louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01480401: Study of Dietary Intervention Under 100 MMOL in Heart Failure
Official title: The Long Term Effects of Dietary Sodium Restriction on Clinical Outcomes in Patients With Heart Failure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Patients with stable heart failure
Lead sponsor: University of Alberta
Sponsor class: OTHER
First posted: 2011-11-28
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to identify the relationship between a low-sodium diet and neurohormonal and clinical status in stable chronic HF patients.


Eligibility criteria: Inclusion Criteria:

* Patients will be recruited from each research center if they are 18 years or older, with confirmed diagnosis of Heart Failure (including both those with a reduced and preserved systolic function), NYHA II-IV, and willing to sign informed consent.

Exclusion Criteria:

* Subjects will be excluded if they have severe hyponatremia (serum sodium \<130 mmol/L)
* Renal failure (a glomerular filtration rate \< 30 mL/min)
* Uncontrolled thyroid disorders
* Hepatic failure
* Implantable cardiac device (ICD or CRT) or myocardial revascularization procedures (coronary angioplasty and/or surgical revascularization) in the previous 3 months
* Uncontrolled atrial fibrillation or recurrent ventricular arrhythmias
* Malignancy, or with moderate-severe dementia.
* Patients will be excluded if, in the opinion of the investigator, another condition exists that would preclude dietary compliance or compliance with the protocol.

Primary outcomes:
measure: composite clinical outcomes
timeFrame: 12 months
Secondary outcomes:
measure: symptoms and quality of life
timeFrame: 12 months
measure: reduces natriuretic peptide levels
timeFrame: 12 months
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: University of Alberta
state: Alberta
Study officials:
affiliation: University of Alberta
name: Justin Ezekowitz, MBBCh MSc
role: PRINCIPAL_INVESTIGATOR
References:
citation: Colin-Ramirez E, McAlister FA, Zheng Y, Sharma S, Ezekowitz JA. Changes in dietary intake and nutritional status associated with a significant reduction in sodium intake in patients with heart failure. A sub-analysis of the SODIUM-HF pilot study. Clin Nutr ESPEN. 2016 Feb;11:e26-e32. doi: 10.1016/j.clnesp.2015.11.002. Epub 2015 Dec 29.
Clinical trial NCT05884801: Phase I Study of QLS1103 in Subjects With Advanced Solid Tumors
Official title: A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of QLS1103 in Subjects With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2023-06-01
Enrollment: 148
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This study is a phase I, dose escalation and dose expansion study of QLS1103, to evaluate the safety, tolerability, pharmacokinetics, and preliminary efficacy of QLS1103 in subjects with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* 1. Subjects must voluntarily agree to participate in the trial and sign a written informed consent form;
* 2. Aged ≥18 years old;
* 3. Histologically or cytologically confirmed advanced or recurrent or metastatic solid tumor;
* 4. Failure of adequate standard treatment, or no effective standard treatment;
* 5. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 1;
* 6. Life expectancy ≥12 weeks;

Exclusion Criteria:

* 1. Subjects received systemic anticancer therapy within 4 weeks prior to the first dose;
* 2. Subjects received experimental medication or therapy within 4 weeks prior to the first dose;
* 3. Subjects received major surgery within 4 weeks prior to the first dose;
* 4. Persistent toxicity of National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Grade \>1 severity that is related to prior therapy;
* 5. Cardiovascular and cerebrovascular diseases with clinical significance;
* 6. Active gastrointestinal disease or other conditions that significantly interfere with drug absorption.

Primary outcomes:
measure: Maximum tolerated dose (MTD)
timeFrame: 21 Days (first cycle)
measure: Recommended dose for phase II (RP2D)
timeFrame: Up to 24 approximately months
measure: Adverse events(AEs) / Serious adverse events(SAEs)
timeFrame: Up to 24 approximately months
Secondary outcomes:
measure: Maximum observed plasma concentration (Cmax) of QLS1103
timeFrame: Up to approximately 2 years
measure: Time of maximum observed plasma concentration (Tmax) of QLS1103
timeFrame: Up to approximately 2 years
measure: Area under the plasma concentration-time curve (AUC) of QLS1103
timeFrame: Up to approximately 2 years
measure: Objective response rate (ORR)
timeFrame: Up to approximately 2 years
measure: Disease control rate (DCR)
timeFrame: Up to approximately 2 years
measure: Duration of response (DOR)
timeFrame: Up to approximately 2 years
measure: Progression free survival (PFS)
timeFrame: Up to approximately 2 years
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
state: Guangdong
Study officials:
affiliation: Guangdong Provincial People's Hospital
name: Yilong Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06835101: Perioperative Music in Obese Patients Under Spinal Anesthesia
Official title: The Effect of Music Versus Midazolam on Perioperative Anxiety of Obese Patients Under Spinal Anesthesia
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Obesity, Adolescent
Keywords: obese
music
anxiety
Lead sponsor: Asklepieion Voulas General Hospital
Sponsor class: OTHER_GOV
First posted: 2025-02-19
Enrollment: 40
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: The goal of this clinical trial is to learn whether music or midazolam has a greater anxiolytic effect on obese patients undergoing spinal anesthesia. It will also determine the safety of music compared to midazolam in this population (differences in blood pressure, heart rate, oxygen saturation). The main question to answer: Music or midazolam is more effective in reducing anxiety in obese patients under spinal anesthesia?


Eligibility criteria: Inclusion Criteria:

* patients who are \> 18 years old
* patients with Body Mass Index -ΒΜΙ\>30 kg/m2
* patients who will give informed consent in receiving spinal anaesthesia
* patients who will give informed consent in participating in the study

Exclusion Criteria:

* absolute contraindications of spinal anaesthesia,
* severe psychiatric, cognitive or sensory impairment
* mother language other than greek,
* known hypersensitivity to midazolam,
* renal impairment

Primary outcomes:
measure: Spielberger State-Trait Anxiety Inventory (STAI): State -anxiety immediately after spinal anesthesia.
timeFrame: State -anxiety is measured immediately after spinal anesthesia.
Secondary outcomes:
measure: Spielberger State-Trait Anxiety Inventory (STAI): State -anxiety immediately after surgery
timeFrame: Immediately after surgery
measure: Time performing spinal anesthesia
timeFrame: From the start of positioning maneuvers for spinal anesthesia to the spinal needle removal
measure: Patient satisfaction 24 hours after surgery
timeFrame: 24 hours after surgery
measure: Communication difficulties between the patient and the anesthesiologist.
timeFrame: Immediately after surgery
measure: Communication difficulties between the anesthesiologist and the patient.
timeFrame: Immediately after surgery
measure: Adverse outcomes
timeFrame: During the operation
Other outcomes:
Locations:
city: Athens
country: Greece
facility: Asklepieion Hospital of Voula
state: Voula
city: Kavala
country: Greece
facility: General Hospital of Kavala
city: Rethymno
country: Greece
facility: General Hopsital of Rethymno
Study officials:
References:
Clinical trial NCT03513601: Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma
Official title: Treatment of Elderly Patients With Diffuse Large B-cell Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Diffuse Large B Cell Lymphoma
Keywords: Curative effect evaluation
Adverse reactions
Clinical characteristics
PR
PFS
OS
Lead sponsor: Zhengzhou University
Sponsor class: OTHER
First posted: 2018-05-01
Enrollment: 20
Sex: ALL
Minimum age (years): 70
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To explore the clinical features and efficacy evaluation of large b-cell lymphoma in old age.

Detailed description: The results of the analysis of the treatment of large b-cell lymphoma in old age were analyzed, and the treatment of large B cell lymphoma was provided.

Eligibility criteria: Inclusion Criteria:

* Above 70 years old，Pathology proved to be diffuse large B cell lymphoma，Estimated survival time \> 3 months，None of chemotherapy contraindication;At least one measurable lesion according to RECIST;None of other serious diseases;Patients could be followed up;None of other relative treatments including the traditional Chinese medicine, immunotherapy,biotherapy except anti-bone metastasis therapy and other symptomatic treatments.

volunteers who signed informed consent.

Exclusion Criteria:

* Currently undergoing chemotherapy, radiotherapy and targeted therapy (received chemotherapy within 3 weeks, received radiotherapy within 2 weeks, or has not recovered from any previous treatment of acute toxicity);Patients with uncontrolled medical problems (including active infection, uncontrolled diabetes, severe heart, liver, kidney dysfunction and interstitial pneumonia, etc.); Pregnant or lactating women;Serious medical illness likely to interfere with participation;Chemotherapy contraindication such as cachexia; patients with other malignancies previously;Serious infection;The evidence of peripheral nervous disorder or dysphrenia; patients estimated to be unsuitable by investigator.

Primary outcomes:
measure: Progression-free survival
timeFrame: up to end of follow-up-phase(approximately 24 months)
Secondary outcomes:
measure: overall survival
timeFrame: up to the date of death (approximately 5 years)
measure: disease control rate
timeFrame: every 6 weeks,up to completion of treatment(approximately 18 weeks )]
measure: objective remission rate
timeFrame: every 6 weeks,up to completion of treatment(approximately 18 weeks )]
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Oncology Department of The First Affiliated Hospital of Zhengzhou University
state: Henan
Study officials:
affiliation: The First Affiliated Hospital of Zhengzhou University
name: Mingzhi zhang
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04226001: Impact of a Carrier (Infection, Colonization) of Highly Bacteria Resistance on the Patient's Quality of Life Hospital Environment
Official title: Impact of a Carrier (Infection, Colonization) of Highly Bacteria Resistance on the Patient's
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Bacterial Infections
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients infected or colonized by emerging highly resistant bacteria.

Brief summary: The quality of life of carriers detected infected or colonized by emerging highly resistant bacteria (BHRe) following the implementation of specific hygiene measures during the discovery of the microorganism has been little studied. To date, there have been no studies to determine the quality of life (QoL) in France of patients with hospitalized HBHRD.


Eligibility criteria: Inclusion Criteria:

* Age\> 18 years old
* Have a positive BHRe screening during the hospital stay and / or have a positive BHRe clinical sample during the hospital stay
* Conscious patients
* All types of stays in the hospital sector
* All pathologies

Exclusion Criteria:

* Known patients with BHRe before hospitalization
* PCH immediately upon admission (history of hospitalization abroad, patients contacted during a previous hospitalization)
* Cognitive problem
* Patients not proficient in French (requiring an interpreter)
* Patients under guardianship

Primary outcomes:
measure: Impact of the implementation of Complementary Hygiene Precautions following a carrier of emerging highly resistant bacteria on the quality of life of hospitalized patients
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hospices Civils de Lyon
name: David NARBEY, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03310801: LAAO With DAPT Versus Antithrombotic Therapy
Official title: Comparison of Clinical Outcomes Between Left Atrial Appendage Occlusion With Dual Antiplatelet Therapy Versus Conventional Antithrombotic Therapy in Patients With Atrial Fibrillation Undergoing Drug-eluting Stent Implantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Coronary Artery Disease
Keywords: left atrial appendage occlusion
antithrombotic therapy
atrial fibrillation
percutaneous coronary intervention
drug eluting stent
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
Collaborators: name: Severance Hospital
name: Sejong General Hospital
name: Gachon University Gil Medical Center
name: Ulsan University Hospital
First posted: 2017-10-16
Enrollment: 480
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with AF who underwent PCI

Brief summary: This study will retrospectively review and compare clinical outcomes between left atrial appendage occlusion with dual antiplatelet therapy versus conventional antithrombotic therapy in patients with atrial fibrillation undergoing drug-eluting stent implantation.

Detailed description: Composite of stroke and major bleeding will be compared after adjusting those groups using inverse probability weighted model.

Eligibility criteria: Inclusion Criteria:

* patients with AF who underwent PCI and treated with LAAO and DAPT or conventional antithrombotic therapy

Exclusion Criteria:

-

Primary outcomes:
measure: Composite of stroke and major bleeding
timeFrame: From date of index procedure until the date of primary endpoint occur or date of last follow up, whichever came first, assessed up to 50 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Korea University Anam Hospital
name: Cheol Woong Yu, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00886301: Fatty Liver and Ectopic Fat in Overweight and Obese Patients
Official title: Fatty Liver and Ectopic Fat in Overweight and Obese Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Steatohepatitis
Keywords: overweight
obesity
steatohepatitis
ectopic fat
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2009-04-22
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The aim of the study is to find new clinico-biological and medical imaging parameters associated with non alcoholic steatohepatitis in overweight and obese patients.

Detailed description: Non invasive assessment of liver fibrosis and liver inflammation and steatosis is clinically relevant in patients exposed to non alcoholic fatty liver diseases.

The aim of the study is to find new clinico-biological and medical imaging parameters associated with non alcoholic steatohepatitis in overweight and obese patients.

Fatty liver and ectopic fat accumulation will be particularly assessed.

Eligibility criteria: Inclusion Criteria:

* BMI between 25 and 40
* ALAT level superior to normal level even after 3 months of diet
* alcohol consumption \< 20 g/j for women and \< 30 g/j for men

Exclusion Criteria:

* HIV, hepatitis B virus, hepatitis C virus positive
* known hemochromatosis
* glycemia \> 1.26 g/L or under anti-diabetic treatment

Primary outcomes:
measure: Liver status will be will be determined by liver biopsy, non invasive liver assessment. Biological and medical imaging parameters will be use to characterize our patients.
timeFrame: at inclusion and at year 1
Secondary outcomes:
measure: Non invasive liver assessment, biological and medical imaging parameters will be use to characterize our patients.
timeFrame: at year 1
Other outcomes:
Locations:
city: Nice
country: France
facility: Hepatogastroenterology, Hôpital l'Archet, CHU de Nice
Study officials:
affiliation: Hepatogastroentérology, CHU de Nice
name: Rodolphe ANTY, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00600301: Vitrectomy Without Internal Limiting Membrane Removal in the Treatment of Diffuse Diabetic Macular Edema: a Comparative Kenalog Vs Bevacizumab Intravitreal Injection Vs Control Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Diffuse Diabetic Macular Edema
Keywords: Macula
Edema
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2008-01-24
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Diabetic macular edema is the most common cause of visual loss among patients with diabetic retinopathy. Pars plana vitrectomy has been reported to be effective for the treatment of diabetic macular edema. Previous report showed a limited improvement in visual acuity and macular thickness posterior intraoperative triamcinolone acetonide. Bevacizumab intravitreal injection has been proven be effective in the treatment of diabetic macular edema, in recent publications. The purpose of this study is to evaluate whether vitrectomy with and without intravitreal triamcinolone acetonide and bevacizumab injection affects vision outcome and macular thickness in patients with diabetic macular edema.


Eligibility criteria: Inclusion Criteria:

* Diffuse diabetic macular edema
* Non proliferative diabetic retinopathy
* No VPP previa
* No previous treament with laser, Triamcinolone acetonide, and Bevacizumab

Exclusion Criteria:

* Proliferative diabetic retinopathy
* Previous pars plana vitrectomy
* Previous treatment with diabetic macular edema
* Focal macular edema
* Macular Ischemia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Mexico
country: Mexico
facility: Asociacion Para Evitar la Ceguera en Mexico
Study officials:
affiliation: Asociación para Evitar la Ceguera en México
name: Maximiliano Gordon, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03438201: Protein Intake Associated With Physical Activity Related to Specific Outcomes
Official title: The Efficiency of Different Amount of Protein Intake Associated With a Physical Activity Protocol in Surgical Cancer Patients Admitted to the Intensive Care Unit : Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cancer
Critically Ill
Surgery
Keywords: Cancer, ICU, Surgery, Protein, Physical Activity
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2018-02-19
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a Randomized Controlled Trial . The purpose of this study is to assess the hypothesis that whether a high protein diet combined with a physical activity protocol in surgical cancer patients admitted to the ICU in the post operative period is associated with better physical function at the hospital discharge as well as a better quality of life.

Detailed description: Surgical cancer patients will be categorized by their nutritional risk using a specific screening toll. During the hospital stay some measurements will be done. Such as resting energy expenditure (REE) before and after surgery; physical function evaluation; strength and quality of life.

The proposed intervention is a post operative diet with a different amount of protein (diet with a standard amount of protein and a diet with high amount of protein) associated to an institutional protocol of physical activity.

Eligibility criteria: Inclusion Criteria:

* Cancer patients
* Age greater than or equal to 18 years old
* Have a tendency to be admitted to the ICU after the surgery
* Fill the eligible criteria to start enteral feeding within 72 hours
* Sign the consent form;

Exclusion Criteria:

* Mechanical ventilation such as fraction of inspired oxygen inspired oxygen fraction (FiO2) \>60% or positive end expiratory pressure (PEEP) \> 12cm H2O
* Bronchopleural fistula
* Karnofsky \<50
* Participant cannot b enrolled in another study

Primary outcomes:
measure: Physical Function
timeFrame: 8 days after randomization
Secondary outcomes:
measure: Physical Function
timeFrame: 30 days after randomization
measure: Quality of life
timeFrame: 6 months after randomization
measure: Body Composition related to prognosis
timeFrame: 8 days after randomization
measure: Postoperative complications
timeFrame: 30 days after randomization
measure: Resting Energy Expenditure
timeFrame: one day before surgery and one day after surgery
measure: Length of hospital stay.
timeFrame: 30 days after randomization
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: Faculty of Medicine University of Sao Paulo
state: SP
Study officials:
affiliation: University of Sao Paulo
name: Juliano P Almeida, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Sao Paulo
name: Ilana Roitman
role: PRINCIPAL_INVESTIGATOR
References: