louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00556023: A Phase 1 Study Testing CP-675,206 In Combination With Gemcitabine In Patients With Previously Untreated, Advanced Pancreatic Cancer
Official title: A Phase 1 Dose Escalation Trial Of CP-675,206 In Combination With Gemcitabine In Patients With Chemotherapy Naive Metastatic Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pancreatic Cancer
Keywords: interventional
dose-finding
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-11-09
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety and tolerability of different doses of CP-675,206 in combination with gemcitabine and to determine the maximum dose of CP-675,206 that is well tolerated when given in combination with gemcitabine to patients with advanced pancreatic cancer.


Eligibility criteria: Inclusion Criteria:

* Patients with metastatic pancreatic cancer
* Patient must have adequate bone marrow, liver and kidney function
* Patient must have an Eastern Cooperative Oncology Group (ECOG) performance score of 0 or 1
* Chemotherapy naive
* Inoperable pancreatic cancer

Exclusion Criteria:

* Patient must not have received prior systemic therapy for pancreatic cancer
* Patient must not have previously received anti-CTLA4 therapy
* History of chronic inflammatory or autoimmune disease

Primary outcomes:
measure: Dose Limiting Toxicities: assessed through adverse event data collected weekly
timeFrame: 8 week intervals
Secondary outcomes:
measure: HAHA Response to CP-675,206:
timeFrame: 12 months
measure: Lymphocyte Subset Analysis:
timeFrame: 12 months
measure: Cytokine Analysis:
timeFrame: 12 months
measure: Pharmacogenomic Analysis:
timeFrame: 1 month
measure: Overall Survival:
timeFrame: 12 months
measure: Pharmacokinetics of CP-675,206 and Gemcitabine:
timeFrame: 2 months
measure: Best Overall Response:
timeFrame: 3 months
measure: Duration of Tumor Response:
timeFrame: 3 months
measure: Progression-Free Survival:
timeFrame: 5 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Research Site
state: Alberta
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Montreal
country: Canada
facility: Research Site
state: Quebec
city: Candiolo (TO)
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
Study officials:
References:
citation: Aglietta M, Barone C, Sawyer MB, Moore MJ, Miller WH Jr, Bagala C, Colombi F, Cagnazzo C, Gioeni L, Wang E, Huang B, Fly KD, Leone F. A phase I dose escalation trial of tremelimumab (CP-675,206) in combination with gemcitabine in chemotherapy-naive patients with metastatic pancreatic cancer. Ann Oncol. 2014 Sep;25(9):1750-1755. doi: 10.1093/annonc/mdu205. Epub 2014 Jun 6.
Clinical trial NCT00264823: Nursing Intervention for HIV Regime Adherence Among People With Serious Mental Illness (SMI)
Official title: Nursing Intervention for HIV Regimen Adherence Among Serious Mental Illness (SMI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: HIV
Mental Illness
Keywords: HIV
Mental Illness
Lead sponsor: National Institute of Nursing Research (NINR)
Sponsor class: NIH
First posted: 2005-12-13
Enrollment: 273
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to investigate how nurses can best help people with serious mental illnesses (SMI) follow their HIV treatment plans.

Detailed description: There is concern that HIV positive SMI persons may be a greater risk for poor treatment adherence, increasing risk for poorer outcomes and development of treatment resistance virus, and also placing others at greater risk. Involvement of advance practice nurses has been previously shown to improve outcomes for persons with HIV/AIDS.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of serious mental illness; HIV positive

Exclusion Criteria:

* None

Primary outcomes:
measure: How to best help people with serious mental illness follow HIV treatment regimens
timeFrame: baseline, 3, 12 and 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Center for Mental Health Services and Policy Research
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: Michael Blank, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dalseth N, Reed RS, Hennessy M, Eisenberg MM, Blank MB. Does Diagnosis Make a Difference? Estimating the Impact of an HIV Medication Adherence Intervention for Persons with Serious Mental Illness. AIDS Behav. 2018 Jan;22(1):265-275. doi: 10.1007/s10461-017-1795-5.
citation: Wu ES, Rothbard A, Holtgrave DR, Blank MB. Determining the Cost-Savings Threshold for HIV Adherence Intervention Studies for Persons with Serious Mental Illness and HIV. Community Ment Health J. 2016 May;52(4):439-45. doi: 10.1007/s10597-014-9788-6. Epub 2014 Dec 23.
citation: Blank MB, Hennessy M, Eisenberg MM. Increasing quality of life and reducing HIV burden: the PATH+ intervention. AIDS Behav. 2014 Apr;18(4):716-25. doi: 10.1007/s10461-013-0606-x.
Clinical trial NCT06957223: Efficacy of Dextromethorphan-Bupropion Versus SSRIs in the Treatment of Major Depressive Disorder
Official title: Efficacy of Dextromethorphan-Bupropion Versus SSRIs in the Treatment of Major Depressive Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Major Depressive Disorder (MDD)
Lead sponsor: Combined Military Hospital Nowshera
Sponsor class: OTHER_GOV
First posted: 2025-05-04
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims to compare the antidepressant effects of a dextromethorphan-bupropion combination versus standard SSRI therapy in adult patients with major depressive disorder. Participants will be randomized into two groups: one receiving dextromethorphan-bupropion and the other receiving an SSRI (e.g., sertraline or escitalopram). Treatment will last for 6 weeks, with assessments at baseline and study completion. The primary outcome will be the remission rate measured by a validated depression rating scale. Secondary outcomes include change in depressive symptoms severity and safety/tolerability measures.


Eligibility criteria: Inclusion Criteria:

Diagnosed with major depressive disorder (MDD) per DSM-5 criteria.

Baseline depression score indicating moderate to severe depression

Ability to provide informed consent

Willing to comply with study requirements

Exclusion Criteria:

History of bipolar disorder, schizophrenia, or other psychotic disorders

Current substance use disorder (within past 6 months)

Active suicidal ideation requiring urgent intervention

Pregnancy or breastfeeding

Known hypersensitivity to study medications

Primary outcomes:
measure: Change in Depression Severity (measured by HAMD-17)
timeFrame: 6 weeks
Secondary outcomes:
measure: Remission Rate
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Nowshera
country: Pakistan
facility: Combined Military Hospital
state: KPK
city: Nowshera
country: Pakistan
facility: Department of Psychiatry, Combined Military Hospital Nowshera
state: KPK
Study officials:
References:
Clinical trial NCT01362023: Efficacy of an Educational School-based Intervention to Reduce Prevalence of Obesity in Childhood-EdAl-2
Official title: A Primary-school-based Study to Reduce Prevalence of Childhood Obesity in Terres de l'Ebre (Catalunya (Spain) - EDAL-Educació en Estils Saludables de Vida alimentació-2: Study Protocol for a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Childhood Obesity
Lead sponsor: University Rovira i Virgili
Sponsor class: OTHER
Collaborators: name: Diputació de Tarragona
First posted: 2011-05-27
Enrollment: 800
Sex: ALL
Minimum age (years): 7
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Our hypothesis is that a regular systematic educational intervention in primary school improves lifestyle choices and reduces obesity. As such, the aim of the study is to evaluate the effects of a 3-year school-based program of lifestyle improvement, including diet and physical activity, implemented by university students acting as "health promoting agents" (HPA) on the prevalence of obesity.

Detailed description: Initial pupil enrollment and continued for 3 years.

Eligibility criteria: Inclusion Criteria:

* In the intervention group, all children of the selected classroom are exposed to the intervention.
* The data a will collected on all the children, but only the data from individuals (and their parents) who provided informed consent are included in the final analyses.
* Name, gender, date and place of birth are recorded at the start of the program, while weight, height, body mass index (BMI) and waist circumference variables (identified set of anthropometric measures) are recorded in each of the 3 academic years of the study.

Exclusion Criteria:

* No adequate age
* Lack of inclusion criteria

Primary outcomes:
measure: Reduction in prevalence of obesity
timeFrame: Changes from baseline in prevalence of obesity at 3 academic years
Secondary outcomes:
Other outcomes:
Locations:
city: Amposta
country: Spain
facility: Spain
state: Tarragona
Study officials:
affiliation: Universitat Rovira i Virgili, Spain
name: Montse Giralt, Md, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Llaurado E, Tarro L, Morina D, Queral R, Giralt M, Sola R. EdAl-2 (Educacio en Alimentacio) programme: reproducibility of a cluster randomised, interventional, primary-school-based study to induce healthier lifestyle activities in children. BMJ Open. 2014 Nov 20;4(11):e005496. doi: 10.1136/bmjopen-2014-005496.
Clinical trial NCT01437423: Regulatory Post-Marketing Surveillance Study for TETRAXIM™
Official title: Regulatory Post-Marketing Surveillance (PMS) Study for TETRAXIM™(Combined Vaccine of Adsorbed Diphtheria, Tetanus, Acellular Pertussis and Enhanced Inactivated Poliomyelitis)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diphtheria
Tetanus
Pertussis
Poliomyelitis
Keywords: Diphtheria
Tetanus
Pertussis
Poliomyelitis
TETRAXIM™
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2011-09-20
Enrollment: 600
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to assess the safety of TETRAXIM™ administered in routine clinical practice according to Korea Food and Drug Administration Notification No. 2009-46 "Basic standard for reexamination of new drug" based on the pharmaceutical law in Korea.

Detailed description: Primary vaccination will be administered from 2 months and booster vaccination from age 4 to 6 years.

Eligibility criteria: Inclusion Criteria:

* Subjects who are 2 months or more of age (as indicated in the currently approved local product labeling) and who are given the study vaccine at least one dose or more, during a routine health-care visit, as primary immunization or booster immunization for the prevention of diphtheria, tetanus, pertussis, poliomyelitis.
* Written informed consent obtained from the subject's parents/legal representative.

Primary outcomes:
measure: Number of Participants Reporting Unexpected Adverse Events Up 30 Days Following A Primary Series and Booster Injection of TETRAXIM™.
timeFrame: Up to 30 days post-primary and booster vaccination
Secondary outcomes:
Other outcomes:
measure: Number of Participants Reporting Solicited Adverse Events Following A Primary Series Injection of TETRAXIM™.
timeFrame: Up to 30 days post-primary and booster vaccination
measure: Number of Participants Reporting Unsolicited Adverse Events Following A Primary Series and Booster Injection of TETRAXIM™.
timeFrame: Up to 30 days post-primary and booster of TETRAXIM™ vaccination
measure: Occurrence of Adverse Events by Demographic Characteristic of Participants Following A Single Dose of TETRAXIM™.
timeFrame: Up to 30 days post-primary and booster of vaccination
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Sanofi Pasteur SA
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Choe YJ, Vidor E, Manson C. Post-Marketing Surveillance of Tetravalent Diphtheria-Tetanus-Acellular Pertussis and Inactivated Poliovirus (DTaP-IPV) Vaccine in South Korea, 2009 to 2015. Infect Dis Ther. 2022 Aug;11(4):1479-1492. doi: 10.1007/s40121-022-00650-8. Epub 2022 May 14.
Clinical trial NCT04466423: Intervention Trial to Increase Meaning in Work and Reduce Burnout
Official title: Intervention Trial Designed to Promote Collegiality and Mutual Support at Work as a Way to Increase Meaning in Work and Reduce Burnout
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Professional
Keywords: well-being
burnout
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two-arm randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Collegiality is a one of the great virtues of physician-hood. Mutual support from colleagues to help deal with the challenges of being a physician has long helped physicians manage the stress related to practicing medicine and helped physicians derive meaning from their work. Unfortunately, increased productivity expectations and other changes to the practice of medicine over the last several decades have decreased the time physicians have to interact with colleagues and eroded the fabric of collegiality. Recent studies suggest burnout affects nearly half of U.S. physicians at any given point in time and has substantial personal and professional consequences. The steps organizations can take to promote collegiality are unknown. The goal of the present study is to evaluate the ability of an organizational intervention to encourage collegiality, shared experience, connectedness, and mutual support. This study builds on two prior intervention studies directed by the Mayo Clinic Department of Medicine Program on Physician Well-Being, the first focusing on a small group facilitated well-being curriculum and the second focusing on individual electronic tasks to prompt positive reflection and gratitude.


Eligibility criteria: Inclusion Criteria:

* Senior Associate Consultants and Consultants in the Mayo Clinic Department of Medicine will be eligible for this study.

Exclusion Criteria:

* None beyond inclusion criteria.

Primary outcomes:
measure: Burnout
timeFrame: 12 month outcomes
Secondary outcomes:
measure: Depressive symptoms
timeFrame: 12 month outcomes
measure: Quality of life
timeFrame: 12 month outcomes
measure: Job satisfaction
timeFrame: 12 month outcomes
measure: Meaning at work
timeFrame: 12 month outcomes
measure: Social support
timeFrame: 12 month outcomes
measure: Social isolation
timeFrame: 12 month outcomes
measure: Job turnover
timeFrame: 12 month outcomes
Other outcomes:
Locations:
Study officials:
affiliation: Mayo Clinic
name: Colin West, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: West CP, Dyrbye LN, Satele DV, Shanafelt TD. Colleagues Meeting to Promote and Sustain Satisfaction (COMPASS) Groups for Physician Well-Being: A Randomized Clinical Trial. Mayo Clin Proc. 2021 Oct;96(10):2606-2614. doi: 10.1016/j.mayocp.2021.02.028. Epub 2021 Aug 5.
Clinical trial NCT02599623: Safety and Efficacy of Local Anesthesia in Emergency Inguinal Hernia Surgery
Official title: Safety and Efficacy of Local Anesthesia in Emergency Inguinal Hernia Surgery, a Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia
Incarcerated Inguinal Hernia
Keywords: Incarcerated
Anesthesia
Hernia
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2015-11-06
Enrollment: 80
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: This prospective randomized is designed to evaluate the safety and efficacy of hernia repairs using local anesthesia compared with those using general anesthesia for patients with incarcerated hernia.

Detailed description: The outcome parameters measured included intraoperative conditions, postoperative conditions and long-term follow-up conditions.

Eligibility criteria: Inclusion Criteria:

1. Age 18-70 years
2. Primary inguinal hernia
3. ASA I-II
4. Clinical diagnosis of incarcerated hernia
5. randomly select patch agreed by patients and family members

Exclusion Criteria:

1. severe organ dysfunction
2. No-tolerate anesthesia
3. No-suitable for operation
4. spirit disease patients
5. automatically exit

Primary outcomes:
measure: Recurrence rate
timeFrame: 1 year
Secondary outcomes:
measure: Time in ICU
timeFrame: 1 week
measure: Time to eat
timeFrame: 1 week to 1 month
measure: Time to ambulation
timeFrame: 1 week to 1 month
measure: Total cost
timeFrame: 1 week to 1 month
measure: Complication rates
timeFrame: 1 week to 1 month
measure: Time in hospital
timeFrame: 1 week to 1 month
measure: Death in 30 days rate
timeFrame: 1 month
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University
Study officials:
affiliation: RenJi Hospital
name: TAO CHEN
role: STUDY_CHAIR
References:
Clinical trial NCT06760923: Urinary Proteomic Assessment of Ovarian Malignancy and Disease Progression
Official title: Urinary Proteomic Assessment of Ovarian Malignancy and Disease Progression
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ovarian Cancer (OvCa)
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2025-01-07
Enrollment: 240
Sex: FEMALE
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: primary care clinic

Brief summary: The goal of this observational study is to determine the urinary proteomic characteristics in women with and without ovarian cancer. The main questions it aims to answer are:

1. What is the difference in urinary protein composition between patients with ovarian cancer and those without it?
2. Can these differences in urinary protein composition aid in the diagnosis of ovarian cancer?
3. Are urinary protein markers associated with tumor burden in urine samples from patients with ovarian cancer?
4. Can urinary protein markers be used for disease surveillance in ovarian cancer patients?


Eligibility criteria: Inclusion Criteria:

* Female patients in the gynecological ward for surgical treatment.
* Initial diagnosis of "pelvic mass" or "malignant ascites" may be considered as ovarian cancer; Or the initial diagnosis of "ovarian cyst", "hydrosalpinx", "uterine fibroids" or "uterine adenomyosis" are considered as gynecological non-malignant diseases.
* Over 18 years of age.
* Voluntary participation and signing of informed consent.

Exclusion Criteria:

* Study participants with a prior history of malignant tumors.
* Study participants with prior chronic kidney disease or renal insufficiency.
* Study participants who have received or are receiving treatment for primary disease.
* Study participants whose pathological diagnosis was not clear.

Any patient should be excluded from the study if:

* Study participants withdraw informed consent and request withdrawal.
* Study participants were unable to provide a qualified urine sample.
* There are situations in which the researcher considers it necessary to withdraw from the study.

Primary outcomes:
measure: Pathological diagnosis
timeFrame: From enrollment to the end of surgery or biopsy at 1 weeks
Secondary outcomes:
measure: Progression
timeFrame: From enrollment to the end of treatment at 6 months
Other outcomes:
Locations:
city: Changsha
country: China
facility: Xiangya Hosipital of Central South University
state: Hunan
Study officials:
References:
Clinical trial NCT04379323: Clinical Trial of YuWell YE900 Electronic Sphygmomanometer
Official title: Validation of the YuWell YE900 Medical Electronic Blood Pressure Monitor in Adults and Children According to the AAMI/ESH/ISO 81060-2:2018 Standard
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Blood Pressure
Keywords: AAMI/ESH/ISO 81060-2: 2018 standard
blood pressure measurement
blood pressure monitor
validation study
YuWell YE900
Lead sponsor: The Second Hospital of Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Jiangsu Yuyue medical equipment & supply Co., Ltd.
First posted: 2020-05-07
Enrollment: 92
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate the accuracy of the YuWell YE900 medical electronic blood pressure monitor for blood pressure measurements in adults and children according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018).


Eligibility criteria: Inclusion Criteria:

1. 3 Years and older (Child, Adult, Older Adult);
2. Subjects voluntarily participate in the clinical trial and sign the informed consent.

Exclusion Criteria:

1. Disturbance of consciousness;
2. Patients requiring hemodialysis;
3. Taking anticoagulant drugs due to cardiovascular and cerebrovascular diseases;
4. Pregnant and lactating women;
5. Patients with cardiac arrhythmias;
6. Other conditions that the investigator considers ineligible for clinical trial.

Primary outcomes:
measure: Blood pressure measurement data
timeFrame: 30 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The Second Affiliated Hospital of Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: The Second Hospital of Nanjing Medical University
name: Mingzhi Long, MD PHD
role: STUDY_DIRECTOR
References:
citation: Zhang HJ, Zhang J, Wang SL, Zhang J, Teng LN, Zhang SJ, Zhou DJ, Long MZ. Validation of the YuWell YE900 oscillometric blood pressure monitor for professional office use in adults and children according to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018). Blood Press Monit. 2021 Oct 1;26(5):396-399. doi: 10.1097/MBP.0000000000000541.