louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00096421: Tight Glycemic Control in Critical Care Patients
Official title: Tight Glycemic Control in Patients Hospitalized in a Medical-Surgery Intensive Care Unit: A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Critical Illness
Hyperglycemia
Insulin Resistance
Keywords: Critical illness
Critical care
Hyperglycemia
Intensive care
Intensive Care Units
Insulin resistance
Intensive insulin therapy
Conventional insulin therapy
Lead sponsor: Hospital Pablo Tobón Uribe
Sponsor class: OTHER
Collaborators: name: Instituto Colombiano para el Desarrollo de la Ciencia y la Tecnología (COLCIENCIAS)
First posted: 2004-11-10
Enrollment: 504
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the impact of tight control of serum glucose levels with an intensive insulin treatment in patients hospitalized in an intensive care unit with medical and surgical patients.

Detailed description: Reduction of morbidity-mortality in critical care patients with tight glycemic control had been proven in surgical patients only.

Study Hypothesis: In critical care patients, medical or surgical, a glucose serum level between 80 - 110 mg/dL means a lower mortality than patients with glucose levels of more than 110 mg/dL.

Eligibility criteria: Inclusion Criteria:

* 15 years of age or older,
* Probability of staying in critical care for more than 48 hours,
* Agreement with the informed consent.

Exclusion Criteria:

* Pregnancy,
* Participating in other trials,
* Diabetic keto-acidosis or diabetic hyperosmolar state,
* Moribund
* Do-not-resuscitate orders,
* Reentry to the critical care unit of the same patient.

Primary outcomes:
measure: Mortality in the next 28 days
Secondary outcomes:
measure: Mortality during intensive care
measure: Mortality overall in-hospital
measure: Mortality among patients who remained in the intensive care unit for more than five days
measure: Infections incidence in the critical care unit: nosocomial pneumonia, urinary tract infection and catheter related infection
measure: Length of stay in the unit
measure: Days of ventilatory support
measure: Acute renal failure requiring dialysis or hemofiltration
measure: The median number of red-cell transfusions
measure: SOFA score
measure: Critical-illness polyneuropathy
Other outcomes:
Locations:
city: Medellin
country: Colombia
facility: Hospital Pablo Tobon Uribe
state: Antioquia
Study officials:
affiliation: Hospital Pablo Tobon Uribe
name: Gisela D De La Rosa, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02960321: Troponin Release Induced by Procedure - Czech
Official title: Myocardial Injury Related to Coronary Angiography in the Era of High-sensitivity Cardiac Troponin I
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Keywords: myocardial injury
high-sensitivity troponin I
periprocedural myocardial infarction
Lead sponsor: Tomas Bata Hospital, Czech Republic
Sponsor class: OTHER
First posted: 2016-11-09
Enrollment: 220
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: Consecutive patients referred for coronary angiography (CAG): stable patients with presumed coronary artery disease, or those referred for acute coronary syndrome without ST-segment elevation (NSTE-ACS) meeting the criteria of low risk with demostrated fall of cTn levels, or patients prepared for cardiac surgery.

Brief summary: A prospective study aiming to analyse the relation between different variables and high sensitivity troponin I (hsTnI) elevation within a group of patients undergoing a coronary angiography with or without subsequent percutaneous coronary intervention.

Detailed description: The study tries to seek potential causes and context of subclinical myocardial injury within patients with baseline concentration of hsTnI below the 99th percentile value upper reference limit or with demonstrated fall of hsTnI levels.

Eligibility criteria: Inclusion Criteria:

* stable or unknown coronary artery disease
* acute coronary syndrome without ST-segment elevation meeting the criteria of low risk with demonstrated fall of cTn levels

Exclusion Criteria:

* acute coronary syndrome with persistent ST-segment elevation
* acute coronary syndrome without ST-segment elevation meeting the criteria of high or intermediate risk

Primary outcomes:
measure: Subclinical myocardial injury
timeFrame: up to 24 hours after procedure
Secondary outcomes:
measure: Postprocedural myocardial infarction
timeFrame: up to 24 hours after procedure
Other outcomes:
Locations:
Study officials:
affiliation: Cardiac Center for Adults, Tomas Bata Hospital, Zlin, Czech Republic
name: Martin Griva, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Griva M, Stastny J, Kopriva P, Slabak M, Coufal Z, Jarkovsky J, Svoboda M, Salek T, Sukupova L, Taborsky M. Selective coronary angiography, percutaneous coronary intervention and asymptomatic peri-procedural myocardial injury. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2019 Dec;163(4):324-330. doi: 10.5507/bp.2018.066. Epub 2018 Nov 6.
Clinical trial NCT02026921: A Phase II Study of Docetaxel and Carboplatin in Late Relapse of Ovarian Cancer
Official title: A Phase II Study of Docetaxel and Carboplatin as Second Line Chemotherapy in First Relapse of Platinum Sensitive Epithelial Ovarian Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ovarian Epithelial Cancer Recurrent
Keywords: Phase II study,
Recurrent platinum-sensitive ovarian cancer
docetaxel
Carboplatin
Toxicity
Lead sponsor: Nordic Society of Gynaecological Oncology - Clinical Trials Unit
Sponsor class: OTHER
First posted: 2014-01-03
Enrollment: 74
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A phase II single arm study of carboplatin and docetaxel in treatment of first sensitive relapse of epithelial ovarian, peritoneal or tubal cancer.

Hypothesis: Treatment with this combination in second line is safe and with a low frequency of neurologic side effect.

Detailed description: Evaluation of toxicity and response of treatment with carboplatin and docetaxel to patients with epithelial cancer of ovary, fallopian tube or peritoneum with their first relapse occurring at least 6 months after end of first line treatment- Evaluation of toxicity according to Clinical Toxicity Criteria version 2.

Eligibility criteria: Inclusion Criteria:

* Epithelial carcinoma of ovarian, peritoneal or fallopian tube origin.
* Female
* age above 18 years
* WHO performance status 0-2
* Life expectancy \> 3 months
* Previous treatment with one platinum and taxane containing regimen.
* Platinum and taxane sensitive relapse
* At least one evaluable/measurable lesion.
* Adequate hematologic, renal and liver function
* Consent form signed and dated before inclusion

Exclusion Criteria:

* Prior treatment with more than one line of chemotherapy
* Concurrent severe and/or uncontrolled co-morbid medical condition.
* History of previous or concurrent malignancy within the previous 5 years • History of prior serious allergic reactions such as anaphylactic shock
* Pregnant or lactating women (or potentially fertile women not using adequate contraception)
* Peripheral neuropathy \> Grade 2
* History of allergy to drugs containing the excipient TWEEN 80®.
* Concomitant administration of any other experimental drug under investigation or concurrent treatment with any other anti-cancer therapy
* Clinical evidence of brain metastases

Primary outcomes:
measure: Safety
timeFrame: Up to 30 days after last chemotherapy course
Secondary outcomes:
measure: Response rate
timeFrame: Up to 30 dayes after last chemotherapy course
measure: Progression free survival
timeFrame: Up to 3 year
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Copenhagen
country: Denmark
facility: Herlev University Hospital
city: Tampere
country: Finland
facility: Tampere University Hospital
city: Oslo
country: Norway
facility: Norwegian Radium Hospital
Study officials:
affiliation: NSGO-CTU
name: Gunnar B Kristensen, MD, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT05328921: Effects of Systemic Drugs on Intraocular Pressure
Official title: Effects of Two Systemic Drugs on Intraocular Pressure in Narrow Angle Glaucoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma, Angle-Closure
Glaucoma Suspect
Glaucoma Secondary to Drugs, Bilateral
Hypertension
Keywords: Angle closure glaucoma
Hypertension
Antihistaminic
Antihypertensive
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2022-04-14
Enrollment: 200
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Glaucoma patients regularly visit glaucoma clinic at Banha university, EGYPT

Brief summary: To assess intraocular pressure changes among glaucoma patients on systemic antihypertensive and antihistaminic drugs.

Detailed description: Changes in intraocular pressure in glaucomatous patients with narrow angle may elicit attacks of angle closure glaucoma.

In this study we aim to assess changes in intraocular pressure (IOP) among glaucomatous patients on systemic antihypertensive and antihistaminic drugs.

Eligibility criteria: Inclusion Criteria:

* patients with narrow angle glaucoma on systemic antihypertensive and/or antihistaminic drugs.

Exclusion Criteria:

* open angle glaucoma patients confirmed by gonioscopy examination.
* Cases with dense corneal opacity or iris trauma that may affects gonioscopy examination.
* cases with secondary glaucoma.

Primary outcomes:
measure: Changes in intraocular pressure (IOP) measured by applanation tonometry
timeFrame: Immediately after visual acuity assessment for each eye after topical anesthetic eye drops and again on one and three months visit
Secondary outcomes:
measure: Changes in pupil diameter
timeFrame: Immediately after slit lamp examination and again on one and three months visit
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Ahmed Abdelshafy
state: QA
Study officials:
References:
Clinical trial NCT06929221: The Effect of Bedside Whiteboard Use on Anxiety, Depression and Nursing Care in Chronic Obstructive Pulmonary Patients
Official title: The Effect of Bedside Whiteboard Use on Anxiety, Depression and Nursing Care in Chronic Obstructive Pulmonary Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: COPD
Nursing Care
Lead sponsor: Agri Ibrahim Cecen University
Sponsor class: OTHER
First posted: 2025-04-16
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: ABSTRACT Chronic obstructive pulmonary disease (COPD) is a disease characterized by the inability of the body to adequately exchange gases, resulting in progressive shortness of breath that can form secretions and compromise the performance of daily activities. COPD is reported as the third most common cause of death worldwide, with 3.23 million deaths in 2019. Anxiety and depression are common in individuals with COPD. However, COPD is more common in patients with other chronic diseases such as hypertension, diabetes, cancer or musculoskeletal disorders. Communication is a key component in interprofessional care as well as in improving patient care outcomes. Strategies to address gaps in the quality of information and communication between patients, caregivers and professionals improve patient safety as well as quality of care. One of these strategies is the use of whiteboards at the bedside. The use of whiteboards at the bedside has emerged as a strategy to improve interprofessional team participation, communication and information sharing with care teams, patients and families. This study will be conducted in randomized controlled single blind parallel groups to examine the effect of bedside whiteboard use on anxiety, depression and nursing care satisfaction in COPD patients. The research will consist of patients who are hospitalized in Atatürk University Research Hospital Chest Diseases Clinic and who meet the inclusion criteria. In the results of the research, it is thought that the use of whiteboard will affect the communication between health care team members.


Eligibility criteria: Inclusion Criteria:

* 18 years of age or older
* Having a medical diagnosis of COPD
* To be in a condition to be followed up with at least 7 days

Exclusion Criteria:

* - Having strong reading and comprehension skills

Primary outcomes:
measure: How does the use of whiteboard affect anxiety, depression and nursing care satisfaction in COPD patients?
timeFrame: From registration until the end of the 3th month
measure: How does the use of whiteboard affect anxiety, depression and nursing care satisfaction in COPD patients?
timeFrame: From registration until the end of the 3th month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05945264: Music Intervention for Preterm Birth
Official title: The Impact of a Culturally-based Live Music Intervention on the Metabolites and Metabolic Pathways Associated With Chronic Stress and the Risk of Pre-term Birth in Black Women
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Preterm Birth
Keywords: Chronic stress
Preterm birth
Black women stress
Metabolomics of chronic stress
Music and medicine
Music intervention
Lead sponsor: Columbia University
Sponsor class: OTHER
Collaborators: name: National Institute on Minority Health and Health Disparities (NIMHD)
name: Emory University
name: Icahn School of Medicine at Mount Sinai
First posted: 2023-07-14
Enrollment: 142
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will test a music intervention (MI) versus a sham control (SC) arm which only includes a verbal intervention, to determine if the effects of the music intervention will reduce the biological impact of chronic stress among pregnant Black women, reduce preterm birth, and improve infant outcomes.

Detailed description: Preterm birth occurs at unacceptably high rates in the United States, with Black women disproportionately affected. A long-recognized risk factor for preterm birth in this population is the relentless exposure to intersectional stress related to racial and sexual discrimination, poverty, and neighborhood disadvantage that Black women often experience from an early age. In this interdisciplinary study, the investigators bring together experts in preterm birth, music therapy, and metabolomics to address this health disparity by testing the efficacy of a live, culturally based music intervention to reduce the production of metabolites and metabolic pathways associated with chronic stress and thereby improve birth outcomes.

Eligibility criteria: Inclusion Criteria

* Aged 18 to 40 years
* Generally healthy pregnant women in the first trimester of pregnancy

Exclusion Criteria:

* Non-pregnant women
* Women with a chronic medical condition that could impact pregnancy health or duration
* Women regularly taking any medications other than prenatal vitamins

Primary outcomes:
measure: Score on the Perceived Stress Scale (PSS)
timeFrame: Week 1
measure: Score on the Perceived Stress Scale (PSS)
timeFrame: Week 5
measure: Score on the Perceived Stress Scale (PSS)
timeFrame: Week 10
measure: Mean Gestational Age
timeFrame: Up to 43 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: New York City
country: United States
facility: Louis Armstrong Center for Music and Medicine at Mount Sinai Health System
state: New York
city: New York
country: United States
facility: Columbia University Irving Medical Center/NYP
state: New York
Study officials:
affiliation: Columbia University
name: Elizabeth J. Corwin, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Icahn School of Medicine at Mount Sinai
name: Joanne V. Loewy, DA, LCAT, MT-BC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05681364: Prediction of Pulmonary Rehabilitation Outcomes in Patients With Chronic Respiratory Disease Based on Metabolomics: a Prospective Cohort Study
Official title: Prediction of Pulmonary Rehabilitation Outcomes in Patients With Chronic Respiratory Disease Based on Metabolomics: a Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Bronchiectasis
Keywords: pulmonary rehabilitation
chronic respiratory disease
metabonomics
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2023-01-12
Enrollment: 300
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: Outpatients in respiratory and critical care medicine department of Peking University Third Hospital

Brief summary: To comprehensively evaluate the pulmonary rehabilitation (PR) outcomes of patients with chronic respiratory disease (CRD), and to screen biomarkers for predicting different PR outcomes of patients with CRD using metabolomics methods, and to build a prediction model.


Eligibility criteria: Inclusion Criteria:

* For COPD

  1. Meets the Global initiative for chronic obstructive lung disease (GOLD) 2022 definition of stable COPD;
  2. Age 30-75 years;
  3. Lung CT images only showed chronic bronchitis and emphysema;
  4. Agree to participate in the study and is able to cooperate with exhaled breath condensate collection.
* For bronchiectasis

  1. Lung CT showed bronchiectasis;
  2. Age 18-75 years;
  3. Spirometry suggests obstructive ventilatory dysfunction: forced expiratory volume in one second (FEV1) is less than 70% of forced vital capacity (FVC) post bronchodilator inhalation.

Exclusion Criteria:

1. Asthma or other respiratory diseases
2. History of pulmonary surgery
3. α1 antitrypsin deficiency
4. Autoimmune diseases
5. Patients with acute myocardial infarction, chronic heart failure, severe cerebral infarction or cerebral hemorrhage
6. A history of malignant disease now or within 2 years
7. History of acute exacerbation or change of medication in the past 4 weeks
8. A history of blood transfusion within the last 4 weeks
9. Drugs or alcohol abuse
10. Breastfeeding or pregnant women
11. Unable to cooperate with pulmonary rehabilitation for various reasons

Primary outcomes:
measure: Pulmonary rehabilitation outcome
timeFrame: At week 12 of pulmonary rehabilitation
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Peking University Third Hospital
name: Fei Wang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02773264: Validation of Ultra Sound (US) Elastography
Official title: Validation of Ultra Sound (US) Elastography for the Evaluation of Soft Tissue and Organ Lesions
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Soft Tissue Lesions
Lead sponsor: University of Zurich
Sponsor class: OTHER
First posted: 2016-05-16
Enrollment: 308
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: Patient scheduled for clinically indicated conventional Ultrasound examination

Brief summary: This is a prospective, single-center, non-randomised, non-blinded trial with US Elastography of Patients referred to our institution to assess soft tissue and organ lesions. All patients will undergo next to the clinical indicated conventional US-examination, US Elastography after informed consent. After completion of these three examinations, the participation in the study is completed.

Detailed description: The investigators propose UltraSound Elastography as an imaging method which allows for a better evaluation of soft tissue and organ lesions compared to the conventional US modalities used nowadays in the dayly clinical routine.

This is a prospective, single-center, non-randomised, non-blinded trial with US Elastography of Patients referred to our institution to assess soft tissue and organ lesions. All patients will undergo next to the clinical indicated conventional US-examination, US Elastography after informed consent. After completion of these three examinations, the participation in the study is completed.

Eligibility criteria: Inclusion Criteria:

* Patient scheduled for clinically indicated conventional Ultrasound examination

Exclusion Criteria:

* Age \< 18 years

Primary outcomes:
measure: Non-Inferiority to conventional Ultrasound (conv. US)
timeFrame: when scheduled for conv. US, 30minutes
Secondary outcomes:
measure: Superiority to conventional Ultrasound (conv. US)
timeFrame: when scheduled for conv. US, 30minutes
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich - Diagnostic Radiology
Study officials:
affiliation: University Hospital Zurich, Institue of Diagnostic Radiology
name: Thomas Frauenfelder, PD MD
role: PRINCIPAL_INVESTIGATOR
References: