louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04578496: A Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)
Official title: A Phase III, Safety Extension Study in Patients With Erythropoietic Protoporphyria (EPP)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Erythropoietic Protoporphyria
Lead sponsor: Clinuvel Pharmaceuticals Limited
Sponsor class: INDUSTRY
First posted: 2020-10-08
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The main objectives of the study were to evaluate the safety and tolerability of afamelanotide by measuring treatment emergent adverse events (AEs) and to determine whether afamelanotide can improve the quality of life of EPP patients.


Eligibility criteria: Inclusion Criteria:

* male or female subjects with a positive diagnosis of EPP who successfully completed the CUV017 or CUV029 studies;
* aged 18-75 years (inclusive);
* provide written informed patient consent prior to the performance of any study-specific procedure.

Exclusion Criteria:

* any serious adverse event considered to be related to afamelanotide or the polymer contained in the implant;
* any allergy to lignocaine or other local anaesthetic to be used during the administration of the study medication;
* EPP patients with significant hepatic involvement;
* personal history of melanoma or dysplastic nevus syndrome;
* current Bowen's disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions;
* any evidence of clinically significant organ dysfunction or any clinically significant deviation from normal in the clinical or laboratory determinations;
* acute history of drug or alcohol abuse (in the last 12 months);
* female who is pregnant (confirmed by positive serum β-Human Chorionic Gonadotropin (HCG) pregnancy test prior to baseline) or lactating;
* females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device);
* sexually active men with partners of child-bearing potential not using barrier contraception during the trial and for a period of three months thereafter;
* participation in a clinical trial for an investigational agent within 30 days prior to the screening visit;
* prior and concomitant therapy with medications which may interfere with the objectives of the study.

Primary outcomes:
measure: Change in Quality of Life Measured Using the EPP-quality of Life Questionnaire (EPP-QoL).
timeFrame: Baseline, Day 60, Day 120, Day 180 or early termination (ET) (if applicable)
measure: Change in Quality of Life Measured Using the Dermatology Life Quality Index Questionnaire (DLQI)
timeFrame: Baseline, Day 60, Day 120, Day 180 or early termination (ET) (if applicable)
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Clinuvel Pharmaceuticals Limited
name: Pilar Bilbao
role: STUDY_DIRECTOR
References:
Clinical trial NCT01496196: The Role of Inhalations of Tranexamic Acid in Patients With Hemoptysis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Hemoptisis
Keywords: hemoptisis
bleeding
tranexamic acid
Lead sponsor: Meir Medical Center
Sponsor class: OTHER
First posted: 2011-12-21
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hemoptysis is defined as the expectoration of blood from respiratory tract, a spectrum that varies from blood-streaking of sputum to coughing up large amounts of pure blood.

Massive hemoptysis variably defined as the expectoration of 100-600 ml over 24-h period.

The most common site of bleeding is the tracheobronchial tree, which can be affected by inflammation (acute or chronic bronchitis, bronchiectasis) or by neoplasm ( bronchogenic carcinoma, endobronchial metastatic carcinoma, bronchial carcinoid tumor). The bronchial arteries, which originate either from aorta or from intercostal arteries, and are part of the high-pressure systemic circulation, are the source of bleeding in bronchitis or bronchiectasis or endo bronchial tumors.


Eligibility criteria: Inclusion Criteria:

* Age \> 18
* Hemodynamicaly stable
* Hemoptysis of varying etiologies
* Coumadin treatment will be switched to clexane or heparine

Exclusion Criteria:

* Age \< 18
* Hemodinamicaly unstable
* Massive hemoptysis ( \> 200 ml / day)
* Renal failure: creatinine \> 3, renal replacement treatment
* Hepatic failure: bilirubin \> 2 mg/dl, AST \> 3 of upper normal limit level
* Coagulation disorders, INR\> 2.
* Hypesensitivity to tranexamic acid
* Pregnant woman

Primary outcomes:
measure: bleeding stops
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Kfar Saba
country: Israel
facility: Pulmonary department, Meir Medical Center
Study officials:
affiliation: Meir Medical Center, Kfar Saba, Israel
name: David Shitrit, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Wand O, Guber E, Guber A, Epstein Shochet G, Israeli-Shani L, Shitrit D. Inhaled Tranexamic Acid for Hemoptysis Treatment: A Randomized Controlled Trial. Chest. 2018 Dec;154(6):1379-1384. doi: 10.1016/j.chest.2018.09.026. Epub 2018 Oct 12.
Clinical trial NCT02211196: Evidence-Based Tobacco Cessation Strategies in Patients With Cancer
Official title: Implementing Evidence-Based Tobacco Cessation Strategies in Oncology Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Malignant Neoplasm
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2014-08-07
Enrollment: 377
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: This pilot clinical trial studies evidence-based tobacco cessation strategies in patients with cancer. Stop-smoking plans suggested by doctors may help patients with cancer quit smoking.

Detailed description: PRIMARY OBJECTIVES:

I. To assess oncology providers' self-reported need for training on evidence-based tobacco cessation strategies and assess their level of interest in future training on evidence-based tobacco cessation strategies.

II. To test the feasibility of the implementation of evidence-based tobacco cessation strategies in community oncology clinics.

III. To test the feasibility of surveying community oncology patients after a clinic visit to assess provider behavior regarding screening and brief intervention for tobacco use.

OUTLINE:

Patients complete a survey over approximately 10-15 minutes related to their provider's cessation advice and assistance with quitting.

After completion of study, patients are followed up at 1 month.

Eligibility criteria: Inclusion Criteria:

* All patients with cancer who saw a provider will be eligible

Exclusion Criteria:

* Having a nurse or lab visit only

Primary outcomes:
measure: Percentage of providers from the Piedmont Oncology Association (POA) reporting a need for training on evidence-based tobacco cessation strategies
timeFrame: Up to 1 month
measure: Percentage reporting feeling very confident in their ability to counsel smokers
timeFrame: Up to 1 month
measure: Percentage reporting they would be willing to participate in training on evidence-based tobacco cessation strategies
timeFrame: Up to 1 month
measure: Proportion of oncology patients willing to complete a survey in an oncology clinic
timeFrame: Up to 1 month
measure: Proportion of patients who report that their provider asked about tobacco use during their visit
timeFrame: Up to 1 month
measure: Proportion of current smokers who report that their provider advised them to quit during their visit and provided tobacco-cessation strategies
timeFrame: Up to 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Erin Sutfin
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00643396: Phase II Trial of Consolidative Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer
Official title: Phase II Trial of Consolidative Thoracic Radiotherapy for Extensive Stage Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Extensive Stage Small Cel Lung Cancer
Keywords: small cell lung cancer
radiotherapy
Lead sponsor: AHS Cancer Control Alberta
Sponsor class: OTHER
Collaborators: name: Cross Cancer Institute
First posted: 2008-03-26
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The majority of patients with small cell lung cancer have incurable extensive stage disease. The usual initial treatment for this condition is chemotherapy which produces responses in about 50-80% of patients. Despite this, the cancer usually returns. Once common body region where it re-grows is in the chest, which can cause symptoms such as shortness of breath, cough, difficulty swallowing, pain and bleeding. These symptoms can worsen a patient's quality of life and in some situation be life-threatening. In this study , we propose to give patients who have extensive stage small cell lung cancer which responds to chemotherapy radiotherapy treatments to the chest. By giving this type of radiation before the cancer has a chance to re-grow, we hope to control the disease within the chest and prevent future symptoms that it may cause if the cancer were to re-grow in the chest. Patients treated on the protocol will be checked regularly for disease control, quality of life and radiation side effects, if any.


Eligibility criteria: Inclusion Criteria:

* Histologic or cytologic confirmation of small cell lung cancer
* extensive stage disease
* adequate pulmonary function tests (FEV-1\>1.0, DLCO\>50%)
* patients of childbearing potential must practice adequate contraception
* age ≧ 18 years
* Karnofsky performance status ≧ 70
* documented objective response to initial chemotherapy
* signed study-specific informed consent form

Exclusion Criteria:

* complete or subtotal tumor resection
* non-small cell histology
* prior or concurrent malignancy except non-melanoma skin cancer unless disease-free for at least 5 years
* prior chest or neck RT
* inadequate pulmonary function tests (FEV-1\<1.0 OR DLCO\<50%)
* pregnant

Primary outcomes:
measure: local control
timeFrame: we anticipate completing accrual to the study in 12 months with most local failure events occuring within 2 years of treatment
Secondary outcomes:
measure: radiotherapy toxicities
timeFrame: 1-2 years after study treatment
measure: patient quality of life
timeFrame: 1-2 years after study treatment
measure: overall survival
timeFrame: 1-2 years after study treatment
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: Cross Cancer Institute
state: Alberta
Study officials:
affiliation: AHS Cancer Control Alberta
name: Don Yee, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02222896: Preoperative Chlorhexidine Gluconate (CHG) Cloth on Healthy Subjects
Official title: Assessment of the Antimicrobial Efficacy of 2% CHG Cloth Preoperative Skin Preparation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Surgery
Keywords: Preoperative surgical skin preparation
Lead sponsor: Medline Industries
Sponsor class: INDUSTRY
First posted: 2014-08-22
Enrollment: 347
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Evaluate the effects of Chlorhexidine Gluconate (CHG) cloth on the reduction of bacteria on the skin.

Detailed description: Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin areas post CHG application.

Eligibility criteria: Inclusion Criteria:

* Males or Females
* 16 years of age or older
* Signed informed consent
* Good Health
* Six inches of abdomen and groin areas without tattoos, or skin disorders

Exclusion Criteria:

* Dermatological Conditions
* Sensitivity to latex
* Sensitivity to CHG

Primary outcomes:
measure: Percent Responder Rates (%) of Bacterial Reduction on the Abdomen and Groin
timeFrame: 10 minutes, 6 hours, 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Sterling
country: United States
facility: MBT
state: Virginia
Study officials:
affiliation: MBT
name: H Bashir
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00301496: Randomized Controlled 8-week Crossover Evaluation of Compression Bandage Systems for Venous Leg Ulcers
Official title: Randomized Controlled Eight Week Cross-over Clinical Evaluation of the 3M Coban 2-Layer Compression System to Evaluate the Product Performance in Patients With Venous Leg Ulcers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Ulcer
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: 3M
First posted: 2006-03-13
Enrollment: 80
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the product performance of a new 2-layer compression bandage for the treatment of venous leg ulcers.

Detailed description: The purpose of this study is to evaluate the product performance of a new 2-layer compression bandage for the treatment of venous leg ulcers. The new bandage is a 2-layer compression system. It will be used over primary dressings to provide the compression that is beneficial to venous leg ulcers.

Eligibility criteria: Inclusion Criteria:

* venous leg ulcer
* patient can walk

Exclusion Criteria:

* cancerous ulcers
* diabetic foot ulcer

Primary outcomes:
measure: Product Performance
Secondary outcomes:
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Institute for Advanced Wound Care
state: Alabama
city: Castro Valley
country: United States
facility: Center for Clinical Research, Inc.
state: California
city: Lawrenceville
country: United States
facility: Gwinnet Hospital System
state: Georgia
city: Joliet
country: United States
facility: Wound Healing and Treatment Center - Silver Cross Hospital
state: Illinois
city: Terre Haute
country: United States
facility: Wound Healing Center
state: Indiana
city: Montreal
country: Canada
facility: Dermatology Clinic - Montreal General Hospital
state: Quebec
city: Mississauga, Ontario
country: Canada
facility: Dermatology Clinic
city: Cardiff
country: United Kingdom
facility: Wound Healing Research Unit
city: Grantham
country: United Kingdom
facility: Grantham & District Hospital
city: London
country: United Kingdom
facility: Clayponds Hospital
Study officials:
affiliation: Centre for Research and Implementation of Clinical Practice
name: Christine Moffatt, PhD, MA, RGN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02038296: Different Protocols for Repeated Transarterial Chemoembolization in the Treatment of Patients With Hepatocellular Carcinoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Liver Cancer
Keywords: Hepatocellular carcinoma
Transarterial chemoembolization
Gemcitabine
Lead sponsor: Guangdong Provincial People's Hospital
Sponsor class: OTHER
First posted: 2014-01-16
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: To evaluate local tumor control and survival rate after repeated transarterial chemoembolization(TACE) using three different protocols in hepatocellular carcinoma (HCC) patients.


Eligibility criteria: Inclusion Criteria:

* Patients with histologically confirmed HCC with unresectable disease without extrahepatic metastases;
* HCC with no previous treatment;
* age between 18 and 75 years;
* Life expectancy of at least 8 weeks;
* main tumor size greater than 5 cm;
* adequate hematologic function (platelet count: \>60 × 109 platelets/L; hemoglobin: \>90g/L; and prothrombin time: \<3 seconds above control);
* adequate renal function (serum creatinine: ≤1.5 × upper limit of normal);
* Child-Pugh classification A or B grade;
* Barcelona Clinic Liver Cancer (BCLC) stage B or C;
* Eastern Co-operative Group performance status of zero or one.

Exclusion Criteria:

* a hypovascular tumor (defined as a tumor with all its parts less contrast-enhanced than the nontumorous liver parenchyma on arterial phase computed tomography scans);
* diffuse-type HCC;
* evidence of hepatic decompensation including esophageal or gastric variceal bleeding or hepatic encephalopathy;
* severe underlying cardiac or renal diseases;
* color Doppler ultrasonography showing portal vein tumor thrombosis with complete main portal vein obstruction without cavernous transformation; or obstructive jaundice.

Primary outcomes:
measure: overall survival
timeFrame: 1-2 year
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Department of Interventional Radiology; Cancer Center; Guangdong General Hospital
state: Guangdong
Study officials:
References:
Clinical trial NCT02263196: The Efficacy of Alcohol After Betadine and Combination of Alcohol and Betadine on Inflammation Vascular Access
Official title: Mashhad University of Medical Sciences
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Complication of Hemodialysis
Lead sponsor: Mashhad University of Medical Sciences
Sponsor class: OTHER
First posted: 2014-10-13
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study was to compare the efficacy of combination of alcohol and povidone iodine 10% and Alcohol 70% after povidone iodine 10% on inflammation and infection related to vascular access area in hemodialysis patients.

Detailed description: These cases were identified from patient that lack of specific diseases; Non-use of antibiotics or immunosuppressive drugs. That the participants will be selected using convenience sampling method and randomly divided into three groups: combination of alcohol and povidone iodine 10%, Alcohol after and control groups. In the Intervention in one group the vascular access site disinfected with Alcohol(group1) and in group 2, Alcohol and povidone iodine 10% was used to separate were disinfected. Then the patient in a month of inflammation and infection of the vascular access will be monitor. Exclusion criteria: inflammation or fistula failure during the study for any reason other than infection. Sample size determination: Through the pilot study. Date: 02.10.2014 till 02.11.2014 Outcome: Washing with both solution affected on reduce the inflammation and infection of the patient.

the efficacy of Alcohol after Betadine and combination of alcohol and Betadine on inflammation and infection related to Vascular access hemodialysis patients.

Eligibility criteria: Inclusion Criteria:

* absence of inflammatory vascular access site
* three dialysis sessions per week

Exclusion Criteria:

* patient dies
* patient withdrew from the partnership

Primary outcomes:
measure: effected of betadin and alcohol on inflammation and infection of the patient
timeFrame: up to one month
Secondary outcomes:
Other outcomes:
Locations:
city: Mashhad
country: Iran, Islamic Republic of
facility: Ali Bazzi
Study officials:
affiliation: Msc Student, Faculty of Nursing and Midwifery
name: mohmmad rajabpoor, student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Branas P, Morales E, Rios F, Sanz F, Gutierrez E, Quintanilla N, Orellana MA, Sanchez M, Rodriguez-Aranda A, Chaves F. Usefulness of endoluminal catheter colonization surveillance cultures to reduce catheter-related bloodstream infections in hemodialysis. Am J Infect Control. 2014 Nov;42(11):1182-7. doi: 10.1016/j.ajic.2014.07.022. Epub 2014 Sep 22.
Clinical trial NCT06592196: Hepatic Safety of Statin Use in Neurology Inpatients
Official title: A Retrospective Study on the Hepatic Safety of Statin Use in Neurology Inpatients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Statin Adverse Reaction
Lead sponsor: Shanghai Yueyang Integrated Medicine Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study included patients admitted to the Department of Neurology at Yueyang Hospital for cerebrovascular diseases, headaches, dizziness, and vertigo from June 2020 to February 2023.

Brief summary: This research employs a cross-sectional study and a retrospective cohort study to analyze the liver safety of statin use among inpatients in the neurology department in China from different perspectives. The aim is to supplement evidence-based medicine and provide guidance for the clinical use of statins.


Eligibility criteria: Inclusion Criteria:

1. Patients hospitalized in the Department of Neurology of Yueyang Hospital from June 2020 to February 2023.
2. Age ≥18 and ≤85 years old, both sexes.
3. Meet the diagnostic criteria of cerebrovascular disease (L1-8B0), headache disease (L1-8A8) and dizziness and vertigo (MB48) in ICD-11.

Exclusion Criteria:

1. Incomplete medical history.
2. 1 days ≤ patients with \< 7 days of prior statin use.
3. Patients with malignant tumors (ICD-11 code L1-2A0, L1-2A2, L1-2B5, L1-2E6 diseases) and hematological diseases (ICD-11 code L1-3A0, L1-3B1, L1-3B8 diseases).

Primary outcomes:
measure: Aspartate aminotransferase(AST)
timeFrame: 4weeks after admission.
measure: Alanine aminotransferase(ALT)
timeFrame: 4 weeks taken after admission.
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Yueyang Integrated Medicine Hospital
state: Shanghai
Study officials:
References: