louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01590303: Outcome Following Vitamin C Administration in Sepsis
Official title: A Pilot Study Examining the Efficacy of Vitamin C Administration in Septic Patients.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Severe Sepsis
Keywords: severe sepsis
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2012-05-02
Enrollment: 20
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 is designed to determine if Vitamin C administration to septic patients will result in an improvement in organ dysfunction which occurs during a septic illness.

Hypothesis: 1. Vitamin C in sepsis will reduce the injury to organs 2. Vitamin C will reduce the length of time on a ventilator, length of stay in the intensive care unit and in hospital.

Detailed description: This study will measure biomarkers of inflammation, coagulation and oxidative stress. These biomarkers have been shown to be increased during periods of oxidative stress eg post-operative, trauma, sepsis. The investigators will determine if Vitamin C administration decreases oxidative stress and as a result, a decrease in the markers of organ dysfunction eg SOFA Scores. Ultimately, if the investigators show a decrease in injury to organs, will this result in a better outcome for patients.

Eligibility criteria: Inclusion Criteria:

* diagnosis of severe sepsis
* admitted to the intensive care unit

Exclusion Criteria:

* allergy to Vitamin C
* history of kidney stones
* glucose-6-phosphate dehydrogenase deficiency
* history of iron overload/hemochromatosis

Primary outcomes:
measure: Sequential organ function assessment score (SOFA)
timeFrame: 28 days or discharge from intensive care unit
Secondary outcomes:
measure: Biomarkers as a measure of coagulation, inflammation and oxidative stress.
timeFrame: 28 days or discharge from intensive care unit
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Sciences Centre - University Hospital
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Michael D Sharpe, MD FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05560503: A Nomogram for Evaluating Significant Liver Fibrosis in Patients With Chronic Hepatitis B Virus Infection
Official title: Establish a New Noninvasive Diagnostic Model Based on Common Clinical Indicators to Evaluate the Liver Fibrosis in Patients With Chronic Hepatitis B
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Liver Fibrosis
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2022-09-29
Enrollment: 259
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From January 2017 to May 2022, a total of 259 patients with chronic hepatitis B who underwent liver biopsy, in Xiangya Hospital of Central South University, were retrospectively reviewed.

Brief summary: Liver fibrosis is the key step for progression to cirrhosis and liver cancer in patients with chronic hepatitis B (CHB). It is crucial to identify significant liver fibrosis in the treatment of CHB patients. Hence, the investigators aim to construct and validate a new nomogram model for evaluating significant liver fibrosis in CHB patients. The nomogram was based on a retrospective study of 259 CHB patients, who underwent liver biopsy. Through random grouping, 182 cases (70%) were included in the training set and 77 cases (30%) were included in the validation set. Biopsy pathological stage was used as the gold standard to screen the factors included in the model. The receiver operating characteristic (ROC), area under the ROC curve (AUC), calibration curve, and decision curve analysis were used to evaluate the diagnostic effect of this nomogram model. In addition, the investigators will compare the diagnostic efficiency of the new nomogram model with APRI, FIB-4, and GPR.


Eligibility criteria: Inclusion Criteria:

* meet the diagnostic standard presented in Asian-Pacific clinical practice guidelines on the management of hepatitis B.
* HBsAg-positive for over 6 months.
* aged 18-65 years old.
* no gender limitation.

Exclusion Criteria:

* co-infection with other types of hepatitis viruses, including types A, C, D, and E.
* co-infection with human immunodeficiency virus (HIV).
* autoimmune hepatitis (AIH), primary biliary cholangitis (PBC), primary sclerosing cholangitis (PSC), inherited metabolic liver disease, drug-induced liver injury (DILI), alcoholic liver disease, and hepatocellular carcinoma (HCC).
* with other malignant tumor and other major systemic diseases.
* incomplete clinical data.

Primary outcomes:
measure: Differences in demographic data and clinical test indicators between significant liver fibrosis group and non-significant liver fibrosis group
timeFrame: 0 week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00911703: Determining When Patients Hospitalized With Acute Heart Failure Can Be Safely Sent Home (The DECIDE Study)
Official title: Treatment Endpoints in Acute Decompensated Heart Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Heart Failure
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
name: Abbott Point of Care
name: Inovise Medical
First posted: 2009-06-02
Enrollment: 835
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 presenting to the emergency department who fulfill the modified Framingham criteria and are treated for acute heart failure.

Brief summary: The purpose of this study is to determine if certain findings (blood tests, symptom improvement, etc.) after acute heart failure treatment can identify a group of patients who are safe for early hospital discharge.

Detailed description: A fundamental question faced by physicians treating acute decompensated heart failure (ADHF) is "When has treatment worked sufficiently for safe discharge, and who requires further treatment?" Patients with ADHF have a high incidence of morbidity and mortality. Current guidelines for emergency department (ED) and hospital disposition of patients with ADHF are based on limited empirical evidence. This creates clinical uncertainty regarding disposition leads to prolonged hospitalizations, higher costs and increased resource consumption. The specific aim of the study is to develop a prediction rule from readily available clinical data to help physicians identify ADHF patients eligible for safe and early discharge from the ED and hospital after treatment is initiated.

Eligibility criteria: Inclusion Criteria:

* Fulfill the modified Framingham criteria
* Have baseline data available within 1 hour of initial ED therapy
* Have previously documented systolic dysfunction (ejection fraction less than 50%) by echocardiogram
* Willing and able to give informed consent

The exclusion criteria are:

* Patients less than 18 years of age.

Primary outcomes:
measure: Heart-failure related adverse events
timeFrame: Measured 5 days and 30 days after ED presentation
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: Vanderbilt University Emergency Medicine
name: Sean P. Collins, MD, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04412603: Emergent Therapies in OBP. Pilot Study
Official title: Conventional Mirror Therapy and Mirror Therapy Virtual Reality in Obstetric Brachial Palsy: Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neonatal Brachial Plexus Palsy
Keywords: Virtual Reality.
family
Mirror Therapy
Obstetrical Brachial Palsy
Upper extremity
Lead sponsor: CEU San Pablo University
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 12
Sex: ALL
Minimum age (years): 6
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A pilot randomized clinical trial was performed with simple blind and randomization of block assignmen.
Primary purpose: TREATMENT

Brief summary: Obstetric Brachial Palsy (OBP) produces functional limitations in the involvement of the affected upper limb within the child's natural environment. The therapeutic interventions of Conventional Mirror Therapy (MT) and Mirror Therapy Virtual Reality (VR) are aimed at the rehabilitation of the affected upper limb and the quality life improvement.

To quantify the increase in the affected upper limb spontaneous use and the quality of life of children with upper OBP from 6-12 years, when They are treated with Conventional MT or Mirror Therapy VR applying specific protocol: 20 min/day in 4 weeks.

Detailed description: The intervention protocol was permorfed for four weeks, three days per week applying Conventional Mirror Therapy or Mirror Therapy Virtual Reality, with 20-minute sessions in 4 weeks. Designed to be done at home.

Two measurements of the affected upper limb spontaneous use and quality of life were performed, a pre-treatment assessment corresponding to the baseline situation, and another post-treatment Assessment to observe the results after the therapy.

Eligibility criteria: Inclusion Criteria:

* Ages between 6 and 12 years old, upper Obstetric Brachial Palsy type Erb-Duchenne (C5-C6) and extended Erb-Duchenne (C5-C7), preserved functionality to do the activities, adequate cognitive level to follow the proposed activities.

Exclusion Criteria:

* associated pathologies, medical complications or cognitive and / or visual impairment that prevent the activities performance, affected upper limb surgeries in the last year, treatment with botulinum toxin in the last three months, no possession of a device with Android operating system for the application of Virtual Reality therapy, families and children no partners.

Primary outcomes:
measure: Children's Hand-use Experience Questionnaire
timeFrame: Four weeks
measure: Pediatric Quality of Life Inventory Generic Core Scales PedsQLTM 4.0
timeFrame: Four weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: San Pablo-CEU Univerity
Study officials:
affiliation: San Pablo-CEU Univerity
name: Rocío Palomo, Physiotherapist
role: STUDY_DIRECTOR
References:
Clinical trial NCT05283603: Clinical Observational Registry of Patients With Left Bundle Branch Block
Official title: Registro Osservazionale Dei Pazienti Con Blocco Della Branca Sinistra
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Left Bundle Branch Block (LBBB) on ECG
Lead sponsor: Azienda Ospedaliero Universitaria di Sassari
Sponsor class: OTHER
First posted: 2022-03-17
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with LBBB

Brief summary: The electromechanical dyssynchrony induced by the presence of LBBB is in some patients, but not all, the cause of progressive left ventricular systolic dysfunction and heart failure.

Aims

1. To investigate the clinical, ECG, imaging-derived features in a large cohort of patients affected by LBBB on ECG.
2. To identify predictors of LBBB-induced LV systolic dysfunction and predictors of outcome in this population.
3. To derive data which may have an impact on therapeutic management.


Eligibility criteria: Inclusion Criteria:

* LBBB on ECG

Exclusion Criteria:

* Previous extensive anterior myocardial infarction
* Previous cardiac surgery or transcatheter aortic valve implantation (TAVI)
* Congenital structural heart disease
* Patients implanted with permanent right ventricular stimulation devices and permanent pacing
* Denial to consent

Primary outcomes:
measure: Left ventricular dysfunction
timeFrame: 20 years
Secondary outcomes:
measure: Adverse cardiovascular events (e.g., heart failure)
timeFrame: 20 years
Other outcomes:
Locations:
city: Sassari
country: Italy
facility: Cardiology, AOU Sassari
Study officials:
References:
citation: Sanna GD, De Bellis A, Zecchin M, Beccu E, Carta P, Moccia E, Canonico ME, Parodi G, Sinagra G, Merlo M. Prevalence, clinical and instrumental features of left bundle branch block-induced cardiomyopathy: the CLIMB registry. ESC Heart Fail. 2021 Dec;8(6):5589-5593. doi: 10.1002/ehf2.13568. Epub 2021 Sep 12.
citation: Sanna GD, Merlo M, Moccia E, Fabris E, Masia SL, Finocchiaro G, Parodi G, Sinagra G. Left bundle branch block-induced cardiomyopathy: a diagnostic proposal for a poorly explored pathological entity. Int J Cardiol. 2020 Jan 15;299:199-205. doi: 10.1016/j.ijcard.2019.06.008. Epub 2019 Jun 4.
citation: Moccia E, Sanna GD, Parodi G. Transient left bundle branch block and intraventricular dyssynchrony as a cause of reversible left ventricular dysfunction: The "in vivo" documentation of spontaneous electrical remodeling. Ann Noninvasive Electrocardiol. 2019 Nov;24(6):e12667. doi: 10.1111/anec.12667. Epub 2019 May 29.
Clinical trial NCT02723903: Hierarchical Treatment Based on Somatization Symptom Checklist
Official title: Efficacy of Hierarchical Treatment For Suspected Coronary Heart Disease Based on Somatization Symptom Checklist and Coronary Angiography
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Syndrome X
Keywords: somatization symptom score
SSS checklist
coronary angiography
Patient Health Questionnaire
Generalized Anxiety Disorder 7-items
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2016-03-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A comparative study is conducted on the patients with suspected coronary artery disease (CAD). The patient will undergo coronary angiography after a somatic symptom scale (SSS) survey is carried out combining with Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder 7-items (GAD-7). Patient is then treated according to the checklist score and coronary angiography result. The efficacy, sensitivity and specificity of the SSS checklist will be evaluated during following up.

Detailed description: The presentation of physical complaints such as chest discomfort suggestive of suspicious coronary artery disease (CAD) but remain unexplained after negative finding from coronary angiography represents one of the most frustrating and puzzling problems in clinical medicine.A comparative study is conducted on the patients with suspected coronary artery disease. A somatic symptom scale (SSS) survey is carried out combining with Patient Health Questionnaire (PHQ-9) and Generalized Anxiety Disorder 7-items (GAD-7). Patient is treated according to the checklist score and coronary angiography result. Three surveys will be re-conducted 2 weeks after treatment. The sensitivity and specificity of the SSS checklist will be evaluated during following up.

Eligibility criteria: Inclusion Criteria:

* patients with suspected coronary artery disease

Exclusion Criteria:

* patients who have lost their self assessments of capacity.
* patients who have been previously confirmed serious mental disorders.
* patients who is taking anti-anxiety agents or anti-depression agents.

Primary outcomes:
measure: The efficacy of somatization symptom score
timeFrame: 2 weeks after the first visit
Secondary outcomes:
measure: scale chest discomfort
timeFrame: 2 weeks after the first visit
measure: The efficacy of Patient Health Questionnaire
timeFrame: 2 weeks after the first visit
measure: The efficacy of Generalized Anxiety Disorder 7-items
timeFrame: 2 weeks after the first visit
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Renji Hospital
Study officials:
affiliation: Renji hosipital,Jiaotong University, School of Medicine
name: Mao Jialiang, Docter
role: STUDY_CHAIR
References:
Clinical trial NCT00957203: Long-Term Safety Study of KW-6002 (Istradefylline) in Parkinson's Disease Patients
Official title: Long-Term Safety Study of KW-6002 (Istradefylline) in the Treatment of Parkinson's Disease (Phase 3)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
levodopa
end of dose wearing off
OFF time
Lead sponsor: Kyowa Kirin Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2009-08-12
Enrollment: 308
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with Parkinson's disease who completed the prior double-blind study 6002-009 are eligible to enter into this long-term study. The purpose of this study is to evaluate the safety and efficacy of KW-6002 administered long-term in patients with advanced Parkinson's disease treated with levodopa.


Eligibility criteria: Inclusion Criteria:

1. Be willing and able to give written informed consent
2. Completion of the study 6002-009

Exclusion Criteria:

1. Mini-mental status examination score of 23 or less
2. Less than 70% of compliance in the study 6002-009
3. Emergency deviation in the study 6002-009
4. Pregnant females

Primary outcomes:
measure: Adverse events
Secondary outcomes:
measure: Reducing the mean total hours of awake time per day spent in the OFF state
measure: Reducing the mean percentage of awake time per day spent in the OFF state
measure: Mean change in the total hours and the percentage of awake time per day spent in the ON state (without dyskinesia, with dyskinesia, with non-troublesome dyskinesia, and with troublesome dyskinesia)
measure: Change in Unified Parkinson's Disease Rating Scale (UPDRS)
measure: Change in the Clinical Global Impression - Improvement scale (CGI-I)
Other outcomes:
Locations:
city: Tokyo
country: Japan
Study officials:
affiliation: Kyowa Kirin Co., Ltd.
name: Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT06889090: Comparing Effect of Opioid-sparing Versus Conventional Anesthesia on Quality of Recovery After Emergency Laparotomy
Official title: Comparing Effect of Opioid-sparing Versus Conventional Anesthesia on Quality of Recovery After Emergency Laparotomy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anesthesia Recovery Period
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Aim of the Work The investigators aim to compare lidocaine-based anesthesia versus conventional anesthesia in the presence of multimodal analgesia protocol in terms of early quality of recovery and analgesic efficacy.

Objectives To compare quality of recovery using the Quality of recovery-15 (QoR-15) score between lidocaine-based anesthesia in relation to conventional anesthesia in patients undergoing emergency laparotomy.

Hypothesis the investigators hypothesize that lidocaine-based regimen would be effective in reducing opioid use and provide superior quality of recovery compared to conventional opioid-routine anesthesia in emergency laparotomy.


Eligibility criteria: Inclusion Criteria:

* Adult patients (18-65 years)
* ASA I-III undergoing emergency laparotomy with midline incision.

Exclusion Criteria:

* Severe cardiac morbidities (impaired contractility with ejection fraction \< 45%, heart block, arrhythmias, tight valvular lesions) and patients on beta-blockers
* Patients on vasopressor infusion, patients with high shock index (heart rate / systolic blood pressure \>1)
* Body mass index \<18 or \> 35 Kg/m2,

  * Pregnant or lactating women,

Primary outcomes:
measure: - Quality of recovery using the QoR-15 score 24 h after surgery.
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01631890: To Compare the Efficacy of Endoscopic Ultrasound Assisted Endoscopic Glue Injection and Conventional Endoscopic Injection Therapy for Prevention of Gastric Variceal Rebleed
Official title: Phase III Study of the Efficacy of Endoscopic Ultrasound (EUS) Assisted Endoscopic Glue Injection and Conventional Endoscopic Injection Therapy for Prevention of Gastric Variceal Rebleed
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Bleeding Gastric Varices
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2012-06-29
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Consecutive patients who meet the eligibility criteria will be enrolled into the study. All patients with gastric varices with no history of gastric variceal bleed (Group C) will undergo Endoscopic ultrasound and Upper Gastrointestinal Endoscopy at baseline, at the end of first year and at the end of study.

The patients who presented to Institute of Liver and Biliary Sciences with gastric variceal bleed or develop Gastric Variceal bleed during hospital stay will be randomized into Group -A (conventional Upper Gastrointestinal Endoscopy + Glue) and Group-B (Endoscopic Ultrasound followed by Upper Gastrointestinal Endoscopy+Glue) therapy for gastric varices. Total 90 patients will be enrolled and randomized into group A and Group B after resuscitation and urgent Upper Gastrointestinal Endoscopy with standard therapy for bleeding gastric varices to achieve hemostasis.


Eligibility criteria: Inclusion Criteria:

* A clinical, radiological or histologic diagnosis of cirrhosis
* Upper Gastrointestinal endoscopy showing gastric varices
* Informed consent to participate in the study

Exclusion Criteria:

* Previous endotherapy (Endoscopic Variceal Ligation/Esophageal Variceal Sclerotherapy/Endoscopic Variceal Obliteration) for gastric variceal haemorrhage
* Diagnosed case of HepatoPulmonary Syndrome.
* Non -cirrhotic portal hypertension/Extra hepatic Portal Venous Obstruction
* transhepatic intrajugular portosystemic shunt, (balloon-occluded retrograde transvenous obliteration), balloon-occluded endoscopic injection sclerotherapy, shunt operation.
* Hepatic encephalopathy grade III/IV,
* Cardio respiratory failure
* Pregnancy

Primary outcomes:
measure: Proportions of patients with gastric varices develops rebleed after complete gastric varices obturation in 2 years
timeFrame: 2 years
Secondary outcomes:
measure: Proportion of patients who will achieve complete Gastric variceal obliteration in both groups
timeFrame: 2 years
measure: Proportions of patients who will show adverse effects of gastric variceal obturation by N Butyl cyanoacrylate.
timeFrame: 2 years
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Ashok Kr Choudhury
role: PRINCIPAL_INVESTIGATOR
References: