louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03557801: Promotora Navigator - Culturally Appropriate Patient Navigator
Official title: Assessing the Impact of a Community Health Worker on Hispanic Women's Reported Measures of Processes of Care in the Screening Mammography Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Screening Mammography
Community Health Worker
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2018-06-15
Enrollment: 101
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: Although there has been interval improvement in reducing disparity in mammography utilization in medically underserved communities since the 1990s, significant disparities persist and should be addressed. In the 40-65 year old age range, there is significant disparity in screening mammography utilization in Hispanic women compared to their white counterparts.

Culturally adapted patient-targeted healthcare interventions can help reduce ethnic inequalities in access to cancer screening programs. Promotoras, culturally appropriate patient navigators for the Hispanic community, have been shown to increase screening mammography rates in the Hispanic/Latino population.

However, there is little research exploring the interaction between these lay community health workers and community members. This proposal aims to assess this interaction by measuring the impact of a Promotora working with community members in either a group setting or individual setting. Understanding this interaction can lead to more effectively designed future community interventions. Primary outcomes in this study will include women's reported measures of interpersonal processes of care (communication and interpersonal style) during screening mammography care, trust in the healthcare system, and satisfaction with cancer screening care when compared to those receiving standard of care.


Eligibility criteria: Inclusion Criteria:

* Women
* Identifying as Hispanic ethnicity
* Age 40-64
* Tennessee resident

Exclusion Criteria:

* Personal history of breast cancer
* Current breast symptoms (palpable mass)

Primary outcomes:
measure: Patient Reported Measures From Interpersonal Processes of Care Survey
timeFrame: Approximately 2 weeks after consent/screening mammogram.
Secondary outcomes:
measure: Patient Reported Measures From the Distrust in the Healthcare System Scale. Reported at Baseline and Post Intervention. Also Reported as the Change Between Baseline and Intervention.
timeFrame: Baseline, approximately 2 weeks after consent/screening mammogram.
measure: Patient Reported Measures From the Satisfaction With Cancer Related Care Scale.
timeFrame: Approximately 2 weeks after consent/screening mammogram.
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Matthew Walker Comprehensive Health Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Lucy Spalluto, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00180401: MODULA-Study: Modul 10: Benefit of CRT-Therapy in CRT-Patients With QRS-Complex of 120 - 150 Ms
Official title: MODULA-Study: Modul 10: Benefit of CRT-therapy in CRT-Patients With QRS-complex of 120 - 150 ms
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Failure
Lead sponsor: Boston Scientific Corporation
Sponsor class: INDUSTRY
Collaborators: name: Guidant Corporation
First posted: 2005-09-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE

Brief summary: The purpose of this study is to compare the benefit of cardiac resynchronization therapy (CRT)-therapy in patients with a QRS-complex of 120-150 ms to patients with a QRS-complex of \> 150 ms.

Detailed description: The objective of this study is to compare the benefit of CRT-therapy in patients with a QRS-complex of 120-150 ms to patients with a QRS-complex of \> 150 ms within 12 months. A benefit is defined as change in quality of life and change in physical ability.

Eligibility criteria: Inclusion Criteria:

* Patients with cardiac resynchronization therapy with a defibrillator (CRT-D) or cardiac resynchronization therapy pacemakers (CRT-P) system
* New York Heart Association (NYHA) III
* Ejection fraction (EF) below 35%
* Optimised medical therapy
* QRS-complex above 120 ms

Exclusion Criteria:

* Patients with CRT-P and atrial fibrillation

Primary outcomes:
measure: Observational: Benefit of CRT
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Kiel
country: Germany
facility: Klinikum der Christian Albrecht Universität / Kardiologische Abteilung
Study officials:
affiliation: Klinikum der Christian Albrecht Universität / Kardiologische Abteilung / Arnold Heller-Str. 7 / 24105 Kiel / Germany
name: Andreas Tiroke, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05933967: A Study of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma
Official title: A Phase II, Prospective ,Multicenter Study Evaluating the Efficacy and Safety of Orelabrutinib Plus R-CHOP in Treatment-naïve Patients With Double Expression Diffuse Large B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: The First Affiliated Hospital of Nanchang University
Lead sponsor: Shandong Cancer Hospital and Institute
Sponsor class: OTHER
Collaborators: name: The First Affiliated Hospital of Nanchang University
First posted: 2023-07-06
Enrollment: 31
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: This is a multicenter prospective single arm phase II study, and the purpose of this study is to evaluate the safety and efficacy of orelabrutinib combined with R-CHOP in the treatment of treatment-naïve patients with double expression DLBCL.

Detailed description: The patients will be treated with 6/8 cycles of orelabrutinib plus R-CHOP regimen（21 days per cycle). The primary objective was the complete response rate (CRR) at end of induction therapy

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed Double Expression Diffuse Large B-cell Lymphoma

  * Age 18-70 years
  * ECOG performance status 0-2
  * Ann Arbor stage II-IV
  * 8.Subjects who in line with the testing standard of the clinical trial laboratory
  * Life expectancy ≥ 3months

Exclusion Criteria:

* • systemic lymphoma involved CNS.

  * Accompanied by uncontrolled cardiovascular and cerebrovascular diseases, coagulopathy, connective tissue diseases.
  * uncontrolled infections (including HBV, HCV, HIV/AIDS)
  * Subjects who prepared for transplantation
  * Pregnancy or active lactation

Primary outcomes:
measure: complete response rate
timeFrame: up to 24 weeks
Secondary outcomes:
measure: ORR
timeFrame: up to 24 weeks
measure: 2 years progression-free survival
timeFrame: From date of receiving the first dose until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 2 years]
measure: 2 years overall survival
timeFrame: From date of receiving the first dose until the date of death from any cause,assessed up to 2 years
measure: The occurrence of adverse events and serious adverse events
timeFrame: up to 30 months
Other outcomes:
Locations:
city: Nanchang
country: China
facility: The First Ailliated Hospital of Nanchang University
state: Jiangxi
city: Jinan
country: China
facility: Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
state: Shandong
Study officials:
affiliation: Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
name: zengjun Li
role: STUDY_CHAIR
References:
Clinical trial NCT00736567: Evaluation of a Diagnostic Enteric Card for Management of Diarrhea
Official title: Evaluation of a Diagnostic Enteric Card for Management of Diarrhea in a Clinical Site in Fortaleza, Brazil
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diarrhea
Keywords: Diarrhea
Diagnostic
Pediatric
Lead sponsor: PATH
Sponsor class: OTHER
Collaborators: name: Universidade Federal do Ceara
name: University of Virginia
name: Micronics, Inc.
name: Washington University Early Recognition Center
First posted: 2008-08-18
Enrollment: 436
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting with diahrreal symptom to out-patient care facilities in Fortaleza, Brazil.

Brief summary: PATH is a member of a consortium that is developing a Diagnostic Enterics Card (DEC) which will allow clinicians to diagnose a group of diarrheagenic pathogens linked to morbidity and mortality. The pathogens detected on DEC include Salmonella, Campylobacter jejuni, Shigella species, and Escherichia coli O157:H7. This study will evaluate the performance of the assays and the platform in clinical conditions with non-expert users. It will provide important data on the performance of DEC for at least one target pathogen, an understanding of the potential impact of different sample types on device performance, and human factors associated with instrument interface in the field.


Eligibility criteria: Inclusion Criteria:

* Have 3 or greater liquid stools in the past 24 hours.
* Provide written informed consent from at least one parent in the case of children under 18 years of age.
* Provide written informed consent for those participants above 18 years of age.
* Provide assent in the case of children 10 years of age or greater.

Exclusion Criteria:

* Previously enrolled in the study.
* Parents are unwilling or unable to provide written informed consent.
* Report using antibiotics in the last 30 days.
* Adolescent (\<18 years old) parent of a child already enrolled in the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fortaleza
country: Brazil
facility: Hospital Infantil Albert Sabin
state: Ceará
Study officials:
References:
Clinical trial NCT03510767: A Study of TQ-B3525 on Tolerance and Pharmacokinetics
Official title: A Phase I Study of TQ-B3525 on Tolerance and Pharmacokinetics
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Relapsed or Refractory Lymphoma or Advanced Cancer
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2018-04-27
Enrollment: 60
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: To study the pharmacokinetic characteristics of TQ-B3525 in the human body, recommend a reasonable regimen for subsequent research.


Eligibility criteria: Inclusion Criteria:

* Relapsed or refractory lymphoma or advanced solid tumor that diagnosed Pathologically or cytologically diagnosed
* ECOG PS≤1
* Adequate blood cell counts, kidney function and liver function
* Patients should participate in the study voluntarily and sign informed consent

Exclusion Criteria:

* Patients with immunodeficiency, including HIV positive or other acquired, congenital immunodeficiency disease, or organ transplant history
* Hypertension (systolic BP ≥150 mmHg, diastolic BP ≥90 mmHg) still uncontrollable by one medication
* Hepatitis B virus patients with active replication (DNA\> 500 cps / mL), hepatitis C

Primary outcomes:
measure: Dose-Limiting Toxicities (DLT)
timeFrame: Baseline up to 28 days
measure: Maximum Tolerated Dose (MTD)
timeFrame: Baseline up to 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tianjin
country: China
facility: People's Hospital of Tianjin
state: Tianjin
Study officials:
affiliation: People's Hospital of Tianjin Tianjin,China,300121
name: Huaqing Wang, doctor
role: STUDY_CHAIR
affiliation: Sun Yat-sen University Cancer Center,Guangzhou,Guangdong,China, 510060
name: Wenqi Jiang, doctor
role: STUDY_CHAIR
References:
Clinical trial NCT01562067: Sonographic Characteristics of Tumor Indices in Patients With Cervical Cancer During Chemo-radiotherpy
Official title: Sonographic Characteristics of Tumor Indices in Patients With Cervical Cancer During Chemo-radiotherpy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cancer
Keywords: Cervical tumors,vascular changes,Sonographic characteristics
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2012-03-23
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women with cervical cancer during radiotherapy

Brief summary: Cervical tumors are characterized by vascular changes (in terms of quantity, volume and Flows) in the tumor. Due to a good access to the cervix through the vagina, these parameters can be assessed using a three dimensional supersonic. Sonographic characteristics of tumor indices measures before and after oncological treatments may shed light on the patient's prognosis.

Detailed description: no editional information. see above

Eligibility criteria: Inclusion Criteria:

* Cervical cancer patients intended to undergo chemotherapy or radiation, or both

Exclusion Criteria:

* no exclusions

Primary outcomes:
measure: Sonographic characteristics of cervical tumors
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: amnon amit, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05768867: French Translation and Validation of the PEYronie's Disease QUESTionnaire
Official title: French Translation and Validation of the PEYronie's Disease QUESTionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Peyronie Disease
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2023-03-14
Enrollment: 30
Sex: MALE
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: Patients with Peyronie's Disease

Brief summary: This study is a prospective cohort dedicated to peyronie's disease. The aim is to validate the french translation of the peyronie's disease questionnaire. The primary endpoint is the response rate to the questionnaire.


Eligibility criteria: Inclusion Criteria:

* Adult patient with Peyronie's Disease clinically diagnosed during a consultation, with palpation of at least one plaque

Exclusion Criteria:

* Patient refusing to participate
* Patient with difficulties in understanding the French language.
* Protected persons referred to in articles L.1121-6 to L.1121-8 of the public health code

Primary outcomes:
measure: Rate of responses
timeFrame: Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Toulouse Hospital
Study officials:
affiliation: University Hospital, Toulouse
name: Eric Huyghe, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02906267: Ultrasonographic Comparison of Gastric Volume After Three Modes of Positive Facemask During Induction of Anaesthesia
Official title: Ultrasonographic Comparison of Gastric Volume After Three Modes of Positive Facemask. A Prospective Randomized Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Positive-Pressure Respiration
Respiratory Aspiration of Gastric Content
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2016-09-20
Enrollment: 123
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study is designed to evaluate the occurrence of gastric insufflation and the critical volume of the stomach after three different modes of positive pressure ventilation during induction (Manual-controlled, volume-controlled and pressure-controlled ventilation)

Detailed description: Aspiration of gastric contents can be a serious perioperative complication, which can be related to facemask positive pressure ventilation with unprotected airway. Even with low peak airway pressure (\<15 cm H2O) gastric insufflation may occur. Since gastric content and volume assessment is a new point-of-care ultrasound recommended application, the cross-sectional antra area will be measured using ultrasonography before, continuously during facemask ventilation and after intubation.

Eligibility criteria: Inclusion Criteria:

* ASA status I and II

Exclusion Criteria:

* Pregnant woman Obese patient (BMI\>30kgm-2) oropharyngeal or facial anomalies anticipated difficult mask ventilation upper respiratory tract infection history of gastric surgery patient refusal

Primary outcomes:
measure: Gastric volume before and after positive pressure ventilation
timeFrame: 15 minutes
Secondary outcomes:
measure: Ultrasonographic detection of gastric insufflation during ventilation
timeFrame: 15 minutes
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU de Brest
Study officials:
affiliation: CHRU de Brest
name: Pierre LAFERE, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00991367: CICATRIX in the Treatment of Recent Post-surgical Scars
Official title: Efficacy of CICATRIX (Asian Gotu Kola or Pennywort) in the Treatment of Recent Post-surgical Scars
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Post-surgical Scars
Keywords: Post-surgical scars
Asian Gotu Kola
Asian Pennywort
Lead sponsor: Catalysis SL
Sponsor class: INDUSTRY
First posted: 2009-10-08
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to assess the efficacy of CICATRIX (Asian Gotu Kola or Pennywort) usage in the treatment of recent post-surgical scars. The duration of this double-blind placebo controlled phase 3 clinical trial will be 4 weeks. The estimated number of persons to be recruited and randomized for the study is 90.


Eligibility criteria: Inclusion Criteria:

* Recent (less than 48 hours) post-surgical wound

Exclusion Criteria:

* Post-surgical wound with sepsis
* Usage of steroids within 30 days
* Malignant neoplastic conditions
* Alcoholism
* Handicap and/or psychiatric condition preventing treatment accomplishment.

Primary outcomes:
measure: Length of the post-surgical scar(s) measured by a millimetric ruler at week 4 (end of the treatment)
timeFrame: 4 weeks
Secondary outcomes:
measure: Occurrence of adverse effects at week 4 (end of the treatment)
timeFrame: 4 weeks
measure: Photographs of lesions at week 4 (end of the treatment)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Havana City
country: Cuba
facility: "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
state: Havana
Study officials:
affiliation: "Cdte. Manuel Fajardo Rivero" Clinical-Surgical-Docent Hospital
name: Omara Lemus, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01840267: The Effect of Pneumoperitoneum on Intracranial Pressure in Pediatric Laparoscopic Surgery: Ultrasonographic Measurement of Optic Nerve Sheath Diameter
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Pressure
Keywords: pneumoperitoneum
pediatric laparoscopy
optic nerve sheath diameter
intracranial pressure
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-04-25
Enrollment: 25
Sex: ALL
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pediatric patients undergoing laparoscopic surgery under general anesthesia

Brief summary: The pneumoperitoneum during laparoscopic surgery in pediatrics has the potential to cause an increase of intracranial pressure (ICP). Previous studies have proposed that ultrasonographic measurements of the optic nerve sheath diameter (ONSD) correlate with signs of increased ICP. Therefore, this study aims to confirm the increased ICP by ultrasonographic measurement of ONSD during laparoscopic surgery in pediatric patients.


Eligibility criteria: Inclusion Criteria:

1. pediatric patients (under 9 yrs) scheduled for undergoing laparoscopic surgery under general anesthesia

Exclusion Criteria:

1. Patients with previous history of neurologic disease or neurosurgery, ocular disease or ocular surgery

Primary outcomes:
measure: ultrasonographic measurement of optic nerve sheath diameter
timeFrame: change of ultrasonographic measurement of optic nerve sheath in 10 minutes after anesthesia induction, 10 minutes after pneumoperitoneum, and 10 minutes after CO2 desufflation.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute
Study officials:
References: