louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04679272: Prognostic Evaluation of COVID-19 in Rheumatoid Arthritis Patients
Official title: Prognostic Evaluation of COVID-19 in Rheumatoid Arthritis Patients : ProCOVRA
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Rheumatoid Arthritis
Keywords: DMARDs
Biotherapy
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 2000
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: Study population description: \*

* Patients with RA, included in the French RMD Covid-19 cohort, with a confirmed COVID-19 diagnosis (positive PCR or serology).
* Patients included in the Montpellier COVID-19 cohort, without autoimmune disease or inflammatory rheumatism, and with a confirmed COVID-19 diagnosis (positive PCR or serology).

Brief summary: COVID-19 is an infectious disease caused by SARS-CoV2 virus. The objective of our study is to analyze the progression and the severity of COVID-19 in patients with RA. Indeed, few data are available on this subject, and this would allow us to improve management of COVID-19 in these potential at-risk patients.


Eligibility criteria: Inclusion criteria:

- Confirmed COVID-19 diagnosis (positive PCR or serology) in RA patients or healthy controls.

Exclusion criteria:

* Age under 18 years old
* Suspected COVID-19 diagnosis (typical symptoms without a positive PCR or serology)

Primary outcomes:
measure: Hospitalization rates for COVID-19
timeFrame: 1 day
Secondary outcomes:
measure: Critical care transfer rate for COVID-19 and death due to COVID-19
timeFrame: 1 day
measure: Pulmonary comorbidities, corticosteroids or DMARDs use
timeFrame: 1 day
measure: Age
timeFrame: 1 day
measure: Number of Participants with co-morbidities
timeFrame: 1 day
measure: Type of clinical presentation
timeFrame: 1 day
measure: Type of associated treatments
timeFrame: 1 day
Other outcomes:
Locations:
city: Montpellier
country: France
facility: UH Montpellier
Study officials:
affiliation: University Hospitals of Montpellier
name: Padern Guillaume, physician
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01374672: Biomarkers in Predicting Response to Chemotherapy in Samples From Young Patients With Osteosarcoma
Official title: Observational - Methylation Status as Predictor of Response to Neoadjuvant Chemotherapy in Osteosarcoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Localized Osteosarcoma
Metastatic Osteosarcoma
Osteoblastic Osteosarcoma
Recurrent Osteosarcoma
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-06-16
Enrollment: 20
Sex: ALL
Minimum age (years): 10
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosed with high-grade osteoblastic osteosarcoma.

Brief summary: This research study is studying biomarkers in predicting response to chemotherapy in samples from young patients with osteosarcoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

Detailed description: Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Children's Oncology Group Sampling Method: Non-Probability Sample

PRIMARY OBJECTIVES:

I. Determine whether methylation status predicts response to neoadjuvant chemotherapy in samples from children and young adults with osteosarcoma.

OUTLINE: Patients are stratified according to response to neoadjuvant chemotherapy (good vs poor).

DNA and RNA extracted from biopsy samples are analyzed for methylation changes and transcription changes by ligation-mediated PCR and mass-array genotyping.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with high-grade osteoblastic osteosarcoma
* Biopsy samples from patients who had good or poor response to neoadjuvant chemotherapy available
* All specimens should be from post-menarchal females or age-matched males with appendicular tumors
* Patients' clinical data including chemotherapy received, event-free survival, and overall survival available
* See Disease Characteristics

Primary outcomes:
measure: Methylated status as predictor of response to neoadjuvant chemotherapy
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Monrovia
country: United States
facility: Children's Oncology Group
state: California
Study officials:
affiliation: Children's Oncology Group
name: Jeremy Rosenblum, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06262672: Evaluation of Some Parameters in University Students During the COVİD-19 Epidemic Process
Official title: The Relationship Between Healthy Lifestyle Behaviors, Sleep Quality, and Body Weight in University Students During the COVID-19 Epidemic Process
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Health Behavior
Sleep
Body Weight
Lead sponsor: Kırklareli University
Sponsor class: OTHER
First posted: 2024-02-16
Enrollment: 236
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Students registered to Kırklareli University Faculty of Health Sciences and attending distance education due to COVID-19 pandema

Brief summary: The physical and mental effects of the COVID-19 pandemic have been examined by many researchers, but this study aims to evaluate in every aspect how university students who had to receive education with the distance education model due to the pandemic went through this process. Data regarding people's positive and negative habits from anthropometric characteristics and sleep quality, which is one of the sub-dimensions of healthy lifestyle behaviors, were evaluated, and the relationship between these parameters was examined in detail.

Detailed description: This study focuses on distance education, remote working, etc. during the pandemic period. It is compatible with the findings of studies on the subject and reveals that the nutrition and physical activity sub-parameters of the healthy lifestyle behaviors scale are related to anthropometric characteristics and sleep quality. Considering that the online working model has become widespread, from this perspective, for future studies, the effects of behavioral change strategies on individuals' sleep quality and anthropometric values can be investigated.

Eligibility criteria: Inclusion Criteria:

* Students who are registered to Kırklareli University Faculty of Health Sciences and aged 18 years and older who agreed to participate in the study
* Those who are capable of filling out surveys online
* Those with internet access
* With the fully answered to the questionnaire and scale questions

Exclusion Criteria:

* Students who are not registered to Kırklareli University Faculty of Health Sciences

Primary outcomes:
measure: Health Promotion Life-Style Profile (HPLP-II)
timeFrame: Students who filled the survey between 20/11/2021 with 20/05/2021
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Students who filled the survey between 20/11/2021 with 20/05/2021
measure: Anthropometric Measurements
timeFrame: Students who filled the survey between 20/11/2021 with 20/05/2021
Secondary outcomes:
Other outcomes:
Locations:
city: Kirklareli
country: Turkey
facility: Kirklareli University
state: Kayalı
Study officials:
affiliation: Trakya University
name: Merve PEHLIVAN, Assoc. prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06604572: TAPP and Open Repair for Recurrent Inguinal Hernia
Official title: Clinical Study of Transabdominal Preperitoneal Approach Versus Open Tension-free Hernia Repair for the Treatment of Recurrent Inguinal Hernia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Recurrent Inguinal Hernia
Lead sponsor: The Second Affiliated Hospital of Kunming Medical University
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 70
Sex: ALL
Minimum age (years): 18
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 this study was to explore the clinical efficacy of transabdominal preperitoneal approach (TAPP) and open tension-free hernia repair in the treatment of recurrent inguinal hernia. This study aims to provide a basis for selecting the optimal treatment methods for recurrent hernias.

Detailed description: The patients were randomly allocated to the TAPP group and the open tension-free repair group. We recorded the general situation, operation time, and intraoperative complications; postoperative visual analogue pain scale (VAS) scores at 24 and 48 h; and the incidence of complications such as seroma, chronic pain, inguinal numbness, foreign body sensation, and recurrence at 1 week, 1 month, 3 months, 6 months and 1 year after surgery. These indicators were compared between the two groups of patients.

Eligibility criteria: Inclusion Criteria:

* age ≥ 18 years
* the diagnosis of recurrent inguinal hernia made by ultrasound or computed tomography (CT) during the present visit
* ability to tolerate general anesthesia and local anesthesia surgery
* all patients and their families agreed to participate in this study and sign relevant informed consent.

Exclusion Criteria:

* patch infection during the first surgery
* multiple (≥ 2) relapses
* inability to cooperate to complete follow-up after surgery

Primary outcomes:
measure: Postoperation pain
timeFrame: 24 hours, 48 hours, three months after surgery
Secondary outcomes:
measure: Numbness and foreign body sensation
timeFrame: The mean follow-up time was 10 months after surgery
measure: Operating time
timeFrame: During surgery
measure: Hemorrhage
timeFrame: During surgery
measure: Urinary retention
timeFrame: One week after surgery
measure: Seroma
timeFrame: The mean follow-up time was 2 weeks after surgery
measure: Recurrence
timeFrame: The mean follow-up time was 1 year after surgery
measure: Fever
timeFrame: One week after surgery
measure: Length of hospital stay
timeFrame: Within a week of surgery
Other outcomes:
Locations:
city: Kunming
country: China
facility: Clinical study of recurrent inguinal hernia
state: Yunnan
Study officials:
affiliation: The Second Affiliated Hospital of Kunming Medical University
name: Weiming Li, doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05186272: mHealth Mindfulness Intervention for Pregnant Black and Latina Women at Risk of Postpartum Depression
Official title: mHealth Mindfulness Intervention for Pregnant Black and Latina Women at Risk of Postpartum Depression
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: PHASE3
Conditions: Post Partum Depression
Perinatal Depression
Lead sponsor: Kaiser Permanente
Sponsor class: OTHER
First posted: 2022-01-11
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Postpartum depression (PPD) is associated with significant health consequences for mothers and children, and the current COVID-19 pandemic has had a major impact on the mental health of particularly vulnerable populations including pregnant Black and Latina women. There is an urgent need for evidence-based, accessible, and scalable mental health care options for these high-risk, vulnerable women. This study aims to: (a) compare the effectiveness of two digitally-delivered self-paced stress reduction programs in pregnant Black and Latina women at increased risk of PPD; and (b) examine barriers and facilitators to implementation within a large healthcare system.


Eligibility criteria: Inclusion Criteria:

* Women seeking prenatal care at KPNC
* Identify as Black or Latina
* Current prenatal PHQ-9 score 10-19
* Gestational age \<30 weeks
* Owns a smartphone or computer with internet access
* English- or Spanish-speaking

Exclusion Criteria:

* Regular (3 times per week or more) stress reduction practice
* Cognitively impaired
* Deaf

Primary outcomes:
measure: Patient Health Questionnaire-9
timeFrame: Baseline
measure: Patient Health Questionnaire-9
timeFrame: 6-week follow-up
measure: Patient Health Questionnaire-9
timeFrame: 4 weeks postpartum
Secondary outcomes:
measure: Perceived Stress Scale
timeFrame: Baseline
measure: Perceived Stress Scale
timeFrame: 6-week follow-up
measure: Perceived Stress Scale
timeFrame: 4 weeks postpartum
measure: Generalized Anxiety Disorder 7-item scale
timeFrame: Baseline
measure: Generalized Anxiety Disorder 7-item scale
timeFrame: 6-week follow-up
measure: Generalized Anxiety Disorder 7-item scale
timeFrame: 4 weeks postpartum
measure: Promis Sleep Disturbance - Short Form 6a
timeFrame: Baseline
measure: Promis Sleep Disturbance - Short Form 6a
timeFrame: 6-week follow-up
measure: Promis Sleep Disturbance - Short Form 6a
timeFrame: 4 weeks postpartum
Other outcomes:
Locations:
city: Oakland
country: United States
facility: Kaiser Permanente Northern California
state: California
Study officials:
References:
Clinical trial NCT01986972: Supragingival Plaque Removal With and Without Dentifrice
Official title: Supragingival Plaque Removal With and Without Dentifrice: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Plaque
Keywords: Toothbrushing
Dental plaque
Dentifrice
Oral hygiene
Lead sponsor: Franciscan University Center
Sponsor class: OTHER
First posted: 2013-11-19
Enrollment: 24
Sex: ALL
Minimum age (years): 17
Maximum age (years): 28
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Purpose: The aim of this study was to compare the efficacy of dental biofilm removal by brushing with and without conventional toothpaste. Settings and Design: Twenty-four students aged 17 to 28 years old participated in this randomized clinical trial.

Materials and Methods: Quadrants 1-3 or 2-4 were randomly allocated to the test group (brushing without dentifrice) or control group (brushing with dentifrice). After 72 hours of cessation of oral hygiene, Quigley \& Hein (Turesky) plaque index was assessed before and after brushing by a calibrated and blind examiner. Overtime and intergroup comparisons were performed by paired sample t test.


Eligibility criteria: Inclusion Criteria:

* students of both genders systemically healthy.

Exclusion Criteria:

* individuals who exhibited gingivitis (presence of gingival bleeding at any site);
* probing depth \> 3mm and/or attachment loss \>3mm at any site;
* using orthodontic appliance devices, dental prostheses, dental implants;
* presence of abrasions, restorations and/or carious lesions at cervical region;
* individuals who had less than 20 natural teeth.

Primary outcomes:
measure: Dental plaque
timeFrame: Three days
Secondary outcomes:
Other outcomes:
Locations:
city: Santa Maria
country: Brazil
facility: School of Dentistry, Franciscan University Center
state: Rio Grande do Sul
Study officials:
References:
Clinical trial NCT00033072: Assessment of Potential Interactions Between Methamphetamine and Selegiline - 1
Official title: Assessment of Potential Interactions Between Intravenous Methamphetamine and Oral Selegiline
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Amphetamine-Related Disorders
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2002-04-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the potential interactions between intravenous methamphetamine and oral selegiline.

Detailed description: To determine the safety of the selegiline concurrent with d-methamphetamine challenges of 15mg \& 30mg i.v. with the focus being on cardiovascular responses (HR,BP) to the i.v. methamphetamine challenges. This is a randomized, single-blind, placebo-controlled, two-arm study design to evaluate the safety of selegiline treatment, compared to placebo treatment, concurrent with i.v. methamphetamine challenges.

Eligibility criteria: Inclusion Criteria:

* Volunteers who meet DSM-4 criteria for methamphetamine abuse or dependence; non-treatment seeking individuals
* Be able to verbalize understanding of consent form; provide written informed consent

Exclusion Criteria:

* Please contact site for more information

Primary outcomes:
measure: safety of selegiline
measure: pharmacokinetic assessment
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Integrated Substance Abuse Program
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Thomas Newton, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05550272: Hospitalizations in Neonatal Period and Early Discharge of Maternity
Official title: Inventory of Hospitalizations in the Neonatal Period and Validation of the Early Maternity Discharge Protocol: Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hospitalization
Neonatal Period
Early Maternity Discharge
Risk Factor Readmission
Keywords: neonatal
readmission
early discharge maternity
causes of readmission
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2022-09-22
Enrollment: 500
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: hospitalized infants less than 28 days old at CHU Nancy hospital through the emergency service of children's hospital, through intensive care unit or through emergency unit of the maternity regional of Nancy

Brief summary: in the past 2 decades the number of early discharge of maternity is increasing. The aim of this study is to observe if an early maternity discharge increase the rate of hospitalization during the neonatal period.

All infants with maximum 28 days old who are hospitalized at the Hospital center of Nancy: through emergency unit of children's hospital or maternity, through intensive care unit of children's hospital.


Eligibility criteria: Inclusion Criteria:

* infants hospitalized maximum at the aged of 28 days (day 28 included)
* infants already discharged from maternity
* infants hospitalized in Hospital Center NANCY: at Children's
* informed by the study, parents did not refused to participate to the study

Exclusion Criteria:

* more than 28 days old
* infants transferred from maternity without discharge at home.

Primary outcomes:
measure: Age at maternity discharge
timeFrame: 1 month
Secondary outcomes:
measure: Etiology of hospitalization
timeFrame: 1 month
measure: Jaundice risk factor
timeFrame: 1 month
measure: Risk factor of early neonatal bacterial infection
timeFrame: 1 month
measure: social environment at home, mother's parity
timeFrame: 1 month
measure: pediatrics follow up
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05587972: Real World Treatment Experience of Patients With Breast, Lung, or GI Cancer or Multiple Myeloma Using Remote Symptom Monitoring
Official title: Real World Treatment Experience of Patients With Breast, Lung, or GI Cancer or Multiple Myeloma Using Remote Symptom Monitoring
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lung Cancer
Gastrointestinal Cancer
Multiple Myeloma
Lead sponsor: Carevive Systems, Inc.
Sponsor class: INDUSTRY
First posted: 2022-10-20
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The Carevive registry collects patient characteristics, patient symptoms, and treatment experience data from patients receiving cancer treatment for breast, lung, GI or multiple myeloma. For this study, a core set of variables is collected on each patient in the Carevive platform. Patients will complete a baseline survey in person using a secured device or remotely using their own electronic device in a location of their choice. Weekly electronic Patient Reported Outcome surveys are collected from the patients using the Carevive platform for a minimum of 12 weeks. Patients may continue weekly surveys as long as they are receiving treatment.


Eligibility criteria: Inclusion Criteria:

* All participants must be 18 years of age or older.
* Subjects may be any stage and anywhere in the treatment continuum.
* Subject participants must have a diagnosis of breast, lung, GI or ovarian cancer or multiple myeloma.
* Subjects must be able to complete on-line surveys using a cell phone, tablet, or computer.
* All participants must be able to understand English.

Exclusion Criteria:

* Any patient who cannot understand written or spoken English.
* Any patient without the ability to complete on-line surveys using a cell phone, tablet, or computer.
* Any patient on a treatment clinical trial.
* Any prisoner and/or other vulnerable persons as defined by NIH (45 CFR 46, Subpart B, C and D).

Primary outcomes:
measure: Create data set
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: Carevive Systems, Inc.
name: Aaron Galaznik, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01082172: South American Thoracic Stent-Graft Study
Official title: A Pilot Trial to Evaluate the Performance of the TriVascular Thoracic Stent Graft System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thoracic Aortic Aneurysm
Keywords: thoracic
aortic
aneurysm
TAA
Lead sponsor: Endologix
Sponsor class: INDUSTRY
First posted: 2010-03-08
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective, non-randomized multi-center clinical evaluation of the performance of the TriVascular Thoracic Stent Graft System when used in the treatment of subjects with thoracic aortic aneurysms (TAA).


Eligibility criteria: Inclusion Criteria:

* The TriVascular Thoracic Stent Graft System is indicated in subjects diagnosed with an aneurysm in the descending thoracic aorta having vascular morphology suitable for endovascular repair, including:

  * Adequate iliac/femoral access compatible with the required delivery systems,
  * Non-aneurysmal aortic segments proximal and distal to the aneurysm.

Primary outcomes:
measure: Absence of device-related serious adverse events within 30-days of endovascular procedure
timeFrame: 30-Days
Secondary outcomes:
Other outcomes:
Locations:
city: Santiago
country: Chile
facility: Pontificia Universidad Caolica de Chile
Study officials:
References: