bioihbjkbjnl/mcl2 huggingface dataset:
Study Evaluating Safety, Tolerability, And Immunogenicity Of ACC-001 In Subjects With Mild To Moderate Alzheimer's Disease
Condition: Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 2

Summary: 
      To assess the safety, tolerability, and immunogenicity of ACC-001, an investigational active
      immunization, in patients with mild to moderate Alzheimer's disease.
    


Intervention name(s): ACC-001 + QS-21; ACC-001; QS-21; Placebo: Phosphate buffered saline
Intervention type(s): Biological; Biological; Biological; Drug
Intervention description(s): Vanutide Cridificar (3, 10, 30µg) + QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12; Vanutide Cridificar (10, 30µg), IM on day 1, month 1, month 3, month 6 and month 12; QS-21 (50µg), IM on day 1, month 1, month 3, month 6 and month 12; Phosphate buffered Saline (pH : 7.4), IM on day 1, month 1, month 3, month 6 and month 12
Intervention MeSH terms: Saponin QA-21V1
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Alzheimer's Disease; active immunization
The Effect of Amlodipine and Lisinopril on Retinal Autoregulation in Type 1 Diabetes
Condition: Type 1 Diabetes; Diabetic Retinopathy; Eye Diseases; Diabetes Complications
MeSH terms: Retinal Diseases; Diabetic Retinopathy; Eye Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Diabetes Complications
Study type: Interventional

Summary: 
      The purpose of this study is to compare the effect of two antihypertensive drugs on retinal
      vessel diameter in young type 1 diabetics. The retinal vessel analyzer (RVA) was used to
      investigate how the drugs affected vessel diameter, when the subjects were exposed to an
      increase in blood pressure, induced by isometric muscle contraction and when they were
      stimulated by flickering light.
    

Detailed description: 
      Diabetes is a leading cause of blindness in the western part of the world. Diabetic patients
      develop diabetic retinopathy which can progress to blindness. Diabetic retinopathy is
      associated with an increase of blood flow in the retinal vessels, ischaemia in the periphery
      and macular oedema. It has been shown in previous trials, that the pressure and metabolic
      autoregulation is disturbed in patients with diabetes, and it is believed to contribute to
      the development of diabetic retinopathy.

      In healthy subjects the retinal arterioles will contract during an increase in blood
      pressure, but trials have shown that this response is impaired in diabetics. When the retina
      is exposed to flickering lights, the metabolism increase and the arterioles in healthy
      subjects dilates. In diabetics this dilation is impaired. In this trial we want to
      investigate if an ACE-inhibitor (lisinopril) or calcium channel blocker (amlodipine)
      influence this response in subjects exposed to increased blood pressure vs increased retinal
      metabolism.
    

Intervention name(s): Amlodipine; Lisinopril
Intervention type(s): Drug; Drug
Intervention description(s): 1 (5mg) tablet daily, given 14 days totally before measure of outcome.; Lisinopril 10 mg given daily for 14 days and then outcome was measured.
Intervention MeSH terms: Amlodipine; Lisinopril
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Keywords: Diabetes; Retinopathy; Blood Pressure; Amlodipine; Lisinopril
Evaluation of Satisfaction in Patients Undergoing Non Surgical Lifting by Means of Coned Wires.
Condition: Pain; Complications
Study type: Observational

Summary: 
      An email questionnaire about subjective satisfaction and discomfort has been sent to 243
      patients undergoing non-surgical facial and cervical lift 1 week, 1 month, 6 months and 1
      year after treatment.
    

Detailed description: 
      243 patients underwent non-surgical coned wires (silhouette soft) facial and cervical lift
      between October 2013 and November 2014. The procedures has been executed in our aesthetic
      clinics in Milan, Bologna, Turin, Genoa, Rome, Asti, San Remo and Palermo.

      Among the 243 patients, 217 were females and 26 males, with age ranging from 19 to 76 years.
      103 patients underwent only facial lift, of which 12 only in the frontal area, 61 only on
      cheek and malar area, and 30 on both the areas.

      39 patients underwent only cervical lift, of those 14 by means of appliance of 1 or 2 wires,
      25 by means of appliance of more than 2 wires.

      101 patients underwent both facial and cervical non surgical lift. We sent to every patient a
      email questionnaire1 week, 1 month, 6 months and 1 year after treatment.

      In the questionnaire, patients has been asked to enter a value between 1 and 5 about
      subjective satisfaction regarding the aesthetic improvement (ranging from 1, poor, to 5,
      excellent), and discomfort related to treatment (ranging from 1, no perceived discomfort, to
      5, impossibility to execute working and social activities).

      The data has been analyzed and related to other factors such as:

        -  number of wires applied on each patient

        -  other aesthetic or regenerative medicine treatments executed on the same patient on the
           same year

        -  total expenditure related to aesthetic treatments in the same year
    

Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients undergoing non surgical facial and carvical lift from 2013 to 2014
      
Keywords: coned wires, wire lift,; patient; discomfort
Vitrectomy With Internal Limiting Membrane Peeling for Myopic Traction Maculopathy
Condition: Myopic Traction Maculopathy; Pars Plana Vitrectomy; Internal Limiting Membrane Peeling
MeSH terms: Myopia; Macular Degeneration
Study type: Interventional

Summary: 
      Investigate the effectiveness and safety of pars plans vitrectomy, with internal limiting
      membrane peeling for cases of myopic traction maculopathy
    

Detailed description: 
      Performing pars plana vitrectomy for highly myopic patients with decreased visual acuity is
      the standard of care for patients with myopic traction. A variety of findings are seen by
      Optical Coherence Tomography. Epiretinal membranes, retinoschisis, lamellar macular holes,
      and full thickness macular holes are seen. Undergoing vitrectomy, with or without tamponade,
      in our center, is retrospectively evaluated. Visual acuity change, as well as improvement of
      the retinal structure by OCT will be examined.
    

Intervention name(s): Pars Plana Vitrectomy with Internal Limiting Membrane peel
Intervention type(s): Procedure
Intervention description(s): Pars plana vitrectomy with staining and peeling of internal limiting membrane
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy and Safety of Ciclesonide Administered With or Without Different Spacers in Patients With Asthma (12 to 75 y) (BY9010/M1-145)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 3

Summary: 
      The aim of the present study is to investigate the efficacy and safety of ciclesonide on lung
      function and safety. Ciclesonide will be inhaled at one dose level once daily, using an
      inhaler device with or without spacer. The study duration consists of a baseline period (1 to
      3 weeks) and a treatment period (12 weeks).
    


Intervention name(s): Ciclesonide
Intervention type(s): Drug
Intervention MeSH terms: Ciclesonide
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Asthma; Ciclesonide
Added Value of Local Clonidine for Spine Postoperative Pain Control, in Addition to Bupivacaine
Condition: Post-operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of this prospective randomized double-blind study is to evaluate the added
      analgesic value of clonidine to the conventional local bupivacaine wound infiltration in
      posterior spine surgery.
    

Detailed description: 
      Patients candidates to posterior spine surgery (Micro-discectomy, Lumbar laminectomy with or
      without fusion, cervical laminectomy) are asked to participate to this prospective study.
      After verification of inclusion and exclusion criteria, patients consenting to enter the
      study are randomly assigned to one of the following subgroups: 1-Pre-incisional wound
      infiltration with 20 mL of bupivacaine 0.25%. 2- Pre-incisional wound infiltration with 150
      μg of clonidine with 20 mL of bupivacaine 0.25%. Demographic parameters, co-morbidities and
      other pre and per operative medical data are noted. In the post-operative period, patients
      received a standardized post-operative analgesic protocol (NSAI and paracetamol). Patients
      are asked to fill their pain diary using Visual Analog Scale (VAS) from day 0 till day 8
      after surgery. Morphine rescue consumption is noted. Finally, the percentage of global
      subjective patient satisfaction regarding the post-operative wound pain is noted from 0 to
      100.
    

Intervention name(s): Bupivacaine; Clonidine
Intervention type(s): Drug; Drug
Intervention description(s): Local infiltration before wound incision with 20 ml of Bupivacaine 0.25 % alone; Clonidine 150μg locally infiltrated with 20 ml of bupivacaine 0.25 % before wound incision
Intervention MeSH terms: Clonidine; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Keywords: clonidine; bupivacaine; post-operative pain; arthrodesis; discectomy; local infiltration
The Correlation of COX-2 Expression in Human Polymorphonuclear Leukocytes/Macrophages (PMNL/MP) and Postoperative Pain
Condition: Post-Operative Pain
MeSH terms: Pain, Postoperative
Study type: Interventional
Phase: Phase 4

Summary: 
      To investigate the dose-effect relations among the expression of COX-2 in polymorphonuclear
      leukocytes (PMNL) and macrophages, systemic and local inflammatory response and postoperative
      pain
    

Detailed description: 
      we detect COX-2mRNA, COX-2 protein expression in inflammatory cells and PGE2 concentration in
      patients with abdominal surgery. The differences of COX-2 expression in PMNL are compared
      between peripheral blood and partial incision transudate to the same individual, and at the
      same time, the COX-2 expression differences in PMNL and macrophages, and PGE2 concentration
      in partial incision transudate also compared interindividually, to show the relevance between
      the difference and postoperative pain. In addition, the effects of Parecoxib Sodium on COX-2
      expression of the amount in PMNL and macrophages are investigated during the development of
      postoperative inflammatory pain. Finally, we will clear the dose-effect relations among the
      expression of COX-2 in inflammatory cell, systemic and local inflammatory response and
      postoperative pain.
    

Intervention name(s): Parecoxib Sodium
Intervention type(s): Drug
Intervention description(s): 40 mg Parecoxib Sodium is give to the patients intravenously (diluted with 5 ml normal saline) at 30 minutes before surgery, 20 mg Parecoxib Sodium (diluted with 5 ml normal saline) at 8 hours,20 hours,32 hours,44 hours,56 hours after surgery respectively.
Intervention MeSH terms: Parecoxib
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: COX-2; PMNL; pain; macrophages; NSAIDs
Topical Compounded Pain Creams And Pain Perception (TOPCAPP)
Condition: Pain
Study type: Observational [Patient Registry]

Summary: 
      To evaluate the change in patient pain perception with the use of a topical compounded pain
      cream regimen.
    

Detailed description: 
      This is a prospective,observational,single center, open label study of patients that receive
      a combination topical compounded analgesic medication with no comparator group.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Participants with neuropathic or nociceptive chronic pain who are between 18 and 65 years
        of age prescribed a combination compounded topical analgesic.
      
Keywords: Topical Compounded Pain Creams and Pain Perception
Effectiveness of ABT-378/Ritonavir Plus Lamivudine Plus Efavirenz Plus Tenofovir DF in HIV-Infected Patients
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to see if a novel 4-drug anti-HIV combination can suppress the
      growth of HIV in patients infected with the virus.
    


Intervention name(s): Lopinavir/ritonavir; Efavirenz; Lamivudine; Tenofovir DF
Intervention type(s): Drug; Drug; Drug; Drug
Intervention MeSH terms: Ritonavir; Lopinavir; Tenofovir; Lamivudine; Efavirenz
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: HIV
Effect of Ethanol Intoxication on the Anti-Hypoglycemic Action of Glucagon
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will test the hypothesis that a BAC (blood alcohol content) of 0.1% will not
      significantly alter the anti-hypoglycemic effect of mico-dose glucagon in individuals with
      type 1 diabetes.
    

Detailed description: 
      This study will test the hypothesis that a BAC (blood alcohol content) of 0.1% will not
      significantly alter the anti-hypoglycemic effect of mico-dose glucagon in individuals with
      type 1 diabetes. The study will aim to quantify the effect of a blood alcohol content on the
      anti-hypoglycemic efficacy of glucagon using a hyperinsulinemic -normoglycemic clamp
      technique in volunteers with type 1 diabetes in a randomized crossover trial.
    

Intervention name(s): Ethanol; Glucagon
Intervention type(s): Drug; Drug
Intervention description(s): IV infusion of ethanol to stabilize BAC (blood alcohol content) at 0.1%; injection of 50 micrograms of glucagon
Other intervention name(s): Ethyl Alcohol; Alcohol
Intervention MeSH terms: Ethanol; Glucagon
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Type 1 Diabetes; Bionic Pancreas; Artificial Pancreas; Insulin; Glucagon; Alcohol; Alcohol Clamp
Multitarget Stool FIT-DNA Study for Colorectal Cancer Early Screening in China
Condition: Colorectal Cancer; Adenomatous Polyps; Adenoma; Advanced Adenoma
MeSH terms: Colorectal Neoplasms; Adenoma; Adenomatous Polyps
Study type: Observational

Summary: 
      The primary objective is to determine the diagnostic sensitivity and specificity of the newly
      developed multitarget FIT-DNA Colorectal Cancer (CRC) screening test (ColoClear) for
      detecting advanced neoplasia (including colorectal cancer and advanced adenomas) in high risk
      patients, using colonoscopy as the reference method. The secondary objective is to compare
      the screening performance of the multitarget FIT-DNA test with commercially available FIT
      (Fecal Immunochemical Test) assay in detecting advanced neoplasia.
    

Detailed description: 
      The study will be carried out in 8 tier-3A hospitals throughout China. Patients who are at
      high risk of developing colorectal cancer and willing to conduct colonoscopy examination will
      be asked to collect stool sample prior to bowl preparation for multitarget FIT-DNA test and
      commercially available FIT assay. Colonoscopy and histopathologic examination are used as
      reference.
    

Intervention name(s): Multitarget stool FIT-DNA test - ColoClear; FIT; Colonoscopy
Intervention type(s): Diagnostic Test; Diagnostic Test; Procedure
Intervention description(s): Multitarget stool FIT-DNA test; fecal immunochemical test; diagnostic colonoscopy
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects with high risk of developing CRC and patients with confirmed CRC
      
Biospecimen description: 
      stool sample
    
Keywords: Cancer; Colorectal Cancer; Colorectal Neoplasms; Adenomatous Polyps; Adenoma; Advanced adenoma; Gastrointestinal Diseases; Colonic Diseases; Neoplasms; Digestive System Diseases; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Intestinal Diseases; Rectal Diseases; Glandular and Epithelial; Neoplasms by Histologic Type
Test the Phototoxicity of Sunscreen Products
Condition: Sunscreen Agents
MeSH terms: Dermatitis, Phototoxic
Study type: Interventional

Summary: 
      The primary objective of this study was to evaluate the potential for phototoxicity of the
      sun care products SPF 50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 compared to that of a
      negative control (0.9% sodium chloride [NaCl]) after a single 24 h application of test
      materials followed by irradiation with ultraviolet A (UVA) and ultraviolet B (UVB).

      The secondary objective of this study was to evaluate the safety of the sun care products SPF
      50 Y65 110, SPF 50 Y51 002, and SPF 15 V27 104 combined with UVA/B irradiation by monitoring
      adverse events (AEs) throughout the study.
    


Intervention name(s): SPF 50 Y65 110 (BAY987519); SPF 50 Y51 002 (BAY987519); SPF 15 V27 104 (BAY987519); Sodium chloride [NaCl]
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Application of 200 µL in an occlusive patch of Webril (0.150 ± 0.010 mg) compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.; Application of 200 µL in an occlusive patch of Webril compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.; Application of 200 µL in an occlusive patch of Webril compared to that of a negative control (0.9% sodium chloride, NaCl) and followed by irradiation with UV A and UVB.; Negative control (200 µL, 0.9% sodium chloride [NaCl]) after a single 24 h application of test materials followed by irradiation with ultraviolet A (UVA) and ultraviolet B (UVB).
Intervention model: Single Group Assignment
Masking: Single (Participant)
Primary purpose: Other
Study of Inhaled Corticosteroid Plus Montelukast Compared With Inhaled Corticosteroid Therapy Alone in Patients With Chronic Asthma (0476-386)
Condition: Asthma
MeSH terms: Asthma
Study type: Interventional
Phase: Phase 2

Summary: 
      This study assesses inhaled corticosteroid plus montelukast compared with inhaled
      corticosteroid therapy alone for treatment of patients with chronic asthma.
    

Detailed description: 
      During this study, all patients will receive mometasone (powder, 220 mcg once-daily, for
      approximately 6 weeks). In a crossover manner, eligible patients will also receive
      montelukast (powder, 1 mg once-daily, for approximately 2 weeks) followed by placebo; or will
      receive placebo followed by montelukast. The order of when each of these 2 treatments are
      added to the mometasone will be randomized.
    

Intervention name(s): Comparator: mometasone; Comparator: montelukast; Comparator: placebo (unspecified)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): mometasone (inhalation powder, 220 mcg once-daily, for approximately 6 weeks); montelukast (inhalation powder, 1 mg once-daily, for approximately 2 weeks); Placebo (Placebo once-daily, for approximately 2 weeks)
Intervention MeSH terms: Mometasone Furoate; Montelukast
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Comparison of Two Ab Interno Procedures in the Treatment of Glaucoma in Patients Undergoing Cataract Extraction
Condition: Open Angle Glaucoma
MeSH terms: Glaucoma; Cataract; Glaucoma, Open-Angle
Study type: Interventional

Summary: 
      The purpose of this study is to compare the safety and efficacy of goniotomy performed with a
      novel ophthalmic knife compared to trabecular bypass stent implantation in mild to moderate
      glaucoma subjects who are also undergoing cataract extraction with phacoemulsification
      (Phaco) and posterior chamber intraocular lens (PCIOL) implant.
    


Intervention name(s): Goniotomy; Trabecular Micro-Bypass Stent; Cataract Extraction
Intervention type(s): Procedure; Device; Procedure
Intervention description(s): Procedure: Goniotomy and trabecular excision with a novel ophthalmic knife in combination with planned cataract extraction via Phaco and PCIOL implant.; Procedure: Trabecular Micro-Bypass stent implantation in combination with planned cataract extraction via Phaco and PCIOL implant.; Cataract extraction via Phaco and PCIOL implant.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Glaucoma; glaucoma surgery; ab interno
Postprandial Effects of Milk and Milk Constituents
Condition: Hyperlipidemia; Inflammation
MeSH terms: Hyperlipidemias; Hyperlipoproteinemias; Inflammation
Study type: Interventional

Summary: 
      The purpose of this study is to determine whether the addition of milk or the milk
      constituents calcium and protein to a high-fat breakfast affects the postprandial lipid and
      inflammatory response.
    


Intervention name(s): Milk; Protein; Calcium; Control
Intervention type(s): Dietary Supplement; Dietary Supplement; Dietary Supplement; Dietary Supplement
Intervention description(s): 500 mL low-fat milk added to high-fat meal; Milk protein in 500 mL water added to high-fat meal; Milk calcium in 500 mL water added to high-fat meal; Lactose in 500 mL water added to high-fat meal
Intervention MeSH terms: Calcium
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Milk; Postprandial hyperlipidemia; Postprandial inflammation; Overweight
Role of Octreotide in Preventing Pancreatic Fistula After Pancreaticoduodenectomy (PD) in Patients With Soft Pancreas
Condition: Pancreatic Fistula
MeSH terms: Pancreatic Fistula; Fistula
Study type: Interventional
Phase: Phase 4

Summary: 
      This randomized controlled trial (RCT) aims at assessing the influence of octreotide on
      pancreatic fistula or complications following pancreatoduodenectomy in patients with soft
      pancreas. Previously reported trials have included all types of pancreatic resections and
      have include all types of pancreas and have shown no clearcut benefit of octreotide after
      pancreaticoduodenectomy (PD). Soft pancreas and normal sized duct are the risk factors for
      fistula following PD. This study's focus is on this select group of patients and aims to
      assess the role of octreotide in patients with soft pancreas.
    

Detailed description: 
      Study design: Prospective open labeled randomized trial. AIM: Study aims at assessing the
      influence of octreotide on pancreatic fistula or complications following
      pancreatoduodenectomy in patients with soft pancreas.
    

Intervention name(s): Inj. Octreotide
Intervention type(s): Drug
Intervention description(s): 100 mcg subcutaneously for 5 days
Other intervention name(s): Inj Octride
Intervention MeSH terms: Octreotide
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: octreotide; pancreatic fistula; soft pancreas; pancreatoduodenectomy