louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01329718: Specimens for Septin 9 Performance
Official title: Specimen Collection Protocol for the Performance Evaluation of the Septin 9 Assay
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Colorectal Cancer
Keywords: Stability of the Septin 9 biomarker
Epi Pro Colon Test
CRC
Lead sponsor: Epigenomics, Inc
Sponsor class: INDUSTRY
First posted: 2011-04-06
Enrollment: 562
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Epigenomics has identified methylated gene regions that are specific for colorectal cancer (CRC). Through Epigenomics' marker discovery and validation process Septin 9 was identified as a particularly robust methylation marker for detection of CRC. Epigenomics is currently developing a blood based CRC screening test based on Septin 9 and is performing a large prospective clinical trial showing its clinical utility in a population at average risk for CRC. Parallel to this trial further activities are needed to evaluate, optimize, and develop pre-analytical and analytical workflows as well as molecular assays making possible the use of Septin 9 methylation in the clinical routine.


Eligibility criteria: Inclusion Criteria:

* 50 years of age or older at the time of the blood draw
* Histologically confirmed or strong clinical suspicion of adenocarcinoma of the colon or rectum
* CRC defined as invasive adenocarcinoma

Exclusion Criteria:

* Previous personal history of colorectal cancer
* Any cancer specific treatment (e.g. polypectomy, chemotherapy, radiation, or surgery) prior to blood draw, including neoadjuvant treatment
* Known infection with HIV, HBV or HCV
* Subject concurrently receiving intravenous fluid at the time of the specimen collection

Primary outcomes:
measure: Effectiveness of the Epi proColon test
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04737018: Impact of a Focal Muscle Vibration Protocol in Front of the the Anterior Tibial Muscle in the Subacute Post-stroke Period on Motor Recovery in Hemiplegic Patients.
Official title: Impact of a Focal Muscle Vibration Protocol in Front of the the Anterior Tibial Muscle in the Subacute Post-stroke Period on Motor Recovery in Hemiplegic Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: muscle vibration protocol
anterior tibia muscle
hemiplegic patient
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
First posted: 2021-02-03
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: In about 40 percent of cases, after a stroke, neuromotor impairment leads to activity limitations and the development of chronic functional disorders, which have a significant impact on patient autonomy.

In the early subacute phase, motor deficit in foot lifters is one of the factors limiting standing posture and ambulation, which is ultimately difficult to rehabilitate due to the lack of available techniques for obtaining early onset of useful active voluntary contraction.

The use of muscular focal vibration therapy, applied to relaxed muscle, may be of interest due to the portability and availability of the system and the neuromotor benefits demonstrated in healthy subjects and in acute and chronic post-stroke patients.


Eligibility criteria: Inclusion Criteria:

* Having had a stroke (with or without previous stroke) and being in the early subacute phase (between 14 days and 3 months of stroke).
* Responsible for a motor deficit in the right or left lower limb.
* No neurological history other than stroke.

Exclusion Criteria:

* Multifocal stroke
* Patient having received a botulinum toxin injection to the lower limb to be vibrated

Primary outcomes:
measure: score of Fugl Meyer Assessment (lower limbs)
timeFrame: day 30
Secondary outcomes:
measure: score of Fugl Meyer Assessment (lower limbs)
timeFrame: day 0, day 15, day 30 and month 2
measure: score of Medical Research Concil
timeFrame: day 0, day 15, day 30 and month 2
measure: assess functional walking ability
timeFrame: day 0, day 15, day 30 and month 2
measure: score of postural assessment scale for stroke
timeFrame: day 0, day 15, day 30 and month 2
measure: analysis of static equilibrium
timeFrame: day 0, day 15, day 30 and month 2
measure: positional measurement of the center of gravity
timeFrame: day 0, day 15, day 30 and month 2
Other outcomes:
Locations:
city: Saint-Etienne
country: France
facility: Centre Hospitalier Universitaire de Saint-Etienne
city: Saint-Priest-en-Jarez
country: France
facility: Le Clos Champirol - Service de Médecine Physique et de Réadaptation
Study officials:
affiliation: CHU SAINT-ETIENNE
name: Bruno FERNANDEZ, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01952418: Effect of Video Monitor Size on Adenoma Detection Rate
Official title: Effect of Video Monitor Size on Adenoma Detection Rate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colon Adenoma
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-09-30
Enrollment: 1805
Sex: ALL
Minimum age (years): 25
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this study is to compare the adenoma detection rate achieved while using either a 24" video monitor or a 32" video monitor.

Detailed description: Gastrointestinal endoscopists perfoming routine endoscopic procedures and their patients will be randomized to one of two endoscopy rooms at the MGH Ambulatory Endoscopy Center at Charles River Plaza. The two rooms will have identical equipment with the exception that one room will have the current standard size video monitor (NDS 26") used at this facility while the other room will have a larger video monitor (NDS 32"). The ADR achieved by each physician in each room will be compared.

Eligibility criteria: Inclusion Criteria:

* Physician endoscopist performing colonoscopy at Massachusetts General Hospital GI Endoscopy Unit
* Patients receiving these procedures at Massachusetts General Hospital GI Endoscopy Unit

Exclusion Criteria:

* Refusal to participate

Primary outcomes:
measure: Adenoma Detection Rate (All Indications)
timeFrame: within 2 weeks (range of 1 day-14 days) of the endoscopy
measure: Adenoma Detection Rate (Screening Exams Only)
timeFrame: within 2 weeks (range of 1 day-14 days) of the endoscopy
Secondary outcomes:
measure: Polyp Detection Rate (All Indications)
timeFrame: recorded during endoscopy (immediate)
measure: Polyp Detection Rate (Screening Exams Only)
timeFrame: recorded during endoscopy (immediate)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Norman S Nishioka, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jovani M, Campbell EJ, Hur C, Joshi AD, Nishioka NS. Effect of video monitor size on polyp detection: a prospective, randomized, controlled trial. Gastrointest Endosc. 2019 Aug;90(2):254-258.e2. doi: 10.1016/j.gie.2019.03.1172. Epub 2019 Apr 12.
Clinical trial NCT03391518: Evaluation of Blood Flow Regulation With Laser Speckle Flowgraphy
Official title: Evaluation of Blood Flow Regulation With Laser Speckle Flowgraphy in Patients With Normal Tension Glaucoma and Healthy Individuals.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Low Tension Glaucoma
Lead sponsor: Augenabteilung Allgemeines Krankenhaus Linz
Sponsor class: OTHER
First posted: 2018-01-05
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study includes Caucasian patients with diagnosis of normal tension glaucoma and age- and sex-matched healthy individuals. Measurements of optic nerve head blood flow will be performed with laser speckle flowgraphy (LSFG). Also, the intraocular pressure (IOP), systolic and diastolic blood pressure, heart rate (HR), mean arterial pressure (MAP) as well as ocular perfusion pressure (OPP) will be evaluated. After baseline measurements individuals will be asked to ingest 800 ml of water in less than five minutes. Measurements will be repeated after 15, 30 and 45 minutes.


Eligibility criteria: Inclusion Criteria:

* presence of glaucomatous optic disc changes in biomicroscopy and visual field defects or abnormal circumpapillary retinal nerve fibre layer (RNFL) thinning (evaluated by OCT as defined by the on-board software)
* IOP ≤ 21mmHg without therapy
* normal open angle in a gonioscopic examination
* age \> 40 years

Exclusion Criteria:

* IOP \> 21 mmHg in patients' history
* ametropia \> 6 diopters
* cataract with severity greater than grade 2 of the lens opacities classification system (LOCS) classification
* presence of corneal opacities
* uncontrolled hypertension with systolic blood pressure (SBP) \> 165mmHg and/or diastolic blood pressure (DBP) \> 100mmHg

Primary outcomes:
measure: Change in ONH blood flow induced by water drinking test
timeFrame: baseline, after 15, 30 and 45 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Linz
country: Austria
facility: AKh Linz
state: Oberösterreich
Study officials:
References:
Clinical trial NCT00894218: New Tool of Subjective and Objective Functional Evaluation and the Quality of Life After Arthroplastic Surgery of the Hip and the Knee Assisted or Not by Computer and Mini-invasive Arthroplasty
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hip Arthritis
Knee Arthritis
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
First posted: 2009-05-06
Enrollment: 1
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hip or knee arthroplasties allow a relief of pain and a good functional habilitative at patients suffering from degenerative osteoarthritis of these articulations with medium and long-term good results. The main objective of this study is to compare the efficiency in short and medium-term functional impact parlance of two surgical techniques: computer-assisted surgery and mini-invasive surgery compared to the conventional techniques thanks to an innovative technology of ambulatory analysis of walking.


Eligibility criteria: Inclusion Criteria:

* Weight \< 100 kg
* score UCLA \> 4
* prosthesis of first intention

Exclusion Criteria:

* Pregnant
* score UCLA \< 4
* osteotomy near to prosthesis
* prosthesis requiring an osseous transplant
* prosthesis already set up
* infections, contagious diseases (HIV, tuberculosis, hepatitis, venereal diseases) or metastasis
* neuromuscular diseases able to perturb walking or staying
* congenital or acquired disease, or previous surgery able to have consequences on results and prosthesis survey according to the surgeon

Primary outcomes:
measure: To compare the efficiency in short and medium-term functional impact parlance of two surgical techniques: computer-assisted surgery and mini-invasive surgery compared to the conventional techniques
timeFrame: 2 years after surgery
Secondary outcomes:
measure: Ambulatory analysis of the walking and coordination of lower limbs, direct and indirect costs
timeFrame: 2 years after surgery
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique-Hopitaux de Marseille
Study officials:
References:
Clinical trial NCT05505318: Pattern and Surgical Treatment of Parotid Gland Neoplasms
Official title: Pattern and Outcome of Surgical Treatment of Parotid Gland Neoplasms in Upper Egypt(Retrospective Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Parotid Gland Neoplasm
Keywords: parotid
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2022-08-17
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: parotid neoplasms patients in upper Egypt

Brief summary: in these study we analyze pattern of parotid gland neoplasms according to histopathological types, most common type clinical presentation and type of surgical treatment(superficial parotidectomy or total parotidectomy radical parotidectomy

Detailed description: aim of study is to analyze pattern of parotid glands neoplasms in upper Egypt as regard

1)age 2) sex , 3) clinical presentation :symptom (parotid lump, pain and facial nerve paralysis) and sign (tenderness, fixation of parotid lump and presence of lymph nodes) 4)histopathological types:(benign or malignant 5)surgical options :superficial parotidectomy, total parotidectomy or radical parotidectomy 6)postoperative complications :facial nerve dysfunction, fistula ,recurrence 7) mortality rate all data will be recorded, tabulated , and statistically analyzed .

Eligibility criteria: Inclusion Criteria:

* all patient with parotid neoplasm with any age and sex at the period between may2015 to May2021 presented in upper Egypt enrolled in this study all the data will recorded ,tabulated and statistically analyzed emphasizing on:

  1) age. 2)sex. 3)clinical presentation: symptoms (parotid lump ,pain and facial nerve paralysis
  * sign (tenderness ,fixations of parotid lump and presence of lymph nodes) . 4)surgical options : - superficial parotidectomy (partial superficial parotidectomy or formal superficial parotidectomy) .
* total parotidectomy .
* radical parotidectomy. 5)postoperative complications: facial nerve dysfunction, fistula , recurrence) .

  6) mortality rate.

Exclusion criteria:

No exclusion criteria

Primary outcomes:
measure: pattern of parotid gland neoplasms
timeFrame: after 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Faculty of Medicine Sohag University
Study officials:
References:
Clinical trial NCT01826318: Stress Coping Strategy on Perceived Stress Levels and Performance During a Simulated Cardiopulmonary Resuscitation
Official title: Impact of a Stress Coping Strategy on Perceived Stress Levels and Performance During a Simulated Cardiopulmonary Resuscitation: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiopulmonary Resuscitations
Keywords: Stress
coping
simulation
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2013-04-08
Enrollment: 124
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: This study assessed the impact of a task-focusing strategy on perceived stress levels and performance during a simulated CPR scenario.

Detailed description: Background: Cardiopulmonary resuscitation (CPR) causes significant stress, which may cause deficiencies in attention and increase distractibility. This may lead to misjudgements of priorities and delays in CPR performance, which may further increase mental stress (vicious cycle).

Aim: This study assessed the impact of a task-focusing strategy on perceived stress levels and performance during a simulated CPR scenario.

Methods: This is a prospective, randomized-controlled trial

Setting: Simulator-center of the University Hospital Basel, Switzerland.

Participants: A total of 124 volunteer medical students

Intervention: Randomization to receive a 10 minute instruction to cope with stress by loudly posing two task-focusing questions ("what is the patient's condition?", "what immediate action is needed?") when feeling overwhelmed by stress (intervention group) or a control group.

Outcome measures: The primary outcome is the perceived levels of stress and feeling overwhelmed (stress/overload); secondary outcomes were hands-on time, time to start CPR and number of leadership statements.

Eligibility criteria: Inclusion Criteria:

* 4th year medical students

Exclusion Criteria:

* none

Primary outcomes:
measure: Average level of stress/overload during the resuscitation period
timeFrame: In the first 120 seconds after the onset of the cardiac arrest
Secondary outcomes:
measure: hands-on time
timeFrame: in the first 120 seconds after the onset of the cardiac arrest.
measure: time elapsed until CPR was started
timeFrame: in the first 120 seconds after the onset of the cardiac arrest
measure: leadership statements
timeFrame: in the first 120 seconds after the onset of the cardiac arrest
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, ICU
state: BS
Study officials:
affiliation: University Hospital Basel, Basel 4031 Basel, Switzerland
name: Sabina Hunziker, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00772018: Quality of Life and Symptom Management in Patients With Bladder Cancer
Official title: A Qualitative Study of Patients With Non-Invasive Bladder Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bladder Cancer
Keywords: stage 0 bladder cancer
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2008-10-15
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Urology specialty clinic

Brief summary: RATIONALE: Learning about quality of life and symptom management in patients with bladder cancer may help doctors learn about the effects of treatment and plan the best treatment.

PURPOSE: This clinical trial is studying of quality of life and symptom management in patients with bladder cancer.

Detailed description: OBJECTIVES:

Primary

* To identify aspects of health-related quality of life (HRQOL) and symptom management in patients with non-invasive, low- or high-risk bladder cancer.
* To obtain feedback on data collection methods to enhance acceptability in these patients.

OUTLINE: Patients undergo a 10-minute screening in person or by phone to obtain demographic data and medical information (e.g., bladder cancer diagnosis and treatment history). Additional information is obtained from the clinical databases at the Baylor College of Medicine and the Michael E. DeBakey Veterans Affairs Medical Center. Patients who are eligible for the study are added to a waiting list for 1 of 4 focus groups based on disease status (high-risk or low-risk non-invasive bladder cancer) and gender. Patients participate in a 1.5- to 2-hour focus group discussion about the impact of bladder cancer on their quality of life and relationships. Patients receive information about community and Internet-based resources at the end of each group session.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of bladder cancer within the past 4 years

  * Non-invasive disease
  * Low- or high-risk disease
* Recruited from patients at the Baylor College of Medicine Scott Department of Urology clinics, the Michael E. DeBakey Veteran Affairs Medical Center, and the Urology Clinic at MD Anderson Cancer Center OR from participants at a community event

PATIENT CHARACTERISTICS:

* Not pregnant
* Able to read, speak, and understand English

PRIOR CONCURRENT THERAPY:

* Not specified

Primary outcomes:
measure: Health-related quality of life (HRQOL) and symptom management in patients with bladder cancer
timeFrame: One timepoint
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Dan L. Duncan Cancer Center at Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Veterans Affairs Medical Center - Houston
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: David M. Latini, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04464941: Oral Health Promotion Program for Persons With Severe Mental Illness
Official title: Oral Health Promotion Program for Persons With Severe Mental Illness: A Cluster Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evaluate the Effects of an Oral Health Promotion Program
Keywords: oral health, promotion program, plaque index, mental illness
Lead sponsor: Chang Bing Show Chwan Memorial Hospital
Sponsor class: OTHER
First posted: 2020-07-09
Enrollment: 68
Sex: MALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster Randomized Controlled Study
Primary purpose: PREVENTION

Brief summary: A cluster randomized controlled study was carried out in chronic psychiatric wards of a general hospital in central Taiwan. Sixty-eight eligible male individuals admitted to 2 wards were randomly assigned to an experimental and a control group. Participants in the experimental group underwent an oral health promotion program that consisted of biweekly group education sessions, and a 12-week individual behavioral modification for oral hygiene course. The participants in the control group received usual care only. Dental plaque (measured by the Plaque Control Index) was examined by a single dentist before and after the experiment.


Eligibility criteria: Inclusion Criteria:

* Patients admitted in chronic psychiatric wards were eligible.

Exclusion Criteria:

* significant cognitive disabilities, severe hearing impairment, orthodontic appliances, an edentulous status, or a handicap when tooth-brushing

Primary outcomes:
measure: Dental Plaque Index
timeFrame: 12-week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kuo MW, Yeh SH, Chang HM, Teng PR. Effectiveness of oral health promotion program for persons with severe mental illness: a cluster randomized controlled study. BMC Oral Health. 2020 Oct 27;20(1):290. doi: 10.1186/s12903-020-01280-7.