louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02495337: Tissue Collection Protocol for Gastroesophageal Cancers
Official title: Tissue Collection for Gastro-esophageal Cancer Primary Cell Line Establishment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Esophageal Cancer
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
First posted: 2015-07-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with esophagogastric cancer and/or GERD +/- Barrett's esophagus who will undergo surgery and/or EGD as standard of care.

Brief summary: This proposed collection of primary tumor cells lines will benefit esophageal cancer research within the University Health Network. This collection of gastro-esophageal tumor samples will be used to grow primary tumor cell lines, which will provide researchers with ready samples of various gastro-esophageal cancers. This will help to address the issue of access to these cell lines due to the limited number of patients with gastro-esophageal tumors, and high rates of contamination.

Detailed description: Samples will be collected during surgery, EGD, or other biopsy. The surgeon will resect a sample for the research coordinator and/or fellow who will collect the sample and take it back to the lab for processing. Samples collected will be in excess of standard samples that are sent for pathology. The surgeon will make sure that excess samples will not affect pathological diagnosis. In addition samples may be purchased from the National Cancer Institute's Cooperative Human Tissue Network.

Eligibility criteria: Inclusion Criteria:

* Patients with esophagogastric cancer and/or GERD +/- Barrett's esophagus who will undergo surgery and/or EGD as standard of care.

Exclusion Criteria:

* Patients who are not well enough to undergo surgery or EGD as standard of care.

Primary outcomes:
measure: Effectively culture, proliferate, and store primary gastro-esophageal cell lines in order to create a bank of primary esophageal / gastric cancers for research purposes
timeFrame: Ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: University Health Network: Toronto General Hospital
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Jonathan Yeung
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06290037: Driving Ability Evaluation System to Improve the Conditional Driving License System: Feasibility Study of High-risk Drivers.
Official title: Driving Ability Evaluation System to Improve the Conditional Driving License System: Feasibility Study of High-risk Drivers.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Automobile Driving
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2024-03-04
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The primary objective of this study is to verify the safety and validity of a VR driving simulator developed for evaluating the driving abilities of elderly drivers.

This study also aims to establish indicators in VR driving simulator to evaluate high-risk group for driving, such as cognitive and physical abilities. Therefore, this study aims to measure the physical driving function, general physical function and cognitive function of elderly drivers. to identify the correlation between their outcomes and the VR driving simulator's result

Detailed description: VR driving simulator is to evaluate the driving abilities of high-risk drivers, including the elderly and those with medical conditions, potentially prone to incapacitate driving.

It aims to evaluate whether drivers who were anticipated to have impaired driving ability can handle highly risky situations for traffic accidents. The results of this study can be used to make the drivers know their status and encourage them to take safety training. Until now, the evaluation of driving abilities could only be conducted at licensing centers. However, the use of VR technology can eliminate spatial limitations, offering a promising tool for the objective assessment of driving skills.

Eligibility criteria: Inclusion Criteria:

* Individuals over the age of 65 who are currently driving.
* Individuals capable of understanding and following the researcher's instructions.
* Individuals who can understand the purpose of the research and have consented to participate

Exclusion Criteria:

* Those who have not signed the consent form.
* Individuals with a history of severe dizziness or epilepsy.
* Patients with restrictions on sitting in a wheelchair or chair for more than 30 minutes.
* Patients with severe shoulder pain.
* Patients whose range of motion in major joints is restricted by more than 50%.
* Pregnant women.
* Patients with pressure sores.
* Patients with limitations on simulator use due to heterotopic ossification.
* Patients with acute fractures.
* Other patients for whom participation in the study is expected difficult.

Primary outcomes:
measure: Feasibility of VR driving simulator
timeFrame: 2 hours
measure: Driving performance in simulator, measured by driving errors
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
References:
Clinical trial NCT01789437: Diameters and Wall-to-lumen Ratio of Retinal Arterioles in Patients With Retinal Vein Occlusion.
Official title: Diameters and Wall-to-lumen Ratio of Retinal Arterioles in Patients With Retinal Vein Occlusion.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertensive Patients With Retinal Vein Occlusion
Keywords: retinal vein occlusion
systemic hypertension
arteriolar diameter
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
First posted: 2013-02-12
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: to evaluate the wall-to-lumen ratio (WLR) of retinal arterioles in hypertensive patients with retinal vein occlusion (RVO) before and after dexamethasone intravitreal implant 0.7 mg (DEX) compared to a matched control group of normal eyes in non-hypertensive subjects.


Eligibility criteria: Inclusion Criteria:

* ability to provide written informed consent and comply with study assessments for the full duration of the study;
* age \> 20 years;
* decreased visual acuity as a result of clinically detectable ME associated with either CRVO or BRVO;
* the duration of macular edema was required to be between 4 and 24 weeks for both CRVO and BRVO;
* retinal thickness in the central subfield (as measured using optical coherence tomography) had to be \> 350 µm in the study eye.

Exclusion Criteria:

* the exclusion criteria were as follows: diabetes; previous intravitreal anti-VEGF therapy or intravitreal steroid therapy; previous photodynamic therapy or focal laser; active retinal or optic disc neovascularization; active or history of choroidal neovascularization; presence of rubeosis iridis; any active infection; glaucoma, current ocular hypertension, or a history of steroid-induced intraocular pressure (IOP) increase in either eye; or concurrent eye disease in the study eye that could compromise visual acuity (e.g., choroidal neovascularization, diabetic retinopathy, epiretinal membrane).

Primary outcomes:
measure: change of outer arteriolar diameter
timeFrame: the primary endpoint was at 6 months
measure: change of inner arteriolar diameter
timeFrame: the primary endpoint was at 6 months
Secondary outcomes:
measure: Secondary outcome measures were as follows: adverse ocular events; mean change in visual acuity; and mean change in central macular thickness.
timeFrame: Outcomes were analyzed at 4 intermediate time points: 30, 60, 90, and 150 days.
Other outcomes:
Locations:
city: Brescia
country: Italy
facility: Spedali Civili di Brescia
state: BS
Study officials:
affiliation: University of Brescia, Italy
name: Andrea Russo, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02833337: Morphological Pattern of the Atrophic Posterior Maxillae
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bone Deficiency, Posterior Maxillae
Keywords: Bone
Maxilla
Cone-Beam Computed Tomography
Regeneration
Lead sponsor: Center of Implantology, Oral and Maxillofacial Surgery, Badajoz, Spain
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study used a retrospective database of preexisting data that included patients treated as part of routine periodontal and oral surgery therapy for each patient's needs. All the patients signed an inform consent approving using their radiographic data for research purposes.

Brief summary: Overcoming the vertical and horizontal bone deficiency in the posterior maxillae are considered as the most challenging scenarios for implant-supported oral rehabilitation in modern implant dentistry. Therefore, a comprehensive and precise understanding of such anatomical structures are needed to avoid potential complications that ultimately might jeopardize the treatment outcome.

Cone-beam computerized tomography (CBCT) offers some advantages to conventional CT-scan such as lower-dose radiation with high isotropic spatial resolution and cost. Therefore, it offers a viable and reliable tool to study anatomical structures such as the posterior atrophic maxillae


Eligibility criteria: * Images were included if:

  1. Pristine maxillary posterior atrophic ridges (between premolars and molars) as a result of missing single or multiple teeth for over than 12 months.
  2. Residual ridge height (RH) was \< 10 mm.
  3. Presence of teeth adjacent to or opposing the edentulous area so the location of the edentulous ridges corresponding to the tooth site could be identified.
  4. The maxillary sinus to be measured was visible from its floor to at least 15 mm from the alveolar crest of the edentulous ridge.
* Images were excluded if:

  1. Images were unclear or incomplete due to scattering or other reasons
  2. Edentulous ridge height was more than 10 mm
  3. Ridge preservation/augmentation simultaneous/delayed to tooth extractions
  4. Grafted maxillary sinus for implant-supported prosthesis
  5. The location of the edentulous ridge cannot be determined
  6. Implants or other prosthetic device restoring the posterior ridge
  7. Presence of sinus pathology that made the measurement impossible
  8. The outline of the edentulous ridge cannot be identified due to low 'grey scale' density

Primary outcomes:
measure: Lateral Wall Thickness
timeFrame: One month
Secondary outcomes:
Other outcomes:
Locations:
city: Badajoz
country: Spain
facility: Florencio Monje Gil
Study officials:
References:
Clinical trial NCT03311737: Compare the Analgesic Effect of Different Anesthesia and Postoperative Analgesic Methods in Uniportal VATS Lung Surgery
Official title: Compare the Analgesic Effect of Different Anesthesia and Postoperative Analgesic Methods in Uniportal VATS Lung Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Postoperative Pain
Single-incision Thoracoscopic Surgery
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2017-10-17
Enrollment: 100
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: This is a single center, randomized, single blind study to compare the analgesic effect of different anesthesia and postoperative analgesic methods in uniportal VATS lung surgery.

Detailed description: Combining epidural with general anesthesia is regarded as the gold standard of general thoracic surgery. The uniportal VATS lung surgery have advantages of minimal invasive surgical incision, less postoperative pain, and so on. Whether general anesthesia can become an alternative method of combining epidural with general anesthesia in uniportal VATS lung surgery, investigators thus plan to make a comparison on intraoperative stress response, postoperative pain, immune function of patients，and hospital expenses.

Eligibility criteria: Inclusion Criteria:

* Patients elective uniportal VATS lung surgery;
* BMI 18-30 kg/m2.

Exclusion Criteria:

* Patient refuse;
* ASA≥3;
* Patients allergic to use anesthetics (propofol,rocuronium), patients with liver and/or kidney and/or mental dysfunction.

Primary outcomes:
measure: visual analogue scale（VAS）
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT03389737: The Effects of the Novel "Step Up Your Game" Program on Men's Lacrosse
Official title: The Effects of the Novel "Step Up Your Game" Program on Men's Collegiate Lacrosse Players: A Comparative Study of a Comprehensive Osteopathic Approach on Performance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Body Weight Changes
Lead sponsor: New York Institute of Technology
Sponsor class: OTHER
First posted: 2018-01-04
Enrollment: 25
Sex: MALE
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: For the purpose of this pilot study, the investigators hypothesize that the use of the Step Up Your Game protocol will result in statistically significant improvements in health and athletic performance. The key to this is the coordination of resources from a supervising physician, physical therapist, trainer, dietitian, coach, competitor, role model, psychologist, and spiritual leader. Notably, Step Up Your Game provides resources which would allow patients to find or be their own physical therapist, trainer, dietitian, coach, competitor, role model, psychologist, and spiritual leader. The role of the supervising physician, however, is meant for a qualified professional, who follows the osteopathic approach to medicine, in which the body is treated as an integrated whole, while also working to prevent and treat injuries. Though not limited solely to osteopathic physicians, it is critical to take into account every health aim and injury in the context of the athlete and how these affect all aspects of participants lives.


Eligibility criteria: Inclusion Criteria:

* Individuals capable of giving consent between ages of 18 and 22.
* Must be members of the NYIT lacrosse team.

Exclusion Criteria:

* Individuals who are not able to participate throughout the season whether it's due to a medical problem or academic probation.
* Individuals who are receiving sports related medical care other than that from the physician in study.

Primary outcomes:
measure: RAND-36 Survey
timeFrame: 3 months
Secondary outcomes:
measure: Patient Health Questionnaire 9
timeFrame: 3 months
measure: Lean muscle mass
timeFrame: 3 months
measure: Adipose tissue
timeFrame: 3 months
Other outcomes:
Locations:
city: Old Westbury
country: United States
facility: NYIT
state: New York
Study officials:
affiliation: NYIT
name: Hallie Zwibel, D.O.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00635037: Myofascial Pain:Acupuncture Versus Trigger Point Injection Combined With Dipyrone and Cyclobenzaprine
Official title: Acupuncture Versus Trigger Point Injection Combined With Dipyrone and Cyclobenzaprine on Pain Relief of Patients With Myofascial Pain: Randomized Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Pain Syndromes
Keywords: Myofascial pain syndrome
Acupuncture
Nonsteroidal anti-inflammatory agents
Muscle relaxants, central
Quality of life.
muscle relaxants, analgesia
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
First posted: 2008-03-13
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: CONTEXT AND OBJECTIVE: Myofascial syndrome is the most frequent condition of chronic pain. The objective of the present study was to compare the analgesic action of acupuncture and trigger point injection combined with cyclobenzaprine and dipyrone.

DESIGN AND SETTING: A randomized study was performed at the Pain Clinic. METHODS: Thirty patients were divided into two groups: G1 received trigger point injection of 0.25% bupivacaine (1 ml/point) twice a week, 10 mg/day cyclobenzaprine and 500 mg dipyrone every 8 h. G2 was submitted to classical and trigger point acupuncture twice a week. The patients were asked to continue physical exercise. The following parameters were evaluated: pain intensity rated on a numerical and verbal scale, quality of life before and four weeks after treatment, and quality of analgesia.

Detailed description: Among the 39 patients selected, nine (3 in group 1 and 6 in group 2) were excluded from the study because they did not attend the visits scheduled for the procedures and assessment or because they did not respond to the questionnaires.

Eligibility criteria: Inclusion Criteria:- patients of both genders

* chronic myofascial syndrome (duration of more than three months),
* ranging in age from 18 to 65 year,
* pain intensity score of 3 or higher (rated on a numerical scale ranging from 0 to 10)

Exclusion Criteria:

* patients with disc herniation,
* osteoarthritis,
* vertebral collapse,
* temporomandibular joint dysfunction,
* infection, -
* tumors,
* coagulopathy, -
* psychiatric disease,
* cognitive disorders.
* Patients who had used any type of analgesic or muscle relaxant agent 15 days before the study and those taking anticoagulants

Primary outcomes:
measure: Pain relief
timeFrame: 1year
Secondary outcomes:
measure: compare the analgesic action of acupuncture and trigger point injection combined with cyclobenzaprine and dipyrone
timeFrame: 1 year
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Pain Setor of Federal University of Sao Paulo
state: SP
Study officials:
affiliation: Federal University of São Paulo
name: Miriam CB Gazi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02007837: Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia Trial
Official title: Prospects for the Prevention of Pregnancy-induced Hypertension and Preeclampsia (4P) - a Randomised, Placebo-controlled, Double-blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Pregnancy Induced Hypertension
Keywords: pregnancy induced hypertension
gestational hypertension
pre-eclampsia
preeclampsia
hypertensive disorders in pregnancy
Lead sponsor: UMC Utrecht
Sponsor class: OTHER
Collaborators: name: Ghana Health Services
name: University of Ghana
First posted: 2013-12-11
Enrollment: 440
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hypertensive disorders of pregnancy (HDP) are with 50.000 deaths every year one of the major causes of maternal mortality worldwide, especially in low and middle income countries. This trial aims to determine whether a daily dose of combined low-dose aspirin, calcium, vitamin D3, folic acid and vitamin B12 in pregnancy reduces the incidence of pregnancy-induced hypertension in women at risk. Secondary and tertiary objectives include other maternal and neonatal outcomes.


Eligibility criteria: Inclusion Criteria:

* \<16 weeks of gestation and over 18 years of age,
* Intention to have subsequent antenatal visits and delivery at the same clinic.
* Can receive text messages by phone or through the phone of a proxy.
* A moderate to high risk (\>20%) of developing PIH

Exclusion Criteria:

* Pre-existing hypertension or hypertension before 20 weeks gestation.
* Likely non-compliance with the protocol in view of the treating physician
* Comorbidity interfering with the protocol
* Known contraindications to Investigational Product components

Primary outcomes:
measure: Development of pregnancy-induced hypertension (PIH) in pregnancy
timeFrame: up to 2 days after delivery.
Secondary outcomes:
measure: Maternal/obstetric outcomes
timeFrame: 6-16 weeks gestation, 16-24 weeks gestation, 26-36 weeks gestation, delivery and first days after
measure: Neonatal and infant outcomes
timeFrame: 6-16 weeks gestation, 16-24 weeks gestation, 26-36 weeks gestation, delivery and first days after
measure: Number of participants with (severe) adverse events as a measure of safety and tolerability
timeFrame: 1 year
Other outcomes:
Locations:
city: Accra
country: Ghana
facility: La General Hospital
city: Accra
country: Ghana
facility: Ridge Regional Hospital
Study officials:
affiliation: UMC Utrecht
name: Diederick E Grobbee, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Ghana Health Services
name: Patrick Frimpong, MBbCh
role: PRINCIPAL_INVESTIGATOR
affiliation: Ghana Health Services
name: Emmanuel K Srofenyoh, MBbCb
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05611437: Ultrafast Ultrasonographic Oro-laryngeal Measurement in Critically Ill Patients During Weaning From Mechanical Ventilation
Official title: Ultrafast Ultrasonographic Oro-laryngeal Measurement in Critically Ill Patients During Weaning From Mechanical Ventilation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Laryngeal Edema
Keywords: Post-extubation stridor
Intensive care unit
Ultrafast ultrasonography
Lead sponsor: Groupe Hospitalier du Havre
Sponsor class: OTHER
First posted: 2022-11-10
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients admitted in Le Havre Hospital intensive care unit.

Brief summary: In ICU, ventilatory weaning failure is common, accounting for up to 25% of extubations. These failures are largely due to swallowing disorders and laryngeal edema. Edema prevalence in ICU varies between 4 and 37%.

Post-extubation stridor is a clinical sign of upper airway obstruction and may require urgent reintubation, which is associated with increased patient length of stay, morbidity and mortality.

Identifying patients at risk is critical, and the need for reliable tools to predict the occurence of laryngeal edema is still relevant.


Eligibility criteria: Inclusion Criteria:

* Adults,
* Intubated and ventilated for more than 24h,
* Filing mechanical ventilation weaning criteria.

Exclusion Criteria:

* Pregnant of breast-feeding woman,
* Under guardianship patient,
* History of laryngeal tumor, stroke, paralysis of recurrent nerve, swallowing disorders,
* History of surgical laryngeal intervention or radiotherapy,
* Unplanned extubation,
* Opposition to take part in the study.

Primary outcomes:
measure: Correlation between laryngeal ultrafast ultrasonography and occurence of laryngeal edema
timeFrame: Within the 24 hours following extubation
Secondary outcomes:
measure: Correlation between laryngeal ultrafast ultrasonography and occurence of swallowing disorders
timeFrame: Within the 24 hours following extubation
Other outcomes:
Locations:
city: Montivilliers
country: France
facility: Groupe Hospitalier du Havre
Study officials:
References: