louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04046315: Early Detection of Cardiac Damage With CMR in Women With Breast Cancer
Official title: Early Detection of Cardiac Damage With CMR in Women With Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiotoxicity
Breast Cancer
Chemotherapy Induced Systolic Dysfunction
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 55
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population will be recruited from the general BC population receiving (neo-) adjuvant chemotherapy. Patients with a new diagnosis of malignant neoplasm of the breast, codes C50.0-C50.9, according to the World Health Organization International Classification of Diseases (WHO-ICD) will be eligible for participation.

Brief summary: With this study the investigators will assess early cardiac damage by means of Global Longitudinal Strain (GLS) in newly diagnosed breast cancer (BC) patients treated with anthracycline-based chemotherapy, and to investigate whether myocardial damage as measured with T1 / T2 Cardiovascular Magnetic Resonance (CMR) mapping and plasma hs-Troponin T is related to changes in GLS.


Eligibility criteria: Inclusion Criteria:

* Female
* Age ≥ 18 years
* A diagnosis of primary breast cancer
* Starting (neo-) adjuvant chemotherapy treatment within 2 months after screening
* Cardiotoxicity risk score of intermediate, high or very high risk

Exclusion Criteria:

* Previous radiotherapy or systemic cancer treatment
* Cancer metastasis
* Life expectancy of less than 6 months
* History of myocardial infarction or heart failure
* Known contra-indications for CMR
* Refusal or inability to provide informed consent

Primary outcomes:
measure: Global Longitudinal Strain (GLS) change after chemotherapy compared to baseline
timeFrame: Baseline and 2 weeks after the last chemotherapy cycle
Secondary outcomes:
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
Study officials:
affiliation: Radboud University Medical Center
name: Saloua El Messaoudi, PhD
role: STUDY_CHAIR
affiliation: Radboud University Medical Center
name: Angela Maas, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Robin Nijveldt, PhD
role: STUDY_CHAIR
References:
Clinical trial NCT03241615: Dysphagia Symptom Severity and Quality of Life
Official title: The Relationship Between Dysphagia Symptom Severity and Quality of Life
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurogenic Dysphagia
Lead sponsor: Hacettepe University
Sponsor class: OTHER
First posted: 2017-08-07
Enrollment: 84
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who have neurogenic dysphagia and willing to participate in the study, being over the age of 20, normal cognitive function (24 points according to the Mini Mental State Examination), and having clinically stable neurological disease will be included.

Brief summary: The aim of the study is to investigate the relationship between dysphagia symptom severity and quality of life of the patients with neurogenic dysphagia.

Detailed description: The dysphagia related quality of life and perceived dysphagia symptom severity by patients will be used as a complementary information on oropharyngeal dysphagia. Thus, the aim of the study is to investigate the relationship between dysphagia symptom severity and quality of life of the patients with neurogenic dysphagia.

Eligibility criteria: Inclusion Criteria:

* Willing to participate in the study
* Being over the age of 20
* Normal cognitive function
* Suffering from dysphagia at least one month

Exclusion Criteria:

* Being under the age of 20 and above 65 years.
* Abnormal cognitive function
* Clinically unstable neurological disease

Primary outcomes:
measure: Dysphagia symptom severity
timeFrame: 1 month
Secondary outcomes:
measure: Quality of life assessment
timeFrame: 1 month
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Hacetttepe University
Study officials:
affiliation: Hacettepe University
name: SELEN SEREL ARSLAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00490815: Pharmacokinetic and Efficacy Study of Fluocinolone Acetonide Inserts in Patients With Diabetic Macular Edema
Official title: An Open Label Pharmacokinetic and Efficacy Study of 0.5 μg/Day and 0.2 μg/Day Fluocinolone Acetonide Intravitreal Inserts in Subjects With Diabetic Macular Edema
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetic Macular Edema
Lead sponsor: Alimera Sciences
Sponsor class: INDUSTRY
First posted: 2007-06-25
Enrollment: 37
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 will evaluate the pharmacokinetics, safety and efficacy of an intravitreal insert of fluocinolone acetonide for the treatment of diabetic macular edema


Eligibility criteria: Inclusion Criteria:

* Age \>= 18 years with diabetic macular edema
* Diagnosis of diabetes mellitus types 1 or 2
* Best corrected visual acuity of ≥ 19 letters
* Retinal thickness \> 250 microns by OCT
* Investigator is comfortable deferring macular laser treatment for 6 weeks

Exclusion Criteria:

* Glaucoma, ocular hypertension, IOP \>21 mmHg or concurrent therapy at screening with IOP lowering agents
* Retinal or choroidal neovascularization due to ocular conditions other than diabetic retinopathy
* Prior intravitreal, subtenon, or periocular steroid therapy within the last 3 months
* Prior intravitreal or subtenon anti-VEGF therapy within the last 2 months
* Any ocular surgery within the last 3 months
* Retinal laser treatment within the last 3 months
* History of uncontrolled IOP elevation with steroid use that did not respond to topical therapy
* Any lens opacity which impairs visualization of the posterior pole

Primary outcomes:
measure: Levels of Fluocinolone Acetonide in Plasma and Aqueous Humor
timeFrame: over 36 months
Secondary outcomes:
measure: Retinal Thickness
timeFrame: over 36 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: John Hopkins University
state: Maryland
Study officials:
References:
Clinical trial NCT03189615: Study Investigating the Pharmacokinetic Properties of the Drug Lu AF35700 in Subjects With Liver Impairment and in Healthy Subjects
Official title: Interventional, Open-label, Three-group, Single-dose Study Investigating the Pharmacokinetic Properties of Lu AF35700 in Subjects With Hepatic Impairment (Mild or Moderate) and in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Lead sponsor: H. Lundbeck A/S
Sponsor class: INDUSTRY
First posted: 2017-06-16
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the impact of mild to moderate hepatic impairment on the pharmacokinetics of a single oral dose of Lu AF35700


Eligibility criteria: Inclusion Criteria:

* Subjects with hepatic impairment disease stage Child-Pugh's Criteria A (mild) or Child-Pugh's Criteria B (moderate) and healthy subjects with normal hepatic function
* Subjects have a body mass index between 18.5 and 34 kg/m2 (inclusive)

Exclusion Criteria:

* Subjects previously been dosed with Lu AF35700

Other protocol defined inclusion and exclusion criteria may apply

Primary outcomes:
measure: Area under the Lu AF35700 plasma concentration-time curve from zero to infinity (AUC0-inf)
timeFrame: Predose to day 57 postdose
measure: Maximum observed plasma concentration (Cmax) of Lu AF35700
timeFrame: Predose to day 57 postdose
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: APEX
Study officials:
affiliation: LundbeckClinicalTrials@Lundbeck.com
name: Email contact via H. Lundbeck A/S
role: STUDY_DIRECTOR
References:
Clinical trial NCT02862015: Multicenter RCT of the Clinical Effectiveness of Oncothermia With Chemotherapy in Metastatic Pancreatic Cancer Patients
Official title: A Multicenter, Prospective, Randomized Clinical Trial of the Clinical Effectiveness of Oncothermia Combined With Standard Chemotherapy in Metastatic Pancreatic Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Cancer, Pancreas
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
Collaborators: name: Hospicare Inc.
First posted: 2016-08-10
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with pancreatic cancer often suffer from pain. Because of such a pain, their quality of life have seriously deteriorated. There have been a few studies that showed an effect for pain control by hyperthermia (heating the patient's body). However, there are several limitations in conventional hyperthermia.

In a previous pilot study (NCT02150135), we found the improvement of quality of life, function, and symptom.

From this background, the investigators tried to show the effect of "Oncothermia" with conventional chemotherapy for pain control, increasing quality of life, and anti-tumor treatment.


Eligibility criteria: Inclusion Criteria:

* Patients with pathologically confirmed pancreatic adenocarcinoma
* Patients with radiologically identified metastasis (CT or MRI)
* Patients with no history of previous chemotherapy
* Patients with ECOG score 0-2

Exclusion Criteria:

* Patients who have an experience of hyperthermia treatment
* Patients who have a difficulty of sensing heat
* Patients who have a skin graft or breast reconstruction surgery
* Patients who have a cardiac pacemaker or an implanted metal
* Pregnant or breast feeding women
* Patients with uncontrolled infection, diabetes, hypertension, ischemic heart disease, myocardial infarct within 6 months
* Patients who were treated with unproved drugs within 30 days
* Patients who have a serious disease which can affect the person's safety
* Patients who do not consent to the study

Primary outcomes:
measure: European Organisation for Research and Treatment of Cancer quality of life questionnaire (EORTC QLQ)-C30 score change
timeFrame: 3 months
Secondary outcomes:
measure: change of opioid use amount
timeFrame: 3 months
measure: change of pain score (VAS score)
timeFrame: 3 months
measure: Adverse effect
timeFrame: 3 months
Other outcomes:
Locations:
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
state: Gyeonggi-do
Study officials:
affiliation: Seoul National University Bundang Hospital
name: Jin-Hyeok Hwang, MD PhD
role: STUDY_CHAIR
References:
Clinical trial NCT01267552: Study of Axillary Lymphadenectomy Without Drainage for Breast Cancer
Official title: Randomized Clinical Trial of Axillary Lymphadenectomy Without Drainage for Breast Cancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Breast Cancer
Complications
Seroma
Keywords: Breast cancer
Surgery
Complications
Drainage
Seroma
Lead sponsor: Universidade Federal de Goias
Sponsor class: OTHER
Collaborators: name: Araujo Jorge Hospital
First posted: 2010-12-28
Enrollment: 240
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To study the safety of not draining the axilla, after breast conserving surgery and full axillary lymphadenectomy.

Detailed description: The primary objective is to study the safety of not draining the axilla, considering the total number of patients without complication among breast cancer patients treated by means of conservative surgery and full axillary lymphadenectomy, with or without axillary drainage.

The secondary objectives will be the numbers of aspiration punctures, volumes of fluid aspirated and the total volumes of fluid produced.

Eligibility criteria: Inclusion Criteria:

* Stage I and II breast cancer patients
* Will be submitted to breast conserving therapy, with full axillary lymphadenectomy

Exclusion Criteria:

* diabetes

Primary outcomes:
measure: Safety
timeFrame: 6 months
Secondary outcomes:
measure: Serous fluid
timeFrame: 6 months
Other outcomes:
Locations:
city: Goiania
country: Brazil
facility: Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias
state: Goias
city: Goiania
country: Brazil
facility: Mastology Program of Federal University of Goias
state: Goias
Study officials:
affiliation: Universidade Federal de Goias
name: Ruffo Freitas-Junior, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Araujo Jorge, Associacao de Combate ao Cancer em Goias
name: Luiz Fernando J Ribeiro, PhD
role: STUDY_CHAIR
References:
citation: Freitas-Junior R, Ribeiro LFJ, Moreira MAR, Queiroz GS, Esperidiao MD, Silva MAC, Pereira RJ, Zampronha RAC, Rahal RMS, Soares LR, Dos Santos DL, Thomazini MV, de Faria CFS, Paulinelli RR. Complete axillary dissection without drainage for the surgical treatment of breast cancer: a randomized clinical trial. Clinics (Sao Paulo). 2017 Jul;72(7):426-431. doi: 10.6061/clinics/2017(07)07.
Clinical trial NCT01409252: Long Term Outcome After Hemorrhagic Stroke Surgery
Official title: Long Term Neurological and Cognitive Outcome After Neurosurgical Operation for Hemorrhagic Stroke (Intracerebral Hemorrhage)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: Stroke
intracerebral hemorrhage
surgery
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2011-08-04
Enrollment: 191
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Spontaneous intracerebral hemorrhage with neurosurgical operations

Brief summary: The investigators retrospectively reviewed all patients with neurosurgical operations for hemorrhagic stroke (intracerebral hemorrhage) between 1999 and 2008. Research assistant then telephoned the survivors for neurological and cognitive status.

Detailed description: Death at one year for intracerebral hemorrhage varies by location, with 42% for cerebellar in one series. Of patients who had intracerebral hemorrhage in the United States during 2002, only 20% are expected to be functionally independently at 6 months. Although case series established the value of selected timely hematoma evacuation, long term clinical outcome, especially on cognition, is not well described in the literature. With these in mind, we carried out this study.

Eligibility criteria: Inclusion Criteria:

* All hemorrhagic stroke patients with neurosurgical operations performed between 1999 and 2008.

Exclusion Criteria:

* Spontaneous subarachnoid hemorrhage as the dominant etiology
* uncommunicable patients
* nonsurvivors

Primary outcomes:
measure: Modified Rankin Scale
timeFrame: Cross-sectional at 2-12 years after ictus
Secondary outcomes:
measure: Barthel Index
timeFrame: Cross-sectional at 2-12 years post-ictus
measure: Telephone Interview of Cognitive Status
timeFrame: Cross-sectional at 2-12 years post-ictus
Other outcomes:
Locations:
city: Hong Kong
country: China
facility: Department of Surgery, The Chinese University of Hong Kong
Study officials:
affiliation: Chinese University of Hong Kong
name: George Wong, MD(CUHK) FRCSEd(SN)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00149552: Zinc Therapy in HIV Infected Individuals Who Abuse Drugs
Official title: Zinc Therapy in Zinc Deficient HIV Positive Drug Users
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV Infections
Substance-Related Disorders
Keywords: Treatment Naive
Treatment Experienced
Lead sponsor: Florida International University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2005-09-08
Enrollment: 231
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: Zinc deficiency is prevalent in HIV infected individuals who abuse drugs. The purpose of this study is to determine if zinc therapy will prevent immune failure in HIV infected individuals who abuse drugs and have low plasma zinc levels.

Detailed description: Low levels of zinc are associated with an increased risk of HIV-related death and opportunistic infections in HIV infected individuals. Drug users are especially susceptible to zinc deficiency. The purpose of this trial is to evaluate the effectiveness of zinc therapy in preventing immune failure in HIV infected individuals who abuse drugs.

This trial will last 30 months. Participants will be randomly assigned to receive either zinc supplements or placebo. Male participants will receive 15 mg of zinc and female participants will receive 12 mg of zinc. Clinical and laboratory study visits will occur at 3 or 6 month intervals throughout the study.

Eligibility criteria: Inclusion Criteria:

* HIV infected
* Drug User
* Blood zinc level greater than 0.35 mcg/mL and less than 0.75mcg/ml

Exclusion Criteria:

* Currently participating in an another clinical trial
* Blood selenium level less than 85 mcg/L
* Pregnant or intends to become pregnant

Primary outcomes:
measure: Immune failure
timeFrame: For at least 6 months
Secondary outcomes:
measure: Morbidity
timeFrame: For at least 6 months
Other outcomes:
Locations:
city: Miami
country: United States
facility: Camillus House
state: Florida
Study officials:
affiliation: Florida International University
name: Marianna K. Baum, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baum MK, Lai S, Sales S, Page JB, Campa A. Randomized, controlled clinical trial of zinc supplementation to prevent immunological failure in HIV-infected adults. Clin Infect Dis. 2010 Jun 15;50(12):1653-60. doi: 10.1086/652864.
Clinical trial NCT05666752: Effect of Intake of Allium Cepa L. Peel Heated Water Extract on Immunity Enhancement
Official title: A 8 Weeks, Randomized, Double-blind, Placebo-controlled Human Trial to Evaluate the Efficacy and Safety of Allium Cepa L. Peel Heated Water Extract on Immunity Enhancement
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Upper Respiratory Infection
Lead sponsor: Hanyang University
Sponsor class: OTHER
First posted: 2022-12-28
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study was conducted to investigate the effects of daily supplementation of Allium Cepa L. Peel Heated Water Extract on Immunity Enhancement

Detailed description: This study was a 8 weeks, randomized, double-blind, placebo-controlled human trial. 40 subjects were randomly divided into Allium Cepa L. Peel Heated Water Extract or a placebo group. Immunity Enhancement profiles before and after the intervention.

Eligibility criteria: Inclusion Criteria:

* Age 19-75 years
* Symptoms of upper respiratory infection at least once within past 12 months

Exclusion Criteria:

* Cardio-cerebrovascular, endocrine, immune, respiratory, musculoskeletal, inflammatory, hematologic, tumorigenic, gastrointestinal diseases, etc.
* Vaccination within past 2 months
* BMI \< 18.5 kg/m2 or 35 kg/m2 ≤ BMI
* Immunity enhancement agents within past one months
* Allergic or hypersensitive to any of the ingredients in the test products
* Antipsychotic drugs therapy within past 3 months
* History of alcoholism or drug abuse
* Participation in any other clinical trials within past 3 months
* Pregnant or lactating women
* Judged ineligible to participate in the trial by the principal investigator

Primary outcomes:
measure: Changes of Natural killer(NK) cell activity
timeFrame: At week 0 and week 8
Secondary outcomes:
measure: Changes of Cytokines(INF-gamma, Interleukin(IL)-2, IL-6, IL-12, Tumor Necrosis Factor(TNF)-alpha, and IL-1beta)
timeFrame: At week 0 and week 8
measure: Changes of Wisconsin Upper Respiratory Symptom Survey-21
timeFrame: At week 0 and week 4 and week 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Hanyang University
Study officials:
affiliation: Hanyang University
name: Yongsoon Park, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03097952: "Real-life" Cohort Study on Patients With Chronic HBV Infection in Jiangsu
Official title: "Real-life" Cohort Study on Patients With Chronic Hepatitis B Virus Infection in Jiangsu
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hepatitis B， Chronic
Lead sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Sponsor class: OTHER
First posted: 2017-03-31
Enrollment: 20000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients chronically infected with hepatitis B virus

Brief summary: Hepatitis B virus (HBV) infection remains one of the most serious health problems worldwide. Patients with chronic HBV infection are at an increased risk for developing hepatic cirrhosis, hepatocellular carcinoma and even death. Although some predictive factors of the outcome of chronic HBV infection were identified, more precisely determine the factors which are associated with the outcome in non-selected patients with chronic HBV infection are still needed. The investigators purpose is to constitute a observational cohort of non-selected Chinese patients to create a database of epidemiological, clinical, biological, virological, immunologic and therapeutic parameters, in order to determine factors associated with the outcome of chronic HBV infection.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic HBV infection (defined as HBsAg positive for at least 6 months)

Exclusion Criteria:

* Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) and/or hepatitis D virus (HDV)
* History of liver transplantation
* History of hepatocellular carcinoma (HCC)

Primary outcomes:
measure: Number of participants with antigen loss (HBeAg and HBsAg loss)
timeFrame: 20 years
measure: Cirrhosis
timeFrame: 20 years
measure: Hepatic decompensation
timeFrame: 20 years
measure: Hepatocellular carcinoma (HCC)
timeFrame: 20 years
measure: Death
timeFrame: 20 years
Secondary outcomes:
Other outcomes:
Locations:
city: Changzhou
country: China
facility: The Third Hospital of Changzhou
state: Jiangsu
city: Huai'an
country: China
facility: Huai'an No.4 People's Hospital
state: Jiangsu
city: Nanjing
country: China
facility: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
state: Jiangsu
city: Nanjing
country: China
facility: Nanjing Jiangbei People's Hospital
state: Jiangsu
city: Suqian
country: China
facility: Suqian People's Hospital
state: Jiangsu
city: Suzhou
country: China
facility: The Fifth People's Hospital of Suzhou
state: Jiangsu
Study officials:
References: