louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03163134: Lumbar Drain After Endoscopic Surgery of the Skull Base
Official title: Lumbar Drain After Endoscopic Surgery of the Skull Base
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Quality of Life
Keywords: Lumbar Drain, CSF Leak
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2017-05-22
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The overall purpose of this study was to assess the necessity of lumbar drain placement after endoscopic endonasal approach (EEA) surgery in reducing cerebrospinal fluid (CSF) leak postoperatively and promote a standardization of its use.

Detailed description: In the past, reconstructions were performed using fat grafts or fascia lata for EEA surgery. Considerably high postoperative CSF leaks were reported and were a major cause of concern due CSF fistula increasing risk of infection. Since external lumbar drain can lower CSF pressure and is believed to prevent post operative CSF leak, it was used commonly after EEA. With improvements in EEA skull base reconstructions using a nasal septal flap in the recent years, postoperative CSF leaks have been reported in much lower rates. With this improvement in reconstruction techniques, the use of lumbar drain may not be necessary as it may not significantly lower the risk of CSF leak further. In this prospective randomized study, we will randomize subjects at high risk for CSF leak to either receive a prophylactic lumbar drain or to not receive a prophylactic lumbar drain and compare the rate of CSF leaks and other complications in the two groups.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Patients undergoing EEA for resection of brain tumors
* Dural defect greater than 1cm
* Extensive arachnoid dissection
* Dissection into a ventricle or cistern

Exclusion Criteria:

* Less than 18 years of age
* Spina Bifida

Primary outcomes:
measure: Number of Participants With Cerebrospinal Fluid (CSF) Leak
timeFrame: 1month
Secondary outcomes:
measure: Number of Participants With Postoperative Complications
timeFrame: 1 year
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh Medical Center
name: Paul Gardner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zwagerman NT, Wang EW, Shin SS, Chang YF, Fernandez-Miranda JC, Snyderman CH, Gardner PA. Does lumbar drainage reduce postoperative cerebrospinal fluid leak after endoscopic endonasal skull base surgery? A prospective, randomized controlled trial. J Neurosurg. 2018 Oct 19;131(4):1172-1178. doi: 10.3171/2018.4.JNS172447. Print 2019 Oct 1.
Clinical trial NCT00820534: A Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers
Official title: A Randomised, Double-blind, Vehicle Controlled, Single Center, Parallel Group, Comparative Study of the Efficacy of Penciclovir 10mg/g (1%) Cream in Preventing the Appearance of Classical Lesion in Recurrent Cold Sore Sufferers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cold Sore
Keywords: cold sore
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2009-01-12
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Comparison of the efficacy of penciclovir 10 mg/g (1%) cream with that of vehicle at 72 hours in preventing the appearance of classical lesions following prodromal symptoms (tingling or burning sensation) based on thermographic assessment among recurrent cold sore sufferers.


Eligibility criteria: Inclusion Criteria:

* Be known to be a cold sore sufferer and presenting a prodromal stage with pain
* Sign the written informed consent form prior to enrolment in the trial;
* Be aged 18 to 75 years;

Exclusion Criteria:

* If female, are pregnant, planning pregnancy or lactating;
* Have a known hypersensitivity to penciclovir or any ingredients of the vehicle;
* Have already ongoing classical cold sore lesions at the baseline visit;
* Have taken any cold sore product, analgesic or NSAID in the 24 hours before the baseline visit;
* Have applied a cosmetic lip balm on their lips in the 12 hours before the baseline thermographic assessment;
* Are known to be immunosuppressed (acquired, congenital or therapeutic);
* Have been involved in any investigational protocol within the 30 days prior to the trial;
* Have evidence or history of drug or alcohol abuse;

Primary outcomes:
measure: Clinical Assessment Performed by the Investigator and Skin Temperature at the Cold Sore.
timeFrame: 72 hours
Secondary outcomes:
measure: Size of the Cold Sore
timeFrame: 72 hours
Other outcomes:
Locations:
city: Belfast
country: United Kingdom
facility: Belfast Health and Social Care Trust, Royal Victoria Hospital
Study officials:
affiliation: Principal Investigator
name: Philip Lamey
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05657834: Open-label Study of the Absorption, Metabolism, and Excretion of [14C]TVB-2640 Following a Single Oral Dose in Healthy Male Subjects
Official title: A Phase I, Open-label Study of the Absorption, Metabolism, and Excretion of [14C]-TVB-2640 Following a Single Oral Dose in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Absorption
Metabolism
Excretion
Radiolabeled Dose
Mass Balance [14C]
Lead sponsor: Sagimet Biosciences Inc.
Sponsor class: INDUSTRY
First posted: 2022-12-20
Enrollment: 8
Sex: MALE
Minimum age (years): 19
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of \[14C\]TVB-2640 healthy male subjects.


Eligibility criteria: Key Inclusion Criteria:

* Males, of any race, between 19 and 55 years of age, inclusive.
* In good health, determined by no clinically significant findings from medical history, physical examination, 12-lead ECG, vital sign measurements, and clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[eg, suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable) at Screening and Check-in as assessed by the Investigator (or designee).
* History of a minimum of 1 bowel movement per day

Key Exclusion Criteria:

* Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the Investigator (or designee).
* History of corneal edema, keratitis, xerophthalmia (dry eye), or other corneal abnormalities.
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (cholecystectomy will not be allowed; uncomplicated appendectomy and hernia repair will be allowed).
* Presence of any other condition (including surgery) known to interfere with the absorption, distribution, metabolism, or excretion of medicines.
* Use of any sensitive substrates of cytochrome P450 (CYP)2C9 or CYP3A4/5, or inhibitors of CYP3A4 within 30 days prior to IMP administration (Day 1).
* Donation or loss of ≥ 550 mL blood from 3 months prior to Screening, plasma from 2 weeks prior to Screening, or platelets from 6 weeks prior to Screening.

Primary outcomes:
measure: [14C]TVB-2640: AUC-inf in plasma
timeFrame: Up to 22 days
measure: [14C]TVB-2640: Amount excreted in urine
timeFrame: Up to 22 days
measure: [14C]TVB-2640: Amount excreted in feces
timeFrame: Up to 22 days
Secondary outcomes:
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion Inc.
state: Nebraska
Study officials:
References:
Clinical trial NCT02665234: A Safety and Efficacy Study of Tavilermide (MIM-D3) Ophthalmic Solution for the Treatment of Dry Eye Disease
Official title: A Safety and Efficacy Study of Tavilermide Ophthalmic Solution for the Treatment of Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Keratoconjunctivitis Sicca
Keywords: Dry Eye
Lead sponsor: Mimetogen Pharmaceuticals USA, Inc.
Sponsor class: INDUSTRY
First posted: 2016-01-27
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of Tavilermide Ophthalmic Solution compared with Placebo Ophthalmic Solution in treating the signs and symptoms of dry eye disease.


Eligibility criteria: Inclusion Criteria:

* Be at least 18 years of age.
* Provided written informed consent.
* Have a reported history of dry eye Have a history of use or desire to use eye drops for dry eye

Exclusion Criteria:

* Be diagnosed with an ongoing ocular infection (bacterial, viral, or fungal) at Visit 1.
* Be diagnosed with ocular rosacea, or any viral or bacterial disease of the cornea or conjunctiva, within the last 12 months.
* Have any planned ocular and/or lid surgeries over the study period.
* Have corrected visual acuity greater than or equal to +0.7 as assessed by Early Treatment of Diabetic Retinopathy Study (ETDRS) scale in both eyes at Visit .
* Have an uncontrolled systemic disease.
* Be a woman who is pregnant, nursing or planning a pregnancy.
* Be a woman of childbearing potential who is not using an acceptable means of birth control
* Have a known allergy and/or sensitivity to the test article or its components.
* Have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
* Be currently enrolled in an investigational drug or device study or have used an investigational drug or device within 45 days of Visit 1 Be unable or unwilling to follow instructions, including participation in all study assessments and visits

Primary outcomes:
measure: Total Corneal Fluorescein Staining Using The Ora Calibra Scale
timeFrame: Day 57
measure: Ocular Discomfort Using The Ora Calibra Scale
timeFrame: Day 57
Secondary outcomes:
measure: Total Corneal Fluorescein Staining Using The Ora Calibra Scale
timeFrame: Day 15
measure: Ocular Surface Disease Index
timeFrame: Day 57
measure: Ocular Dryness Using The Ora Calibra Scale
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Torrance
country: United States
facility: MIM-726 Investigational Site
state: California
Study officials:
affiliation: Mimetogen Pharmaceuticals USA, Inc.
name: Garth Cumberlidge, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03745534: Cochlear Implantation After Gamma Knife Radiosurgery with EABR and Correlation to Postoperative Hearing Results - a Pilot Study
Official title: Cochlear Implantation After Gamma Knife Radiosurgery with EABR and Correlation to Postoperative Hearing Results - a Pilot Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Vestibular Schwannoma
Hearing Loss
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2018-11-19
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients after radio surgery for vestibular schwannoma undergoing cochlear implantation

Brief summary: Patients undergoing cochlear implantation after radio surgery for vestibular schwannoma will be included in the study. Patients will undergo preoperative and intraoperative eABR measurement. Correlations to postoperative hearing results will be drawn.

Detailed description: Patients treated with radio surgery for vestibular schwannoma often suffer from hearing loss. Especially when the contralateral side has progressive hearing loss assessment if cochlear implantation is feasible, should be carried out. Patients undergo extensive audiometric testing. Additionally, patients will undergo preoperative eABR. Intraoperatively eABR is carried out and cochlear implantation is performed. The eABR results will be correlated with postoperative hearing. EABR measurements are not part of the study. The results of eBAR will be categorized in three groups (good response, weak response and no response). The eABR results will then be correlated to speech understanding with cochlear implants measured with Freiburger monosyllables test.

Eligibility criteria: Inclusion Criteria:

* Patients who have undergone radio surgery for vestibular schwannoma
* Patients wanting cochlear implantation for hearing rehabilitation

Exclusion Criteria:

* Patients not wanting to participate in the study

Primary outcomes:
measure: eABR correlation
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: AKH; MUW
Study officials:
References:
Clinical trial NCT05852834: Using YouTube to Learn Anatomy: Perspectives of Mexican Medical Students
Official title: Using YouTube to Learn Anatomy: Perspectives of Mexican Medical Students
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Learning Techniques
Lead sponsor: Universidad Nacional Autonoma de Mexico
Sponsor class: OTHER
First posted: 2023-05-10
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Students of medicine in mexico

Brief summary: The study is aimed at exploring the popularity, impact, and usefulness of using YouTube in learning anatomy as perceived by Mexican medical students studying at different universities along the country


Eligibility criteria: Inclusion Criteria:

* Student of medicine

Exclusion Criteria:

* Not student of medicine

Primary outcomes:
measure: Use of Youtube
timeFrame: In the last year
Secondary outcomes:
Other outcomes:
Locations:
city: Ciudad de mexico
country: Mexico
facility: Ernesto Calderon
Study officials:
References:
Clinical trial NCT06638034: Diagnosis of Metastatic Tumors on 68Ga-FAPI-RGD PET-CT and Radioligand Therapy With 177Lu-FAPI-RGD
Official title: Diagnosis of Metastatic Tumors on 68Ga-FAPI-RGD PET-CT and Radioligand Therapy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: FAP- Expressing Positive Tumors
RGD- Expressing Positive Tumors
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2024-10-15
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: FAP and RGD are overexpressed in many tumor tissues. This study is intended to conduct preliminary clinical transformation and internal irradiation dosimetry research on 177Lu-FAPI-RGD--a new dual-targeted 177Lu therapeutic drug for the first time in the world.

Detailed description: Fibroblast activation protein (FAP) and RGD are serine peptidase on the surface of tumor associated fibroblasts. It has special biological characteristics and stable genome. They are usually not expressed or expressed at a low level in the resting tissues of normal adults, but it is highly expressed in diseases related to tissue repair and matrix reconstruction,Receptor imaging with a single target also has some limitations in clinical application. For example, not all diseased cells express a large amount of single receptor on the surface, which greatly affects the judgment of the nature of the lesion. The dual-target molecular imaging based on FAP expressed in the lesion site and integrin αvβ3 receptor highly expressed on the surface of the lesion neovascularization will overcome the above limitations and make full use of the advantages of the dual-target molecular imaging, which will greatly assist the diagnosis of malignant tumors and used to 177Lu PRRT. We'll try to assess the safety and therapeutic response to 177Lu-FAPI-RGD in patients with metastatic tumors in human.

Eligibility criteria: Inclusion Criteria:

* confirmed treated or untreated metastatic tumors patients;
* 68Ga-FAPI PET/CT and 18F-FDG PET/CT within two weeks;
* signed written consent.

Exclusion Criteria:

* pregnancy;
* breastfeeding;
* any medical condition that in the opinion of the investigator may significantly interfere with study compliance

Primary outcomes:
measure: tandarStandardized uptake value of 177Lu-TATE-RGD in normal organs and tumors.
timeFrame: through study completion, an average of half-year
measure: Adverse events collection
timeFrame: through study completion, an average of 2 months
Secondary outcomes:
measure: SUVmax, SUVmean, lesion-based analysis
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese Academy of Medical Science & Peking Union Medical College Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT04064034: ALateral Flow Assay to Detect QSOX1 Peptide in Patients With or at Risk for Pancreatic Cancer
Official title: Evaluation of the Diagnostic Potential a Lateral Flow Assay to Detect QSOX1 Peptide in Patients With or at Risk for Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pancreas Cancer
Pancreas Cyst
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2019-08-21
Enrollment: 60
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Researchers have developed a new test to measure a protein QSOX1 that is found to be elevated in subjects with pancreas cancer. Researchers are looking to use this test to compare subjects with pancreas cancer and subjects without pancreas cancer to see if this test could be used to diagnosis pancreas cancer.


Eligibility criteria: Inclusion Criteria:

* Adult patients with biopsy-proven adenocarcinoma prior to receiving any therapy such as surgery, radiation or chemotherapy.
* Patients without pancreas cancer.
* Adult patients with benign pancreas disorders such as pancreatitis with imaging within 12 months (CT, MRI, EUS) documenting no cancer.
* Healthy adults with blood specimens in an existing biobank.
* Patients with pancreatic cystic lesions.
* Adult patients undergoing clinically indicated EUS-guided FNA biopsy of pancreatic cystic lesions.

Exclusion Criteria:

* Prior treatment for pancreas cancer.
* Unable or unwilling to give consent.

Primary outcomes:
measure: Quiescin Sulfhydryl Oxidase 1 (QSOX1) in the blood
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Douglas Faigel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00912834: Study of Prevalence of Proteinuria, Urinary Tract Infection or Hematuria in Athletes
Official title: Urine Analysis in Different Types of Athletes
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Proteinuria
Keywords: hematuria
urinary tract infection
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2009-06-03
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: In some types exercise, including basketball, swimming, tract \& field, tennis, football athletes, we make a study analysis of their urine data to find any abnormality such as microhematuria, proteinuria or pyuria.

Brief summary: To understand the urine analysis of athletes

Detailed description: there maybe some genitourinary problem related to athletes, such as proteinuria, hematuria, scrotal pain, STD, etc. To explore these problems and give adequate management for them not only improved athletes' health, but also it can do their best in their exercise performance.

Eligibility criteria: Inclusion Criteria:

* proteinuria, hematuria, pyuria

Exclusion Criteria:

* bacteriuria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Chung Yin Wu
name: Chung Yin Wu, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05305534: QIAstat-Dx® BCID Plus AMR Panels Clinical Performance Study
Official title: Clinical Performance Evaluation Study of the QIAstat-Dx® BCID GN and GPF Plus AMR Panels on Positive Blood Culture and Pure Colony Isolates From Subjects With Signs and Symptoms of Bloodstream Infection
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Blood Disease
Lead sponsor: QIAGEN Gaithersburg, Inc
Sponsor class: INDUSTRY
First posted: 2022-03-31
Enrollment: 2880
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suspected of bloodstream infection

Brief summary: Study for performance evaluation of the QIAstat-Dx® BCID Plus AMR GPF-Panel and the QIAstat Dx® BCID Plus AMR GN-Panel in comparison with other chosen comparator methods

Detailed description: This multicenter study aims to evaluate the performance of QIAstat-Dx® BCID Plus AMR GPF-Panel and the QIAstat Dx® BCID Plus AMR GN-Panel with another validated comparator method.

Eligibility criteria: Inclusion Criteria:

* Positive (as identified through Gram stain) blood culture media specimens cultured within bottle types listed in IFU.
* Residual and de-identified specimens.
* Specimen from subject who has not previously been enrolled.
* Fresh prospectively collected specimens tested within 24 hours of initial blood culture bottle positivity.
* Frozen prospectively collected specimens frozen within 24 hours of initial blood culture bottle positivity.
* Minimum 1.5 mL volume available
* In stage 2 - Pure colony isolates of Bacilli, Actinobacteria, fungi (except Fusarium), Enterobacterales, Pseudomondales, Nesseriales, Pasteurellales, Bacterioidales, or Xanthomonadales.

Exclusion Criteria:

* Positive Blood Culture specimens inoculated with a sample type other than Blood (i.e. Paracentesis, or other body fluids)
* Specimens collected off-label from the manufacturer's package insert (e.g., less than the minimum required blood volume was collected).
* Frozen specimens which are unable to be cultured after thawing.
* Specimen from subject previously enrolled

Primary outcomes:
measure: PPA
timeFrame: 6 moths
measure: NPA
timeFrame: 6 moths
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: QIAGEN
Study officials:
affiliation: QIAGEN Gaithersburg, Inc
name: Sarah Johnson
role: PRINCIPAL_INVESTIGATOR
References: