bioihbjkbjnl/mcl2 huggingface dataset:
Foveal Cone Outer Segment Resumption to Predict Visual Recovery After Macular Hole Surgery
Condition: Macular Holes
MeSH terms: Retinal Perforations
Study type: Interventional

Summary: 
      Spectral domain optical coherence tomography (SD-OCT) was used to determine whether the
      repair of photoreceptor cone outer segment tips defect is significantly correlated with the
      visual outcomes after macular hole surgery.
    

Detailed description: 
      Spectral domain optical coherence tomography (SD-OCT) was used to calculate the mean length
      of photoreceptor cone outer segment tips (COST) defect on 1, 3, 6, 9, and 12 months after
      macular hole surgery. The correlation between the mean length of COST defect and the BCVA was
      determined. Prognostic factors might have influenced for COST repair was also evaluated by
      multivariable analysis.
    

Intervention name(s): Vitreous surgery for macular hole
Intervention type(s): Procedure
Intervention description(s): Vitreous surgery for macular hole
Intervention model: Single Group Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: spectral-domain optical coherence tomography; idiopathic macular hole; cone outer segment tips line; vitrectomy
Pharmacokinetics of Co-administration of Seretide 250 Diskus (HCP0910) and Spiriva Capsule for Inhalation (HGP1011)
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Study type: Interventional
Phase: Phase 1

Summary: 
      This pilot study was designed to evaluate the pharmacokinetic characteristics of fluticasone,
      salmeterol, and tiotropium after co-administration of HCP 0910 (Seretide 250 diskus) and
      HGP1011 (Spiriva capsule for inhalation) which are prescribed concomitantly for the patients
      with chronic obstructive pulmonary disease (COPD).
    

Detailed description: 
      Within 3 weeks prior to the first administration of study drug, volunteers who agreed the
      participation of this study by their written consent will undergo screening, including
      physical examination and clinical laboratory test etc, to evaluate whether they are eligible
      to participate in this study. Study drugs will be administered at about 8 A.M. in the morning
      of the drug administration day, followed by blood collection for evaluation of
      pharmacokinetics. The same schedule with increased dose will be proceeded after 14-day
      washout period.
    

Intervention name(s): HCP0910 and HGP1011
Intervention type(s): Drug
Intervention description(s): Inhalation of HCP0910 (Seretide 250 diskus (Fluticasone Propionate 250 mcg/Salmeterol Xinafoate 72.5 mcg)) and HGP1011 (Spiriva capsule for inhalation (Micronized Tiotropium Bromide Monohydrate 22.5 mcg))
Other intervention name(s): Seretide 250 diskus and Spiriva capsule for inhalation; Fluticasone/Salmeterol and Tiotropium
Intervention MeSH terms: Fluticasone; Tiotropium Bromide; Salmeterol Xinafoate; Fluticasone-Salmeterol Drug Combination
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Screening
Individualized Telemedical Assistance for Lifestyle Modification in the Treatment of Obesity and Cardiometabolic Risk Prevention
Condition: Obesity Type I and II
MeSH terms: Obesity
Study type: Interventional

Summary: 
      This project is based on the contribution that could offer a technological system for a
      continuous monitoring, individualized treatment of obesity and prevention of cardiometabolic
      complications in high risk population.

      The main objective of PREDIRCAM study is to evaluate the benefits obtained with the use in
      high cardiometabolic risk individuals of a telemedical platform integrating applications for
      monitoring and providing recommendations to improve lifestyle habits (diet and physical
      activity) in a healthier way.

      The study population are obese subjects (type I or II) aged between 25 and 65 years with a 12
      month follow-up. In this population it will be analysed the cost-effectiveness of a telemedic
      assistance with a technological system and its ability to modify lifestyle habits, reduce
      weight and cardiovascular risk associated parameters.

      Previously to the clinical implementation, a pilot study for testing the telemedical system
      will be made. Efficacy and security variables will be evaluated along the study.
    


Intervention name(s): Telemedic assistance with a technological system; Standard care
Intervention type(s): Device; Other
Other intervention name(s): PREDIRCAM
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
A Study to Determine the Influence of Co-ingestion of Alcohol on Hydrocodone Bitartrate Extended Release (HC-ER)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      To determine the influence of co-ingestion of alcohol on HC-ER.
    

Detailed description: 
      Determine the influence of co-ingestion of alcohol on the safety, pharmacokinetics, and
      relative bioavailability of HC-ER 50 mg under fasted conditions
    

Intervention name(s): HC-ER + 40% Alcohol; HC-ER + 20% Alcohol; HC-ER + 0% Alcohol
Intervention type(s): Drug; Drug; Drug
Intervention description(s): HC-ER 50 mg + 240 mL solution of 40% alcohol/orange juice in fasted state; HC-ER 50 mg + 240 mL solution of 20% alcohol/orange juice in fasted state; HC-ER 50 mg + 240 mL solution of 0% alcohol/orange juice in fasted state
Other intervention name(s): Zohydro ER; Zohydro ER; Zohydro ER
Intervention MeSH terms: Ethanol; Hydrocodone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Phase 1; Alcohol; Hydrocodone Bitartrate; Pharmacokinetics
Neurotech Vital Compact Versus Itouch Sure Pelvic Floor Exerciser US
Condition: Stress Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Stress
Study type: Interventional

Summary: 
      A prospective, randomised, controlled, single-blind, multi-site clinical study employing
      Neuromuscular Electrical Stimulation (NMES) to stimulate the pelvic floor muscles of women
      suffering from stress urinary incontinence.

      Approximately one-hundred and eighty (180) female patients diagnosed with stress urinary
      incontinence will be enrolled in this study. All patients who are considered eligible to
      participate in the clinical study and give consent will be randomised to complete either a
      12-week treatment programme with the Neurotech Vital Compact device or a 12-week treatment
      programme with the itouch Sure Pelvic Floor Exerciser. The 12-week treatment programme will
      be completed by the subjects at home with treatment with the device in accordance with the
      device Instructions for Use.
    

Detailed description: 
      This is a prospective, randomised, controlled, single-blind, multi-site clinical study to be
      conducted in the United States of America (USA) employing Neuromuscular Electrical
      Stimulation (NMES) to stimulate the pelvic floor muscles of women suffering from stress
      urinary incontinence.

      Approximately one-hundred and eighty (180) female patients diagnosed with stress urinary
      incontinence will be enrolled in this study. All patients who are considered eligible to
      participate in the clinical study and give consent will be randomised to complete either a
      12-week treatment programme with the Neurotech Vital Compact device or a 12-week treatment
      programme with the itouch Sure Pelvic Floor Exerciser. The 12-week treatment programme will
      be completed by the subjects at home with treatment with the device in accordance with the
      device Instructions for Use.

      Subjects included in the clinical study will be evaluated at screening, on enrolment into the
      study (baseline) and during the 12-week treatment programme at 4 and 12 weeks. A telephone
      call will be made at 1 week to check on the patient's progress. In addition, subjects will be
      evaluated at 26 week following their commencement of the treatment.
    

Intervention name(s): Neurotech Vital Compact; itouch Sure Pelvic Floor Exerciser
Intervention type(s): Device; Device
Intervention description(s): Neuromuscular electrical stimulation of the pelvic floor via an arrangement of external electrodes held in place by a garment.; Vaginal probe with electrodes designed to deliver electrical stimulation to the pelvic floor muscles.
Other intervention name(s): EmbaGYN
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Stress urinary incontinence; Neurotech Vital Compact; 1h Provacative Pad Test; Neuroelectrical Muscle Stimulation (NEMS)
A Study Comparing PF-06273340 Immediate Release Tablet, PF-06273340 Modified Release Tablets To PF-06273340 Oral Solution In The Fasted State. This Study Will Also Compare PF-06273340 Modified Release Tablets In Fasted And Fed State
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary purpose of this study is to estimate the relative bioavailability and food effect
      of PF-06273340 tablets.
    


Intervention name(s): PF-06273340; PF-06273340; PF-06273340; PF-06273340; PF-06273340; PF-06273340
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention description(s): Oral solution, single dose, fasted; Immediate Release Tablet, single dose, fasted; Modified Release Tablet (short duration, MR1), single dose, fasted; Modified Release Tablet (long duration, MR2), single dose, fasted; Modified Release Tablet (short duration, MR1), single dose, fed; Modified Release Tablet (long duration, MR2), single dose, fed
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Pain
GrafixPRIME® for the Treatment of Chronic Diabetic Foot Ulcers
Condition: Foot Ulcer, Diabetic
MeSH terms: Diabetic Foot; Foot Ulcer; Ulcer
Study type: Interventional
Phase: Phase 4

Summary: 
      The objective of the study is to compare the efficacy of weekly GrafixPRIME® administration
      to an Active Comparator in patients with chronic DFUs in a randomized, single-blind study.
    


Intervention name(s): GrafixPRIME®; Dressing Application; Off-loading (walking boot)
Intervention type(s): Other; Procedure; Device
Intervention description(s): Human tissue, Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing.; Wound cover, Application of a non-adherent dressing, a moisture retentive dressing, and a secondary dressing.; Patients will be fitted for an off-loading device (walking boot) and agree to comply with use of the device during the course of the study
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: Grafix
Short Term Effect of Glucocorticoids on Brown Adipose Tissue Thermogenesis in Humans
Condition: Brown Adipose Tissue
Study type: Interventional
Phase: Phase 4

Summary: 
      Interventional, Placebo controlled cross-over study to investigate the short-term effects of
      glucocorticoids (prednisone) on human brown adipose tissue.
    

Detailed description: 
      Active brown adipose tissue (BAT) has recently been unambiguously discovered in human adults.
      Active BAT increases energy expenditure and improves glucose tolerance. Pharmacological use
      of glucocorticoids (GCs) is widespread in clinical practice due to their high
      anti-inflammatory efficacy. While short-term administration even of high doses usually is
      well tolerated, long-term use of medium to high amounts of GCs leads to unfavorable metabolic
      changes, characterized by an increase in intra-abdominal fat mass, a decrease in muscle mass
      and insulin resistance.

      In line with these well-known side-effects of GCs, several in vitro studies and animal models
      demonstrate an inhibiting effect of GCs on BAT thermogenesis.
    

Intervention name(s): Prednisone; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 2 tablets of Prednisone 20 Mg in the morning; 2 Placebo tablets in the morning
Intervention MeSH terms: Prednisone
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: glucocorticoids; brown adipose tissue; cold induced thermogenesis
Study Evaluating Venlafaxine ER in Children and Adolescents With Social Anxiety Disorder
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional
Phase: Phase 3

Summary: 
      To determine the anxiolytic efficacy, safety, and tolerability of a flexible-dose of
      venlafaxine extended release (ER) administered for 16 weeks in the treatment of children and
      adolescent outpatients with social anxiety disorder (generalized) in a placebo-controlled
      study.
    


Intervention name(s): Venlafaxine ER
Intervention type(s): Drug
Intervention MeSH terms: Venlafaxine Hydrochloride
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: Social Anxiety; Children Disorders
Natural History of Human Papillomavirus (HPV) Infections in Mid-Adult Women (WHIM)
Condition: Papillomavirus Infections
MeSH terms: Infections; Communicable Diseases; Papillomavirus Infections
Study type: Observational

Summary: 
      The purpose of this study is to determine rates of oral and genital human papillomavirus
      (HPV) infections, and look at risk factors for HPV infection in healthy mid-adult women.
    

Detailed description: 
      The investigators propose a longitudinal study of 500 women in order to determine rates and
      risk factors for HPV infections in 30-50 year old women. Participants will be followed for 6
      months and will be asked to complete online questionnaires on their health, sexual behavior,
      HPV vaccinations, and cervical cancer screening. The investigators will ask participants to
      self-collect monthly vaginal swab samples and self-collect 2 oral swab samples. Women will
      also be asked to provide 2 blood samples. All swab samples will be tested for type-specific
      HPV deoxyribonucleic acid (DNA) using a polymerase chain reaction (PCR)-based assay, blood
      samples will be tested for HPV antibodies.
    

Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        30 to 50 year old women affilitated with Univeristy of Washington (student, staff, faculty)
      
Biospecimen description: 
      Self-collected vaginal samples for HPV testing. Self-collected oral samples for HPV testing.
      Serum samples for HPV antibody testing.
    
Keywords: HPV; Cervical Cancer
Safety and Efficacy of House Dust Mite Allergoid in the Treatment of Bronchial Asthma
Condition: Respiratory Hypersensitivity
MeSH terms: Asthma; Respiratory Hypersensitivity; Hypersensitivity
Study type: Interventional
Phase: Phase 3

Summary: 
      The trial is performed to assess efficacy and safety of the Allergopharma house dust mite
      allergoid in bronchial asthma.
    

Detailed description: 
      The rationale for the present study was to demonstrate clinical efficacy and tolerability
      compared to placebo in a phase III clinical study of pivotal character with a representative
      number of patients suffering from fully reversible asthma +/- allergic rhinitis. This
      condition is present in paediatric and adult patients with a shorter history of GINA II and
      III asthma, who were investigated in this study.
    

Intervention name(s): Acaroid; Placebo
Intervention type(s): Biological; Drug
Intervention description(s): The drug tested in this study (aluminium hydroxide-adsorbed house dust mite (D. pteronyssinus) allergoid preparation) was given as a subcutaneous injections of increasing doses.; Placebo was given the same way as a subcutaneous (just under the skin) injection. Patients were treated according the same dosing schedule of active group. Children received lifestyle counselling.
Other intervention name(s): Specific Immunotherapy; Comparator
Intervention MeSH terms: Immunomodulating Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: House dust mite; Bronchial Asthma; Allergy; House Dust Mite Allergy
Toxicity of Perirenal Fat in Overweight or Obese Subjects: A Pathophysiological Link Between Uric Acid Stones and Renal Ammonium Formation
Condition: Uric Acid Stones
MeSH terms: Nephrolithiasis; Overweight
Study type: Interventional

Summary: 
      Patients who are overweight or obese, diabetic or not, share with those who are suffering
      from uric stones the same way to remove abnormal acidity of the body in urine, ie a kidney
      ammoniogenesis default. This results in an overly acidic urine pH which is directly
      pathogenic in people predisposed to develop uric stones because the precipitation of urate
      soluble uric acid is accelerated in acid medium.

      Excess visceral fat, particularly perirenal, this defect may promote formation of renal
      ammonium. Indeed, the perirenal fat is adjacent to the renal cortex and shares with it a
      common arterial supply via the plexus Turner. Adipokines and fatty acids of the perirenal fat
      are predisposed to gain the renal cortex, seat of the ammoniogenesis. In humans the
      pathogenic role of the perirenal fat is demonstrated in chronic kidney disease and essential
      hypertension. However, the amount of fat and perirenal that of intra-abdominal fat are
      positively correlated.

      Investigators hypothesis is that the perirenal fat also exert a pathogenic role in uric
      because of anatomical links between kidney stones and greasy environment and because excess
      fatty acids reaching the renal cortex decreases ammoniogenesis in an animal model metabolic
      syndrome.

      For the test, the investigators will compare the amount of fat and perirenal renal ability to
      form ammonium in patients with uric or calcium lithiasis taking into account the amount of
      intra-abdominal fat.
    


Intervention name(s): acid load test
Intervention type(s): Other
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Renal Ammonium ;uric acid
The Effects of Acute Administration of Bupropion on Neural Substrates Underlying Hedonic Capacity
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depressive Disorder, Major
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of the study is to evaluate the effects of a single-dose of Wellbutrin XL
      (bupropion hydrochloride) on reward processing.
    

Detailed description: 
      A cardinal feature of Major Depressive Disorder is anhedonia, which is a lack of pleasure in
      normally enjoyable activities. In order to understand reward processing in depressed
      individuals it is also necessary to study reward processing in people who are not depressed.
      Bupropion, the active drug in the anti-depressant Wellbutrin XL, has been shown to increase
      brain reward functioning in animals. The goal of the present study is to investigate the
      effects of Wellbutrin XL administered to psychiatrically healthy individuals as they perform
      a computer task known to assess reward processing.
    

Intervention name(s): Bupropion; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): 150 mg of bupropion administered 5 hours before fMRI scanning; Administered 5 hours prior to fMRI scanning (randomly assigned, double blind)
Other intervention name(s): Wellbutrin XL
Intervention MeSH terms: Bupropion
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Reward Processing; Wellbutrin; Bupropion
The Effect of Astym Treatment on Muscle Performance
Condition: Musculoskeletal Pathology to the Lower Extremity
Study type: Interventional

Summary: 
      Subjects were randomized into 3 treatment groups (15 subjects per group): 1) Control -
      received no treatment 2) Placebo - received a sham Astym® treatment 3) Astym® Treatment -
      received Astym® treatment to the lower extremity. Subjects were blinded to whether they
      received the Astym® treatment or placebo treatment intervention. After a 5-minute warm-up on
      a lower body ergometer the subjects were familiarized to the operations of a computerized leg
      press machine that measured the maximum force output (Newtons) during a unilateral isometric
      squat test. A baseline measure of maximal force output (pre-test) was determined by the
      average of 3 trials with a 30 second rest period between the trials. The subjects then
      received the designated treatment intervention. Immediately following the treatment
      intervention (0 minutes following treatment intervention) the subjects were retested
      (post-test) using identical testing procedures by an investigator blinded to the treatment
      intervention received by the subject. Maximum force output measured in Newtons for the
      post-test was subtracted from the maximum force output (Newtons) pre-test and then converted
      to a percentage of change [(post-test - pretest)/pretest X 100). The percent change of
      maximal force output from pre-test to post-test measures was compared using a one-way
      analysis of variance with alpha set at 0.05. A Tukey's post-hoc analysis determined
      statistical differences between the groups.
    


Intervention name(s): Astym treatment
Intervention type(s): Other
Intervention description(s): Astym is a manual therapy technique applied by a certified therapist with advanced training in the technique. The technique is applied to a limb or body segment with specialized instruments in a specific sequential protocol that incorporates the muscle groups and joints of the entire kinetic chain.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Sugammadex Dosage Based on Ideal Body Weight for Profound Rocuronium-induced Neuromuscular Blockade Reversal in Morbidly Obese Patients
Condition: Morbid Obesity
MeSH terms: Obesity, Morbid
Study type: Interventional
Phase: Phase 2

Summary: 
      This randomized double blind clinical trial focuses on patients with Body Masse Index ≥ 40
      kg/m2, undergoing scheduled surgery. Neuromuscular transmission monitoring at the adductor is
      performed using. Anaesthesia is induced with anaesthesic and maintained with curare. At the
      end of the procedure, patients with profound neuromuscular blockade receive either 1 mg/kg, 2
      mg/kg or 4 mg/kg Sugammadex based on ideal body weight. A complete reversal failure is
      defined by a Train Of Four ratio < 0.9 within 10 min after administration of Sugammadex or if
      recurarization occurs within 15 min after complete reversal success.
    


Intervention name(s): Sugammadex 1 mg/kg; Sugammadex 2 mg/kg; Sugammadex 4 mg/kg
Intervention type(s): Drug; Drug; Drug
Keywords: General anaesthesia; Curarization with rocuronium