louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00972829: Tolerability and Lipid Lowering Effect of Weekly/Biweekly Crestor in Statin Intolerant Patients Treated With Zetia
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hypercholesterolemia
Keywords: Hypercholesterolemia
Lead sponsor: Bronx VA Medical Center
Sponsor class: FED
First posted: 2009-09-09
Enrollment: 30
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: Recently, research studies have shown that patients who have had trouble taking statins every day, are able to take statins if they take them only once or twice a week. The investigators are doing a research study which involves switching people who are taking ezetimibe to the statin Crestor once or twice a week and to see how ell Crestor lowers cholesterol and if it is tolerated.


Eligibility criteria: Inclusion Criteria:

* Patients with a history of intolerance to statins
* Patients currently receiving ezetimibe
* Patients willing and able to provide signed informed consent

Exclusion Criteria:

* Patients receiving a statin (Lipitor, Crestor, Lescol, Simvastatin, or Pravachol)
* Stroke, TIA, myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass surgery, or major surgery within 3 months
* Cancer undergoing active treatment
* Creatinine clearance \< 40 ml/minute
* Active liver disease or persistent elevation of SGOT or SGPT \> 2 times the upper limit of normal level
* Participation in any clinical study within the last 30 days
* Drug addition or alcohol abuse within the past 6 months
* Use of cyclosporine within the last 3 months
* Use of gemfibrozil within the last month
* Patients unwilling or unable to provide informed consent
* Patients with poor compliance
* Women of childbearing potential
* History of rhabdomyolysis due to statins

Primary outcomes:
measure: Low-density lipoprotein (LDL) cholesterol
timeFrame: 6 weeks
measure: Low-density lipoprotein (LDL) cholesterol
timeFrame: 3-4 months
Secondary outcomes:
measure: The ability to remain on Crestor for the study period
timeFrame: 12 months
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Bronx VA Medical Center
state: New York
Study officials:
affiliation: James J.Peters VA Medical Center
name: Lawrence Baruch, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03723629: Progression of Untreated Pulmonary Ground Glass Opacity
Official title: Progression of Untreated Pulmonary Ground Glass Opacity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: Ground glass opacity
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2018-10-29
Enrollment: 2000
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Clinic out patients of thoracic surgery.

Brief summary: In this study, about 2000 GGO patients will be included for a 5-year follow-up. The aim of this study is to elucidate the biological nature of pulmonary GGO lesion and provide evidence for GGO treatment.


Eligibility criteria: Inclusion Criteria:

* 35-80 years' old
* found pulmonary GGO with chest CT scan and CT follow-up after 3 months shows that the GGO remains
* Diameter of GGO \> 5mm and \< 3cm
* Solid component of GGO in pulmonary window \< 5mm
* signed informed consent form

Exclusion Criteria:

* receiving immunosuppressor or steriods
* receiving chemo- or radio- therapy
* can not receive regular follow-up

Primary outcomes:
measure: Changes from baseline GGO diameter
timeFrame: 6 months, 1year, 2 years, 3 years, 4 years and 5 years
measure: Changes from baseline GGO CT index.
timeFrame: 6 months, 1year, 2 years, 3 years, 4 years and 5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
state: Shanghai
Study officials:
References:
Clinical trial NCT04625829: Anthropological Survey on the Use of Essential Oils (EOs) by Cystic Fibrosis Patients: a Quantitative and Qualitative Approach
Official title: Anthropological Survey on the Use of Essential Oils (EOs) by Cystic Fibrosis Patients: a Quantitative and Qualitative Approach
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mucoviscidosis
Lead sponsor: University Hospital, Grenoble
Sponsor class: OTHER
First posted: 2020-11-12
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cystic fibrosis patient

Brief summary: Patients and parents of patients will be asked to answer a questionnaire on paper or online, by the CRCMs and through communication campaigns distributed by the association Vaincre La Mucoviscidose (VLM).

This questionnaire includes about fifty items that will take 5 to 12 minutes to complete. The study aims to interview 250 patients / parents of patients, users and non-users of essential oils.

Thirty patients or volunteer parents will then meet with a health anthropologist for qualitative interviews to document very precisely the modalities of use of essential oils: which ones, at what dose, advised by whom, the dedicated budget. Relationships with CRCM doctors, the effects felt, the side effects will also be explored.

The global data of the two phases will be integrated and put into perspective with the scientific data currently available on essential oils.


Eligibility criteria: Inclusion Criteria:

* Cystic fibrosis patient or parent of a child with cystic fibrosis

Exclusion Criteria:

* patient who refused

Primary outcomes:
measure: Frequency of use of the different EO by the patients who answered the questionnaire
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05620329: UNC Pleural Fluid Registry
Official title: University of North Carolina Pleural Fluid Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Cancer
Lung Infection
Breast Cancer
Malignant Pleural Effusion
Empyema
Keywords: biospecimen
pleural fluid
lung cancer
cancer
infection
breast cancer
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 9999
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: UNC patients

Brief summary: Research with biospecimens such as blood, tissue, or body fluids can help researchers understand how the human body works. Researchers can make new tests to find diseases, understand how treatments work, or find new ways to treat a disease. The purpose of this study is to collect biospecimens for research from patients with known or suspected lung cancer. The information learned from the biospecimens may be used in future treatments. The purpose of this protocol is to create a pleural fluid registry for use in future studies.


Eligibility criteria: Inclusion Criteria:

* Patients who are 18 years or older
* Inpatients and outpatients
* Diagnosed with pleural fluid, are referred for and undergo clinically indicated drainage who have clinical evidence of:
* pulmonary infection (such as fever, leukocytosis, new or worsening infiltrate on chest x-ray, or clinical deterioration) with effusion
* malignancy

Exclusion Criteria:

* A subject will not be eligible for inclusion in this registry if, in the investigator's (or treating clinician's) opinion, the patient has any concurrent medical condition that may preclude their ability to undergo pleural fluid drainage safely.
* Incarcerated individuals

Primary outcomes:
measure: Creation of a pleural fluid registry
timeFrame: 32 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Lingeberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: UNC Lineberger Comprehensive Cancer Center
name: Jason Akulian
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00945529: The Effects of Inhaled Nitric Oxide After Fontan Operation
Official title: The Effects of Inhaled Nitric Oxide on Patient Morbidity and Length of Hospital Stay Following Fontan Operation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Congenital Heart Defect
Keywords: Fontan
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
Collaborators: name: Mallinckrodt
First posted: 2009-07-24
Enrollment: 21
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Pleural effusions continue to be a post-operative complication seen after Fontan operation. This study will examine the use inhaled nitric oxide (iNO) given for 54 hours after Fontan operation to improve fluid balance. The study hypothesis is that inhaled nitric oxide after Fontan operation will improve fluid balance, thus decreasing the incidence of pleural effusions and shortening hospital stay.


Eligibility criteria: Inclusion Criteria:

* Male/female patients
* Undergoing Fontan operation at the Nemours Cardiac Center at A. I. duPont Hospital for Children
* Written parental permission to participate in this research study

Exclusion Criteria:

* Any condition which the PI feels will interfere with the patient's safe and effective participation

Primary outcomes:
measure: Length of Hospital Stay Following Fontan
timeFrame: until hospital discharge
Secondary outcomes:
measure: Percent of Patients With Significant Pleural Fluid Collections That Required Thoracostomy Drainage
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: A. I. duPont Hospital for Children/Nemours Cardiac Center
state: Delaware
Study officials:
affiliation: Nemours Children's Clinic - A. I. duPont Hospital for Children
name: Ellen Spurrier, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01901029: Male Reproductive Health of Floating Population: a Large-Scale Survey in Dongguan
Official title: Prevalence of Reproductive Health Problems and Their Social, Psychological and Physical Association Among Men in Floating Population: a Large-Scale Cross-Sectional Study in Dongguan City
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sexual Behavior
Erectile Dysfunction
Premature Ejaculation
Keywords: Male Reproductive Health
Floating Population
Sexual Behavior
Erectile Dysfunction
Premature Ejaculation
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Dongguan Taiping People's Hospital
First posted: 2013-07-17
Enrollment: 3100
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: male workers in several towns of Dongguan city

Brief summary: To determine the prevalence of sexual problems particularly premature ejaculation and erectile dysfunction among men working in factories of Dongguan city, using the self-rating scales like International Index of Erectile Function, and to investigate the characteristics or risk factors associated with these sexual problems in floating population through regression analysis.

Detailed description: In China, the floating population is a special group of people who work and live outside their hometowns and without residence cards of that area they reside. Sexual problems are common in floating population, majority of whom are in their sex active age. There is a lack of studies concerning these sexual problems, so we conduct this survey to investigate the sexual dysfunctions among men, especially the floating population, and to find out whether most of these sexual problems are related to their social lives, medical illnesses, and psychological status.

Eligibility criteria: Inclusion Criteria:

* have reached 18 years old
* live in Dongguan more than 6 months
* floating population
* with or without residence card

Exclusion Criteria:

* younger than 18 years old
* live in Dongguan less than 6 months

Primary outcomes:
measure: Prevalence of sexual problems
timeFrame: one month
Secondary outcomes:
measure: Association between risk factors and sexual problems
timeFrame: one month
Other outcomes:
Locations:
city: Dongguan
country: China
facility: Dongguan Taiping People's Hospital Andrology Department
state: Guangdong
Study officials:
affiliation: Dongguan Taiping People's Hospital
name: Jianbo Ruan, MM
role: STUDY_DIRECTOR
References:
Clinical trial NCT05388929: Methocarbamol in Ventral and Inguinal HR
Official title: Addition of Methocarbamol to Postoperative Multimodal Analgesic Regimen: A Prospective, Randomized Pilot Study
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE4
Conditions: Ventral Hernia
Inguinal Hernia
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
First posted: 2022-05-24
Enrollment: 164
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: The purpose of this study is to gather information on methocarbamol as a pain management treatment for ventral or inguinal hernia repair.

Methocarbamol has been part of the pain management treatment for both inpatient and outpatient procedures at Prisma Health. This study will compare the outcomes of patients who receive methocarbamol, those who receive the standard opioid pain management treatment, and those who receive methocarbamol plus the standard opioid pain management treatment.

Participants will be randomized into one of the study groups listed below.

Primary ventral hernia repair or inguinal hernia repair:

Group 1: standard opioid after surgery Group 2: methocarbamol after surgery

Open or robotic ventral hernia repair outpatient:

Group 1: standard opioid after surgery Group 2: standard opioid plus methocarbamol after surgery

Open or robotic ventral hernia repair inpatient:

Group 1: standard opioid at discharge Group 2: standard opioid plus methocarbamol at discharge

A total of 200 participants will be included in the study.

Participation will last for about 30 days after surgery.


Eligibility criteria: Inclusion Criteria:

* \>18 y/o
* Patients undergoing open primary ventral hernia repair (group 1)
* Patients undergoing inguinal hernia repair (open, laparoscopic, or robotic; group 2)
* Patients undergoing open incisional hernia repair (group 3)
* Robotic repair ventral or incisional hernias (group 4)
* Given consent for randomization

Exclusion Criteria:

* \<18 y/o
* Pregnancy
* Chronic opioid users

Primary outcomes:
measure: Proportion of patients requiring a rescue opioid prescription
timeFrame: 30 days post surgery
measure: Average total morphine milligram equivalents (MME) consumption
timeFrame: 30 days post surgery
Secondary outcomes:
measure: European Registry of Abdominal Wall Hernias (EuraHS) Quality of Life tool scores
timeFrame: 30 days post surgery
measure: Visual Analog Scale pain scores
timeFrame: 7 days post surgery
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Prisma Health
state: South Carolina
Study officials:
affiliation: Prisma Health
name: Jeremy A Warren, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04173429: Efficacy and Safety of Anticoagulant Therapy in Portal Vein Thrombosis
Official title: Efficacy and Safety of Nadroparin Calcium-Warfarin Sequential Anticoagulation in Portal Vein Thrombosis in Cirrhotic Patients：A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Liver Cirrhosis
Portal Vein Thrombosis
Keywords: Portal vein thrombosis
Nadroparin calcium
Warfarin
Anticoagulation
Lead sponsor: Qilu Hospital of Shandong University
Sponsor class: OTHER
First posted: 2019-11-22
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study is aimed at evaluating the efficacy and safety of anticoagulant therapy with nadroparin calcium and warfarin in patients with portal vein thrombosis (PVT).

Detailed description: Portal vein thrombosis (PVT) is a frequent complication of liver cirrhosis, referred to partial or complete thrombosis formed in the lumen of portal vein or/and branches of it. Currently, clinical guidelines of PVT in cirrhotic patients has not been addressed, and anticoagulant therapy of PVT patients with cirrhosis remains controversial. Although numerable studies have reported that anticoagulation therapy is effective, while a majority of them were respective and a few took control into consideration. In addition, no agreement has reached about the safety of anticoagulation. So, the efficacy and safety of anticoagulant therapy needs more prospective randomized controlled trial to be investigated.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 75 years
* Liver cirrhosis diagnosis based on clinical, laboratory, and imaging studies, and PVT diagnosed by abdominal contrast-enhanced computed tomography, contrast-enhanced MRI, or portal angiography

Exclusion Criteria:

* Cavernous transformation of the portal vein
* Uncontrolled active bleeding
* Platelet count lower than 10\*10\^9/L
* Creatinine more than 170 mmol/L
* Ongoing or received antithrombotic/thrombolytic treatment
* Primary thrombophilia
* Budd-Chiari syndrome
* Pregnancy or breast-feeding period
* Severe cardiopulmonary diseases
* Severe systemic infection or sepsis
* Inability to sign informed consent

Primary outcomes:
measure: Recanalization Rate
timeFrame: 6 months
Secondary outcomes:
measure: Rate of Bleeding
timeFrame: 6 months
Other outcomes:
Locations:
city: Jinan
country: China
facility: Department of Gastroenterology,Qilu Hospital,Shandong University
state: Shandong
Study officials:
affiliation: Qilu Hospital, Shandong University
name: Yanjing Gao, PhD.MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02885129: Development of the General Scale Observance for Chronic Diseases
Official title: Development of the General Scale Observance for Chronic Diseases (EGOMAC)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Diseases
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2016-08-31
Enrollment: 397
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: Population of consultants in diabetology, cardiology and rheumatology hospital and liberal and hospital oncology and Infectious disease

Brief summary: The main objective is to assess the measurement characteristics (validity, reproducibility) and the invariance of EGOMAC scale in a population of consultants in diabetology, cardiology and rheumatology hospital and liberal and hospital oncology and Infectious disease, by following the evolution of patient compliance at D0 and D15.

The second objective is to assess the sensitivity to change of scale EGOMAC following developments compliance 3 months.

Detailed description: During a routine appointment (D0), the patient filled a newsletter and a questionnaire to complete.

The doctor collects medical informations for the case report form.

At the end of the first consultation (D0), an additional EGOMAC scale and a stamped envelope is delivered to the patient by asking him to fill that scale to 15 days and return it by Post Office (reproducibility study).

Finally, a new scale will be addressed to the patient at the end of 3 months, which will return by Post Office too (stability study).

Eligibility criteria: Inclusion Criteria:

* patient age of 18 years
* from routine patient counseling
* with at least one of these diseases : heart failure, hypertension, coronary disease, type 2 diabetes, osteoarthritis of the knee or hip, osteoporosis, inflammatory rheumatism (rheumatoid arthritis, spondyloarthropathy), cancer ( with only non-hormonal oral anti cancer treatments) and HIV.
* patient can read the French language in order to complete the self -administered questionnaire
* patient agreeing to participate in the study

Exclusion Criteria:

* patient treated for more than 3 conditions mentioned in the inclusion criteria (
* patient receiving no drug prescription or recommendation of lifestyle or diet (for example consultationpurely diagnostic ).

Primary outcomes:
measure: EGOMAC questionnaire
timeFrame: baseline
measure: Change in EGOMAC questionnaire
timeFrame: 15 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: Central hospital
Study officials:
affiliation: CHRU Nancy
name: Francis GUILLEMIN, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03617029: Localization for Deep Lung Nodules: Microcoil Versus Contrast Injection
Official title: Preoperative Localization With Microcoil Placement or Contrast Injection for Deep-seated Pulmonary Nodule : A Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Keywords: Deep-seated
Needle localization
CT-guided
Thoracoscopy
Fiducial marker
Lead sponsor: National Taiwan University Hospital Hsin-Chu Branch
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: In recent years, the development of low-dose pulmonary computed tomography screening has led to the discovery of many small pulmonary nodules in the early stages.

Surgical resection is still the main treatment for those suspected malignant lesions. In the face of such small pulmonary nodules, accurate preoperative localization has become the key to successful resection, and the deep-seated nodules are the most challenging parts. Because the deep-seated nodules cannot be localized by surface dye injection, however, it is necessary to place a fiducial marker (such as a microcoil) or contrast medium injection in combination with intraoperative fluoroscopy to ensure adequate resection of the deep-seated nodules. . This study will be carried out at the Hsinchu Branch of National Taiwan University Hospital. It is expected that 60 patients with pulmonary nodules with a depth larger than 2 cm will be randomly assigned into two groups. One group will receive microcoil placement, and the other group will receive contrast medium injection. The primary goal of the study was to compare the localization duration of the two groups of patients, the total dose of radiation exposure during localization and the incidence of location-related complications, and the secondary goals were the results of the surgical procedure, including the surgical duration.


Eligibility criteria: Inclusion Criteria:

Deep lung lesions

Exclusion Criteria:

Emphysema COPD Previous ilpislateral surgery

Primary outcomes:
measure: Procedure success rate
timeFrame: 1 day
measure: Successful localization for surgery
timeFrame: 1 day
Secondary outcomes:
measure: Procedure-related complication rate
timeFrame: 1 day
measure: Duration of the localization procedure
timeFrame: 1 day
measure: Duration of wedge resection
timeFrame: 1 day
measure: Surgical margin of wedge resection
timeFrame: 1 day
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital, Hsin-Chu Branch
state: Hsin-Chu County
Study officials:
References: