louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00635115: The VEPRO Trial: A Cross-Over Randomised Controlled Trial Comparing 2 Corrective Lenses for Patients With Presbyopia
Official title: The VEPRO Trial: A Cross-Over Randomised Controlled Trial Comparing 2 Corrective Lenses for Patients With Presbyopia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Presbyopia
Lead sponsor: Santéclair
Sponsor class: OTHER
First posted: 2008-03-13
Enrollment: 127
Sex: ALL
Minimum age (years): 43
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The VEPRO trial is a cross-over randomised controlled trial comparing 2 corrective lenses for patients with presbyopia. The aim of the study is to compare the effectiveness of two corrective lenses: an old generation (Varilux Comfort Orma Crizal) and a new generation (Varilux Panamic Orma Crizal) of corrective lenses prescribed in presbyopia.


Eligibility criteria: Inclusion Criteria:

* age 43 to 60 years old
* outpatients wearing corrective lenses for presbyopia, referred to an optician within the last 6 months for a change in their optical correction
* associated hyperopia or astigmatism, the required correction had to be ≤ 3 dioptres in that case
* understanding, speaking French and able to answer a questionnaire

Exclusion Criteria:

* first prescription of corrective lenses for presbyopia
* associated strabism
* associated amblyopia
* orthoptics therapy
* associated anisometropia \> 1.5 dioptres
* patients treated for diabetes

Primary outcomes:
measure: patient preference for a corrective lens
timeFrame: 8 weeks
Secondary outcomes:
measure: subjective measures of different areas of visual performance.
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Paris
country: France
facility: INSERM, U738, Paris, France ; Université Paris 7 Denis Diderot, UFR de Médecine, Paris, France ; AP-HP, Hôpital Bichat, Département d'Epidémiologie, Biostatistique et Recherche Clinique
Study officials:
References:
citation: Boutron I, Touizer C, Pitrou I, Roy C, Ravaud P. The VEPRO trial: a cross-over randomised controlled trial comparing 2 progressive lenses for patients with presbyopia. Trials. 2008 Sep 19;9:54. doi: 10.1186/1745-6215-9-54.
Clinical trial NCT05703815: EpCAM and p53 Expressions in Infiltrating Duct Carcinoma of the Breast
Official title: EpCAM and p53 Expressions in Infiltrating Duct Carcinoma of the Breast and Their Association With the Clinicopathological Prognostic Paremeters
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Invasive Breast Cancer
Keywords: EpCAM, P53 , IDC
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-01-30
Enrollment: 40
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: formalin-fixed and paraffin embedded tissue blocks from 40 patients with breast cancer

Brief summary: Breast cancer represents the most frequently diagnosed cancer in women. It represents the 5th leading cause of cancer mortality all over the world.

In Egypt, breast cancer represents the 2nd most diagnosed cancer among all population. But among Egyptian females it represents the 1st diagnosed cancer representing 32.4%.

The main cause of death in breast cancer patients is tumor metastasis. Although only 5-10% of recently diagnosed breast cancer cases show metastasis to distant sites, but still there is a high risk for metastasis in patients with localized primary tumor following successful surgical management.

Epithelial cell adhesion molecule (EpCAM) is a cell adhesion molecule. It modifies cadherin mediated cell adhesion and it induces epithelial cell migration and proliferation. Some authors elucidate that EpCAM is involved in metastasis.

P53 is a known tumor suppressor gene involved in the control of cell cycle, DNA repair and apoptosis. It's one of the most mutated genes in cancer including breast cancer. Mutant p53 has a big role in tumor progression.


Eligibility criteria: Inclusion Criteria:

- Both incisional and excisional biopsy specimens. 2. All the studied cases include sufficient materials for the immunohistochemical study.

3. Complete clinical data.

Exclusion Criteria:

1. Patients with recurrence of the primary tumor.
2. Patients with a history of preoperative chemotherapy and/or radiotherapy.
3. Insufficient or tiny tissue biopsies

Primary outcomes:
measure: Diagnosis of breast cancer
timeFrame: two day after staining sections with Immnnohistochemical markers
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Sohag University
name: Rasha M Abdelkareem
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05064215: Lymphatic Drainage of the Breast, a Retrospective Assessment of Data
Official title: Lymphatic Drainage of the Breast, a Retrospective Assessment of Data
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lymph Drainage of Breast
Lead sponsor: Wilhelminenspital Vienna
Sponsor class: OTHER
First posted: 2021-10-01
Enrollment: 14
Sex: FEMALE
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients, who were operated on breast reduction

Brief summary: retrospective evaluation of patients, in whom blue colour was injected into different sites of the breast before breast reduction, to investigate direction and localisation of lymphatic flow. Investigations were performed at the Wilhelminenspital, Vienna, in the years 1998 to 2009.


Eligibility criteria: Inclusion Criteria: Patients, who understood and supported the aim of the study and signed the written consent -

Exclusion Criteria: language barriers, patients, who did not understand and support the aim of the study

-

Primary outcomes:
measure: Lymphatic flow is guided by the ligamentous suspension
timeFrame: The ligamentous suspension (horizontal septum, vertical ligaments merging into superficial fascia) is exposed in the course of breast reduction in the technique, that I described usually within about 40 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Wien
country: Austria
facility: Elisabeth Wuringer
state: Österreich
Study officials:
affiliation: Dr. Elisabeth Würinger
name: Elisabeth Würinger
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02078115: Assessment of Blood Pressure Control and Target Organ Damage in Patients With Chronic Kidney Disease and Hypertension -II
Official title: Observational Study of Blood Pressure Control Pattern and the Impact on the Target Organ Damages
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Kidney Disease
Hypertension
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-03-05
Enrollment: 400
Sex: ALL
Minimum age (years): 20
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chronic kidney disease patients with hypertension

Brief summary: The purpose of this study is to find the change of blood pressure (BP) control pattern (true controlled, white-coat, masked, and sustained uncontrolled/ dipper, non-dipper, reverse-dipper, and extreme-dipper) in patients with chronic kidney disease (CKD) over 3 years. And Other objective is the relationship between the BP control pattern and the target organ damages such as renal function, proteinuria, left ventricular hypertrophy (LVH), and so on. In addition, we will find clinical factors related to the BP control pattern.


Eligibility criteria: Inclusion Criteria:

1. with informed consent
2. 20 \<= age \< 75 years
3. diagnosed as hypertension 6 months (or 3 visits) prior to enrollment, taking anti-hypertensive drugs over 3 months
4. all-cause chronic kidney disease patients with 15 \<= estimated GFR \< 90
5. no change of anti-hypertensive drugs within 2 weeks and good compliance

Exclusion Criteria:

1. changed prescription according to ambulatory blood pressure monitoring (ABPM) regularly
2. had acute kidney injury/hospitalization
3. had a proteinuria of \> 6 g/day (spot urine protein to creatinine ratio \> 6.0 g/g Cr)
4. had end stage renal disease (ESRD) with dialysis and/or were a kidney recipient
5. had diseases, such as uncontrolled arrhythmia, uncontrolled bronchial asthma/chronic obstructive pulmonary disease, or primary endocrinologic diseases except diabetes mellitus
6. were pregnant/lactating women
7. were night shift workers.

Primary outcomes:
measure: The change of blood pressure control pattern in patients with CKD
timeFrame: 1 year after enrolling the last participant
Secondary outcomes:
measure: 1) target organ damages in kidney and heart
timeFrame: 1 year after enrolling the last participant
measure: 2) the relationship between the change of BP control pattern and the target organ damages
timeFrame: 1 year after enrolling the last participant
measure: 3) assessment of related clinical factors with BP control pattern
timeFrame: 1 year after enrolling the last participant
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Hallym University Hospital
name: Sung Kyun Kim, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00973115: Efficacy and Safety of Morning Versus Evening Intake of Simvast Controlled Release (CR) Tablet in Patients With Hyperlipidemia
Official title: Efficacy and Safety of Morning Versus Evening Intake of Simvast CR Tablet in Patients With Hyperlipidemia: A Randomized, Double-blind, Multicenter Phase 3 Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Hyperlipidemia
Lead sponsor: Hanmi Pharmaceutical Company Limited
Sponsor class: INDUSTRY
First posted: 2009-09-09
Enrollment: 132
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
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 evaluate the efficacy and safety of morning versus evening intake of Simvastatin Controlled Release tablet 20mg for 8 weeks in patients with hyperlipidemia. This study will investigate equivalence of the low-density lipoprotein(LDL) cholesterol percent change.


Eligibility criteria: Inclusion Criteria:

* Aged between 19 and 75
* Defined as a fasting 100mg/dl≤ LDL cholesterol \<220mg/dl and triglyceride level\<400 mg/dl
* Need drug therapy by NCEP ATP III guideline
* Signed informed consent

Exclusion Criteria:

* Has a hypersensitivity to HMG-CoA reductase inhibitor or simvastatin
* Has a presence or history of alcohol abuse or drug abuse
* Active gallbladder disease within 12 months
* Pancreatitis or Hepatic dysfunction (ALT or AST levels \> 2XUNL)
* HbA1c≥ 9% in type 2 diabetes mellitus patients
* SBP \< 90mmHg or \> 160mmHg
* DBP \< 50mmHg or \> 100mmHg
* Myocardial infarction or revascularization procedure within 6 months
* Has significant cardiovascular disease
* Malignant tumor within 5years
* Has fibromyalgia, myopathy, rhabdomyolysis or acute myalgia
* Uric acid level \> 9 mg/dl
* Thyroid stimulating hormone ≥ 2XUNL
* Active peptic ulcer disease
* CPK levels \> 3XUNL
* creatinine level \> 2 mg/dl
* Negative pregnancy test for women of childbearing age and agreement to use contraception while on study
* Had participated other clinical trial within 4 weeks
* Need systemic administration of corticosteroids intermittently

Primary outcomes:
measure: the percent change from baseline in LDL cholesterol
timeFrame: week 8
Secondary outcomes:
measure: the change and the percent change from baseline for total cholesterol, HDL cholesterol, Triglyceride, apolipoprotein A-I, apolipoprotein B, and lipoprotein(a)
timeFrame: week 8
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: 8 Sites
Study officials:
affiliation: Ehwa Womans University Mokdong Hospital
name: Seong-Hoon Park, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06002815: Comparison of Nasogastric Tube Insertion Success in Difficult and Easy Airway Patients
Official title: Comparison of Nasogastric Tube Insertion Success in Difficult and Easy Airway Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation; Difficult or Failed
Lead sponsor: Taksim Egitim ve Arastirma Hastanesi
Sponsor class: OTHER_GOV
First posted: 2023-08-21
Enrollment: 244
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are scheduled for surgery for any reason and who will receive general anesthesia requiring perioperative nasogastric tube insertion will be included in the study.

Brief summary: This research aims to investigate potential variations in the success rate and occurrence of complications during nasogastric tube insertion between Difficult and Easy Airway Patients.

Detailed description: Patients who are scheduled for surgery for any reason and who will receive general anesthesia requiring perioperative nasogastric tube insertion will be included in the study. Two groups will be formed, the easy airway group and the difficult airway group. The main aim is to investigate whether there is a difference between the groups in terms of the success of insertion of the nasogastric tube (first attempt, second attempt etc.) and the duration of insertion. Investigating the differences between the groups in terms of complications such as bleeding, twisting in the mouth, kinking, and going to the trachea is determined as a secondary aim. At the end of the study, determining the correlation between the failure of nasogastric tube insertion and difficult airway parameters is planned as another secondary goal.

Eligibility criteria: Inclusion Criteria: Patients who are scheduled for surgery for any reason and who will receive general anesthesia requiring perioperative nasogastric tube insertion will be included in the study.

-

Exclusion Criteria:

* Patients under 18 year-old
* Patients who do not require nasogastric tube insertion
* Patients with anatomical changes in the head and neck region
* Patients without an informed consent form

Primary outcomes:
measure: Comparison of Nasogastric Tube Insertion in Difficult and Easy Airway Patients
timeFrame: 10 minutes
Secondary outcomes:
measure: Complications in Difficult and Easy Airway Patients
timeFrame: 5 minutes
measure: Airway parameters and failure of nasogastric tube insertion
timeFrame: 10 minutes
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Taksim Training and Research Hospital
state: Please Select
Study officials:
affiliation: Taksim Training and Research Hospital
name: Celal Kaya, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02797015: Pharmacokinetics and Pharmacodynamics Study of RPC1063 in RMS
Official title: A Phase I, Multicenter, Randomized, 12-Week, Open-Label Study to Evaluate the Multiple Dose Pharmacokinetics and Pharmacodynamics of RPC 1063 in Patients With Relapsing Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Sclerosis
Keywords: MS
RMS
Multiple Sclerosis
Relapsing Multiple Sclerosis
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2016-06-13
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of this study is to learn about the pharmacokinetics and pharmacodynamics of RPC1063 in RMS.

Detailed description: The purpose of this study is to characterize the full pharmacokinetic and pharmacodynamics profiles of RPC1063 in patients with relapsing multiple sclerosis (RMS) following multiple-dose administration of the two different dosing regimens that are being evaluated in the Phase 3 RMS studies.

Eligibility criteria: Key Inclusion Criteria:

* MS, as diagnosed by the revised 2010 McDonald criteria
* Exhibits a relapsing clinical course consistent with RMS and history of brain MRI lesions consistent with MS
* Expanded disability status scale (EDSS) score between 0 and 6.0

Key Exclusion Criteria:

* Primary progressive MS
* Clinically relevant cardiovascular conditions or other relevant diseases that could impact the implementation or interpretation of the trial, or put the patient at risk

Primary outcomes:
measure: Maximum plasma concentration (Cmax)
timeFrame: 24 hours after the last RPC1063 dose on Day 85
measure: Area under the plasma concentration-time curve (AUC)
timeFrame: Approximately 3 months
Secondary outcomes:
measure: Adverse Events
timeFrame: Up to 28 days after the last RPC1063 dose
measure: EDSS (Expanded Disability Status Scale)
timeFrame: Up to the last RPC1036 dose on Day 85
measure: Pharmacodynamic response measured in change from baseline in Absolute Lymphocyte Count
timeFrame: Up to 28 days after the last RPC1063 dose
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Breastlink Medical Group, Inc.
state: California
city: San Francisco
country: United States
facility: Multiple Sclerosis Center at UCSF
state: California
city: Raleigh
country: United States
facility: Raleigh Neurology Associates PA
state: North Carolina
city: Akron
country: United States
facility: Neurology and Neuroscience Associates Inc.
state: Ohio
city: Knoxville
country: United States
facility: Hope Neurology MS Center
state: Tennessee
city: Round Rock
country: United States
facility: Central Texas Neurology Consultants PA
state: Texas
Study officials:
References:
citation: Harris S, Tran JQ, Southworth H, Spencer CM, Cree BAC, Zamvil SS. Effect of the sphingosine-1-phosphate receptor modulator ozanimod on leukocyte subtypes in relapsing MS. Neurol Neuroimmunol Neuroinflamm. 2020 Jul 31;7(5):e839. doi: 10.1212/NXI.0000000000000839. Print 2020 Sep.
Clinical trial NCT01279915: A Safety and Pharmacokinetics Study of ASP0456 in Healthy Subjects
Official title: Phase I Study of ASP0456 - A Randomized, Double-blind, Placebo-controlled, Single Ascending Dose Study in Non-elderly Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Pharmacokinetics of ASP0456
Keywords: ASP0456
Pharmacokinetics
safety
tolerability
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2011-01-20
Enrollment: 32
Sex: MALE
Minimum age (years): 20
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: A study to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single ascending dose of ASP0456 in non-elderly healthy subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy, as judged by the investigator/subinvestigator based on the results of physical examination and all tests obtained
* Body weight (at screening); ≥50.0 kg,\<80.0 kg
* BMI(at screening): ≥17.6,\<26.4

Exclusion Criteria:

* Received any investigational drugs in other clinical or post-marketing studies within 120 days before the study
* Donated 400 mL of whole blood within 90 days, 200 mL of whole blood within 30 days, or blood components within 14 days before the study
* Received medication within 10 days before dose is administered or is scheduled to receive medication
* History of drug allergies
* Upper (e.g. nausea, vomiting, stomachache) and lower (e.g. abdominal pain) gastrointestinal disease within 7 days before the study
* Concurrent or previous hepatic disease
* Concurrent or previous heart disease
* Concurrent or previous renal disease

Primary outcomes:
measure: Pharmacokinetics of ASP0456 assessed by its plasma concentration change
timeFrame: For 48 hours after dosing
Secondary outcomes:
measure: Safety assessed by the incidence of adverse events, vital signs, 12-lead ECGs and labo tests
timeFrame: For 48 hours after dosing
Other outcomes:
Locations:
city: Kantou
country: Japan
Study officials:
affiliation: Astellas Pharma Inc
name: Use Central Contact
role: STUDY_CHAIR
References:
Clinical trial NCT05462015: Elastic Band Resistance Training on Physical Fitness and Risk of Falls in Elderly.
Official title: Effects of Elastic Band Resistance Training on Physical Fitness and Risk of Falls in Old Adults With Hospitalized and High Fall Risk.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Falls
Old Age; Debility
Hospitalisation
Resistance Training
Physical Fitness
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2022-07-18
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A lack of studies has applied elastic band resistance training exercises on hospitalized elderly, so the effect of elastic band resistance training exercises on physical fitness and risk of falls was unclear. Therefore, the purposes of this study were to investigate the effectiveness of elastic band resistance training on improving physical fitness and reducing the risk of falls in hospitalized elderly with high risk of falls. This study is an experimental study. The experimental group was given 3 times a week for 2 consecutive weeks of elastic band resistance training, while the control group was given regular rehabilitation exercises. The differences in physical fitness and fall risk between the two groups were examined.


Eligibility criteria: Inclusion Criteria:

1. Elders are over 65 years old and admitted to this medical ward due to acute/chronic disease
2. Elders have no physical impairment
3. Elders have a clear cognition, can follow movement commands in Chinese or Taiwanese
4. Elders have greater than 4 points in lower extremity muscle strength measured by the Manual Muscle Power Test
5. Elders have greater than 45 points in the Morse Fall Scale, which indicate a high risk of falling

Exclusion Criteria:

1. Unclear consciousness
2. Unable to follow the execution of elastic band resistance training
3. With restricted activities, musculoskeletal disorders, or nerve diseases
4. Unsuitable athletic trainers

Primary outcomes:
measure: Functional Fitness Test
timeFrame: first day
measure: Functional Fitness Test
timeFrame: one week
measure: Functional Fitness Test
timeFrame: completed through training, usually two weeks
measure: Tw-FROP-Com
timeFrame: first day
measure: Tw-FROP-Com
timeFrame: completed through training, usually two weeks
measure: Tw-FROP-Com
timeFrame: one week
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: