bioihbjkbjnl/mcl2 huggingface dataset:
Evaluation of Retinal and Vascular Features in Coats Disease After Intravitreal Injections of Ranibizumab
Condition: Coats Disease
MeSH terms: Retinal Telangiectasis
Study type: Observational

Summary: 
      This study evaluates the retinal and vascular features in patients affected by Coats disease
      under the effects of Ranibizumab intravitreal injections using optical coherence tomography
      and optical coherence tomography angiography
    

Detailed description: 
      Coats disease is an idiopathic retinal vascular disorder, occurs in young males, and is
      characterized by retinal telangiactasias, numerous yellowish exudates in the subretinal
      space, macular edema, hemorrhages and, in advanced end-stage, by exudative retinal
      detachment.

      Ranibizumab is a vascular endothelial growth factor antagonist represent an efficacy
      treatment acting on vascular hyperpermeability. The optical coherence tomography and optical
      coherence tomography angiography represent novel and non-invasive diagnostic techniques that
      allow a detailed analysis of retinal and vascular features. The study evaluates the changes
      in optical coherence tomography and optical coherence tomography angiography parameters at
      baseline and after three monthly injections of Ranibizumab in Coats disease.
    

Intervention name(s): Ranibizumab Injection
Intervention type(s): Drug
Intervention description(s): Ranibizumab Injection (0.5 mg/0.05 ml): Three monthly intravitreal injections
Intervention MeSH terms: Ranibizumab
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        The participans were older than 18 years with diagnosis of Coats disease. They did not
        present other ophthalmological diseases.
A Proof of Concept Study of Serum Progesterone Levels for IVF/ICSI Following HCG Trigger for Oocyte Maturation
Condition: Infertility; Infertility, Female; IVF; hCG
MeSH terms: Infertility; Infertility, Female
Study type: Observational

Summary: 
      This study will determine the rise of progesterone levels after human chorionic gonadotrophin
      (hCG) trigger in stimulated cycles IVF/ICSI
    

Detailed description: 
      Studies have suggested that controlled ovarian hyperstimulation adversely affects endometrial
      receptivity. In ovarian stimulation cycles with exogenous gonadotrophins there is an ongoing
      debate regarding the effect of a late follicular phase progesterone level on reproductive
      outcomes. It is not yet clarified if an elevated serum progesterone level in the late
      follicular phase is a symptom or cause of an adverse effect on reproductive outcomes. A new
      hypothesis is evolving and gaining momentum providing a novel explanation for the association
      between late follicular phase progesterone rise and reproductive outcome. It is proposed that
      exogenous FSH (Follicle-stimulating hormone) administration results in supraphysiological
      levels of FSH, which induce an abundance of LH (luteinizing hormone) receptors on granulosa
      cells causing the follicles to become hypersensitive to LH-like activity (ie hCG trigger).
      Based on this hypothesis, the focus should be placed on the hCG trigger rather than on the
      late follicular phase progesterone rise.
    

Intervention name(s): hCG; Ultrasound; Blood test
Intervention type(s): Drug; Diagnostic Test; Other
Intervention description(s): human chorionic gonadotropin; Endometrial thickness monitoring; Progesterone, Luteinizing Hormone, Estradiol
Other intervention name(s): human chorionic gonadotropin; transvaginal scan; Progesterone, Luteinizing Hormone, Estradiol
Intervention MeSH terms: Chorionic Gonadotropin; Estradiol; Progesterone
Observational model: Case-Only
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Female patients who are planned to commence ovarian stimulation for IVF/ICSI with hCG
        trigger for oocyte maturation and plan to avail of pre-implantation genetic screening with
        embryo vitrification of their biopsied embryos at blastocyst stage
      
Biospecimen description: 
      Blood sample
Autophagy and Inflammasome in Obesity: Effect of Weight Loss and Potential Therapeutic Implications
Condition: Obesity
MeSH terms: Obesity; Weight Loss
Study type: Observational

Summary: 
      The main aim of this project is to determine the implication of autophagy and inflammasome in
      the pathogenesis of obesity and related comorbidities, and to explore in depth the mechanisms
      associated with the activation of immune cells leading early stages of the atherosclerotic
      process and metabolic disease. The hypothesis of the present study is that weight loss
      mediated by Roux-en-Y gastric bypass (RYGB) improves the protein expression of markers of
      autophagy and inflammation within immune cells. Moreover, the investigators will explore the
      association of these mechanisms with the mitochondrial function and dynamics, Endoplasmic
      Reticulum (ER) stress an intracellular nutritional status of leukocytes (measured by
      fluorescence microscopy and western blot). Further, the potential relationship between
      changes in the mentioned intracellular pathways and systemic pathological mechanisms
      including oxidative stress, inflammation and glucose and lipid metabolism will be explored.
      Hence, serum carbonylated proteins, myeloperoxidase (MPO) levels, antioxidant enzymatic
      activities including SOD (Superoxide dismutase) and catalase, circulating cytokines, and
      glucose and lipid metabolism parameters will be evaluated in a cohort of obese subjects
      before and 12 months after RYGB intervention.
    


Intervention name(s): Roux-en-Y gastric bypass
Intervention type(s): Procedure
Intervention description(s): Gastric bypass, also called Roux-en-Y gastric bypass, is a type of weight-loss surgery that involves creating a small pouch from the stomach and connecting the newly created pouch directly to the small intestine. After gastric bypass, swallowed food will go into this small pouch of stomach and then directly into the small intestine, thereby bypassing most of your stomach and the first section of your small intestine.
Gastric bypass is one of the most commonly performed types of bariatric surgery. Gastric bypass is done when diet and exercise haven't worked or when you have serious health problems because of your weight.
Other intervention name(s): RYGB
Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Subjects with obesity prescribed bariatric surgery to treat their obesity and related
        comorbidities
      
Biospecimen description: 
      Blood
    
Keywords: bariatric surgery; autophagy; inflammasome; atherosclerosis; cardiovascular disease
A Study of Ramucirumab (LY3009806) in Participants With Advanced Liver Cancer
Condition: Carcinoma, Hepatocellular
MeSH terms: Carcinoma; Carcinoma, Hepatocellular
Study type: Interventional
Phase: Phase 1

Summary: 
      The main purpose of this study is to determine if the advised dose of ramucirumab is safe to
      be taken with chemotherapy treatment in participants with advanced liver tumors.
    


Intervention name(s): Ramucirumab; FOLFOX4
Intervention type(s): Biological; Drug
Intervention description(s): Administered IV.; Administered IV.
Other intervention name(s): IMC-1121B; LY3009806; FOLFOX4 (leucovorin + fluorouracil + oxaliplatin)
Intervention MeSH terms: Leucovorin; Fluorouracil; Oxaliplatin; Ramucirumab
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Effect of Low-Fat Food on Pexidartinib Pharmacokinetics in Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      All participants in this study are healthy volunteers.

      Throughout the study, healthy volunteers will have physical exams, electrocardiograms and
      clinical laboratory tests. The study staff will keep track of symptoms, diet, and what
      medications they are taking.

      Each participant will get all three treatments (A, B and C). Only the order in which they
      receive them will be different.

      There are six groups based on the order: ABC, ACB, BAC, BCA, CAB, or CBA. Participants have
      an equal chance of being assigned to any of these groups.

      For each treatment period, participants will:

        -  fast overnight

        -  receive the assigned treatment with or without food

        -  have a small tube of blood drawn prior to treatment

        -  after dosing, additional blood samples will be drawn at 0.5, 1, 1.5, 2, 2.5, 3, 3.5, 4,
           4.5, 5, 6, 8, 10, 12, 14, 22, 24, 28, 32, 36, 48, 54, 60, 72, 84, 96, 108, 120, 132, and
           144 hours

        -  have a break from treatment for 6 days between each treatment period

      All participants must reside in the clinic for a total of 20 days.
    

Detailed description: 
      The primary objectives of this study are:

        -  To assess the effect of low-fat food on the pharmacokinetics (PK) of pexidartinib
           following a single oral dose of 400 mg administered in healthy subjects

        -  To assess the PK of pexidartinib following a single oral dose of 200 mg administered
           with low-fat food in healthy subjects

      The secondary objective of this study is:

        -  To characterize the safety and tolerability of pexidartinib in healthy subjects
           following administration of a single oral dose of pexidartinib with low fat food and
           without food
    

Intervention name(s): Treatment A - 400 mg Fasting; Treatment B - 400 mg Fed; Treatment C - 200 mg Fed
Intervention type(s): Drug; Drug; Drug
Intervention description(s): Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning under fasting conditions; Single oral 400 mg (2 × 200 mg capsules) dose of pexidartinib in the morning within 30 minutes (min) after a low-fat standard breakfast meal; Single oral 200 mg (1 × 200 mg capsule) dose of pexidartinib in the morning within 30 min after a low-fat standard breakfast meal
Other intervention name(s): Pexidartinib; Pexidartinib; Pexidartinib
Allocation: Randomized
Intervention model: Sequential Assignment
Masking: None (Open Label)
Primary purpose: Basic Science
Keywords: Pharmacokinetics
LUX Lung 2 Phase II Single Arm BIBW 2992 "Afatinib" in NSCLC With EGFR Activating Mutations
Condition: Carcinoma, Non-Small-Cell Lung
MeSH terms: Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2

Summary: 
      The primary objective of this open-label, single arm Phase II trial is to explore the
      efficacy of BIBW 2992 defined by the objective response rate (CR, PR) as determined by RECIST
      criteria in patients with advanced NSCLC Stage IIIB or IV whose tumors harbor activating
      mutations within exon 18 to exon 21 of the EGFR receptor. Patients progressing or relapsing
      after one prior cytotoxic chemotherapy regimen as well as chemotherapy naïve patients (only
      in stage 2) will be allowed to enter into the trial.
    


Intervention name(s): BIBW 2992
Intervention type(s): Drug
Intervention description(s): This is an open label study. Patients are treated with BIBW 2992 until disease progression or undue AEs
Intervention MeSH terms: Afatinib
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Immunogenicity and Safety of Quadrivalent Influenza Vaccine in Children Aged 6~35 Months
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 3

Summary: 
      This study is a multi-center, randomized, double-blind Phase III Clinical trial. The purpose
      of this study is to assess the immunogenicity and safety of the quadrivalent cell
      culture-derived influenza vaccine compare to the trivalent cell culture-derived influenza
      vaccine in children aged 6~35 months.
    

Detailed description: 
      Subjects are randomly assigned in a 2:1 ratio to NBP607-QIV 0.5mL versus NBP607-TIV 0.25mL.
      To assess the immunogenicity, antibody levels are evaluated by hemagglutination
      inhibition(HI) assay from sera obtained at pre-vaccination and 28 days post-vaccination. To
      assess the safety, solicited adverse events for 7 days post-vaccination and unsolicited
      adverse events for 28 days post-vaccination are assessed and reported. The serious adverse
      events are collected during 6 months post-vaccination.
    

Intervention name(s): NBP607-QIV; NBP607-TIV
Intervention type(s): Biological; Biological
Intervention description(s): For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular [* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart]; For subjects 6 months to 35 months of age, Single dose administration, Intra-muscular [* 2 doses for subjects without influenza vaccination history, administered at least 4 weeks apart]
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza Vaccines; Vaccines, Inactivated; Cell Culture-Derived
Postural and Anthropometric Properties of Foot and Ankle of Patients With DMD
Condition: Duchenne Muscular Dystrophy; Ambulation Difficulty; Posture Disorders in Children; Ambulation Disorder, Neurologic
MeSH terms: Muscular Dystrophies; Muscular Dystrophy, Duchenne; Nervous System Diseases; Gait Disorders, Neurologic; Mobility Limitation
Study type: Observational [Patient Registry]

Summary: 
      Introduction: Progressive muscle weakness, joint contractures and body alignment disorders
      seen in patients with Duchenne Muscular Dystrophy (DMD) adversely affect the foot structure
      of the patients.

      Objective: The aim of this study is to examine the relationship between foot posture,
      performance and ambulation in patients with DMD.

      Method: The patient with ambulatory DMD will be included in the study. The foot postures of
      the patients will be evaluated with the Foot Posture Index. Relationships between the Foot
      Posture Index and performance tests (6 minute walk test, timed performance tests (10m
      walking, Gower's, climb/descend 4 stair)) and the North Star Ambulation Evaluation, an
      ambulation evaluation, will be examined.
    


Intervention name(s): foot posture index, north star ambulation assessment, timed performance tests, 6 minute walk test
Intervention type(s): Other
Intervention description(s): Patients will be evaluated only observationally without intervention by foot posture index, north star ambulation assessment, timed performance tests, 6 minute walk test
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Ambulated Duchenne Muscular Dystrophy patients aged of 5-18 years
      
Keywords: Duchenne Muscular Dystrophy; foot posture; performance; ambulation
Evaluation of Lamotrigine on Neuropathic Facial Pain Using fMRI
Condition: Facial Neuropathy
MeSH terms: Facial Nerve Diseases; Facies; Facial Pain
Study type: Interventional

Summary: 
      The aim of this project is to evaluate the effects of the anticonvulsant drug lamotrigine
      (trade name Lamictal) on neuropathic facial pain or neuralgia using functional magnetic
      resonance imaging (fMRI).
    

Detailed description: 
      Currently there are no pharmacological agents that can control neuropathic pain akin to the
      efficacy of antibiotics for bacterial infection. All current neuropathic pain drugs have
      approximately the same efficacy of less than 30% in controlled trials, and many of these
      drugs do not have known mechanisms of action. fMRI studies may provide insight into how brain
      circuitry is altered by chronic pain, and how these drugs act on altered circuitry. The
      trigeminal system in particular offers unique advantages for studying such alterations,
      including a large central representation and high degree of somatotopy. The administration of
      lamotrigine to neuropathic pain patients in conjunction with fMRI will allow us to compare
      subjective ratings of pain with objective measures of neural activity during increased
      conditions of allodynia/hyperalgesia.
    

Intervention name(s): Lamotrigine; Placebo (for Lamotrigine)
Intervention type(s): Drug; Drug
Intervention description(s): : 25mg and 50mg tablets; Sugar pill manufactured to mimic Lamotrigine tablets
Other intervention name(s): LAMO; LAM; Placebo
Intervention MeSH terms: Lamotrigine; Anticonvulsants
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: pain; neuropathic; face; trigeminal
A 6 Week Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of GK1-399 in Type 2 Diabetes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The purpose of this trial is to study the drug levels and biomarkers in the body and the
      safety of an investigational drug (GK1-399) in patients with Type 2 diabetes. Patients in the
      study will receive placebo for 1 week followed by 1 of 4 treatments for 6 weeks. One of the 4
      treatments will be placebo, which does not contain an active ingredient. The study
      participation includes in-patient and out-patient days.
    


Intervention name(s): GK1-399 (formerly TTP399); GK1-399 (formerly TTP399); GK1-399 (formerly TTP399); Placebo
Intervention type(s): Drug; Drug; Drug; Drug
Intervention description(s): Treatment A: GK1-399 200 mg. Oral administration, twice per day.; Treatment B: GK1-399 800 mg. Oral administration, once per day.; Treatment C: GK1-399 800 mg. Oral administration, twice per day.; Dose-matched placebo. Oral administration.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Basic Science
Keywords: Type 2 diabetes mellitus; pharmacokinetics; pharmacodynamics
Genetic Analysis of Gray Platelet Syndrome
Condition: Genetic Linkage; Myelofibrosis
MeSH terms: Gray Platelet Syndrome
Study type: Observational

Summary: 
      This study will identify and characterize the gene or genes responsible for Gray Platelet
      syndrome (GPS). Platelets are small blood cells that stick on injured blood vessels to form a
      plug and stop bleeding. When a blood vessel is injured (like a cut on a finger), platelets
      release the proteins stored in their sacs to help form a blood clot. Patients with GPS bleed
      longer than other people because their platelets lack some of these protein-carrying sacs.
      Platelets without sacs look pale gray under the microscope rather than pink, giving the
      syndrome its name. Except for rare patients with severe hemorrhage, the bleeding tendency in
      GPS is usually mild to moderate, with patients experiencing easy bruising, nosebleeds, and,
      in women, excessive menstrual bleeding.

      Patients with GPS and members of their family with GPS may be eligible for this study.
      Participants will provide a personal and family medical history and will have blood drawn.
      About 1 to 2 tablespoons of blood will be drawn in adults, and about 1 teaspoon in children.
      The blood will be analyzed for genes that cause GPS
    

Detailed description: 
      Patients with Gray Platelet Syndrome (GPS) and their unaffected family members will be
      studied to identify the gene(s) involved in GPS using linkage analysis and gene mapping
      strategies. Up to 200 individual members of GPS families will be investigated to identify
      candidate regions of the human genome, which will be further studied using fine mapping and
      sequence analysis. Characterization of gene(s) involved in GPS could provide important
      insight into the mechanisms of vesicle formation and protein sorting in human cells.
    

Keywords: Gene Identification; Linkage Analysis; Homozygosity Mapping; Gray Platelet Syndrome; GPS; Platelet Function Defect; Bleeding Disorder
Injection Site Study In Patients With Type 2 Diabetes Mellitus (T2DM) And Healthy Volunteers
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 1

Summary: 
      This study is an open-label study in healthy volunteers and in patients with Type 2 Diabetes
      Mellitus to assess safety and tolerability parameters, the levels of GSK716155 in the
      bloodstream after a single dose given at different injection sites, and the impact this
      medication has on various substances in the blood. Assessments include ECGs, vital signs,
      repeat blood sampling and monitoring of any side effects.
    

Detailed description: 
      An Open-Label, Randomized, Multi-Site Study to Assess the Pharmacokinetics of Single
      Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered at Three Different
      Injection Sites in Adult Male and Female Subjects with Type 2 Diabetes and of Single
      Subcutaneous Injections of 16mg and 64mg of GSK716155 Administered in the Abdomen of Healthy,
      Normal Volunteers
    

Intervention name(s): GSK716155 subcutaneous injections
Intervention type(s): Drug
Intervention description(s): GSK716155 will be available as lyophilize uniform cake in 10 milliliter (mL) clear glass vials with 20 millimeter (mm) closure. Subjects will administer dose of either 16mg or 64mg of GSK716155 via subcutaneous injection(s). For dose of 16 mg 1 injection of 0.62 mL will be administered and for dose of 64 mg 3 injections of 0.82 mL each will be administered.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: GSK716155 pharmacodynamics pharmacokinetics injection site