louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00788619: Use of Nitric Oxide Metabolites for Predicting Embryo Quality in In-Vitro Fertilization (IVF)
Official title: Use of Nitric Oxide Metabolites for Predicting Embryo Quality in In-Vitro Fertilization
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Infertility
Keywords: Infertility
Assisted reproductive technology
Nitric oxide
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2008-11-11
Enrollment: 2
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 37
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Improvements in In-Vitro Fertilization (IVF) outcomes have largely been due to the generation of excess embryos allowing for multiple embryo transfer. Unfortunately this has also increased the risk of multiple pregnancy with associated maternal and neonatal morbidity and mortality. The investigators believe that the concentration of nitric oxide metabolites measured in the culture medium from the first day of culture can identify the best quality embryos allowing us to transfer a limited number of embryos without compromising the optimum chance for pregnancy.


Eligibility criteria: Inclusion Criteria:

* Age 21-37
* Female
* Less than two previous unsuccessful IVF cycles

Exclusion Criteria:

* Day 3 FSH \>9.9
* Fewer than 8 mature oocytes retrieved
* Fewer than 8 normally fertilized embryos on day 2 after fertilization

Primary outcomes:
measure: Percentage of subjects with viable pregnancy one month after embryo transfer
timeFrame: 1 month
Secondary outcomes:
measure: Percentage of subjects with > 2 viable embryos one month after embryo transfer
timeFrame: 1 month
Other outcomes:
Locations:
city: Lutherville
country: United States
facility: Johns Hopkins Fertility Center
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Lisa A Kolp, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06235619: Arch Size Study for Anatomical Variations
Official title: CT Anatomical Characteristics of the Aortic Arch in Subjects With or Without Aneurysms Requiring Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Aortic Arch
Aneurysm
Dissection, Aortic
Keywords: Aortic arch
Bovine arch
Thoracic aortic disease
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-02-01
Enrollment: 500
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: The population of the study is the general population undergoing Angio CT scan both the thoracic aorta

Brief summary: The aortic arch with a common origin of the innominate and left carotid artery (CILCA) prevalence in the general population is 13.6%. Its reputation as a benign anatomical variant has been ultimately shattered by further studies that identified the CILCA arch as a potential marker for thoracic aortic disease (TAD) The aim of this work is to report the CT anatomical characteristics of the aortic arch in subjects with or without aneurysms requiring treatment, in 5 major European cardiovascular centers.


Eligibility criteria: Inclusion Criteria:

all patients with aortic arch CT scan at investigating centers

Exclusion Criteria:

none

Primary outcomes:
measure: difference from baseline of aortic arch anomalies
timeFrame: 30 day
Secondary outcomes:
Other outcomes:
Locations:
city: Milan
country: Italy
facility: IRCCS San Raffaele Hospital
Study officials:
References:
Clinical trial NCT02737319: A Randomized Trial of Rosuvastatin in Elective Angioplasty to Prevent Contrast-induced Nephropathy (CLEAR-CIN).
Official title: A Randomized Trial of Rosuvastatin in Elective Percutaneous Coronary Intervention to Prevent Contrast-induced (CLEAR-CIN).
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nephropathy
Keywords: Contrast,nephropathy, angioplasty, stable coronary
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Instituto Dante Pazzanese de Cardiologia
First posted: 2016-04-13
Enrollment: 493
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The investigators analyzed the HMG-CoA reductase inhibitor, rosuvastatin, for the prevention of contrast-medium-induced nephropathy in patients undergoing primary angioplasty.

Detailed description: Patients with stable coronary artery disease already taking chronic statin undergoing elective angioplasty are at risk for contrast-medium-induced nephropathy because there are specified risk factors as age more than 75 years, chronic renal insufficiency, diabetes, use of contrast and the lack of effective prophylaxis.

Eligibility criteria: Inclusion Criteria:

* chronic statin use
* positive stress test findings (electrocardiography, nuclear imaging, or stress echocardiography
* elective angioplasty.

Exclusion Criteria:

* non-statin therapy
* any presentation of ACS within 24 hours before the time of randomization
* current use of potent CYP3A4 inhibitors, including azole antifungals, protease inhibitors, macrolide antibiotics, and cyclosporine
* renal replacement therapy, a history of kidney transplant, pregnant and with renal failure (serum creatinine \> 3.0 mg/dl).

Primary outcomes:
measure: Contrast induce nephropathy defined by serum creatinine increase more than 0.3mg/dl or 50% higher than baseline
timeFrame: 48 hours
Secondary outcomes:
measure: Composite end-point ( all cause of death; acute renal failure and no-fatal mayocardial infarctio.
timeFrame: 48 hours
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Instituto Dante Pazzanese de Cardiologia
Study officials:
affiliation: Instituto Date Pazzanese de Cardiologia
name: Kleber Bomfim A Martins, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05672719: Hemodynamic Testing Strategies to Assess Pulmonary Hypertension in Heart Failure
Official title: Hemodynamic Testing Strategies to Assess Pulmonary Hypertension and Right Ventricular Function in Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Heart Failure
Lead sponsor: Mount Sinai Hospital, Canada
Sponsor class: OTHER
Collaborators: name: Heart and Stroke Foundation of Canada
First posted: 2023-01-05
Enrollment: 74
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: PROBABILITY_SAMPLE
Study population: Patients assessed in the advanced heart failure program for heart transplant candidacy at the University of Toronto referred for right heart catheterization.

Brief summary: The goal of this observational study is to learn about heart function and high lung blood pressure in patients with heart failure. The main question\[s\] it aims to answer are whether we can improve the ability to predict patients who will have complications after they receive treatment including heart transplant and left ventricular assist devices.

Detailed description: Prospective cohort study of patients with heart failure with reduced ejection fraction that are referred for diagnostic right heart catheterization as part of their evaluation for candidacy for advanced heart failure therapies.

Eligibility criteria: Inclusion Criteria:

* Adults age 18 years or older
* Heart failure with reduced ejection fraction (\<40%)
* referred for RHC at our centre for evaluation of candidacy for advanced HF therapies.

Exclusion Criteria:

Severe valvular or complex congenital heart disease Short-term mechanical circulatory support for progressive cardiogenic shock (e.g. extracorporeal membrane oxygenation) Acute coronary syndrome or revascularization occurred within 7 days prior to the RHC.

Pregnant or breast-feeding Known hypersensitivity to sodium nitroprusside Advanced liver dysfunction Reduced capacity or inability to provide informed consent

Primary outcomes:
measure: Mean pulmonary artery pressure
timeFrame: First study 1 day visit
measure: right ventricular end systolic elastance
timeFrame: First study 1 day visit
measure: pulmonary arterial elastance
timeFrame: First study 1 day visit
Secondary outcomes:
measure: Right ventricular failure after heart transplant
timeFrame: 1 year
measure: Right ventricular failure after left ventricular assist device
timeFrame: 1 year
Other outcomes:
measure: right ventricular pulmonary arterial elastance coupling response to vasodilator
timeFrame: First study 1 day visit
Locations:
city: Toronto
country: Canada
facility: Mount Sinai Hospital
state: Ontario
Study officials:
affiliation: University of Toronto
name: Susanna Mak, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05072119: Monaldi Hospital Rhythm Registry
Official title: Registry of Patients Underwent Cardiac Implanted Electronic Device Implantation at Monaldi Hospital
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pacemaker
ICD
Implanted Loop Recorder
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2021-10-08
Enrollment: 5000
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study requires patients implanted with PM/ICD/ILR that meet all inclusion/exclusion criteria.

Brief summary: The study is a prospective registry. Consecutive patients with indications of implant / replacement or upgrade of pacemaker (PM), implantable cardioverter defibrillator (ICD), Implanted loop recorder (ILR) will be enrolled.

The primary objective of the study is to describe the clinical events during a long-term follow-up of non-selected population of patients implanted with an PM, ICD or ILR.


Eligibility criteria: Inclusion Criteria:

* All consecutive patients underwent PM/ICD/ILR implantation
* Patient is willing and able to sign an authorization to use and disclose health information or an Informed Consent
* Patient must be able to attend all required follow-up visits at the study center for at least 12 months

Exclusion Criteria:

* No informed consent
* Patient is participating in another clinical study that may have an impact on the study endpoint

Exclusion Criteria:

* No informed consent

Primary outcomes:
measure: CIEDs Infection
timeFrame: through study completion, an average of 1 year
measure: Appropriate ICD Therapies Antitachycardia pacing therapy or shock delivered by ICD for device detected ventricular arrhythmia
timeFrame: through study completion, an average of 1 year
measure: Inappropriate ICD Therapies
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Vincenzo Russo
state: Napoli
Study officials:
affiliation: University of Campania Luigi Vanvitelli
name: Vincenzo Russo, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT02099019: Usefulness of Coronary Computed Tomography Angiography for Therapeutic Decision- Making; Revascularization
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease, Ischemic Heart Disease
Keywords: Coronary CT angiography; Revascularization; Decision-making
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-03-28
Enrollment: 3000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who visited the tertiary hospital for coronary angiography who are undergone CT angiography prior to conventional coronary agniography

Brief summary: As the prospective, observational, cross-sectional study, the accuracy of CT angiography-based therapeutic decision-making for revascularization will be evaluated. The primary objective of this study is to evaluate the accuracy of CT angiography-based therapeutic decision-making for revascularization prior to conventional angiography whether CT angiography is an accurate non-invasive technique to determine the most appropriate therapeutic strategies.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 20 years old
* Patients who are scheduled for elective conventional coronary angiography and are undergone CT angiography prior to conventional coronary angiography.

Exclusion Criteria:

* Pregnant women or women with potential childbearing

Primary outcomes:
measure: Accuracy of CT angiography
timeFrame: 1day
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Division of Cardiology, Department of Internal Medicine, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT03105219: IvaBradinE to Treat MicroalbumiNuria in Patients With Type 2 Diabetes and Coronary Heart Disease
Official title: IvaBradinE to Treat MicroalbumiNuria in Patients With Type 2 Diabetes and Coronary Heart Disease
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Diabetic Kidney Disease
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2017-04-07
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore the efficacy of Ivabradine for the treatment of microalbuminuria in patients with type 2 diabetes and coronary heart disease.

Detailed description: This is a multi-center, randomized, open-label, investigator-initiated study with a parallel design. Patients with type 2 diabetes and coronary heart disease who are microalbuminuric \[urinary albumin excretion (UAE): 30-500 mg/day\], will be randomized after informed consent, in a 1:1 ratio to the following treatment groups: Group Α: Ivabradine 5mg twice a day (on day 0), heart rate evaluated at day 14 and 28 repeatedly, and the targeted value of heart rate 50-60bpm, the largest dosage 7.5mg twice a day.

Group Β: Placebo. Urinary albumin excretion (UAE) assessment will be performed before randomization (Day 0), 28-day after randomization (Day 28), and 90-day after randomization (Day 28).

Eligibility criteria: Inclusion Criteria:

* 1. Type 2 diabetes and coronary heart disease;
* 2. Urinary albumin excretion: 30-500mg/24h;
* 3. Sinus rhythm, and resting heart rate ≥ 70bpm;

Exclusion Criteria:

* 1. Renal dysfunction defined as eGFR \< 30ml/min/1.73m\^2;
* 2. Atrial flutter, and atrial fibrillation;
* 3. Resting heart rate \< 70bpm;
* 4. Combined with non-dihydropyridine CCB;
* 5. UAE\<30mg/24h, or \> 500mg/24h;
* 6. Acute heart failure;
* 7. Low blood pressure (BP\<90/50mmHg);
* 8. Acute myocardial infarction (\<14 days);

Primary outcomes:
measure: Urinary albumin excretion
timeFrame: 3 month
Secondary outcomes:
measure: Serum creatinine
timeFrame: 3 month
measure: Blood urea nitrogen
timeFrame: 3 month
measure: Cyscatin-c
timeFrame: 3 month
measure: Hypersensitive c-reactive protein (hsCRP)
timeFrame: 3 month
measure: β2-microglobulin
timeFrame: 3 month
measure: Neutrophil gelatinase-associated lipocalin(NGAL)
timeFrame: 3 month
measure: Albuminuria and urine creatinine ratio (ACR)
timeFrame: 3 month
measure: N-acyl-β-D-glucosidase
timeFrame: 3 month
measure: Retinol binding protein
timeFrame: 3 month
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Shaoliang Chen, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05134519: RC48 for Neoadjuvant Chemotherapy of HER2 Positive Breast Cancer
Official title: Phase II Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Coupling Agent (RC48-ADC) for Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression (Seraph)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
HER2-positive Breast Cancer
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2021-11-26
Enrollment: 20
Sex: FEMALE
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: TREATMENT

Brief summary: This is a single-arm exploratory study to explore the effect of RC48 in HER2-positive neoadjuvant therapy and evaluate the non-inferiority of RC48 by comparing the latest reported data of T-DM1 in neoadjuvant therapy.

Detailed description: A single-arm exploratory study was conducted in 20 patients with HER2-positive breast cancer to explore the effect of RC48 in HER2-positive neoadjuvant therapy (treatment regimen: RC482.0 mg/kg, intravenous drip, once every 2 weeks). After 4-6 cycles, surgery was performed to evaluate the effect of neoadjuvant chemotherapy. The latest reported data of T-DM1 in neoadjuvant therapy were compared to evaluate the non-inferiority of RC48.

Eligibility criteria: Inclusion Criteria:

1. Enrolled were ≥ 18 years of age and \< 80 years of age
2. Female or male breast cancer
3. Patients with early or locally advanced breast cancer who are HER2-positive, have a tumor larger than 2 cm and/or have lymph node metastasis: HER2-positive is defined as 3 + by immunohistochemistry, or 2 + by immunohistochemistry, with a positive FISH test.
4. Left ventricular score ≥ 55%
5. ECOGPS score 0 or 1
6. Able to understand the test requirements, willing and able to comply with the test and follow-up procedures
7. Adequate organ function

Exclusion Criteria:

1. cardiac, hepatic, renal, or psychiatric disease history
2. History of other malignancy within the last 5 years, with the exception of adequately treated basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix.

Primary outcomes:
measure: Pathological complete response rate (pCR)
timeFrame: At the end of Cycle 1 (each cycle is 14 days)
Secondary outcomes:
measure: adverse effects
timeFrame: during the period of neadjuvant chemotherapy
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04002219: Efficacy Evaluation of the Mushroom Beverage on Emotion Regulation
Official title: Efficacy Evaluation of the Mushroom Beverage on Emotion Regulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammation, Brain
Emotional Problem
Lead sponsor: National Science and Technology Council, Taiwan
Sponsor class: OTHER_GOV
Collaborators: name: National Taiwan University
First posted: 2019-06-28
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A triple-blind, randomized-controlled trial
Primary purpose: TREATMENT

Brief summary: Major Depression Disorder is one of the most common psychiatric disease and has affecting approximately 350 million people in the world. According to World Health Organization's report, it may be the first burden of disease in 2030. Due to the high morbidity and low acceptance in the treatment, it is necessary to find some nature compounds to prevent the disease.

Cordyceps militaris, one of the most treasure Chinese herbs in Asia, contains many kinds of component such as cordycepin, polysaccharide, mannitol. In winter, it appears as an worm in the soil, afterwards, it grows out of the soil and convert into grass in summer. A previous study has demonstrated that Cordyceps militaris has anti-depressive effect in mouse tail suspension test, and in this study we will explore its effect in human subjects.


Eligibility criteria: Inclusion Criteria:

1. 21 -items Hamilton Rating Scale for Depression scores 8-17 points upon interview
2. At least 2 weeks not taking antidepressants, antipsychotics or antiepileptics.
3. Understand the whole process of the study and had signed the informed consent form

Exclusion Criteria:

1. Had been diagnosed with severe mental disorder, schizophrenia, bipolar disorder, personality disorder, substance use disorder or alcohol use disorder, or other severe physical illness that is not expected to survive during the intervention period.
2. Currently taking antidepressants or other medication that may impact the study.
3. Expected to be non-adherent.
4. Without sufficient data to confirm safety.
5. Pregnant woman
6. Allergic to fungal products.
7. Currently taking MAO-inhibitors

Primary outcomes:
measure: Change of subjective depressive symptoms
timeFrame: 8 weeks
measure: Change of objective depressive symptoms
timeFrame: 8 weeks
measure: Change of somatic symptoms
timeFrame: 8 weeks
measure: Cortisol level
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
affiliation: China Medical University, China
name: Kuan-Pin Su, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04545619: Performance of QDOT Micro™ Catheter With nGEN Generator for Patients With AFIB.
Official title: Acute Performance Evaluation of the QDOT Micro™ Catheter Used With nGEN Generator in Treatment of Patients With Atrial Fibrillation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Lead sponsor: Biosense Webster, Inc.
Sponsor class: INDUSTRY
First posted: 2020-09-11
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: This workflow study will further evaluate the acute performance and safety of the QDOT MICRO™ catheter in a clinical setting used in combination with nGEN Generator. Subjects will be followed for 7 days post procedure.


Eligibility criteria: Inclusion Criteria:

1. Subjects diagnosed with symptomatic paroxysmal or early persistent AF undergoing a catheter ablation procedure through pulmonary vein isolation.
2. Age 18 or older.
3. Signed the Patient Informed Consent Form (ICF).

Exclusion Criteria:

1. If the patient has had a ventriculotomy or atriotomy within the preceding twelve weeks.
2. Presence of a myxoma or an intracardiac thrombus.
3. Presence of prosthetic valves.
4. Presence of active systemic infection
5. Patient with an interatrial baffle or patch
6. Women who are pregnant (as evidenced by pregnancy test if pre-menopausal), lactating, or who are of child bearing age and plan on becoming pregnant during the course of the clinical investigation.

Primary outcomes:
measure: Number of Participants Who Achieved Acute Procedural Success
timeFrame: Up to 104 days
Secondary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 104 days
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Institut de Cardiologie de Montréal (Montreal Heart Institute)
state: Quebec
Study officials:
References: