louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04406779: The Frequency of Thyroid Diseases in Women With Breast Cancer
Official title: The Frequency of Thyroid Diseases in Women With Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Thyroid Diseases
Lead sponsor: Uşak University
Sponsor class: OTHER
First posted: 2020-05-28
Enrollment: 160
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: women, aged between 18-65 years who were diagnosed with breast cancer, but not underwent surgery, radiotherapy or chemothreapy were included into the study as patients groups. Age matched healthy controls were enrolled as controls.

Brief summary: Breast cancer and thyroid disorders are important health challenges commonly encountered in women. The relationship between both conditions still remains unknown. In this study, the frequency of thyroid diseases was investigated in breast cancer patients


Eligibility criteria: Inclusion Criteria:

* women, the age between 18-65 years who were diagnosed with breast cancer, but not underwent surgery, radiotherapy or chemothreapy were included into the study

Exclusion Criteria:

* Those with pregnancy, known liver and renal failure, the history of any malignancy other than breast cancer, undergoing a surgical operation due to breast cancer, also those receiving chemotherapy/radiotherapy for the same reason or undergoing partial or complete thyroid surgery or a surgical operation within the past 6 months, and also the patients taking oral anti-diabetic medication, insulin, steroids, thiazide, anti-psychotics and immuno-suppressive medicines affecting the levels of blood glucose, insulin and IR, smokers and those consuming alcohol were excluded

Primary outcomes:
measure: to investigate the frequency of thyroid diseases in breast cancer patients.
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01406379: Comparison of Prophylactic Clip and Detachable Snare
Official title: Comparison of Clip and Detachable Snare in Preventing Postpolypectomy Bleeding for Pedunculated Colonic Polyps: a Prospective, Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Polyp
Lead sponsor: The Catholic University of Korea
Sponsor class: OTHER
First posted: 2011-08-01
Enrollment: 203
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Although endoscopic colonic polypectomy has been an established procedure for two decades, the risk of bleeding is still higher after resecting of pedunculated polyps, because of the presence of a large artery in the stalk. Several preventive methods such as detachable snare and adrenaline injection have been proposed in the management of postpolypectomy bleeding in large colonic polyps. For prophylactic clip, there was no prospective randomized study assessing the efficacy in the prevention of postpolypectomy bleeding for the large pedunculated polyps. So we designed a prospective, randomized study to compares the efficacy of application of prophylactic clip and detachable snare in the prevention of postpolypectomy bleeding in large polyps. Application of prophylactic clip will be as effective and safe method as detachable snare in the prevention of postpolypectomy bleeding for the large pedunculated colonic polyps.


Eligibility criteria: Inclusion Criteria:

* Patients with pedunculated colorectal polyps, the heads of which were larger than 10mm and the stalk of which were large than 5 mm in diameter, were included.

Exclusion Criteria:

* bleeding tendency
* poor preparation
* sessile polyp

Primary outcomes:
measure: Postpolypectomy bleeding
timeFrame: Immediate (bleeding occurring immediately after polypectomy and lasting for 30 s or more) and delayed bleeding complications were assessed. Delayed bleeding was subdivide into early (<24 h) and late (>24 h-30 days).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Ji JS, Lee SW, Kim TH, Cho YS, Kim HK, Lee KM, Kim SW, Choi H. Comparison of prophylactic clip and endoloop application for the prevention of postpolypectomy bleeding in pedunculated colonic polyps: a prospective, randomized, multicenter study. Endoscopy. 2014 Jul;46(7):598-604. doi: 10.1055/s-0034-1365515. Epub 2014 May 15.
Clinical trial NCT02777879: Lung Microbiome and Inflammation in Early COPD
Official title: Lung Microbiome and Inflammation in Early Chronic Obstructive Pulmonary Disease (COPD)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Obstuctive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease (COPD)
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-05-19
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Utilizing cohorts built at NYU over the last several years, this project is uniquely positioned to investigate the microbiome signatures among subjects with COPD.

Brief summary: This is a cross sectional case controlled study to assess lung microbiome and inflammation in smokers with and without Chronic Obstructive Pulmonary Disease (COPD). Investigators will look at active bacterial metabolic pathways in the lower airways using metagenomic and metabolomic approaches an assess relationships among microbiome, metagenome, metabolome and host immune responses in COPD and controls. Investigators believe COPD cases will have higher prevalence of pneumotype supraglottic predominant taxa (SPT) than matched controls.


Eligibility criteria: Inclusion Criteria:

* Case definition: Smokers (\>20 pack-year) with airflow obstruction (FEV1/FVC\<70) and FEV1\>50% predicted (early COPD GOLD 1 or 2)
* Control definition: Smokers with normal spirometry will serve as controls.

Exclusion Criteria:

* FEV1 \< 50% NOT 70
* Significant cardiovascular disease defined as abnormal EKG, known or suspected coronary artery disease or congestive heart failure.
* Diabetes mellitus
* Significant liver or renal disease
* Severe coagulopathy (INR \> 1.4, PTT \> 40 seconds and platelet count \< 150x103 cells).
* Pregnancy
* ETOH use of more than \>6 beers or \>4 mixed drinks daily
* Lack of capacity to provide informed consent.
* Antibiotic use within the prior 2months

Primary outcomes:
measure: Site specific microbiome (supraglotic area) constituents using background subtraction and source tracking approaches via a multivariable conditional logistic regression model. following broncho-alveolar lavage, BAL
timeFrame: 4 Hours
Secondary outcomes:
measure: Bacterial metabolic pathways in the lower airways using metagenomic and metabolomic approaches
timeFrame: 4 Hours
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University School of Medicine
state: New York
Study officials:
affiliation: New York University Medical School
name: Leopoldo Segal, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04812379: Specified Drug-use Survey on Abilify Prolonged Release Aqueous Suspension for IM Injection (Prevention of Relapse of Mood Episodes in BP)
Official title: Abilify Prolonged Release Aqueous Suspension for Intramuscular Injection Specified Drug-use Results Survey (Prevention of Recurrence/relapse of Mood Episodes in Bipolar I Disorder)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Bipolar Disorder I
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2021-03-23
Enrollment: 535
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 in Japan with bipolar I disorder who are planned to be newly started on Abilify prolonged release aqueous suspension for IM injection, switching from oral aripiprazole for the purpose of prevention of recurrence/relapse of mood episodes

Brief summary: To investigate the safety for an observation period of 52 weeks with use of Abilify prolonged release aqueous suspension for intramuscular (IM) injection in patients with bipolar I disorder for prevention of recurrence/relapse of mood episodes in the routine clinical setting. The early stage safety after the switching from oral aripiprazole to this IM injection is investigated including extrapyramidal syndrome and malignant syndrome. Information regarding efficacy is collected as well.


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* patients with a known hypersensitivity to aripiprazole

Primary outcomes:
measure: Safety Information (Adverse Event)
timeFrame: 52 weeks from the start date of Abilify prolonged release aqueous suspension for IM injection therapy
measure: Number of Special Situations (e.g. Maternal (pregnancy and breastfeeding) exposure, paternal (via semen) exposure or Overdose/Incorrect dosage)
timeFrame: 52 weeks from the start date of Abilify prolonged release aqueous suspension for IM injection therapy
measure: Number of off-Label Use
timeFrame: 52 weeks from the start date of Abilify prolonged release aqueous suspension for IM injection therapy
measure: Incidence of Serious Adverse Event (e.g. resulting in death or life-threatening)
timeFrame: 52 weeks from the start date of Abilify prolonged release aqueous suspension for IM injection therapy
measure: Incidence of Non-serious Adverse Events (i.e. all Adverse Events that do not meet the definition of a serious Adverse Event)
timeFrame: 52 weeks from the start date of Abilify prolonged release aqueous suspension for IM injection therapy
Secondary outcomes:
measure: Number of patients who recurrence/relapse of Mood Episodes
timeFrame: 52 weeks from the start date of Abilify prolonged release aqueous suspension for IM injection therapy
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Pharmacovigilance Department
Study officials:
affiliation: Otsuka Pharmaceutical Co., Ltd.
name: Yasuhiko Fukuta, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04398979: Surgical Ablation for Atrial Fibrillation
Official title: Minimally Invasive Surgical Ablation for Standalone Atrial Fibrillation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2020-05-22
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with symptomatic, drug-resistant, stand-alone, paroxysmal, persistent or long-standing persistent atrial fibrillation

Brief summary: Minimally invasive approaches for surgical treatment have been advocated as a treatment option for stand-alone atrial fibrillation (AF). This study will investigate the clinical outcomes after minimally invasive surgical ablation of both paroxysmal and persistent/longstanding persistent AF.

Detailed description: Atrial fibrillation (AF) patients with a previous stroke are often at a high risk of recurrent stroke and bleeding. Minimally invasive approaches for surgical treatment have been advocated as a treatment option for stand-alone AF. This study will investigate the clinical outcomes after minimally invasive surgical ablation of both paroxysmal and persistent/longstanding persistent AF. Neurological safety will be assessed by cerebral magnetic resonance, neuropsychological examination and periprocedural transcranial Doppler measurement.

Eligibility criteria: Inclusion Criteria:

* Patients age \> 18 years
* Patients with paroxysmal, or persistent/long-standing persistent AF according to the standard EHRA definition.
* Patients with symptomatic AF that is refractory to at least one antiarrhythmic medication.
* Absence of significant structural heart disease (dilated cardiomyopathy, hypertrophic cardiomyopathy, valvular heart disease, untreated coronary artery disease)

Exclusion Criteria:

* AF secondary to a reversible cause (i.e., thyreopathy, etc.) Indication for open-heart surgery (coronary artery bypass grafting, valve surgery, etc.)
* Severe left ventricle dysfunction that is clearly caused by some other cardiac disease (dilated cardiomyopathy, ischaemic heart disease, etc.) where the AF is clearly of secondary etiology
* Known severe pericardial and pleural adhesions (e.g., history of cardiac surgery)

Primary outcomes:
measure: efficacy - sinus rhythm
timeFrame: 1 year
Secondary outcomes:
measure: periprocedural complications - surgery
timeFrame: 30 days after surgery
Other outcomes:
Locations:
Study officials:
References:
citation: Tanaka K, Koga M, Lee KJ, Kim BJ, Park EL, Lee J, Mizoguchi T, Yoshimura S, Cha JK, Lee BC, Nakahara J, Suzuki N, Bae HJ, Toyoda K; CRCS-K Investigators and the SAMURAI Study Investigators. Atrial Fibrillation-Associated Ischemic Stroke Patients With Prior Anticoagulation Have Higher Risk for Recurrent Stroke. Stroke. 2020 Apr;51(4):1150-1157. doi: 10.1161/STROKEAHA.119.027275. Epub 2020 Feb 26.
Clinical trial NCT00874679: REPEAT - Real-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra Therapy
Official title: REal-Life Perception of Efficacy, Attitude, Satisfaction and Safety of Levitra® Therapy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Erectile Dysfunction
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-04-02
Enrollment: 7293
Sex: MALE
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 with diagnosis of erectile dysfunction who get vardenafil in routine treatment

Brief summary: The aim of this prospective, non-interventional post-marketing surveillance study is to obtain data on safety and efficacy of Levitra in routine treatment of erectile dysfunction. Furthermore, the data collection particularly focuses on the experience of the patient and his satisfaction with the treatment. Treatment naive patients as well as pre-treated patients will be included in the study.The maximum observation period per patient is 12 months.Besides the physician's documentation, the patient should fill out a questionnaire at every visit. The questionnaires will be handed out and collected by the physician. Furthermore, an additional questionnaire for the patient's partner can be distributed at each visit in case the partner is willing to participate.


Eligibility criteria: Inclusion Criteria:

* Outpatients with diagnosis of erectile dysfunction, decision taken by the investigator to prescribe Vardenafil.

Exclusion Criteria:

* Exclusion criteria must be read in conjunction with the local product information. All contraindications listed in the local product information are applicable.

Primary outcomes:
measure: Physician's assessment of safety (incidence of adverse events)
timeFrame: During observation period
Secondary outcomes:
measure: Severity of ED symptoms
timeFrame: End of study
measure: General quality of partnership as assessed by patient
timeFrame: Initial visit and after 3, 6, 9 and 12 months
measure: General quality of partnership as assessed by partner
timeFrame: Initial visit and after 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: Many Locations
country: China
city: Many Locations
country: Croatia
city: Many Locations
country: France
city: Many Locations
country: Germany
city: Many Locations
country: Hungary
city: Many Locations
country: Indonesia
city: Many Locations
country: Korea, Republic of
city: Many Locations
country: Malaysia
city: Many Locations
country: Poland
city: Many Locations
country: Saudi Arabia
city: Many Locations
country: Singapore
city: Many Locations
country: South Africa
city: Many Locations
country: Spain
city: Many Locations
country: Sweden
city: Many Locations
country: Thailand
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01939379: Adductor Canal Nerve Block Following Total Knee Arthroplasty
Official title: Adductor Canal Nerve Block Following Total Knee Arthroplasty: A Randomized, Prospective Study Comparing High vs. Low Volume Bolus of 0.33% Ropivacaine
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Post-op Pain
Keywords: Total knee arthroplasty
nerve block
Pain control after surgery
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2013-09-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is that an adductor canal nerve block (putting numbing medicine near the nerve) has been shown to produce excellent pain relief with less pain medication use after knee replacement surgery.The investigators will be comparing the amount of pain relief following knee replacement surgery when you have a nerve block in place. There will be approximately 66 subjects participating in this study. After surgery subjects will receive numbing medication every 6 hours for 48 hours. Subjects will also receive a morphine PCA (patient controlled analgesia) after surgery and pain medication by mouth every 4 hours around the clock with the option to receive more pain medication if needed. Subjects will participate in the study up to 3 days.


Eligibility criteria: Inclusion Criteria:

1. Is the subject undergoing primary unilateral total knee arthroplasty?
2. Is the subject 18 to 99 years of age?
3. Is the subject ASA class 1, 2, or 3?
4. Does the subject have a BMI less than 35?
5. Can the subject consent in the English language?

Exclusion Criteria:

1. Does subject have an allergy to drugs used in this study;
2. Does subject have a daily intake of opiate medications that are considered stronger than hydrocodone?
3. Does subject have a history of alcohol or drug abuse
4. Has subject had a previous total knee arthroplasty?
5. Has subject had any neurologic deficits in the lower extremity being studied?

Primary outcomes:
measure: Total Opiate pain medication
timeFrame: The total amount of opiate pain medication will be recorded at 6 hour intervals for 48 hours after surgery.
Secondary outcomes:
measure: Patient satisfaction with pain control
timeFrame: We will look at the secondary outcome measure beginning every six hours for 48 hours after surgery
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center East Campus Hospital
state: California
Study officials:
References:
Clinical trial NCT03026179: Education of Parents About Discipline in a Way That is Culturally Sensitive
Official title: Education of Parents About Discipline in a Way That is Culturally Sensitive
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Violence
Parenting
Lead sponsor: Vanderbilt University Medical Center
Sponsor class: OTHER
First posted: 2017-01-20
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: To determine if a brief primary care intervention can educate under-resourced and minority parents about discipline in a way that is culturally sensitive.


Eligibility criteria: Inclusion Criteria:

* Parents presenting with their children to a pediatric clinic.

Exclusion Criteria:

-

Primary outcomes:
measure: Cultural Sensitivity
timeFrame: baseline
Secondary outcomes:
measure: Changes in discipline questionnaire
timeFrame: baseline
Other outcomes:
measure: Spanking questionnaire
timeFrame: baseline
Locations:
Study officials:
affiliation: Vanderbilt University
name: Seth Scholer, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00920179: Confocal Microscopy and Lacrimal Gland in Sjogren's Syndrome
Official title: The Application of In Vivo Confocal Scanning Laser Microscopy in the Evaluation of the Secretory Glands in Patients With Sjögren's Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Primary Sjogren's Syndrome
Keywords: dry eye, in vivo confocal microscopy, inflammation, acinar unit density, lacrimal gland
Lead sponsor: Keio University
Sponsor class: OTHER
First posted: 2009-06-15
Enrollment: 30
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with primary SS and healthy controls

Brief summary: Traditional methodological clinical and instrumental diagnostics of the lacrimal gland for the study of glandular architecture and functions are limited and include analysis of tear constituents, evaluation of apparent diffusion coefficients in magnetic resonance imaging and histopathological evaluation of lacrimal gland biopsy specimens. Confocal microscopy is a new emerging technology which is useful as a supplementary diagnostic tool for in vivo assessment of anterior-segment disorders.The use of in vivo confocal microscopy in a comparative study of the microscopic morphology of the salivary/lacrimal glands have not been reported up to date. In this study, we employ laser scanning confocal microscopy to evaluate the morphological changes of the salivary/lacrimal glands in patients with primary Sjögren's syndrome and compare the results with those of healthy control subjects.


Eligibility criteria: Inclusion Criteria:

* The Sjögren's syndrome diagnosis was made according to the revised American-European consensus criteria.
* Briefly, the patients had to have ocular and oral symptoms of dryness,
* clinically diagnosed dry eye and dry mouth disease,
* serum rheumatoid factor and antinuclear antibody levels ≥1:160,
* positive serology for anti SS-A or anti SS-B antibodies,
* labial salivary gland inflammatory infiltration focus score ≥2 and consents for lacrimal gland biopsy to be included into this study.

Exclusion Criteria:

* Patients with any history of ocular surgery including punctal occlusion,
* other ocular or systemic disease
* or a history of topical/ systemic drug use or contact lens wear or
* other systemic disorders that would cause dry eyes or that would alter the ocular surface.

Primary outcomes:
measure: Inflammatory cell density
timeFrame: 1.5 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Keio University School of Medicine
Study officials:
affiliation: Keio University
name: Kazuo Tsubota, Professor
role: STUDY_DIRECTOR
References: