bioihbjkbjnl/mcl2 huggingface dataset:
A Study of Sodium Carboxymethylcellulose for Post Cataract Surgery Dry Eye Symptoms
Condition: Dry Eye Syndromes; Cataract
MeSH terms: Cataract; Dry Eye Syndromes; Keratoconjunctivitis Sicca
Study type: Interventional
Phase: Phase 4

Summary: 
      This study will evaluate the effect of sodium carboxymethylcellulose eye drops in the
      treatment of dry eye after cataract surgery.
    


Intervention name(s): Sodium Carboxymethylcellulose; Levofloxacin; Prednisolone
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Sodium carboxymethylcellulose (Refresh Liquigel®) 1 drop in the study eye 4 times a day for 30 days post-cataract surgery.; Levofloxacin 1 drop in the study eye 3 times a day for 7 days post-cataract surgery.; Prednisolone 1 drop in the study eye 4 times a day for the 1st week post surgery, 3 times a day for the 2nd week post surgery, 2 times a day for the 3rd week post surgery, and 1 time a day for the 4th week post surgery.
Other intervention name(s): Refresh Liquigel®; Cravit®; PRED FORTE®
Intervention MeSH terms: Levofloxacin; Prednisolone; Prednisolone acetate; Carboxymethylcellulose Sodium
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effects of Retinoids on CYP2D6 Activity During Pregnancy
Condition: CYP2D6 Polymorphism
Study type: Interventional
Phase: Phase 1

Summary: 
      Prospective drug interaction study during pregnancy.
    

Detailed description: 
      A randomized pharmacokinetic study to evaluate CYP2D6 activity with and without vitamin A
      administration during pregnancy and compared to postpartum control.
    

Intervention name(s): Vitamin A
Intervention type(s): Drug
Intervention description(s): vitamin A daily X3-4 weeks
Intervention MeSH terms: Vitamin A
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, randomized, parallel group study
Masking: None (Open Label)
Primary purpose: Basic Science
A Systematic Investigation of Phonetic Complexity Effects on Articulatory Motor Performance in Progressive Dysarthria
Condition: Amyotrophic Lateral Sclerosis; Parkinson Disease
MeSH terms: Parkinson Disease; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Dysarthria
Study type: Interventional

Summary: 
      The goal is to improve the fundamental knowledge about articulatory motor performance in
      people with Lou Gehrig's disease (also known as ALS) and Parkinson's disease (PD), in order
      to develop more sensitive assessments for progressive speech loss, which may lead to the
      improved timing of speech therapies.
    

Detailed description: 
      The long-term goal is to optimize dysarthria assessment by improving the early detection and
      tracking of articulatory performance in progressive dysarthrias. The short-term goal of the
      proposed cross-sectional study is to focus on ALS and PD and quantify articulatory kinematic
      performance as a function of phonetic complexity, which is experimentally manipulated based
      on theoretical principles of speech motor development. The research strategy is to use 3D
      electromagnetic articulography to examine phonetic complexity effects of single word stimuli
      at the articulatory kinematic level in 15 talkers each with preclinical, mild, and moderate
      dysarthria, relative to 45 controls. The central hypothesis is that as dysarthria severity
      increases the discrepancy in articulatory performance, indexed by movement speed, distance,
      coordination, and variability, between people with dysarthria and typical controls will
      significantly increase at a lower phonetic complexity level.
    

Intervention name(s): Phonetic complexity effects on speech motor performance
Intervention type(s): Behavioral
Intervention description(s): Use of 3D electromagnetic articulography to examine phonetic complexity effects of single word stimuli at the articulatory kinematic level in talkers each with preclinical, mild, and moderate dysarthria, relative to healthy controls.
Intervention model: Single Group Assignment
Intervention model description: Two groups of participants i.e., participants with ALS or PD and healthy controls will be asked to repeat sentences that have target words with varying phonetic complexity.
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Dysarthria; Speech motor performance; Speech motor control; Speech kinematics
24 Month Follow-up of Patients With Osgood Schlatter (OSD)
Condition: Osgood-Schlatter Disease; Apophysitis
MeSH terms: Osteochondrosis
Study type: Observational

Summary: 
      Osgood Schlatter is a common knee condition, affecting approximately 10% of adolescents. OSD
      is thought to be a growth related pain conditon, and thus resolve after maturation. Despite
      this, there a lack of prospective data investigating whether this is in fact the case.
    

Detailed description: 
      This is a prospective cohort study of 51 adolescents (aged 10-14 at baseline) with Osgood
      schlatter. Participants are followed for two years.
    

Intervention name(s): Activity modification
Intervention type(s): Other
Intervention description(s): Activity modification, exercises and gradual return to sport
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Adolescents aged 10-14 years old diagnosed with Osgood Schlatter
Brain Activity in Adults With ADHD During Neuropsychological Tasks
Condition: Attention Deficit Hyperactivity Disorder (ADHD)
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Observational

Summary: 
      The aim of the study is to investigate the response on cognitive testing of healthy persons
      compared to adults with or without medication against ADHD.
    

Detailed description: 
      Attention Deficit Hyperactivity Disorder (ADHD) is one of the most prevalent psychiatric
      disorders in children and adolescents. It is characterized by inattentive, hyperactive,
      impulsive behaviour and neuropsychological deficits. In 40-60% of cases emerge in childhood
      and persists into adulthood.

      The aim of the study is to investigate the response on cognitive testing of healthy persons
      compared to adults with or without medication against ADHD. As a secondary endpoint a more
      robust diagnosing method combining advanced imaging methods with neuropsychological
      evaluation is tested.

      Neuropsychological testing, functional MRI and spectroscopy will be performed. Statistical
      analysis will assess differences in the functional magnetic resonance imaging, spectroscopy
      and neuropsychological evaluation results between three groups: 1) group of healthy
      volunteers, 2) participants with ADHD with medication and 3) participants with ADHD without
      medication.
    

Intervention name(s): MRI
Intervention type(s): Device
Intervention description(s): Functional Magnetic Resonance Imaging technique measures brain activity by detecting associated changes in blood oxygenation level dependency
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Three groups:

          1. healthy volunteers

          2. ADHD subjects receiving medications

          3. medication-naive ADHD subjects
The Effects of Gevokizumab in Corticosteroid-resistant Subjects With Autoimmune Inner Ear Disease
Condition: Autoimmune Inner Ear Disease
MeSH terms: Ear Diseases; Labyrinth Diseases; Labyrinthitis
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to determine if gevokizumab therapy may be an alternate therapy
      in patients with steroid resistant Autoimmune Inner Ear Disease.
    


Intervention name(s): gevokizumab
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Autoimmune Inner Ear Disease; Inner Ear Disease; Meniere's Disease; Sudden Sensorineural Hearing Loss
Self Acupressure on Fatigue and Sleep Quality in Epilepsy Patients
Condition: Epilepsy
MeSH terms: Epilepsy; Fatigue
Study type: Interventional

Summary: 
      The aim of this study is to examine the effect of Self-acupressure application on fatigue and
      sleep quality in epilepsy patients.
    

Detailed description: 
      Acupressure is a therapy method performed with an instrument or hand, fingertip, palm, elbow,
      knee, thumb relaxation and wrist bands on various points representing the waist organs in our
      body in order to ensure the continuation and balance of the energy in our body.
    

Intervention name(s): Self-Acupressure
Intervention type(s): Other
Intervention description(s): Acupressure is a therapy method performed with an instrument or hand, fingertip, palm, elbow, knee, thumb relaxation and wrist bands on various points representing the waist organs in order to ensure the continuation and balance of the energy in our body.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: This study is an experimental study with pre-test and post-test control groups
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: Self Acupressure; Fatigue; Sleep Quality; Epilepsy Patients
L-carnitine and Metformin in Obese PCOS Women.
Condition: PCOS
Study type: Interventional
Phase: Phase 2

Summary: 
      L-carnitine and plus metformin in clomiphene-resistant obese PCOS women, reproductive and
      metabolic effect: a randomized clinical trial
    

Detailed description: 
      the trial aims to compare L-carnitine and plus metformin in clomiphene-resistant obese PCOS
      women with placebo to state the reproductive and metabolic effects in form of pregnancy and
      insulin resistance parameters and lipid metabolism.
    

Intervention name(s): L-carnitine and Metformin; placebo
Intervention type(s): Drug; Drug
Intervention description(s): L-carnitine plus Metformin was given Obese PCOS Women trying induction of ovulation with clomiphene citrate.; placebo was given Obese PCOS Women trying induction of ovulation with clomiphene citrate.
Other intervention name(s): motova plus and glucphage
Intervention MeSH terms: Metformin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Surgical Management of Posterior Tibial Plateau Fractures
Condition: Tibial Fractures
MeSH terms: Fractures, Bone; Tibial Fractures; Tibial Plateau Fractures
Study type: Observational

Summary: 
      This protocol concerns an academic, multicentric, and prospective clinical trial. In this
      study the investigators will evaluate the recently approved WAVE-plate (7S Medical) for open
      reduction and internal fixation and buttressing of the posterior proximal tibial column via a
      posteromedial reversed L-shaped approach. The reversed L-shaped approach has been shown as a
      safe technique with adequate visualisation of the posterior tibial surface. The investigators
      will thoroughly evaluate all important clinical, radiological and functional variables. The
      functional outcome will be reported in patient reported outcome measures by means of the
      validated Knee injury and Osteoarthritis Outcome Score (KOOS).
    


Intervention name(s): Osteosynthesis
Intervention type(s): Procedure
Intervention description(s): Osteosynthesis of posterior tibial plateau fracture with a posterior tibial plateau plate
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Outpatient at emergency room and clinic of the department of traumatology.
      
Keywords: classification; questionnaires; open reduction; internal fixation
Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT- 267 (ABT-450/r/ABT-267) in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection
Condition: Hepatitis C Virus
MeSH terms: Hepatitis A; Hepatitis C; Hepatitis C, Chronic; Hepatitis
Study type: Interventional
Phase: Phase 3

Summary: 
      This is a Phase 3, randomized, open-label, multicenter study, enrolling non-cirrhotic and
      cirrhotic subjects. The purpose of this study is to evaluate the efficacy and safety of
      ABT-450/r/ABT-267 co-administered with weight-based RBV for 12 or 16 weeks in adult chronic
      HCV genotype 2-infected treatment-naïve and interferon (IFN) treatment-experienced subjects
      with and without compensated cirrhosis.
    


Intervention name(s): ABT-450/r/ABT-267; Ribavirin
Intervention type(s): Drug; Drug
Intervention description(s): Tablet; ABT-450 coformulated with ritonavir and ABT-267; Capsule
Other intervention name(s): ABT-267 also known as ombitasvir; ABT-450 also known as paritaprevir; ritonavir also known as Norvir; VIEKIRAX Combination Tablets; VIEKIRA Combination Tablets; Technivie; Qurevo
Intervention MeSH terms: Ritonavir; Ribavirin
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Japanese; Hepatitis C; Treatment naive; Treatment experienced; Genotype 2; Ombitasvir; Paritaprevir; Ritonavir; Ribavirin; VIEKIRAX Combination Tablets
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Ionis AGT-LRx in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose is to assess the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of
      IONIS AGT-LRx in up to 82 Healthy Volunteers
    


Intervention name(s): Ionis AGT-LRx; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Ascending single and multiple doses of Ionis AGT-LRx administered subcutaneously; Saline .9%
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: Healthy Volunteers, IONIS AGT-Lrx
GPR vs Manual PT for Chronic Neck Pain
Condition: Nonspecific Chronic Neck Pain
MeSH terms: Neck Pain
Study type: Interventional

Summary: 
      Effective treatment for nonspecific chronic neck pain is a clinical challenge. Patients will
      be randomized into two groups to compare the outcomes of Global Postural Re-education (GPR)
      with standard manual physical therapy on with respect to pain, function, kinesiophobia, range
      of motion, perceived effect, and satisfaction.
    

Detailed description: 
      These study will use two groups: one to receive GPR which is a systematic method of
      addressing musculoskeletal pain and related functional deficits and the other to receive
      "usual care" manual PT which will be individualized to the patient's condition. Usual care
      will include techniques commonly used in clinical practice selected by the physical therapist
      after initial examination. After nine weeks of treatment, baseline measures will be
      re-evaluated. After conclusion of the first phase of the study, patients who were randomized
      to the "usual care" group will cross-over and receive GPR.
    

Intervention name(s): Global Postural Re-education; Standard manual physical therapy
Intervention type(s): Other; Other
Intervention description(s): Global Postural Re-education is a physical therapy method comprising a series of gentle active movements, implemented by the therapist using manual contacts and verbal commands, to promote postural symmetry.; Standard manual physical therapy in this study involves a combination of exercises, pompage (gentle manual techniques of distraction and articulation of a joint), anterior-posterior mobilizations as described by Maitland, and massage that have been selected to meet the needs of each individual patient.
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: neck pain; chronic; Global Postural Re-education; manual therapy; physical therapy
The ACE Follow-up Study
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The Articulating Circular Endoscopic (ACE) Stapler is an investigational system using
      endoscopic guidance to trans-orally place plications in the stomach in obese subjects to
      reduce volume and expansion of the fundus and greater curve to abate hunger as part of a
      supervised weight reduction program.

      The primary objective of this study is to perform an evaluation of the safety of the
      plication procedure.

      The secondary objective of this study is to evaluate the preliminary efficacy of the ACE
      Stapler for the treatment of obesity over a 24 month follow-up period.
    

Detailed description: 
      This study was originally sponsored by BaroSense, Inc (protocol 11-03). 69 subjects were
      enrolled and treated as part of the study at 6 centers in 4 countries outside the United
      States. On April 30, 2013 BaroSense Inc went out of business and the study was terminated
      with all participating centers' Ethics Committees. At the point of study termination, all
      patients were in the middle of post procedure follow-up.

      Boston Scientific has since acquired the technology and study and will re-initiate follow-up
      to 24 months in order to collect data to support the original safety and efficacy endpoints
      of the protocol. Only the 69 subjects previously enrolled and treated in BaroSense's protocol
      11-03 will be eligible for participation in the Boston Scientific continued follow-up study
      ("The ACE Follow-up Study" protocol 90891629). The Boston Scientific protocol will be
      approved by participating centers' Ethics Committees and patients who choose to participate
      in The ACE Follow-up Study will need to sign a new, Ethics Committee Approved, informed
      consent form.
    

Intervention name(s): ACE Stapler
Intervention type(s): Procedure
Intervention description(s): The ACE Stapler is used endoscopically, and incorporates a unique tissue capture mechanism to produce large, permanent serosa to serosa plications in a completely trans-oral approach.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Weight Loss; Trans-oral Endoscopic Procedure; Gastric Plication
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Single Doses of Mipomersen in Japanese Healthy Volunteers
Condition: Healthy Volunteer
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study is being conducted to evaluate 3 increasing subcutaneous (SC) doses (50,
      mg, 100 mg or 200mg) of mipomersen in Japanese healthy volunteers. Eligible subjects will
      receive a single study injection of either mipomersen or placebo. Subjects will be enrolled
      into 1 of 3 treatment cohorts (Cohorts A, B, and C) in a dose-escalation design.
      Dose-escalation will proceed only if there is an acceptable safety profile from the previous
      dosing level.
    


Intervention name(s): mipomersen; placebo
Intervention type(s): Drug; Drug
Intervention description(s): 50 mg (cohort A), 100mg (cohort B) or 200mg (cohort C) subcutaneous (SC) single dose of study drug; 50 mg (cohort A), 100mg (cohort B), or 200mg (cohort C) subcutaneous (SC) single dose of study drug
Other intervention name(s): ISIS 301012
Intervention MeSH terms: Mipomersen
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Analgesic Efficacy of Transmuscular Quadratus Lumborum in Patients Undergoing Total Abdominal Hysterectomy
Condition: Pain Postoperative
MeSH terms: Pain, Postoperative
Study type: Interventional

Summary: 
      Patients who have undergone laparotomies often require multimodal postoperative pain regimes.
      In recent years, abdominal wall blocks have been included to become part of this in order to
      overcome side effects of systemic opioids and complications from epidural analgesia.

      Borglum popularised a new approach on abdominal wall blocks by introducing the transmuscular
      quadratus lumborum (QL) block. Transmuscular QL block is thought to be effective against
      somatic and visceral pain as local anaesthetic tends to spread from the site of injection to
      thoracic paravertebral spaces where the sympathetic chain lies.

      The objective of this study is to evaluate the analgesic efficacy of transmuscular QL block
      in patients undergoing total abdominal hysterectomy (TAH) by measuring cumulative opioid
      consumption, pain score at rest and on movement 24 hours after TAH. Our hypothesis is
      patients given transmuscular QL block will have lower cumulative opioid consumption.
    


Intervention name(s): Transmuscular quadratus lumborum block; morphine; ropivacaine
Intervention type(s): Procedure; Drug; Drug
Intervention MeSH terms: Morphine; Ropivacaine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Transmuscular quadratus lumborum block, total abdominal hysterectomy
Pathophysiological Implications of the Incretin Hormones in Patients With Liver Disease With and Without Diabetes
Condition: Non Alcoholic Fatty Liver Disease; Type 2 Diabetes; Liver Cirrhosis
MeSH terms: Liver Diseases; Fatty Liver; Non-alcoholic Fatty Liver Disease; Liver Cirrhosis; Diabetes Mellitus
Study type: Observational

Summary: 
      The main objective of this study is to analyze the pathophysiological implications of
      glucagon and the incretin hormones in patients with liver disease (Non alcoholic fatty liver
      disease (NAFLD) or cirrhosis) with and without diabetes compared with healthy controls. The
      present study will contribute significantly to the understanding of the pathophysiology of
      liver disease and glucose metabolism. The final goal is that the results could pave the way
      for new treatment modalities for patients with liver disease.
    

Detailed description: 
      Comparison of of insulin secretion (Area Under the Curve (AUC)) during the experimental days.
      Furthermore a comparison of GIP, GLP1 and glucagon responses as well as plasma glucose
      levels.
    

Intervention name(s): OGTT; IIGI
Intervention type(s): Other; Other
Intervention description(s): 50g waterfree glucose dissolved in 300 ml water consumed over 5 min.; iso glycemic intravenous (iv) glucose infusion (IIGI) with 20% glucose
Other intervention name(s): Waterfree glucose, The Pharmacy of the capital region; Glucose infusion, 20%
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients with NAFLD and liver cirrhosis confirmed by liver biopsy, and patients with or
        without well characterized type 2 diabetes recruited in the the hospitals out patients
        clinic
      
Biospecimen description: 
      DNA (whole blood) will be kept for 15 years
    
Keywords: NAFLD; Incretin hormones