bioihbjkbjnl/mcl2 huggingface dataset:
Sitagliptin Therapy and Kinetics of Inflammatory Markers
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 3

Summary: 
      Inflammatory processes are increasingly being recognized as a critical step in the
      pathogenesis of both diabetes and heart disease and may constitute a biological link between
      the two diseases. Inflammatory cytokines increase vascular permeability, change
      vasoregulatory responses, increase leukocyte adhesion to endothelium, and facilitate thrombus
      formation by inducing procoagulant activity, inhibiting anticoagulant pathways, and impairing
      fibrinolysis. Leukocyte adhesion to arterial endothelial cells is thought to be an important
      step in the development of atherosclerosis, and adhesion molecules, such as intercellular
      adhesion molecule-1 (ICAM-1) and L-selectin, play key roles in this process. Therefore,
      identifying novel therapeutic approaches that would favorably affect inflammation,
      endothelial function, and glucose is of significant interest. Investigators have recently
      demonstrated that, relative to placebo, sitagliptin treatment resulted in a significant
      reduction in plasma levels of various inflammatory markers and cell adhesion molecules. The
      results also suggest that the beneficial effects of sitagliptin on both inflammation and
      endothelial function are most likely mediated by an elevation in plasma GLP-1 levels and
      global improvement of the glucose-insulin homeostasis. However, the mechanisms underlying the
      beneficial effects of sitagliptin on these markers remain to be fully elucidated. The
      proposed study will address this key issue.
    


Intervention name(s): Sitagliptin; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Sitagliptin 100 mg/d for 6 weeks; Placebo for 6 weeks
Other intervention name(s): Januvia
Intervention MeSH terms: Sitagliptin Phosphate
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: sitagliptin; diabetes; inflammation
Impatto Emodinamico Dell'Anestesia Subaracnoidea Titrata Versus Tecnica Single-shot Nei Pazienti Sottoposti ad Artroprotesi d'Anca. RCT
Condition: Anesthesia; Adverse Effect; Anesthesia, Local
Study type: Interventional

Summary: 
      Studying the hemodynamic effects of titrated subarachnoid anesthesia versus conventional
      single-shot subarachnoid anesthesia
    

Detailed description: 
      This study aims to investigate whether a different hemodynamic effect is related to the
      injection o titrated local anesthetic for subarachnoid anesthesia versus the conventional
      single shot injection. The data to be recorded are blood pressure and pulse rate at different
      timing. As secondary outcomes the investigators will record the anesthetic level achieved
      using the Bromage score.
    

Intervention name(s): subarachnoid block
Intervention type(s): Procedure
Intervention description(s): subarachnoid block with levobupivacaine at different dosage for pation undergoing total hip arthroplasty
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Preoperative Pain Threshold and Rapid Recover Programs
Condition: Knee Arthritis; Hip Arthritis
MeSH terms: Arthritis
Study type: Interventional

Summary: 
      To investigate the association between grip strength and preoperative pain threshold as
      measured by pressure algometer and validated pain outcome surveys.
    

Detailed description: 
      A minimum of 200 patients, 100 hip and 100 knee arthroplasty participants, will be recruited
      for this study. Preoperatively, patient pain threshold will be recorded both objectively
      (Pressure algometer) and subjectively (brief pain inventory). In terms of location,
      objectively this will be tested during the preoperative visit in clinic by the approved,
      trained research staff, as well as the subjective brief pain inventory.

      Objective pain measure: Pressure algometer will be obtained in the standard fashion as
      follows: the probe is applied at a 90 degree angle to the skin at a constant rate of 10kPa/s
      to minimize the impact of the examiner's reaction time on recorded pain thresholds. The
      participant is instructed by the measurer to say "stop" when the sensation of pressure became
      the very first sensation of pain. There will be three spots to test patients, one for
      familiarity of the testing and the other 2 for data collection.

        1. This is initially performed once on ipsilateral the tibialis anterior as a "warm up."

        2. Then 3 measurements are taken on the operative medial epicondyle (for TKA) or
           ipsilateral lateral iliac crest (for THA) and averaged for the official score.

        3. Lastly, three measurements are also taken on the contralateral olecranon to measure
           systemic pain sensitivity. If the contralateral elbow has had prior surgery or active
           bursitis, the ipsilateral elbow will be used. Of important note, the algometer has a max
           force lock out of 100N to prevent any harm to the patient.

        4. Dominant Hand Grip strength measured by the average of 3 attempts on a Dynamometer.

      Subjectively, the brief pain inventory is a validated pain outcome measure which will be
      filled out by the participant during their preoperative clinic visit.

      Postoperative, the study team will ask the participant at the 6 week mark:

        1. How many and what kind of opiates did the participant require?

        2. How many days did the participant require opiates?

        3. Did the participant require a refill? a. If so, did the participant have this filled in
           clinic preemptively or place a phone call to the office?
    

Intervention name(s): Wagner Pain Algometer; Dynamometer
Intervention type(s): Device; Device
Intervention description(s): applied at a 90 degree angle to the skin at a constant rate of 10kPa/s to minimize the impact of the examiner's reaction time on recorded pain thresholds; Dominant Hand Grip strength measured by the average of 3 attempts
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: Knee Arthroplasty; Hip Arthroplasty
Multiple Ascending Dose Study of GLPG0634 in Japanese and Caucasian Healthy Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this multiple ascending dose study is to characterize the safety,
      tolerability, and the amount of GLPG0634 present in the blood and urine (pharmacokinetics) of
      once daily oral administrations of GLPG0634 at 3 different dose levels for 10 days in
      Japanese healthy subjects.

      Furthermore, the study will compare the safety, tolerability, pharmacokinetics, and effects
      of GLPG0634 on mechanism of action-related parameters in the blood (pharmacodynamics) of once
      daily oral administrations of GLPG0634 given at one dose level for 10 days in Japanese vs
      Caucasian healthy subjects.
    


Intervention name(s): GLPG0634 50 mg; GLPG0634 100 mg; GLPG0634 200 mg; Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): 2 tablets of 25 mg GLPG0634 once daily for 10 days; 1 tablet of 100 mg GLPG0634 once daily for 10 days; 2 tablets of 100 mg GLPG0634 once daily for 10 days; 1 or 2 matching placebo tablets once daily for 10 days
Other intervention name(s): 50 mg GLPG0634 as tablets; 100 mg GLPG0634 as tablets; 200 mg GLPG0634 as tablets; Placebo as matching tablets
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Treatment
Subantimicrobial Doxycycline in Acne
Condition: Acne Vulgaris; Pediatrics
MeSH terms: Acne Vulgaris
Study type: Interventional
Phase: Phase 4

Summary: 
      Antibiotic resistance is a public health problem that worsens the more physicians prescribe
      standard dose antibiotics for acne. Regardless of race, acne vulgaris is one of the most
      common dermatologic conditions among pediatric populations. As such, clinicians can make a
      large impact by practicing good antibiotic stewardship while still addressing the impact of
      acne on adolescents' self-esteem. Subantimicrobial doxycycline maintains its
      anti-inflammatory effects while eliminating antimicrobial properties and associated risks of
      drug resistance. Few studies, focused primarily on adults, have shown that subantimicrobial
      doxycycline is efficacious in treating acne from a physician standpoint. The investigators
      aim to investigate the patient experience of acne treatment with subantimicrobial dose
      doxycycline in the pediatric population.
    


Intervention name(s): Doxycycline Hyclate
Intervention type(s): Drug
Intervention description(s): 100 mg vs 20 mg doxycycline hyclate BID for 12 weeks
Intervention MeSH terms: Doxycycline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Acne Vulgaris; Doxycycline; Sub-Antimicrobial; Pediatrics
Objective Testing of Tear Film Stability
Condition: Contact Lens Solutions
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the in-vivo wettability of soft contact lenses when
      cared with two different multi-purpose solutions over a two week wearing period.
    


Intervention name(s): Opti-Free® RepleniSH® MPDS; ReNu MultiPlus®
Intervention type(s): Device; Device
Intervention description(s): soft contact lens disinfecting solution; soft contact lens disinfecting solution
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Contact lenses, wettability, Contact Lens Disinfectant Solutions, pre-lens tear film
Food Intake and Gut Hormones in Patients Who Have Undergone Upper Gastrointestinal Surgery for Cancer
Condition: Esophageal Neoplasms; Stomach Neoplasms; Weight Loss; Malnutrition
MeSH terms: Neoplasms; Stomach Neoplasms; Esophageal Neoplasms; Malnutrition; Weight Loss
Study type: Interventional

Summary: 
      Improvements to treatment strategies for patients upper gastrointestinal cancers have
      produced an increasing population of people who remain free from disease recurrence in the
      long term. Weight loss and nutritional problems are common among patients who attain
      long-term remission and cure after surgery for upper gastrointestinal cancers. However, the
      mechanisms underlying these problems are not well understood. In this study the investigators
      aim to determine whether reduced food intake after upper gastrointestinal surgery is caused
      by early satiety related to exaggerated post-prandial gut hormone responses.

      This is a randomized, double-blind, placebo controlled, crossover study of the effect of
      100μg octreotide SC on ad libitum food intake in patients free from complications or
      recurrence at least one year post-oesophagectomy, gastrectomy or pancreaticoduodenectomy. A
      comparator group of age, weight and gender matched subjects will be studied concurrently, and
      caloric intake and subjective symptom scores after administration of octreotide versus
      placebo among surgical and comparator subjects will be assessed.
    


Intervention name(s): Octreotide; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Octreotide 100mcg (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating; 0.9% saline (1mL) single dose, subcutaneously, into the lower abdomen, 50 minutes prior to eating
Other intervention name(s): Sandostatin
Intervention MeSH terms: Octreotide
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Glucagon-Like Peptide 1; Peptide YY; Ghrelin; Satiety Response; Appetite; Hunger; Somatostatin; Octreotide; Anastomosis, Roux-en-Y; Digestive System Surgical Procedures; Pharmacologic Actions; Physiological Effects of Drugs; Endocrine System Diseases; Enteroendocrine Cells; Gastrointestinal Agents
Observational Prospective Study OPTIMA II - Follow-up
Condition: Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Study type: Observational

Summary: 
      The current follow-up study was planned to reveal the rates of Major Adverse Cardiovascular
      and Cerebrovascular Events (MACCE) during 4-year follow-up in patients participated in OPTIMA
      study. In addition, the long-term effects of statins on LDL-cholesterol and different
      biomarkers in patients after drug-eluting stents implantation will be assessed. In addition,
      such project implementation will allow to clarify the treatment options used by Russian
      patients with CAD (Coronary Artery Disease) after drug-eluting stent implantation. The
      information received in this study will help to optimize management of Russian patients with
      CAD after PCI in order to improve prognosis and quality of life of these patients.
    

Detailed description: 
      This project is 3-years follow-up of OPTIMA study. This is an observational retro-prospective
      study based on the data collected during one visit: 4-year after PCI performed at the Russian
      Cardiological Research Center (РКНПК). From the date of the study start and until the end of
      the study investigators will enroll those patients participated in OPTIMA study. Only
      patients, who consent to participate in the study and sign the informed consent form after
      being informed by a physician on the objectives and methods of the study, will be enrolled
      into this project.

      This study is an observational one, and there is no intervention into routine clinical
      practice either in terms of therapy, or special examinations. The main point of this project
      is the data collection using the out-patient medical records or disease history of a patient,
      as well as collection of data received during patient routine examination. Data collection
      will be performed only once during single routine patient visit to treating physician or
      hospitalized patient examination. Study participation will be finished after this visit. Data
      collection will be performed at the visit 4 years after PCI and will include medical history,
      current medications, physical examination, ECG (electrocardiogram) and laboratory
      assessments.

      The study will be conducted in Russian Federation. It is planned that 80-90% of patients
      participated in OPTIMA study will be enrolled into current project. One clinical site -
      Russian Cardiological Research Center (РКНПК) - is supposed to participate in this study.

      The total period of the study is anticipated to be about 18 months.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Follow-up OPTIMA (NIS-GRU-NEX-2009/) study patients
      
Keywords: Major Adverse Cardiovascular and Cerebrovascular Events (MACCE); Statins; LDL-cholesterol; Inflammatory markers; Percutaneous Coronary Intervention (PCI)
Exercise and Overnight Motor Sequence Task
Condition: Schizophrenia and Related Disorders; Psychotic Disorders
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional

Summary: 
      The objective of this randomized controlled trial (RCT) is to compare the changes of the
      sleep-related memory functions in patients with psychosis after they have completed the
      12-week high-intensity exercise intervention, the 12-week low-intensity exercise
      intervention, or the 12-week controlled non-exercise intervention respectively. Fifty-one
      patients with psychosis, patients who received either the high-intensity exercise or
      low-intensity exercise as intervention shown a significant improvement to their impaired
      sleep-related memory function, while those who received non-exercise intervention has no such
      improvement. Moreover, high-intensity exercise may have a more prominent effect compare to
      low-intensity exercise.
    


Intervention name(s): Exercise; Non-exercise
Intervention type(s): Other; Other
Intervention description(s): Indoor cycling exercise intervention; Psycho-education
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Exercise; Sleep-dependent memory consolidation; Aerobic; Anaerobic
Efficacy and Safety Study of Ingavirin® to Treat Influenza and Acute Respiratory Viral Infections in Children 7-12 y.o.
Condition: Influenza, Human; Acute Respiratory Infection; Viral Infection; Common Cold
MeSH terms: Infections; Communicable Diseases; Influenza, Human; Respiratory Tract Infections; Virus Diseases; Common Cold
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine whether Ingavirin ® dosed 60 mg daily is effective
      and safe in the treatment of influenza and other acute respiratory viral infections in 7-12
      years old patients.
    


Intervention name(s): Ingavirin; Placebo oral capsule
Intervention type(s): Drug; Drug
Intervention description(s): Ingavirin capsules 60 mg once daily, regardless of meal, for 5 days.; Placebo, capsules daily for 5 days.
Other intervention name(s): Imidazolyl ethanamide pentandioic acid
Intervention MeSH terms: Pentanedioic acid imidazolyl ethanamide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
To Investigate Efficacy and Safety of Pemetrexed as Second or Third Line Therapy in Patients With Non-small Cell Lung Cancer (NSCLC)
Condition: Non-small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      To investigate efficacy and safety of pemetrexed as second or third line therapy in patients
      with non-small cell lung cancer (NSCLC).
    


Intervention name(s): Pemetrexed 500 mg/m2; Pemetrexed 1000 mg/m2
Intervention type(s): Drug; Drug
Intervention description(s): 500 mg/m2, intravenous (IV), every 21 days, one year from registration date; 1000 mg/m2, intravenous (IV), every 21 days, one year from registration date
Other intervention name(s): Alimta; LY231514; Alimta; LY231514
Intervention MeSH terms: Pemetrexed
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Fat and Transcapillary Insulin Transport
Condition: Lipid-induced Insulin Resistance
MeSH terms: Insulin Resistance
Study type: Interventional

Summary: 
      There is a current debate whether impaired insulin-mediated microvascular perfusion limits
      the delivery of hormones and nutrients to muscle and whether short term FFA elevation affects
      transcapillary transport of insulin and glucose thereby representing a rate-controlling step
      for insulin-stimulated muscular glucose disposal in humans.

      To address these questions, the investigators determined the changes of interstitial glucose
      and insulin in skeletal muscle of healthy volunteers during intravenous administration of
      triglycerides or glycerol under physiologic and supraphysiologic hyperinsulinemic conditions.
    

Detailed description: 
      Increased lipid availability reduces insulin-stimulated glucose disposal in skeletal muscle,
      which is generally explained by lipid induced inhibition of myocellular insulin signalling,
      It remains unclear whether lipids also impair transcapillary transport of insulin and glucose
      which could thereby become rate-controlling for glucose disposal Increased accumulation and
      availability of lipids cause impaired skeletal muscle insulin sensitivity. It is yet unclear
      if transcapillary transport of insulin and glucose is impaired by acute elevation of free
      fatty acids and represents a rate-limiting step during the development of short-term
      lipid-induced insulin resistance. We determined the changes of interstitial glucose and
      insulin in skeletal muscle of healthy volunteers during intravenous administration of
      triglycerides and heparin or glycerol under physiologic and supraphysiologic hyperinsulinemic
      conditions.
    

Intervention name(s): Elevation of FFA during OGTT; Elevation of FFA during Clamp
Intervention type(s): Other; Other
Intervention description(s): 0-240 min: Intralipid® 20%, Pharmacia AB, Stockholm, Sweden, 90 ml/hr; Heparin "Immuno"®, Immuno AG, Vienna, Austria, bolus: 200IU, continuous infusion: 0.2 IU.kg-1.min-1; 0-240 min: Intralipid® 20%, Pharmacia AB, Stockholm, Sweden, 90 ml/hr; Heparin "Immuno"®, Immuno AG, Vienna, Austria, bolus: 200IU, continuous infusion: 0.2 IU.kg-1.min-1.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: Insulin resistance; vascular impairment; diabetes
Imatinib in Patients With Desmoid Tumor and Chondrosarcoma
Condition: Advanced Desmoid Tumor; Advanced Chondrosarcoma
MeSH terms: Chondrosarcoma; Fibromatosis, Aggressive
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether Imatinib Mesylate is active in diseases -
      such as Desmoid Tumor and Chondrosarcoma - expressing the receptor for the platelet-derived
      growth factor (PDGF) both in its isoform alpha and beta
    


Intervention name(s): Imatinib Mesylate
Intervention type(s): Drug
Intervention description(s): 800 mg p.o./day (400 mg b.i.d.) for a maximum of 24 months
Intervention MeSH terms: Imatinib Mesylate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: PDGFr alpha; PDGFr beta; KIT
Effects of Tipranavir/Ritonavir on the Pharmacokinetic Characteristics of Triple Drug Nucleoside and Non-nucleoside Reverse Transcriptase Inhibitor Therapy in HIV-1-infected Subjects
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Primary: Sequentially determine the effects of three dose combinations of tipranavir (TPV) /
      ritonavir (RTV) (administered b.i.d.), TPV 1250 mg/RTV 100 mg vs. TPV 750 mg/RTV 100 mg vs.
      TPV 250 mg/RTV 200 mg on the steady-state pharmacokinetics of zidovudine, lamivudine,
      stavudine, didanosine, abacavir, nevirapine and efavirenz at approved doses. The three
      treatment groups will be enrolled sequentially starting with the highest tipranavir dosage
      group first and ending with the lowest tipranavir dosage group.

      Secondary: A) To assess the effects of zidovudine, lamivudine, stavudine, didanosine,
      abacavir, nevirapine, and efavirenz on the pharmacokinetics of tipranavir/ritonavir compared
      to historical controls.

      B) To assess the safety of three tipranavir/ritonavir combinations when used in combination
      with protocol defined antiretrovirals.
    


Intervention name(s): Tipranavir low dose; Tipranavir medium dose; Tipranavir high dose; Ritonavir low dose; Ritonavir high dose
Intervention type(s): Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Ritonavir; Tipranavir
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Primary purpose: Treatment