bioihbjkbjnl/mcl2 huggingface dataset:
Intranasal SB-705498 in Non-allergic Rhinitis Patients
Condition: Rhinitis
MeSH terms: Rhinitis; Common Cold
Study type: Interventional
Phase: Phase 2

Summary: 
      This study is designed to look at the affect of SB-705498 on rhinitis symptoms, as induced by
      capsaicin challenge
    


Intervention name(s): Placebo; SB-705498
Intervention type(s): Drug; Drug
Intervention description(s): SB-705498 placebo; 12mg intranasal SB-705498
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: NAR; Capsaicin challenge
Propofol With Clonidine and Ketamine Throughout Colon Cancer Surgery
Condition: Colon Cancer; Post Operative Pain
MeSH terms: Colonic Neoplasms; Pain, Postoperative
Study type: Interventional
Phase: Phase 1

Summary: 
      The Study Showed that combining clonidine and ketamine together can increase the likelihood
      of achieving a sufficient level of anaesthesia while minimizing post-operative discomfort and
      inflammation.
    

Detailed description: 
      This study aimd to determine whether propofol infusion combined with clonidine and ketamine
      is more efficient in lowering the level of IL-8, preserving operation stability, and dropping
      post-operative pain and morphine intake.

      When paralleled to propofol alone, TIVA employing propofol infusion along with pre-operation
      clonidine and ketamine is effective at preserving hemodynamic stability, dropping
      post-operative pain, and dipping morphine intake.

      For this study, sixty contestants with ASA physical status I and II, ranging in age from 35
      to 65, were scheduled for colon cancer operation lasting longer than 120 minutes. This study
      excluded participants with a history of heart, renal and liver cell failure, allergic
      reaction to studied drugs, and history of epilepsy, hemodynamic instability, chronic pain, or
      mental illness. Using a computer-generated randomization list, the patients were randomly
      allocated into two groups (30 patients each).

      The treated group(Group T),which got intravenous anaesthesia with TCI propofol mixed with
      clonidine and ketamine, the control group(Group C),which received intravenous anaesthesia
      with TCI propofol mixed with a placebo (NaCl 0.9%) .A third party was included in this study
      so neither the researchers nor the research subjects are aware of the intervention which the
      patients got.
    

Intervention name(s): TCI Propofol Injection
Intervention type(s): Drug
Intervention description(s): To decrease postoperative pain after cancer colon surgery
Other intervention name(s): Ketamine and clonidine
Intervention MeSH terms: Clonidine; Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: preserving hemodynamic stability, dropping post-operative pain, and dipping morphine intake
Masking: Single (Participant)
Primary purpose: Treatment
A Study of Lasmiditan on Simulated Driving Performance in Healthy Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the effect of lasmiditan on simulated driving
      performance in healthy participants. Participants are expected to complete each of four study
      periods, which will last a total of about 10 days. During this time, participants will remain
      in the clinical research unit. Screening must be completed within 28 days before the start of
      the study. Follow-up will be completed about one week after discharge.
    


Intervention name(s): Lasmiditan; Placebo; Diphenhydramine
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Administered orally; Administered orally; Administered orally
Other intervention name(s): LY573144
Intervention MeSH terms: Diphenhydramine; Promethazine; Lasmiditan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Basic Science
A Study in Healthy Men and Women Who Are Either Between 18 - 45 Years or Between 65 - 80 Years to Test How Different Doses of BI 474121 Are Tolerated
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The main objectives of this trial are to investigate safety and tolerability of BI 474121 in
      healthy male and female young and elderly subjects following oral administration of multiple
      rising doses per day over 14 days.
    


Intervention name(s): BI 474121; Midazolam; Placebo
Intervention type(s): Drug; Drug; Drug
Intervention description(s): BI474121; Midazolam; Placebo
Intervention MeSH terms: Midazolam
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of Vegetable Oils for Use by the Snack Food Industry on Plasma Lipid Levels and Inflammatory Markers
Condition: Hyperlipidemias; Metabolic Syndrome X; Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases; Metabolic Syndrome; Hyperlipidemias
Study type: Interventional

Summary: 
      The current study is designed to assess the effect of a conventional cooking oil
      (hydrogenated oil) and a reformulated fat low in trans fatty acids on cardiovascular disease
      risk factors.
    

Detailed description: 
      It is known that in subjects with high cholesterol levels that substitution of hydrogenated
      fat (high in trans fat) with vegetable oil results in higher levels of total and LDL
      cholesterol ("bad" cholesterol). There has been tremendous interest within the food industry
      to identify cooking fats that have the physical properties necessary to make shelf stable
      products and have textural characteristics similar to existing products but that also
      favorably affects risk factors for coronary heart disease (CHD) such as LDL cholesterol
      levels and inflammatory markers. The current study is designed to assess the effect of a
      conventional cooking oil (hydrogenated oil) and a reformulated fat low in trans fatty acids
      on cardiovascular disease risk factors.
    

Intervention name(s): Comparison of cooking oils
Intervention type(s): Behavioral
Intervention description(s): 30 subjects will consume each of the two diets in randomized order for 5 weeks each. Diets will be designed to maintain body weight; will have 30% of energy as fat which 2/3 or 20% of energy will be either the conventional or reformulated fat. Blood lipids and C reactive protein (CRP) as well as indicators of how lipids are processed in the blood will be measured at the end of each dietary phase.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Safety and Tolerability Study of MEDI-551, a B-cell Depleting Agent, to Treat Relapsing Forms of Multiple Sclerosis
Condition: Multiple Sclerosis, Relapsing Forms
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to evaluate the safety and tolerability of ascending intravenous
      (IV) and subcutaneous (SC) doses of MEDI-551 in adult subjects with relapsing forms of
      multiple sclerosis (MS).
    

Detailed description: 
      This is a Phase 1, multicenter, multinational, randomized, blinded, placebo-controlled,
      dose-escalation study to evaluate the safety and tolerability of IV and SC doses of MEDI-551
      in adult subjects with relapsing forms of MS.
    

Intervention name(s): MEDI-551 30 MG-IV; MEDI-551 60 MG-SC; PLACEBO-IV-SC; MEDI-551 100 MG-IV; MEDI-551 300 MG-SC; MEDI-551 600 MG-IV
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Participants received a fixed IV dose of 30 milligram (mg) MEDI-551 infused on Days 1 and 15.; Participants received SC injection of 60 mg MEDI-551 on Day 1.; Participants received either a fixed IV dose of placebo matching with MEDI- 551 on Days 1 and 15 or SC injection on Day 1; Participants received a fixed IV dose of 100 mg MEDI-551 infused on Days 1 and 15.; Participants received SC injection of 300 mg MEDI-551 on Day 1.; Participants received a fixed IV dose of 600 mg MEDI-551 infused on Days 1 and 15.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: MAb, B cell, depletion, RMS
Success of Zirconia and Stainless Steel Crowns for Permanent Molars
Condition: Caries Active; Dentin, Carious
MeSH terms: Dental Caries
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate and compare the clinical and radiographic
      performance of zirconia and stainless steel crowns on permanent molar
    

Detailed description: 
      Zirconia and stainless steel crowns will be placed on at least two permanent molars, in a
      split mouth design. 100 patients will be included in the study. The teeth will be randomized
      into two groups according to the crown type.

      Group 1: Zirconia crown 2: Stainless steel crown. Plaque index, gingival index, crown
      retention, presence of restoration failure, gingival margin extension and pulpal health of
      the teeth will be clinically evaluated at baseline and 1., 6., 12., 18., 24. months. The
      restorations will be evaluated radiographically at 6., 12. and 18. months. Intra-oral photos
      will be taken directly after treatment and at control appointments.

      The data will be analysed statistically using Fisher's Exact Test and pearson's chi-square
      test; and Log-rank and the Kaplan-Meier will be used to estimate survival percentages.
    

Intervention name(s): zirconia crowns; stainless steel crowns
Intervention type(s): Device; Device
Intervention description(s): esthetic crowns for capping permanent molars with caries; stainless steel crowns for capping permanent molars with caries
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: zirconia crowns; stainless steel crowns; dental caries
Bioavailability, Safety, and Pharmacodynamics of Dexlansoprazole Delayed-Release Orally Disintegrating Tablets in Healthy Participants
Condition: Bioavailability
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the pharmacokinetics (PK) and Pharmacodynamics (PD) of
      dexlansoprazole delayed-release orally disintegrating (OD) tablets administered on the tongue
      and swallowed without water.
    

Detailed description: 
      The drug being tested in this study is called dexlansoprazole. Dexlansoprazole is being
      tested to see if two different forms of the medication react the same way in the human body.
      This study will look at biological samples from people who take an orally disintegrating
      tablet of dexlansoprazole compared to a swallowed capsule of dexlansoprazole.

      The study will enroll approximately 52 patients. Participants will be randomly assigned (by
      chance, like flipping a coin) to one of the two treatment groups. Both treatment groups will
      receive both forms of dexlansoprazole at different time periods:

        -  Two dexlansoprazole 30 mg orally disintegrating tablets for 5 days

        -  One dexlansoprazole 60 mg capsule for 5 days.

      All participants will be asked to take two tablets or one capsule at the same time each day
      throughout each treatment period of the study.

      This single-centre trial will be conducted in the United States. Participants will make 3
      visits to the clinic including two 6-day periods of confinement to the clinic, and will be
      contacted by telephone 5 to 10 days after last dose of study drug for a follow-up assessment.

      The overall time to participate in this study is up to 57 days.
    

Intervention name(s): Dexlansoprazole Delayed Release Orally Disintegrating Tablets; Dexlansoprazole Delayed Release Capsules
Intervention type(s): Drug; Drug
Intervention description(s): Dexlansoprazole delayed-release, orally disintegrating (OD) tablets; Dexlansoprazole delayed-release capsules
Other intervention name(s): Dexilant
Intervention MeSH terms: Dexlansoprazole; Lansoprazole
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Drug therapy
A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4
Condition: Hepatitis C, Chronic
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 2

Summary: 
      This equally randomized (1:1), double-blind, parallel arm study will assess the safety and
      antiviral efficacy of RO5024048 added to standard Pegasys (peginterferon alfa-2a) plus
      Copegus (ribavirin) therapy in patients with chronic hepatitis C genotype 1 or 4. Patients in
      arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys
      (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). Patients achieving a
      rapid virological response (RVR) at week 4, sustained through week 22, will stop all
      treatment at week 24; non-RVR patients will continue treatment with Pegasys and Copegus for
      another 24 weeks up to week 48. Patients in arm B will receive standard treatment with
      Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks.
      Anticipated time on study treatment is up to 48 weeks. Target sample size is <200.
    


Intervention name(s): RO5024048; Ribavirin [Copegus]; peginterferon alfa-2a [Pegasys]
Intervention type(s): Drug; Drug; Drug
Intervention description(s): 1000mg bid po, 24 weeks; 1000mg or 1200mg po daily; 180mcg sc weekly
Intervention MeSH terms: Ribavirin; Peginterferon alfa-2a
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
A Study to Evaluate Changes in Smokers Using Oral Tobacco-derived Nicotine Products.
Condition: Tobacco Use
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate changes in exposure to selected harmful and
      potentially harmful constituents (HPHC) by measuring biomarkers in adult smokers who
      partially or completely switch from smoking cigarettes to oral tobacco-derived nicotine
      (OTDN) products compared to those who continue exclusive smoking cigarettes or stop using all
      tobacco products.
    

Detailed description: 
      This is an open label, randomized, 6 parallel-group clinical study evaluating changes in
      exposure to selected HPHCs, subjective effects, and product use behavior in adult smokers
      relative to continued smoking who are randomly assigned to continue smoking, partially or
      completely switch to oral tobacco-derived nicotine products, or stop using any tobacco
      products for 7 days.
    

Intervention name(s): OTDN product 1; OTDN product 2; Tobacco Cessation
Intervention type(s): Other; Other; Other
Intervention description(s): Oral tobacco-derived nicotine product; Oral tobacco-derived nicotine product; Tobacco Cessation
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
DAPROCA Pelvic Lymph Node Irradiation to Prostate for High Risk Prostate Cancer: Phase I/II Study
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Study type: Interventional

Summary: 
      This is a prospective, open label 1 arm study, multicentre, Phase I/II clinical safety study.
      The trial is designed to gain initial safety and efficacy data on pelvic lymph node radiation
      with simultaneous integrated boost to prostate in high risk prostate cancer patients.
    


Intervention name(s): Radiation: pelvic lymph nodes with boost to prostate
Intervention type(s): Radiation
Intervention description(s): 78(74)Gy/39(37) fractions to prostate, 56(55)GY /39(37) fractions to pelvic lymph nodes, 5 fractions per week.
Intervention model: Single Group Assignment
Intervention model description: Patients are allocated for lymph node irradiation, either up front combined with prostate irradiation or lymph node irradiation after primary lymph adenectomy after combined with prostate irradiation.
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: prostate cancer; locally advanced; lymph node positive; radiation therapy; morbidity; early morbidity; late morbidity
Dexamethasone-Implant for the Treatment of Macula Edema Due to Irvine Gass Syndrome
Condition: Macular Edema; Visual Acuity
MeSH terms: Macular Edema; Edema
Study type: Observational

Summary: 
      To analyze macula edema formation after cataract surgery called Irvine-Gass-Syndrome.
    

Detailed description: 
      20 to 25 patients suffering from Irvine Gass Syndrom should be monitored for at least six
      months, controlled monthly. In all cases best corrected visual acuity, Spectralis-OCT (volume
      thickness scan), fundus photography (Optomap), intraocular pressure, slitlamp assessment and
      indirect ophthalmoscopy should be performed on every visit. Fluorescein angiography should be
      performed at baseline and after 3 and 6 months.

      Inclusion criteria:

      Patients older than 18 years who develop macula edema secondary to cataract surgery.

      - Consent agreement - Patients should be informed that it is possible to get an active
      medication (Ozurdex implant) as an "on label" indication from the health insurance company if
      the diagnosis is accepted as an intraocular inflammation form of "Uveitis posterior".

      Exclusion criteria:

      Visual acuity worse than 20/400, known history of glaucoma and steroid response, any macular
      disease interfering with visual acuity (DME, AMD, etc.), history of vitrectomy, use of
      systemic, periocular, or intraocular corticosteroids within 30 days.

      Outcome:

        -  BCVA

        -  Patients suffering from diabetes mellitus should be evaluated also separately.

        -  Change in central retinal thickness using optical coherence tomography (OCT)

        -  Secondary parameters (elevated IOP, retinal detachments, vitreous hemorrhage,
           endophthalmitis rates)
    

Intervention name(s): Ozurdex
Intervention type(s): Drug
Intervention description(s): - Consent agreement - Patients should be informed that it is possible to get an active medication (Ozurdex implant) as an "on label" indication from the health insurance company if the diagnosis is accepted as an intraocular inflammation form of "Uveitis posterior".
Other intervention name(s): Dexamethasone-implant
Intervention MeSH terms: Dexamethasone
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Patients older than 18 years.
      
Keywords: macular edema, irvine gass syndrome, ozurdex
Dextroamphetamine as Adjunct in Cocaine/Opiate Dependent Patients - 3
Condition: Cocaine-Related Disorders; Opioid-Related Disorders
MeSH terms: Opioid-Related Disorders; Cocaine-Related Disorders
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to evaluate dextroamphetamine sulfate (sustained release) as an
      adjunct in concurrent cocaine and opiate dependent patients.
    

Detailed description: 
      This 27-week double-blind, placebo controlled treatment is designed to evaluate
      dextroamphetamine sulfate (sustained release) as an adjunct in concurrent cocaine and opiate
      dependent patients. All subjects will receive methadone. For the treatment of cocaine
      dependence, subjects will receive one of 2 doses of dextroamphetamine (15 or 30mg) or
      placebo. After 4 weeks of treatment the dose level of dextroamphetamine is doubled (30 or
      60mg). This dose is maintained for 20 weeks; during which subjects attend twice weekly visits
      to the clinic and receive weekly cognitive behavioral therapy. Follow up evaluations will be
      conducted out to 3 months post treatment. Subjects will be assisted in transferring to
      Houston area methadone clinics to maintain treatment for opiate dependence following
      treatment completion.
    

Intervention name(s): Dextroamphetamine
Intervention type(s): Drug
Intervention MeSH terms: Dextroamphetamine
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Double
Primary purpose: Treatment
Keywords: cocaine dependence
Omega-3 Polyunsaturated Fatty Acids in Youth With ADHD
Condition: Attention Deficit Hyperactivity Disorder; ADHD
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional

Summary: 
      N-3 polyunsaturated fatty acids(N-3 PUFAs) is important in balancing the immune function and
      crucial for the developing brain. Deficiency in n-3 PUFAs might be linked to the poor
      cognitive performances resulting in inattention and hyperactivity in youth with attention
      deficit hyperactivity disorder (ADHD). N-3 PUFAs appears to be a promising treatment that is
      safe, beneficial to youth with ADHD. In this proposal, investigators aim the test the
      hypothesis that n-3 polyunsaturated fatty acids will be more effective than placebo in
      improving cognitive function in youth with ADHD after 12 weeks of intervention.
    

Detailed description: 
      This is a 1-year study and a randomized, double-blind, and placebo controlled Clinical the
      study. investigators plan to enrol 100 subjects from Child and Adolescent Psychiatry
      Outpatient Clinic of China Medical University Hospital.Participants will be randomized into
      omega-3 polyunsaturated fatty acids or placebo group.The intervention period is 12 weeks.
      Evaluation of the cognitive function ( using Continuous Performance Test 3rd Edition ) of the
      subjects who are enrolled into the study will take place at baseline and after the 12th week.
      The symptom severity of ADHD will be measured with Swanson, Nolan, Pelham Questionnaire
      (SNAP-IV) at baseline, 2,4,8, and 12 weeks. The plasma level of n-3 polyunsaturated fatty
      acids, blood and salivary inflammatory markers will also be measured at the beginning and at
      the end of the study.
    

Intervention name(s): n-3 Polyunsaturated fatty acid; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): 1g of Eicosapentaenoic acid (EPA); Olive oil ethyl esters
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: ADHD; n-3 polyunsaturated fatty acids; children; adolescents