louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00271778: A Comparative Study of the Outcomes of 2 Surgical Procedures for Safe Type of Chronic Otitis Media
Official title: A Randomized Control Study of the Outcomes of Mastoidotympanoplasty Versus Tympanoplasty in Quiescent Tubotympanic Otitis Media
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Chronic Otitis Media
Tubotympanic Disease
Keywords: Otitis media suppurative
surgery ear
Lead sponsor: Karnataka Institute of Medical Sciences
Sponsor class: OTHER
First posted: 2006-01-04
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Mastoidotympanoplasty is a recognised surgery that is performed for chronic otitis media. But whether mastoidectomy in addition to tympanoplasty is really necessary in each and every case of quiescent chronic otitis media still remains controversial. Hence this study has been undertaken to study the differences in the outcomes of the 2 surgical procedures performed for chronic otitis media in a randomized control design.

Detailed description: Design: single blinded randomized control study. Setting: Tertiary referral medical college hospital. Sample size: 60. No of groups: 2 \[30 cases in each group\]. Group 1: Patients undergoing mastoidotympanoplasty. Group 2: Patients undergoing tympanoplasty only. No of strata: 3.

Outcomes:

1. Improvement of hearing
2. Closure of tympanic perforation
3. Recurrence of disease
4. external ear canal stenosis

Tools for measurement of outcomes \[before and after surgery\]:

1. Pure tone audiometry
2. Impedance audiometry
3. Otoendoscopy
4. External ear canal dimensions

Eligibility criteria: Inclusion Criteria:Chronic tubotympanic otitis media in quiescent phase with intact ossicular chain -

Exclusion Criteria:1. atticoantral otitis media 2. Specific otitis media 3. Sensorineural hearing loss 4. Fixed/Dislocated ossicular chain 5. Uncorrectable disease focus in nose/throat 6. Chronic otitis media in active phase 7. Chronic otitis media with complications 8. Extensive unresectable tympanosclerosis

-

Primary outcomes:
measure: Pure tone audiometry
measure: Impedance audiometry
measure: Otoendoscopy
measure: External ear canal dimensions
Secondary outcomes:
Other outcomes:
Locations:
city: Hubli
country: India
facility: Department of ENT, KIMS
state: Karnataka
Study officials:
affiliation: Karnataka Institute of Medical Sciences, Hubli, India
name: Vikram K Bhat, MS, DNB.
role: PRINCIPAL_INVESTIGATOR
affiliation: Vijayanagar Institute of Medical Sciences, Bellary, India
name: Khaja Naseeruddin, MS, DLO.
role: STUDY_DIRECTOR
References:
Clinical trial NCT00293878: Study on the Safety and Effects on Lipids of FM-VP4 in Subjects With Primary Hypercholesterolemia
Official title: A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study of the Safety and Effects on Lipids of 12 Weeks of 2 Doses of FM-VP4 in Subjects With Primary Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hypercholesterolemia
Lead sponsor: Forbes Medi-Tech
Sponsor class: INDUSTRY
First posted: 2006-02-20
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effects on lipids of FM-VP4 administered for 12 weeks in subjects with mild to moderate primary hypercholesterolemia.


Eligibility criteria: Inclusion Criteria:

* Mild to moderate primary hypercholesterolemia
* Able to give informed consent and to comply with study procedures (including diet)

Exclusion Criteria:

* Homozygous familial hypercholesterolemia
* Age \<18 or \>75 years
* Pregnant women or women of child-bearing potential

Primary outcomes:
measure: Percent change from baseline in LDL-C at 12 weeks
Secondary outcomes:
measure: Percent change from baseline in TC, HDL-C, TG, HDL:LDL ratio and CRP at 12 weeks
measure: Percent change from baseline in serum lipids at 2, 4 and 8 weeks
measure: Safety
Other outcomes:
Locations:
city: Mobile
country: United States
facility: Coastal Clinical Research
state: Alabama
city: San Diego
country: United States
facility: Radiant Research
state: California
city: Daytona Beach
country: United States
facility: Radiant Research
state: Florida
city: Gainesville
country: United States
facility: Radiant Research
state: Florida
city: Boise
country: United States
facility: Radiant Research
state: Idaho
city: Chicago
country: United States
facility: Radiant Research
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Institute for Clinical Research
state: Indiana
city: Lenexa
country: United States
facility: PRA International Pharmacology Center
state: Kansas
city: Kansas City
country: United States
facility: The Center for Pharmaceutical Research
state: Missouri
city: Portland
country: United States
facility: Radiant Research
state: Oregon
city: Mount Pleasant
country: United States
facility: Coastal Carolina Research Center
state: South Carolina
city: Austin
country: United States
facility: Radiant Research
state: Texas
city: Dallas
country: United States
facility: Research Across America
state: Texas
city: Dallas
country: United States
facility: Radiant Research
state: Texas
Study officials:
affiliation: Clinical Consultant
name: Jean Warner, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01261078: The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine
Official title: The Bupivacaine Dose Sparing Effect of Intrathecal Epinephrine for Spinal Anesthesia in Total Knee Replacement Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Anesthesia
Keywords: intrathecal epinephrine
duration of anesthesia
quality of anesthesia
intrathecal fentanyl
Lead sponsor: Seoul Medical Center
Sponsor class: OTHER
First posted: 2010-12-16
Enrollment: 75
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Intrathecal epinephrine has been known to increase the duration of spinal anesthesia, or increase the quality of anesthesia. However, there is still a controversy, and the mechanism of epinephrine is recently suggested as a modulator of pain information in the spinal cord. Therefore, the investigators try to investigate the dose sparing effect of intrathecal epinephrine for spinal anesthesia with bupivacaine.

Detailed description: For patient undergoing total knee replacement arthroplasty, patients injected intrathecally with bupivacaine 8 mg were compared with those with bupivacaine 8 mg with 25 mcg of epinephrine, bupivacaine 8 mg with 50 mcg of epinephrine, and those with bupivacaine 8 mg with 100 mcg of epinephrine. The investigators compared the characteristics of spinal anesthesia including the quality and complication of spinal anesthesia. The researchers investigated whether intrathecal dose of epinephrine can reduce bupivacaine requirement and this effect is dependent on the dose of epinephrine.

Eligibility criteria: Inclusion Criteria:

* patient undergoing total knee replacement arthroplasty

Exclusion Criteria:

* patient with cardiac or pulmonary disease (ASA class III or more)
* patient undergone previous spine surgery
* patient undergoing revised knee replacement

Primary outcomes:
measure: the sensory level of spinal anesthesia, the quality of intraoperative analgesia
timeFrame: every 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul Medical Center
Study officials:
affiliation: Seoul Medical Center
name: Won Ho Kim, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01420978: Cerebrospinal Fluid (CSF) Drainage Study
Official title: High Volume Cerebrospinal Fluid Diversion in the Management of Aneurysmal Subarachnoid Hemorrhage: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aneurysmal Subarachnoid Hemorrhage
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2011-08-22
Enrollment: 20
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: When patients suffer a subarachnoid hemorrhage (bleeding around the brain), they often develop hydrocephalus. This is an enlargement of the fluid-filled spaces (ventricles) in the brain. Standard-of-care treatment includes placing an external ventricular drain (EVD) to drain off fluid. Eventually the EVD is weaned with the goal of removing it. Occasionally a patient does not tolerate this and a permanent surgery needs to be done to internalize a shunt.

Though this is done commonly and routinely throughout the world, there are no good studies to address how to optimally set the EVD level and how fast to wean it. Most set the EVD to a level of around 15 mmHg. The investigators hypothesize that setting the EVD lower (which will allow higher volume Cerebrospinal Fluid (CSF) drainage through the EVD) will improve perfusion at the level of the microcirculation in the brain, and result in improved neurologic outcomes.


Eligibility criteria: Inclusion Criteria

* Age ≥ 18 years
* Diagnosis of acute subarachnoid hemorrhage (SAH), confirmed with noncontrast head CT
* SAH is suspected to be aneurysmal in source
* Clinical management requires placement of EVD within 2 days of suspected time of hemorrhage

Exclusion Criteria

* Age \< 18 years
* SAH of traumatic or non-aneurysmal etiology
* Patients treated with lumbar drains
* EVD placement ≥ 3 days after suspected time of hemorrhage
* Known contraindication to induction of relative intracranial hypotension (e.g. acute subdural hematoma)
* Pre-morbid mRS ≥ 3
* EVD that is suboptimally placed by CT obtained after EVD placement (i.e. EVD not in the ventricular system)

Primary outcomes:
measure: Modified Rankin Scale
timeFrame: 90-days
Secondary outcomes:
measure: Infarction
timeFrame: 90-days
measure: Vasospasm
timeFrame: 90-days
measure: Shunt placement
timeFrame: 90-days
measure: Ventriculitis
timeFrame: 90-days
measure: Modified Rankin Scale
timeFrame: Hospital discharge (average 3 weeks)
measure: MMSE
timeFrame: 90-days
measure: Length of ICU stay
timeFrame: Average 3 weeks
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Giuseppe Lanzino, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02957578: Clinical Study of Solo Tympanostomy Tube Device (TTD)
Official title: Post-Market Approval Study of the Solo Tympanostomy Tube Device
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Otitis Media
Middle Ear Effusion
Keywords: Tympanostomy Tube
Ventilation Tube
Grommet
Otitis Media
Middle Ear Effusion
Lead sponsor: Nottingham University Hospitals NHS Trust
Sponsor class: OTHER
Collaborators: name: AventaMed DAC
name: University Hospitals of Derby and Burton NHS Foundation Trust
name: Sheffield Children's NHS Foundation Trust
First posted: 2016-11-06
Enrollment: 20
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a multi-centre, single arm study to evaluate the placement of tympanostomy tubes with the AventaMed Solo Tympanostomy Tube Device (TTD)


Eligibility criteria: Basic Inclusion Criteria:

* Listed for bilateral tympanostomy tube insertion only

Basic Exclusion Criteria:

* Anatomy that precludes sufficient visualisation of both the left and right eardrum with the Solo TTD in place.
* Anatomy that precludes safe access to both the left and right eardrum with the Solo TTD
* Patients in whom a reliable audiogram is not possible

Primary outcomes:
measure: Intraoperative Device Success
timeFrame: Intraoperative
Secondary outcomes:
measure: Conversion from moderate sedation
timeFrame: Intraoperative
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
Study officials:
affiliation: Royal Derby Hospitals NHS Foundation Trust
name: Owen Judd
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheffield Children's NHS Foundation Trust
name: Tawakir Kamani
role: PRINCIPAL_INVESTIGATOR
affiliation: Nottingham University Hospitals NHS Trust
name: Matija Daniel
role: STUDY_CHAIR
affiliation: Nottingham University Hospitals NHS Trust
name: Anand Kasbekar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04843878: COVID-19 Testing Pilot Study
Official title: Feasibility Testing of a New COVID-19 Testing Platform
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diagnostic Test, Routine
Coronavirus
Diagnoses Disease
Rapid Coronavirus Test
Keywords: COVID-19
Detect
Pandemic
Symptomatic
Asymptomatic
Anterior Nares
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Benjamin S. Abella, MD, MPhil
name: Marcelo Der Torossian Torres, Ph.D.
name: Cesar De La Fuente, Ph.D.
First posted: 2021-04-14
Enrollment: 326
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited as they present for treatment at ambulatory Penn testing sites. Subjects who present with symptoms of COVID-19-like illness at the study site as defined in Inclusion Criteria below and have come to the study site for routine evaluation of their condition may be enrolled in this clinical study. Males and females aged \>17 years old may be enrolled, and should be represented in proportions representative of the population.

Brief summary: The purpose of this study is to determine the reliability of a low-cost rapid diagnostic test for COVID-19. The method of the testing procedure uses electrochemistry to detect COVID-19 spike proteins within human samples. To test the effectiveness of this new method, patients will be recruited as they present for testing at ambulatory Penn testing sites. Patients will be asked to self-collect one anterior nares samples under the supervision of authorized study personnel.


Eligibility criteria: Inclusion Criteria:

1. The subject must be an adult (age\>17) and either sex.
2. Written informed consent must be obtained prior to study enrollment.

   a. A subject who is eighteen (18) years or older must be willing to give written informed consent and must agree to comply with study procedures.
3. Subject must be able to read and write in English.

Exclusion Criteria:

1. The subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, drug, or device including either treatment or therapy.
2. The subject has previously participated in this research study.

Primary outcomes:
measure: Device Accuracy - Positive and Negative Percentage
timeFrame: 3 Months
measure: Device Accuracy - False positive and False negative percentage
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Benjamin S Abella, MD, MPhil
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03082378: Central Obesity and Hepatocellular Carcinoma
Official title: Central Obesity and the Prognosis of Hepatocellular Carcinoma After Microwave Ablation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hepatocellular Carcinoma
Obesity
Microwave Ablation
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2017-03-17
Enrollment: 200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: HCC patients are treated by ultrasound-guided percutaneous MWA

Brief summary: Recurrence and metastases after microwave ablation(MWA) of hepatocellular carcinoma(HCC) are the major factors that influence the survival. Obesity has been reported was significantly correlated with increased risk of developing HCC.

In this study, we will analysis the association of multiple obesity index(waist circumference,waist-hip ratio and body mass index) with the prognosis of HCC treated by MWA.


Eligibility criteria: Inclusion Criteria:

* absence of ascites or the depth of ascites on US detection less than 4 cm;
* a normal serum total bilirubin level or less than 60 µmol/L;
* a normal albumin level or not less than 30 g/L;
* for radical treatment, single lesion of 8 cm or smaller, three or fewer multiple lesions with a maximum diameter of 4 cm or less, absence of portal vein cancerous thrombus or extrahepatic metastases;
* for palliative treatment, those with large or multiple lesions, suffering multiple metastases and unsuitable for other modalities can be considered to undergo the MWA on the condition of good hepatic function and blood coagulation function to tolerate the procedure.

Exclusion Criteria:

1. clinical evident liver failure, such as massive ascites or hepatic encephalopathy or with a trance-like state
2. severe blood coagulation dysfunction (prothrombin time of more than 30 seconds, prothrombin activity less than 40%, and platelet count less than 30 cells×109/L)
3. high intrahepatic tumor burden (tumor volume \>70% of the target liver volume or multiple tumor nodules) or high extrahepatic tumor burden
4. acute or active inflammatory and infectious lesions at any organ
5. acute or severe chronic renal failure, pulmonary insufficiency or heart dysfunction
6. relative contraindication concerns medical risk for the tumor proximity to diaphragm, gastrointestinal tract, gallbladder, pancreas, hepatic hilum and major bile duct or vessels, which may require adjunctive techniques to prevent off-target heating of adjacent structures during the ablation procedure.

Primary outcomes:
measure: survival
timeFrame: 3 years
Secondary outcomes:
measure: intra-hepatic metastasis
timeFrame: 3 years
measure: extra-hepatic metastasis
timeFrame: 3 years
measure: local tumor progression
timeFrame: 3 years
measure: complication
timeFrame: 3 years
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
state: Beijing
Study officials:
affiliation: Chinese PLA General Hospital
name: Jie Yu, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04625478: Clinical Relevance of Intracellular Staphylococci in BOne and Joint Infections
Official title: Clinical Relevance of Intracellular Staphylococci in BOne and Joint Infections
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone and Joint Infection
Staphylococcus
Keywords: Bone and Joint Infection
Staphylococcus
intracellulare
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients having had an osteo-articular infection with Staphylococci managed at the Croix-Rousse Hospital

Brief summary: Different mechanisms have been proposed to explain the pathophysiology of chronic staphylococcal BJI, including biofilm formation and the ability of staphylococci to be internalized and to survive within cells. The intracellular localization of staphylococci is well documented by in vitro studies, however, few studies have shown the presence of intracellular staphylococci in clinical specimens from patients with BJI.

The aim of the CRISBO study is to document the clinical relevance of intracellular staphylococci in the context of BJI. Immunostaining targeting staphylococci and components will be carried out on tissue samples taken from patients with BJI during their treatment (samples similar to those used for routine diagnosis in pathology). Our objectives are to identify whether intracellular staphylococci are observable in these samples and if so, in which cell type (s) are they housed.


Eligibility criteria: Inclusion Criteria:

* patients having had an osteo-articular infection with Staphylococci

Exclusion Criteria:

-

Primary outcomes:
measure: detection of intracellular staphylococci
timeFrame: 2 months
measure: rate of localisation of intracellular staphylococci
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT05240378: Mortality of Cancer Surgery During SARS CoV2 Pandemic
Official title: Preoperative Screening for COVID-19 and Strict COVID Cancer Protocol Helps to Reduce Postoperative Infection, Mortality and Morbidity in Cancer Patients Undergoing Surgery. A Comparative Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS CoV 2 Infection
Cancer
Lead sponsor: Banaras Hindu University
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 1576
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All cases of cancer operated between April 2019 to May 2021

Brief summary: The impact of cancer surgery during covid epidemic is not clear. The published reports show contradictory findings that extend from no change in mortality to increased mortality, further no data on exposure and outcome of health care worker is available. This study is designed to address the above questions

Detailed description: This is a retrospective study from the prospectively collected data that is extracted from the electronic database of Department of Surgical Oncology, IMS, BHU The data is inform of two cohorts one extending from April 2019-April 2020 and other from May 2020 to May 2021 i.e. pre covid and during covid pandemic

Eligibility criteria: Inclusion Criteria:

* All patients operated during the study period

Exclusion Criteria:

* None

Primary outcomes:
measure: 30 day mortality
timeFrame: 30 days
measure: number of participants developing major or minor complications
timeFrame: 30 days
Secondary outcomes:
measure: number of health care worker with SARS CoV2 infection
timeFrame: 1 year
Other outcomes:
Locations:
city: Varanasi
country: India
facility: Banaras Hindu University
state: UP
Study officials:
affiliation: Banaras Hindu University
name: Manoj Pandey, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References: