louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01159769: Patient Perceptions and Quality of Life Associated With the Use of Olapatadine 0.2% for the Treatment of Allergic Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Allergic Conjunctivitis
Keywords: Allergic conjunctivitis
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2010-07-09
Enrollment: 215
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
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 evaluate patient perceptions of olopatadine 0.2% dosed once daily in patients previously treated with twice-daily, topical, ocular, anti-allergy medications.


Eligibility criteria: Inclusion Criteria:

* 12 years of age or older.
* History (within the past 24 months) of allergic conjunctivitis.
* Active signs and symptoms of ocular allergies.
* Ocular health within normal limits, as determined by the investigator or subinvestigator.
* Willing to avoid contact lens wear each study visit immediately prior to study medication instillation and for 10 minutes after instillation of study drug.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Contraindications or hypersensitivity to study medication or its components.
* One sighted eye or not correctable to 0.6 logMAR or better in both eyes at the screening visit.
* Known history of recurrent corneal erosion syndrome.
* Ocular trauma or surgical intervention within 6 months prior to Visit 1.
* Participation in any other investigational study within 30 days before Visit 1.
* Pregnant or nursing.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Overall Patient Satisfaction
timeFrame: Day 0
measure: Overall Patient Satisfaction
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04934969: The Adjunctive Use of Lavender and Peppermint Essential Oils
Official title: The Adjunctive Use of Lavender and Peppermint Essential Oils to Manage Nausea, Pain, and Anxiety in an Adult Orthopedic Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Joint Diseases
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2021-06-22
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: feasibility of using essential oils post joint replacement surgery and trends toward relief of symptoms
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will use passive inhalation of lavender for discomfort, anxiety and peppermint for nausea following joint replacement and spine surgery

Detailed description: Following review of records for eligibility and consent obtained during pre op visit subjects will be enrolled in study post op they will validate desire to participate and chose to inhale (2 drops of essential oil on cotton ball in a plastic bag) lavender for discomfort or anxiety or peppermint for GI distress

Visual analogue scales will be used to rate discomfort , anxiety and nausea

Eligibility criteria: Inclusion Criteria:

- elective joint replacement able to read and speak English and describe study procedures

Exclusion Criteria:

pregnancy

* unable to smell, sensitivity to fragrances asthma or breathing problems have smoke or vaped in last 2 weeks if atrial fibrillation history no peppermint uncontrolled hypertension above 160/100 non employees of UH or students of CWRU

Primary outcomes:
measure: discomfort, anxiety, or GI distress
timeFrame: total of 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals of Cleveland
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Denise Kresevic, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02368769: Assessment of Tele-expertise for Frozen Section Diagnosis
Official title: Multidimensional Assessment of Tele-expertise for Frozen Section Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Frozen Sections
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Agence Regionale de Sante d'Ile de France
First posted: 2015-02-23
Enrollment: 253
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who need a frozen section diagnosis

Brief summary: The purpose of the study is to assess whether performing a frozen section diagnosis off site with virtual slides would be as quick and accurate as usual technique.


Eligibility criteria: Inclusion Criteria:

* All patients

Exclusion Criteria:

* None

Primary outcomes:
measure: Proportion of delay under 30 minutes between the sample extraction and the communication of the result to the surgeon
timeFrame: 30 minutes after the sample extraction
Secondary outcomes:
measure: Delay between extraction of the sample and the diagnosis given to the surgeon
timeFrame: 24h after procedure
measure: Number of frozen section diagnosis among surgical procedures in need of frozen section diagnosis
timeFrame: Once a month
measure: Overall cost of a frozen section diagnosis
timeFrame: 6 months after the first patient enrollment
Other outcomes:
Locations:
city: Clamart
country: France
facility: Service d'Anatomie pathologique. Hôpital Antoine Béclère
city: Le Kremlin Bicêtre
country: France
facility: Service d'anatomie pathologique. Hôpital Bicêtre
city: Montfermeil
country: France
facility: Service d'anatomie pathologique. Hôpital de Raincy-Montfermeil
city: Montfermeil
country: France
facility: Service d'ORL. Hôpital du Raincy-Montfermeil
city: Paris
country: France
facility: Service d'anatomie pathologique. Hôpital Saint Antoine
city: Paris
country: France
facility: Service de chirurgie viscérale. Hôpital des Diaconnesses
Study officials:
affiliation: Hôpital Bicêtre. Assistance Publique - Hôpitaux de Paris
name: Catherine Guettier, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: DRCD URC Eco. Assistance Publique - Hôpitaux de Paris
name: Isabelle Durand-Zaleski, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gould PV, Saikali S. A comparison of digitized frozen section and smear preparations for intraoperative neurotelepathology. Anal Cell Pathol (Amst). 2012;35(2):85-91. doi: 10.3233/ACP-2011-0026.
citation: Tetu B, Fortin JP, Gagnon MP, Louahlia S. The challenges of implementing a "patient-oriented" telepathology network; the Eastern Quebec telepathology project experience. Anal Cell Pathol (Amst). 2012;35(1):11-8. doi: 10.3233/ACP-2011-0023.
citation: Charrier N, Zarca K, Durand-Zaleski I, Calinaud C; ARS Ile de France telemedicine group. Efficacy and cost effectiveness of telemedicine for improving access to care in the Paris region: study protocols for eight trials. BMC Health Serv Res. 2016 Feb 8;16:45. doi: 10.1186/s12913-016-1281-1.
Clinical trial NCT00772369: Retrospective Survey of Safety of Fourth Dose Pentacel® in Children
Official title: Retrospective Safety Survey of Selected Events in the 6 Months Following the 4th Dose of the Pentacel® Vaccination Series in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diphtheria
Pertussis
Haemophilus Infection
Tetanus
Polio
Keywords: Pertussis
Whooping cough
Diphtheria
Tetanus
Haemophilus influenzae
Poliovirus Types 1, 2, and 3.
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-10-15
Enrollment: 3214
Sex: ALL
Minimum age (years): 12
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children residing in the Canadian Province of British Columbia who have received the 4th dose of the Pentacel® series before their 2nd birthday

Brief summary: The purpose of this survey is to collect selected safety data.

Primary Objective:

To collect selected safety data at 6 months following the 4th dose of the Pentacel® series.

Detailed description: This is a retrospective survey to collect selected safety data at 6 months following the 4th dose of Pentacel® in children residing in the Canadian Province of British Columbia who have received the 4th dose of the Pentacel® series before their 2nd birthday.

Eligibility criteria: Inclusion Criteria:

* Children residing in the Canadian Province of British Columbia who have received the 4th dose of the Pentacel® series before their 2nd birthday.
* Written Informed Consent and Telephone consent from the parent(s) or guardian(s).
* Able to comply with the survey procedures.

Exclusion Criteria:

* Fourth dose of the Pentacel® series received on or after the child's 2nd birthday.

Primary outcomes:
measure: Number of Participants Who Had Positive Response to the Solicited Adverse Events Questionnaire Post 4th Dose of the Pentacel® Vaccination Series
timeFrame: 6 months post 4th dose vaccination
measure: Number of Participants Reporting Serious Adverse Events (SAE) Post 4th Dose of the Pentacel® Vaccination Series and Relationship to Study Vaccine.
timeFrame: 6 Months post 4th dose vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
state: British Columbia
Study officials:
affiliation: Sanofi Pasteur Inc.
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT01827969: Feasibility Study of Ablathermy Focused Ultrasound (USF) of Breast Tumors Before Mastectomy
Official title: Feasibility Study of Ablathermy Focused Ultrasound (USF) of Breast Tumors Before Mastectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Tumor
Keywords: Women
breast tumor
planned mastectomy
Lead sponsor: Institut Bergonié
Sponsor class: OTHER
First posted: 2013-04-10
Enrollment: 1
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: The treatment consists of tumor ablation by Ablathermy Focused Ultrasound (USF), guided by MRI, performed under local anesthesia and sedation.

Detailed description: The treatment consists of tumor ablation by USF, guided by MRI, performed under local anesthesia and sedation. Patients will be operated (mastectomy) from 48 hours after ablation.

Eligibility criteria: Inclusion Criteria:

* Invasive Breast Carcinoma with histologically confirmed hormone receptor analysis, the grade of the tumor, the expression of Her-2.
* Lesion classified T1-T2-T3 unifocal or multifocal with or without associated microcalcifications
* Lesion recognizable and identifiable in MRI
* Indication of mastectomy with or without axillary
* Lesion located more than 10 mm from the skin, the nipple and pectoralis major
* No cons-indication to MRI (pacemaker)
* Women whose age is ≥ 18 years
* If premenopausal patient: patient contraceptives
* Patient has signed informed consent
* Affiliation to a social security scheme

Exclusion Criteria:

* Tumor-TD T4B classified or non-palpable lesion
* If age \<70 years: no indication of adjuvant chemotherapy and neoadjuvant
* MRI lesions have not been identified, located within 10 mm of the skin and pectoral muscle, greater than 25 mm diameter
* Inability to hold still in the prone position, arms extended, for 30 minutes
* Contraindication to MRI
* Patient deprived of liberty and major subject of a measure of legal protection or unable to consent
* Patient participating in another interventional clinical trial within 30 days prior to baseline and during the trial.

Primary outcomes:
measure: Evaluate the effectiveness of ablathermy
timeFrame: 2 years
Secondary outcomes:
measure: - Assessment of apoptotic phenomena in the margins of lesions treated
timeFrame: 2 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Institut Bergonié
state: Aquitaine
Study officials:
affiliation: Institut Bergonié
name: PALUSSIERE Jean, MD
role: STUDY_CHAIR
References:
Clinical trial NCT03546569: Tumor Cells, Tumor DNA and Immunological Response in Colonic Stent Placement
Official title: Circulation Tumor Cells, Tumor DNA and Immunological Response in Relation to Colonic Stent Placement for Malignant Obstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer of Colon
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2018-06-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We intend to include 20 patients with malignant obstruction who are treated with a colorectal stent as bridge to surgery or as palliation.

Brief summary: This study aims to investigate levels of circulating cell free DNA (cfDNA), circulating tumor DNA (ctDNA), circulating tumor cells (CTC) and immunological changes after self-expanding metal stent (SEMS) placement for malignant obstruction in the colon, and interpret these levels in relation to overall- and disease-free survival.

Furthermore, we intend to study the opportunity to identify patients with a higher risk of recurrence due to the SEMS placement by monitoring cfDNA and ctDNA-levels, as it may be a potential biomarker to initiate or optimize chemotherapy and thereby ensure a better prognosis for the patients.

Detailed description: Study design This prospective study will include 20 patients undergoing SEMS placement as a bridge to elective surgery at Koege- and Slagelse Hospital. Baseline blood samples will be collected before the procedure. After the procedure blood samples will be collected 1, 4, 12 and 24 hours after SEMS placement. After elective surgery a tumor sample will be collected.

Prior to SEMS placement:

When potential candidates are admitted to the hospital they will be presented to the study by the relevant surgeon. The investigators will be contacted, when the patient is admitted to hospital.

Eligibility criteria: Inclusion Criteria:

* Patients between the ages of 18 to 95 years
* Patients with acute malignant obstruction in the colon.
* ASA class I-III (Classification of the American Society of Anesthesiology)
* Signed informed consent

Exclusion Criteria:

* Known immune-defects
* Withdrawal of informed consent
* Bloodtransfusion 24 hours prior to stent-placement until 24 hours after stent-placement.
* Surgery within 24 hours after stent-placement
* Known inflammatory bowel disease

Primary outcomes:
measure: ctDNA/cfDNA levels in relation to colorectal stent placement
timeFrame: 2 years
Secondary outcomes:
measure: Immunological response
timeFrame: 2 years
measure: Metastatic ability of the cancer cells
timeFrame: 2 years
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Zealand University Hospital
Study officials:
References:
Clinical trial NCT00179569: Molecular Processes of the Relaxation Response in Older Adults
Official title: Molecular Processes of the Relaxation Response in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Stress
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2005-09-16
Enrollment: 40
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to examine the molecular (nitric oxide) and biochemical (epinephrine, norepinephrine, cortisol and ACTH) parameters that are associated with RR elicitation and which may counteract the effects of acute stress in the elderly.


Eligibility criteria: Inclusion Criteria:

* 60-80 years of age
* healthy individuals
* willing and able to attend treatment sessions
* willing to learn how to do and practice the relaxation-response
* access to a working telephone
* read and write English

Exclusion Criteria:

* Major medical or psychiatric illness
* asthma or seasonal allergies (resulting in nitric oxide levels \>60 ppb)
* smoking
* previous relaxation-response practice
* current use of the following medications:systemic corticosteroids, anti-convulsants/psychotics, immunosuppressants, cytotoxic therapy, anabolic steroids, antidepressants (other than SSRIs), dicyclomine, bile acid binding resins, or sympathomimetic medication

Primary outcomes:
measure: A primary goal of this study is to quantify the magnitude of relaxation response elicitation by comparing oxygen consumption during rest versus during elicitation of the relaxation response in a sample of healthy older adults.
timeFrame: 8 weeks
Secondary outcomes:
measure: A second area of interest is the relationship between exhaled levels of nitric oxide (NO) and oxygen consumption (VO2) during relaxation response elicitation.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: BIDMC
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Jeffery A Dusek, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01063569: Glucocorticoid Treatment in Addison's Disease
Official title: Glucocorticoid Treatment in Addison's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Addison's Disease
Keywords: Addison's disease
Glucocorticoid treatment
Continuous subcutaneous hydrocortisone infusion
CSHI
Quality of Life
Sleep
Lead sponsor: Haukeland University Hospital
Sponsor class: OTHER
First posted: 2010-02-05
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Addison's disease is a rare condition which in most cases is caused by autoimmune destruction of the adrenals, leading to deficiency of cortisol, aldosterone and adrenal androgens. Unrecognized the disease is life threatening, but with proper treatment patients can live near normal lives.

The conventional glucocorticoid replacement therapy renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. Glucocorticoid replacement therapy is technically feasible by continuous subcutaneous hydrocortisone infusion (CSHI), and can mimic the normal diurnal cortisol rhythm. This study aims to further evaluate CSHI treatment in terms of metabolic effects, effects on health-related quality-of-life and sleep in an 8 months randomised open label clinical trial with crossover design.


Eligibility criteria: Inclusion Criteria:

* Patients with verified Addison's disease on stable treatment.

Exclusion Criteria:

* Insulin treated Diabetes Mellitus, cardiovascular disease,malignant disease, pregnancy.
* Treatment with glucocorticoids or drugs that interfere with cortisol metabolism (antiepileptics, rifampicin, St. John's wart).

Primary outcomes:
measure: Morning (08-09) plasma ACTH
timeFrame: Time 0, months 2, 3, 5, 7 and 8
Secondary outcomes:
measure: Health-Related Quality of Life; evaluated by SF-36 vitality scores and AddiQoL scores
timeFrame: At time 0 and months 2,3,5,7 and 8
measure: Sleep; evaluated by Pittsburgh Sleep Quality Index (PSQI), and 7-days' Actigraph registration combined with self-reported sleep diary
timeFrame: PSQI: 0 and months 2,3,5,7 and 8; Actigraph/sleep diary: months 2 and 7
measure: 24h cortisol profiles in serum and saliva
timeFrame: months 2 and 7
measure: S-glucose, 24 h profile
timeFrame: months 2 and 7
measure: Insulin sensitivity assessed by euglycemic clamp
timeFrame: Months 2 and 7
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Stockholm
country: Sweden
facility: Karolinska Institutet
city: Uppsala
country: Sweden
facility: Uppsala University
Study officials:
affiliation: Haukeland University Hospital
name: Kristian Løvås, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00063869: Study Evaluating the Safety and Efficacy of Etanercept in Patients With Idiopathic Pulmonary Fibrosis
Official title: A Double-blind, Parallel, Placebo-controlled, Randomized Study of the Efficacy and Safety of Etanercept in Patients With Idiopathic Pulmonary Fibrosis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pulmonary Fibrosis
Keywords: Idiopathic Pulmonary Fibrosis
Fibrosis, Pulmonary
Pulmonary Fibroses
Fibroses, Pulmonary
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2003-07-09
Enrollment: 88
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate the safety and efficacy of etanercept in comparison with placebo in a double-blind, parallel, randomized fashion in subjects with idiopathic pulmonary fibrosis (IPF) who failed previous therapy. The treatment period will be up to 1 year. The primary objective is evaluation of safety and efficacy. Secondary: The secondary objective is to evaluate quality of life (QoL) and pharmacokinetics (PK).


Eligibility criteria: Inclusion Criteria:

* Diagnosis of IPF based on American Thoracic Society (ATS) guidelines

Exclusion Criteria:

* Subjects with end-stage
* Previous treatment with etanercept or other TNF antagonists (eg, a TNF monoclonal antibody or a soluble TNF-receptor)
* Receipt of any investigational drug or biological agent within 4 weeks of screening visit

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor, MD
role: STUDY_DIRECTOR
References:
citation: Raghu G, Brown KK, Costabel U, Cottin V, du Bois RM, Lasky JA, Thomeer M, Utz JP, Khandker RK, McDermott L, Fatenejad S. Treatment of idiopathic pulmonary fibrosis with etanercept: an exploratory, placebo-controlled trial. Am J Respir Crit Care Med. 2008 Nov 1;178(9):948-55. doi: 10.1164/rccm.200709-1446OC. Epub 2008 Jul 31.