louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03162341: Study of the Correlation Between UltraSonography and Dual-Energy Computed Tomography Assessment of Urate Deposit
Official title: Study of the Correlation Between UltraSonography and Dual-Energy Computed Tomography Assessment of Urate Deposit in Urate Lowering Therapy Initiators
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gout
Keywords: Dual-Energy Computed Tomography
UltraSonography
Gout
Urate deposition
Lead sponsor: Lille Catholic University
Sponsor class: OTHER
Collaborators: name: Horizon Pharma Rheumatology LLC
First posted: 2017-05-22
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this research is to evaluate the correlation between DECT and US explorations performed in a routine clinical setting for the measurement of change in tophus size in gout patients after 24 months of treatment.


Eligibility criteria: Inclusion Criteria:

* diagnosis of gout based on the ACR/EULAR 2015 criteria
* uricemia ≥6 mg/dL
* warranted introduction of urate-lowering therapy according to the ACR 2012 or EULAR 2016 criteria
* signature of the informed consent
* social insurance affiliation

Exclusion Criteria:

* pregnancy or breastfeeding
* patient under legal guardianship

Primary outcomes:
measure: Correlation between US and DECT measurement of change in tophus volume
timeFrame: after 24 months of treatment
Secondary outcomes:
measure: Correlation between US and DECT measurement of change in tophus volume
timeFrame: after 6 months, 12 months and 24 months of treatment
measure: Change of DECT urate score
timeFrame: after 6 months, 12 months and 24 months of treatment
measure: Link between the change of DECT urate score and the persistence of the double contour sign
timeFrame: after 6 months, 12 months and 24 months of treatment
measure: Correlation between the change of DECT urate score and the change in serum uric acid levels
timeFrame: after 6 months, 12 months and 24 months of treatment
measure: Correlation between the change of DECT urate score and the number of gout attacks
timeFrame: after 6 months, 12 months and 24 months of treatment
Other outcomes:
Locations:
city: Lomme
country: France
facility: Hospital Group of the Catholic Institute
city: Paris
country: France
facility: Bichat Hospital
city: Paris
country: France
facility: Lariboisière Hospital
Study officials:
affiliation: Hospital Group of the Catholic Institute of Lille
name: Tristan Pascart, MD
role: STUDY_DIRECTOR
affiliation: Bichat Hospital of Paris
name: Sébastien Ottaviani, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Lariboisiere Hospital of Paris
name: Pascal Richette, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04024241: Medium Dose of Cytarabine and Mitoxantrone
Official title: The Clinical Observationg on HAM for Acute Myeloid Leukemia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Myelogenous Leukemia
Chemotherapy
Keywords: AML HAM
Lead sponsor: Shenzhen People's Hospital
Sponsor class: OTHER
First posted: 2019-07-18
Enrollment: 250
Sex: ALL
Minimum age (years): 14
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: people diagnosed as AML expect acute promyeloytic leukemia

Brief summary: By observation of the inpatients in shenzhen people's hospital,research the curative effect of the two chemotherapy schemes on AML-High dose of cytarabine and HAM.

Detailed description: The patients of AML in shenzhen people's hospital were randomly divided into two therapy groups.One group was treated by High dose of cytarabine ,and the other was HAM.Evaluate the two chemotherapy schemes by bone marrow suppression time and patient survival time.

Eligibility criteria: Inclusion Criteria:

people diagnosed as AML

Exclusion Criteria:

* acute promyeloytic leukemia

Primary outcomes:
measure: bone marrow suppression time
timeFrame: one month
measure: patient survival time
timeFrame: three years
Secondary outcomes:
Other outcomes:
Locations:
city: Shenzhen
country: China
facility: Shenzhen
state: Guangdong
Study officials:
References:
Clinical trial NCT04316741: Brief Intervention Combined With Health Coaching Via Social Media for Cannabis Use
Official title: Harnessing Social Media to Reduce Cannabis Use Among Adolescents and Emerging Adults in an Urban Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cannabis Use
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2020-03-20
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of the study is to develop and test social media interventions to help young people increase well-being and reduce risky behaviors. The study will help researchers learn about ways to deliver wellness information in a way that is appealing and helpful to young people who use Snapchat.


Eligibility criteria: Inclusion Criteria:

Individuals seen in the Emergency Department at Hurley Medical Center who meet these criteria

* self-report of weekly or more frequent cannabis use for past 3 months
* past month Snapchat use
* ability to consent
* English-speaking
* between ages 18-25
* smart phone ownership

Exclusion Criteria:

* Emergency Department presentation for suicidality and/or acute psychosis, being in police custody, or present with psychological distress requiring intensive social work (e.g. sexual assault)
* having a medical cannabis card

Primary outcomes:
measure: Brief Intervention Acceptability
timeFrame: Immediate post-test administered after the session
measure: Snapchat Acceptability Rating
timeFrame: 1 month
measure: Brief Intervention Feasibility
timeFrame: Immediate
measure: Snapchat Health Coaching Feasibility
timeFrame: Up to 1 month
measure: Snapchat Health Coaching Feasibility
timeFrame: Up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Flint
country: United States
facility: Hurley Medical Center
state: Michigan
Study officials:
affiliation: University of Michigan
name: Erin Bonar
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06191341: Consequences in ICU of Vaccination Status of Covid-19 Patients
Official title: Consequences in ICU of Vaccination Status of Covid-19 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: SARS CoV 2 Infection
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 1058
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: Adult patient with Sars-Cov-2 pneumonia

Brief summary: It is a retrospective cohort study aiming to describe the characteristics, management and prognosis of vaccinated patients hospitalized in the intensive care unit (ICU), in comparison with non-vaccinated patients.

Detailed description: In December 2019 started the first wave of Sars-Cov-2 virus infections in Wuhan, China : the start of a major, deadly global pandemic, which has so far caused more than 6 million deaths worldwide. In response to the scale of this pandemic, a large-scale vaccination campaign was rapidly in place, starting in December 2020. Despite this measure, admission of vaccinated patients to intensive care has been noticed. The aim of this study is to describe the characteristics, management and prognosis of vaccinated patients hospitalized in the intensive care unit (ICU), in comparison with non-vaccinated patients.

Eligibility criteria: Inclusion Criteria:

* Adult patient with Sars-Cov-2 pneumonia confirmed by positive reverse transcription polymerase chain reaction (RT-PCR) assay and hospitalized in the general intensive care unit of the CHR de Metz-Thionville, between 01/03/2020 and 01/06/2022.

Exclusion Criteria:

* missing data for primary or secondary outcomes

Primary outcomes:
measure: World Health Organisation (WHO) clinical progression scale
timeFrame: at hospital discharge
Secondary outcomes:
measure: Mortality
timeFrame: at D28 after hospital admission
measure: Prognosis factors
timeFrame: at hospital admission
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz-Thionville/Hopital Mercy
Study officials:
affiliation: CHR Metz Thionville Hopital Mercy
name: Guillaume LOUIS, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06820541: Gallbladder Stenting in FC-SEMS
Official title: Prophylactic Endoscopic Transpapillary Gallbladder Drainage to Prevent Post-ERCP Cholecystitis After Covered Metal Stent Placement for Distal Biliary Obstruction: a Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Biliary Obstruction
Acute Cholecystitis
Lead sponsor: Azienda Ospedaliera Universitaria Integrata Verona
Sponsor class: OTHER
First posted: 2025-02-11
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this randomized controlled trial is to determine whether primary prophylaxis with transpapillary gallbladder drainage prevents acute cholecystitis after fully-covered self-expandable metal stents placement during endoscopic retrograde cholangiopancreatography for malignant distal biliary obstruction in patients at higher risk of post-endoscopic retrograde cholangiopancreatography acute cholecystitis.

The main question it aims to answer is:

Does prophylactic transpapillary gallbladder drainage reduce the rate of post-endoscopic retrograde cholangiopancreatography acute cholecystitis in high-risk patients? Researchers will compare patients who undergo transpapillary gallbladder drainage to patients without transpapillary gallbladder drainage to see if transpapillary gallbladder drainage reduces the rate of acute cholecystitis.

Participants will:

1. receive or not transpapillary gallbladder drainage before fully-covered self-expandable metal stents placement
2. will be followed up at one, three, and six months to ascertain the onset of acute cholecystitis


Eligibility criteria: Inclusion Criteria:

* Adult patients
* Signed informed consent
* Patients requiring covered metal stent placement for managing MBO
* High-risk of post-endoscopic cholangiopancreatography acute cholecystitis according to the following criteria:
* tumor involvement of the cystic duct orifice confirmed on magnetic resonance imaging, computed tomography, endoscopic ultrasound, or at endoscopic cholangiopancreatography;
* presence of at least 2 of the following:

  1. gallbladder stones;
  2. CBD diameter ≤ 10 mm;
  3. intraprocedural gallbladder opacification;
  4. cystic duct orifice at risk of being covered by the fully-covered stent

Exclusion Criteria:

* History of cholecystectomy
* Endoscopic retrograde cholangiopancreatography not feasible for duodenal stenosis or failed biliary cannulation
* Patients with previous gallbladder drainage
* Acute cholecystitis is already present based on the Tokyo guidelines

Primary outcomes:
measure: Acute cholecystitis
timeFrame: 6 months
Secondary outcomes:
measure: Overall adverse events
timeFrame: 6 months
measure: Hospitalization
timeFrame: 6 months
measure: Disease-free survival
timeFrame: 6 months
measure: Technical success
timeFrame: 1 mont
measure: Procedure time
timeFrame: 1 month
Other outcomes:
Locations:
city: Verona
country: Italy
facility: AOUI Verona
Study officials:
References:
Clinical trial NCT00102141: Effect of Angeliq on Blood Pressure (BP) in Postmenopausal Hypertensive Women
Official title: A Multicenter, Double-blind, Randomized, Placebo-controlled Study Comparing 3 Continuous Oral Angeliq (Drospirenone 3 mg/17ß-estradiol 1 mg, Drospirenone 2 mg /17ß-estradiol 1 mg, Drospirenone 1 mg /17ß-estradiol 1 mg) Combinations and 17ß-estradiol (1 mg) With Placebo for a Treatment Period of 8 Weeks on Ambulatory and Office Cuff Blood Pressure in Postmenopausal Women With Stage 1 or Stage 2 Essential Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hypertension
Postmenopause
Keywords: Postmenopausal
vasomotor symptoms
essential hypertension
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2005-01-24
Enrollment: 750
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The objective of the study is to evaluate the effects of Angeliq on BP over a period of 8 weeks in postmenopausal women who may benefit from hormone replacement therapy (HRT) for the relief of vasomotor symptoms and who have hypertension.

Detailed description: This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Eligibility criteria: Inclusion Criteria:- Have hypertension- Are currently taking antihypertensive medications- Have had natural menopause at least 1 year prior to screening- Must require hormone therapy in the opinion of the investigator

Primary outcomes:
measure: Mean change in systolic office blood pressure measured at through
timeFrame: After 8 weeks of treatment
measure: Mean change in 24-hour systolic ambulatory blood pressure measurement (ABPM)
timeFrame: After 8 weeks of treatment
Secondary outcomes:
measure: Mean change in diastolic blood pressure measured at through
timeFrame: After 8 weeks of treatment
measure: Mean changes in 24-hour diastolic ABPM
timeFrame: After 8 weeks of treatment
measure: Mean change in daytime systolic ABPM
timeFrame: After 8 weeks of treatment
measure: Mean change in daytime diastolic ABPM
timeFrame: After 8 weeks of treatment
measure: Mean change in nighttime systolic ABPM
timeFrame: After 8 weeks of treatment
measure: Mean change in nighttime diastolic ABPM
timeFrame: After 8 weeks of treatment
measure: Mean change in systolic APBM at through
timeFrame: After 8 weeks of treatment
measure: Mean change in diastolic APBM at through
timeFrame: After 8 weeks of treatment
Other outcomes:
Locations:
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06269341: Outcomes of Smoker and Drinker With Esophageal Squamous Cell Carcinoma After Esophagectomy
Official title: Long-term Outcomes of Smoker and Drinker With Esophageal Squamous Cell Carcinoma After Esophagectomy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Outcomes of Smoker and Drinker After Esophagectomy
Keywords: survival
esophgeal cancer
smoker
drinker
Lead sponsor: Sichuan Cancer Hospital and Research Institute
Sponsor class: OTHER
First posted: 2024-02-21
Enrollment: 2957
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with esophageal cancer

Brief summary: Our study demonstrates that patients who did not consume alcohol or smoke had a significant advantage in overall survival (OS) after undergoing esophagectomy. Furthermore, our findings indicate that there was no statistically significant difference in OS between patients with a history of both smoking and drinking, and those who only smoked or drank


Eligibility criteria: Inclusion Criteria:

patients with esophageal cancer

Exclusion Criteria:

(1) pathology confirmed a non-squamous cell carcinoma, (2) the tumor was located outside of the thoracic region, (3) R1/R2 resection was performed indicating incomplete tumor removal, (4) evidence of distant tumor metastasis was observed, (5) they underwent preoperative neoadjuvant therapy, (6) pTis/T1a stage (7) Missing data.

Primary outcomes:
measure: Overall Survival
timeFrame: April 2022-April 2024
Secondary outcomes:
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Cancer Hospital and Research Institute
state: Sichuan
Study officials:
References:
Clinical trial NCT06785441: Older Men's Decision Making About Active Surveillance for Prostate Cancer - Aim 3: Decision Aid Efficacy Testing
Official title: Older Men's Decision Making About Active Surveillance for Prostate Cancer - Aim 3: Decision Aid Efficacy Testing
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Prostate Cancer
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2025-01-21
Enrollment: 180
Sex: MALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Male

Brief summary: This protocol describes pilot testing of an educational shared decision-making intervention to help men with localized prostate cancer make decisions with their health care providers about if and when to de-escalate surveillance testing. The project is important because for many patients their cancer does not progress to the point of needed curative treatment or their health status changes such that they are no longer good candidates for treatment. For these men, de-escalating ongoing surveillance (e.g., fewer biopsies or imaging studies) is a reasonable option.

Detailed description: Primary Objective:

The overall goal of this protocol is to test initial efficacy of three versions of an educational tool for use by patients and health-care providers to help men with localized prostate cancer make informed decisions about discontinuation of active surveillance. A pre-post design was selected to provide initial efficacy data of the different versions of the shared decision-making intervention. Thereby, providing preliminary data in preparation for a follow-up comparative study.

Eligibility criteria: Inclusion Criteria:

Patients:

1. Males aged 65 or older
2. Diagnosis of localized prostate cancer
3. Have not received curative intent treatment for their prostate cancer
4. Fluent in English

Care partners/caregivers:

1. Aged 18 or older
2. Fluent in English
3. Involved with the care of an eligible patient (i.e. partner, close friend, family member, companion)

Exclusion Criteria:

Patients

1. Currently receiving treatment for another cancer (primary or recurrence)

Care partners/caregivers

1. None

Primary outcomes:
measure: Preparation for Decision Making Scale
timeFrame: Through study completion and average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: M.D. Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Lisa Lowenstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01554241: Optimizing Vitamin D in the Elderly
Official title: Optimizing Vitamin D in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deficiency of Vitamin D3
Keywords: vitamin D3
D3
cholecalciferol
25-OH vitamin D
elderly
nursing home resident
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2012-03-14
Enrollment: 86
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Vitamin D deficiency is highly prevalent in older people in the absence of vitamin D supplementation. The limited data available show marked inter-individual variability in response to vitamin D supplementation in very old, frail elderly with almost 25% remaining vitamin D deficient (25-OH D \< 20 ng/mL) when receiving the currently recommended 800 IU/day vitamin D. This proposal is for exploratory research on the use of a wide range of oral vitamin D3 doses in frail elderly living in controlled living environments.

Detailed description: The investigators will determine the dose response relationship of circulating total and unbound 25-OH vitamin D3 to supplemental vitamin D3 at daily doses of 800 (currently recommended for the elderly), 2000, and 4000 IU or 50,000 IU/weekly in a randomized blinded investigation of 16 weeks duration. The investigators will also compare the efficacy of each dosing regimen in achieving 25-OH vitamin D levels \>20 ng/mL (50 nmol/L) and identify covariates that contribute to inter-individual variation in the dose response relationship. In patients with osteoporosis, relationships between unbound vs. total 25-OH on intact parathyroid hormone and a marker of bone resorption (beta-Ctx) will be analyzed. The investigators will also examine responses of inflammatory cytokines.

Note: as of April 8,2014, there will be no further enrollment in the 50,000 IU/weekly dose group

Eligibility criteria: Inclusion Criteria:

* age over 65
* medically stable
* residing in long-term care or assisted living

Exclusion Criteria:

* hypercalcemia or high risk for hypercalcemia
* active cancer or malignancy other than non-melanoma skin cancer
* severe renal disease (eGFR \<30 ml/mkin/M2)
* small bowel resection or intestinal bypass surgery
* hyperparathyroidism
* granulomatous disease
* clinically unstable (changes in medications or diagnoses within a month, hospitalizations, within 6 months)
* allergy to vitamin D

Primary outcomes:
measure: Total 25-OH Vitamin D3 Level
timeFrame: 16 weeks
Secondary outcomes:
measure: Free 25-OH Vitamin D3
timeFrame: 16 weeks
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California
state: California
Study officials:
affiliation: University of California, San Francisco
name: Janice B Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06441734: Iron Status in Autism Spectrum Disorders
Official title: Iron Status in Autism Spectrum Disorders in Children Attending Assiut Pediatric University Hospital
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Anemia, Iron Deficiency
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-06-04
Enrollment: 46
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: children age from 2years to 12 years not having an infection or inflammatory conditions or physical illness

Brief summary: to evaluate the prevalence of iron deficiency anemia in group with autism spectrum disorders in comparison to normal children group


Eligibility criteria: Inclusion Criteria:

* children who are diagnosed with autism spectrum disorder according to DSM -V
* not having infection inflammatory conditions chronic physical illness
* children who are not receiving iron supplementation

Exclusion Criteria:

* age below 2 years and above 12 years
* having an infection or inflammatory conditions chronic physical illness
* receiving iron supplementation

Primary outcomes:
measure: iron status in autism spectrum disorders
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: khalaf abdelaal said, lecturer
role: STUDY_CHAIR
References:
citation: Al-Beltagi M. Autism medical comorbidities. World J Clin Pediatr. 2021 May 9;10(3):15-28. doi: 10.5409/wjcp.v10.i3.15. eCollection 2021 May 9.