louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02399059: Effect of Peritoneal Lavage With Clindamycin-Gentamicin Solution & Oncologic Outcome
Official title: Effect of Peritoneal Lavage With Clindamycin-Gentamicin Solution During Elective Colorectal Cancer Surgery on the Oncologic Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Colorectal Tumors
Keywords: recurrence
Lead sponsor: Hospital General Universitario Elche
Sponsor class: OTHER
First posted: 2015-03-26
Enrollment: 106
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Antibiotic lavage reduces bacterial contamination and decreases SSI infection rate. SSI leads to an immunocompromised situation, leaving unattended the neoplasm. It has been described that SSI may result in a worse oncologic outcome.

Detailed description: Antibiotics combined with lavage have demonstrated a reduction in the bacterial contamination and decreases SSI infection rate. SSI leads to an immunocompromised situation, as immunologic defense is focused on controlling the septic focus, leaving unattended the neoplasm. It has been described that SSI may result in a worse oncologic outcome. The aim of this study is to evaluate prospectively the effect of peritoneal lavage with clindamycin and gentamicin on the oncologic outcome of colorectal tumours.

Eligibility criteria: Inclusion Criteria:

* diagnosis of colon neoplasms
* plans to undergo an elective surgery with curative aims

Exclusion Criteria:

* preoperative diagnosis of chronic renal failure (because of the risk of nephrotoxicity associated with intraperitoneal gentamicin absorption)
* allergy to gentamicin or clindamycin.

Primary outcomes:
measure: Global survival
timeFrame: 36 months after intervention
Secondary outcomes:
measure: Disease free survival
timeFrame: 36 months after intervention
Other outcomes:
Locations:
Study officials:
affiliation: Hospital Rey Juan Carlos
name: Jaime Ruiz-Tovar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03160300: The Effect of Binaural Beats on Pain Perception and Analgesic Medication Use in Patients Suffering From Chronic Pain
Official title: Placebo-Controlled, Randomized, Double-Blind Trial on the Effect of Binaural Beats on Pain Perception and Analgesic Medication Use in Patients Suffering From Chronic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Pain
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2017-05-19
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study evaluates the effect of binaural beats on pain perception and subsequent need for analgesic medication use in patients suffering from diseases causing chronic pain. All patients will receive two consecutive interventions: binaural beat signals embedded in relaxing music and placebo (relaxing music without the binaural beat component), in random order.

Detailed description: Binaural beats consist of two artificially produced sound waves, differing in wave frequency, presented simultaneously and separately to each ear. The brain, following binaural beat processing, synchronizes to the frequency difference between the two waves. Therefore, using a 5 Hz frequency difference (theta rhythm), which promotes relaxation, we could alleviate pain perception and subsequent analgesic medication use.

Patients suffering from chronic pain will receive two consecutive interventions: binaural beat signals embedded in relaxing music and placebo (relaxing music without the binaural beat component), in random order.

Electroencephalogram (EEG) recordings will be used to confirm brain frequency synchronization, whereas pain severity scales and a diary recording analgesic medication use will be used to identify differences between intervention and placebo arms.

Eligibility criteria: Inclusion Criteria:

* Chronic pain
* Regular analgesic medication use

Exclusion Criteria:

* Malignant pain
* Headache as the cause of chronic pain
* Hearing disability
* Neuropsychiatric disease
* Previous experience with binaural beats

Primary outcomes:
measure: Effect on pain severity
timeFrame: After 30 minutes of listening to binaural beat signals or sham intervention
measure: Effect on analgesic medication use
timeFrame: One week on an "as needed" basis intervention use to alleviate pain, keeping a diary
Secondary outcomes:
measure: Effect on electroencephalogram (EEG)
timeFrame: 30 minutes of listening to binaural beat signals or sham intervention
Other outcomes:
Locations:
city: Thessaloníki
country: Greece
facility: University General Hospital of Thessaloniki AHEPA
Study officials:
affiliation: Aristotle University Of Thessaloniki
name: Dimitrios Kouvelas, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT02684500: Aneurysmal Subarachnoid Hemorrhage and Superior Mesenteric Artery Flow Study
Official title: Evaluation of Superior Mesenteric Artery Diameter and Flow in Aneurysmal Subarachnoid Hemorrhage Patients Undergoing Hypertensive Therapy for Cerebral Artery Vasospasm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysm
Keywords: aSAH
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2016-02-18
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects will be recruited from the neurointensive care unit (NICU).Patients admitted to the neurointensive care unit (NICU) with a diagnosis of aSAH or are diagnosed with aSAH while an inpatient at the NICU at and area hospital.

Brief summary: The purpose of this research study is to determine if the diameter and flow of the superior mesenteric artery in patients with aneurysmal subarachnoid hemorrhage undergoing hypertensive therapy for cerebral artery vasospasm are effected enough to justify withholding enteral nutrition.

Detailed description: Study measurements of the diameter and Doppler flow velocity of the superior mesenteric artery (SMA) using abdominal ultrasound in order to evaluate the potential additional risk of non-occlusive mesenteric ischemia (NOMI) and non occlusive bowel necrosis (NOBN) in patients undergoing hypertensive therapy for cerebral vasospasm in Aneurysmal Subarachnoid Hemorrhage (aSAH), to justify the withholding of enteral nutrition.

Eligibility criteria: Inclusion Criteria:

* Patient diagnosed with aSAH

Exclusion Criteria:

* Hemodynamic instability
* Already receiving vasopressor therapy
* Non-aneurysmal SAH
* Intracranial hemorrhage of other cause
* Not anticipated to receive hypertensive therapy with vasoactive medications for cerebral vasospasm from SAH or suspected aSAH
* Unable to visualize SMA using ultrasound
* Pregnancy

Primary outcomes:
measure: Change between baseline and 21 days of abdominal ultrasound measurement of the diameter in the superior mesenteric artery
timeFrame: Change from baseline up to 21 days
measure: Change between baseline and 21 days of abdominal ultrasound measurement of the doppler flow velocity in the superior mesenteric artery
timeFrame: Change from baseline up to 21 days
Secondary outcomes:
measure: Number of participants with non-occlusive mesenteric ischemia (NOMI)
timeFrame: Change from baseline up to 21 days
measure: Number of participants with non occlusive bowel necrosis (NOBN)
timeFrame: Change from baseline up to 21 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Peggy White, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06588400: AOSEPT (CLEAR CARE) PLUS Study
Official title: AOSEPT™ PLUS With HydraGlyde FID 120947A and AOCup Lens Case (CLEAR CARE PLUS) and AOSEPT™ PLUS FID 119056 and AOCup Lens Case (CLEAR CARE) Family PMCF Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Contact Lens Care
Keywords: Contact Lens Solution
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2024-09-19
Enrollment: 200
Sex: ALL
Minimum age (years): 7
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The purpose of this post-market clinical follow-up (PMCF) study is to evaluate the long-term safety and performance of 2 commercially available contact lens cleaning and disinfecting systems in a pediatric population.

Detailed description: Subjects will participate in the study for approximately 90 days, with telephone calls scheduled on Day 30 ± 7 (Visit 2) and Day 60 ± 7 (Visit 3) and an in-office follow-up visit scheduled on Day 90 ± 7 (Visit 4). Subjects may have unscheduled visits if deemed necessary per the Investigator's judgment.

Eligibility criteria: Key Inclusion Criteria:

* Subject and parent/legally authorized representative able to understand and sign an Institution Review Board approved informed consent/assent form.
* Subject willing to follow and be able to attend all scheduled study visits as required per protocol.
* Successful wear of daily wear, reusable, soft (including hydrogel and silicone hydrogel) or rigid gas permeable (RGP) contact lenses in both eyes for the past 3 months for a minimum of 5 days per week and 8 hours per day.
* Other protocol-specified inclusion criteria may apply.

Key Exclusion Criteria:

* Any ocular disease or condition that would contraindicate contact lens wear.
* Use of systemic or ocular medication that would contraindicate contact lens wear.
* Any known sensitivity to any ingredients in the study products.
* Current or history of pathological dry eye in either eye that would in the opinion of the Investigator preclude contact lens wear.
* Any use of habitual/prescribed topical ocular medication or artificial tear or rewetting drop (habitual) that would require instillation during the study.
* Other protocol-specified exclusion criteria may apply.

Primary outcomes:
measure: Front surface deposits at Day 90
timeFrame: Day 90
measure: Back surface deposits at Day 90
timeFrame: Day 90
measure: Incidence of corneal infiltrative events
timeFrame: Up to Day 90
measure: Incidence of microbial keratitis
timeFrame: Up to Day 90
measure: Incidence of solution induced corneal staining (SICS)
timeFrame: Up to Day 90
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT02026700: Bariederm Cream in Chronic Contact Dermatitis
Official title: Bariederm Cream in Chronic Contact Dermatitis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Contact Dermatitis
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2014-01-03
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We intend to evaluate the efficiency and tolerability of a barrier cream (bariederm) in protecting hands of individuals with hand dermatitis, either due to allergy or irritation. We believe that the use of the cream would benefit with the skin.

Detailed description: The aim of the study is the evaluation of the effectiveness, tolerance and cosmetic acceptability of Bariéderm cream among patients presenting with chronic allergic or irritant contact dermatitis of the hands. We shall enrol adults presenting with CONTACT DERMATITIS EXCLUDING FLARE-UPS of the hands: whether allergic or irritant, able to understand the protocol and agrees to sign the information and informed consent form. Bariéderm cream will be applied minimum twice daily over 21 days. Response will be evaluated by self and physician filled questionnaires. effectiveness, tolerance and cosmetic acceptability will be evaluated by a scale of 1-10, 1 meaning "not at all" and 10 meaning "very much". Statistics will be performed by SPSS software with suitable statistical tests. In case of an adverse event caused by the product, patch-test with ingredients of Bariéderm cream will be performed.

Eligibility criteria: Inclusion Criteria:

* patients with dermatitis of the hands

Exclusion Criteria:

* pregnant ladies,
* known allergy to ingredients -

Primary outcomes:
measure: self evaluation of effectiveness and tolerance in a 1-10 scale
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: : Hadassah Medical Organization, Jerusalem, Israel
Study officials:
affiliation: Dept of Dermatology, Hadassah Medical Center, Jerusalem 911201, Israel
name: Liran Horev Yakir, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01274000: A Study to Evaluate Efficacy of YM060 on Diarrhea-predominant Irritable Bowel Syndrome (D-IBS) in Female Patients
Official title: Phase II Study of YM060 - Double-blind, Parallel-group Comparative Study in Patients (Female) With Diarrhea-predominant Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome
Keywords: diarrhea
IBS
Colonic disease
YM060
Ramosetron
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-01-11
Enrollment: 409
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A study to verify the superiority of YM060 (ramosetron) to placebo for female patients with diarrhea-predominant irritable bowel syndrome (D-IBS) and to evaluate its safety.


Eligibility criteria: Inclusion Criteria:

* Patients meeting the Rome III Diagnostic Criteria
* Loose (mushy) or watery stools within the last 3 months
* Abdominal discomfort and/or pain during their non-menstrual period

Exclusion Criteria:

* Patients with a history of surgical resection of the stomach, small intestine or large intestine
* Patients with a history or current diagnosis of inflammatory bowel disease (Crohn's disease or colitis ulcerative)
* Patients with a history or current diagnosis of colitis ischemic
* Patients with a current diagnosis of enteritis infectious
* Patients with a current diagnosis of hyperthyroidism or hypothyroidism
* Patients who are currently participating in another clinical trial (including a post-marketing clinical study) or those who participated in another clinical trial (including a post-marketing clinical study) within 12 weeks before the study
* Patients with a history or current diagnosis of malignant tumor
* Patients with a history of abuse of drugs or alcohol within 1 year or those who are currently abusing them

Primary outcomes:
measure: Responder rate of patients reported global assessment of relief of IBS symptoms
timeFrame: for 4 weeks
Secondary outcomes:
measure: Responder rate of patients reported assessment of relief of abdominal discomfort and/or pain
timeFrame: for 4 weeks
measure: Responder rate of patients reported assessment of improvement of abnormal bowel habits
timeFrame: for 4 weeks
measure: Change in weekly average scores of stool form (appearance)
timeFrame: Baseline and for 4 weeks
measure: Safety assessed by the incidence of adverse events and abnormal values in lab-tests
timeFrame: for 4 weeks
Other outcomes:
Locations:
city: Hokkaido
country: Japan
city: Kansai
country: Japan
city: Kantou
country: Japan
city: Kyusyu
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
citation: Fukudo S, Matsueda K, Haruma K, Ida M, Hayase H, Akiho H, Nakashima Y, Hongo M. Optimal dose of ramosetron in female patients with irritable bowel syndrome with diarrhea: A randomized, placebo-controlled phase II study. Neurogastroenterol Motil. 2017 Jun;29(6). doi: 10.1111/nmo.13023. Epub 2017 Feb 16.
Clinical trial NCT03311100: Immunological Profile of Solid Tumors Sample
Official title: Study of the Immunological Profile of Archival Formalin-fixed Paraffin-embedded Solid Tumors Sample
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Solid Cancer
Lead sponsor: Assistance Publique Hopitaux De Marseille
Sponsor class: OTHER
Collaborators: name: Innate Pharma
First posted: 2017-10-16
Enrollment: 1040
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with solid cancer

Brief summary: It has become clear in the recent year that the nature of the immune cells infiltrate within a tumor was essential in the control of the tumor growth. This so-called immune contexture does vary between cancer types and in response to treatments. In this context, this trial is a non-interventional, mono-centric in patients with solid tumors. Samples in paraffin-embedded material block of biopsies or surgical pieces (either primitive tumor or metastases) will be analysed. For each sample, clinically relevant data associated with treated cancer and needed for characterization of tumor microenvironment will be documented.

This trial is, through accessing to well documented selected archival tumor materials, to validate selected biomarker for early phase trial.


Eligibility criteria: Inclusion Criteria:

* Sample must have had a valid written informed consent for available archival tumor samples for scientific purposes.
* Sample from patients with histologically documented cancer in target population.

Exclusion Criteria:

* Samples from subject unwilling to give their informed consent;
* Unusable sample or biologically deteriorated.

Primary outcomes:
measure: Immunohistochemistry scores
timeFrame: 24 months
measure: Immunohistochemistry scores
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Marseille
country: France
facility: Assistance Publique Hôpitaux de Marseille
Study officials:
affiliation: Assistance Publique Hôpitaux de Marseille
name: ARNAUD Jean-Olivier, Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01675700: Topical Nitrates for Myofascial Trigger Points
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myofascial Trigger Points
Keywords: Myofascial pain
Trigger point
Nitroglycerin
Lead sponsor: GF Strong Rehabilitation Centre
Sponsor class: OTHER
First posted: 2012-08-30
Enrollment: 10
Sex: ALL
Minimum age (years): 19
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether a topical nitroglycerine patch applied daily over a trapezius trigger point can improve patients' symptoms.

If there is improvement, this open label study will help determine the degree of improvement and contribute to the design of a larger double blind placebo controlled trial.

We would consider moving forward to a large randomized trial if:

* The intervention is acceptable to patients (\>= 70%) and
* Compliance is satisfactory (\>=80%) and
* We find preliminary evidence of efficacy, i.e. average reduction in pain of 20mm on the VAS.


Eligibility criteria: Inclusion Criteria:

* Inclusion criteria include age between 19 and 65 years old, myofascial pain lasting at least 6 months, and a myofascial trigger point point in the trapezius muscle.

Exclusion Criteria:

* Our exclusion criteria include symptomatic disc herniation, symptomatic cervical osteoarthritis, systemic infection, malignancy, collapsed vertebra, thoracic outlet syndrome, temporomandibular joint dysfunction, collagen-vascular disease, or brachial plexopathy. Patients with ongoing litigation regarding their symptoms are not eligible for this study. Also excluded are patients with underlying cardiac disease, hypotension, or medical conditions that may not allow them to tolerate the use of vasodilators, and those who use phosphodiesterase inhibitors.

Primary outcomes:
measure: Pain at the time of clinic visit and over the previous week as measured by a Visual Analog Scale, VAS, for pain and a pressure algometer measurement to obtain pressure pain thresholds over the patients trigger point.
timeFrame: 1 month
Secondary outcomes:
measure: As another secondary outcome we will ask the participants whether the benefits of the treatment are good enough that they would continue using the nitroglycerin patch. This will be a yes or no response.
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
affiliation: University of British Columbia
name: Hubert A Anton, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00331500: Olopatadine 0.2% for the Treatment of Allergic Conjunctivitis
Official title: A Comparative Study of Olopatadine 0.2% Versus Vehicle in Patients With Seasonal Allergic Conjunctivitis or Rhinoconjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-05-31
Enrollment: 287
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to demonstrate that Olopatadine 0.2% is superior to vehicle in the treatment of the signs and symptoms associated with allergic conjunctivitis or rhinoconjunctivitis.


Eligibility criteria: Inclusion Criteria:

* History of seasonal allergic conjunctivitis or rhinoconjunctivitis, a positive grass antigen challenge reaction (skin test), and a positive response to grass in the Conjunctival Allergen Challenge (CAC) model

Exclusion Criteria:

* Under 10 years of age

Primary outcomes:
measure: Daily ocular itching and redness scores
timeFrame: Up to Day 14
Secondary outcomes:
measure: Percentage of patients with daily ocular itching and redness scores of 0
timeFrame: Up to Day 14
Other outcomes:
Locations:
Study officials:
affiliation: Alcon, a Novartis Company
name: Alcon, A Novartis Company
role: STUDY_DIRECTOR
References:
citation: https://www.ncbi.nlm.nih.gov/pubmed/23379201