bioihbjkbjnl/mcl2 huggingface dataset:
A Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Repeat Doses of RV1729 for 28 Days in Patients With COPD
Condition: Chronic Obstructive Pulmonary Disease
MeSH terms: Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      RV1729 is a new medicine being developed for the potential treatment of asthma and smoking
      related lung disease (also known as chronic obstructive pulmonary disease - COPD). The
      objective of this study is to investigate the safety, tolerability, pharmacokinetics and
      pharmacodynamics repeat doses of RV1729 in patients with COPD for 28 days.
    


Intervention name(s): RV1729 28 day repeat dose; RV1729 matching placebo 28 day repeat dose
Intervention type(s): Drug; Drug
Intervention description(s): Safety and tolerability of repeat doses; Safety and tolerability of repeat doses
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Pharmacodynamic Study of an Oral Iron Chelator Given for 6 Months to Patients With Iron Overload
Condition: Transfusional Iron Overload; Beta-thalassemia
MeSH terms: Thalassemia; beta-Thalassemia; Iron Overload
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this research study is to evaluate the safety of two doses of FBS0701, a new
      oral iron chelator, and its effectiveness in clearing iron from the liver. FBS0701 is a
      medication taken by mouth that causes the body to get rid of iron. Iron chelators are used in
      patients with β-thalassemia and other forms of anemia who experience iron overload - iron
      increases in the body as a result of regularly required blood transfusions. Patients who
      qualify will be randomized to receive one of two doses of FBS0701 for up to 24 weeks (6
      months) with a total study duration of up to 33 weeks. These patients will be eligible to
      participate in a dosing extension for up to 72 weeks. The maximum duration of dosing will be
      up to 96 weeks. The safety of patients will be monitored frequently during the study by
      physical exams, ECGs, and blood tests. To assess the amount of iron in the liver and heart,
      each patient must undergo 6 MRI scans during the study. Patients will not need to stay in the
      hospital for this study but will need to visit the outpatient clinic up to 28 times over the
      96 week period. Patients currently taking an iron chelator will be required to stop for a
      total of up to 26 weeks. The results of this study will help to determine if FBS0701 may be
      effective as an iron chelator.
    


Intervention name(s): SPD602 (FBS0701, SSP-004184)
Intervention type(s): Drug
Intervention description(s): Oral FBS0701 taken one time daily for up to 96 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Beta-thalassemia; Sickle cell anemia; Transfusional iron overload; Iron overload; Iron chelation
Fractionated Vs Single Dose Injection for Spinal C-Section in Patients With Pregnancy-Induced Hypertension
Condition: Pregnancy Induced Hypertension
MeSH terms: Hypertension, Pregnancy-Induced; Hypertension
Study type: Interventional

Summary: 
      The aim of this study was to compare haemodynamic changes, total dose of ephedrin
      requirement, and level of sensory blockade between fractionated dose and single dose spinal
      anesthesia injection in obstetric patients with pregnancy-induced hypertension who underwent
      Caesarean section
    

Detailed description: 
      Approval from Ethical Committee of Faculty of Medicine Universitas Indonesia was acquired
      prior conducting the study. Subjects were given informed consent before enrolling the study
      and randomized into two groups; single dose (SD) and fractionated dose (FD). All subjects
      will receive spinal anesthesia with 2,5 ml of 10 mg bupivacaine hyperbaric 0,5% and fentanyl
      25 mcg. After IV cannulas (18 - 20 G) were properly placed, premedication with intravenous
      (IV) ranitidine 50 mg and metoclopramide 10 mg were given. Additional IV access was added if
      MgSO4 must been continuously administered intravenously perioperatively. Standard monitor
      device were placed after patients had been transferred to operating room. Additional
      premedication such as intravenous midazolam 0.02 mg/BW or fentanyl 1 mcg/BW were given if the
      patients were anxious or in pain. Baseline haemodynamic measurement was done two minutes
      after premedication. Spinal anesthesia was performed while patients in sitting position at
      L3-4 or L4-5 level with median or paramedian approach, with total dose 2,5 ml of 10 mg
      bupivacaine hyperbaric 0,5% and fentanyl 25 mcg. After skin wheal of lidocaine at the
      intended spinous interspace were placed, spinal needle (SpinocanR, B Braun, 27 G) were
      inserted and advanced until subarachnoid space were reached. In group FD, 1,5 ml of total
      dose followed by 1 ml remaining dose after 90 s interval were given. In SD group, 2,5 ml
      total dose were given with 0.2 ml/second rate, and subjects were asked to remain sitted for
      90 seconds. If there were more than three injection attempts, the patients were excluded from
      the study. Co-loading 5 - 10 ml/kg ringer lactate in 20 minutes were given for all subjects.
    

Intervention name(s): Bupivacaine-fentanyl; Bupivacaine-fentanyl
Intervention type(s): Drug; Drug
Intervention description(s): 2,5 ml total anesthetic drug dose were given with 0.2 ml/second rate, and subjects were asked to remain sitted for 90 seconds; 1,5 ml of total anesthetic drug dose followed by 1 ml remaining dose after 90 s interval were given
Intervention MeSH terms: Fentanyl; Bupivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: spinal anesthesia; pregnancy-induced hypertension; Cesarean section
Evaluation of the Efficacy of OMK2 in Recovering Corneal Neural Damage in Patients With Diabetes
Condition: Cornea
MeSH terms: Corneal Diseases
Study type: Interventional

Summary: 
      This will be a single-centre, randomized, pilot study. 30 patients with diabetes who
      previously had received Argon laser photocoagulation will be enrolled.
    

Detailed description: 
      This will be a single-centre, randomized, pilot study. 30 patients with diabetes who
      previously had received Argon laser photocoagulation will be enrolled. These patients will
      receive corneal esthesiometry and will be divided in those with esthesiometry < 45 mm [6]
      (clinically detectable corneal neuropathy, CDCN) and not (NCDCN).

      Patients will be randomized to the two treatment arms: 20 patients will be treated with
      active treatment (OMK2) and 10 patients will be treated with placebo (lubricant eye drops)
      given three times daily (8 am, 2 pm, 8 pm) for 18 months. Stratification for (1) CDCN, (2)
      duration of the disease, and (3) insulin-dependent diabetes will be adopted.

      The randomization will be operator-masked.
    

Intervention name(s): OMK2
Intervention type(s): Device
Intervention description(s): OMK2 (including citicoline 2%, high molecular weight hyaluronic acid 0.2%, cyanocobalamin and 0.01% BAK, Omikron Italia SRL) is a Class IIa device CE marked registered in Medical Devices Database of Italian Ministry of Health (identification number of registration: 1170558).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Cornea; Diabetes; Neural damage
Assessment of Visual Performance in Patients With Low Levels of Astigmatism
Condition: Cataract Extraction; Corneal Astigmatism
MeSH terms: Cataract; Astigmatism
Study type: Observational

Summary: 
      To assess visual performance in patients with low levels (0.5-0.75 Diopters) of corneal
      astigmatism.
    


Intervention name(s): Visual performance measures
Intervention type(s): Other
Intervention description(s): Collection of visual performance measures in subjects with low levels of astigmatism.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Subjects were selected from a single investigator's primary care clinic.
      
Keywords: Corneal astigmatism; post-cataract surgery; visual performance; Corneal astigmatism 0.5-0.75 Diopter
Relative Bioavailability of Multiple Oral Doses of BI 187004 and Metformin After Co-administration Compared to Multiple Oral Doses of BI 187004 Alone and Metformin Alone in Healthy Male Subjects
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To investigate bioavailability of BI 187004 and of metformin after concomitant multiple oral
      administration of 240 mg BI 187004 q.d. and 1000 mg metformin b.i.d. in comparison to BI
      187004 and metformin given alone.
    


Intervention name(s): metformin; BI 187004; BI 187004; metformin
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): multiple doses metformin given as tablet; multiple doses BI 187004 given as tablets; multiple doses BI 187004 given as tablets; multiple doses metformin given as tablet
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Proof-of-Concept Study of AC-201 to Prevent Gout Flares
Condition: Gout Flares
MeSH terms: Gout
Study type: Interventional
Phase: Phase 2

Summary: 
      Initiation of ULT for gout increases the occurrence of acute gouty arthritis flares due to
      mobilization of urate from tissue deposits. IL-1β plays a key role in mediating the
      inflammatory response in gouty arthritis. The efficacy of IL-1β blockade in the prophylaxis
      of gouty flares during initiation of ULT has been validated in multiple trials of IL-1β
      inhibitor therapies. Therefore, it is believed that IL-1β is a relevant therapeutic target
      for gout flares. AC-201 is an IL-1β modulator indicated for the treatment of osteoarthritis
      with good safety record and very few contraindications to the co-morbidities commonly among
      gout patients. AC-201 has also been demonstrated to have uric acid-lowering effects in
      clinical trials. The favorable product profile of AC-201 overall provides a strong rationale
      for investigating its clinical utility as prophylaxis against flares when initiating ULT.
    

Detailed description: 
      Clinical trials have demonstrated that anti-IL-1 agents (IL-1Ra, IL-1 Trap, and anti-IL-1β
      monoclonal antibody) can reduce the frequency of gout flares during the initial period of
      treatment with urate-lowering therapy and prevent of gout flares in gout patients with
      frequent flares. AC-201 is an oral IL-1 modulator but with a mechanism distinct from that of
      existing anti-IL-1 agents. The active metabolite of AC-201 has been shown in vitro and in
      vivo to inhibit the production and activity of IL-1, down-regulate IL-1 receptors, and
      increase IL1-Ra. Molecular research further suggests that these effects are mediated upstream
      via inhibition of MAPK signaling pathways and binding of NF-κB and AP-1 transcription factors
      that encode for a range of pro-inflammatory factors, including IL-1β, TNF-α, IL-6, IL-8,
      iNOS, and MMPs, which have been implicated in gout flares. AC-201 has also been demonstrated
      to have uric acid-lowering effects in clinical trials. The favorable product profile of
      AC-201 overall provides a strong rationale for investigating its clinical utility as
      prophylaxis against flares when initiating ULT.
    

Intervention name(s): Placebo; AC-201; Febuxostat
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Placebo Capsule BID for 16 Weeks; AC-201 50mg Capsule BID for 16 Weeks; Febuxostat 80 mg QD for 16 Weeks
Other intervention name(s): PBO; ULT
Intervention MeSH terms: Febuxostat
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Prevention
Keywords: Prophylaxis of Acute Gout Flares; Urate-Lowering Therapy; Hyperuricemia; Gouty arthritis
Effects of Total Parenteral Nutrition on Skeletal Muscle Genomics.
Condition: Wasting;Muscle(S)
MeSH terms: Muscular Atrophy
Study type: Interventional

Summary: 
      The study investigates effects related to muscle protein metabolism at provision of Total
      Parenteral nutrition.
    

Detailed description: 
      Randomized study investigating alterations in muscle protein metabolism at provision of
      parenteral nutrition. The study uses a genomic/transcriptomic/proteomic approach to evaluate
      factors related to activation of skeletal muscle protein synthesis. Patients scheduled for
      major gastrointestinal surgery are included. Muscle specimens are collected during surgery.
    

Intervention name(s): TPN; Control
Intervention type(s): Drug; Other
Other intervention name(s): TPN infusion; Physiological saline infusion
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Multiple Ascending Doses of SY-008 in Type 2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a phase Ib placebo-controlled study to assess safety, tolerability, pharmacokinetics
      and pharmacodynamics of SY-008 after Multiple Ascending Doses in patients with Type 2
      Diabetes Mellitus (T2DM).
    

Detailed description: 
      This is a multicenter, randomized, double-blind, placebo-controlled, dose-increasing,
      multiple oral administration clinical trial. The planned dose increasing level was 6, 12 and
      18 mg daily dose (3 administration groups).

      After the completion of the test and safety evaluation of the initial dose 6mg daily dose
      group, the main researchers of the team leader and the sponsor jointly determine whether to
      enter the 12mg daily dose study.

      After the completion of the test and safety evaluation of the 12 mg daily dose group, the
      main researchers of the team leader and the sponsor jointly determine whether to enter the 18
      mg daily dose study.
    

Intervention name(s): SY-008; SY-008 matching placebo
Intervention type(s): Drug; Drug
Intervention description(s): The subjects were admitted to the clinical trial center two days before the administration period (D-2), fasted for 10 hours overnight on the day before the Administration (D-1), and banned water for 1 hour before the administration. Take sy-009 test drug or placebo immediately before meal (QD is before breakfast, bid is before breakfast and dinner) in the morning of the first day of administration, and deliver it with not more than 200ml warm boiled water. From the day 2 (D2) to the day 7 (D7) before dinner, the oral cavity of the subjects was checked for residual drugs after each administration.; SY-008 matching placebo
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Metabolic Effects of Honey in Type 1 Diabetes Mellitus
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      This study aimed at evaluation of the metabolic effects of honey, as a supplemental food, in
      patients suffering from type 1 diabetes mellitus. A crossover design (two 12-weeks
      intervention periods) was used to measure honey effects. The subjects were randomized into
      two groups (intervention to control [I/C] and control to intervention [C/I] groups. Each
      group consisted of 10 patients. . The subjects in the I/C group consumed 0.5 ml honey/kg/day
      in the first 12-week period (period 1) while the subjects in the C/I group did not receive
      honey as a control in period 1. After period 1 the subjects of each group exchanged their
      protocol for the following 12-week period (period 2).
    


Intervention name(s): honey
Intervention type(s): Dietary Supplement
Intervention description(s): The subjects in the I/C group consumed 0.5 ml honey/kg/day in the first 12-week period (period 1) while the subjects in the C/I group did not receive honey as a control in period 1. After period 1 the subjects of each group exchanged their protocol for the following 12-week period (period 2).
Other intervention name(s): bee honey
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: honey; diabetes; lipids; c-peptide
Influence of Meal Schedule: Gender Differences
Condition: Healthy
Study type: Interventional

Summary: 
      Gender differences in the effect of meal schedule will be studied in a parallel design (10
      women and 10 men). In two separate days a probe meal (290 stewed beans, 35 g bread, 100 mL
      water; 549 Kcal) will be administered in the afternoon, i.e. conventional schedule, and in
      the morning, i.e. unconventional schedule. The effect of meal schedule will be measured as
      the differences between the responses on both study days. Participants will be instructed to
      eat standard dinner the day before and to consume standard breakfast at home the day of the
      afternoon test. Studies will be conducted in a quiet, isolated room with participants siting
      on a chair. Perception will be measured at 5 min intervals 10 min before and 20 min after
      ingestion and at 10 min intervals up to 60 min after the probe meal.
    


Intervention name(s): Probe meal
Intervention type(s): Other
Intervention description(s): The probe meal will be administered either in the afternoon (conventional schedule) or in the morning (unconventional schedule).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: meal ingestion; meal schedule; postprandial responses; hedonic sensations; homeostatic sensations
Evaluation Efficacy of Melatonin Gel as Adjunctive Therapy in Chronic Periodontitis
Condition: Chronic Periodontitis
MeSH terms: Periodontitis; Chronic Periodontitis
Study type: Interventional
Phase: Phase 4

Summary: 
      This study was conducted to assess the benefit of locally delivered melatonin gel as
      adjunctive to scaling and root planning (SRP) in the treatment of chronic periodontitis.
    

Detailed description: 
      Forty chronic periodontitis selected patients ,divided into two groups. Group I: included 20
      chronic periodontitis patients, treated by conventional periodontal therapy SRP combined with
      intra- pocket application of Melatonin gel once weekly for 1 month begin application at the
      second week after initial therapy. Group II: included 20 chronic periodontitis patients,
      treated by SRP combined with the injection of placebo, weekly for one month. The periodontal
      parameters were recorded at baseline, 1week, 1and 3 months.Gingival crevicular fluid (GCF)
      samples were collected and a quantitative measurement of receptor activator nuclear K ligand
      (RANKL) was carried out by using Enzyme-Linked Immunosorbent Assay (ELISA) at baseline,
      1week, 1 and 3 months.
    

Intervention name(s): Melatonin2%gel; PLACEBO
Intervention type(s): Drug; Drug
Intervention description(s): Intra-pocket application of 2% Melatonin gel; placebo intra-pocket application
Other intervention name(s): intra- pocket Melatonin gel
Intervention MeSH terms: Melatonin
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Forty chronic periodontitis selected patients ,divided into two groups. Group I: included 20 chronic periodontitis patients, treated by conventional periodontal therapy SRP combined with intra- pocket application of Melatonin gel once weekly for 1 month begin application at the second week after initial therapy. Group II: included 20 chronic periodontitis patients, treated by SRP combined with the injection of placebo, weekly for one month.
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Chronic periodontitis; Melatonin; RANKL (Receptor activator nuclear K ligand); ELISA (Enzyme-Linked Immunosorbent Assay); Gingival crevicular fluid
Assess the Ability of MetroGel 1% to Deliver Moisture to Facial Skin After a Single Application
Condition: Rosacea
MeSH terms: Rosacea
Study type: Interventional
Phase: Phase 4

Summary: 
      This eight-hour kinetic regression clinical study was conducted to assess the ability of
      MetroGel® 1% to deliver moisture to facial skin after a single application.
    

Detailed description: 
      This eight-hour kinetic regression clinical study was conducted to assess the ability of
      MetroGel® 1% to deliver moisture to facial skin after a single application as measured by the
      Corneometer CM 825.
    

Intervention name(s): Metronidazole gel 1%
Intervention type(s): Drug
Intervention description(s): Applied once to a test site on the right or left cheek (as determined by a randomization design)
Other intervention name(s): MetroGel® 1%
Intervention MeSH terms: Metronidazole
Allocation: Randomized
Intervention model: Single Group Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Effect of Angulus on Patient-elevation Compliance
Condition: Ventilator Adverse Event; Ventilator Associated Pneumonia; Hospital Acquired Condition; Hospital-acquired Pneumonia; Recumbency; Head-of-bed
MeSH terms: Pneumonia; Pneumonia, Ventilator-Associated; Healthcare-Associated Pneumonia; Iatrogenic Disease
Study type: Interventional

Summary: 
      Ventilator-associated events (VAE) are a scourge of critical care settings and hospital
      systems at large. There is extensive evidence that ventilator-associated pneumonia (VAP) and
      related VAEs increase mortality rates in critically ill patients by up to 50%, while
      simultaneously increasing cost of care. C

      Best-practice guidelines state that positioning ventilated patients at an angle between 30-45
      degrees significantly reduces the potential for VAP and other VAE to develop. While the
      intent of the guidelines is to govern patient elevation angle, the lack of a mechanism to
      accurately measure patient elevation requires that nurses rely on the head-of-bed (HOB)
      protractor - a tool which reflects the angle of the bed, not the patient - to measure
      compliance. Depending upon the position and posture of the patient in the bed, a patient's
      elevation angle may be significantly different from the HOB angle. Critical care teams
      currently rely on built-in HOB protractors and digital inclinometers that measure the angle
      of the bed not the patient.

      Angulus, LLC has developed a dual-component Angulus sensor to fill this gap in critical care
      technology. Angulus enables critical care practitioners to instantaneously understand a
      patient's elevation, identify when the patient is outside of the desired 30-45 degree
      recumbency scope, and efficiently correct the patient's orientation with immediate feedback.
      Angulus supports real-time minute-to-minute data display as well as longitudinal aggregation
      of data.
    


Intervention name(s): Angulus
Intervention type(s): Device
Intervention description(s): Feedback on patient recumbency
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: Clustered randomized cross over trial
Masking: None (Open Label)
Primary purpose: Prevention