bioihbjkbjnl/mcl2 huggingface dataset:
Influence of Cardiorespiratory Fitness and Body Composition on Resting and Post-exercise Indices of Vascular Health in Young Adults
Condition: Endothelial Dysfunction; Arterial Stiffness
Study type: Interventional

Summary: 
      This research is being done to determine whether acute exercise causes differences in numbers
      of novel blood factors associated with vascular health in college-aged adults across
      different physical activity habits. As only ~50% of cardiovascular (CV) events can be
      explained by traditional CV risk factors such as high blood pressure and high cholesterol, it
      is anticipated that this research will provide a more comprehensive look into novel risk
      factors that may better explain CV risk and that may be modifiable through regular physical
      activity.
    


Intervention name(s): Acute submaximal exercise
Intervention type(s): Other
Intervention description(s): 30 min of treadmill running at 70% of the participants maximal oxygen consumption
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pharmacokinetics of SP-104
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, 3-period, 3-treatment, randomized study will characterize the
      pharmacokinetics and safety and tolerability of SP-104 under fasting and fed conditions as
      compared to the pharmacokinetics of Naltrexone Hydrochloride Tablets, USP, 50 mg in healthy
      adult subjects.
    

Detailed description: 
      The study will characterize the single-dose pharmacokinetics of naltrexone and metabolite (6
      Beta-naltrexol) following administration of SP-104 compared to Naltrexone Hydrochloride
      Tablets, USP, 50 mg in healthy adult subjects under fasting conditions. The study will also
      characterize the effect of food intake on the pharmacokinetics of SP-104 in healthy adult
      subjects. Additionally, the safety and tolerability of single doses of SP-104 under fed and
      fasting conditions will be characterized.
    

Intervention name(s): SP-104; Naltrexone Hydrochloride 50Mg Oral Tablet
Intervention type(s): Drug; Drug
Intervention description(s): single oral dose; single oral dose
Intervention MeSH terms: Naltrexone
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Subjects randomized to Treatment A will fast at least 10 hours prior to and for at least 4 hours following dosing and will be treated with a single dose of SP-104. Subjects randomized to Treatment B will be fed a high-fat breakfast 30 minutes prior to dosing, SP-104 will be administered 30 minutes after start of the meal. No food will be allowed for at least 4 hours after the dose. Subjects randomized to Treatment C will fast at least 10 hours prior to and for at least 4 hours following dosing and will be treated with a single dose of Naltrexone Hydrochloride Tablet. Subjects will crossover to each treatment after a wash out period.
Masking: None (Open Label)
Primary purpose: Basic Science
Sirolimus (Rapamune®) for Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Condition: Autosomal Dominant Polycystic Kidney Disease (ADPKD)
MeSH terms: Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of our study is to investigate whether Rapamune used at a low dose (2 mg/d) retards
      cyst growth and slows renal functional deterioration in patients with ADPKD.
    

Detailed description: 
      Currently there is no treatment for ADPKD other than supportive care and blood pressure
      control. Usually dialytic treatment or renal transplantation becomes necessary when the
      disease has progressed to end-stage renal failure.We and others could demonstrate that
      rapamycin, a classical mTOR inhibitor, retards cyst growth and preserves renal function in a
      rodent model of ADPKD. The aim of our study is to investigate whether Rapamune (2 mg/d)
      retards cyst growth and slows renal functional deterioration in patients with ADPKD. We
      anticipate that we can slow disease progression and delay the need for chronic renal
      replacement therapy by the inhibition of mTOR with Rapamune. This is a 24-month prospective,
      controlled, open label study with 2 parallel groups in patients with ADPKD. Patients will be
      randomized at a 1:1 ratio to one of the 2 treatment arms. Primary endpoint is percentage
      change of renal volume measured by high resolution magnetic resolution imaging.
    

Intervention name(s): Sirolimus; Standard
Intervention type(s): Drug; Other
Intervention description(s): Standard plus Sirolimus; Standard
Other intervention name(s): Rapamune (R); Treatment of hypertension, cyst infections and flank pain
Intervention MeSH terms: Sirolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADPKD; autosomal dominant polycystic kidney disease; Sirolimus; volumetry
Safety and Efficacy Study of the BioVentrix PliCath HF System
Condition: Heart Failure
MeSH terms: Heart Failure
Study type: Interventional

Summary: 
      The purpose of this prospective, single-armed, multi-center clinical trial is to further
      establish the safety and feasibility of using the BioVentrix PliCath HF System for the
      treatment of left ventricular dysfunction in appropriate cohorts of humans suffering from
      heart failure.
    

Detailed description: 
      Congestive heart failure is the "epidemic" of cardiovascular disease (Eugene Braunwald, NEJM
      1997), yet there is no cure. The American Heart Association reports the nearly five million
      Americans are afflicted. Approximately 1.5 million admissions in the US are due to heart
      failure; it is the number one cost-item for Medicare, comprising 6% of its total
      expenditures.

      BioVentrix has developed the PliCath heart failure system, which is used to place permanent
      cardiac implants into the heart for the purpose of excluding scar, reconfiguring abnormal
      cardiac geometry that is causing dysfunction, by excluding an abnormal portion of the
      ventricular wall. Conceptually, the final configuration in SVR can be achieved by placing
      these implants.

      The procedure called PliCath Epicardial Catheter-based Ventricular Restoration System (ECVR)
      is designed for left ventricular volume reduction in patients with heart failure in a
      magnitude similar to that of the predicate surgical procedure, but much less invasively. The
      PliCath HF System utilizes anchors that are implanted into the scarred portion of the heart,
      which when deployed, exclude some of the scar similar to what is excluded by cinching the
      purse string suture with the patch, rendering the ventricle smaller, and is employed in a
      surgical setting, with and without the use of cardiopulmonary bypass.

      The PliCath HF System has anchors (implants) that are deployed using fluoroscopic imaging.
    

Intervention name(s): PliCath HF System
Intervention type(s): Device
Intervention description(s): This study is a multi-center, prospective, single-armed, study designed to evaluate the safety and efficacy of the BioVentrix PliCath HF System for left ventricular volume restoration in patients with ischemic cardiomyopathy.
Other intervention name(s): Epicardial Catheter-based Ventricular Restoration; Dor; Surgical/Left Ventricular Reconstruction
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epicardial Catheter-based Restoration; Surgical/Left Ventricular Reconstruction; Ventricular Remodeling; Dor
A Study to Investigate How Safe and Well Tolerated RV568 is in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 2

Summary: 
      RV568 is being developed as a possible treatment of diseases such as smoking related lung
      disease (also known as Chronic Obstructive Pulmonary Disease - COPD) and asthma.

      The main purpose of this study is to examine the safety of RV568 in COPD patients. Two dose
      strengths of RV568 and a placebo will be tested in this study, which will be given by
      inhaling a liquid suspension from a nebuliser once a day for 2 weeks.
    


Intervention name(s): RV568; RV568; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): RV568 50 ug administered via a nebuliser once daily for 14 days; RV568 100 ug administered via a nebuliser once daily for 14 days; Placebo administered via a nebuliser once daily for 14 days
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COPD
A Study To Test The Interaction of Two Medications for Treatment of Overactive Bladder
Condition: Overactive Bladder
MeSH terms: Urinary Bladder, Overactive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to determine the effect of repeat doses of solabegron and
      oxybutynin when taken alone or together
    


Intervention name(s): solabegron and oxybutynin
Intervention type(s): Drug
Intervention MeSH terms: Oxybutynin; Solabegron
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: solabegron,; oxybutynin,; healthy adults,; drug interaction
Intubating Conditions During Propofol-remifentanil Anesthesia With Topical Lidocaine
Condition: Drug Usage
MeSH terms: Disease
Study type: Interventional

Summary: 
      When not using neuromuscular blocking agent, even at optimal dosage, target-controlled
      infusion (TCI) of propofol and remifentanil occasionally produce unsatisfactory intubating
      conditions. Therefore, the investigators evaluated that the effect of tracheal lidocaine on
      the intubating conditions for tracheal intubation during anesthesia induction of propofol and
      remifentanil TCI without neuromuscular blocking agent in day-case anesthesia.
    

Detailed description: 
      Anesthesia was induced with propofol-remifentanil TCI with the effect-site concentration of
      5μg/ml and 5ng/ml, respectively. After TCI, 3 ml of normal saline or 3 ml of 4% lidocaine was
      instilled to larynx and trachea, following intubation was performed.
    

Intervention name(s): lidocaine; normal saline
Intervention type(s): Drug; Drug
Intervention description(s): 3 ml of 4% lidocaine was instilled to larynx and trachea; 3 ml of normal saline was instilled to larynx and trachea before endotracheal intubation
Other intervention name(s): 4%lidocaine; control
Intervention MeSH terms: Lidocaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: intubating conditions; propofol; remifentanil; topical lidocaine
PRO-POWER: Hypertension With Risk Factors for a Duration of 24 Weeks With Micardis 80mg/Micardis Plus 80mg/12.5mg
Condition: Hypertension
MeSH terms: Hypertension
Study type: Observational

Summary: 
      PRO-POWER is an observational cohort study for a period of 24 weeks. All recruited patients
      will have essential hypertension. In addition, the patients will have at least one other
      contributing risk factor for cardiovascular events. The study aims to evaluate the safety,
      efficacy and protection of Micardis 80mg/Micardis plus 80/12.5mg from cardiovascular risks in
      patients with essential hypertension
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hypertensive patients in the Kingdom of Saudi Arabia, Egypt and United Arab Emirates
Clinical Evaluation of Two Daily Disposable Contact Lenses
Condition: Refractive Error
MeSH terms: Refractive Errors
Study type: Interventional

Summary: 
      The objective of this study is to compare the ease of removing two daily disposable soft
      contact lenses off the eye.
    


Intervention name(s): delefilcon A; narafilcon A
Intervention type(s): Device; Device
Intervention description(s): Daily disposable soft contact lens to be worn at least 8 hours daily; Daily disposable contact lens to be worn at least 8 hours daily
Other intervention name(s): DAILIES Total 1; 1-Day ACUVUE TruEye
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Other
A Study of Systemic Chemotherapy With CPT-11 Plus HAI (FUDR+L-OHP) in Patients With Initially Unresectable CRCLM
Condition: Colo-rectal Cancer; Liver Metastases
MeSH terms: Neoplasm Metastasis
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the trial is to optimize response rates and rates of secondary resections of
      metastases in patients with initially non-resectable metastatic colorectal cancer Liver
      Metastasis. The patients will be treated with systemic chemotherapy With irinotecan plus
      hepatic arterial infusion With floxuridine and oxaliplatin
    

Detailed description: 
      Recent studies and our experience have proved the efficacy and safety of systemic
      chemotherapy combined with hepatic arterial infusion (HAI) with floxuridine and dexamethasone
      in patients with initially unresectable colorectal liver metastasis. Hepatic arterial
      infusion oxaliplatin trials have been done with oxaliplatin alone and in combination with
      irinotecan, 5-FU/LV, and mitomycin-C and have showed that Hepatic arterial infusion
      oxaliplatin could increase response rate and resection rate for colorectal liver metastasis.
      Therefore, we designed this study to determine whether systemic chemotherapy With irinotecan
      plus hepatic arterial infusion With floxuridine and oxaliplatin can increase the complete
      resection rate (R0) and improve the overall survival in patients with initially unresectable
      colorectal liver metastasis.
    

Intervention name(s): Irinotecan; Oxaliplatin; Floxuridine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Irinotecan 150 mg/m2 IV over 90 minutes on Day 1, 15; Oxaliplatin 85 mg/m2 over 3 hours will be administered through the HAI pump on day 1. Oxaliplatin 85 mg/m2 IV over 3 hours on day 15.; 0.12 mg/kg/day floxuridine (FUDR) and 25 mg dexamethasone in normal saline to a total volume of 300 ml will be administered through the HAI pump.
Intervention MeSH terms: Oxaliplatin; Irinotecan; Floxuridine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
BEEP Follow Up: Evaluation of Repeatability of Lamotrigine Pharmacokinetics in Epileptic Patients
Condition: Epilepsy
MeSH terms: Epilepsy
Study type: Interventional
Phase: Phase 4

Summary: 
      The prior BEEP study involved patients being switched between brand and generic in a very
      structured manner. Other secondary comparisons were also made (i.e. any differences in
      adverse effects and seizure control). Some subjects were more disparate than other, in terms
      of generic being similar to brand. In this follow up study, BEEP subjects that showed
      disparate results will be tested again to assess reproducibility of disparate results.
    

Detailed description: 
      This is an double-blind, multiple-dose, full replicate design, pharmacokinetic study of
      lamotrigine in "enriched" patients with epilepsy who previously participated in HP-00048923.
      LAMICTAL 100mg tablets and the most commonly used generic lamotrigine 100mg tablet (from
      Teva) will be compared pharmacokinetically.
    

Intervention name(s): lamotrigine (brand Lamictal); lamotrigine (generic Teva)
Intervention type(s): Drug; Drug
Intervention description(s): an anti-epileptic drug (brand); an anti-epileptic drug (brand)
Other intervention name(s): Lamictal; generic lamotrigine
Intervention MeSH terms: Lamotrigine; Anticonvulsants
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Basic Science
A Study of the Effect of SYN-010 on Subjects With IBS-C
Condition: Irritable Bowel Syndrome With Constipation (IBS-C)
MeSH terms: Irritable Bowel Syndrome; Constipation
Study type: Interventional
Phase: Phase 2

Summary: 
      A Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Multi-Dose Study of the
      Effect of Two Dosage Strengths of SYN-010 Compared with Placebo on Breath Methane Production
      in Breath Methane-Positive Subjects with Irritable Bowel Syndrome with Constipation (IBS-C)
    

Detailed description: 
      This is a Phase 2, randomized, multi-center, multi-dose study. Sixty subjects with irritable
      bowel syndrome with constipation who are between the ages of 18 and 65, inclusive, will be
      enrolled. The entire duration of the study may be up to 43 days (from Screening to the post
      end-of-study [EOS] visit telephone call).
    

Intervention name(s): SYN-010 21 mg; SYN-010 42 mg; Placebo
Intervention type(s): Drug; Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate the Pharmacokinetics and Safety Between HCP2001 and Co-administration of Each Component in Healthy Volunteers
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the pharmacokinetic characteristics and safety
      between HCP2001 and co-administration of each component in fasting and fed conditions
      respectively in healthy volunteers.
    


Intervention name(s): HCP2001; RLD2007; RLD2008; RLD2102
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Take it once per period.; Take it once per period.; Take it once per period.; Take it once per period.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Incidence, Risk Factors and Consequences of Acute Kidney Injury in Patients Undergoing Esophageal Cancer Surgery
Condition: Acute Kidney Injury; Postoperative Complications
MeSH terms: Esophageal Neoplasms; Acute Kidney Injury; Postoperative Complications; Wounds and Injuries
Study type: Observational

Summary: 
      Esophagectomy serves as an exemplar of major operative trauma, with well-known risk of
      pulmonary, cardiac, anastomotic, and septic complications and the presence of postoperative
      complications after esophagectomies for cancer is associated with a reduced long-term
      survival. There is a paucity in the literature regarding postoperative renal outcomes after
      esophageal surgery, with a wide range of incidence.

      The investigators will conduct a historical cohort study aiming to evaluate the incidence of
      postoperative acute kidney injury in patients undergoing elective esophageal cancer surgery.
      Secondary, the investigators will assess the progression of the acute injury and the
      association with adverse pulmonary, cardiac, anastomotic, and septic events, as well as
      increase in hospital stay and mortality. The investigators will also identify risk factors
      associated with acute kidney injury occurrence.
    


Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        All consecutive patients who underwent elective esophageal surgery for cancer
Reduction in Pain Intensity Following IV or Oral Pain-relieving Products
Condition: Pain
MeSH terms: Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to evaluate two experimental pain models to see if they would be
      useful for comparing different products for reduction in pain intensity.

      The models evaluated were the ultraviolet-B (UVB) burn and intradermal capsaicin experimental
      pain models. Medications compared were a single dose each, of intravenous (IV) acetaminophen,
      oral acetaminophen, placebo, and IV morphine.
    


Intervention name(s): IV Acetaminophen (Treatment A); Oral Acetaminophen (Treatment B); Placebo (Treatment C); Morphine (Treatment D)
Intervention type(s): Drug; Drug; Drug; Other
Intervention description(s): Acetaminophen administered by intravenous (IV) infusion; Acetaminophen administered by oral tablets; Placebo administered by IV infusion or oral tablets; Morphine administered by IV infusion
Other intervention name(s): OFIRMEV; Acetaminophen tablets; IV Placebo; Placebo tablets; IV Morphine
Intervention MeSH terms: Acetaminophen; Morphine
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Other
Keywords: comparison
The Effects of Walnuts, Walnut-Oil, Almonds and Fish Oils on Glucose Homeostasis in Polycystic Ovary Syndrome
Condition: Polycystic Ovary Syndrome; Insulin Resistance
MeSH terms: Polycystic Ovary Syndrome; Insulin Resistance; Syndrome
Study type: Interventional

Summary: 
      The purpose of this study is to learn more about the effects of walnuts, walnut-oil, almonds
      and fish oils on blood sugar and insulin levels in polycystic ovary syndrome (PCOS) patients.
      The hypothesis is that a diet rich in these foods will improve insulin resistance in women
      with PCOS.
    

Detailed description: 
      Polycystic ovary syndrome is a common disease that affects 1 out of 16 women. Metabolic and
      endocrine abnormalities seen in PCOS include insulin resistance, androgen excess and
      infertility. This study focuses on the insulin resistance aspect because increased insulin
      resistance leads to premature onset of impaired glucose tolerance or diabetes whereas
      decreased insulin resistance reduces androgen excess, improves the ovarian function and
      increases fertility. Although insulin resistance can be treated with insulin-sensitizing
      drugs, PCOS clinically manifests during adolescence and the long-term safety of the
      drug-treatment can be a concern. Thus, improving insulin resistance with effective
      nutritional approaches would be very desirable. Epidemiological studies and animal
      experiments suggest that replacement of dietary saturated fats with monounsaturated (MUFA)
      and polyunsaturated (PUFA) fats improves insulin resistance.
    

Intervention name(s): walnuts; almonds
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Subjects will follow their usual diet for 4 weeks; after that they will be randomized to walnuts. They will eat walnuts once daily for six weeks.; Subjects will follow their usual diet for 4 weeks; after that they will be randomized to almonds. They will eat almonds once daily for six weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PCOS; polycystic ovary syndrome; insulin resistance; fish oil; walnut-oil; walnuts; almonds; monounsaturated fats; polyunsaturated fats; MUFA; PUFA