaccine To Treat HLA-A*02-positive Advanced Non-small Cell Lung Cancer
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety, tolerability, immune response and
      clinical efficacies of HLA-A*0201 or HLA-A*0206 restricted epitope peptides URLC10 emulsified
      with Montanide ISA 51 for advanced non-small cell lung cancers.
    

Detailed description: 
      The investigators previously identified three novel HLA-A*0201 or HLA-A*0206-restricted
      epitope peptides, which were derived from a cancer-testis antigen, URLC10, as targets for
      cancer vaccination against lung cancer. In this phase I trial, the investigators examine
      using a combination of these three peptides the safety, immunogenicity, and antitumor effect
      of vaccine treatment for HHLA-A*0201 or HLA-A*0206-positive advanced non-small cell lung
      cancer patients who failed to standard therapy.
    

Intervention name(s): HLA-A*0201 or HLA-A*0206-restricted URLC10 peptides
Intervention type(s): Biological
Intervention description(s): Escalating doses of every peptide will be administered by subcutaneous injection on days 1, 8, 15 and 22 of each treatment cycle. Planned doses of peptides are 1.0mg, 2.0mg and 3.0mg.
Other intervention name(s): URLC10
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: URLC10; lung cancer; vaccine; HLA-A*0201; HLA-A*0206
The Effect of Placental Spontaneous Delivery Versus Manual Removal on Blood Loss During Cesarean Section. A Comparative Study
Condition: Cesarean Section Complications
MeSH terms: Hemorrhage
Study type: Interventional

Summary: 
      The mode of placental delivery may contribute to an increase or decrease in the morbidity
      associated with CS, and many studies have shown it to be a key role in determining the blood
      loss during CS. Manual removal of the placenta has been implicated in increased blood loss
      during CS. However, other researchers concluded that it had no detrimental effect on blood
      loss
    


Intervention name(s): Manual placental separation
Intervention type(s): Procedure
Intervention description(s): Manual separation of the placenta from uterus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
Group Study To Investigate The Safety, Toleration And Pharmacokinetics Of Multiple Oral Doses Of PF-04531083 In Healthy Subjects
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the safety and toleration of single and multiple
      doses of PF-04531083. (To investigate the plasma and urinary pharmacokinetics of PF-04531083
      and its metabolites, following single and multiple dose administration in healthy male and/or
      female subjects; and to determine whether PF-04531083 raises levels of enzymes involved in
      metabolism of other drugs following multiple dosing).
    


Intervention name(s): PF-04531083 or Placebo; PF-04531083 or Placebo; PF-04531083 or Placebo; PF-04531083 or Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Subjects will receive multiple oral doses of less than or equal to 100mg PF-04531083 or placebo for 14 days.; Subjects will receive multiple oral doses of less than or equal to 300mg PF-04531083 or placebo for 14 days.; Subjects will receive multiple oral doses of less than or equal to 500mg PF-04531083 or placebo for 14 days.; A fourth cohort may be used to investigate alternative dosing regimens, formulations or food effects.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pharmacokinetics safety tolerability multiple dosing
A Study to Evaluate Pharmacokinetics, Safety and Tolerability of Single and Multiple Intravenous Doses of N-acetylcysteine (NAC) in Chinese Healthy Volunteers
Condition: Respiratory Tract Disorders
MeSH terms: Respiratory Tract Diseases
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a single and multiple dose, single centre, open-label, one-way, pharmacokinetics,
      safety and tolerability clinical trial of Phase I to be performed in Chinese healthy male and
      female volunteers. Twenty-four (24) healthy male and female Chinese volunteers will be
      included in the study. Drop-out subjects will not be replaced. The study has been designed in
      agreement with the Chinese Technical Guideline on Clinical Pharmacokinetic Research of
      Chemical Drugs, 18 March 2005 and the European Guideline on the Investigation of
      Bioequivalence. No randomisation will take place in this study. All the participant will
      receive the same treatment with the investigational medicinal product (IMP), i.e. NAC, 300
      mg/ 3 mL solution for injection.
    


Intervention name(s): N-acetylcysteine (NAC)
Intervention type(s): Drug
Intervention description(s): Two ampoules of IMP (300 + 300 mg) corresponding to a total dose of 600 mg of NAC diluted in 10 mL of NaCl 0.9% sterile saline solution, will be administered by a 5-minute i.v. infusion.
Intervention MeSH terms: Acetylcysteine; N-monoacetylcystine
Allocation: Non-Randomized
Intervention model: Factorial Assignment
Intervention model description: All the subjects enrolled in the study will receive the same treatment with the investigational medicinal product (IMP), i.e. NAC, 300 mg/ 3 mL solution injection as single dose and multiple dose regime. Single dose of IMP will be administered under fasting conditions on day 1 at 08:00 ±1 h. Multiple doses (5) of IMP will be administered twice a day (b.i.d.) on days 4 and 5 at 08:00 ±1 h and 20:00 ±1 h and one dose will be administered on day 6 at 08:00 ±1.
Masking: None (Open Label)
Primary purpose: Other
Muscle Architecture of Lower Extremity In Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Observational [Patient Registry]

Summary: 
      The aim of this study was to determine the muscle architecture of the lower extremity muscles
      (pennation angle, muscle fiber length and muscle thickness) in patients with multiple
      sclerosis. Lower extremity muscles of patients with multiple sclerosis and healthy
      individuals; rectus femoris, biceps femoris, tibialis anterior, gastrosoleus and
      gastrocnemius muscles will be examined by ultrasound method.
    

Detailed description: 
      Multiple sclerosis (MS) is characterised by complex and heterogeneous symptoms, often leading
      to reduced quality of life and impaired functional capacity. The latter is related to reduced
      muscle strength of predominately the lower limbs . The mechanisms underlying the observed
      strength deficits are of muscular as well as neural origin . At the whole muscle level, a
      number of studies have examined skeletal muscle characteristics of MS patients, with some
      studies but not all, reporting loss of muscle mass and decreased or comparable maximal muscle
      strength.

      However, there is no study describing the features of lower extremity muscle architecture in
      multiple sclerosis. Muscle architecture is defined as the alignment of muscle fibers with
      respect to the axis of force. Although the diameters of the muscles of different sizes are
      quite similar to the diameters of the fibers, the sequences of these fibers contain several
      differences. The alignment of the muscle forming fibers has a significant effect on the force
      of muscle formation. The parameters that determine muscle architecture characteristics are
      the muscle fiber length, pennation angle, the physiological cross-sectional area. For each
      muscle these parameters may differ from each other. Any type of load in the case is the
      result of an adaptation process that results in muscle development. Muscle architecture
      allows the macroscopic understanding and interpretation of this adaptation process.

      Determining the muscle architecture of multiple sclerosis patients by ultrasound will guide
      the rehabilitation process.
    

Observational model: Other
Time perspective: Cross-Sectional
Sampling method: Non-Probability Sample
Study population: 
        Study Population consists of Multiple Sclerosis Patients and Healthy Volunteers.
      
Keywords: Multiple Sclerosis; Muscle Architecture; Lower extremity
Study to Evaluate the Effects of Cytochrome P450 (CYP) 3A4 Inducer Carbamazepine on Tavapadon Pharmacokinetics in Healthy Adult Participants
Condition: Parkinson Disease
MeSH terms: Parkinson Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to evaluate the effect of carbamazepine, a strong CYP3A4
      inducer, on the steady-state pharmacokinetics (PK) of tavapadon in healthy adult
      participants.
    


Intervention name(s): Tavapadon; Carbamazepine
Intervention type(s): Drug; Drug
Intervention description(s): Oral tablets; Extended-release oral tablets
Other intervention name(s): CVL-751; PF-06649751
Intervention MeSH terms: Carbamazepine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Comparison of Outcomes Between TransPRK and Off-flap Epi-LASIK
Condition: Refractive Surgery
Study type: Observational

Summary: 
      To compare the quantitative and qualitative optical outcomes between single-step
      transepithelial photorefractive keratectomy (TransPRK) and off-flap epipolis laser in situ
      keratomileusis (Epi-LASIK) in moderate to high myopia.we included patients with moderate to
      high myopia who were randomized to have TransPRK in one eye and Epi-LASIK in the other eye.
      All patients underwent comprehensive ophthalmological examinations, including uncorrected
      (UDVA) and corrected distance visual acuities (CDVA), manifest refraction, intraocular
      pressure, anterior and posterior segment examination, corneal topography measured by
      Scheimpflug scanning-slit topographer (Pentacam, Oculus Optikgerate GmbH), contrast
      sensitivity (CS) under photopic and mesopic conditions (CSV-1000E, Vector Vision Inc.,
      Greenville, OH, USA) with correction by spectacles, ocular wavefront aberrometry (OPD-Scan
      II, Nidek Co. Ltd). At each follow-up, CS and aberration measures were repeated 3 times and
      the average value was analyzed. Optical parameters were repeated 1, 3, 6, and 12 months after
      surgery.Statistical analysis was performed using SPSS software (version 22.0, SPSS, Chicago,
      Inc.). Kolmogorov-Smirnov test was used to check the normal distribution of variables.
      Student t-test or Wilcoxon rank sum test was used based on the normality of data. A P value
      less than 0.05 was considered statistically significant.
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        people accepted refractive surgery
Patient Satisfaction After Switching to Oral Testosterone Undecanoate
Condition: Testosterone Deficiency
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this research study is to evaluate patient satisfaction with an oral
      testosterone agent, Jatenzo, compared to other forms of testosterone therapy.
    


Intervention name(s): Jatenzo
Intervention type(s): Drug
Intervention description(s): 237 mg soft gel capsule taken twice a day by mouth with food.
Intervention MeSH terms: Methyltestosterone; Testosterone 17 beta-cypionate; Testosterone; Testosterone undecanoate; Testosterone enanthate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Hypertension Study: Multinational Torasemide Trial in Mild to Moderate Hypertension.
Condition: Hypertension
MeSH terms: Hypertension
Study type: Interventional
Phase: Phase 4

Summary: 
      Primary objective:To demonstrate the no-inferiority in efficacy of treatment with
      Torsemide-PR in relation to Torsemide-IR in patients with mild and/or moderate hypertension.

      Secondary objectives: To evaluate the safety and tolerability of Torsemide-PR.
    

Detailed description: 
      Torsemide is a loop diuretic from the group of pyridine-sulfonylureas, which acts on the
      ascending large portion of the Henle loop where it inhibits the Na+/K+/2Cl- transport!system
      and blocks Cl- channels.Therefore, sodium and chlorine ions and water can not be reabsorbed
      in the tubule and the urine volume increases significantly. Torsemide is used for the
      treatment of oedema associated with congestive heart failure, kidney or liver disease and,
      either alone or combined with other anti-hypertensive drugs, for the treatment of arterial
      hypertension.

      This trial compares the effect of a new formulation of Torasemide (Torasemide prolonged
      release)to the already available immediate release formulation of the same drug on the
      treatment of mild to moderate hypertensive patients.

      Eligible patients will be randomised to either treatment with Torasemide prolonged release or
      with Torasemide immediate release and will be followed-up until completing 3 months of
      treatment.Blood pressure will be measured by an OMRON pressure gauge. Additionally, ABPM will
      be performed on a sub-group of the patients taking part in this trial.
    

Intervention name(s): Torasemide Prolonged Release (loop diuretic); Torasemide Immediate Release (loop diuretic)
Intervention type(s): Drug; Drug
Intervention MeSH terms: Torsemide; Diuretics; Sodium Potassium Chloride Symporter Inhibitors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Hypertension; Anti-hypertensive effect; Diuretic