louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04374617: Risk of Venous Thromboembolism in Critically Ill Patients With Severe COVID-19
Official title: Risk of Venous Thromboembolism in Critically Ill Patients With Severe COVID-19
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Critical Illness
Venous Thromboembolism
Venous Thromboses
Venous Thromboses, Deep
Venous Thrombosis Pulmonary
Pulmonary Embolism
Pulmonary Embolism and Thrombosis
Sars-CoV2
SARS-CoV Infection
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2020-05-05
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with severe COVID-19 pneumonia admitted to the intensive care unit.

Brief summary: Severe COVID-19 patients at a high risk of venous thromboembolism. We studied patients in 2 intensive care units of university hospitals in Barcelona and Badalona, Spain. We performed a cut-off screening of deep venous thrombosis (DVT) with bilateral duplex ultrasound to 230 patients.

Detailed description: SARS-CoV-2 infection has been associated with coagulation disorders and increased risk of venous thromboembolism (VTE). The aim of the study is to determine the cumulative incidence of VTE in critically ill patients with COVID-19 and its impact on prognosis.

Methods Cohort study of critically ill patients due to COVID-19. A bilateral venous compression (CUS) ultrasound screening of the lower extremities was performed during a cut-off period in 2 intensive care units of university hospitals in Spain. Asymptomatic and symptomatic VTE were registered: pulmonary embolism (PE) (diagnosed by CT-angiography) and deep venous thrombosis (DVT). The characteristics of the patients, results of their blood tests and their evolution after 7 days of follow-up were recorded.

Eligibility criteria: Inclusion Criteria:

* Patients with severe COVID-19 pneumonia admitted to the intensive care unit

Exclusion Criteria:

* Treatment with Extracorporeal membrane oxygenation (ECMO)
* Pregnant or postpartum women
* Under 18 years old

Primary outcomes:
measure: Venous thromboembolisms
timeFrame: 7 days
Secondary outcomes:
measure: Deaths
timeFrame: 7 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Vall d´Hebron Research Institute VHIR
state: Catalunya
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol. Universitat Autònoma de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitari Vall d'Hebron. Universitat Autonoma de Barcelona
Study officials:
affiliation: Hospital Vall d'Hebron
name: Sergi Bellmunt, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00097617: A Study in Children With Growth Failure Due to Chronic Renal Insufficiency (CRI) or End Stage Renal Disease (ESRD)
Official title: National Cooperative Growth Study (NCGS) of Nutropin AQ, Nutropin, and Protropin in Children With Growth Failure Due to Chronic Renal Insufficiency (CRI) or End Stage Renal Disease (ESRD)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Renal Insufficiency
End-Stage Renal Disease
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
First posted: 2004-11-25
Enrollment: 395
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: This study is a multicenter, open-label, observational, postmarketing surveillance study that will collect information on the use of Genentech growth hormone (GH) preparations to treat children with CRI in the United States.


Eligibility criteria: Inclusion Criteria:

* Children diagnosed with CRI or ESRD and treated with a Genentech GH preparation on or after 1 January 2001
* CRI documented using the Schwartz formula indicates a calculated creatinine clearance (CrCl) of \<=75 mL/min/1.73 m\^2
* Ability to keep follow up appointments throughout the study

Exclusion Criteria:

* Subjects receiving a non-Genentech GH preparation
* Subjects with closed epiphyses
* Subjects with active neoplasia
* Current participation in another GH clinical study
* Current participation in the core study

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Genentech, Inc.
name: Barbara Lippe, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01236417: Exercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia
Official title: Exercise Intervention in Breast Cancer Patients With Treatment-Induced Arthralgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Arthralgia
Lead sponsor: Roswell Park Cancer Institute
Sponsor class: OTHER
First posted: 2010-11-07
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a pilot study of a specifically designed exercise intervention developed for breast cancer patients with aromatase-inhibitor related joint pain.


Eligibility criteria: Inclusion Criteria:

* Post menopausal women with a history of estrogen positive breast cancer who are receiving aromatase inhibitors for at least one month.
* Patients must complain of mild to moderate arthralgia.
* Ability to understand and sign informed consent.
* Patients meet criteria for low to moderate risk for moderate exercise based oon the ACSM guidelines.

Exclusion Criteria:

* Inability to comply with study requirements.
* Metastatic breast cancer.
* Patients with orthopedic or neuromuscular disorders that preclude participation in exercise.
* Rheumatoid arthritis.
* History of MI, angina or congestive heart failure.
* Pregnant or lactating females.
* Patients that are high risk for moderate exercise based on ACSM risk classification.
* Patients who exceed minimal physical activity recommendations from the US Surgeon General's Report: Accumulation of 30 minutes or more of moderate physical activity on most days of the week.
* Morbidly obese with BMI ≥ 40

Primary outcomes:
measure: Effects of exercise
timeFrame: Length of study
Secondary outcomes:
measure: Feasibility of Multi-institutional study
timeFrame: Length of the study
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
Study officials:
affiliation: Roswell Park Cancer Institute
name: Tracy O'Connor, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05479617: Personalised Prediction of Disease Course in Ulcerative Colitis Using Multimodal Machine Learning - Part of the Presager Project
Official title: Personalised Prediction of Disease Course in Ulcerative Colitis Using Multimodal Machine Learning - Part of the Presager Project
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Ulcerative Colitis
Lead sponsor: Copenhagen University Hospital, Hvidovre
Sponsor class: OTHER
First posted: 2022-07-29
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: This is a prospective cohort of a total of 400 UC patients with an active flare

Brief summary: In patients achieving clinical remission following a flare, artificial intelligence can reliably predict a new flare within the next 12 months utilizing clinical and objective information at day 0 and week 8.

Secondary endpoints:

* An artificial intelligence model's precision in predicting a new flare within 2 and 3 years
* An artificial intelligence model's precision to rule out patients who will not experience a new flare within 1, 2 and 3 year


Eligibility criteria: Inclusion criteria:

* Signed informed consent
* Diagnosis of UC for at least 1 year
* Relapse due to UC.
* First endoscopic and histological evaluation of the flare Exclusion criteria
* Well-founded doubt that the flare is due to other than the patients UC

Primary outcomes:
measure: Flare I
timeFrame: within 1 year
Secondary outcomes:
measure: Flare II
timeFrame: within 2 years
measure: Flare III
timeFrame: within 3 years
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Gastrounit, medical section, Copenhagen University Hospital Hvidovre
Study officials:
References:
Clinical trial NCT02150317: Transarterial Chemoembolization (TACE) Plus Sorafenib Versus TACE for Advanced Hepatocellular Carcinoma
Official title: A Prospective Randomized Trial Comparing Transcatheter Arterial Chemoembolization (TACE) Followed by Sorafenib Versus TACE Alone for Advanced Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Advanced Hepatocellular Carcinoma
Keywords: Carcinoma, Hepatocellular
Chemoembolization, Therapeutic
Sorafenib
Lead sponsor: Eastern Hepatobiliary Surgery Hospital
Sponsor class: OTHER
First posted: 2014-05-29
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the outcomes of Transarterial Chemoembolization (TACE) followed by Sorafenib with TACE alone in patients with advanced hepatocellular carcinoma.


Eligibility criteria: Inclusion Criteria:

* Male or female patients \> 18 years and \<=70 years of age.
* at least 2 radiologic imaging showing characteristic features of hepatocellular carcinoma or cytologic/histologic evidence.
* tumor in liver and radiologically definable vascular invasion or extrahepatic metastasis.
* Criteria of liver function: Child A-B level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
* No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal.
* Hb ≥90g/L,white blood cell count ≥3.000 cells/mm³,platelets ≥80.000 cells/mm³
* Patients who can understand this trial and have signed information consent

Exclusion Criteria:

* Patients with apparent cardiac, pulmonary, cerebral and renal dysfunction,which may affect the treatment of liver cancer.
* Patients with other diseases which may affect the treatment mentioned.
* Patients with a medical history of other malignant tumors.
* Subjects participating in other clinical trials.
* liver function:Child C.
* no pathological evidence of hepatocellular carcinoma.

Primary outcomes:
measure: the overall survival rate of each group
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Eastern Hepatobiliary Surgery Hospital
state: Shanghai
Study officials:
affiliation: Eastern Hepatobiliary Surgery Hospital, Second Military Medical University
name: Ai-jun Li, M.D.
role: STUDY_CHAIR
References:
Clinical trial NCT05538117: Diagnostic Performance of Coronary Calcification Detection on CT Scan
Official title: Diagnostic Performance of Coronary Calcification Detection on CT Scan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: Thoracic pain
Acute coronary event
CT scan
Thoracic scan
Coronary calcifications
Acute Coronary Syndrome
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient (≥18 years old) admitted to the emergency room of the Nouvel Hôpital Civil in Strasbourg between 06/01/2021 and 12/31/2021 and presenting with typical chest pain \<30min or atypical symptoms but non-eliminable cardiac origin.

Brief summary: thoracic pain is one of the most frequent reasons for consulting the emergency room. Chest pain can be a sign of different pathologies with a wide range of severity, from life-threatening aortic dissection or myocardial infarction to chest pain during an anxiety attack. Efficient triage of patients is therefore a crucial issue for emergency physicians in order not to ignore an acute coronary event requiring early and specific management.

The investigators seek to evaluate whether a diagnostic strategy based on a thoracic CT scan to rule out coronary calcifications and a single troponin assay can exclude an acute coronary event with sufficient accuracy compared to usual management.


Eligibility criteria: Inclusion criteria:

* Adult patient (≥18 years old)
* Patient admitted to the emergency room of the Nouvel Hôpital Civil in Strasbourg between 06/01/2021 and 12/31/2021 and presenting with typical chest pain \<30min or atypical symptoms but non-eliminable cardiac origin.
* Patient with an initial assessment within the norms (ECG not modified, first troponin negative) and having performed a chest CT scan
* Patient who has not expressed his opposition to the reuse of his data for scientific research purposes.

Exclusion criteria:

- Patient who has expressed his opposition to the retrospective reuse of his data for scientific research purposes

Primary outcomes:
measure: Ability of scan CT to detect coronary calcifications in patients presenting with thoracic pain to the emergency department
timeFrame: 30 minutes after onset of pain
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'accueil des urgences - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT02160717: Risk of Diabetes in Young Turner Syndrome Patients
Official title: Beta-Cell Function in Young Turner Syndrome Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Turner Syndrome
Keywords: Turner Syndrome
Diabetes
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
Collaborators: name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2014-06-11
Enrollment: 120
Sex: FEMALE
Minimum age (years): 6
Maximum age (years): 22
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic Turner Syndrome Center of Cincinnati Community Sample

Brief summary: Turner Syndrome is a common genetic disorder. Seventy percent of adults with Turner Syndrome have abnormalities in glucose metabolism which can lead to diabetes. The current screening guidelines for diabetes in Turner Syndrome are not specific and involve a fasting blood sugar once a year. The objective of this study is to determine if there are abnormalities in glucose metabolism and pancreatic function in young girls with Turner Syndrome. The study hypothesis is that pancreatic dysfunction (specifically of the beta cells that make insulin) is more prevalent in girls with Turner Syndrome compared to healthy controls.

Detailed description: The study will be conducted at Children's Hospital Medical Center, Cincinnati. The study will require 1 visit to the hospital where the subject will have an oral glucose tolerance test and a physical exam

Eligibility criteria: Turner Syndrome Females:

Inclusion Criteria:

* Turner Syndrome confirmed by chromosomal testing
* On standard therapy (growth hormone and or estrogen)

Exclusion Criteria:

* Type 1 or Type 2 diabetes
* Polycystic Ovarian Syndrome
* Pregnancy
* On any medications that alter blood sugar

Healthy Female Controls:

Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Type 1 or Type 2 diabetes
* Polycystic Ovarian Syndrome
* Pregnancy
* On any medications that alter blood sugar

Primary outcomes:
measure: Beta-Cell Function measured as Disposition Index
timeFrame: 1 day at screening
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Children's Hospital Medical Center, Cincinnati
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Nicole Sheanon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06522217: Prosthetic Rehabilitation of Lip and Palate Deformaties in Neonates Using Two Different Approaches
Official title: Prosthetic Rehabilitation of Lip and Palate Deformaties in Neonates Using Two Different Approaches
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Evaluation
Keywords: nasoalveolar molding
digital nasoalveolar molding
complete unilateral cleft lip and palate
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-07-26
Enrollment: 20
Sex: ALL
Minimum age (years): 2
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2 groups : Group A receiving conventional nasoalveolar molding appliance and Group B receiving CAD NAM
Primary purpose: TREATMENT

Brief summary: This study was conducted to compare the use of conventional nasoalveolar molding appliances and the use of digitally designed and produced nasoalveolar molding appliances in rehabilitating neonates born with unilateral complete cleft lip and palate.

Detailed description: For this prospective study, twenty newborns with non-syndromic complete unilateral cleft lip and palate were referred from the Outpatient Clinics of several pediatric surgeons and obstetricians to the Department of Prosthodontics -Faculty of Dentistry - Tanta University.

Inclusion criteria:

* Age range from 2-3 weeks after birth.
* Only the Non-syndromic unilateral cleft lip and palate neonates.
* Newborn infants without any surgical intervention.

Exclusion criteria:

* Patients with the life threatening syndromes.
* Respiratory difficulties are not considered for presurgical treatment.
* Uncooperative guardians.

Eligibility criteria: Inclusion Criteria:

* Age range from 2-3 weeks after birth.
* Only the Non-syndromic unilateral cleft lip and palate neonates.
* Newborn infants without any surgical intervention.

Exclusion Criteria:

* Patients with the life threatening syndromes.
* Respiratory difficulties are not considered for presurgical treatment.
* Uncooperative guardians.

Primary outcomes:
measure: intraoral measurements
timeFrame: 3 -4 months
measure: extraoral measurements
timeFrame: 3-4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Faculty of Dentistry -Tanta university
state: Gharbia
Study officials:
affiliation: tanta university faculty of dentistry
name: hoda amin rashad, phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00027417: Study of Triostat in Infants During Heart Surgery
Official title: Triostat in Children During CardioPulmonary Bypass (CPB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Heart Defects, Congenital
Keywords: Congenital heart defects
Hypoplastic left heart syndrome
Complete atrioventricular canal defect
Triostat
Cardiac surgery
Lead sponsor: Seattle Children's Hospital
Sponsor class: OTHER
First posted: 2001-12-07
Enrollment: 195
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study to determine the safety and efficacy of liothyronine sodium/triiodothyronine (Triostat), a synthetic thyroid hormone, when given to infants with congenital heart disease during cardiopulmonary bypass surgery.

Detailed description: Patients will be randomized to receive study drug or placebo and randomization will occur stratified to each diagnostic category. All patients undergo preoperative echocardiograms to provide preoperative cardiac function data. The study drug or placebo will be provided in the operating room as an iv bolus just prior to cardiopulmonary bypass and as a bolus delivered on release of the aortic cross-clamp. This will be followed by iv for 12 hours. Operative data will be collected including CPB time, aortic cross-clamp time, length and degree of hypothermia. These data will be extracted from the anesthesia record.

Eligibility criteria: Inclusion criteria:

Diagnosis of one of the following:

* Ventricular septal defect (VSD)
* Infant coarctation of the aorta
* Transposition of the great arteries
* Tetralogy of Fallot
* Complete atrioventricular canal defect
* Hypoplastic left heart, including patients who undergo a Norwood type procedure for aortic or mitral atresia

Patient must be scheduled for surgery.

Exclusion criteria:

* Certain additional defects and/or requirement for additional surgery.

Primary outcomes:
measure: duration of mechanical ventilation after cardiopulmonary bypass.
timeFrame: 0 to 72 hours
Secondary outcomes:
measure: Assess other parameters
timeFrame: 0 to 72 hrs
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Children's Hospital and Regional Medical Center
state: Washington
Study officials:
affiliation: Seattle Childrens Hospital
name: Michael Portman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Portman MA, Slee A, Olson AK, Cohen G, Karl T, Tong E, Hastings L, Patel H, Reinhartz O, Mott AR, Mainwaring R, Linam J, Danzi S; TRICC Investigators. Triiodothyronine Supplementation in Infants and Children Undergoing Cardiopulmonary Bypass (TRICC): a multicenter placebo-controlled randomized trial: age analysis. Circulation. 2010 Sep 14;122(11 Suppl):S224-33. doi: 10.1161/CIRCULATIONAHA.109.926394.