louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01955967: The Effect of Intravenous Lidocaine on Trigeminal Neuralgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Trigeminal Neuralgia
Keywords: Effect
Lidocaine
Lead sponsor: Pain Relief & Palliative Care Center, Athens, Greece
Sponsor class: OTHER
First posted: 2013-10-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aim of this randomized double blind, placebo controlled, crossover study is to investigate in a prospective way the effect of lidocaine in patients with trigeminal neuralgia. Included patients will undergo four weekly sessions, two of which with lidocaine (5mgs/kg) and two with placebo infusions administered over 60 minutes. Effect will be measured with pain diaries and visual analogue scales.


Eligibility criteria: Inclusion Criteria:

(1) confirmed diagnosis of TN according to IASP definition, (2) age equal to or greater than 18 years, (3) visual analogue scale (VAS) score equal to or greater than 3 (out of a maximum 10), (4) DN4 score equal to or greater than 4 (out of a maximum 10), (5) having received the recommended medications for TN (antiepileptics, spasmolytics, opioids, anti-inflammatory and simple analgesic drugs) for an adequate period without therapeutic results, (6) TN duration of at least 12 months, (8) no history of allergy to lidocaine, (9) no history of substance abuse, (10) absence of severe psychiatric diseases, (11) not being pregnant, (12) not lactating, (13) absence of severe cardiac, hepatic and renal decease, and (14) be willing to provide a written informed consent to undergo the experimental procedures.

Primary outcomes:
measure: Pain intensity
timeFrame: 24h
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Stavropoulou E, Argyra E, Zis P, Vadalouca A, Siafaka I. The Effect of Intravenous Lidocaine on Trigeminal Neuralgia: A Randomized Double Blind Placebo Controlled Trial. ISRN Pain. 2014 Mar 10;2014:853826. doi: 10.1155/2014/853826. eCollection 2014.
Clinical trial NCT03748901: PD-L1 Expression in Japanese Renal Cell Carcinoma Patients
Official title: A Retrospective Multicenter Analysis of PD-L1 Expression in Japanese Renal Cell Carcinoma Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Cell Carcinoma
Lead sponsor: Chugai Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2018-11-21
Enrollment: 830
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with recurrent or metastatic RCC who have initiated first line treatment between 1 January 2010 and 31 December 2015, with representative FFPE of nephrectomy surgical specimen which are suitable for assessment of PD-L1 expression

Brief summary: This is a multicenter retrospective study designed to compare overall survival (OS) by PD-L1 expression status in patients with RCC who have received systemic chemotherapy for recurrent or metastatic RCC, to determine whether the prognosis is worse in PD-L1-positive than in PD-L1-negative RCC.

Total 600 RCC surgical specimens will be collected from patients who started systemic chemotherapy for recurrent or metastatic RCC between January 1, 2010 and December 31, 2015 at about 30 participating study sites in Japan.

PD-L1 expression status (IC; immune cell) on tumor-infiltrating immune cells will be evaluated by IHC, and classified by score: IC0 (PD-L1-negative) and IC1, IC2, IC3 (PD-L1-positive). Unless otherwise specified, between-group comparisons will be performed between IC0 and IC1/2/3.


Eligibility criteria: Inclusion Criteria:

* 1. Written informed consent for this study. In the case obtaining written informed consent is difficult due to death, change of address, and so on, the opt-out consent is accepted by giving patients or their relatives notification regarding the usage of their clinical information and surgical samples for the research.
* 2. Age at nephrectomy≧20 years
* 3.Patients with recurrent or metastatic RCC who have initiated first line treatment between 1 January 2010 and 31 December 2015, with representative FFPE of nephrectomy surgical specimen which are suitable for assessment of PD-L1 expression

Exclusion Criteria:

* 1. Malignancies other than RCC is co-existed from the time of nephrectomy and death.
* 2. Treatment with anti-CTLA-4 antibody, anti-PD-1/PD-L1 antibodies as first-line therapy for recurrent or metastatic RCC.

Primary outcomes:
measure: Overall survival in PD-L1 negative (IC0) and positive (IC1/2/3) patients.
timeFrame: Baseline
Secondary outcomes:
measure: Overall survival by PD-L1 expression status (IC0, IC1, IC2, IC3)
timeFrame: Baseline
measure: Overall survival after nephrectomy (including cytoreductive nephrectomy)
timeFrame: Baseline
measure: Time to recurrence after radical nephrectomy
timeFrame: Baseline
measure: Treatment duration (first-line and second-line therapy)
timeFrame: Baseline
Other outcomes:
Locations:
city: Nagoya-city
country: Japan
facility: Aichi Medical University
state: Aichi
Study officials:
References:
Clinical trial NCT03908567: AM-125 in the Treatment of Acute Peripheral Vertigo Following Neurosurgery
Official title: Multicenter Randomized Controlled Phase 2 Trial to Evaluate AM-125 in the Treatment of Acute Peripheral Vertigo Following Neurosurgery (TRAVERS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Vestibular Vertigo
Keywords: Vertigo
Balance
Lead sponsor: Auris Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2019-04-09
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Treatment of vertigo after removal of a tumor of the balance and hearing nerve after neurosurgery, which damages or cuts the vestibular nerve (balance).

This trial explores the efficacy and safety of AM-125 in the treatment of acute vertigo. In this proof of concept trial patients experiencing vertigo after neurosurgery (vestibular schwannoma labyrinthectomy and vestibular neurectomy) will receive AM-125 or placebo. It evaluates the potential of AM-125 versus placebo in reducing the symptoms of vestibular dysfunction and accelerating vestibular compensation following neurosurgery.


Eligibility criteria: Main Inclusion Criteria:

1. Scheduled for neurosurgery (vestibular schwannoma resection, labyrinthectomy or vestibular neurectomy).
2. Small to moderately large vestibular schwannoma (Koos grade I-III; Samii grade T1-T3b; ≤ 30 mm in diameter in cerebellopontine angle) that does not displace the brainstem, documented by magnetic resonance imaging not older than six months or Indication for labyrinthectomy or vestibular neurectomy.
3. Confirmed vestibular function on both sides.

Main Exclusion Criteria:

1. Prior radiotherapy (gammaknife, intensity modulated radiation therapy) irradiating the brain-stem with more than 4 Gy.
2. Any ongoing other peripheral vestibular disorder (e.g. Meniere's disease, benign paroxysmal vertigo, vestibular neuritis) or central vestibular disorder (e.g. vestibular migraine, central vertigo).
3. Vestibular rehabilitation therapy or presurgical gentamicin therapy (i.e. "pre-habilitation therapy") within the past three months prior neurosurgery.
4. Any clinically relevant nasal obstruction or pathology precluding effective and/or safe intranasal delivery.

Primary outcomes:
measure: Improvement of time standing on foam (eyes closed)
timeFrame: Day 3 to Day 14
measure: Improvement in tandem Romberg test (eyes closed)
timeFrame: Day 3 to Day 14
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: CHP Clairval
Study officials:
References:
Clinical trial NCT04307901: Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy
Official title: Safety Of ColoRectal Assessment and Tumor Evaluation by Colon Capsule Endoscopy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colorectal Cancer
Colorectal Polyp
Keywords: colon capsule endoscopy
ct colonography
colonoscopy
endoscopy
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
First posted: 2020-03-13
Enrollment: 600
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 adults referred to colon capsule endoscopy from the surgical department of Odense University Hospital, which signs consent form enabling us to retrieve personal data.

Brief summary: Following European guidelines patients undergoing colonoscopy in one of Odense University Hospitals units will now be offered a colon capsule endoscopy (CCE) in case of incomplete examinations. Patients formerly referred to colonoscopy in general anesthesia or patients who decline colonoscopy after having completed bowel preparation will also be offered a CCE. In our department we have conducted a comparison study documenting that the sensitivity of CCE is superior to CT colonography in both polyps \>9 mm and polyps \>5 mm, which is also supported by an Italian study. The safety and completion rate of CCE following incomplete colonoscopy is confirmed by several studies including one multicenter study and the completion rate is not significantly lower compared to other patient groups. In an incomplete colonoscopy it is always the most oral part of the colon which is not visualized, whereas in CCE, an incomplete investigation will most often have visualized the oral part. By combining incomplete colonoscopy results and incomplete CCE results we can identify patients who have had a complete colon investigation although both investigations were incomplete.

Aim: to investigate the quality of CCE and the completion rate in patients who have undergone an incomplete colonoscopy, have completed bowel preparation but declines colonoscopy or have been referred to colonoscopy in general anesthesia.


Eligibility criteria: Inclusion Criteria:

* Incomplete colonoscopy, referral for colonoscopy under general anesthesia or declining colonoscopy after completion of bowel preparation.

Exclusion Criteria:

* Chrohn's disease with symptoms of stenosis and/or pacemaker

Primary outcomes:
measure: Complete mucosal visualization combining incomplete investigations
timeFrame: 10 years
Secondary outcomes:
measure: Completion rate of colon capsule endoscopy
timeFrame: 2 years
measure: Safety of colon capsule endoscopy
timeFrame: 1 year
measure: Quality of colon capsule endoscopy
timeFrame: 1 year
measure: Economic evaluation
timeFrame: 1 year
measure: Patient preference
timeFrame: 2 years
Other outcomes:
Locations:
city: Svendborg
country: Denmark
facility: Odense University Hospital
Study officials:
References:
Clinical trial NCT06493201: Research Into Risk Factors for Hospitalization Following a Fall in Older Patients
Official title: Research Into Risk Factors for Hospitalization Following a Fall in Older Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Accidental Falls
Keywords: Accidental Falls
Older adults
Gait Analysis
Hospitalization
Rehabilitation
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-07-09
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient over 65 years old having had at least one fall and able to walk without human assistance

Brief summary: Every year, a considerable number of older people fall, with a variety of consequences. These falls can lead to hospitalization, with consequent adverse effects on these people, as well as a significant cost to society. The risk factors for falls themselves are well identified, but not those that lead to hospitalizations in older people who all fall. Some risk factors, such as age, cannot be modified. With a view to preventing hospitalizations in older patients who fall, The investigators aimed to identify functional, and therefore modifiable, risk factors for hospitalizations in patients who fall, such as gait parameters. The investigators hope that the results of this study will lead to early identification of the risk of hospitalization in these patients and thus to appropriate rehabilitation as early as possible to limit this risk.


Eligibility criteria: Inclusion Criteria:

* Patient over 65 years old
* Patient having had at least one fall
* Patient able to walk without human assistance
* Hospitalized at the geriatrics center or seen in fall consultation at the Strasbourg University Hospital during the period from 05/01/2023 to 01/31/2024

Exclusion Criteria:

- Subject (and/or their legal representative if applicable) having expressed their (their) opposition to the reuse of their data

Primary outcomes:
measure: Gait parameters assessed using the GAITrite® mat
timeFrame: The outcome measure is assessed at inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Gériatrie Aigue - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT00670267: Oral Nadolol for the Treatment of Adults With Mild Asthma
Official title: An Open-Label, Dose-Escalating, Study to Evaluate the Safety, Efficacy and Tolerability of Oral Nadolol for the Treatment of Adults With Mild Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Asthma
Keywords: Asthma
hyperresponsiveness
Lead sponsor: Invion, Inc.
Sponsor class: INDUSTRY
Collaborators: name: University of Houston
name: Sandler Program for Asthma Research
name: Baylor College of Medicine
First posted: 2008-05-01
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to confirm previous observations in asthmatics that chronic nadolol treatment reduces asthmatic airway hyper-responsiveness.


Eligibility criteria: Inclusion Criteria:

* Pre-bronchodilator FEV1 80% or greater than the predicted value.
* PC20 FEV1 ≤4 mg/ml on methacholine challenge test.
* Blood Pressure ≥ 100/65mm Hg.
* Pulse rate ≥ 60 beats/min.
* No significant health issues.
* Non-smoker or X-smoker \< 10 pack/year.

Exclusion Criteria:

* History of upper/lower respiratory tract infection or asthma exacerbation within 6 weeks of first baseline visit.
* Currently diagnosed with chronic obstructive pulmonary disease (COPD).
* Used any oral or inhaled corticosteroids within 4 weeks of the first baseline visit.

Primary outcomes:
measure: Mean Daily Dose at Study Termination Across Participants
timeFrame: Baseline to end of study (105 days)
measure: Daily Dose at Study Termination Across Participants
timeFrame: Baseline to end of study (105 days)
Secondary outcomes:
measure: Change in Airway Hyper-reactivity Compared to Baseline (Change in PC20 Doubling Dose by Methacholine Challenge)
timeFrame: Baseline to end of study (105 days)
measure: Percent Change in FEV1% Predicted From Baseline to End of Study
timeFrame: Baseline to end of study (105 days)
measure: Change in Asthma Control Questionnaire (ACQ) Score Compared to Baseline
timeFrame: Baseline to end of study (105 days)
Other outcomes:
Locations:
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
Study officials:
affiliation: University of Houston
name: Nicola A Hanania, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hanania NA, Singh S, El-Wali R, Flashner M, Franklin AE, Garner WJ, Dickey BF, Parra S, Ruoss S, Shardonofsky F, O'Connor BJ, Page C, Bond RA. The safety and effects of the beta-blocker, nadolol, in mild asthma: an open-label pilot study. Pulm Pharmacol Ther. 2008;21(1):134-41. doi: 10.1016/j.pupt.2007.07.002. Epub 2007 Jul 17.
citation: Nguyen LP, Lin R, Parra S, Omoluabi O, Hanania NA, Tuvim MJ, Knoll BJ, Dickey BF, Bond RA. Beta2-adrenoceptor signaling is required for the development of an asthma phenotype in a murine model. Proc Natl Acad Sci U S A. 2009 Feb 17;106(7):2435-40. doi: 10.1073/pnas.0810902106. Epub 2009 Jan 26.
Clinical trial NCT02481167: Evaluation of Meibomian Gland Dysfunction in Chinese Old Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dry Eye
Keywords: Aged
Meibomian Glands
dry eye
Elderly
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2015-06-25
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: This study was consisted of patients with older than 40 years of age who complained with dry eye. The institutional review board of Wenzhou Medical College approved the study protocol, and all patients provided their informed consent.

Brief summary: The purpose of this study is to identify age-related changes in chinese meibomian glands that may be associated with meibomian gland dysfunction (MGD).


Eligibility criteria: Inclusion Criteria:

* have dry eye symptom
* have meibomian gland dysfunction

Exclusion Criteria:

* diabetes
* history of ocular surgery
* systemic disease or inflammation

Primary outcomes:
measure: Tear film break-up time
timeFrame: 1 year
measure: Lower tear meniscus
timeFrame: 1 year
measure: The morphology of meibomian glands
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Wenzhou Medical University
state: Zhejiang
Study officials:
affiliation: Wenzhou Medical University
name: ZHAO YUNE, MS
role: STUDY_CHAIR
References:
citation: Li J, Ma J, Hu M, Yu J, Zhao Y. Assessment of tear film lipid layer thickness in patients with Meibomian gland dysfunction at different ages. BMC Ophthalmol. 2020 Oct 6;20(1):394. doi: 10.1186/s12886-020-01667-8.
citation: Wu Y, Li J, Hu M, Zhao Y, Lin X, Chen Y, Li L, Zhao YE. Comparison of two intense pulsed light patterns for treating patients with meibomian gland dysfunction. Int Ophthalmol. 2020 Jul;40(7):1695-1705. doi: 10.1007/s10792-020-01337-0. Epub 2020 Mar 21.
Clinical trial NCT03543267: Study on Neurocognitive Plasticity in Patients With Focal and Drug-resistant Epilepsy
Official title: Feasibility Study on Neurocognitive Plasticity in Patients With Focal and Drug-resistant Epilepsy, Before and After Surgery. Evaluation by Functional and Anatomic Neuroimaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Epilepsy
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
Collaborators: name: Laboratoire de Psychologie et NeuroCognition
First posted: 2018-06-01
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study consist of define anatomo-functional reorganization (plasticity) profiles for the mentioned cognitive functions, before surgery (chronic plasticity induced by the epileptogenic zone) in patients with drug-resistant epilepsy.

For that, patients will have 2 MRI examinations, one before surgery and the second, between 3 and 8 months after surgery.


Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of pharmaco-resistant focal epilepsy
* Patient candidate for surgery to resect the epileptogenic zone
* Patients affiliated to a social security scheme or beneficiaries of such a scheme
* Patients with French as their mother tongue
* Patients who have given signed informed consent before performing any procedure related to the study.

Exclusion Criteria:

* Contraindication to performing an MRI:
* Intellectual disability objectified by a Mini Mental Score (MMS) score \<24 in the year preceding inclusion,
* Existence of a severe condition in general: cardiac, respiratory, hematological, renal, hepatic, cancerous,
* Participation in other research protocols underway with exclusion period or in the previous week,
* Persons referred to in Articles L1121-5 to L1121-8 of the Public Health Code.

Primary outcomes:
measure: to define anatomo-functional reorganization (plasticity) profiles by functional MRI for the mentioned cognitive functions, before surgery (chronic plasticity induced by the epileptogenic zone) in patients with drug-resistant epilepsy.
timeFrame: One hour and thirty minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Grenoble
country: France
facility: CHU Grenoble-Alpes
Study officials:
affiliation: Centre National de la Recherche Scientifique, France
name: Monica BACIU, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01187667: Evaluation of Delirium Prevention in Critically Ill Patients
Official title: Evaluation Study of a Delirium Prevention Policy Using Prophylactic Haloperidol in Critically Ill Patients With a High Risk for Delirium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: delirium
prevention
critical care
haloperidol
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2010-08-24
Enrollment: 650
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted in the ICU of a tertiary care clinic

Brief summary: Haloperidol is prescribed in high risk ICU patients concerning delirium (50% or more chance to develop delirium detected with the delirium prediction model PRE-DELIRIC, or patients with history of dementia or alcohol abuse)since the delirium protocol is changed and haloperidol is added as a prevention treatment we are gathering information what the effect is on several aspects of delirium

Detailed description: Measurement the effect of haloperidol as delirium preventive intervention. Determining effect on:

- delirium incidence in the ICU - different subtypes of delirium - delirium free days in 28 days - days on the ventilator - length of stay on the ICU and In-Hospital - 28-day mortality - incidence of unexpected removal of tubes, and effect between different groups of patients. Safety of haloperidol concerning QT-time, extrapyramidal symptoms.

Data are compared with the data of a historical cohort

Eligibility criteria: Inclusion Criteria:

* Patients With Predicted Delirium Chance of \>50% or history of dementia or alcohol abuse and treated with haloperidol

Exclusion Criteria:

* CAM-ICU is Not Applicable
* Patients Admitted 24hours or Shorter on the ICU, Patients Who Are Delirious Within 24 Hours After ICU Admission
* patients whereby haloperidol is contra-indicated

Primary outcomes:
measure: Delirium incidence
timeFrame: one year
Secondary outcomes:
measure: duration of delirium days on mechanical ventilator Length of stay in the ICU and in-hospital in-hospital mortality incidence of unplanned removal of tube incidence of delirium subtypes
timeFrame: one year
measure: Effect haloperidol on biomarkers
timeFrame: one year
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
Study officials:
affiliation: Radboud University Medical Center
name: Peter Pickkers, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van den Boogaard M, Schoonhoven L, van Achterberg T, van der Hoeven JG, Pickkers P. Haloperidol prophylaxis in critically ill patients with a high risk for delirium. Crit Care. 2013 Jan 17;17(1):R9. doi: 10.1186/cc11933.