louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00284453: Ventricular Tachyarrhythmia (VT) Storm, Gene Expression in Implantable Cardioverter Defibrillator (ICD) Patients With Electrical Storm
Official title: Gene Expression in ICD Patients With Electrical Storm
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhythmias
Keywords: ventricular
arrhythmias
ICD
VT storm
ICD patients with VT storm
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2006-01-31
Enrollment: 65
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: Thirty men and women over age 18 with electrical strom that we hope will volunteer to participate in this genetic research study

Brief summary: The purpose of the proposed pilot study is to identify factors which are associated with periods of high ventricular arrhythmia burden. This will be performed by analysis of gene expression from peripheral blood samples.

Detailed description: This is a study of patients with ICD implants who present with multiple(\>2), low-level(1-2) or inappropriate therapies to their defibrillator. The purpose of this pilot study is to identify factors which are associated with periods of high ventricular arrhythmia burden by looking at gene expression from peripheral blood, in addition to levels of known markers of CHF, including catecholamine levels, B-type natriuretic peptide, and troponin. This study hypothesizes that extrinsic or systemic factors play a role in triggering these events, and if true should yield candidate proteins which would spawn functional studies to prove a role in causation. Additionally, identification of a marker of increased recurrence of events may aid in guiding therapy (starting an anti-arrhythmic versus awaiting the next event).

Eligibility criteria: Inclusion Criteria:

* ICD patients at least 18 years of age that present within a 72 hour period: 1) \> 2 therapies for ventricular arrhythmias; 2) 1-2 therapies for ventricular arrhythmias; 3) inappropriate therapies for ventricular arrhythmias
* Able to give informed consent

Exclusion Criteria:

* Inability to give informed consent

Primary outcomes:
measure: Genetic Testing
timeFrame: Day 1 Enrollment
measure: Genetic Testing
timeFrame: Day 90 +/- 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: UPMC Presbyterian Hospital
state: Pennsylvania
city: Pittsburgh
country: United States
facility: UPMC Shadyside Hospital
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Sandeep K. Jain, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02970253: Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular Resection Versus Capsular Flap Retention
Official title: Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular Resection Versus Capsular Flap Retention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Coxarthritis
Lead sponsor: ZOL
Sponsor class: OTHER
First posted: 2016-11-21
Enrollment: 190
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular resection versus capsular flap retention.

Prospective study design comparing clinical data in randomized THA patients who either had capsular resection or capsular flap retention.


Eligibility criteria: Inclusion Criteria:

* primary THA

Exclusion Criteria:

* neurologic disease
* painful contralateral THA
* severe back or knee pain
* rheumatology

Primary outcomes:
measure: Clinical data will be measured with scoring list HHS (Harris Hip Score).
timeFrame: One year
measure: Clinical data will be measured with scoring list WOMAC (The Western Ontario and McMaster Universities Arthritis Index).
timeFrame: One year
measure: Clinical data will be measured with scoring list UCLA (University of California Los Angles activity score).
timeFrame: One year
measure: Clinical data will be measured with scoring list HOOS (Hip dysfunction and Osteoarthritis Outcome Score).
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Genk
country: Belgium
facility: ZOL
state: Limburg
Study officials:
References:
Clinical trial NCT00501553: Vitamin D in Patients With Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Heart Failure
Keywords: Heart Failure,
Vitamin D status,
NT-proBNP
Lead sponsor: Hvidovre University Hospital
Sponsor class: OTHER
First posted: 2007-07-16
Enrollment: 148
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: Heart Failure patients

Brief summary: To investigate the prevalence of vitamin D deficiency in patients with Heart Failure.

To investigate if vitamin D levels are correlated to the degree of Heart Failure.


Eligibility criteria: Inclusion Criteria:

* Patient in the Heart Failure Clinic, Hvidovre Hospital
* Willing to participate and sign informed consent over 18 years of age

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Hvidovre
country: Denmark
facility: Hvidovre University Hospital
Study officials:
affiliation: Hvidovre UH
name: Louise L Schierbeck, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hvidovre UH
name: Jens-Erik B Jensen, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05875753: 68Ga-FAPI-FS PET/CT and PET/MR in Pancreatic Cancer
Official title: Preliminary Study of 68Ga-FAPI-FS PET/CT in Patients With Pancreatic Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: EARLY_PHASE1
Conditions: Pancreatic Cancer
Keywords: 68Ga-FAPI-FS
PET/CT
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2023-05-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a preliminary study of 68Ga-FAPI-FS PET/CT or PET/MR in patients with confirmed or suspicious pancreatic cancer. The goal is to determine the safety, biodistribution, and tumor uptake of 68Ga-FAPI-FS.

Detailed description: This is a preliminary phase 0 study in patients with confirmed or suspicious pancreatic cancer. Each patient will receive one dose of 68Ga-FAPI-FS by intravenous route. Dedicated whole-body PET/CT imaging will be performed. A comparative 18F-FDG PET/CT will also be performed within a week.

Eligibility criteria: Inclusion Criteria:

1. Pancreatic cancer confirmed by histopathological results or pancreatic lesions with typical radiological appearance.
2. Expected survival of at least 3 months
3. ECOG ≤ 2
4. Written informed consent provided for participation in the trial
5. In the opinion of investigator, willing and able to comply with required study procedures.

Exclusion Criteria:

1. Pregnancy or breastfeeding.
2. Severe claustrophobia.

Primary outcomes:
measure: Adverse events after injection of 68Ga-FAPI-FS
timeFrame: From tracer injection to 3 hour post-injection
Secondary outcomes:
measure: SUVmax of liver on 68Ga-FAPI-FS
timeFrame: From study completion to 1 month after completion
measure: SUVmax of normal pancreas on 68Ga-FAPI-FS
timeFrame: From study completion to 1 month after completion
measure: SUVmax of blood pool on 68Ga-FAPI-FS
timeFrame: From study completion to 1 month after completion
measure: SUVmax of lung on 68Ga-FAPI-FS
timeFrame: From study completion to 1 month after completion
measure: SUVmax of brain on 68Ga-FAPI-FS
timeFrame: From study completion to 1 month after completion
measure: SUVmax of muscle on 68Ga-FAPI-FS
timeFrame: From study completion to 1 month after completion
measure: SUVmax of tumor lesions on 68Ga-FAPI-FS
timeFrame: From study completion to 1 month after completion
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Uion Medical College Hospital
name: Li Huo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01125553: A Comparison Between Two Formulations of NN5401 in Healthy Subjects
Official title: A Trial to Test for Bioequivalence Between Two NN5401 Formulations in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-05-18
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in the United States of America (USA). The aim of the trial is to compare the exposure of two formulations of insulin degludec/insulin aspart (NN5401) in healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the physician
* Body mass index between 18.0 and 27.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to trial start
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Primary outcomes:
measure: Area under the serum insulin degludec concentration-time curve
timeFrame: from 0 to 120 hours after single-dose
measure: Maximum observed serum insulin degludec concentration
timeFrame: from 0 to 120 hours after single-dose
measure: Area under the serum insulin aspart concentration-time curve
timeFrame: from 0 to 12 hours after single-dose
measure: Maximum observed serum insulin aspart concentration
timeFrame: from 0 to 12 hours after single-dose
Secondary outcomes:
measure: Time to maximum observed serum insulin degludec concentration
timeFrame: from 0 to 120 hours after single-dose
measure: Time to maximum observed serum insulin aspart concentration
timeFrame: from 0 to 12 hours after single-dose
Other outcomes:
Locations:
city: Chula Vista
country: United States
facility: Novo Nordisk Clinical Trial Call Center
state: California
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT00900653: Low Dose Estriol With Lactobacilli Treatment for Preventing Recurrent Urinary Tract Infection in Postmenopausal Women
Official title: Low Dose Estriol With Lactobacilli (Gynoflor) Treatment for Preventing Recurrent Urinary Tract Infection in Postmenopausal Women: A Randomized, Open, Parallel-Group Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Urinary Tract Infections
Keywords: urinary tract infections
postmenopause
lactobacillus
estriol
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2009-05-13
Enrollment: 142
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Recurrent urinary tract infections (UTI) are a problem for postmenopausal women. The aim of this trial is to evaluate the effectiveness of lactobacilli in combination with low dose estriol for preventing recurrent urinary tract infections in postmenopausal women.


Eligibility criteria: Inclusion Criteria:

* Postmenopausal woman
* History of urinary tract infection
* Agree to abstain from self-medication with antibiotics for UTI symptoms
* Agree to abstain from the use of any other intra-vaginal product
* Capable of providing informed consent

Exclusion Criteria:

* Ovarian cancer, cervical cancer, breast cancer
* Estrogen treatment within last 2 years
* Vaginal bleeding
* Antibiotic therapy fewer than three days prior to randomization visit
* Known congenital urologic or gynecologic abnormalities
* Indwelling urinary catheter
* Thromboembolic disease
* Uncompensated liver disease
* Immunosuppressive drug within 60 days

Primary outcomes:
measure: Incidence of urinary tract infection
timeFrame: 6 months
Secondary outcomes:
measure: vaginal pH
timeFrame: 6 months
measure: lactobacillus colonization
timeFrame: 6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT00787553: Tinidazole Versus Cefazolin Antibiotic Prophylaxis of Vaginal and Abdominal Hysterectomy
Official title: Tinidazole Versus Cefazolin Antibiotic Prophylaxis of Vaginal and Abdominal Hysterectomy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hysterectomy
Keywords: hysterectomy
antibiotic prophylaxis
bacterial vaginosis
tinidazole
cefazolin
Lead sponsor: University of Campinas, Brazil
Sponsor class: OTHER
First posted: 2008-11-07
Enrollment: 75
Sex: FEMALE
Minimum age (years): 32
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Purpose: to compare the efficacy of tinidazole and cefazolin on the prophylaxis of the febrile and infectious morbidity after vaginal or abdominal hysterectomy. Methods: A randomized clinical trial carried out at the Women's Integrated Healthcare Center (CAISM)/UNICAMP, Campinas, Brazil. Women undergoing to total vaginal or abdominal hysterectomy were randomly enrolled into one of these three groups of antibiotic prophylaxis: tinidazole, cefazolin or an association of both.

Detailed description: A randomized clinical trial carried out at the Women's Integrated Healthcare Center (CAISM)/UNICAMP, Campinas, Brazil, to compare the efficacy of tinidazole and cefazolin on the prophylaxis of the febrile and infectious morbidity after vaginal or abdominal hysterectomy. Women undergoing to total vaginal or abdominal hysterectomy were randomly enrolled into one of these three groups of antibiotic prophylaxis: tinidazole, cefazolin or an association of both.

Eligibility criteria: Inclusion Criteria:

* women undergoing to hysterectomy due to non-oncologic causes

Exclusion Criteria:

* previous pelvic infection
* antibiotic use within 7 days before surgery
* study drugs allergy
* immuno-incompetence
* urinary tract infection

Primary outcomes:
measure: Post-operative infection
timeFrame: one month after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Campinas
country: Brazil
facility: University of Campinas
state: SP
Study officials:
affiliation: University of Campinas
name: Jose A Simoes, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01704053: Effect of New Oral Anticoagulants Dabigatran and Rivaroxaban on Point of Care Coagulation Testing - an Ex-Vivo Study
Official title: Monitoring The Anticoagulatory Effects of Dabigatran and Rivaroxaban On Plasmatic and Cellular Coagulation by Rotational Thrombelastometry/-Graphy and Multiple Platelet Function Analyzer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Clot Formation and Platelet Aggregation in Point of Care Testing
Keywords: New Oral Anticoagulants
Dabigatran
Rivaroxaban
Thrombelastometry/-graphy (ROTEM, TEG)
Multiple Platelet Function Analyzer (Multiplate)
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2012-10-11
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary Care Clinic. Patients with non-valvular atrial fibrillation who receive Dabigatran or Rivaroxaban for prevention of stroke and systemic embolism.

Brief summary: The purpose of this study is determine whether point of care coagulation testing is able to map the anticoagulatory effects of new oral anticoagulants dabigatran and rivaroxaban. Used as devices are thrombelastometry/-graphy (ROTEM, TEG)and multiple platelet function analyzer (Multiplate).

Detailed description: Patients receiving dabigatran or rivaroxaban in therapeutic doses are recruited. Blood will be taken twice in correlation to the time of drug intake (before and 3 hours after drug intake). The results of thrombelastometry/-graphy and multiple platelet function analyzer will be compared directly with the concentrations determined by plasma concentration assays.

Eligibility criteria: Inclusion Criteria:

* Patients receiving Dabigatran or Rivaroxaban
* Adults \> 18 years

Exclusion Criteria:

* Patients receiving concomittantly inhibitors of platelet function
* Renal insufficiency (Creatinine \> 1,5 mg/dl), Urea \> 80 mg/dl)
* Hemodialysis
* Hepatic Dysfunction (AST \> 30 U/l, ALT \> 30 U/l)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Frankfurt/Main
country: Germany
facility: University Hospital of University hospital of Frankfurt/Main, Department of Anesthesiology, Intensive-Care Medicine and Pain Therapy
state: Hessen
Study officials:
References:
Clinical trial NCT04387253: Study of Late Fetal Loss in Poitou-Charentes. GYNE-COVID
Official title: Study of Late Fetal Loss in Poitou-Charentes. GYNE-COVID
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Identification of the Mother or Fetus Contamination by SARS Cov-2
Research the Presence of Viruses at Different Sites of the Mother and the Fetus or Father
The Survey Builds on a Network Work Already Organized Around the CPDPN of Poitou-Charentes
Analysis Laboratories of the Poitiers CHU
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Maternal-fetal transmission in the second or third trimester of pregnancy of the SARS-COV-2 virus could explain some late fetal losses.

Finding a cause in the context of fetal loss is essential for parents and caregivers. It helps to understand the history of the disease, to address the possible risk of a recurrence and to plan for future pregnancies.

If the maternal-fetal transmission of COVID 19 is confirmed and that it is responsible for obstetric complications, a preventive action could be proposed to the patients by the preconception vaccination.

The investigators are seeking to clarify the frequency of this transmission is information awaited by caregivers, women, couples in particular when the latter are in distress from late fetal loss.


Eligibility criteria: Inclusion Criteria:

* Major patient
* Patient with late spontaneous abortion (≥15 weeks of gestation)
* Benefiting from a Social Security scheme
* Patient who consented to participate in the study
* Free subject, without tutorship, curatorship or subordination

Exclusion Criteria:

* Persons not benefiting from a Social Security scheme or not benefiting from it through a third party.
* Concurrent participation in another clinical research study.

Primary outcomes:
measure: Estimate the prevalence of SARS-CoV-2 infection in women with late fetal loss of unexplained cause.
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: CHU de Poitiers
Study officials:
References:
Clinical trial NCT01364753: Age-related Longitudinal Changes in Aviator Performance
Official title: Age-related Longitudinal Changes in Aviator Performance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Memory Impairment
Keywords: Memory
Aviation
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute on Aging (NIA)
First posted: 2011-06-02
Enrollment: 139
Sex: ALL
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: healthy older pilots holding active airplane license

Brief summary: Our overall goal has been twofold: 1) to evaluate whether there are significant age-related changes in flight simulator performance near age 60, and 2) to assess whether there is an alternative model that can explain longitudinal flight simulator performance on the basis of measures of cognitive function and expertise.

Detailed description: Our overall goal has been twofold: 1) to evaluate whether there are significant age-related changes in flight simulator performance near age 60, and 2) to assess whether there is an alternative model that can explain longitudinal flight simulator performance on the basis of measures of cognitive function and expertise. Such a model might be able to predict change in aviator performance better than what could be predicted by chronological age alone.

Eligibility criteria: Inclusion Criteria:1) licensed aircraft pilot 2) 45 to 70 years of age 3) at least 100 hours of total flight experience 4) current FAA (Federal Aviation Administration) medical certificate of class III or higher

Exclusion Criteria:1) taking psychotropic medications 2) taking other medications with arousal or sedative effects

Primary outcomes:
measure: Aviation-related performance over time.
timeFrame: longitudinal
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
affiliation: Stanford University
name: Jerome A Yesavage
role: PRINCIPAL_INVESTIGATOR
References: