bioihbjkbjnl/mcl2 huggingface dataset:
Clinical Study to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients
Condition: Acute Otitis Media
MeSH terms: Otitis; Otitis Media
Study type: Interventional
Phase: Phase 3

Summary: 
      The purpose of this study is to determine if the combination of DF289 plus DF277 is safe and
      effective in treating middle ear infections in children with ear tubes.
    


Intervention name(s): DF289; DF277; DF289 plus DF277
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Ear drops; Ear drops; Ear drops
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: with tubes
Nutritional Prevention Pilot Trial for Type 1 Diabetes
Condition: Type 1 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 1
Study type: Interventional
Phase: Phase 2

Summary: 
      The overall objective of the study is to assess whether complete avoidance of cow's milk (CM)
      proteins, for at least the first 6 months of life, prevents type 1 diabetes
      (insulin-dependent diabetes mellitus, IDDM) in genetically susceptible children who have a
      mother, biological father or sibling affected by type 1 diabetes.
    

Detailed description: 
      Among the environmental factors leading to type 1 diabetes in childhood, the most important
      are certain viral infections and possibly some dietary factors. Among the latter cow's milk
      proteins are of special interest. They have been shown to be involved in the pancreatic
      beta-cell lesion in animal experiments. In humans there are some indications of a role of
      early exposure to cow's milk proteins as a risk factor for later type 1 diabetes. The
      hypothesis has not been confirmed, but a randomized, controlled double-blinded intervention
      trial should provide a definite answer.

      This study aims at assessing whether one can decrease the future incidence of beta-cell
      autoimmunity and/or type 1 diabetes in children who have an increased genetic risk for the
      disease, by administering in infancy after breast feeding until the age of 6-8 months such a
      formula, in which the cow's milk proteins have been hydrolyzed to smaller peptides. The
      children in the control group, carrying a similar increased genetic risk, will receive a
      conventional cow's milk based formula .

      This project is a pilot multicenter trial comprising 15 hospitals in Finland.
    

Intervention name(s): A highly hydrolyzed formula; A regular cow's milk based formula
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): Weaning to a highly hydrolyzed formula, avoidance of all supplemental food containing cow's milk proteins and/or bovine serum albumin up to the age of 6-8 months; Weaning to a regular cow's milk based formula supplemented with 20% of the highly hydrolyzed formula used in arm 1 to make the study formulas similar in smell and taste, avoidance of all supplemental food containing cow's milk proteins and/or bovine serum albumin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: dietary manipulation; infants; feasibility; Type 1 Diabetes Mellitus, Beta-cell Autoimmunity
Pharmacokinetic and Pharmacodynamics of B12019 and Neulasta® in Healthy Subjects
Condition: Clinical Pharmacology
Study type: Interventional
Phase: Phase 1

Summary: 
      Multi-centre, double-blind, randomised, 2-way cross-over study to investigate the PK and PD
      of B12019 as compared to Neulasta® administered as a single subcutaneous (s.c.) dose in
      healthy male subjects. B12019 or Neulasta will be administered by s.c. injection.
    


Intervention name(s): B12019 and Neulasta
Intervention type(s): Biological
Intervention description(s): GCSF, Growth Colony Stimulating Factor
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Cafedrin/Theodrenalin (Akrinor®) Versus Ephedrine for Treatment of Hypotension in the Peri-operative Phase in Inpatient Setting
Condition: Hypotension
MeSH terms: Hypotension
Study type: Observational

Summary: 
      This is a national, multicentre, prospective, open, two-arm, non-interventional study with
      hospitalized patients, who are treated routinely with cafedrine/theodrenaline or ephedrine
      after occurrence of perioperative hypotension, wherein the patients are assigned to a
      treatment arm based on the department.
    


Intervention name(s): Cafedrine/theodrenaline; Ephedrine
Intervention type(s): Drug; Drug
Intervention MeSH terms: Theodrenaline; Cafedrine; Ephedrine
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Hospitalized patients, who are treated routinely with cafedrine/theodrenaline or ephedrine
        after occurrence of perioperative hypotension,
Evaluation of the Pharmacokinetics, Safety, and Tolerability of Intravenous ETX2514 and Sulbactam Administered Concurrently to Subjects With Various Degrees of Renal Impairment and Healthy Matched Control Subjects
Condition: Acinetobacter Baumannii Infection
MeSH terms: Renal Insufficiency
Study type: Interventional
Phase: Phase 1

Summary: 
      This research project is being conducted to look at the pharmacokinetics (PK; how the human
      body processes a substance), safety, and tolerability of a single dose of ETX2514 and
      sulbactam (ETX2514SUL) when concurrently administered by separate intravenous (IV) infusion
      in participants with various degrees of renal impairment (RI), in participants with end-stage
      renal disease (ESRD) who are on hemodialysis (HD), and in healthy matched control
      participants with normal renal function.
    

Detailed description: 
      This Phase 1, open-label, non-randomized study evaluates the PK, safety, and tolerability of
      a single concurrent IV infusion of ETX2514SUL in participants with various degrees of RI, in
      participants with ESRD who are on HD, and in healthy matched control participants with normal
      renal function.

      Participants will be enrolled into five cohorts, according to renal function status, and will
      receive an IV infusion of ETX2514SUL (single dose of up to 1000 milligrams [mg] ETX2514 and
      1000 mg sulbactam given by concurrent 3-hour IV infusion). Participants in Cohort 5 will
      receive the ETX2514SUL infusion both post-HD (Period 1) and pre-HD (Period 2).
    

Intervention name(s): ETX2514SUL
Intervention type(s): Drug
Intervention description(s): Single dose of up to 1000 mg ETX2514 and 1000 mg sulbactam given by concurrent 3-hr IV infusion
Intervention MeSH terms: Durlobactam
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: infection; gram-negative bacterium; renal impairment
Dietary Intervention in Type-2 Diabetes and Pre-Diabetes
Condition: Diabetes Mellitus, Type 2; Pre-diabetes; Metabolic Syndrome
MeSH terms: Diabetes Mellitus; Metabolic Syndrome; Diabetes Mellitus, Type 2; Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      The primary purpose of this research is to demonstrate the therapeutic effects of
      implementing a well-formulated low carbohydrate lifestyle program over 2 years in patients
      with type 2 diabetes, pre-diabetes, and metabolic syndrome.
    

Detailed description: 
      The primary purpose of this research is to demonstrate the therapeutic effects of
      implementing a well-formulated low carbohydrate lifestyle program over 2 years. Positive
      therapeutic effects would be represented by improved glycemic control in patients with type 2
      diabetes without use of additional glycemic control medications and failure to progress to
      type 2 diabetes in individuals with pre-diabetes and metabolic syndrome.

      Secondary purposes of this research are to determine if therapeutic effects of the
      intervention differ between patients who self-select onsite vs. web-based education delivery,
      explore relationships between change in LDL cholesterol and carotid intima media thickness,
      and to evaluate the sustainability of health outcomes achieved and the economic impact of
      therapeutic effects over 5 years.
    

Intervention name(s): Virta Program
Intervention type(s): Other
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Intervention model description: open label, non-randomized, before-and-after study of patients with type 2 diabetes who self-select the intervention (with education delivered via onsite group classes or web-based, self-selected by participant) or usual care
single arm, before-and-after study of patients with prediabetes who self-select to receive the intervention (no comparison group)
Masking: None (Open Label)
Primary purpose: Treatment
Early Versus Late Initiation of Feeding in Premature Growth Restricted Newborns With Absent or Reversed End Diastolic Flow On Umbilical Artery Doppler (AREDF)
Condition: Prematurity of Fetus; Postnatal Growth Disorder
MeSH terms: Growth Disorders
Study type: Interventional

Summary: 
      The purpose of the study is to compare early versus late initiation of enteral feeding in
      premature growth restricted babies below the gestational age of 35 weeks born to mothers with
      prenatal absent or reversal of end diastolic flow in the umbilical artery. Normally the blood
      flow from the mother to the baby brings all the nutrients required for growth and the very
      vital oxygen required for survival. These deprived babies with poor blood flow adapt to the
      not so conducive uterine environment by certain adjustments in blood supply to internal
      organs. This permits the best possible blood flow to brain heart etc., which are the vital
      organs and whose adequate functioning is required for survival. As a consequence, the gut
      (intestines) gets poor blood supply and hence its appropriate functioning may be jeopardized.
      Such 'premature growth restricted' babies are at increased risk of further growth faltering
      if not fed adequately as also to a condition called 'Necrotising enterocolitis' if fed
      liberally like other healthy neonates, characterized by abdominal distension, blood in stools
      and inability to feed for longer durations thereby further affecting growth. In the past such
      babies (after birth) were not fed for days together which compromised their growth even
      further. It is not clear whether continuing to withhold feeds for prolonged duration will
      prevent NEC but lead to growth faltering and initiating feeds early will potentiate NEC with
      further compromised growth and increased morbidity. There are no randomized trials on feeding
      strategies in this group of neonates and hence the investigators planned to carry out this
      study on comparison of early versus delayed initiation of feeding in preterm SGA infants with
      AREDF.
    


Intervention name(s): Early Feeding; Late Feeding
Intervention type(s): Other; Other
Intervention description(s): Feeding with expressed breast milk @ 8ml/kg/day for 48 hrs after randomization at 60+/-12 hrs of life; Nil per oral for another 48 hrs after randomization at 60+/-12 hrs of life followed by Feeding with expressed breast milk @ 8ml/kg/day for 48 hrs
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Keywords: Preterm; SGA; AREDF; Early feeding; Late feeding; Feed intolerance; Necrotizing enterocolitis; Days to achieve Full Feeds defined as 150 mL/kg
Patient Registry Of Magnetic Resonance Imaging in Non-Approved DEvices
Condition: Magnetic Field Exposure
Study type: Observational [Patient Registry]

Summary: 
      The investigators are providing MRI in patients with non-MRI approved CIED's (Cardiac
      Implanted Electronic Devices)
    

Detailed description: 
      At Saint Luke's Hospital, despite growing evidence to the contrary, there is extremely
      limited data and experience with performing MRIs on patient with abandoned and epicardial
      leads in patients with non-approved ICDs and PMs. There is a limited mechanism to discuss
      this issue with the patient, screen the patient and assess their device beforehand, monitor
      them during the MRI examination, keep track of pulse sequences used, assess their devices
      after (and if necessary, resume prior programming before any changes), and to maintain that
      experience. The objective of this study is to create a protocol for an MRI at the commonly
      used magnetic strength of 1.5 T in patients that do not have conditional pacemakers and/or
      defibrillators and have abandoned or epicardial leads and maintain a registry of
      participants, devices involved, MRI examinations and pulse sequences used, and to keep
      records of any follow up events.
    

Intervention name(s): Initiate ACLS protocol if lethal arrythmia develops
Intervention type(s): Other
Intervention description(s): Cardiac Rhythm Management
Observational model: Other
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        For all patients in whom a clinical MRI examination is felt to be important in the patients
        care, and in whom the potential benefits clearly outweigh the risks of an MRI exam as
        referred from various primary and/or subspecialty physicians.
      
Keywords: Cardiac Implanted Device
A Pilot Study of MabThera (Rituximab) Evaluated by MRI in Patients With Rheumatoid Arthritis.
Condition: Rheumatoid Arthritis
MeSH terms: Arthritis; Arthritis, Rheumatoid
Study type: Interventional
Phase: Phase 4

Summary: 
      This single arm study will measure the effect of MabThera in combination with methotrexate on
      the progression of synovitis, the extent of bone marrow edema, and the number of erosions in
      the wrist and hand of patients with rheumatoid arthritis, using a new MRI technique. Patients
      will receive MabThera 1000mg i.v. on days 1 and 15, in combination with a stable dosage of
      10-25mg/week methotrexate throughout the duration of the study. Further courses of MabThera
      will be provided to eligible patients. MRI will be performed 1-2 weeks before treatment
      initiation, and repeated 1 and 6 months after the first MabThera infusion. The anticipated
      time on study treatment is 1-2 years, and the target sample size is <100 individuals.
    


Intervention name(s): rituximab [MabThera/Rituxan]; Methotrexate
Intervention type(s): Drug; Drug
Intervention description(s): 1000mg iv on days 1 and 15; 10-25mg/week
Intervention MeSH terms: Rituximab; Methotrexate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Efficacy of Trace Elements in the Treatment of Endometriosis: a Pilot Study
Condition: Endometriosis
MeSH terms: Endometriosis
Study type: Interventional
Phase: Phase 3

Summary: 
      The primary objective of this pilot study is to evaluate the efficacy of trace elements,
      versus placebo, on the reduction of pain in endometriosis of an American Fertility Society
      (AFSr) score of 2 to 4, combined or not to an adenomyosis, during a chronic treatment of 4
      months.
    

Detailed description: 
      The objectives of this pilot study are to evaluate the efficacy of trace elements, versus
      placebo, on the reduction of pain, on the quality of life, on the use of rescue medication
      (ibuprofen) in patients with an endometriosis of an American Fertility Society (AFSr) score
      of 2 to 4, combined or not to an adenomyosis, during a chronic treatment of 4 months. The
      safety of trace elements versus placebo will also be assessed.

      This will be a prospective, interventional, randomized, placebo-controlled, two
      parallel-group, double-blind study.

      Trace elements or placebo are administered in the absence of any other treatment or as add-on
      treatments to common therapies such as sexual hormones, anti-inflammatory drugs or surgery.

      A run-in placebo period of 30 days will allow eliminating the patients who are responding to
      strongly to a placebo.

      The treatment will last for 4 months. The total duration of the study will be 5 months for
      each patient. Four medical visits (Days -45 to -30, 0, 60 and 120) and two phone contacts
      (Days 30 and 90) will be scheduled.

      A urine pregnancy test will be undertaken at each visit. The quality of life scale (EHP-30)
      will be filled in on Days 0, 60 and 120. During the whole study period, patients will be
      asked to fill in a diary, in which they will score their pain on a visual analog scale, their
      blood loss and their consumption of rescue medication (ibuprofen).

      Phone contacts will be used to reinforce the compliance and to collect potential adverse
      events.

      Non-serious and serious adverse events will be collected between Days 0 and 120.

      All concomitant medications will be recorded, including the rescue medication between Day -45
      and Day 120.

      A paper case report form will be used.

      A total of 60 patients (30 receiving trace elements and 30 receiving placebo) will be
      randomized to achieve a total of 50 patients.
    

Intervention name(s): ENDO 1/ENDO 2; Placebo
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention description(s): NUTRI ENDO 1 (1 sequence of 10 tablets on the morning) and NUTRI ENDO 2 ( sequence of 10 tablets at the evening), daily, during 120 days.; Placebo: 1 sequence of 10 tablets on the morning and 1 sequence of 10 tablets at the evening, daily, during 120 days.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pelvic pain; quality of life; adenomyosis
Hs-CRP as Clinical Marker of Inflammatory Atherogenic Dyslipidemia
Condition: Dyslipidemia
MeSH terms: Dyslipidemias
Study type: Observational

Summary: 
      The objective of this proposal is to study the applicability of the hs-CRP assay in the
      assessment of CV risk in daily clinical conditions where hyperlipidemic population with or
      without CHD are currently evaluated.
    

Detailed description: 
      Coronary heart disease (CHD) is the major cause of death in the developed world. Cholesterol
      screening has been used as a tool to identify individuals who are at increased risk of
      developing future coronary events, but almost one-half of patients who develop myocardial
      infarction have either normal or only moderately increased serum cholesterol concentrations.
      In the last years, experimental and clinical evidence has demonstrated that atherosclerosis
      is not simply a disease of lipid deposits. Rather, there is growing recognition that CHD has
      an inflammatory component which plays a critical role in the arterial plaque rupture that
      triggers most episodes of coronary thrombosis. In the last years, C-reactive protein (CRP),
      an exquisitely sensitive marker of systemic inflammation, has emerged as a powerful predictor
      of cardiovascular diseases, in particular of CHD, beyond what can be estimated by traditional
      risk factors. The availability of high-sensitivity (hs) CRP assays has enabled the detection
      of even low-grade inflammatory responses that have previously been regarded as clinically not
      meaningful. However, for hs-CRP to make the transition from epidemiological and clinical
      research to the routine clinical setting, several important issues must be satisfactorily
      addressed.

      Therefore, the overall objective of this proposal is to study the applicability of the hs-CRP
      assay in the assessment of CV risk in daily clinical conditions where hyperlipidemic
      population with or without CHD are currently evaluated and to evaluate hs-CRP response to
      statins.
    

Time perspective: Prospective
An Evaluation of PDI-192 0.1% in Comparison to PDI-192 0.15% in the Treatment of Mild to Moderate Atopic Dermatitis
Condition: Atopic Dermatitis
MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will compare the safety and efficacy of three test article foams (PDI-192 0.1%
      Foam, PDI-192 0.15% Foam, and Vehicle Foam) such that a final commercial product may be
      selected for future development.
    


Intervention name(s): PDI-192; Vehicle
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: atopic dermatitis; eczema; PDI-192; Precision
Buprenorphine Disposition and CYP3A
Condition: Healthy
Study type: Interventional

Summary: 
      To evaluate role of CYP3A in buprenorphine disposition and effect
    

Detailed description: 
      Subjects will be studied during a maximum of seven occasions.

      Study drugs are intravenous buprenorphine (0.025-0.2 mg infused over 1 hr) and sublingual
      buprenorphine (2-4 mg), with 1-3 week washout between sessions.

      Sessions 1&2: Control (no pretreatment) - intravenous and sublingual buprenorphine. Some
      subjects will only undergo session 1 (IV)

      Sessions 3&4: Liver and gut CYP3A induction (rifampin 600 mg daily), intravenous and
      sublingual buprenorphine

      Session 5: Gut only CYP3A inhibition (grapefruit juice the night before), sublingual
      buprenorphine

      Sessions 6&7: Liver and gut CYP3A inhibition (ketoconazole 400 mg daily), intravenous and
      sublingual buprenorphine
    

Intervention name(s): Buprenorphine Control; Buprenorphine + Rifampin; Buprenorphine + Grapefruit juice; Buprenorphine + Ketoconazole
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Control (no pretreatment) - intravenous and sublingual buprenorphine. Some subjects will only undergo session 1 (IV); Liver and gut CYP3A induction (rifampin 600 mg daily), intravenous and sublingual buprenorphine; Gut only CYP3A inhibition (grapefruit juice the night before), sublingual buprenorphine; Liver and gut CYP3A inhibition (ketoconazole 400 mg daily), intravenous and sublingual buprenorphine
Intervention MeSH terms: Rifampin; Ketoconazole; Buprenorphine
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: buprenorphine CYP3A
Mechanisms of Tissue Repair After Muscle Injury and Tendon Strain
Condition: Muscle; Injury, Quadriceps (Thigh); Tendon Strain
MeSH terms: Wounds and Injuries; Sprains and Strains
Study type: Interventional

Summary: 
      The study is a 5-week human study including 24 18-35 year old healthy men. Each participant
      will have muscle injury and tendon strain induced in one leg using neuromuscular electrical
      stimulation in conjunction with forced lengthening contractions. The investigators will
      monitor the recovery from injury/strain over a 4 week period, in which half of the subjects
      will receive growth hormone (somatropin) to stimulate the connective tissue synthesis.
    


Intervention name(s): Neuromuscular electrical stimulation
Intervention type(s): Other
Intervention description(s): One bout of neuromuscular electrical stimulation in conjunction with forced lengthening contractions on one leg
Other intervention name(s): Neuromuscular electrical stimulation using Theta 4 channel stimulator from Chattanooga. Coupled with forced eccentric contractions.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Basic Science