bioihbjkbjnl/mcl2 huggingface dataset:
The Influence of Aerobic Exercise on Cognitive Functioning in Schizophrenia.
Condition: Schizophrenia
MeSH terms: Schizophrenia
Study type: Interventional

Summary: 
      The aim of this study is to look at the effects of Aerobic Exercise (AE) on daily and
      neurocognitive functioning including memory, attention, the ability to plan activities, and
      learn new information. Participants will be assigned by chance to receive regular care or
      exercise sessions in addition to regular care. This study will allow determining the
      potential positive influence of AE on cognitive and daily functioning in individuals with
      schizophrenia.
    

Detailed description: 
      Individuals with schizophrenia often display cognitive difficulties. Studies among
      non-clinical populations suggest that Aerobic Exercise (AE) training is effective in
      increasing both aerobic fitness and cognitive functioning. However, these associations have
      not been studied among individuals with schizophrenia, despite the presence of highly
      sedentary lifestyle in this population To elucidate this putative link, the present study
      will evaluate the influence of AE on cognitive functioning and daily functioning in
      individuals with schizophrenia using a single-blind, randomized clinical trial. Outpatient
      individuals with schizophrenia receiving treatment will be randomly assigned to AE training
      or Treatment As Usual (TAU). Participants in the AE training will undergo a 12-week, 3 times
      per week, 1-hour AE sessions. All participants will continue their regular psychiatric and
      medical care. Assessments of neurocognitive and daily functioning abilities, along with
      symptom severity, and physiological and behavioral measures of aerobic fitness will be
      completed before and after the 12-week program.
    

Intervention name(s): Aerobic Exercise; Standard Psychiatric Treatment
Intervention type(s): Behavioral; Other
Intervention description(s): 36 sessions of aerobic exercise (12 weeks of 3 times/week, 60-minute exercise sessions) in small groups (3-5 individuals), in addition to standard psychiatric care.; Standard psychiatric treatment.
Other intervention name(s): AE; Treatment As Usual (TAU)
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Schizophrenia; Cognition; Aerobic Exercise
Efficacy of High-oleic Canola and Flaxseed Oils for Hypercholesterolemia and Cardiovascular Disease Risk Factors
Condition: Cardiovascular Disease
MeSH terms: Cardiovascular Diseases; Hypercholesterolemia
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy of high-oleic canola oil and a high-oleic
      canola/flaxseed oil blend as compared to a typical Western diet on plasma lipids, fatty acid
      profiles, and risk factors associated with cardiovascular disease in hypercholesterolemic
      patients. Furthermore, the metabolism of dietary oleic acid and alpha-linolenic acid
      contained in high-oleic canola oil and flaxseed oil will be investigated.
    


Intervention name(s): High-Oleic Canola Oil; High-Oleic Canola/Flaxseed Oil Blend; Western Dietary Control
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): Diets contained 35% energy as fat; of which 70% was provided by high-oleic canola oil (high in monounsaturated fat (oleic acid)); Diets contained 35% energy as fat; of which 70% was provided by a 1:1 blend of high-oleic canola oil and flaxseed oil (high in monounsaturated fat (oleic acid) and omega-3 polyunsaturated fat (alpha-linolenic acid)); Diets contained 35% energy as fat; of which 70% was provided by a blend of oils typical to the Western diet (high in saturated fat and omega-6 polyunsaturated fat (linoleic acid))
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Participant)
Primary purpose: Prevention
Keywords: High-Oleic Canola Oil; Flaxseed Oil; Monounsaturated Fatty Acids; Polyunsaturated Fatty Acids; Alpha Linolenic Acid; Cardiovascular; Hypercholesterolemia; Lipids; Inflammation; Metabolism
The Improvement of Black Raspberry in Obese and Mild AZ Patients Infected With H. Pylori
Condition: Alzheimer Disease; H Pylori Infection
MeSH terms: Alzheimer Disease
Study type: Interventional

Summary: 
      The current study was designed to check the impact of black raspberry (BR) on obese and mild
      Alzheimers (AZ) patients infected with Helicobacter pylori (H pylori). Through checking
      various parameters including anthropometric, antioxidants, and CDR.
    

Detailed description: 
      The current study was designed to check the impact of black raspberry (BR) on obese and mild
      Alzheimers (AZ) patients infected with Helicobacter pylori (H pylori).

      Preclinical studies (In vitro model) were conducted using 3T3-L1 adipocyte cells to check the
      anti-adhesion activity of BR.

      For the clinical trial, a total of 21 obese mild AZ patients were recruited and separated
      into 2 groups: Experimental (BR group) and Placebo group.

      Experimental group and Placebo group subjects were requested to take either 50 g of BR or 50
      g of dextrin respectively for 4 weeks.
    

Intervention name(s): Black raspberry; Placebo
Intervention type(s): Dietary Supplement; Other
Intervention description(s): Experimental group subjects were requested to take 50 g of Black Raspberry powder for 4 weeks.; Placebo group subjects were requested to take 50 g of dextrin for 4 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: black raspberry; Alzheimer's patients; H pylori; Inflammatory cytokines; Antioxidant
GSK2251052 Mass Balance in Healthy Adult Subjects
Condition: Community-acquired Infection
MeSH terms: Community-Acquired Infections
Study type: Interventional
Phase: Phase 1

Summary: 
      Approximately 6 healthy male subjects will be administered a single 1500 mg intravenous dose
      of 14C-GSK2251052 under fasted conditions. Blood, urine and fecal samples will be collected
      for a minimum of 14 days following study drug administration. Safety and tolerability will be
      monitored throughout the study. A follow-up visit will occur 7-14 days after study drug
      administration.
    


Intervention name(s): 14C GSK2251052
Intervention type(s): Drug
Intervention description(s): 1500 mg iv dose GSK2251052
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Mass balance; intravenous; GSK2251052; Healthy volunteer; Antimicrobial; Radiolabel
A Study to Assess the Efficacy and Safety of Brivaracetam as Treatment for Increased Seizure Activity in an Epilepsy Monitoring Unit Setting
Condition: Epilepsy
MeSH terms: Epilepsy; Seizures
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to assess the efficacy of intravenous brivaracetam (BRV)
      compared to intravenous lorazepam (LZP) in subjects with epilepsy undergoing Epilepsy
      Monitoring Unit (EMU) evaluation who experience seizures that require prompt treatment.
    


Intervention name(s): Brivaracetam; Lorazepam
Intervention type(s): Drug; Drug
Intervention description(s): Pharmaceutical Form: Solution for infusion
Concentration: 10 mg/ml
Route of Administration: intravenous; Pharmaceutical Form: Solution for injection
Route of Administration: intravenous
Other intervention name(s): Briviact
Intervention MeSH terms: Lorazepam; Brivaracetam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Epilepsy; Brivaracetam; Epilepsy Monitoring Unit; Increased seizure activity
Bioavailability and Food Effect Study of Gelatin Formulation and Immediate Release Tablet Formulation of Afuresertib
Condition: Cancer
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is being conducted to measure the relative bioavailability of the original gelatin
      capsule formulation and a new formulation, immediate release (IR) tablet of Afuresertib
      (GSK2110183). The study will be composed of Screening, Treatment, and Follow-up Periods. A
      subject's total time involved in the study will be approximately 9 weeks. The study will
      enroll approximately 18 healthy volunteers.
    


Intervention name(s): GSK2110183 Gelatin Capsule; GSK2110183 IR Tablet
Intervention type(s): Drug; Drug
Intervention description(s): White opaque hard gelatin capsule with a unit dose strength of 25 milligrams (mg) for oral administration; White round biconvex film coated IR tablet with a unit dose strength of 25 mg for oral administration
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: bioavailability; food effect; formulation; GSK2110183; afuresertib; AKT inhibitor
Aerosolized Randomized Iloprost Study II (AIR - II) Long-Term Safety, Tolerability, and Clinical Effects of Iloprost Inhalation in Patients With Primary or Secondary Pulmonary Hypertension
Condition: Hypertension, Pulmonary
MeSH terms: Hypertension, Pulmonary; Hypertension
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine whether the study drug is effective in the
      long-term treatment of primary or secondary pulmonary hypertension
    

Detailed description: 
      The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been
      renamed to Bayer Schering Pharma AG, Germany.

      Bayer Schering Pharma AG, Germany is the sponsor of the trial.
    

Intervention name(s): Ventavis (Iloprost, BAYQ6256)
Intervention type(s): Drug
Intervention MeSH terms: Iloprost
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Primary or secondary Pulmonary hypertension; Iloprost; Inhaled; Long-term treatment
NUtraceutical TReatment for hYpercholesterolemia in HIV-infected Patients
Condition: Hypercholesterolemia; Inflammation; Atherosclerosis
MeSH terms: Atherosclerosis; Hypercholesterolemia; Inflammation
Study type: Interventional
Phase: Phase 4

Summary: 
      The effects of a nutraceutical combination (NC) containing low-dose monacolin K and berberine
      on lipid profile, proprotein convertase subtilisin/kexin type 9 (PCSK9), subclinical
      inflammation and arterial stiffness were investigated in human immunodeficiency virus
      (HIV)-infected patients receiving stable antiretroviral therapy (ART).
    

Detailed description: 
      This is a crossover interventional study of 26 HIV-infected patients on stable ART with low
      density lipoprotein cholesterol (LDL-C) >100 mg/dL, not receiving any lipid-lowering
      treatment. After a 3-week lipid stabilization period with a standardized diet regimen, the
      effect of a 3-month oral NC containing red yeast rice-derived monacolin K 3 mg, berberine 500
      mg, policosanol 10 mg, astaxanthin 0.5 mg, folic acid 0.2 mg and coenzyme Q10 2 mg vs no
      active treatment (noNC) was tested on plasma total cholesterol (TC), LDL-C, high density
      lipoprotein cholesterol (HDL-C), triglyceride, lipoprotein(a), PCSK9, high-sensitivity
      C-reactive protein (hsCRP) levels and aortic pulse wave velocity (aPWV).
    

Intervention name(s): Nutraceutical combination (NC); No nutraceutical combination (noNC)
Intervention type(s): Dietary Supplement; Behavioral
Intervention description(s): An oral NC (red yeast rice-derived monacolin K 3 mg, berberine 500 mg, policosanol 10 mg, astaxanthin 0.5 mg, folic acid 0.2 mg and coenzyme Q10 2 mg) one pill/day was administered for 3 months along with prosecution of standardized diet regimen; Prosecution of standardized diet regimen for 3 months
Other intervention name(s): Armolipid Plus, Meda Pharma - Mylan
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: NC vs noNC
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: cholesterol; nutraceutical; HIV; PCSK9; hsCRP; stiffness
A Trial to Assess the Safety, Tolerability, and Immunogenicity of Bivalent rLP2086 Vaccine When Given to Healthy Young Adults Aged >=18 to <26 Years.
Condition: Healthy
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is looking at a new vaccine that might prevent meningococcal disease, and will
      study the immune response elicited by this vaccine when given to healthy young adults. The
      study will also look at the safety of the new vaccine as well as how it is tolerated.
    


Intervention name(s): rLP2086; Placebo
Intervention type(s): Biological; Other
Intervention description(s): 0.5 mL dose, given at 0, 2 and 6 months; 0.5 mL dose, given at 0, 2 and 6 months
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Hyaluronic Acid With Scaling & Root Planing In Chronic Periodontitis Patients With Diabetes Mellitus Type 2
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The present study aimed to assess the adjunctive use of Hyaluronic acid with scaling & root
      planing (SRP) in patients with chronic periodontitis & diabetes mellitus type 2.
    

Detailed description: 
      Thirty subjects with chronic periodontitis & diabetes mellitus type 2 were included in this
      randomized clinical trial. These subjects were randomly allocated into test & control equal
      groups. The test group comprised fifteen patients who received SRP with subgingival
      application of Hyaluronic acid as an adjunct. The control group included fifteen patients who
      received SRP alone. Plaque index (PI), gingival index (GI), probing depth (PD) & clinical
      attachment level (CAL) were measured & documented at baseline, 6 weeks & 12 weeks intervals.
    

Intervention name(s): Periodontal treatment with Hyaluronic acid associated with SRP; Scaling & root planning alone
Intervention type(s): Procedure; Procedure
Intervention description(s): In addition to SRP, patients in the test group received adjunct subgingival application of hyaluronic acid in all selected periodontal pockets.; Patients received full-mouth supra- & sub-gingival SRP with the use of ultrasonic device & periodontal universal & Gracey curettes under local anesthesia.
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Blood Lipid-lowering Effect of Brown Alga Ecklonia Cava
Condition: Hypercholesterolemia
MeSH terms: Hypercholesterolemia
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The investigators performed a 12-week, randomized, double-blind, placebo-controlled human
      trial to evaluate the efficacy and safety of Ecklonia cava extract on hyperlipidemia.
    

Detailed description: 
      The investigators performed a 12-week, randomized, double-blind, placebo-controlled human
      trial to evaluate the efficacy and safety of Ecklonia cava extract on hyperlipidemia. The
      investigators measured improvement of lipid profile, including total cholesterol,
      triglyceride, HDL-cholesterol, and LDL-cholesterol.
    

Intervention name(s): ECE (Ecklonia cava extract); Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): ECE 200mg, twice a day; Placebo 200mg, twice a day
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Multicenter Trial for Adults With Partial Seizures
Condition: Epilepsy
MeSH terms: Seizures
Study type: Interventional
Phase: Phase 2

Summary: 
      To compare seizure frequency in patients with refactory partial seizures (with or without
      generalization) who are taking Talampanel versus placebo as an add-on therapy to other
      licensed concomitant antiepileptic drugs (AEDs) and to determine the safety of Talampanel in
      this group of patients.
    

Detailed description: 
      A randomized, double-blind, placebo controlled, multicenter, efficacy and safety study of
      talampanel (TLP) in 190 patients (18-65 years old) with refractory partial seizures.
    

Intervention name(s): Talampanel; Placebo; Talampanel; Talampanel; Placebo; Talampanel
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Non-enzyme-inducing TLP 35mg TID; Enzyme-inducing placebo TID; Enzyme-inducing Talampanel 35 mg TID; Enzyme-inducing TLP 50mg TID; Non-enzyme-inducing placebo TID; Non-enzyme-inducing TLP 25mg TID
Primary purpose: Treatment
Combination Chemotherapy in Treating Patients With Unresectable or Metastatic Biliary Tract or Gallbladder Cancer
Condition: Extrahepatic Bile Duct Cancer; Gallbladder Cancer; Liver Cancer
MeSH terms: Liver Neoplasms; Gallbladder Neoplasms; Bile Duct Neoplasms; Cholangiocarcinoma
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
      they stop growing or die. Combining more than one drug may kill more tumor cells.

      PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating
      patients who have unresectable or metastatic biliary tract or gallbladder cancer.
    

Detailed description: 
      OBJECTIVES: I. Determine the 6-month survival and overall survival of patients with
      unresectable or metastatic biliary tract carcinoma or gallbladder cancer treated with
      gemcitabine, fluorouracil, and leucovorin calcium. II. Determine the tumor response in these
      patients treated with this regimen. III. Determine the toxicity of this regimen in these
      patients.

      OUTLINE: Patients receive gemcitabine IV over 30 minutes followed by leucovorin calcium IV
      and fluorouracil IV over 5-10 minutes on days 1, 8, and 15. Treatment repeats every 4 weeks
      for a minimum of 2 courses in the absence of disease progression or unacceptable toxicity.
      Patients are followed every 3 months for 1 year and then every 6 months for 4 years.
    

Intervention name(s): fluorouracil; gemcitabine hydrochloride; leucovorin calcium
Intervention type(s): Drug; Drug; Drug
Intervention MeSH terms: Leucovorin; Gemcitabine; Fluorouracil; Calcium; Levoleucovorin
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: localized unresectable adult primary liver cancer; advanced adult primary liver cancer; recurrent adult primary liver cancer; unresectable gallbladder cancer; recurrent gallbladder cancer; unresectable extrahepatic bile duct cancer; recurrent extrahepatic bile duct cancer
A Study of Omalizumab in Preventing Bronchoconstriction Following Environmental Cat Dander Exposure in Patients With Cat Dander-induced Asthma
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 4

Summary: 
      This was a 3-center, randomized, double-blind, parallel-group, placebo-controlled study with
      a 16-week treatment phase to determine whether subcutaneous omalizumab, compared with
      placebo, reduces the degree of bronchoconstriction induced by environmental cat dander
      exposure in patients 18-65 years old with stable, moderate asthma and a history of cat
      dander-induced asthma symptoms.
    

Detailed description: 
      A cat dander allergen challenge model was used to collect data for all of the Outcome
      Measures. The cat allergen levels in the model are similar to those found in homes with cats
      and are capable of inducing lower- and upper-airway responses that have been used to assess
      the efficacy of several asthma and allergy therapies.

      Cat allergen exposure was performed in a room furnished with upholstered furniture, a
      blanket, and a cat litter box. The door was kept closed at all times, except when personnel
      or study patients were entering or leaving the room. The ventilation system was operating at
      all times except during cat allergen challenges. Two neutered adult cats were kept in the
      room at all times and were free to move about except during challenges, at which time they
      are placed in wire cages. Immediately before a challenge, the blanket was shaken vigorously
      to distribute cat allergen throughout the room.
    

Intervention name(s): Omalizumab; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Omalizumab was supplied as a sterile, white, preservative-free, lyophilized powder in single-use vials that was reconstituted with sterile water for injection.; Placebo contained the same ingredients as the omalizumab formulation, excluding omalizumab.
Other intervention name(s): Xolair
Intervention MeSH terms: Omalizumab
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Xolair; Allergic asthma; Cat allergy
Is Non-Cardiac Chest Pain Caused by Sustained Longitudinal Smooth Muscle Contraction?
Condition: Chest Pain Atypical Syndrome
MeSH terms: Chest Pain
Study type: Observational

Summary: 
      Non-cardiac chest pain (NCCP) is a common disorder whose pathophysiology is poorly
      understood. Some evidence suggests it may be related to sustained esophageal contractions
      (SECs) of longitudinal smooth muscle. The investigators have previously shown that acid is a
      trigger for SECs and results in shortening of the esophagus. In this study, the investigators
      plan to prospectively evaluate esophageal shortening responses to acid in a group of patients
      with NCCP compared to controls. The investigators will use high resolution esophageal
      manometry coupled with acid infusion to evaluate shortening. The investigators hypothesize
      that at least a subset of patients with NCCP will have an exaggerated esophageal shortening
      response to acid which correlates with symptom production. If our hypothesis proves true,
      this may lead to a future therapeutic target in the treatment of these patients.
    


Intervention name(s): Esophageal Manometry
Intervention type(s): Other
Intervention description(s): Both cohorts will undergo standard high resolution esophageal manometry testing. This entails a catheter passed through the nose into the esophagus and measures pressure changes with a series of wet swallows. As part of the study, we will also be instilling both weak acid and saline into the esophagus.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with non cardiac chest pain as diagnosed by cardiologist or other physician.
        Healthy Volunteers will include anyone in the Kingston area who fulfils Inclusion and
        Exclusion criteria.
      
Keywords: Non Cardiac Chest Pain