louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01075867: Multi-dimensional Prevention Program After Acute Coronary Syndrome (ELIPS) (SPUM-ACS- SP1)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2010-02-25
Enrollment: 2498
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 Admitted for an Acute Coronary Syndrome

Brief summary: To demonstrate the effectiveness of the ELIPS programme (Multi-dimEnsionaL preventIon Program after Acute coronary Syndrome), which aims at improving quality of care of patients admitted to hospital with Acute Coronary Syndrome (ACS) in the Swiss setting. The program targets an increase in prescription rates by physicians and long term medication adherence and adoption of healthy lifestyle attitudes by patients.

The program is dedicated to caregivers to increase their application of guidelines into practice, to increase their confidence in therapeutic education of patients, and to patients to improve their understanding of ACS and its treatment and to increase their motivation for long term treatment,.


Eligibility criteria: Inclusion Criteria:

* Patients \>18 years
* Admitted for an ACS, that is with symptoms compatible with angina pectoris (chest pain, breathlessness) and at least one of the following 3 features : a) Elevation or depression of the ST segment, inverted T waves or dynamic changes in the repolarization phase b) Positive troponin c) Known coronary artery disease. A significant coronary artery disease must be confirmed angiographically.

Exclusion Criteria:

* Severe physical disability or dement
* Less than 1 year of life expectancy for non cardiac reason

Primary outcomes:
measure: composite of death and cardiovascular event
timeFrame: 1 year
Secondary outcomes:
measure: Process outcome at discharge
timeFrame: 1 year
measure: Clinical outcomes at follow-up
timeFrame: 1 year
measure: Surrogate outcomes at follow-up
timeFrame: 1 year
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital
city: Geneva
country: Switzerland
facility: University Hospitals
city: Lausanne
country: Switzerland
facility: University Hospital
city: Zürich
country: Switzerland
facility: University Hospital,
Study officials:
References:
citation: Weidmann L, Obeid S, Mach F, Shahin M, Yousif N, Denegri A, Muller O, Raber L, Matter CM, Luscher TF. Pre-existing treatment with aspirin or statins influences clinical presentation, infarct size and inflammation in patients with de novo acute coronary syndromes. Int J Cardiol. 2019 Jan 15;275:171-178. doi: 10.1016/j.ijcard.2018.10.050. Epub 2018 Oct 16.
Clinical trial NCT05536167: Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the Aspiration Catheters Family
Official title: Prospective Multicenter Study to Characterize the REAL-WORLD EVIDENCE Regarding Safety and Performance of the Aspiration Catheters Family
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Thrombus in the Central and Peripheral Circulatory System, Including Saphenous Vein Grafts
Lead sponsor: Arthesys
Sponsor class: INDUSTRY
First posted: 2022-09-10
Enrollment: 57
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing PTA/PTCA and/or stenting procedures and presenting thrombus in the central and peripheral circulatory system, including saphenous vein grafts.

Brief summary: The purpose of this post market study is to collect clinical data of the Arthesys Aspiration catheters family during percutaneous intervention and/or stenting procedure of vessels in the central and peripheral circulation system, including saphenous vein grafts, to support MDR submission.


Eligibility criteria: Inclusion Criteria:

* Patients will be included as per Instructions for Use (IFU), Hospital standard of care and Good Clinical Practice (GCP):

  1. Patient with a percutaneous intervention to a native coronary, saphenous vein graft, or peripheral arteries;
  2. Patient with angiographic evidence of thrombus;
  3. Patient \> or = 50 kg;
  4. Patient \>18 years;
  5. Patient who understands the trial requirements and the treatment procedures and provides written informed consent.

Exclusion Criteria:

* Patients will be excluded as per IFU, Hospital standard of care and GCP, also if there are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision.

Primary outcomes:
measure: Efficacy endpoint
timeFrame: up to end of procedure
measure: Safety endpoint
timeFrame: up to end of procedure
Secondary outcomes:
measure: Performance - TIMI flow grade
timeFrame: up to end of procedure
measure: Safety - absence of complications
timeFrame: up to end of procedure
measure: Performance - TIMI thrombus grade
timeFrame: up to end of procedure
measure: Performance
timeFrame: up to end of procedure
measure: Safety - absence of Serious Adverse Event
timeFrame: up to end of procedure
measure: Safety - absence of stroke
timeFrame: up to end of procedure
Other outcomes:
Locations:
city: La Rochelle
country: France
facility: Hôpital Saint Louis
Study officials:
References:
Clinical trial NCT01325467: Detection of Coronary Artery Disease Using Analysis of High Frequency QRS: The HyperQ Registry
Official title: Detection of Coronary Artery Disease Using Analysis of High Frequency QRS: The HyperQ Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: coronary artery disease
high frequency QRS analysis
ischemia
exercise testing
diagnosis of coronary artery disease
Lead sponsor: BSP Biological Signal Processing Ltd.
Sponsor class: INDUSTRY
First posted: 2011-03-29
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients referred for an exercise ECG treadmill test with nuclear myocardial perfusion imaging (MPI).

Brief summary: This will be a registry study that will enroll patients referred for an ECG treadmill test with nuclear myocardial perfusion imaging (MPI). The high frequency QRS (HFQRS) information will be recorded and analyzed automatically and simultaneous with the standard ECG signals by the HyperQ System. Results of subsequent tests performed on each patient will be collected and used to enhance the reliability of designating each patient as a CAD-negative (i.e., no significant coronary artery disease) or a CAD-positive (i.e., significant coronary artery disease).


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Referred for exercise MPI due to suspected coronary artery disease

Exclusion Criteria:

* Acute Coronary Syndrome (Unstable angina/NSTEMI/STEMI)
* Pre-excitation syndrome
* QRS duration \> 120 ms
* Atrial Fibrillation or significant ventricular arrhythmia
* Treatment with Digoxin
* Pacemaker with 100% pacemaker dependence

Primary outcomes:
measure: CAD status
timeFrame: one month follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: University of Virginia Health System
name: Jamieson M Bourque, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Minneapolis Heart Institute Foundation
name: Robert Schwartz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03787667: Application of Radiomics in Precise Preoperative Diagnosis and Prognsis Evaluation of Colorectal Cancer.
Official title: Application of Radiomics in Precise Preoperative Diagnosis and Prognsis Evaluation of Colorectal Cancer: a Prospective, Clinical Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Colorectal Cancer Stage I-IV
Lead sponsor: Fudan University
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients received enhaced CT or MRI test must have baseline evaluations performed prior to the study and must meet all inclusion and exclusion criteria. In addition, the patient must be thoroughly informed about all aspects of the study, including the study visit schedule and required evaluations and all regulatory requirements for informed consent.

Brief summary: This is a prospective, clinical study. This study is to collect and analyze data of radiomics of primary site or metastasis of colorectal cancer aiming to precisizing preoperative diagnosis and long-term prognsis evaluation.


Eligibility criteria: Inclusion Criteria:

* Patients with pathologically confirmed colorectal cancer
* Male or female aged 18-75 years old on the day of signing informed consent.
* Patients who received imageological examination of primary or metastasis
* Patients who received surgical resection of primary or metastasis
* Patients must have a performance status of ≤1 on the ECOG Performance Scale.
* Colorectal cancer is the only malignant tumor
* Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study

Exclusion Criteria:

* Patients received adjuvant treatment prior to imageological examination
* Tis stage patients
* Paitents who diagnosed with malignant disease within 5 years.
* Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Investigator.

Primary outcomes:
measure: Sensitivity
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fudan University Shanghai Cancer Center
state: Shanghai
Study officials:
References:
Clinical trial NCT02811367: The HPV Self-test as a Test of Cure in Madagascar
Official title: The HPV Self-test as a Test of Cure in the Follow-up of HPV-positive Women in Madagascar
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papilloma Virus Infection
Cervical Intraepithelial Neoplasia Grade 2/3
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 117
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to find out whether Self-HPV may be an accurate method for the follow-up of women with a history of HPV infection.

Detailed description: The efficacy and the availability of cold coagulation render it a valuable technique for the treatment of precancerous lesions in low-resource settings. The Human Papillomavirus (HPV) test performed by women themselves (HPV self-test) could be an efficient method to assess the long-term risk of recurrent/persistent disease in women with a history of HPV infection and cervical intra-epithelial lesions grade 2 or higher (CIN2+).

A total of 443 HPV-positive women, aged 30-65 years, have been selected through a screening campaign conducted in Ambanja, Madagascar, between 2013 and 2015. Of these, 260 have been treated by cold coagulation, conisation or electrocauterization. A follow-up visit at 1-3 years after primary screening will be organized for all HPV-positive women detected at primary screening. Participants will perform an HPV self-test. A sample for cytology and HPV testing will also be collected by the physician. The goal of the study will be the histological search for CIN2+ lesions at one to three years after primary screening.

The investigators expect to see that Self-HPV may be an accurate method for the follow-up of women with a history of HPV infection.

Eligibility criteria: Inclusion Criteria:

* women previously positive at HPV testing

Exclusion Criteria:

* pregnancy

Primary outcomes:
measure: Cervical intra-epithelial neoplasia grade 2 or worse
timeFrame: 4 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ambanja
country: Madagascar
facility: Saint Damien Medical Center
Study officials:
References:
Clinical trial NCT02100267: A Study to Evaluate Efficacy and Safety of Methacholine Chloride Challenge Test in Diagnosis of Adult Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Sanwa Kagaku Kenkyusho Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2014-03-31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 64
Standard ages: ADULT
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to evaluate efficacy and safety of Methacholine Chloride challenge test in diagnosis of adult asthma


Eligibility criteria: Inclusion Criteria:

* FEV1/forced vital capacity(FVC) must be 70% or more
* \<10% decrease in FEV1 in response to inhalation of normal saline

Exclusion Criteria:

* Moderate airflow limitation (FEV1 \< 60% predicted or \< 1.5 L)
* Heart attack or stroke in last 3 months
* Uncontrolled hypertension, systolic BP\>200, or diastolic BP\>100

Primary outcomes:
measure: Sensitivity and specificity of methacholine challenge test (Cutoff value of PC20: 8mg/mL)
timeFrame: Visit 2 (Day 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Setagaya-ku
country: Japan
facility: Showa University Clinical Research Center
state: Tokyo
Study officials:
References:
Clinical trial NCT04896567: Isolation of Cells From Biopsy Tissue to Aid in Kidney Repair
Official title: Isolation of Cells From Biopsy Tissue to Aid in Kidney Repair
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Kidney Diseases
Endothelial Dysfunction
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
First posted: 2021-05-21
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Consecutive patients will be consented to obtain kidney biopsy material.
Primary purpose: BASIC_SCIENCE

Brief summary: Endothelial progenitor cells that reside in renal vasculature may be stimulated to initiate differentiation programs during episodes of injury. It is hypothesized that endothelial progenitor cells resident in the kidney can transition to a post-injury phenotype that promotes endothelial repair.

Detailed description: Endothelial dysfunction is central to the pathophysiology of vascular ischemia, bacterial sepsis, toxin-induced thrombotic microangiopathy, and antibody-mediated kidney transplant rejection and often manifest with renal failure. With each of these diagnoses circulating components of the complement cascade bind to endothelial cells and induce disease progression through anaphylactic cellular messaging, monocyte homing, and direct cell membrane disruption. In response to injury during embryologic development avascular metanephric blastema initiate endothelial differentiation. Although circulating hematopoietic progenitor cells have shown therapeutic promise they incorporate into renal vasculature at very low density.

Eligibility criteria: Inclusion Criteria:

* Only patients who have a clinical indication for kidney biopsy will be considered.
* All subjects will be at least 18 years of age and may be of any gender.
* Patients undergoing a native or kidney transplant biopsy will be considered.

Exclusion Criteria:

* Patients not undergoing a kidney biopsy will be excluded.

Primary outcomes:
measure: Cell growth
timeFrame: 1 week
Secondary outcomes:
measure: Kidney disease progression
timeFrame: 3 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT04186767: Weight Loss Impact on Male Fertility
Official title: Significative Weight Loss Impact on Oxidative Stress, Metabolic, Hormonal, Inflammatory and Seminal Parameters of Obese Men.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Sub Fertility, Male
Metabolic Syndrome
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2019-12-05
Enrollment: 20
Sex: MALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, unicentre, single group
Primary purpose: TREATMENT

Brief summary: This is a prospective non-randomized unicentric clinical trial, characterized by the inclusion of obese (BMI\> 35) male with subfertility (sperm count showing low sperm counts and / or motility and / or morphology and / or DNA fragmentation). Patients selected at the endocrinology obesity HC-FMUSP outpatient will be submitted to very low calorie diet (VLCK) for 6 months, being reassessed clinically and laboratorially monthly.


Eligibility criteria: Inclusion Criteria:

Obesity in male patients

* Metabolic Syndrome (NCEP-ATP III)
* Alteration of some of the seminal parameters evaluated in conventional seminal analysis

Exclusion Criteria:

* Other causes of hypogonadotrophic hypogonadism

  * Hypergonadotrophic hypogonadism
  * Contraindications for performance of ketogenic diet:
  * Type 1 or type 2 diabetes mellitus in insulin use
  * Food drive
  * Alcoholism or drug addiction
  * Severe psychiatric illness
  * Use of coumarin anticoagulants
  * Hepatic insufficiency
  * Severe renal impairment
  * Hematologic diseases
  * Cancer in activity,
  * Cardiovascular or cerebrovascular diseases (arrhythmias, recent myocardial infarction, unstable angina, decompensated heart failure, recent stroke)
  * Gout
  * Renal or biliary lithiasis
  * Major depression or other serious psychiatric illness.

Primary outcomes:
measure: Seminal evaluation
timeFrame: Six months
measure: Seminal evaluation
timeFrame: Six months
measure: Seminal evaluation
timeFrame: Six months
Secondary outcomes:
measure: Metabolic response
timeFrame: Six months
measure: Hormonal measurements
timeFrame: Six months
measure: Inflamatory response
timeFrame: Six months
measure: Adipose tissue evaluation
timeFrame: Six months
measure: Microbiota evaluation
timeFrame: Six months
measure: Epigenetic evaluation
timeFrame: Six months
measure: Body composition changes
timeFrame: Six months
measure: Brow tissue study
timeFrame: Six months
measure: Adipose tissue toxins study
timeFrame: Six months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clinicas da Faculdade de Medicina da USP
state: Sao Paulo
Study officials:
References:
Clinical trial NCT00276367: The Impact of Post Discharge One-Time Home Visit: Bridging the Gap Between Hospital and Home.
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: COPD
Coronary Artery Disease
Diabetes Mellitus
Stroke
Lead sponsor: Maimonides Medical Center
Sponsor class: OTHER
First posted: 2006-01-13
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Although IRB approval was received, study was not initiated.

Brief summary: A single post-hospital discharge home visit by a geriatric nurse practitioner or geriatric fellow can bridge the gap and ease the transition for elderly frail patients returning home after hospital admission. We believe this intervention will reduce medication errors, ensure follow-up discharge plans, decrease re-hospitalization rates, and decrease morbidity and mortality.


Eligibility criteria: Inclusion Criteria:

Patients admitted to the ACE unit during the study time frame, age 65 and over, and residing in the community before and after discharge from the hospital. Selected patients will have complex discharge plans including referrals to home care agencies, poly-pharmacy, multiple co-morbidities, history of repeated hospitalizations, and poor social support systems in the community. In addition, eligible patients will have at least one of eight admitting diagnoses, chosen for their high likelihood of requiring post-discharge home care needs. These diagnosis include: CHF, COPD, coronary artery disease, diabetes mellitus, stroke, hip fracture, peripheral vascular disease or cardiac arrhythmia. The GNP or fellow will then request permission from the patient's primary physician to do a one-time post-discharge home visit.

Exclusion Criteria:

Patients discharged to settings other than their homes (i.e. nursing home, sub-acute rehabilitation, etc.)Patients discharged to settings other than their homes (i.e. nursing home, sub-acute rehabilitation, etc.)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Maimonides Medical Center
name: Aleksandra Zagorin, MA, GNP-C, ANP-C
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01194167: Study of Eltrombopag in Platelet Refractory Thrombocytopenia
Official title: A Phase II Study of Eltrombopag in Platelet Refractory Thrombocytopenia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Thrombocytopenia
Keywords: Platelet refractory thrombocytopenia
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: GlaxoSmithKline
First posted: 2010-09-02
Enrollment: 0
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: This phase II trial is studying the effects of the drug eltrombopag has on thrombocytopenia (low platelet count). Eltrombopag is approved by the FDA for the treatment of thrombocytopenia (low platelet count) in adults who have had an insufficient response to medications such as corticosteroids and immunoglobulins. Eltrombopag is not approved by the FDA (Food and Drug Administration) for the treatment of thrombocytopenia refractory to platelet transfusion and so for this study is considered investigational.


Eligibility criteria: Inclusion Criteria:

* Laboratory diagnosis of platelet refractoriness
* Diagnosis of platelet dependence
* Adequate liver and renal laboratory screening tests

Exclusion Criteria:

* Patients with thrombocytopenia that are responsive to platelet therapy
* Patients actively receiving intravenous immunoglobulin, plasmapheresis or cytotoxic medications for thrombocytopenia

Primary outcomes:
measure: Determine the likelihood of eltrombopag allowing platelet transfusion independence in patients with platelet refractoriness at doses of 75 mg, 150 mg, and 300 mg per day
timeFrame: 3 years average
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Patricia Carey, MD
role: PRINCIPAL_INVESTIGATOR
References: