bioihbjkbjnl/mcl2 huggingface dataset:
Dexamethasone Intravitreal Implant in Retinal Vein Occlusion
Condition: Macular Edema, Cystoid
MeSH terms: Macular Edema; Retinal Vein Occlusion; Edema
Study type: Observational

Summary: 
      Purpose: To evaluate retinal functional improvement by means of visual acuity and retinal
      sensibility examination after intravitreal dexamethasone implant in patients affected by
      cystoid macular edema secondary to retinal vein occlusion.
    

Detailed description: 
      Cystoid macular edema represents the most important cause of visual impairment after retinal
      vein occlusion. The etiological factors of this complication are under investigation, from
      inflammatory cytokines to the breakdown of vascular barrier with increased permeability and
      diffusion of angiogenic factors. Clinical research developed different drugs and therapeutic
      strategies to treat and control macular edema, to evaluate the correct timetable and to reach
      long-term clinical significative results. At now, different experiences have been published
      with available drugs, from steroids to anti Vascular Endothelial Growth Factor. A debate
      still remains about the correct approach, the correct combination of drugs (if necessary) and
      the correct evaluation of drug effectiveness.

      In our study, we will evaluate extensive functional recovery and its relation to macular
      thickness after steroid injection. Considering that visual acuity reflects only foveal
      function, it may not be sufficient to evaluate the overall function on the macular area. We
      introduce microperimetry study as a valuable and reproducible tool to create a functional
      mapping of the entire macula.
    

Intervention name(s): Intravitreal injection
Intervention type(s): Drug
Intervention description(s): Long term release steroid injection
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Patients affected by cystoid macular edema (CME) due to retinal vein occlusion of recent
        onset (less than three months) were enrolled
      
Keywords: steroid; retinal vein occlusion; macular edema
Safety Trial of High Dose Oral Vitamin D3 With Calcium in Multiple Sclerosis
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      Vitamin D likely plays a role in the geography of Multiple Sclerosis (MS), and patients at
      risk and with MS have relatively low Vitamin D levels compared to their normal counterparts.

      This trial examines the safety of high dose oral Vitamin D3 titrated up to a maximum of
      40,000 IU per day over a 12 month period. Fifty patients matched for MS and non-MS
      characteristics will be divided into two groups: one group receiving the high dose Vitamin D
      regimen, and the other restricted to a maximum of 4000 IU per day. The hypothesis is that
      patients with MS can tolerate seemingly high doses of Vitamin D3 without adverse events
      and/or calcium-related abnormalities. It is also hypothesized that those receiving the higher
      doses will demonstrate improved relapse and disability status compared to controls, and that
      the treatment group will show improved markers of bone health and immune indicators of
      reduced inflammation.
    


Intervention name(s): Vitamin D3; Vitamin D3
Intervention type(s): Dietary Supplement; Dietary Supplement
Intervention MeSH terms: Vitamin D; Ergocalciferols; Cholecalciferol; Vitamins
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Multiple Sclerosis; Vitamin D; Safety
Antibiotic Therapy and Antacids in Patients With Malt Lymphoma of the Stomach
Condition: Lymphoma
MeSH terms: Lymphoma; Lymphoma, B-Cell, Marginal Zone
Study type: Interventional
Phase: Phase 2

Summary: 
      RATIONALE: Antibiotic therapy and antacids are used to treat Helicobacter pylori infection of
      the stomach. These treatments may also have an effect on gastric MALT lymphoma of the
      stomach.

      PURPOSE: Phase II trial to study the effectiveness of antibiotic therapy with amoxicillin,
      clarithromycin, tetracycline, and metronidazole plus antacids in patients with MALT lymphoma
      of the stomach.
    

Detailed description: 
      OBJECTIVES: I. Evaluate the response of gastric lymphoma of mucosa-associated lymphoid tissue
      (MALT) to treatment for Helicobacter pylori infection with antibiotics (amoxicillin,
      clarithromycin, tetracycline, and metronidazole) and with gastric acid inhibitors (omeprazole
      and bismuth subsalicylate). II. Correlate response with endoscopic tumor grade and clinical
      and pathological parameters. III. Assess the incidence of H. pylori infection in patients
      with gastric MALT lymphoma.

      OUTLINE: All patients are treated on Regimen A; those receiving tetracycline on Regimen A are
      switched to Regimen B for their second course; those receiving amoxicillin for their first
      course receive tetracycline for their second course. Regimen A: Antibiotic Therapy with
      Gastric Acid Inhibition. Amoxicillin (or Tetracycline in penicillin-allergic patients);
      Clarithromycin; with Bismuth Subsalicylate; Omeprazole. Regimen B: Antibiotic Therapy with
      Gastric Acid Inhibition. Tetracycline; Metronidazole, METRO, NSC-50364; with Bismuth
      Subsalicylate; Omeprazole.

      PROJECTED ACCRUAL: 75 patients will be entered over 3 years.
    

Intervention name(s): Amoxicillin; Bismuth Subsalicylate; Clarithromycin; Metronidazole Hydrochloride; Omeprazole; Tetracycline Hydrochloride
Intervention type(s): Drug; Drug; Drug; Drug; Drug; Drug
Intervention MeSH terms: Amoxicillin; Metronidazole; Clarithromycin; Tetracycline; Omeprazole; Bismuth; Bismuth subsalicylate
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Antibiotic Treatment; Gastric Malt Lymphoma; stage I marginal zone lymphoma; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
Safety and Tolerability of AFFITOPE AD03
Condition: Alzheimer's Disease
MeSH terms: Alzheimer Disease
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a randomized, controlled, parallel group, patient-blinded, single-center, phase I
      pilot study to assess tolerability and safety of repeated subcutaneous administration of a
      single-dose of AFFITOPE AD03 applied with or without adjuvant to patients with mild to
      moderate Alzheimer's disease.
    


Intervention name(s): AFFITOPE AD03; AFFITOPE AD03 + Alum
Intervention type(s): Biological; Biological
Intervention description(s): s.c. injection; s.c. injection
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Treatment
A Multiple Dose Study to Assess the Safety, Tolerability and PK of Risperidone Extended Release Capsules
Condition: Schizophrenia Schizoaffective
MeSH terms: Schizophrenia
Study type: Interventional
Phase: Phase 2

Summary: 
      Lyndra is developing an oral, extended release (ER) formulation of risperidone (LYN-005)
      presented in a capsule dosage form with the intent of reducing the frequency of dosing
      orally-administered medications to once weekly or less and thereby improving the management
      of schizophrenia.

      Study LYN-005-C-004 will evaluate the safety, tolerability, and pharmacokinetics (PK) of
      multiple dose administration of the ER formulation at two dose levels of LYN-005 relative to
      IR risperidone.
    

Detailed description: 
      LYN-005-C-004 is a blinded, multiple-dose, randomized, parallel group, safety, tolerability
      and PK study of LYN-005 in subjects with a primary diagnosis of schizophrenia or
      schizoaffective disorder in general good health. Eligible subjects must be clinically stable
      and receiving a therapeutic dose of an approved oral antipsychotic drug for a minimum of 6
      weeks at the time of Screening. Enrolled subjects will be evaluated under steady-state
      conditions on commercially-available IR risperidone tablets and then assigned in blinded
      fashion either to LYN-005 weekly or continued encapsulated IR risperidone daily for 3 weeks
      to attain (or continue) steady-state exposure.
    

Intervention name(s): LYN-005
Intervention type(s): Drug
Intervention description(s): LYN-005 (14 or 28 mg weekly) plus IR risperidone matched placebo.
Other intervention name(s): Risperidone
Intervention MeSH terms: Risperidone
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: LYN-005-C-004 was a blinded, multiple-dose, randomized, parallel group, safety, tolerability and PK study of LYN-005 in subjects with a primary diagnosis of schizophrenia or schizoaffective disorder in general good health. Eligible subjects were clinically stable and receiving a therapeutic dose of an approved oral antipsychotic drug for a minimum of 6 weeks at the time of Screening. Enrolled subjects were evaluated under steady-state conditions on commercially-available IR risperidone tablets and then assigned in blinded fashion either to LYN-005 weekly or continued encapsulated IR risperidone daily for 3 weeks to attain (or continue) steady-state exposure.
Masking: Double (Participant, Care Provider)
Primary purpose: Treatment
A Multi-Center Trial of Botox for Severe Urge Urinary Incontinence
Condition: Urinary Incontinence
MeSH terms: Urinary Incontinence; Enuresis; Urinary Incontinence, Urge
Study type: Interventional

Summary: 
      The purpose of the study is to determine how effective Botox is in reducing the amount of
      urine leaked and which dose of Botox is more effective and safe in those who have urinary
      urge incontinence.
    

Detailed description: 
      A multi-center clinical trial of Botulinum-A Toxin (Botox) for refractory urge incontinence.
    

Intervention name(s): Botox; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Injected; Injected
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Safety and Feasibility of TachoSil®: Application on Esophageal Anastomoses
Condition: Esophageal Disease; Gastric Disease
MeSH terms: Esophageal Diseases; Stomach Diseases
Study type: Interventional

Summary: 
      Rationale: The construction of esophageal anastomoses is associated with considerable risk at
      postoperative anastomotic leakage. Application of TachoSil®, a tissue sealant with human
      fibrinogen and thrombin, can improve strength of the esophageal anastomosis and potentially
      prevent anastomotic leakage.

      Objective: Evaluation of feasibility and safety of TachoSil® application on esophageal
      anastomoses.

      Study design: Non-randomized, non-blinded, single-center intervention study. Study
      population: Patients, 18-80 years old, undergoing an elective total gastrectomy with an
      esophago-jejunostomy or esophagectomy with a planned esophagogastric anastomosis will be
      enrolled. A total number of 15 patients will be included in the study.

      Intervention: Gastric or esophageal resection will be executed according to the common
      procedures used in the UMC Utrecht. After construction of the esophageal anastomosis, all
      enrolled participants will receive a TachoSil® patch, which will be applied on the esophageal
      anastomosis intra-operatively. Hence, TachoSil® is used as an add-on therapy. TachoSil® will
      be degraded enzymatically in a period of approximately 24 weeks after application.

      Main study parameters/endpoints: The primary endpoint is feasibility, which is assessed by
      evaluation of adherence of the patch. A time-action analysis of the application of the
      Tachosil patch will be performed.

      Nature and extent of the burden associated with participation: The burden for the patient is
      minimal. The total surgical procedure will be prolonged with 10-15 minutes. Postoperative
      care and outpatient visits do not differ from regular protocol. TachoSil® is approved and
      registered for supportive treatment in surgery for improvement of haemostasis and to promote
      tissue sealing by the European Commission.
    


Intervention name(s): Tachosil patch
Intervention type(s): Drug
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Esophagus; Stomach; Resection; Esophageal disease requiring surgery; Gastric disease requiring surgery
The Effects of Health Education in Cardiovascular Diseases Prevention and Treatment
Condition: Cardiovascular Diseases
MeSH terms: Cardiovascular Diseases
Study type: Interventional

Summary: 
      The purpose of this study is to evaluate the effects of health education given by nurse on
      out-patient compliance in cardiovascular diseases prevention and treatment.
    


Intervention name(s): no intervention; health education
Intervention type(s): Other; Other
Intervention description(s): no intervention; 15 minutes health education given by nurse according to " The Chinese Resident Meals Guide " , "National Revision Committee of the Guidelines of Hypertension Prevention and Control in 2005" , " Guidelines on Prevention and Treatment of Blood Lipid Abnormality in Chinese Adults " , " Guideline for diagnosis and treatment of patients with chronic stable angina "," Guideline for prevention and treatment overweight and obesity in chinese adults "
Other intervention name(s): health education given by nurse
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Keywords: Out-patient Compliance; Nurse, Heath Education; Cardiovascular Diseases; Treatment and Prevention
Effects of L-Theanine in Boys With ADHD
Condition: Attention Deficit Hyperactivity Disorder
MeSH terms: Hyperkinesis; Attention Deficit Disorder with Hyperactivity
Study type: Interventional
Phase: Phase 2

Summary: 
      This study will examine the effects of L-theanine (an amino acid found in green tea) on the
      behavior, cognitive performance and sleep quality of boys with ADHD.
    


Intervention name(s): L-theanine
Intervention type(s): Drug
Intervention description(s): This study will examine the effects of L-theanine (an amino acid found in green tea) on the behavior, cognitive performance and sleep quality of boys with ADHD.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Treatment
Keywords: ADHD; attention; insomnia; hyperactivity; anxiety
A Natural History Study of Infantile Neuroaxonal Dystrophy
Condition: Neuroaxonal Dystrophy, Infantile
MeSH terms: Neuroaxonal Dystrophies
Study type: Observational

Summary: 
      This study is a longitudinal and prospective study of the natural history of infantile
      neuroaxonal dystrophy (INAD).
    

Detailed description: 
      After obtaining informed consent, the study participants' relevant medical records will be
      collected and reviewed for this study. Next, a clinic visit will be scheduled with the
      patient's family and an observing MD/DO/MBBS from a sponsor site to confirm and clarify
      information in the medical records.

      A baseline evaluation of clinical status will also be performed during this visit to serve as
      visit one in this longitudinal, prospective natural history study. Subsequent visits will
      take place every 6 months, for up to 24 months. Key components of this prospective study at
      each visit include a neurodevelopment exam tailored for INAD, application of the CHOP-INTEND
      neurodevelopment scale, the Hammersmith infant neurological examination and the modified
      Ashworth spasticity scale as well as collection of monthly parental severity scoring and
      monthly home videos of activities of daily living (ADLs).

      Data from this study will be pooled and presented in aggregate, without identification of
      individual subjects.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Living males or females with a diagnosis of classic INAD between 18 months to 10 years of
        age.
      
Keywords: PLA2G6-related NBIA; INAD; PLA2G6
The Canadian E-PAraDiGM (Exercise Physical Activity and Diabetes Glucose Monitoring) Protocol
Condition: Walking; Seated Control
Study type: Interventional

Summary: 
      Walking is encouraged for people with type 2 diabetes but there is little evidence that
      performing a bout of walking can improve glucose control. Furthermore, it is unknown how
      participant characteristics (e.g., age, sex, medications) impact the acute glucose responses
      to walking in people with type 2 diabetes. The primary purpose of this study is to examine
      how a standardized bout of walking impacts glucose control assessed over 24 hours using
      continuous glucose monitoring. A secondary purpose is to determine whether responses are
      influenced by age, sex, and medication use.
    


Intervention name(s): Walking; Seated Control
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Walking on a treadmill at 3.5 METS for 50 minutes; Sitting for 50 minutes
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
The Effect of a Gastric Bypass on Type 2 Diabetes in the Morbidly Obese Patient
Condition: Type 2 Diabetes; Morbid Obesity
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2; Obesity, Morbid
Study type: Observational

Summary: 
      Proof of concept, of RYGBP and its capabilities to cure type 2 diabetes (DM 2) and sleep
      apnea has already been recognized in the reports on weight loss surgery.

      The investigators project aims to prove that RYGBP also recovers the beta cell function (BCF)
      Clamp tests, the gold standard for testing IS and BCF, will be performed preoperative and
      early postoperatively.

      Aims & methodology:

      Analysis of the short-term effect of gastric bypass and sleeve gastrectomy on insulin
      sensitivity and beta cell function.

      Preoperative baseline insulin sensitivity and beta cell function will be assessed with
      euglycemic and hyperglycemic clamp tests. These results will be compared with the results of
      the same tests carried out 3 weeks postoperative.

      To determine if the duodenal exclusion is causing this effect. The results of the clamp tests
      3 weeks postoperative will be compared
    


Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        type 2 diabetes patients with a BMI > 35kg/m²
      
Biospecimen description: 
      blood samples
    
Keywords: type 2 diabetes; gastric bypass; sleeve gastrectomy; clamp study; weight loss surgery
Study of Intravenous (I.V.) Iclaprim Versus Linezolid in Complicated Skin and Skin Structure Infections [cSSSI] (ASSIST-2)
Condition: Skin Diseases, Bacterial
MeSH terms: Infections; Skin Diseases, Bacterial; Skin Diseases
Study type: Interventional
Phase: Phase 3

Summary: 
      The study is now completed
    

Detailed description: 
      Primary Objective:

      The primary objective of this study is to compare the clinical cure rates of iclaprim and
      linezolid at the test of cure (TOC) visit (7 to 14 days after the end of treatment).

      Secondary Objectives:

      The secondary objectives of this study are to compare iclaprim with linezolid regarding:

        -  Clinical efficacy at the end of study medication treatment;

        -  Time to resolution of systemic and local signs and symptoms of complicated skin and skin
           structure infection (cSSSI);

        -  Clinical outcome in the microbiologically evaluable (ME) population;

        -  Bacteriologic outcome in the ME population;

        -  Bacteriologic eradication rates of Baseline (BL) pathogens;

        -  Clinical outcome in the modified intent-to-treat (MITT) population;

        -  Bacteriologic outcome in the MITT population;

        -  Baseline in vitro susceptibility of isolated pathogens in the ME population; and

        -  Safety and tolerability of iclaprim treatment.
    

Intervention name(s): Intravenous iclaprim; Intravenous linezolid
Intervention type(s): Drug; Drug
Intervention MeSH terms: Linezolid; Iclaprim
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double
Primary purpose: Treatment
Keywords: skin infection; complicated skin infection; skin structure infection; Complicated Skin and Skin Structure Infection
Surgical Management of Multiple Mucoepidermoid Carcinoma and Adenocarcinoma
Condition: Adenocarcinoma; Mucoepidermoid Carcinoma
MeSH terms: Carcinoma; Adenocarcinoma; Carcinoma, Mucoepidermoid; Mucoepidermoid Tumor
Study type: Interventional

Summary: 
      A case series of patient having mucoepidermoid carcinoma, had standard treatment protocol and
      surgeries and followup was performed and the patient postoperative quality of life and
      recurrent rate was recorded
    

Detailed description: 
      This case series presents mucoepidermoid carcinoma. Palatal mass was resected with safety
      margin then immediate opturator inserted; superficial parotidectomy was also done for parotid
      lesion sparing facial nerve. Post-operative radiotherapy was recommended by pathologist due
      to evident perineural spread. The patient is tumor free after one year follow-up.

      Clinical reports about synchronous multiple salivary tumors are very rare, consequently there
      is little known about its management and clinical presentation. Presence of one or more risk
      factor should favor expectation of multiple tumors and mandate examination of all salivary
      tissues. Each tumor should be diagnosed and treated separately according to its nature and
      extension.
    

Intervention name(s): resection of mucoeidermoid carcinoma
Intervention type(s): Procedure
Intervention description(s): Surgical resection parotid with preservation of facial nerve
Other intervention name(s): Conservative superficial partoidectomy
Intervention model: Single Group Assignment
Intervention model description: a case series was performed on 7 patients having mucoepidermoid carcinoma
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: salivary gland tumor