bioihbjkbjnl/mcl2 huggingface dataset:
Long-term Assessment of Safety and Efficacy of BI 695501 in Patients With Rheumatoid Arthritis
Condition: Arthritis, Rheumatoid
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 3

Summary: 
      The main objective of this trial is to provide long-term safety, pharmacokinetics (PK), and
      immunogenicity data on BI 695501 administered via prefilled syringe in patients with
      Rheumatoid Arthritis who have completed Trial 1297.2. The primary endpoint thereby is the
      number (proportion) of patients with drug-related adverse events (AEs) during the treatment
      phase. The secondary objective in this trial is the assessment of Long-term efficacy of BI
      695501 by evaluation of:

        -  the change from Baseline in DAS28 (ESR) at Week 48

        -  the proportion of patients meeting American College of Rheumatology 20% (ACR20) response
           criteria at Week 48

        -  the proportion of patients who meet the American College of Rheumatology (ACR)/European
           League Against Rheumatism (EULAR) definition of remission at Week 48

        -  the proportion of patients with EULAR response (good response, moderate response, or no
           response) at Week 48.
    


Intervention name(s): BI 695501
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Nutritional Evaluation of Canola Protein in Comparison With Soy Protein
Condition: Men
Study type: Interventional

Summary: 
      The objective of the study is to evaluate the nutritional and physiological properties of two
      canola proteins focusing on the bioavailability in humans.
    

Detailed description: 
      The physiological effects of a single administration of two different industrially
      manufactured canola proteins (hydrolyzate, isolate) were investigated compared to soy
      protein.

      Twenty-eight healthy men (ø 25 years) completed a double-blind, placebo-controlled, crossover
      study. The subjects were randomly divided into two groups (group A: canola protein isolate
      and soy protein isolate and group B: canola protein hydrolyzate and soy protein isolate).
      After a three-day run-in period, on the intervention day, the subjects consumed a protein
      drink containing 30.0 g protein powder added to a final volume of 500 mL tomato juice. Half
      of the subjects in each group consumed a protein drink containing 30.0 g canola protein, the
      other half received the soy protein. After taking of fasting blood samples in the morning of
      the intervention day, blood samples were drawn at regular intervals for a period of eight
      hours. At the end of the run-in period and on the intervention day, a 24-hour urine
      collection took place.

      Within a second experiment (after 4 weeks), the protein source was crossed within the four
      subgroups for the second intervention.
    

Intervention name(s): Protein drink - protein isolate; Protein drink - protein hydrolyzate
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): The subjects consumed 500 mL of a protein drink (tomato juice) containing 30 g protein (canola protein isolate or reference protein) after overnight fasting. After run-in period, each volunteer have to pass both protein-intervention days in different order with a four-week wash out period in between.; The subjects consumed 500 mL of a protein drink (tomato juice) containing 30 g protein (canola protein hydrolyzate or reference protein) after overnight fasting. After run-in period, each volunteer have to pass both protein-intervention days in different order with a four-week wash out period in between.
Other intervention name(s): CPI; CPH
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Screening
Keywords: Dietary protein; Canola protein; Protein metabolism; Protein-enriched drinks; Nitrogen balance
Diameter Changes of Retinal Vessels During Hypoxia
Condition: Diabetes Mellitus Type 1; Diabetic Maculopathy
MeSH terms: Macular Degeneration; Diabetes Mellitus, Type 1; Hypoxia
Study type: Interventional

Summary: 
      The primary objective is to study if an inhibition of nitric oxide and/or prostaglandins
      affect the diameter changes of retinal vessels observed during hypoxia. Diameter changes are
      studied using the Dynamic Vessel Analyzer.
    


Intervention name(s): COX inhibitor; L-NG-monomethyl arginine citrate; COX inhibitor + L-NG-monomethyl arginine citrate
Intervention type(s): Other; Other; Other
Intervention description(s): Administration of 1 drop voltaren 45 minutes before recordings of diameter changes of retinal vessels are initiated; Intravenous administration of L-NMMA during recordings of diameter changes of retinal vessels; Combination of interventions. Administration of an eye drop voltaren and 45 minutes later infusion with L-NMMA is started and recording of diameter changes of retinal vessels is performed
Other intervention name(s): Eye drops voltaren 1 mg/ml; L-NMMA
Intervention MeSH terms: Cyclooxygenase Inhibitors; Citric Acid; Sodium Citrate; omega-N-Methylarginine
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Pharmacokinetics and Bioavailability of Single Subcutaneous Doses of Methylnaltrexone Versus Intravenous Dose
Condition: Healthy Subjects
Study type: Interventional
Phase: Phase 1

Summary: 
      This is an open-label, Phase I study. Study treatments will entail a four-way crossover among
      three single, ascending, subcutaneous doses and one intravenous dose of MNTX in six healthy
      normal male volunteers. Blood samples will be obtained to determine plasma pharmacokinetics,
      dose proportionality for subcutaneous doses, and absolute bioavailability versus an
      intravenous dose.
    


Intervention name(s): SC Methylnaltrexone (MNTX); SC Methylnaltrexone (MNTX); SC Methylnaltrexone (MNTX); IV Methylnaltrexone (MNTX)
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Dose 1; Dose 2; Dose 3
Intervention MeSH terms: Naltrexone; Methylnaltrexone
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Abdominoplasty Under Spinal Anesthesia
Condition: Spinal Anesthesia Suitability for Abdominoplasty
Study type: Interventional

Summary: 
      100 patients undergoing abdominoplasty under spinal anesthesia. 100 patients undergoing
      abdominoplasty under general anesthesia
    

Detailed description: 
      200 patients, American Society of Anesthesiologists (ASA) physical status classes I and II,
      were enrolled in this feasible study. All patients were subjected to abdominoplasty operation
      under spinal anesthesia or general anesthesia. Any intraoperative complications like
      hypotension, bradycardia, pain, nausea and vomiting related to spinal anesthesia were managed
      and recorded. Postoperative visual analogue scale (VAS) was used to assess pain severity and
      the need for analgesia to be administered.
    

Intervention name(s): Propofol 10 Mg/mL Intravenous Emulsion
Intervention type(s): Drug
Intervention description(s): when spinal anesthesia is not satisfactory intervention drugs are used
Other intervention name(s): ketamine
Intervention MeSH terms: Ketamine; Propofol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary purpose: Supportive Care
Keywords: Abdominoplasty; spinal anesthesia; general anesthesia; postoperative pain
Efficacy and Safety of Evoglitin in Patients With Type 2 Diabetes and Non-alcoholic Fatty Liver Diseases
Condition: Type2 Diabetes; Non-Alcoholic Fatty Liver Disease
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

Summary: 
      A multicenter, double-blind, active-controlled, randomized, parallel, phase IV clinical trial
      to evaluate the efficacy and safety of evogliptin in patients with type 2 diabetes and
      non-alcoholic fatty liver diseases
    

Detailed description: 
      1. Evogliptin 5mg Group: Administration with Evogliptin 5mg and Placebo for 24weeks

        2. Pioglitazone 15mg Group: Administration with Pioglitazone 15mg and Placebo for 24weeks
    

Intervention name(s): Evogliptin; Pioglitazone
Intervention type(s): Drug; Drug
Intervention description(s): evogliptin 5mg tablet qd + placebo tablet matching to pioglitazone 15mg qd; pioglitazone 15mg tablet qd + placebo tablet matching to evogliptin 5mg qd
Other intervention name(s): Suganon; Gluconon
Intervention MeSH terms: Pioglitazone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Study of the Effects of Oral AT1001 (Migalastat Hydrochloride) in Patients With Fabry Disease
Condition: Fabry Disease
MeSH terms: Fabry Disease
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this study was to compare the effect of migalastat (123 milligrams
      [mg] of migalastat [equivalent to 150 mg of migalastat hydrochloride]) (migalastat) versus
      placebo on kidney globotriaosylceramide (GL-3).
    

Detailed description: 
      This double-blind, randomized, placebo-controlled study was conducted in 67 participants at
      46 sites worldwide. The study consisted of 2 stages and an optional open-label treatment
      extension phase:

      Stage 1 included a screening period of up to 2 months followed by a 6-month treatment period
      which involved 4 visits to the clinic. Participants were randomized in equal proportions to
      receive either migalastat or placebo.

      After completing the 6-month double-blind phase, all participants entered Stage 2 of the
      study and received migalastat in an open-label manner. Stage 2 treatment lasted for 6 months
      and involved up to 4 visits to the clinic.

      Participants who completed both Stage 1 and Stage 2 of the study as scheduled were offered
      the opportunity to participate in an open-label treatment extension phase with migalastat.
      The open-label treatment extension phase lasted 12 months and involved 2 visits to the
      clinic. A follow-up visit was undertaken 1 month following completion or discontinuation from
      the open-label treatment extension. Participants completing the 12-month open-label treatment
      extension and providing consent to enter a separate long-term extension were not required to
      complete this follow-up visit.

      Study assessments included clinical laboratory tests, 12-lead electrocardiogram, kidney
      biopsy, kidney function testing, echocardiography, and patient-reported outcomes.
    

Intervention name(s): migalastat hydrochloride; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral capsule QOD; Oral capsule QOD
Other intervention name(s): AT1001; Galafold; Migalastat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Amicus Therapeutics; AT1001; Migalastat; Pharmacokinetics; Substrate; Galafold
Market Research - Acceptability Study for a Range of MCT Products
Condition: Ketosis; Epilepsy; Ketogenic Diet; Fatty Acid Oxidation Disorder; Malabsorption
MeSH terms: Malabsorption Syndromes; Epilepsy; Ketosis
Study type: Interventional

Summary: 
      This is a market research, observational study to evaluate the tolerability and acceptability
      of MCT supplements for young children and young people with intractable epilepsy, GLUT-1 or
      PDHD from 3 years to adulthood. Patients with a confirmed diagnosis of a fatty acid oxidation
      disorder, which requires a specialist diet including MCT will be included in this study
    


Intervention name(s): MCT fats
Intervention type(s): Dietary Supplement
Intervention description(s): Subjects will be asked to take 3 new MCT products for 7 days each over a 25 day period (21 days taking the new products with 2 days between each new product trialled).
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
A Proof-of-Concept Study of Minocycline in Autism
Condition: Autism Spectrum Disorder; Autism
MeSH terms: Autistic Disorder; Autism Spectrum Disorder; Child Development Disorders, Pervasive
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to determine if Minocycline shows initial evidence of efficacy,
      safety, and tolerability in youth with Autism Spectrum Disorder ages 12 to 22 years.
    

Detailed description: 
      This is a double-blind, placebo-controlled, crossover, proof-of-concept study that compares
      the pharmacodynamic and tolerability profiles of minocycline versus placebo in autism
      spectrum disorder.
    

Intervention name(s): Minocycline; Placebos
Intervention type(s): Drug; Drug
Intervention description(s): Minocycline 100 mg capsules or matching placebo will be prepared by the central investigational pharmacy at Cincinnati Children's Hospital Medical Center. Drug identity will be masked by over encapsulation of the study drug.; Minocycline 100 mg capsules or matching placebo will be prepared by the central investigational pharmacy at Cincinnati Children's Hospital Medical Center. Drug identity will be masked by over encapsulation of the study drug.
Other intervention name(s): Minocin
Intervention MeSH terms: Minocycline
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Autism; Autism Spectrum Disorder; Minocycline
Prothrombotic Biomarkers and Ovarian Stimulation
Condition: Sterility, Female; Reproductive Technology, Assisted
MeSH terms: Infertility; Infertility, Female
Study type: Observational

Summary: 
      The aim of this study is to assess the impact of different protocols used for ovarian
      stimulation during in vitro fertilization procedures (IVF) on prothrombotic biomarkers (blood
      coagulation markers associated with thromboembolic events) in the units of reproductive
      medicine in two university hospitals (HUG, Geneva and CHUV, Lausanne).
    

Detailed description: 
      HEMO-STIM is a prospective multicentric cohort study of subfertile women undergoing ART. It
      is an epidemiologic observational study. All women older than 18 years attending the
      reproductive medicine unit (UMREG, Geneva, HUG or UMR, Lausanne, CHUV) and undergoing an IVF
      have been and will be recruited consecutively and included. The type of stimulation protocol
      used is recorded.

      All measurements (specific haemostasis test with a thrombin generation assay before and after
      adjunction of APC) that are part of the study will be performed in the HUG laboratories in
      order to limit inter-dosage variability.

      The 1st blood test will be performed at inclusion in the absence of any hormonal treatment
      (T1). A 2nd blood test will be performed on the day of ovulation triggering (T2). A 3rd blood
      test will be performed 7 days after ovulation triggering (T3).

      The comparison of different protocols has never been performed and data on the effect of
      antagonist protocols for IVF on haemostasis are lacking. The measurement of intermediate
      biomarkers of thromboembolic risk during different IVF stimulation protocols (agonists and
      antagonists) would allow the comparison of their thrombotic profile and to optimize the
      risk/benefit ratio during ART by prescribing protocols at lower vascular risk, in particular
      in women identified as being at risk for thromboembolic events.
    

Intervention name(s): Blood test
Intervention type(s): Biological
Intervention description(s): 20 ml of blood, three times
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Women will be recruited in reproductive unit from 2 hospitals (HUG, Geneva and CHUV,
        Lausanne) in Switzerland
      
Biospecimen description: 
      Serum and plasma
    
Keywords: Ovarian stimulation; thrombin generation; haemostasis; thrombosis
Effect of Vitamin D Supplementation on Hemoglobin A1c in Patients With Uncontrolled Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The purpose of this study is to determine if daily supplementation with 2000 International
      Units of Vitamin D will improve hemoglobin A1c in uncontrolled type 2 diabetics.
    

Detailed description: 
      Vitamin D is typically understood to support musculoskeletal health when administered
      concomitantly with calcium. A number of recent studies suggest, however, that this important
      nutrient may play a significant role in many pathophysiological processes, including diabetes
      mellitus. With the prevalence of diabetes mellitus ever increasing, novel mechanisms for
      controlling blood glucose and hemoglobin A1c are being sought to help prevent the costly and
      debilitating complications of this chronic disease.
    

Intervention name(s): Vitamin D3 2000 international units daily; Vitamin C 500mg daily
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Vitamin D3 2000 international unit tablets once daily for 3 months; Vitamin C 500mg tablets once daily for 3 months
Intervention MeSH terms: Vitamin D; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Crossover Study to Evaluate the Relative Oral Bioavailability and Food Effect After Single Dose Administration of JNJ-54861911 Tablet in Healthy Elderly Participants
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the effect of a high-fat/high-caloric breakfast on the
      rate and extent of absorption of the single oral dose of 25 mg JNJ-54861911 test formulation
      in healthy elderly participants.
    

Detailed description: 
      This is a randomized (study medication assigned to participants by chance), open-label (all
      people know the identity of the intervention), 3-treatment, 3-period, 6-sequence crossover
      (participants may receive different interventions sequentially during the trial), and
      single-center study of JNJ-54861911. The duration of study will be approximately of 7 weeks
      per participant. The study consists of 3 parts: Screening (that is, 21 days before study
      commences on Day 1); Open-label Treatment (consists of 3 single-dose treatments, either
      JNJ-54861911 formulation 1 [reference] or JNJ-54861911 formulation 2 [test] under fed or
      fasted condition), in subsequent 3-treatment periods, each separated with washout period of 7
      days); and End-of-Study (up-to 14 days after last study drug administration). All the
      eligible participants will be randomly assigned to 1 of the 6 treatment sequences. In fasted
      conditions, study drug will be administered following a 10-hour overnight fast. In fed
      conditions, participants will also fast from food for 10 hours, but will consume a high
      fat/high calorie breakfast within a 30-minute period. Study drug will be administered 30
      minutes after the start of breakfast. Participants will not be allowed to have food until 4
      hours of drug administration. Blood samples will be collected for evaluation of
      pharmacokinetics at pre-dose and post-dose of study treatment. Relative bioavailability of
      two formulations of JNJ-54861911 (test and reference) will be evaluated primarily.
      Participants' safety will be monitored throughout the study.
    

Intervention name(s): JNJ-54861911 (Treatment A); JNJ-54861911 (Treatment B); JNJ-54861911 (Treatment C)
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Participants will receive a single oral 25 mg formulation 1 of JNJ-54861911 tablet as Treatment A under fasted conditions in one of the treatment periods.; Participants will receive a single oral 25 mg formulation 2 of JNJ-54861911 tablet as Treatment B under fasted conditions in one of the treatment periods.; Participants will receive a single oral 25 mg formulation 2 of JNJ-54861911 tablet as Treatment C under fed conditions in one of the treatment periods.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Bioavailability; Healthy Participants; JNJ-54861911; Food Effect
Effect of Low Level Laser on Orthodontic Canine Retraction
Condition: Dental Malocclusion
MeSH terms: Malocclusion
Study type: Interventional

Summary: 
      The aim of this study was to determine whether orthodontically moved maxillary canines
      exposed to two different protocols and dosage of LLLT exhibited differences in amount and
      rate of orthodontic tooth movement.
    

Detailed description: 
      Fifteen orthodontic patients, 12 females and 3males, with a mean age of 17.48 ± 2.95 years
      were included. They had a clinical indication for bilateral extraction of at least first
      maxillary premolars. Using a split mouth design, maxillary left and right sides were randomly
      divided into two groups. In group 1, LLLT was delivered at 10 points; 5 from buccal and 5
      from palatal aspects with a total dose of 8 Joule (J) per session that distributed as
      follows; 2 cervical, 1 middle, 2 apical. In group II, laser was applied from buccal side only
      at 5 points through the same order with a dose of 4 J per session. In both protocols,
      maxillary canines were irradiated with a gallium aluminum-arsenide diode laser in continuous
      mode with 635 nm, 100 mW, 25 J/cm2, 8 seconds/ point, 0.8 J/point. Both sides were distalized
      by a standard protocol with uniform 150 gm retraction force via a nickel-titanium closed coil
      spring. In both protocols, laser regimen was applied on days 0, 3, 7, and 14 in the 1st
      month, and thereafter on every 15th day until 6-month observation period of canine retraction
      phase. Amount and monthly rate of maxillary canine retraction and degree of anchorage loss
      were determined by direct intraoral and indirect 3D digital models measurements. Evaluations
      were undertaken immediately before initiating retraction (T0), after 4 weeks (T1), after 8
      weeks (T2), after 12 weeks (T3), after 16 weeks (T4), after 20 weeks (T5), and after 24 weeks
      (T6). Significance level was set at p < 0.05.
    

Intervention name(s): Low Level Laser Therapy
Intervention type(s): Radiation
Other intervention name(s): Photobiomodulation
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Buccal &palatal LLLT Group, Buccal &palatal LLLT Group
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Low Level Laser Therapy; Orthodontic Tooth movement; Canine Retraction; Two Protocols and Energy Doses