bioihbjkbjnl/mcl2 huggingface dataset:
Novel Noninvasive Techniques to Study Neutrophil Airway Inflammation in an Ozone Challenge Model
Condition: Healthy Subjects
MeSH terms: Inflammation
Study type: Interventional

Summary: 
      The primary objective of this pilot study is to establish a model of neutrophil airway
      inflammation for future testing of anti-inflammatory substances in an early stage of clinical
      development. Moreover, the suitability of an electronic nose for early detection and
      diagnosis of airway inflammation will be determined.
    

Detailed description: 
      Experimental ozone exposure of human subjects is known to induce transient neutrophilic
      airway inflammation with sputum neutrophilia and elevated concentrations of inflammatory
      mediators in bronchoalveolar lavage and sputum supernatants. In this study, ozone at a
      concentration of 250 ppb will be inhaled for three hours in an ozone challenge chamber.

      In a recent study, ozone challenge has been discussed as a model for pulmonary diseases
      dominated by neutrophilic inflammation such as COPD, providing the possibility to test new
      anti-inflammatory substances in early stages of clinical development.
    

Intervention name(s): ozoneexposure
Intervention type(s): Other
Intervention description(s): subjects will be exposed to either ozone (250 ppb) or filtered air in an ozone challenge chamber for three hours. Ventilation will be increased to 20 l/min/m2 by intermittent exercise on a bicycle ergometer.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Efficacy and Safety of Hypertonic Sodium Lactate Solution Compared With 6% HES Solution in CABG Patients
Condition: Coronary Heart Disease
MeSH terms: Heart Diseases; Coronary Disease; Coronary Artery Disease; Myocardial Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      The choice of fluid therapy is controversial in cardiac surgery. Numerous studies have shown
      that colloid is better as compared to crystalloids. Several previous studies have
      demonstrated that Hypertonic Sodium Lactate (HSL) administration during cardiac surgery shows
      a promising effect. This study aims to compare hemodynamic effects and fluid balance of HSL
      with 6% Hydroxy Ethyl Starch (HES).
    

Detailed description: 
      The primary objectives of this prospective, randomized and open-label study are as follows:

        -  To evaluate the clinical efficacy of Hypertonic Sodium Lactate (HSL) in comparison with
           6% HES to maintain hemodynamic stability in intra CABG patients related to hemodynamic
           status and Body fluid balance.

        -  To assess the safety of HSL in intra CABG patients related to defined laboratory
           parameters clinical adverse events which occur during the trial.

      Subjects meeting enrolment criteria will be randomly assigned to HSL or 6%HES treatment
      groups.

      Assessment of comparability will be done by unpaired student t-test or Chi-Square test or by
      a two-way ANOVA for repeated measures followed by post-hoc analysis when significant
      difference is found within the two groups.

      The hypothesis tested is that HSL is effective in intra CABG surgery patients, requiring less
      volume with better cardiac index, as compared to 6% HES.
    

Intervention name(s): Hypertonic sodium lactate; 6% Hydroxy Ethyl Starch
Intervention type(s): Drug; Drug
Intervention description(s): Administered at beginning of surgery as loading dose at 3 mL/kg body weight within 15 minutes. Additional fluid administered if needed and this was was managed similarly in both groups; the types and amount of additional fluid was measured and recorded. Surgery procedure and concomitant medication was managed similarly.; Administered at beginning of surgery as loading dose at 3 mL/kgBW within 15 minutes. Additional fluid given if needed and this was managed similarly in both groups; the types and amount of additional fluid was measured and recorded. Surgery procedure and concomitant medication was managed similarly
Other intervention name(s): Totilac; Voluven
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Heart disease; cardiac surgery; CABG; Totilac; Voluven; 6% HES
Comparison of Removing and Non-removing Patellofemoral Joint Osteophytes Following Medial Unicompartment Knee Arthroplasty
Condition: Anterior Knee Pain
MeSH terms: Osteophyte; Exostoses
Study type: Observational

Summary: 
      Background: Anterior knee pain (AKP) is a challenge following unicompartmental knee
      arthroplasty (UKA). Some surgeons remove patellofemoral joint (PFJ) osteophytes to reduce
      osteophyte impingement and AKP. However, there is evidence that PFJ osteophytes compensate
      for knee osteoarthritis (OA) by increasing and improving stability and increase contract
      surface area in knee osteoarthritis. Moreover, when PFJ osteophytes are not removed, some
      studies report good clinical outcomes. The issue of removing or leaving PFJ osteophytes is
      controversial.

      The objective of this study was to compare AKP following mobile bearing UKA after removing or
      leaving PFJ osteophytes.

      Methods: The prospective non-randomized study included 89 isolated medial osteoarthritis (OA)
      of knee. They were classified into 2 groups. Group (Gp)1 was removing PFJ osteophytes;
      consists of 44 knees. Gp2 was non-removing PFJ osteophytes: consists of 45 knees. The
      patients were follow up and recorded incidence of AKP and VAS for AKP at 6 weeks, 3months, 6
      months, 1 year and 2 years. No patients were lost to follow up. The patellar tilt and shift
      were measured at 6 weeks, 3months, 6months, 1year and 2 years via skyline view radiography.
      The knee society scores, Oxford knee score, knee injury and osteoarthritis outcome score,
      forgotten joint score and Kujala scale also were recorede at 6 weeks, 3months, 6months, 1
      year and 2 years.
    

Detailed description: 
      Removing and non-removing osteophyte at patellofemoral joint is controversial topic. The
      osteophyte may help to reduce load and improve stability of patellofemoral joint. Therefore,
      the purpose of this study is to compared anterior knee pain between removing and non-removing
      osteophyte at patellofemoral joint following medial mobile bearing unicompartmental knee
      arthroplasty
    

Intervention name(s): removing osteophyte at patellofemoral joint
Intervention type(s): Procedure
Intervention description(s): to compare anterior knee pain between removing patellofemoral joint osteophytes and non-removing patellofemoral joint osteophytes after medial unicompartmental knee arthroplasty
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        isolated medial osteoarthritis of the knee
      
Keywords: patellofemoral osteophyte; anteromedial osteoarthritis knee; mobile bearing UKA; patellofemoral pain
An Exploratory Study of PRX167700 in Patients With Knee Osteoarthritis
Condition: Osteoarthritis, Knee
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 2

Summary: 
      This is an exploratory study to evaluate a new anti-inflammatory drug, PRX167700, in subjects
      with painful osteoarthritis of the knee.

      The purpose of this study is to investigate if PRX167700 improves the pain from
      osteoarthritis of the knee, and to assess its safety and tolerability. The study will also
      investigate PRX167700 pharmacokinetics.
    

Detailed description: 
      Up to 74 subjects will receive either PRX167700 or placebo (a dummy treatment) for 15 days.
      Subjects will need to stop taking their usual pain reliever medicines for at least 7 days
      before starting treatment to induce a 'flare' in osteoarthritis symptoms (but they will be
      allowed to continue to use paracetamol for immediate pain relief as needed throughout the
      trial). The effect of PRX167700 or placebo on knee pain will be assessed before and after
      exercise on Days 1, 3, 7 and 14. On Day 15, blood samples will be collected to measure levels
      of PRX167700 and assess its activity.
    

Intervention name(s): PRX167700; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral capsule; Oral capsule
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: PRX167700; Osteoarthritis
Physical Exercise and Its Impact on Signs of Inflammation in Fibromyalgia
Condition: Exercise Therapy; Pain
MeSH terms: Fibromyalgia; Myofascial Pain Syndromes; Inflammation
Study type: Interventional

Summary: 
      The study aims to compare low-intensive and high-intensive physical exercise and its impact
      on physical function, pain and signs of inflammation.
    


Intervention name(s): Physical exercise; Active comparator: low intensive exercise
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Supervised walks with poles twice a week at moderate-high intensity; Supervised walks once a week at low-intensity.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Fibromyalgia; Physical activity; Function; Pain; Exercise; Inflammation
Exploratory Study of Upper and Lower Endoscopic Fuse System
Condition: Gastrointestinal Diseases
MeSH terms: Gastrointestinal Diseases; Digestive System Diseases
Study type: Interventional

Summary: 
      Single-Center, Exploratory Study of EndoChoice's Upper and Lower Gastrointestinal Endoscopic
      Systems Utilizing EndoChoice's Full Spectrum Optical Technology
    

Detailed description: 
      The investigational devices are EndoChoice gastrointestinal endoscopic systems that are
      similar in their fit, form, and functions to the corresponding commercially available models
      with the exception of the EndoChoice's proprietary Optical system that enhances their field
      of view.
    

Intervention name(s): Fuse® Colonoscope; Fuse® Gastroscope
Intervention type(s): Device; Device
Intervention description(s): Endoscopic diagnostic procedures for lower GI tract; Endoscopic diagnostic procedures for upper GI tract
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Long Term Bowel Function Following Rectal Cancer Surgery
Condition: Bowel; Functional Syndrome; Rectal Cancer
MeSH terms: Rectal Neoplasms; Irritable Bowel Syndrome
Study type: Interventional

Summary: 
      -  In this longitudinal study, 171 patients were evaluated and compared based on the
           radiation therapy they received.

        -  Bowel function was assessed longitudinally with Memorial Sloan Kettering Cancer Center
           and Wexner scores every 6 months after restoration of bowel continuity. Patients with at
           least two follow-up visits were included.
    

Detailed description: 
      Background Despite advances in the neoadjuvant chemoradiation therapy and anal
      sphincter-preserving surgeries for rectal cancer, bowel dysfunction is still unavoidable
      which negatively affect the patients' quality of life. In this longitudinal study, The aim of
      this study was to investigate the changes in bowel function with follow up time and the
      effect of the neoadjuvant chemo radiotherapy on bowel function following low anterior
      resection for rectal cancer.

      Materials and methods In this study, 171 patients with rectal cancer who underwent low
      anterior resection between 2012 and 2018 were included. Bowel function was assessed
      longitudinally with Memorial Sloan Kettering Cancer Center and Wexner scores every 6 months
      after restoration of bowel continuity. Patients with at least two follow-up visits were
      included.
    

Intervention name(s): chemoradiotherapy
Intervention type(s): Radiation
Intervention description(s): exposure of patients with rectal cancer to radiotherapy and assessment of their bowel function after surgery
Other intervention name(s): neoadjuvant chemoradiotherapy
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Rectal cancer; Sphincter preserving surgery; Neoadjuvant therapy; ow anterior resection syndrome
Letrozole and Misoprostol for Termination of Pregnancy up to 63 Days' Gestation
Condition: Pregnancy
Study type: Interventional
Phase: Phase 2

Summary: 
      Study to determine if a user-friendly medical abortion regimen using letrozole and
      misoprostol is safe and acceptable.
    


Intervention name(s): 30 mg letrozole followed by 800 mcg misoprostol
Intervention type(s): Drug
Intervention description(s): 30 mg letrozole on day 1 followed by 800 mcg misoprostol on day 3
Intervention MeSH terms: Letrozole; Misoprostol
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
High Dose Chemotherapy and Allogeneic Hematopoietic Cell Transplant for Non-Hodgkin's Lymphoma
Condition: Lymphoma, Non-Hodgkin; Blood and Marrow Transplant (BMT); Lymphomas: Non-Hodgkin
MeSH terms: Lymphoma; Lymphoma, Non-Hodgkin
Study type: Interventional
Phase: Phase 2

Summary: 
      To evaluate the role of allogeneic hematopoietic cell transplantation in the treatment of
      NHL.
    

Detailed description: 
      To determine safety and toxicity of a regimen of high dose chemotherapy with allogeneic
      peripheral blood progenitor cell transplantation; determine the efficacy of the procedure by
      following clinical outcomes and quality of life measures; and evaluate graft versus host
      disease incidence and severity with regimen.
    

Intervention name(s): ablative allogeneic hematopoietic cell transplantation
Intervention type(s): Procedure
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Glycaemic Control of Weekly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes
Condition: Type 2 Diabetes
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine the optimal dose or doses of HM11260C, when
      administered once a week under the skin, to improve the control of blood sugar levels in
      patients with early-stage type 2 diabetes mellitus (T2DM).
    


Intervention name(s): HM11260C; liraglutide; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): HM11260C is a novel long-acting form of CA Exendin-4 (an Exendin-4 analogue); Liraglutide is a GLP-1 agonist.; Placebo
Other intervention name(s): LAPS-Exendin-4; Victoza
Intervention MeSH terms: Liraglutide; Exenatide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Keywords: glycaemic control; HM11260C; placebo; safety; tolerability; type 2 diabetes mellitus; efficacy; T2DM; glycated haemoglobin (HbA1c); glycosylated haemoglobin (HbA1c); Glucagon-Like Peptide-1 (GLP-1) agonists; blood sugar levels; fasting plasma glucose (FPG)
Effect of Plant Sterols Esterified to Fish Oil Fatty Acids on Plasma Lipid Levels
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Interventional
Phase: Phase 4

Summary: 
      The purpose of this study is to determine whether plant sterols esterified to fish oil fatty
      acids in a fish oil matrix improve the lipid profile, predominantly LDL-cholesterol and TG
      concentrations in healthy hyperlipidemic subjects.
    

Detailed description: 
      Phytosterols and omega-3 fatty acids (n-3) are natural food ingredients with potential
      cardiovascular (CVD) benefits. Phytosterols inhibit dietary cholesterol absorption and
      biliary cholesterol re-absorption, thereby reducing blood cholesterol levels, while
      consumption of n-3 is associated with a significant reduction in plasma triglyceride
      concentrations. Furthermore, n-3 may also beneficially modify a number of other risk factors
      of CHD, like anti-inflammatory and anti-thrombotic.

      The primary objective of this study is to determine whether plant sterols esterified to fish
      oil fatty acids in a fish oil matrix improve the lipid profile, predominantly LDL-cholesterol
      and TG concentrations in healthy hyperlipidemic subjects. In addition the supplement efficacy
      to lower other CVD-related risk factors of healthy will be evaluated.
    

Intervention name(s): Plant sterols esters; placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1.6g phytosterols and 1.3g omega-3 fatty acids per day; 4 gr of corn oil
Other intervention name(s): PS-FO
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Hypercholesterolemia; Hypertriglyceridemia; Plant sterol; Cholesterol; Fish oil
Stroke Imaging Package Study
Condition: Acute Ischemic Stroke; Intracranial Arteriosclerosis; Cerebral Small Vessel Diseases
MeSH terms: Stroke; Ischemic Stroke; Cerebral Small Vessel Diseases; Intracranial Arteriosclerosis; Arteriosclerosis
Study type: Observational [Patient Registry]

Summary: 
      Our study aims to explore the value of new imaging technique package in predicting early
      neurological deterioration (END) as well as 90-day unfavorable outcome in patients with acute
      ischaemic stroke.
    

Detailed description: 
      1. Patients with acute ischemic stroke within 4.5-72h after onset were prospectively
           enrolled in our study and underwent standardized clinical and new imaging technique
           package assessment.

        2. New imaging technique package mainly includes conventional cranial MRI （T1,T2,T2
           FLAIR,DWI, and ADC), cranial magnetic resonance angiography (MRA), and intracranial
           vessel wall imaging (High-Resolution Magnetic Resonance Imaging,HRMRI) as well as
           susceptibility weighted imaging (SWI).

        3. The neurofunctional fluctuation during hospitalization as well as 90-day outcomes were
           carefully assessed. Patients were followed up for 90-days after stroke onset.

        4. Our study aims to explore the value of new imaging technique package in predicting early
           neurological deterioration (END) as well as 90-day unfavorable outcome in patients with
           acute ischaemic stroke.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients will be recruited from the collaborative stroke centers and will be followed for
        the duration of their hospitalization. Patients will be followed up until at least 3 months
        after stroke onset.
      
Keywords: AIS; ICAS; CSVD
Nasal Administration of Sufentanil+Ketamine for Procedure-related Pain in Children
Condition: Pain
Study type: Interventional
Phase: Phase 2

Summary: 
      The aim of the study is to investigate the absorption and clinical effect of nasal
      administration of an analgesic nasal spray containing sufentanil+ketamine for pain related to
      medical procedures in hospitalized children.
    

Detailed description: 
      The management of procedural pain in children ranges from physical restraint to
      pharmacological interventions. Pediatric formulations that permit accurate dosing, are
      accepted by children and a have a rapid onset of analgesia are lacking. The objectives were
      to investigate a pediatric formulation of intranasal sufentanil 0.5 mcg/kg and ketamine 0.5
      mg/kg for procedural pain and to characterize the pharmacokinetic (PK) profile. Fifty
      children (≥10 kg) scheduled for a painful procedure were included in this prospective
      nonrandomized open-label clinical trial. Thirteen of these children had central venous access
      for drug assay sampling; enabling a compartmental PK analysis using nonlinear mixed-effects
      models. Pain intensity before and during the procedure was measured using age-appropriate
      pain scales. Heart rate, oxygen saturation and sedation were recorded.
    

Intervention name(s): Intranasal sufentanil/ketamine
Intervention type(s): Drug
Intervention description(s): Nasal spray sufentanil+ketamine, 0,5 microg/kg sufentanil+0,5 mg/kg ketamine, single dose
Intervention MeSH terms: Sufentanil; Ketamine
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Painful medical procedures
Efficacy and Safety of Different Concentrations of Sirolimus in the Treatment of Kaposiform Hemangioendothelioma.
Condition: Kaposiform Hemangioendothelioma
MeSH terms: Sarcoma, Kaposi; Hemangioendothelioma; Kasabach-Merritt Syndrome
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the efficacy and safety of different concentration
      gradients of sirolimus in the treatment of Kaposiform hemangioendothelioma.
    

Detailed description: 
      Kaposiform hemangioendothelioma (KHE) is a rare aggressive vascular neoplasm that occurs
      predominantly in infancy or early childhood, with an incidence of approximately 0.71/100,000.
      Currently, sirolimus is a promising treatment modality for KHE. Most scholars consider
      sirolimus blood concentration of 5-15 ng/ml to be an effective therapeutic concentration.

      However, long-term higher dose sirolimus treatment can cause some common complications such
      as oral mucositis which affects the quality of life of the patient. Finer control of the
      plasma concentration of sirolimus may contribute to the efficacy of treatment and reduce the
      incidence of complications. Therefore, we conducted this study to see if low-dose sirolimus
      is beneficial to the prognosis of patients.
    

Intervention name(s): Sirolimus
Intervention type(s): Drug
Intervention description(s): Use of different doses of the same drug
Other intervention name(s): Rapamycin; Rapamune
Intervention MeSH terms: Sirolimus
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Kaposiform Hemangioendothelioma; Sirolimus; Efficacy; Safety
Bioequivalence Study of Clopidogrel Tablets 75 mg of Dr. Reddy's Under Fasting Conditions
Condition: Fasting
Study type: Interventional
Phase: Phase 1

Summary: 
      The objective of this study was to compare the rate and extent of absorption of Dr. Reddy's
      Laboratories Ltd, clopidogrel and Bristol-Myers Squibb Company, USA Plavix®, clopidogrel 75
      mg tablet under fasting condition.
    

Detailed description: 
      Randomized, Open-label, 2-Way Crossover, Bioequivalence Study of Clopidogrel 75 mg Tablet
      (Dr. Reddy's Laboratories Ltd., India) and Plavix® (Bristol-Myers Squibb Company, USA)
      Following a 75 mg Dose In Healthy Subjects Under Fasting Conditions.
    

Intervention name(s): Clopidogrel
Intervention type(s): Drug
Intervention description(s): Clopidogrel Tablets 75 mg
Other intervention name(s): Plavix
Intervention MeSH terms: Clopidogrel
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment