louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06265987: Maternal and Fetal Characteristics Influencing Image Quality in Prenatal Ultrasonography
Official title: ECHOQUALITY2: Maternal and Fetal Characteristics Influencing Image Quality in Prenatal Ultrasonography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasonography
Obstetrics
Fetus
Pregnant Women
Keywords: Quality
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 198
Sex: FEMALE
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: Women having undergone an ultrasound between 18 weeks and 18 weeks + 6 days at the Multidisciplinary Prenatal Diagnostic Center of Poitiers University Hospital

Brief summary: The objective of this observational study is to identify maternal and fetal characteristics that impact image quality in prenatal ultrasonography. The investigators have assembled a retrospective cohort of 198 patients, each contributing three ultrasound images taken between 18 and 18 weeks and 6 days of gestation. For each image, the investigators assess the quality of two distinct elements as well as the overall image through both subjective and objective evaluations.

The primary questions the study seeks to address are:

What maternal and fetal characteristics influence image quality in prenatal ultrasonography?


Eligibility criteria: Inclusion Criteria:

- Patient who underwent ultrasound between 18 weeks and 18 weeks + 6 days for prenatal diagnosis

* Ultrasound performed by the same practitioner
* Ultrasound performed on the same ultrasound machine "Voluson E10", with the "RM6C" probe

Exclusion Criteria:

- Patient's refusal

* Use of another ultrasound device other than the "Voluson E10", and/or an ultrasound probe other than the "RM6C"
* Intrauterine fetal deaths

Primary outcomes:
measure: Maternal and fetal characteristics can influence quality image in ultrasonography
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: University Hospital La MILETRIE
Study officials:
References:
Clinical trial NCT00117871: Study With a Topical Gel to Treat Common Warts in Adults
Official title: A Two-Stage, Single-Blind, Dose-Escalating Study to Assess Efficacy and Safety of Resiquimod Gel Applied 5 Times Per Week for up to 12 Weeks for the Treatment of Common Warts in Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Warts
Keywords: Warts
Adults
Common Warts
Resiquimod
Lead sponsor: Graceway Pharmaceuticals, LLC
Sponsor class: INDUSTRY
First posted: 2005-07-11
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary purpose of this study is to evaluate the effectiveness in adults of 2 different strengths of resiquimod gel applied to common wart(s) five times a week for up to 12 weeks.

A second purpose is to evaluate the safety of the drug.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of common warts
* Two forms of birth control

Exclusion Criteria:

* Pregnant or breast feeding
* Other types of warts, ie. plantar
* Currently participating in another clinical study
* Chronic viral hepatitis B or C

Primary outcomes:
measure: Clearance of treated wart(s)
Secondary outcomes:
measure: Partial clearance of treated wart(s)
Other outcomes:
Locations:
city: Fridley
country: United States
facility: Minnesota Clinical Study Center
state: Minnesota
Study officials:
References:
Clinical trial NCT05757193: Ketone Pharmacokinetic Study in HFrEF
Official title: Ketone Pharmacokinetic Study in Heart Failure With Reduced Ejection Fraction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Heart Failure With Reduced Ejection Fraction
Keywords: DeltaG
ketone ester
metabolites
metabolomics
ketoacidosis
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: American Heart Association
First posted: 2023-03-07
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants stratified based on use of background use of SGLT2 inhibitors
Primary purpose: OTHER

Brief summary: The purpose of this study is to test whether an over-the-counter ketone ester drink is well tolerated in people with heart failure on, and not on, a heart failure medication class called SGLT2 inhibitors. The research team is trying to determine the safest dose of Delta G. The study has a single visit. Participants will be served a light breakfast with the study drink, a physical exam will be conducted, and the study team will obtain information about demographics and medical history. The study team will draw blood intravenously up to eight times over the course of the half-day visit.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of HFrEF (ejection fraction\<=45%)
* Systolic blood pressure greater \>=90 mmHg

Exclusion Criteria:

* Intentional ketogenic (high fat, low carbohydrate) diet (must be off ketogenic diet for \>7 days prior to visit)
* Significant liver disease (cirrhosis) or alcohol abuse disorder (\>14 drinks/week).
* Unique cardiomyopathies: infiltrative/hypertrophic cardiomyopathy, pericardial disease, or other cardiomyopathies that in the investigator's opinion have unique treatment options that would be less likely to be affected by ketone therapy.
* Estimated glomerular filtration rate\<25 mL/min/1.73 m2 as the most recent value in the last year.
* Type 1 diabetes mellitus
* Use of ventricular assist device, history of heart transplant, or use of continuous inotropes
* Pregnant women. Due to unknown affects of nutritional ketosis in pregnant women, pregnancy will be an exclusion. Accordingly, women of childbearing age with a menstrual cycle within the past year will be asked to submit a urine specimen for pregnancy testing.

Primary outcomes:
measure: Venous pH Measured Via Peripheral Blood
timeFrame: 1 hour
measure: Glucose Level Measured Via Peripheral Blood
timeFrame: 1 hour
measure: Systolic Blood Pressure
timeFrame: 1 hour
measure: Beta-hydroxybutyrate (BHB) Level Measured Via Peripheral Blood
timeFrame: 1 hour
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: Duke University
name: Senthil Selvaraj, MD, MSTR, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00137293: Study Evaluating GAP-486 in Heart Rhythm
Official title: A Study to Characterize the Acute Electrophysiologic Properties, Safety and Tolerability of GAP-486
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Arrhythmia
Keywords: Arrhythmia, syncope, antiarrhythmic
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-08-29
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study is to learn the effects of a test drug on heart rhythm, and to provide additional data to see if the test drug is well tolerated and safe.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing an electrophysiology study for evaluation of heart rhythm.

Exclusion Criteria:

* Patients with uncontrolled blood pressure
* Patients with certain cardiac risk factors
* Patients with significant kidney or liver problems

Primary outcomes:
measure: This study takes place within 24 hours. The measure to determine the effect of the intervention will be the difference in values from the baseline electrophysiology study, and the values obtained after intervention within the test drug.
Secondary outcomes:
measure: This study takes place within 24 hours, and looks at the changes in values of electrophysiology studies, before and after administration of test article.
Other outcomes:
Locations:
city: San Francisco
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Hershey
country: United States
state: Pennsylvania
city: Ottawa
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Montreal
country: Canada
state: Quebec
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06569693: Dyadic Sleep Study
Official title: Dyadic Sleep Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Gastrointestinal Cancer
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2024-08-26
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to learn about sleep behaviors and test different ways to help patients with cancer and caregiver partners.


Eligibility criteria: Inclusion Criteria:

* The eligibility criteria for patients are:

  * newly diagnosed with stage I to IV of a GI cancer (anus, colon, esophagus, gallbladder, large and small intestine, liver, pancreas, rectum, stomach, other biliary or digestive organs)
  * diagnosis in the past 12 months at the time of enrollment
  * having a consistent sleep partner.
* The eligibility criterion for caregivers is:

  * a sleep partner of the patient.
* Additional eligibility criteria for both patients and caregivers are:

  * Pittsburgh Sleep Quality Index (PSQI) ≥ 5,
  * willing to change sub-optimal sleep habits,
  * 18 years or older,
  * able to speak/listen English at the 8th grade level for intervention sessions,
  * able to read English or Spanish at the 8th grade for self-reported questionnaires,
  * \> 4 weeks after surgery, if any, prior to enrollment, and no surgery planned in the next 5 weeks during the study period because surgery affects sleep.

Exclusion Criteria:

* Exclusion criteria for both patients and caregivers are having had a diagnosis of major depressive disorder, psychosis, or bipolar disorder that is not currently treated;
* Active suicidality, or substance or alcohol dependency in the past year;
* Currently have narcolepsy, restless leg syndrome, or untreated sleep apnea that is screened using the Sleep Health Screen;
* Both patients and caregivers have an extreme chronotype, or do shift work to have no overlap in sleep schedule between them; and plan trans-meridian travel during the period of data collection blocks; and having hearing or visual impairment, dementia, or cognitive dysfunction.
* Adults unable to consent, individuals who are not yet adults, pregnant women, or prisoners will be excluded.

Primary outcomes:
measure: Change in sleep disturbance symptoms as measured by scores on the Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline, Up to 13 weeks
Secondary outcomes:
measure: Change in insomnia symptoms as measured by scores on the Insomnia Severity Index (ISI)
timeFrame: Baseline, Up to 13 weeks
Other outcomes:
Locations:
city: Coral Gables
country: United States
facility: University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Youngmee Kim, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00567593: Gene Regulation by Thiazolidinediones
Official title: Gene Regulation by Thiazolidinediones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Inflammatory Bowel Disease
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2007-12-05
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to determine the effect of rosiglitazone on the genes of the colon

Detailed description: The primary aim of the study is to examine the effect of rosiglitazone (Avandia) on gene regulation in colonic epithelium in the absence of pathologic acute and chronic intestinal inflammation. The secondary aims are to determine the effect of rosiglitazone (Avandia) therapy on T cell activation and cytokine expression in the absence of pathologic acute and chronic intestinal inflammation.

Eligibility criteria: Inclusion Criteria:

* Capable of giving informed consent
* Agrees to use a barrier method of birth control for the duration of the study

Exclusion Criteria:

* History of inflammatory bowel disease
* Has taken prescription or over the counter medications in the two weeks prior to enrollment
* History of diabetes, heart failure, angina, hypertension, coronary heart disease, cancer, bleeding disorder, HIV, AIDS
* Fasting LDL \>160 mg/dl
* History of smoking in the year prior to enrollment
* Pregnant or breastfeeding

Primary outcomes:
measure: PDK4 mRNA
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania Clinical and Translational Research Center
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: James D Lewis, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01627093: Medical Data Collection of Patients With Head and Neck Cancer Treated With Proton Therapy
Official title: Prospective Data Collection of Patients Treated With Proton Therapy for Head and Neck Malignancies
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Head and Neck Carcinoma
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2012-06-25
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients documented to have head and neck cancer treated with proton therapy at MD Anderson Cancer Center in Houston, Texas (MDACC) from January 1, 2008 through April 30, 2012, and patients who receive treatment from May 1, 2012 through December 31, 2018

Brief summary: This trial collects medical information from patients with head and neck cancer that have received or are scheduled to receive proton therapy. Collecting and analyzing medical information from patients may provide information on the outcomes and treatment related side effects of proton therapy for head and neck cancer and help doctors improve therapy for future patients with head and neck cancer.

Detailed description: PRIMARY OBJECTIVE:

I. To evaluate the outcomes in patients who have received treatment for their head and neck malignancy with proton radiation therapy.

OUTLINE:

Patients complete questionnaires over 30 minutes before treatment begins, at each visit during treatment, and again at all follow-up visits related to treatment. Patients also have their medical records reviewed.

Eligibility criteria: Inclusion Criteria:

* Patients documented to have head and neck cancer treated with proton therapy at MDACC from January 1, 2008 through April 30, 2012 and patients who receive treatment from May 1, 2012 through December 31, 2018

Primary outcomes:
measure: Overall survival analysis of proton therapy for head and neck malignancies
timeFrame: 7 years
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: Steven J Frank
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03341793: Impact of Changes in Muscle Secretome in the Remission of Type 2 Diabetes Mellitus Induced by Bariatric Surgery
Official title: Impact of Changes in Muscle Secretome in the Remission of Type 2 Diabetes Mellitus Induced by Bariatric Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabete Type 2
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2017-11-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Bariatric surgery is recognized as a therapeutic modality of type 2 diabetes. The mechanisms of this remission of diabetes remain poorly understood.

The aim of our research is to characterize the changes in muscle secretome induced by bariatric surgery and to determine their role in improving the insulin sensitivity of skeletal muscle and insulin secretion by the B cell responsible for the remission of diabetes.

Detailed description: Bariatric surgery is recognized as a therapeutic modality of type 2 diabetes. The mechanisms of this remission of diabetes remain poorly understood.

The aim of our research is to characterize the changes in muscle secretome induced by bariatric surgery and to determine their role in improving the insulin sensitivity of skeletal muscle and insulin secretion by the B cell responsible for the remission of diabetes.

This prospective study will be carried out in insulin-resistant diabetic patients or not in whom blood and muscle samples will be carried out before and after bariatric surgery

Eligibility criteria: Inclusion Criteria:

* Age from 19 to 69 year-old Candidate for bariatric surgery BMI ≥ 35kg / m² with at least one subsequent comorbidity (SAS or type 2 diabetes mellitus or refractory HTA) or BMI ≥ 40kg / m² Non-diabetic or diabetic with HbA1c \<7.5% without treatment except metformin Caucasian No pregnancy or breastfeeding No history of neoplasia in the last 5 years No history of uncontrolled endocrinopathy other than diabetes Informed consent signed by patient

Exclusion Criteria:

* Non-caucasian Major Depression Hemorrhagic risk (biopsy) associated with taking anticoagulants/antiaggregants Known myopathy Systemic administration of steroids (\> 1mg/kg in hydrocortisone) Hyperthyroidism Type 1 diabetes Psychological, familial, sociological or geographical condition potentially limiting compliance with the protocol Participation in other clinical drug studies Modification of anti-diabetic treatment during the month preceding surgery

Primary outcomes:
measure: Changes in myokine (muscle secretome) secretion induced by bariatric surgery
timeFrame: Level of myokines in culture media conditioned by muscle cells taken before and 3 months after bariatric surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Cliniques universitaires Saint-Luc
Study officials:
References:
Clinical trial NCT01809093: Thrombospondin-1 and Pigmented Epithelium Derived Factor Levels in Patients With Diabetes Mellitus.
Official title: Modulation of Thrombospondin-1 and Pigment Epithelium Derived Factor Levels in Vitreous Fluid and Plasma of Patients With Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus
Keywords: PEDF
TSP1
Thrombospondin
pigment epithelium derived factor
Wills Eye Institute
Pars plana vitrectomy
Vitreous levels
Mid Atlantic Retina
Blood draw
Blood test
Lead sponsor: Wills Eye
Sponsor class: OTHER
First posted: 2013-03-12
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with diabetes mellitus who are undergoing pars plana vitrectomy for any reason

Brief summary: You are being asked to be in a research study to determine blood levels and vitreous levels of compounds called thrombospondin 1 (TSP1) and pigment epithelium derived factor (PEDF). These compounds exists naturally in your body.

Detailed description: The hypothesis tested here is that diabetic patients that express the higher molecular weight pigment epithelium-derived factor (PEDF) isoform have lower thrombospondin-1 (TSP1) level and, as a result, are at a greater risk for the development of more severe diabetic retinopathy.

Eligibility criteria: Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Diabetes Mellitus
* Undergoing pars plana vitrectomy for any reason

Exclusion Criteria:

* Use of any anti-VEGF (vascular endothelial growth factor ) medications

Primary outcomes:
measure: Level of thrombospondin (TSP1) and pigment epithelium derived factor (PEDF) in the vitreous and plasma
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Mid Atlantic Retina- Wills Eye Institute
state: Pennsylvania
Study officials:
name: Marc Spirn, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00493493: Pore Excision, Curettage, and Injection of Cymetra for Pilonidal Disease
Official title: Pore Excision, Curettage, and Injection of a Tissue Scaffold as Treatment for Pilonidal Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pilonidal Sinus
Keywords: Cymetra
Lead sponsor: Matino, James, M.D.
Sponsor class: INDIV
Collaborators: name: LifeCell
First posted: 2007-06-28
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Chronic pilonidal disease is a common problem with no ideal treatment. This is a prospective study that will evaluate the results of surgical pore excision, curettage, and injection of a regenerative tissue matrix, Cymetra, on patients with chronic pilonidal disease.

Detailed description: In addition, the study will evaluate the credibility and reproducibility of results within other surgeons trained to perform the procedure. Data collection will focus on post-operative wound failure, infection ratwes, analgesic requirements, time lost from work or school, wound care requirements, and 6 month recurrence rates. These outcomes will be compared to outcomes using conventional pilonidal surgical intervention using published data.

Eligibility criteria: Inclusion Criteria:

* Any patient with pilonidal diseas

Primary outcomes:
measure: wound failure, time lost from work or school, analgesic requirements, recurrence rates
timeFrame: 6 months
Secondary outcomes:
measure: infection rates, wound care requirements
timeFrame: 6 months
Other outcomes:
Locations:
city: Hartford
country: United States
facility: St Francis Hospital
state: Connecticut
Study officials:
affiliation: Surgical Group,PC
name: James J Matino, MD
role: PRINCIPAL_INVESTIGATOR
References: