bioihbjkbjnl/mcl2 huggingface dataset:
Phaco-UCP Versus Phaco Alone for OAG and Cataract
Condition: Cataract; Glaucoma, Open-Angle
MeSH terms: Glaucoma; Cataract; Glaucoma, Open-Angle
Study type: Interventional

Summary: 
      This study was carried out to evaluate the safety and efficacy of combined
      phacoemulsification and Ultrasound ciliary plasty (Phaco-UCP) as a first-line surgical
      treatment of coexisting cataract and op

      /en angle glaucoma compared to phacoemulsification alone. To our knowledge, this is the first
      report of results of combined Phaco-UCP
    

Detailed description: 
      the study involved 61 eyes of 61 patients with coexisting cataract and open angle glaucoma,
      31 eyes were managed with Phaco-UCP and 30 eyes of age and sex matched patients were managed
      with phacoemulsification alone.

      Patients were randomized for either combined phacoemulsification and ultrasound ciliary
      plasty (Phaco-UCP) (the study group) or phacoemulsification alone (the control group). All
      surgeries were performed by one experienced surgeon (Y EZ).

      Preoperative evaluation included manifest refraction, BCVA measurement, slit-lamp
      biomicroscopy, gonioscopy, indirect ophthalmoscopy, measurement of IOP with Goldmann
      applanation tonometry (average of 3 readings taken). Corneal diameter (White-to-white) and
      axial length measurement were done using IOL Master 500 (Carl Zeiss Meditec AG., Germany).
      Ultrasound pachymetry with Tomey SP-100 (Tomey Corp. Nagoya, Japan) and visual fields using
      Humphrey Field Analyzer (24-2, SITA, standard program Carl Zeiss Meditec AG., Germany) were
      also performed.
    

Intervention name(s): combined phacoemulsification and ultrasound ciliary plasty (Phaco-UCP); Phacoemulsification alone
Intervention type(s): Procedure; Procedure
Intervention description(s): performing ultrasound ciliary plasty then performing standard phacoemulsification; standard phacoemulsification for catarct extraction
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary purpose: Treatment
Study Comparing Cortical Function and Dysfunction Tests in Low Back Pain
Condition: Chronic Nonspecific Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

Summary: 
      The purpose of this study is to explore the cortical regulation of the paraspinal muscles in
      chronic low back pain. These (possible) changes in regulatory mechanisms are being compared
      to other motor control tests in order to determine whether correlations are found.
      Furthermore the patients are being treated with repetitive transcranial magnetic stimulation
      (rTMS) and tested afterwards. The purpose is to find out if rTMS-therapy is capable of
      normalizing motor control deficits.
    


Intervention name(s): transcranial magnetic stimulation
Intervention type(s): Device
Intervention description(s): rTMS therapy daily for two weeks, five times per week each lasting for half an hour
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Basic Science
Keywords: low back pain; motor control; cortical regulation; transcranial magnetic stimulation
Effect of Negative Pressure Wound Therapy for Soft Tissue Injuries of Foot and Ankle in Patients at a Tertiary Care Hospital
Condition: Soft Tissue Injuries
MeSH terms: Soft Tissue Injuries
Study type: Interventional

Summary: 
      Effect of Negative Pressure Wound Therapy for Soft Tissue Iinjuries of Foot and Ankle in
      Patients at a Tertiary care Hospital.

      To evaluate the effect of negative pressure wound therapy for soft tissue injuries of foot
      and ankle.This will be assessed through measuring the wound surface area covered with healthy
      granulation tissue measured in centimetre square on follow-up.
    

Detailed description: 
      All patients aged 18 years or above with foot and ankle trauma resulting in soft tissue
      injury with or without bones and tendon exposed were included in the study. 35 patients were
      randomized into Negative Pressure Wound Therapy group and 35 in conventional treatment
      group.In NPWT group ,NPWT was applied to injured area of foot and ankle after debridement and
      cleaning of the necrosed/dead tissue. The effect of technique was assessed through measuring
      wound surface area covered with healthy granulation tissue measured in centimetre square on
      follow-up at 10 days ,20 days and 27 days respectively.

      In Conventional treatment group patients were kept on simple moist gauze dressings and the
      wound was assessed through measuring wound surface area covered with healthy granulation
      tissue measured in centimeter square on followup at 10 days , 20 days and 27 days
      respectively.
    

Intervention name(s): Negative Pressure Wound Therapy; Conventional treatment
Intervention type(s): Procedure; Procedure
Intervention description(s): NPWT technique was applied to injured area of the foot and ankle after debridement and cleaning of the necrosed tissue and using Vacuum Assisted Closure (VAC) consisting of evacuation tube, vacuum pump, collecting canister and a multiporous polyurethane sponge. VAC dressings were changed every 72 hours.; In conventional treatment moist gauze dressings were applied and change of dressings were done daily.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
Bioelectrical Impedance Vector Analysis in Cirrhotic Patients
Condition: Cirrhosis; Hepatic Encephalopathy
MeSH terms: Liver Cirrhosis; Hepatic Encephalopathy; Brain Diseases; Fibrosis
Study type: Observational

Summary: 
      Protein-energy malnutrition and muscle wasting are a common finding among patients with liver
      cirrhosis. Its prevalence may range from 50-90% depending on the methods used for nutritional
      assessment. Even stable cirrhotic patients referred as Child A have muscle depletion and the
      majority of patients classified as Child C have significant depletion. Malnutrition has been
      shown to be related to several complications of cirrhosis

      Despite the importance of nutritional status in patient's outcome, there is no gold standard
      for nutritional assessment. Traditional techniques used in healthy subjects to assess
      nutritional status cannot be used in cirrhotic patients due especially to ascites and
      peripheral edema, and altered rates of biochemical markers due to liver failure.

      Bioelectrical impedance vector analysis has emerged as a useful method to assess body
      composition and nutritional status especially in patients at the extremes of body weight
      (fluid overload, excess of adipose tissue, etc.).

      The aim of this study is to evaluate whether malnutrition assessed by bioelectrical impedance
      vector analysis is related to the development of hepatic encephalopathy
    


Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The participants will be recruited from the Gastroenterology Department of a tertiary care
        setting.
A Study to Evaluate the Blood Levels, Safety, and Tolerability of PF-00734200 in Subjects With Impaired Kidney Function and Normal Kidney Function
Condition: Renal Insufficiency, Chronic
MeSH terms: Renal Insufficiency; Renal Insufficiency, Chronic
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to compare how PF-00734200 is adsorbed, distributed, broken down
      and eliminated by subjects with mild, moderate and severe kidney impairment, by subjects
      receiving chronic hemodialysis, and by subjects with normal kidney function. The removal rate
      of PF-00734200 by hemodialysis will be calculated. The safety and tolerability of PF-00734200
      in subjects with various degrees of kidney function or undergoing chronic hemodialysis will
      be assessed.
    


Intervention name(s): PF-00734200
Intervention type(s): Drug
Intervention description(s): The drug is administered as a single dose of four 5-mg tablets
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Selenium in the Prevention of Cancer
Condition: Cancer
Study type: Interventional

Summary: 
      This is a pilot study proceeding an intended international trial.

      Hypothesis: Daily intake of selenium supplementation in the form of selenium-enriched yeast
      tablets will reduce the risk of cancer in healthy individuals.

      Objective: The objective of this pilot study was to assess the viability of a full scale
      randomised trial.

      AMENDMENT TO STUDY OBJECTIVE: Mortality analysis during intervention and follow-up as
      specified in the sections concerning study design and outcome measures.
    


Intervention name(s): SelenoPRECISE selenium-enriched yeast tablet, Pharma Nord Denmark A/S
Intervention type(s): Dietary Supplement
Intervention MeSH terms: Selenium
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: AMENDMENT TO STUDY DESIGN: Towards the end of the intervention period, it was decided to follow-up participants for an additional ten years via Danish public registries for data on morbidity and mortality.
Masking: Triple (Participant, Care Provider, Investigator)
Primary purpose: Prevention
Keywords: selenium; selenium supplementation; randomised controlled trial; prevention
Effects of Modafinil on Brain Function in Patients With Schizophrenia
Condition: Schizophrenia; Schizoaffective Disorder
MeSH terms: Schizophrenia; Psychotic Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will evaluate whether modafinil improves cognition in patients with schizophrenia
      and healthy volunteers. Modafinil is a drug that has been FDA approved for day-time
      sleepiness and allegedly increase the amount of the neurotransmitter dopamine in the frontal
      cortex of the brain

      ...
    

Detailed description: 
      Psychopharmacological modulation of the catecholaminergic system can enhance some aspects of
      cognitive function. For example, COMT inhibitors can slightly improve working
      memory/executive function. Similarly, modafinil, a catecholaminergic agonist that increases
      extracellular dopamine in the prefrontal cortex was also shown to improve delay-dependent
      working memory. Differences in the response between individuals might be related to a number
      of factors, including variations in the genes. The recent finding that a polymorphism in the
      catechol-o-methyl-transferase (COMT) gene, which produces a 4 fold change in enzyme activity,
      accounts for 4% of the variance in performance of working memory tasks in humans suggest that
      COMT genotype may predict response to COMT inhibitors or to other agonists that increase
      catecholaminergic function in the frontal cortex.

      In the present investigation our goal is to examine, in normal controls and patients with
      schizophrenia, the effect of modafinil, a drug that increases DA output in the frontal
      cortex, on cognitive function and brain physiology. We predict that both normal controls and
      patients with schizophrenia with the val/val genotype will have a significant improvement in
      working memory compared with individuals possessing other genotypes. Furthermore, in
      conjunction with other NIMH imaging protocols, we predict that modafinil will produce a
      similar genotype-dependent effect on the neurophysiological correlates related to working
      memory assayed with fMRI. The present protocol will provide new insights on the importance of
      this genetic polymorphism in the regulation of aminergic-controlled cognitive function in
      normal individuals. Furthermore, this protocol will test whether modafinil offers a new
      treatment -based on genotype - for cognitive impairment in schizophrenia. The FDA granted a
      waiver for the use of Modafinil in this study.
    

Intervention name(s): Modafinil; Functional MRI; Neuropsychological Testing
Intervention type(s): Drug; Procedure; Procedure
Intervention description(s): Placebo 1 week-Wash out 1 week - Drug 1 week (or vice versa)
Intervention MeSH terms: Modafinil
Allocation: Randomized
Intervention model: Crossover Assignment
Primary purpose: Other
Keywords: Catecholamines; Dopamine; fMRI; Working Memory; Clinical Trial; Stabilization; Inpatients; Placebo; Modafinil; Normal Volunteers; Schizophrenia; Schizoaffective Disorder; Healthy Volunteer; HV
Study to Assess the Safety, Pharmacokinetics and Pharmacodynamics of DS-1150b in Healthy Subjects and Subjects With Type-2 Diabetes Mellitus
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      DS-1150b is being developed by Daiichi Sankyo for the treatment of Type 2 Diabetes Mellitus.
      This is a Phase I, single-blind (subjects and principal investigator blinded, Sponsor
      unblinded), placebo-controlled, randomized, 2-part, sequential, single ascending dose, single
      center study to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of
      single oral dose of DS-1150b in healthy subjects and subjects with Type 2 Diabetes Mellitus.
    


Intervention name(s): DS-1150b; Placebo
Intervention type(s): Drug; Other
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Effect of a High-fat Meal on the Pharmacokinetics of SHR3824 and Mass Balance Study in Healthy Subjects
Condition: Type 2 Diabetes
Study type: Interventional
Phase: Phase 1

Summary: 
      This open-label, randomized, two-period, two-treatment (single doses of 10 mg SHR3824 fasted
      or fed), crossover study was conducted to evaluate the effect of a high-fat meal on the
      pharmacokinetics of SHR3824 and mass balance study in 12 healthy subjects.
    


Intervention name(s): SHR3824
Intervention type(s): Drug
Intervention description(s): SHR3824 tablet,10mg, fasting conditions and high fat, high calorie breakfast.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: SHR3824; food effect; mass; balance; Phase I
Effect of Bosentan on Exercise Capacity at High Altitude
Condition: Altitude; Pulmonary Hypertension
MeSH terms: Hypertension, Pulmonary
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is to determine whether bosentan will alter exercise capacity after rapid ascent
      to high altitude.

      We hypothesize that bosentan administration will improve arterial oxygenation and exercise
      capacity.
    

Detailed description: 
      Both the prostacyclin and the nitric oxide pathways are important in modulating hypoxic
      pulmonary vasoconstriction (HPV). There is little information about the role of the
      endothelin pathway at high altitude. The endothelin pathway involves the activation of two
      distinct receptors, A and B. Bosentan is a nonpeptide, specific, competitive, dual antagonist
      of both endothelin receptor subtypes. The primary objective of this study will be to
      determine the effect of endothelin receptor blockade with bosentan on exercise performance
      and HPV. This is a prospective, double blind, placebo-controlled, randomized cross-over study
      involving healthy subjects aged 25-55 years of age. Subjects will undergo echocardiography
      and exercise testing at low altitude (< 500m) and at 3800m. Subjects will receive either
      bosentan vs. placebo and will be studied at low and high altitude on two occasions in a
      crossover design. Primary outcome measures will be pulmonary artery systolic pressure
      measured by echo-Doppler and exercise capacity. A better understanding of the role of the
      endothelin pathway in HPV may lead to improved treatments for some patients.
    

Intervention name(s): Bosentan administration
Intervention type(s): Drug
Intervention MeSH terms: Bosentan
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double
Primary purpose: Treatment
Keywords: hypoxia; endothelin; exercise
A Study to Assess the Safety and Tolerability of N-Acetylcysteine When Administered With Pirfenidone to Participants With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a Phase 2, randomized, double-blind, placebo-controlled safety and tolerability study
      of N-acetylcysteine or placebo in participants with mild to moderate idiopathic pulmonary
      fibrosis (IPF) receiving background pirfenidone therapy.
    


Intervention name(s): Matching Placebo; N-acetylcysteine; Pirfenidone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Matching Placebo, oral administration, three times daily for 24 weeks.; N-acetylcysteine, 600 mg, oral administration, three times daily for 24 weeks.; Pirfenidone, at least 1602 mg/day, oral administration, for 32 weeks, during the wash-out and screening period and for at least 8 weeks prior to randomization.
Intervention MeSH terms: Acetylcysteine; Pirfenidone; N-monoacetylcystine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Impact of Bariatric Surgery on the Evolution of Nonalcoholic Fatty Liver Disease: a Comparative Clinical Trial Between Sleeve Gastrectomy and Gastric Bypass
Condition: Obesity; Fatty Liver
MeSH terms: Fatty Liver
Study type: Interventional
Phase: Phase 1

Summary: 
      Aim: To compare prospectively two bariatric surgery techniques: sleeve gastrectomy (SG) vs
      gastric bypass (GB) in the evolution of nonalcoholic fatty liver disease (NAFLD) measured by
      the transient elastography in the first year. Methods: This is a randomized clinical trial
      with morbidly obese patients, between 18-60 years old from a Federal Hospital, Ministry of
      Health, Brazil. Patients were divided into 2 groups: group 1 - SG (n = 30) and group 2 - GB
      (n = 30). The randomization was made by lots. In the GB the investigators created 30 ml
      pouch, with a pancreatic and an alimentary limb of 1 meter, and a calibrated
      gastroenterostomy (1.5 cm diameter). In SG the investigators calibrated the gastric tube with
      a bougie number 32 (70 ml). The variables were compared one week before surgery and in the
      postoperative time (1, 3, 6 and 12 months). The variables were: patient anthropometry,
      laboratory tests and the transient liver elastography.
    


Intervention name(s): Transient hepatic elastography
Intervention type(s): Device
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: bariatrics; transient elastography
Study Evaluating the Pharmacokinetics of Doxylamine Succinate in Children
Condition: Allergic Rhinitis; Upper Respiratory Infection
MeSH terms: Rhinitis; Respiratory Tract Infections; Rhinitis, Allergic
Study type: Interventional
Phase: Phase 1

Summary: 
      The primary goal of this study is to characterize the pharmacokinetics of doxylamine
      succinate in children ages 2 to < 18 years. Once characterized, these pediatric
      pharmacokinetic data will be pooled with historical adult PK data from other studies to
      assess whether the existing Over-the-Counter (OTC)doses provide comparable systemic drug
      exposure as that associated with efficacy in adults.
    


Intervention name(s): Doxylamine Succinate USP
Intervention type(s): Drug
Intervention description(s): One dose of liquid, dosing range 3.125mg/7.5mL - 12.5mg/30mL
Other intervention name(s): Doxylamine Succinate United States Pharmacopeia (USP)
Intervention MeSH terms: Doxylamine; Doxylamine succinate
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: Pharmacokinetic study
Early Treatment of Skeletal Anterior Open Bite by Two Appliances
Condition: Open Bite
MeSH terms: Open Bite
Study type: Interventional

Summary: 
      Open bite is a common dentoalveolar component of the facial pattern of the excessive vertical
      dimension patients that is also known as the gaping angle face pattern.It is a deformation in
      the vertical relationship between the upper and the lower dental arches that is characterized
      by the loss of contact between the opposite dental segments.
    

Detailed description: 
      An open bite develops as a result of the interaction of many etiologic factors, both
      hereditary and environmental. Prolonged sucking habits and hyper-divergent facial
      characteristics are significant risk factors for an anterior open bite in the mixed
      dentition. Abnormal tongue posture (frequently associated with enlarged adenoids or tonsils)
      and tongue thrust also can be involved in the establishment of alveolar and skeletal
      discrepancies concurrent with vertical problems Two types of an open bite are recognized in
      this profession: (1) dentoalveolar open bite: the abnormality formalities aspects limiting in
      the dental and alveolar region, usually associated with abnormal function habits as the thumb
      sucking and (2) Skeletal open bite: that's associated with an over high of the lower facial
      vertical dimension and a large plane angle of the lower jaw. open bites associated with
      excessive vertical skeletal dimensions are difficult to treat and tend to relapse The
      investigators must be recognized between the dentoalveolar open bite and the open bite caused
      by formalities disorders and the position disorders of the upper or the lower jaw or both.
      Dental an open bite can be corrected by itself if the treatment was beginning early and it's
      responding Easley to the mechanical treatment methods and the functional treatment approaches
      that depending on the muscular activity
    

Intervention name(s): Bionator; Removable Appliance with Posterior Bite Planes
Intervention type(s): Device; Device
Intervention description(s): This is a functional appliance that is used to overcome the functional problems and to correct the open bite deformity; This is a one-jaw appliance that is used in conjunction with a tongue crib to control the faulty positions of the tongue and to help in closing the open bite through the use of posterior bite planes.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Single Increasing Dose Study to Assess Safety and Tolerability of DX-2930 in Healthy Subjects
Condition: Hereditary Angioedema (HAE)
MeSH terms: Angioedema; Angioedemas, Hereditary
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the safety and tolerability of the study drug
      (DX-2930) administered subcutaneously in healthy subjects. Subjects will be randomized to
      receive DX-2930 or placebo.
    

Detailed description: 
      Approximately 32 healthy subjects will be randomized to receive DX-2930 or placebo.
    

Intervention name(s): DX-2930; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): placebo, subcutaneous administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment