louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02676557: The Lamina Cribrosa (LC) Changes in the Eyes After Laser-Assisted in Situ Keratomileusis (LASIK)
Official title: The Lamina Cribrosa (LC) Morphologic Changes in the Eyes After Laser-Assisted in Situ Keratomileusis (LASIK)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Lamina Cribrosa and Optic Nerve Head Changes
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2016-02-08
Enrollment: 40
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: The myopic patients who were supposed to undergo LASIK surgery

Brief summary: The burden of LASIK surgery on optic nerve head (ONH) has been controversial. Until now, the change of retinal nerve fiber layer (RNFL) thickness was used as the indicator of the study. In the present study, the investigators intended to investigate whether the changes of the deep and superficial structures around ONH exist or not using EDI OCT.


Eligibility criteria: Inclusion Criteria:

* the myopic patients who were supposed to undergo LASIK surgery in the Samsung Medical Center

Exclusion Criteria:

* Optic nerve head abnormalities at preoperative examination
* Previous ocular surgical history

Primary outcomes:
measure: Change of lamina cribrosa (LC) depth
timeFrame: before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months
measure: Change of lamina cribrosa (LC) thickness
timeFrame: before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months
measure: Change of optic nerve head (ONH) width
timeFrame: before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months
Secondary outcomes:
measure: Change of optic nerve head minimum rim width
timeFrame: before the surgery, postoperative 1 day, 1 week, 1 month, and 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00005257: Diet and Plasma Cholesterol - Secular Trend Analysis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiovascular Diseases
Heart Diseases
Coronary Disease
Hypercholesterolemia
Lead sponsor: National Heart, Lung, and Blood Institute (NHLBI)
Sponsor class: NIH
First posted: 2000-05-26
Sex: MALE
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: To define the role of dietary variables on changes in plasma cholesterol levels over time in the Framingham cohort and the Framingham Offspring cohort.

Detailed description: BACKGROUND:

Mortality from coronary heart disease has declined over 40 percent since the late 1960s. Possible explanations for the decline include the observed trends in risk factors such as changes in rates of hypertension, dyslipidemia, and glucose intolerance; lifestyle changes such as improvements in diet and decreases in the levels of cigarette smoking; and better detection and treatment of heart disease. The specific effects of risk factor, lifestyle, or detection and treatment changes on the declining population rates of coronary heart disease morbidity and mortality were unknown in 1990. Secular trend analyses were needed to elucidate the relative contribution of these factors, particularly dietary variables, on population rates of coronary heart disease.

DESIGN NARRATIVE:

Multiple regression was used to assess the effect of dietary variables on changes in serum cholesterol between 1957-1960 and 1966-1969 in a sample of 200 men for whom repeated measurements existed in the Framingham cohort. Analysis of covariance was used to assess influence of dietary intake on differences in serum cholesterol levels between independent samples of men studied in 1957-1960 and 1966-1969 in the Framingham cohort, and independent samples of women studied between 1957-1960 and 1984-1988 in the Framingham cohort and Offspring cohort, and independent samples of men studied between 1966-1969 and 1984-1988 in the Framingham cohort and Offspring cohorts respectively.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility criteria: No eligibility criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Boston University
name: Barbara Posner
References:
citation: Campos H, Willett WC, Peterson RM, Siles X, Bailey SM, Wilson PW, Posner BM, Ordovas JM, Schaefer EJ. Nutrient intake comparisons between Framingham and rural and Urban Puriscal, Costa Rica. Associations with lipoproteins, apolipoproteins, and low density lipoprotein particle size. Arterioscler Thromb. 1991 Jul-Aug;11(4):1089-99. doi: 10.1161/01.atv.11.4.1089.
citation: Posner BM, Franz MM, Quatromoni PA, Gagnon DR, Sytkowski PA, D'Agostino RB, Cupples LA. Secular trends in diet and risk factors for cardiovascular disease: the Framingham Study. J Am Diet Assoc. 1995 Feb;95(2):171-9. doi: 10.1016/S0002-8223(95)00043-7.
Clinical trial NCT00775957: Assessment of Hematopoietic Recovery Following Chemotherapy for Non-Hodgkin's Lymphoma
Official title: Assessment of Hematopoietic Recovery Following Chemotherapy for Non-Hodgknin's Lymphoma
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Non-Hodgkin's Lymphoma
Lead sponsor: University of Oklahoma
Sponsor class: OTHER
Collaborators: name: Midwest Medical Isotopes
First posted: 2008-10-20
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects diagnosed with lymphoma and are about to start treatment with chemotherapy

Brief summary: A study to determine the accuracy of FLT-PET in quantifying tumor cell proliferation at the initial staging of patients with Non-Hodgkin's Lymphoma in comparison wit the "gold standard" FDG-PET.

Detailed description: The first primary objective reflects a necessary and preliminary requirement: to reproduce published results and validate the use of FLT-PET. In this study, 35 patients will be selected to undergoing imaging with both FLT and FDG PET.

Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Women must not be pregnant or breast feeding
* Histologic diagnosis of non-Hodgkin's lymphoma (any stage)
* Must undergo treatment with chemotherapy and/or radiotherapy

Exclusion Criteria:

* May not have received previous therapy with radiopharmaceuticals
* May not have received prior therapy with cytotoxic chemotherapy and/or monoclonal antibodies

Primary outcomes:
measure: Staging and ReStaging scans
timeFrame: after hematopoetic recovery
Secondary outcomes:
Other outcomes:
Locations:
city: Oklahoma City
country: United States
facility: University of Oklahoma Health Sciences Center
state: Oklahoma
Study officials:
References:
Clinical trial NCT01571557: A Safety and Efficacy Study to Assess OZURDEX® in Patients With Macular Oedema Secondary to Retinal Vein Occlusion (RVO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Edema
Retinal Vein Occlusion
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2012-04-05
Enrollment: 573
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with macular oedema due to retinal vein occlusion

Brief summary: This study will evaluate the relationship between time since onset of macular oedema symptoms and the achievement of vision gain in patients prescribed OZURDEX®. All care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and local standard of medical care.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of macular edema following retinal vein occlusion
* Prescribed OZURDEX®

Exclusion Criteria:

* Previous treatment with OZURDEX®

Primary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye
timeFrame: Baseline, Week 12
Secondary outcomes:
measure: Percentage of Patients With an Increase of ≥2 Lines From Baseline BCVA in the Study Eye
timeFrame: Baseline, 48 Weeks
measure: Percentage of Patients With an Increase of ≥3 Lines From Baseline BCVA in the Study Eye
timeFrame: Baseline, 48 Weeks
measure: Mean Change From Baseline in Central Retinal Thickness
timeFrame: Baseline, Week 24
Other outcomes:
Locations:
city: Berlin
country: Germany
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Augustin AJ, Holz FG, Haritoglou C, Mayer WJ, Bopp S, Scheuerle AF, Maier M, Sekundo W, Sandner D, Shirlaw A, Hattenbach LO. Retrospective, observational study in patients receiving a dexamethasone intravitreal implant 0.7 mg for macular oedema secondary to retinal vein occlusion. Ophthalmologica. 2015;233(1):18-26. doi: 10.1159/000368840. Epub 2014 Dec 5.
Clinical trial NCT01203657: UCLA Tai Chi in a Community Setting Study
Official title: Tai Chi, Vitality and Activity in a Community Setting
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Physical Activity
Fatigue
Keywords: exercise
physical activity
tai chi
Lead sponsor: University of California, Los Angeles
Sponsor class: OTHER
First posted: 2010-09-16
Enrollment: 47
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: Although a number of studies have examined the effects of Tai Chi in older adult populations, few have methodically assessed its effects on vitality, fatigue and physical activity. Some studies have shown that fatigue relates to negative mood and poor health-related quality of life in older persons.

Tai Chi is an ancient Chinese form of calisthenics that utilizes the body's internal energy (chi), mind, and breathing; which may be a useful exercise for older adults in increasing their activity level. A twenty-four of Yang style of Tai Chi is a simple form of Tai Chi that is particularly well-suited for older adults. This proposed study to investigate the effects of a Tai Chi intervention on decreasing fatigue level, and increasing level of activity in healthy older adults.

The investigators research group has focused on the Tai Chi as a strategy to reduce stress and improve sleep, and their preliminary evidence suggest it strongly affects energy level and vitality. The investigators are focused on taking this intervention into the community testing its efficacy. The investigators preliminary data shows that Tai Chi is of benefit to older adults; however, this study will test whether their research findings are generalizable to community settings.

Tai Chi-naïve participants from Culver City Senior Center will receive a 10-week Tai Chi. The investigators will compare this group to a wait-list control group. All subjects will receive a packet of questionnaires of pre- and post-intervention vitality, fatigue and health-related quality of life. Subjects will also be given an activity monitor to wear for 2 days before they start the Tai Chi class and for 2 days after they complete the class, to determine if there is a change in general physical activity level.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Older adult \> 60 years of age

Exclusion Criteria:

* Older adults who have severe osteoarthritis or chronic pain disorders
* Non ambulatory
* Any condition that would adversely impact their participation in Tai Chi

Primary outcomes:
measure: Physical Activity
timeFrame: Immediately post-intervention (10 weeks)
Secondary outcomes:
measure: Vitality
timeFrame: Immediately post-intervention (10 weeks)
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA
state: California
Study officials:
affiliation: University of California, Los Angeles
name: Sarosh Motivala, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01498757: Genome-wide Association Study
Official title: Genome-wide Association Study to Predict Treatment Response for Chemotherapy in Esophageal Squamous Cell Carcinoma
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Esophageal Squamous Cell Carcinoma
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2011-12-23
Enrollment: 0
Sex: ALL
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: Esophageal squamous cell carcinoma Patients treated with Taxane/5-FU/platinum based chemotherapy.

Brief summary: To explore biomarkers predictive of clinical response to Taxane/5-FU/platinum based chemotherapy in esophageal squamous cell carcinoma. To identify negative predictive markers to 5-FU/platinum/Taxane. To elucidate signal transduction pathway attributable to 5-FU/platinum/Taxane resistance. To analyze correlation between the quantity of circulating tumor cells and circulating endothelial cell precursors and treatment response to Taxane/5-FU/platinum based chemotherapy.


Eligibility criteria: Inclusion Criteria:

* Histological confirmed esophageal squamous cell carcinoma
* Patients treated with Taxane or 5-FU or platinum based chemotherapy.
* provision of a signed written informed consent.

Exclusion Criteria:

* patients not signed written informed consent.
* patient unacceptable for study in the judgement of the investigator.

Primary outcomes:
measure: Biomarkers predictive
timeFrame: 24months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung medical Center
Study officials:
References:
Clinical trial NCT03499457: Penicillin Allergy in Shfayim Clinic
Official title: Penicillin Allergy in Shfayim Clinic
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Penicillin Allergy
Keywords: Penicillin Allergy
chalenge test
primary clinic
Lead sponsor: Clalit Health Services
Sponsor class: OTHER
First posted: 2018-04-17
Enrollment: 100
Sex: ALL
Minimum age (years): 5
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: revising penicillin allergy in the medical records, by taking full medical history and giving a challange test, in order to imrove the medical records and treatment possibilities.

Detailed description: issuing a list of patients with a title of penicillin allergy in their medical record. inviting these patients to an appointmnet with their family physician, in which a specific history will be take to evaluate the quality of the allergy.

patients with suscpition of a life threatening allergic reaction will be reffered to an allergy clinic for the challange test. the rest of the pateints will be given the test in the primary clinic: 1ml (50 grams) of amoxicillin, and an hour later a full dose of 500 mg amoxicillin.

after determining no allergic reaction develops the title will be erased from the medical record.

Eligibility criteria: Inclusion Criteria:

penicillin allergy in the medical record

Exclusion Criteria:

pregnancy lack of informed consent

Primary outcomes:
measure: immidiate urticarial reaction
timeFrame: with 2 hours of test
Secondary outcomes:
measure: rash
timeFrame: with 2 hours of test
Other outcomes:
Locations:
Study officials:
affiliation: Clalit Health Services
name: lital f goldberg, MD. MPH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04787757: Autonomous Robotics for Transcatheter Cardiac Procedures
Official title: Autonomous Robotics for Transcatheter dEliveRy sYstems
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Valve Disease
Heart Valve Diseases
Structural Heart Abnormality
Lead sponsor: Università Vita-Salute San Raffaele
Sponsor class: OTHER
Collaborators: name: Politecnico di Milano
name: Scuola Superiore di Studi Universitari e di Perfezionamento Sant'Anna
name: KU Leuven
name: SwissVortex
name: Artiness SRL
name: FBGS
name: IRCCS Ospedale San Raffaele
First posted: 2021-03-09
Enrollment: 401
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: Candidates to percutaneous cardiac defects repair

Brief summary: Cardiovascular diseases represent the most common cause of death worldwide. Percutaneous approaches with intravascular catheters are pivotal, since they allow to treat patients with high perioperative risks. However, catheter-based treatments require steep learning curves and are characterized by poor ergonomics and exposure to damaging radiation. ARTERY will offer a radiation-free approach based on shared-autonomy robotic catheters, with increased user engagement and easy interaction. Intraprocedural three-dimensional echocardiography as well as computed tomography images obtained during usual clinical practice will provide artificial intelligence algorithms that will turn catheter navigation to a simple task. Optical and electromagnetic sensing techniques will ensure a superior view upon the cardiovascular anatomy and will guide the autonomous catheter upon the interventionist supervision, who will be able to take over control at any instant.


Eligibility criteria: Inclusion Criteria:

* adult patients
* patients admitted to hospital undergoing percutaneous cardiac procedure
* patients able to give informed consent

Exclusion Criteria:

* age \<18 years
* refuse to give informed consent

Primary outcomes:
measure: Identification of key procedural elements that will benefit from the technological developments introduced by ARTERY by collecting intraprocedural images
timeFrame: Intraoperative period
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Università Vita-Salute San Raffaele
state: MI
Study officials:
References:
Clinical trial NCT00700557: Probiotics at the Treatment of Antibiotic Associated Diarrhea
Official title: Lactobacillus Casei e Bifidobacterium Breve as Probiotics at the Treatment of Antibiotic Associated Diarrhea: a Randomized Double Blind Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Antibiotic-Associated Diarrhea
Keywords: Antibiotic Associated Diarrhea
probiotics
treatment
Lead sponsor: Federal University of Uberlandia
Sponsor class: OTHER
First posted: 2008-06-18
Enrollment: 70
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 know the efficacy of the treatment with probiotics, Lactobacillus casei and Bifidobacterium breve, on clinical evidences and occurence of relapses on antibiotic-associated diarrhea.

Detailed description: The Antibiotic-Associated Diarrhea (AAD)is defined as that developed after the started antibiotic therapy ou until six to eight weeks after the end of the treatment. The occurence of AAD is about 5% to 25% of the patients using antibiotics and cause watery diarrhea, fever and vomit, mainly on pseudomembranous colitis. Several studies had demonstrated the use of probiotics as therapeutic or preventive form of AAD with or without the presence of C. difficile. About the tolerance of the probiotics,there weren´t observed deleterious effects on health with the consumption of 106 - 107 UFC of Lactobacillus spp and Bifidobacterium spp during a period of one year. The realization of this study can demonstrate the efficacy of Lactobacillus casei e Bifidobacterium breve at the treatment of AAD.

Eligibility criteria: Inclusion Criteria:

* Hospitalized patients with diarrhea using antibiotic during, at least, 24 hours or had used antibiotic 07 days prior to study entry.

Exclusion Criteria:

* Patients with chronic diarrhea, viral diarrhea, critical patients, during or after radio or chemiotherapy treatment,
* HIV infections,
* Ulcerative colitis,
* Crohn´s disease,
* Hydroelectrolytic disturbance,
* Small intestine syndrome,
* Colostomized, jejunostomized
* Lactose intolerance,
* Rapid enteral diet infusion (\>120mh/h),
* Hyperosmolar enteral diet.

Primary outcomes:
measure: Reduction of discharge numbers, change the consistency of the feces and occurence of relapses.
timeFrame: After 24 hours of the intervention started
Secondary outcomes:
Other outcomes:
Locations:
city: Uberlândia
country: Brazil
facility: Federal University of Uberlândia
state: MG
Study officials:
affiliation: Federal University of Uberlandia
name: Miguel T Jorge, Medicine
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04895657: Extended-infusion of Piperacillin-Tazobactam Versus Intermittent Infusion
Official title: Extended-infusion Piperacillin-Tazobactam Versus Intermittent-Infusion Dosing Strategy in Critically Ill Patients With Suspected or Confirmed Bacterial Infections.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Gram-Negative Infections
Keywords: Antibiotics
Beta-lactams
Continuous administration
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 56
Sex: ALL
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Continuous-infusion of piperacillin/tazobactam over 4 hrs instead of 30-minute intermittent dosage regimen has shown observable outcomes. Our objective is to assess whether continuous infusion of piperacillin/tazobactam is superior in terms of efficacy, safety and cost to the intermittent regimen to treat suspected or proved infections due to gram negative bacteria. The setting is Critical Care Medicine Department at Cairo University Hospitals. Methods A prospective randomized comparative study.

Detailed description: A total of 56 patients were recruited from ICU- Cairo University Hospitals. All adult critically ill patients admitted to Critical Care Medicine Department with suspected or confirmed bacterial infections on admission or during their ICU stay were assessed for inclusion into the study. All patients were subjected to the following: A. Patient's full history: Age, sex ,medical history ,concurrent diseases, concurrent medications

B. Patient evaluation and assessment:

The following were evaluated at baseline and periodically thereafter until day of stopping antibiotic, discharge and/or death :

1. Kidney functions (Serum creatinine, blood urea nitrogen)
2. Liver functions (ALT, AST, Bil D, Bil T, Albumin)
3. Complete blood count
4. Microbiological Evaluation: Cultures and sensitivity tests from suspected site of infection
5. Clinical signs and symptoms of infection documented by the attending physician on patient's medical record
6. APACHE II Variables

Eligibility criteria: Inclusion Criteria:

* Adults aged 18-74 years
* Expected ICU stay more than 24 hours

Exclusion Criteria:

* Allergy or potential allergy to the study medications

  * Pregnancy
  * Patients with CrCl\< 20 ml/min or on dialysis
  * Cancer patients

Primary outcomes:
measure: Clinical cure
timeFrame: ICU length of stay, assessed up to 30 days
measure: Total cost
timeFrame: ICU length of stay, assessed up to 30 days
Secondary outcomes:
measure: ICU Length of stay
timeFrame: ICU length of stay, assessed up to 30 days
measure: Mortality
timeFrame: ICU length of stay, assessed up to 30 days
measure: Readmission within 30- days
timeFrame: 30 days
measure: Adverse drug events
timeFrame: ICU length of stay, assessed up to 30 days
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo University Hospitals
Study officials:
References: