louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00511992: Study of Bevacizumab Followed by Bevacizumab Consolidation for Ovarian Cancer
Official title: Phase II Study of Paclitaxel (TAXOL), Intraperitoneal Cisplatin and IV Avastin Followed by Avastin Consolidation for Advanced Ovarian and Peritoneal Carcinoma or Fallopian Tube Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Advanced Ovarian Carcinoma
Primary Peritoneal Carcinoma
Ovarian Carcinosarcoma
Keywords: Ovarian Cancer
Gynecologic Cancer
Ovarian Carcinoma
Peritoneal Carcinoma
IP chemotherapy
Intraperitoneal
Avastin
Bevacizumab
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Genentech, Inc.
First posted: 2007-08-06
Enrollment: 20
Sex: FEMALE
Minimum age (years): 18
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 evaluate the tolerability of intraperitoneal cisplatin with intravenous paclitaxel and Avastin as defined by the proportion of patients able to complete 6 cycles of treatment.

Detailed description: Ovarian cancer is the leading cause of death from gynecologic cancer in the United States. The high death rate stems from late presentation and tumor that has spread beyond the ovary at the time of diagnoses.

Ovarian cancer typically spreads throughout the peritoneal cavity. Three randomized clinical trial have recently demonstrated the superiority of intraperitoneal(IP) over intravenous platinum based chemotherapy in optimally debulked advance ovarian cancer. The success of Bevacizumab in metastatic colorectal cancer has led to trials evaluating its' efficacy in advanced ovarian cancer. Based on the mechanism of action of Bevacizumab, there may be benefit of extended therapy with this agent.

Eligibility criteria: Inclusion Criteria:

* Patients with stage II and III epithelial ovarian carcinoma, primary peritoneal carcinoma, or ovarian carcinosarcoma.
* Adequate bone marrow, renal, and hepatic function
* Patients must be entered no more than twelve weeks postoperatively

Exclusion Criteria:

* Patients with epithelial ovarian carcinoma of low malignant potential (borderline carcinomas).
* Stage IV or suboptimally debulked disease following primary cytoreductive surgery
* Patients who have received prior radiotherapy or chemotherapy.

Primary outcomes:
measure: Number of Patients Able to Complete 6 Cycles of Treatment.
timeFrame: 2 years
Secondary outcomes:
measure: Number of Patients Who Experienced Toxicities Associated With Intraperitoneal Cisplatin With Intravenous Paclitaxel and Avastin.
timeFrame: 2 years
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
affiliation: University of Oklahoma
name: D. Scott McMeekin, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01969292: Colometer - A Real Time Quality Improvement Feedback System for Screening Colonoscopy
Official title: Colometer - A Real Time Quality Improvement Feedback System for Screening Colonoscopy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Colon Cancer
Keywords: colonoscopy
quality assurance
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2013-10-25
Enrollment: 79
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Our team has created an automated, real-time software based image analysis tool called Colometer to improve screening colonoscopy providing real time visual feedback on image quality. There are three components to this study. The first is to validate the bowel assessment preparation using the recorded colonoscopy videos from 50 consented normal risk patients. In the second phase, technological and machine user interface refinements will be identified and completed. Finally, the third phase will be a sham controlled prospective study of Colometer versus standard care in 100 consented average risk patients undergoing screening colonoscopy as performed by 10 consented endoscopists.


Eligibility criteria: Inclusion Criteria:

* Patients: patients categorized as normal risk who have been referred for screening colonoscopy at the Forzani \& MacPhail Colon Cancer Screening Centre in Calgary, Alberta
* Endoscopists: Gastroenterologists with practices at the Forzani \& MacPhail Colon Cancer Screening Centre, Calgary, Alberta

Exclusion Criteria:

* Patients: patients who are not categorized as normal risk

Primary outcomes:
measure: %Clear
timeFrame: Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes
Secondary outcomes:
measure: Average withdrawal velocity
timeFrame: Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes.
measure: Ottawa Stool Score
timeFrame: Measurement will occur during the withdrawal phase as indicated by the physician during the colonoscopy procedure; on average, 12 minutes.
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: Forzani&MacPhail Colon Cancer Screening Centre
state: Alberta
Study officials:
affiliation: University of Calgary
name: Christopher N Andrews, MD MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03270592: Assessment of Service and Hearing Dogs
Official title: Assessment of Service and Hearing Dogs
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impairment
Diabetes
Epilepsy
Keywords: Service dogs
Alert dogs
Costs
Quality of Life
Cost-effectiveness
Lead sponsor: Linkoeping University
Sponsor class: OTHER_GOV
Collaborators: name: Ministry of Health and Social Affairs, Sweden
First posted: 2017-09-01
Enrollment: 56
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: For persons with impairments and certain illnesses the use of service dogs may have positive effect. The effects of using these dogs to assist in every day life need to be studied further.The aim of the study was to assess how health care consumption was effected by using certified service dogs and to study the cost-effectiveness of having a certified service dog.

Detailed description: This is an exploratory before and after study with the aim to study how health care consumption was effected by using certified service dogs and to study the cost-effectiveness of having a certified service dog. Data was collected before the education of the dog started and the follow-up was made three months after completion of the education. Data was collected on Health care consumption and outcomes in terms Health related quality of life and Health outcomes.

Eligibility criteria: Inclusion Criteria:

* Age over 16 years
* Having a regular companion dog
* Being in need of a certified service dog (due to impairment, diabetes, epilepsy and deafness)

Exclusion Criteria:

* Psychiatric illness

Primary outcomes:
measure: Total costs
timeFrame: Three months follow-up
measure: Health related quality of life, EQ-5D
timeFrame: Tree months follow-up
Secondary outcomes:
measure: Cost-effectiveness
timeFrame: Life time perspective
measure: Health related quality of life, RAND-36
timeFrame: Three months follow-up
measure: WHO-5 wellbeing index
timeFrame: Three months follow-up
measure: Rosenberg self-esteem scale
timeFrame: Three month follow-up
measure: EQ-VAS
timeFrame: Three months follow-up
Other outcomes:
Locations:
Study officials:
affiliation: Linkoeping University
name: Lars-Åke Levin, Professor
role: STUDY_DIRECTOR
References:
citation: Lundqvist M, Levin LA, Roback K, Alwin J. The impact of service and hearing dogs on health-related quality of life and activity level: a Swedish longitudinal intervention study. BMC Health Serv Res. 2018 Jun 27;18(1):497. doi: 10.1186/s12913-018-3014-0.
Clinical trial NCT04365192: Comparison of Efficacy of Two Supraglottic Airway Devices: I-gel and the Self-pressurized Air-q in Elderly Patients
Official title: Comparison of Efficacy of Two Supraglottic Airway Devices: I-gel and the Self-pressurized Air-q in Elderly Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Supraglottic Airway Devices
Lead sponsor: Istanbul Medeniyet University
Sponsor class: OTHER
First posted: 2020-04-28
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 65-85 years old patients who undergo urologic surgery

Brief summary: Supraglottic airway devices with noninflatable cuff have advantages in omitting the cuff pressure monitoring and reducing potential pharyngolaryngeal complications. Typical devices without cuff inflation available are the i-gel™ and the self-pressurized air-Q™ intubating laryngeal airway (air-Q SP).

The i-gel airway is a supraglottic airway management device made of thermoplastic elastomer, which is soft, gel-like, and transparent. It was designed to create a noninflating anatomical seal of the pharyngeal, laryngeal, and perilaryngeal structures while avoiding the compression trauma that can occur with inflatable SADs.

The i-gel has evolved as a device that accurately positions itself over the laryngeal framework, providing a reliable perilaryngeal seal, and therefore no cuff inflation is necessary. Its advantages include easier insertion, minimal risk for tissue compression, and stability after insertion.

The air-Q is a new SAD intended for use as a primary airway and an aid for tracheal intubation in situations of anticipated or unanticipated difficult airways. The intracuff pressure of air-Q dynamically equilibrates with the airway pressure and adjusts to the patient's pharyngeal and periglottic anatomy, potentially providing improved airway fit and seal.

The anatomical and physiological changes that accompany ageing may have a significant influence on the efficacy and safety of SADs. The distinctive features of the air-Q SP and i-gel may lead to a substantial difference in performance in the elderly, and it is planned a head-to-head comparison of these two devices in patients aged between 65 and 85 years.


Eligibility criteria: Inclusion Criteria:

* 65-85 years old
* ASA I-III
* Elective urologic surgery
* Mallampati 1-2

Exclusion Criteria:

* BMI\>35kg/m2
* Operation time more than 2 hours

Primary outcomes:
measure: Success in first attempt
timeFrame: 3 minutes
Secondary outcomes:
measure: Fiberoptic view grade
timeFrame: 4 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Medeniyet University
Study officials:
References:
Clinical trial NCT05581992: Study to Evaluate the Drug-drug Interaction Effect of Omeprazole on the Pharmacokinetics (PK) of AMG 510 in Healthy Participants
Official title: An Open-label Study to Evaluate the Drug-drug Interaction Effect of Omeprazole, a Proton-pump Inhibitor, on the Pharmacokinetics of AMG 510 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: AMG 510
Healthy Participants
Omeprazole
Lead sponsor: Amgen
Sponsor class: INDUSTRY
First posted: 2022-10-17
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective of this study is to evaluate the PK profile of AMG 510 alone and in combination with omeprazole in healthy participants.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects or female participants, between 18 and 60 years of age (inclusive), at the time of Screening.
* Body mass index, between 18 and 30 kg/m2 (inclusive), at the time of Screening.
* Females of nonchildbearing potential.

Exclusion Criteria:

* Inability to swallow oral medication or history of malabsorption syndrome.
* History of hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee) and in consultation with the Sponsor.
* Poor peripheral venous access.
* History or evidence, at Screening or Check in, of clinically significant disorder, condition, or disease not otherwise excluded that, in the opinion of the Investigator (or designee), would pose a risk to subject safety or interfere with the study evaluation, procedures, or completion.

Primary outcomes:
measure: Maximum Observed Plasma Concentration (Cmax) of AMG 510
timeFrame: Day 1 and Day 9
measure: Area Under the Plasma Concentration-time Curve (AUC) from Time Zero to the Last Quantifiable Concentration (AUClast) of AMG 510
timeFrame: Day 1 and Day 9
measure: AUC from time Zero to Infinity (AUCinf) of AMG 510
timeFrame: Day 1 and Day 9
Secondary outcomes:
measure: Number of Participants with an Adverse Event (AE)
timeFrame: Day 1 to Day 11
Other outcomes:
Locations:
city: Daytona Beach
country: United States
facility: Covance Clinical Research Unit, Inc
state: Florida
Study officials:
affiliation: Amgen
name: MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00765492: AZD8529 Multiple Ascending Dose Study in Healthy Subjects
Official title: A Phase I, Single-Center, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of AZD8529 When Given as Single and Multiple Ascending Oral Doses in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Phase I
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-10-03
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP

Brief summary: This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD8529 after multiple ascending doses


Eligibility criteria: Inclusion Criteria:

* Female subjects must be of non-child bearing potential.

Exclusion Criteria:

* Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 30months of the first administration of investigational prod
* Plasma donation within one month of screening or any blood donation/blood loss \> 500mL during the 3 months prior to screening
* Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis

Primary outcomes:
measure: To assess the safety and tolerability of multiple dose administration of AZD8529 when given orally to healthy male subjects and female subjects of non-childbearing potential.
timeFrame: each visit, at least daily, during the study.
Secondary outcomes:
measure: To characterize the pharmacokinetics of AZD8529 in plasma
timeFrame: Blood samples will be taken during the study.
Other outcomes:
Locations:
Study officials:
affiliation: AstraZeneca
name: Mark Smith, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06820892: Quality of Information Provided During Antenatal Consultations
Official title: Evaluation of the Concordance Between the Information Delivered in Antenatal Diagnosis Consultation and Parents Experience After the Birth of Their Infant
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Congenital Anomalies
Prematurity
Antenatal Consultation
Keywords: Antenatal
Antenatal consultation
information
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 113
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Of the patients who were followed up at the multidisciplinary prenatal diagnosis centre and had an antenatal consultation with a pediatric neonatologist, 113 patients met the inclusion criteria.

Brief summary: The objective of this questionnaire study is to evaluate the concordance between the information provided to parents during antenatal consultations and their subsequent experiences following childbirth.


Eligibility criteria: Inclusion Criteria:

* Patients were observed at the multidisciplinary prenatal diagnosis centre.
* Patients who had attended at least one antenatal consultation with a pediatric neonatologist
* Patients who gave birth between January 2020 and December 2022 and whose newborn was hospitalized in the neonatology department

Exclusion Criteria:

* a child who died in hospital or had a condition with a high risk of death in the first few years of life
* non-French speaking mothers
* Mothers who were minors at the time of the study

Primary outcomes:
measure: Question 8 of the questionnaire
timeFrame: The outcome is measured at the time of questionnaire completion, typically at hospital discharge or within one week post-discharge.
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Femme Mère Enfant Hospital (HFME)
Study officials:
References:
Clinical trial NCT02723292: City of Rochester Teen Outreach Program (TOP™) Evaluation
Official title: City of Rochester Teen Outreach Program (TOP™) Evaluation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Problems
Sex Behavior
Academic Underachievement Disorder of Childhood or Adolescence
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: State University of New York at Binghamton, Decker School of Nursing
name: City of Rochester Department of Recreation and Youth Services
First posted: 2016-03-30
Enrollment: 1188
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: As part of a 5-year national effort to reduce teen pregnancy, the University of Rochester is partnering with the City of Rochester Department of Recreation and Youth Services to evaluate the City's replication of the Teen Outreach Program (TOP™) for 11-14 year old youth registered at 11 selected Recreation Centers (RCs). A youth development program with demonstrated efficacy to reduce teen pregnancy, school failure and drop-out rates, TOP™ has never been studied in RCs. Advancing from efficacy to effectiveness, the investigators will also measure program fidelity obtained in RCs.


Eligibility criteria: Inclusion Criteria:

* must be registered at a participating RC
* age 11 through 14 years
* participants must assent and parent(s) or legal guardian(s) provide permission to participate
* basic understanding of the English language

Exclusion Criteria:

* age at enrollment of less than 11 or greater than 14 years
* for facilitators, age less than 21 is an exclusion criterion

Primary outcomes:
measure: Number of participants who become pregnant
timeFrame: 21 months
measure: Number of youth who report ever having had sexual intercourse
timeFrame: 21 months
measure: Amount of sexual intercourse in preceding 3 months without an effective means of birth control
timeFrame: 21 months
Secondary outcomes:
measure: Number of failing grades on report card
timeFrame: 21 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04941092: Comparison of ARDS COVID-19 (WHO) vs ARDS Influenza in the ICU
Official title: Clinical Outcomes and Characteristics of Critically Ill Patients With Influenza and COVID-19 Induced ARDS: a Retrospective, Matched Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS
COVID-19 Acute Respiratory Distress Syndrome
Influenza
Keywords: ards
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-06-28
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients hospitalized in Intensive Care Unit Hopital Central, Regional University Hospital of Nancy, France

- hospitalized between 2009 and 2019 if influenza and in 2020 if SARS CoV 2

Brief summary: Since the beginning of the SARS CoV 2 pandemia, the SARS CoV 2 was frequently compared with the seasonal influenza virus. However, few studies compared patients presenting acute respiratory distress syndrome (ARDS) induced by these viruses, with results being discordant. Our study means to compare mortality and morbidity of patients hospitalized in an intensive care unit (ICU) with ARDS induced by SARS CoV-2 and seasonal influenza.


Eligibility criteria: Inclusion Criteria:

* patients hospitalized in ICU
* under mechanical ventilation
* presenting an ARDS according to the Berlin definition
* induced by either influenza or SARS CoV 2

Exclusion Criteria:

* pregnant women
* mechanical ventilation\>48 hours before admission

Primary outcomes:
measure: mortality
timeFrame: at 28 days
Secondary outcomes:
measure: length of stay in ICU
timeFrame: at 28 days
measure: length of mechanical ventilation
timeFrame: at 28 days
measure: length of vasopressors
timeFrame: at 28 days
measure: length of extrarenal epuration
timeFrame: at 28 days
measure: amount of drugs for sedation
timeFrame: at 28 days
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
Study officials:
References: