bioihbjkbjnl/mcl2 huggingface dataset:
C7-T1 Epidural Steroid Injections Versus Targeted Injection for Treatment of Cervical Radicular Pain
Condition: Radicular; Neuropathic, Cervical; Neck Pain
MeSH terms: Radiculopathy; Neck Pain
Study type: Interventional
Phase: Phase 4

Summary: 
      Cervical radicular pain is a common, disabling problem, occurs in 83:100,000 individuals per
      year. Symptoms are most often caused by intervertebral disc herniation (21.9%) or central or
      foraminal stenosis from spondylosis (68.4%). Patients complain of pain in the head, neck,
      scapula or arm. The diagnosis of radicular pain is made clinically by history and physical
      examination, supported by imaging studies and electrodiagnostic tests. No study has compared
      the differences in pain, medication utilization, functional outcomes, or patient satisfaction
      between interlaminar and targeted epidural injections in the cervical spine. In theory, the
      technique of targeted epidural steroid delivery with a catheter has a lower risk of
      accidental vascular trespass or disc penetration during the procedure, and far less risk of
      dural penetration or spinal cord injury at rostral levels of the cervical spinal cord as
      compared with the interlaminar technique. The investigators hypothesize that this technique
      results in superior pain control, decreased medication use, improved function and fewer
      repeat injections. This data could improve patient safety and affect the evolving treatment
      guidelines for cervical epidural injections.
    

Detailed description: 
      Cervical radicular pain is a common, painful, disabling problem, often treated by epidural
      steroid injection (ESI). Two techniques of steroid delivery into the cervical epidural space
      include the transforaminal and interlaminar approaches. We aimed to determine if the CIESI
      with versus without a catheter is associated with superior clinical outcomes at follow-up. We
      hypothesized that the use of a targeted epidural catheter technique would result in superior
      pain control, function, decreased analgesic use, and lower surgical incidence as compared to
      standard CIESI at C7-T1.
    

Intervention name(s): Triamcinolone 80mg
Intervention type(s): Drug
Intervention description(s): C7-T1 Cervical interlaminar epidural steroid injection with Triamcinolone 80mg and 1 mL 1% lidocaine. Total volume is 2 cc.
Other intervention name(s): Kenalog
Intervention MeSH terms: Triamcinolone
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
A Pharmacokinetic Study to Assess the Influence of Simultaneous CYP3A4 and P-glycoprotein Inhibition on E7080 Pharmacokinetics Following Single Dose Oral Administration of 5 mg E7080 to Healthy Volunteers
Condition: Healthy Volunteers
Study type: Interventional
Phase: Phase 1

Summary: 
      The purpose of this study is to assess the influence of simultaneous CYP3A4 and
      p-glycoprotein inhibition on lenvatinib pharmacokinetics following a single oral dose of 5 mg
      lenvatinib.
    

Detailed description: 
      This is a single-center, randomized, open-label, two-period, crossover study consisting of
      two phases: Prerandomization and Randomization. The Prerandomization Phase will have two
      periods: Screening and Baseline 1. The Randomization Phase will have two periods: Treatment
      Period 1 and Treatment Period 2 with a Baseline 2 assessment prior to Treatment Period 2. In
      the Randomization Phase, subjects will be randomized to one of two possible treatment
      sequences (placebo/ketoconazole or ketoconazole/placebo). Ketoconazole 400 mg or placebo will
      be orally administered once daily for the first four days of each treatment period. On the
      fifth day of each treatment period, in addition to ketoconazole/placebo, 5 mg lenvatinib will
      be orally administered. Ketoconazole/placebo administration will then continue for 13
      additional days. Subjects are crossed over from Treatment Period 1 to Treatment Period 2
      after a 2-week washout.
    

Intervention name(s): ketoconazole-placebo; placebo-ketoconazole
Intervention type(s): Drug; Drug
Intervention description(s): Treatment Period 1: 400 mg ketoconazole orally once daily + single oral dose of 5 mg lenvatinib on fifth day of 19-day treatment period. Treatment Period 2: Placebo orally once daily + single oral dose of 5 mg lenvatinib of fifth day on 19-day treatment period.; Treatment Period 1: Placebo orally once daily + single oral dose of 5 mg lenvatinib on fifth day of 19-day treatment period Treatment Period 2: 400 mg ketoconazole orally once daily + single oral dose of 5 mg lenvatinib on fifth day of 19-day treatment period
Other intervention name(s): E7080; E7080
Intervention MeSH terms: Ketoconazole; Lenvatinib
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Healthy Volunteers
A Phase 1 Study of ARN-6039
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis
Study type: Interventional
Phase: Phase 1

Summary: 
      This Phase 1 study intends to determine the safety and tolerability of ARN-6039 in healthy
      subjects.
    

Detailed description: 
      To determine the safety and tolerability in healthy subjects, ARN-6039 will be dosed in a
      single-center, randomized, double-blind, placebo-controlled, ascending dose study. Five
      cohorts of 10 subjects will be dosed in ascending order, beginning with a single dose of 50
      mg of ARN-6039. Subsequent cohorts will be administered single doses of 100 mg, 150 mg, 200
      mg, or 300 mg. Safety, tolerability, and pharmacokinetics will be evaluated prior to each
      dose escalation using the assessment of all available safety and pharmacokinetic data.

      In Cohorts 1 through 4, subjects will receive a single dose of ARN-6039 or matching placebo
      under fasted conditions. In Cohort 5, subjects will be administered a single dose of ARN-6039
      or a single dose of matching placebo under fasted conditions in Period 1 and under fed
      conditions in Period 2 with a minimum 5-day washout period between each dose.

      To support the administration of ARN-6039 in humans, preclinical toxicology studies performed
      in rats and dogs demonstrated tolerability exceeding the intended therapeutic dose. In
      addition, the safety and efficacy of ARN-6039 has been demonstrated in model systems and is
      anticipated to be well tolerated in humans. This study will be the first administration of
      ARN-6039 in human subjects.
    

Intervention name(s): ARN-6039; Placebo
Intervention type(s): Drug; Other
Intervention description(s): Ascending doses per Cohort; Placebo to match ARN-6039
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Determine safety and tolerability of ARN-6039 ascending doses compared to placebo
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Health Services Research
Safety, Reactogenicity and Immunogenicity of Vi-DT;Typhoid Conjugate Vaccine
Condition: Typhoid
MeSH terms: Typhoid Fever
Study type: Interventional
Phase: Phase 2

Summary: 
      This is a randomized, observer-blinded Phase 2 study in healthy infants and toddlers 6-23
      months of age at the time of the first vaccine dose.

      The purpose of this study is to assess the safety and immunogenicity of the Vi-DT vaccine in
      age group 6-23months of age.

      The Vi-DT vaccine is administered at 25 µg either as a single dose, or two doses given 6
      months apart.
    

Detailed description: 
      This study is carried out in healthy children aged 6 to 23 months at a single site. A total
      of 285 participants are enrolled, 114, 114 and 57 participants are randomized to either the
      single dose, two-dose Vi-DT regimens or placebo/comparator group, respectively within age
      strata. Three age strata is 6 to less than 9 months, 9 to 12 months and 13 to 23 months. The
      investigators allow the 9-12 months old children to receive Measles-Mumps-Rubella (MMR)
      vaccine concomitantly with Vi-DT vaccine and descriptive analysis of immune response to MMR
      only and to MMR and Vi-DT vaccines are performed to assess the possible immunological
      interference with MMR vaccine.
    

Intervention name(s): Vi-DT; FluQuadri™; 0.9% sodium chloride isotonic solution
Intervention type(s): Biological; Biological; Other
Intervention description(s): Manufacturer: SK Bioscience Co., Ltd. Ingredient: Purified Vi-polysaccharide conjugated to diphtheria toxoid Dose: 0.5 mL/Vial; Manufacturer: Sanofi Pasteur Dose: 0.25 ml
*Participants who have not been vaccinated for flu before, will receive a second dose of flu-vaccine after unblinding.; Manufacture: Euro-Med Inc. Dose: 0.5 mL
Other intervention name(s): Vi-DT typhoid conjugate vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants age 6-23 months
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Typhoid; Vi-DT; Conjugate vaccine; First in human; New vaccine
Safety and Mode of Action of a Single Dose and Multiple Doses of Long Acting Activated Recombinant Human Factor VII in Patients With Haemophilia A and B
Condition: Congenital Bleeding Disorder; Haemophilia A; Haemophilia B
MeSH terms: Hemostatic Disorders; Hemophilia A; Hemophilia B; Blood Coagulation Disorders
Study type: Interventional
Phase: Phase 1

Summary: 
      This trial is conducted in Europe. The aim of this clinical trial is to investigate the
      safety and pharmacokinetics (the effect of the body on the investigated drug) of long acting
      activated recombinant human factor VII (LA-rFVIIa) in patients with haemophilia.
    


Intervention name(s): activated recombinant human factor VII, long acting; activated recombinant human factor VII, long acting
Intervention type(s): Drug; Drug
Intervention description(s): Single dose of 0,2 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration; Multiple doses of 100 mg/kg LA-rFVIIa injected i.v. (intravenous) of 2 minutes duration every 48 hours
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Dark Halo and MNV: a Study Between ICGA and OCTA
Condition: Macular Neovascularisation
MeSH terms: Retinal Neovascularization; Neovascularization, Pathologic
Study type: Observational

Summary: 
      The aim of study is to compare the evaluation of dark halo area of macular neovascularization
      (MNV) between indocyanine green angiography (ICGA) and optical coherence tomography
      angiography (OCTA) in order to identify OCTA as effective and useful biomarker in MNV
    

Detailed description: 
      Dark halo is defined as a dark perilesional of flow decrease due to an area of reduced
      choroidal flow adjacent to the macular neovascularization (MNV).

      The detection of MNV vascular details was only possible through invasive dye injection, such
      as fluorescein angiography (FA) or indocyanine green angiography (ICGA).

      Optical coherence tomography angiography (OCTA) is a recent imaging technique that is able to
      detect the perfusion and non-perfusion areas carefully.

      The aim of study is to compare the evaluation of dark halo area of MNV between ICGA and OCTA
    

Intervention name(s): Optical Coherence Tomography Angiography (OCTA) and indocyanine green angiography (ICGA)
Intervention type(s): Diagnostic Test
Intervention description(s): OCTA and ICGA is able to detect the dark halo as a area of reduced perfusion around MVN
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        A group of patients affected by MNV is subjected to OCTA and ICGA analysis in order to
        evaluate which of two methods is able to detect in a peculiar way the dark halo around the
        MNV
Early Vitrectomy for Endophthalmitis After Cataract Surgery
Condition: Endophthalmitis; Cataract; Vitreous Detachment; Retinal Detachment
MeSH terms: Endophthalmitis; Cataract; Retinal Detachment; Capsule Opacification; Vitreous Detachment; Dissociative Disorders
Study type: Observational

Summary: 
      Post-operative infectious endophthalmitis is devastating condition that causes a diffuse
      intraocular inflammation and may lead to blindness. Acute post-operative endophthalmitis
      usually presented within 6 weeks of intraocular procedure and diagnosis is confirmed by
      clinical examination and by the aid of B-scan ultrasonography.
    

Detailed description: 
      There is no consensus regarding the timing of vitrectomy in cases with endophthalmitis after
      cataract surgery. The Endophthalmitis Vitrectomy Study concluded that vitrectomy should be
      preserved for cases with only light perception. The advances in posterior segment machines
      and small gauge cannulas decrease the incidence of intra-operative complications and
      encourage for early intervention in cases with endophthalmitis after primary cataract
      surgery.
    

Intervention name(s): Early 23-gauge pars-plana vitrectomy
Intervention type(s): Procedure
Intervention description(s): pars-plana vitrectomy for management of acute post-operative endophthalmitis.
Observational model: Case-Only
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Patients that were diagnosed as acute post-operative endophthalmitis at ophthalmology
        department, Benha University Hospital, EGYPT.
      
Keywords: endophthalmitis; cataract; vitrectomy; retinal detachment
Study of Etoposide, Cisplatin, and Radiotherapy Versus Paclitaxel, Carboplatin and Radiotherapy to Treat Non-Small Cell Lung Cancer
Condition: Non-Small Cell Lung Cancer
MeSH terms: Lung Neoplasms; Carcinoma, Non-Small-Cell Lung
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      Cisplatin-based combination chemotherapy given concurrently with radiotherapy is the standard
      of care for patients with inoperable stage III NSCLC. The most common chemotherapeutic agents
      used concurrently with radiotherapy have been vinorelbine, vinblastine, and etoposide in
      conjunction with cisplatin or weekly paclitaxel and carboplatin. No randomized phase III
      trials of concurrent chemoradiotherapy have shown the superiority of one chemotherapy regimen
      over another. The clinical trial is to compare radiotherapy concurrently with PE (etoposide
      and cisplatin) and PC (paclitaxel and carbplatin) for local advanced NSCLC (stage IIIA/IIIB).
      It is a randomized, multicenter, open labeled phase III clinical trial. All patients receive
      conformal radiotherapy or intensity modulated radiotherapy with conventional fraction. The
      chemotherapy regimens are PE (etoposide 50mg/m2 d1-5, 29-33 and cisplatin 50mg/m2 d1,8,29 and
      36 29-33 ) and PC (paclitaxel 45mg/m2 weekly over 1hour and carbplatin AUC =2mg/mL/min over
      30min weekly). The primary purpose is to evaluate objective response rate, complications,
      progression-free survival, overall survival. The second purpose is to evaluate quality of
      life and cost.
    


Intervention name(s): Chemoradiotherapy Regimen between PC and PE
Intervention type(s): Other
Intervention description(s): etoposide 50mg/m2 d1-5, 29-33 and cisplatin 50mg/m2 d1,8,29 and 36 29-33 during radiotherapy paclitaxel 45mg/m2 weekly and carbplatin AUC =2mg/mL/min weekly during radiotherapy
Other intervention name(s): Chemoradiotherapy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Overall survival
Norethindrone for the Delay of Menstruation
Condition: Menstrual Flow Altered
Study type: Interventional
Phase: Phase 4

Summary: 
      Comparison of oral contraceptive pills versus norethindrone to delay menstuation.
    

Detailed description: 
      Many women ask the OBGYN for help in delaying a poorly timed period in order to participate
      in events that menstruation would normally interfere with. While most OBGYNs prescribe
      combined oral contraceptives for this purpose, this method often results in unpredictable
      spotting, especially at the beginning of therapy. Norethindrone, a progesterone agonist,
      inhibits ovulation through its antagonistic effect at the anterior pituitary, preventing the
      release of LH. Additionally, it thickens cervical mucus to inhibit sperm migration into the
      uterine cavity . Norethindrone downregulates estrogen receptors on the endometrium lining
      preventing endometrial proliferation, enhancing glandular secretion, and maintaining
      endometrium integrity. Therefore, norethindrone is well suited in preventing the endometrium
      from breakdown and preventing menstrual bleeding. Indeed, many OBGYNs have consistently used
      it for this purpose in women who desire to remain fertile. The intention of our study was to
      compare norethindrone to birth control pills in order to determine the effectiveness at
      suppressing bleeding and spotting, compare side effect profiles and to find a method allowing
      women to freely and comfortably participate in their life events.

      OBJECTIVES:

        1. Determine if norethindrone can delay menstruation without breakthrough bleeding

        2. Compare norethindrone with oral contraceptive pills for delaying menstruation

        3. Compare patient satisfaction of each method

        4. Compare side effect profiles of each method
    

Intervention name(s): Norethindrone; oral contraceptive pill
Intervention type(s): Drug; Drug
Intervention description(s): Women desiring to postpone their periods may be randomized to norethindrone 5mg three times daily.; Women desiring to postpone their periods may be randomized to daily oral contraceptive pills.
Other intervention name(s): (Aygestin); Combined oral contraceptive pill
Intervention MeSH terms: Contraceptive Agents; Norethindrone; Norethindrone Acetate; Contraceptives, Oral; Contraceptives, Oral, Combined
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomized to receive oral contraceptive pills or norethindrone
Masking: Single (Investigator)
Primary purpose: Prevention
Keywords: norethindrone
GLP-1 Response in Women With PCOS and Prediabetes
Condition: Incretin Hormones in PCOS With Prediabetes
MeSH terms: Prediabetic State; Glucose Intolerance
Study type: Interventional

Summary: 
      Women with PCOS are more prone to obesity which exacerbates insulin resistance, the abdominal
      fat disposition and metabolic risk of these patients. With development of obesity these women
      have high conversion rate from normal glucose tolerance to impaired glucose tolerance and in
      turn to type 2 diabetes.

      Glucagon-like peptide 1 (GLP-1) is involved in body weight maintenance. Beside energy balance
      it is also involved in glucose homeostasis. Functional deficit in GLP-1 facilitates obesity.
      We investigated the link between the concentration of incretin hormones and glucose
      homeostasis, metabolic complications and the distribution of body composition in obese women
      with PCOS.
    


Intervention name(s): oral glucose tolerance test
Intervention type(s): Diagnostic Test
Intervention description(s): GLP1 response to oral glucose load during oral glucose tolerance test was assessed.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Screening
ENDObesity® II Study: TransPyloric Shuttle® System for Weight Loss
Condition: Obesity
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this clinical research trial is to study safety and effectiveness of the
      TransPyloric Shuttle System (TPSS) for weight reduction in patients who are considered
      medically obese.
    


Intervention name(s): TransPyloric Shuttle; Sham procedure; Lifestyle Counseling
Intervention type(s): Device; Device; Behavioral
Intervention description(s): The goal of lifestyle modification counseling is to promote adherence to a reduced calorie diet, increased physical activity and to recommend behavioral modification strategies.
Other intervention name(s): TPS
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Obesity; Weight loss; Device; Non-surgical; Endoscopic; TransPyloric Shuttle; TPS
Surveillance Study of Viral Infections Following Lung Transplantation
Condition: Lung Transplantation; Bronchiolitis Obliterans; Epstein-Barr Virus Infections; Paramyxoviridae Infections
MeSH terms: Infections; Communicable Diseases; Virus Diseases; Bronchiolitis; Epstein-Barr Virus Infections; Paramyxoviridae Infections; Bronchiolitis Obliterans; Bronchiolitis Obliterans Syndrome
Study type: Observational

Summary: 
      The present study was conducted to study the impact community acquired respiratory virus
      (CARV) infections in an outpatient setting on graft function of lung transplant recipients.
      The study was aimed to identify risk factors for CARV infections.

      The study was further intended to investigate an association of Epstein-Barr virus (EBV),
      cytomegalovirus (CMV) and human adenovirus (HAdV) with the development of BOS and to identify
      risk factors for virus detection in blood.
    

Detailed description: 
      Informed consent was obtained from the LTx recipients and the study was approved of by the
      institutional review board of Hannover medical school.

      LTx recipients are screened for CARV infections during the cold season (end October until end
      April) in a single-centre outpatient clinic. Symptoms of upper (URTI) and lower respiratory
      tract infections (URTI) are recorded by questionnaires and findings.

      Nasopharyngeal and oropharyngeal swabs (NOS) were performed to detect RV-antigens by
      immunofluorescence testing (IFT) of respiratory-syncytial virus (RSV), adenovirus,
      parainfluenza (PIV), influenza and cultures for CARV are performed. BAL was performed when
      clinically indicated and processed by IFT. Multiplex-PCR to detect 14 CARV are processed in
      symptomatic patients.

      In addition blood samples are monitored at each contact to investigate an association of
      Epstein-Barr virus (EBV), cytomegalovirus (CMV) and human adenovirus (HAdV) with the
      development of BOS and to identify risk factors for virus detection in blood.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        lung transplant recipients in in a single-centre outpatient clinic
      
Biospecimen description: 
      Nasopharyngeal and oropharyngeal swabs

      bronchoalveolar lavage

      blood samples
    
Keywords: lung transplantation; Bronchiolitis Obliterans; Epstein-Barr Virus Infections; Paramyxoviridae Infections; Herpesviridae