louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01084876: Demonstrate Efficacy and Safety of Metastatic Breast Cancer
Official title: A Double-blind, Randomised, Parallel Group, Phase III Study to Demonstrate Equivalent Efficacy and Comparable Safety of CT-P6 and Herceptin, Both in Combination With Paclitaxel, in Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Metastatic Breast Cancer
Keywords: Herceptin
metastatic breast cancer
CT-P6
Her 2-positive
Lead sponsor: Celltrion
Sponsor class: INDUSTRY
First posted: 2010-03-11
Enrollment: 475
Sex: FEMALE
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 the study is to demonstrate equivalence

Detailed description: Patients will receive CT-P6 or Herceptin every 3 weeks.

Eligibility criteria: Inclusion Criteria:

* Are females
* Have Her 2 over-expression
* Have Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

Exclusion Criteria:

* Current clinical or radiographic evidence central nervous system (CNS) metastases
* Current Known infection
* Pregnant or nursing mother

Primary outcomes:
measure: Objective Response Rate
timeFrame: 6 months (up to 24 weeks)
Secondary outcomes:
measure: Time to Progression
timeFrame: Through study completion, approximately 40 months
measure: Time to Response
timeFrame: Through study completion, approximately 40 months
measure: Progression Free Survival
timeFrame: Through study completion, approximately 40 months
measure: Overall Survival
timeFrame: Through study completion, approximately 40 months
measure: Safety Endpoints; Cardiotoxicity
timeFrame: Through study completion, approximately 40 months
measure: Safety Endpoints; Immunogenicity
timeFrame: During treatment, median of 13 cycles (every cycle is 3 weeks)
measure: Pharmacokinetic Endpoints; Ctroughss
timeFrame: predose and at 1.5 hours (end of infusion) of each cycle
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Samsung Medical Center
Study officials:
affiliation: Samsung Medical Center
name: Investigational Site
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06758076: A Clinical Comparison of Two Soft Contact Lenses (C24-755)
Official title: A Clinical Comparison of Two Soft Contact Lenses (C24-755)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperopia
Myopia
Lead sponsor: CooperVision International Limited (CVIL)
Sponsor class: INDUSTRY
First posted: 2025-01-03
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of this study is to compare the short-term clinical performance of two soft contact lenses.

Detailed description: The aim of this study is to evaluate the short-term clinical performance of two soft contact lenses when compared to each other after 15 minutes of daily wear each.

Eligibility criteria: Inclusion Criteria:

1. They are of legal age (18) and capacity to volunteer.
2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They currently wear soft contact lenses, or have done so within the past two years.
5. They are expected to be able to be fitted with the study lenses within the power range available.

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens wear.
2. They have a systemic disorder which would normally contra-indicate contact lens wear.
3. They are using any topical medication such as eye drops or ointment.
4. They are aphakic.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
7. They are pregnant or breastfeeding.
8. They have an eye or health condition including an immunosuppressive or infectious disease which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
9. They have taken part in any contact lens or care system clinical research within two weeks prior to starting this study.

Primary outcomes:
measure: Subjective Overall Score
timeFrame: At the end of 15 minutes of daily wear
Secondary outcomes:
measure: Subjective Vision
timeFrame: At the end of 15 minutes of daily wear
measure: Subjective Comfort
timeFrame: At the end of 15 minutes of daily wear
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Eurolens Research
Study officials:
affiliation: Eurolens Research
name: Carole Maldonado-Codina, PhD, FBCLA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01391676: Imaging of Trabeculectomy Blebs Using the Spectral Domain Optical Coherence Tomography
Official title: Imaging of Blebs After Trabeculectomy With Mitomycin C 0,02% Using the Spectral Domain Optical Coherence Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Filtering Blebs
Keywords: glaucoma
trabeculectomy
filtering bleb
spectral domain optical coherence tomography
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2011-07-12
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: glaucoma patients who need a trabeculectomy with mitomycin C 0,02% for further reduction of intraocular pressure (IOP)

Brief summary: The aim of this study is imaging of trabeculectomy blebs regarding structure and function with the spectral domain optical coherence tomography.

Detailed description: After a trabeculectomy with mitomycin C 0,02% for 3 minutes, the blebs are controlled by a glaucoma specialist on day 1, week 1,2,3,4, month 3 and 6 after surgery. The glaucoma specialist will evaluate the bleb appearance according to a standardized protocol. At the same time points the bleb will be imaged with the spectral domain optical coherence tomography, to monitor bleb changes objectively. The investigators hope to see signs of bleb incapsulation and scarring earlier and then treat the patient accordingly.

Eligibility criteria: Inclusion Criteria:

glaucoma patients who need a trabeculectomy with mitomycin C 0,02% for further reduction of intraocular pressure, informed consent

Exclusion Criteria:

patient without glaucoma, under 18 years of age, not willing to take part in the study

Primary outcomes:
measure: grading of filtering bleb
timeFrame: December 2011
Secondary outcomes:
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Eye Clinic Dresden
state: Saxony
Study officials:
affiliation: University Eye Clinic Dresden, Fetscherstrasse 74, 01307 Dresden, Germany
name: Karin R Hornykewycz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00949676: DECIDE-HF: Heart Rate Variability in Heart Failure Patients
Official title: DECIDE-HF - Heart Rate Variability in Heart Failure Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Systolic Heart Failure
Lead sponsor: Medtronic BRC
Sponsor class: INDUSTRY
First posted: 2009-07-30
Enrollment: 60
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: Systolic Heart Failure Patients with NYHA class II or III and a ventricular ejection fraction of less then 40%.

Brief summary: The purpose of this study is to determine whether heart rate variability-like parameters are related to changes in the disease status of a subject that suffers from a disease that decreases the pumping function of the heart.


Eligibility criteria: Inclusion Criteria:

* Subject has signed and dated the study-specific informed consent form
* Subject is 18 years of age or older
* Subject is expected to remain available for follow-ups
* Subject is able and willing to comply with the protocol requirements
* Subject has predominant Normal Sinus Rhythm
* Subject has systolic Heart Failure and is at the moment of enrollment in NYHA class II or III and has an ejection fraction of less then 40%
* Subject has had a HF-related hospitalization in the past 12 months

Exclusion Criteria:

* Subject needs permanent atrial pacing (\> 10%)
* Subject has intermittent 2nd or intermittent 3rd degree block
* Subject has persistent or permanent AF
* Subject has Long QT syndrome, Brugada syndrome, Jervell and Lange- Nielsen syndrome, Romano-Ward syndrome, Andersen-Tawil syndrome or Timothy's syndrome
* Subject has had recent (\<2 months) acute coronary syndrome
* Subject has had recent (\<2 months) revascularization
* Subject has a pending cardiac transplant or revascularization
* Subject has severe stenotic valvular heart disease
* Subject has severe pulmonary (forced expiratory volume in 1 s \< 1 L) hepatic or renal (plasma creatinine \> 0.2 mmol/L) disease
* Subject is participating in another study that may affect the results of this study

Primary outcomes:
measure: HF diagnostic
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
city: Kiel
country: Germany
city: Munich
country: Germany
city: Tubingen
country: Germany
city: Leeds
country: United Kingdom
Study officials:
affiliation: Medtronic BRC
name: DECIDE HF Team
role: STUDY_CHAIR
References:
Clinical trial NCT04796376: The Outcome of Combined Partial Fistulectomy or Fistulotomy and Cutting Seton Procedure in High Perianal Fistula
Official title: The Outcome of Combined Partial Fistulectomy or Fistulotomy and Cutting Seton Procedure in High Perianal Fistula: Prospective Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: High Anal Fistula
Keywords: Cutting seton
Fistulectomy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-03-12
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this study is to assess the effectiveness and suitability of the tight (cutting) seton as a surgical treatment of high anal fistula combined with partial fistulotomy or fistulectomy in a prospective study.

Detailed description: Anal fistula is an abnormal tract with two openings: external one opens in perianal skin and the internal one opens in anal canal. And according to relation between fistula and anal sphincters there are intersphincteric, transphincteric, suprasphincteric and extrasphincteric. Varieties of surgical procedures are encountered for management of this disease but complications such as recurrence and incontinence still facing surgeons strongly. In previous study of total 31 patients post-operative complications were; incontinence of gas (16.13%), incontinence of stool (3.23%), recurrence (3.23%) with conclusion of that: outcomes of fistulotomy with cutting seton were satisfactory in most patients (1). In this study and aiming to reduce the complications rate data will be collected about the outcomes of combined partial fistulectomy or fistulotomy and cutting seton procedure in a prospective study. The goals of treatment are draining infection, eradicating the fistulous tract and avoiding persistent or recurrent disease while preserving anal sphincter function.

Eligibility criteria: Inclusion Criteria:

* Adult with age of or above 18 years.
* Patients with high perianal fistula; trans-sphincteric, intra-sphincteric or supra-sphincteric.
* Patients sable to comply to with the study protocol.

Exclusion Criteria:

* Patients with low perianal fistula
* Patients with preoperative incontinence.
* Patients with comorbidities such as TB , malignancy or inflammatory bowel disease.
* Patients diagnosed with acute anal sepsis
* Recurrent cases

Primary outcomes:
measure: - Cure of high perianal fistulas -Reduce incontinence rate
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
name: Mina Nb Zaher, Resident doc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04498676: 50 Human Subject Repeat Insult Patch Test
Official title: 50 Human Subject Repeat Insult Patch Test Skin Irritation/Sensitization Evaluation (Occlusive Patch)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Erythema
Sensitisation
Keywords: HRIPT
irritant
Lead sponsor: CAGE Bio Inc.
Sponsor class: INDUSTRY
Collaborators: name: AMA Laboratories Inc.
First posted: 2020-08-04
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Consumer products or raw materials designed for consistent reapplication to areas of the skin may, under proper conditions, prove to be contact sensitizers or irritants in certain individuals. It is the intention of a Repeat Insult Patch Test (RIPT) to provide a basis for evaluation of this irritation/sensitization potential if such exists.


Eligibility criteria: Inclusion Criteria:

* Individuals who are not currently under a doctor's care
* Individuals free of any dermatological or systemic disorder which would interfere with the results, at the discretion of the Investigator.
* Individuals free of any acute or chronic disease that might interfere with or increase the risk of study participation.
* Individuals who will complete a preliminary medical history form mandated by AMA Laboratories, Inc. and are in general good health.
* Individuals, who will read, understand and sign an informed consent document relating to the specific type of study they are subscribing. Consent forms are kept on file and are available for examination on the premises of AMA Laboratories, Inc. only.
* Individuals able to cooperate with the Investigator and research staff, willing to have test materials applied according to the protocol, and complete the full course of the study.

Exclusion Criteria:

* Individuals under 18 years of age.
* Individuals who are currently under a doctor's care.
* Individuals who are currently taking any medication (topical or systemic) that may mask or interfere with the test results.
* Subjects with a history of any acute or chronic disease that might interfere with or increase the risk associated with study participation.
* Individuals diagnosed with chronic skin allergies.
* Female volunteers who indicate that they are pregnant or lactating.

Primary outcomes:
measure: Erythema
timeFrame: 21 days
measure: Sensitisation
timeFrame: 24 hours
measure: Sensitisation
timeFrame: 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: New City
country: United States
facility: AMA Laboratories Inc.
state: New York
Study officials:
affiliation: AMA Laboratories Inc.
name: Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02443376: The Effects of Hemodialysis Session on Vascular Stiffness
Official title: The Effects of Hemodialysis Session on Pulse Wave Velocity and Central Arterial Pressure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arteriopathic Disease
Arterial Calcification
Complication of Hemodialysis
Aortic Stiffness
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 80 consecutive patients on maintenance hemodialysis and 30 healthy subjects were included in this study.

Brief summary: Central blood pressure and pulse wave velocity were measured using a Complior Analyse device before and immediately after the end of the dialysis session.


Eligibility criteria: Inclusion Criteria:

* give voluntary consent to participate in the study
* patients on maintenance hemodialysis at least 3 months
* stable dry weight
* single-pool Kt/V \>1.4
* no clinical cardiovascular disease during the 6 months preceding entry
* medical staff (medical doctors, nurses)

Exclusion Criteria:

* not meet the above criteria
* episode of illness (for example: infection)
* pregnancy

Primary outcomes:
measure: Differences in carotid-femoral pulse wave velocity [m/s] just before and after hemodialysis session
timeFrame: 1 day
Secondary outcomes:
measure: Differences in central aortic pressure [mmHg] just before and after hemodialysis session
timeFrame: 1 day
measure: Differences in central aortic pressure [mmHg] and cuff blood pressure [mmHg] just before and after hemodialysis session
timeFrame: 1 day
measure: Impact of fluid and nutritional status on carotid-femoral pulse wave velocity and central aortic pressure
timeFrame: 1 day
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Medical University of Warsaw
state: Mazovian
Study officials:
affiliation: Medical University of Warsaw, Department of Nephrologic Nursing
name: Janusz Wyzgał, Professor
role: STUDY_CHAIR
References:
citation: Czyzewski L, Sanko-Resmer J, Wyzgal J, Kurowski A. Assessment of health-related quality of life of patients after kidney transplantation in comparison with hemodialysis and peritoneal dialysis. Ann Transplant. 2014 Nov 9;19:576-85. doi: 10.12659/AOT.891265.
citation: Czyzewski L, Sanko-Resmer J, Wyzgal J, Kurowski A. Comparative analysis of hypertension and its causes among renal replacement therapy patients. Ann Transplant. 2014 Nov 3;19:556-68. doi: 10.12659/AOT.891248.
citation: Czyzewski L, Wyzgal J, Kolek A. Evaluation of selected risk factors of cardiovascular diseases among patients after kidney transplantation, with particular focus on the role of 24-hour automatic blood pressure measurement in the diagnosis of hypertension: an introductory report. Ann Transplant. 2014 Apr 28;19:188-98. doi: 10.12659/AOT.890189.
Clinical trial NCT04997876: Diagnostic Reliability of OCT Biomarkers for iERM
Official title: Diagnostic Reliability of OCT Biomarkers for Idiopathic Epiretinal Membranes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Epiretinal Membranes
Lead sponsor: Vienna Institute for Research in Ocular Surgery
Sponsor class: OTHER
First posted: 2021-08-10
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with iERM sheduled for vitrectomy with membrane peeling.

Brief summary: Several optical coherence tomography (OCT) biomarkers with potential to influence postsurgical outcomes after vitrectomy with membrane peeling for idiopathic epiretinal membranes (iERM) have been described in single predictor analyses in the past. Aim of the study is to assess the reliability of diagnosis of OCT biomarkers and to calculate their impact on postsurgical visual acuity in a multiple regression analysis.

Detailed description: Several optical coherence tomography (OCT) biomarkers with potential to influence postsurgical outcomes after vitrectomy with membrane peeling for idiopathic epiretinal membranes (iERM) have been described in single predictor analyses in the past. A recent multifactorial analysis outlined macular thickness and DRIL to be significant predictors for postsurgical visual acuity (Karasavviodou et al.). Nevertheless, reliability of diagnosing OCT biomarkes among patients with iERM was not yet assessed, to our knowledge. Aim of the study is to assess the reliability of diagnosis of OCT biomarkers and to calculate their impact on postsurgical visual acuity in a multiple regression analysis.

Eligibility criteria: Inclusion Criteria:

* a) presence of an iERM,
* b) indication for membrane peeling, defined as significant loss of visual acuity and/or metamorphopsia due to the ERM,
* c) pseudophakia at the final visit at 3 months after surgery, and
* d) written informed consent for study participation.

Exclusion Criteria:

* macular edema caused by conditions other than ERM were excluded from the study.

Primary outcomes:
measure: reliability of diagnosing OCT biomarkers
timeFrame: 1 week
Secondary outcomes:
measure: postsurgical best corrected visual acuity
timeFrame: 3 months
measure: central macular thickness
timeFrame: 5 minutes
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: VIROS at Hanusch-Hospital Vienna
Study officials:
affiliation: head of department
name: Oliver Findl, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Karasavvidou EM, Panos GD, Koronis S, Kozobolis VP, Tranos PG. Optical coherence tomography biomarkers for visual acuity in patients with idiopathic epiretinal membrane. Eur J Ophthalmol. 2021 Nov;31(6):3203-3213. doi: 10.1177/1120672120980951. Epub 2020 Dec 14.
Clinical trial NCT01566227: Within-subject Comparison of Mandibular Overdentures Retained by 1,2,or 3 Implants
Official title: Within-subject Comparison of Mandibular Overdentures Retained by 1,2,or 3 Implants
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Complete Edentulism
Keywords: overdenture
implant
edentulism
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2012-03-29
Enrollment: 30
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This research is being done to find out the ideal number of implants/attachments required to provide adequate stability of dentures during function.

Detailed description: The aim of this study is threefold: i) to evaluate within-subject response to complete lower dentures retained by 1 or 2 or 3 implants fitted with independent overdenture attachments; ii) laboratory evaluation of the retention force generated with 1-2 or 3-implants and study its correlation to patients' response; iii) study the wear pattern of the plastic inserts on the overdenture abutments during each retention mode (i.e. the number of implants used to retain the dentures) and correlate its effects to denture stability.

Eligibility criteria: Inclusion Criteria:

* subjects completely edentulous on maxilla and mandible for at least a year (w/out dentures)
* Adult age (25 plus) male or female
* Stable medical health
* Ability to participate in the study for at least 3-4 years
* Able to understand and respond to surveys used in the study
* Adequate amount of bone in the mandible to receive 3 implants.

Exclusion Criteria:

history of drug and alcohol abuse, excessive smoking (more than 1 pack/day)

* surgical limitations:
* uncontrolled systemic disease: diabetes, etc.. that may compromised healing
* irradiated surgical site
* inadequate bone height and width (re: implant size)
* inability to undergo minor oral surgery because of health or personal reasons
* psychological and handicapped conditions that may hinder 4-year involvement (physical handicap conditions)
* Severe TMDs related to joint pathology

Primary outcomes:
measure: Patient Satisfaction survey (questionnaires)
timeFrame: every 6 months up to three years
Secondary outcomes:
measure: Radiographs
timeFrame: every 6 months up to three years
measure: Wear of 1 vs 2 vs 3 GPS retention components on complete dentures.
timeFrame: baseline and 6 months
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba, Faculty of Dentistry
state: Manitoba
Study officials:
affiliation: Univ. of Manitoba, Faculty of Dentistry
name: Igor Pesun, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: Univ of Manitoba, Faculty of Dentistry
name: Reynaldo Todescan, DDS.
role: STUDY_DIRECTOR
affiliation: Univ of Manitoba, Faculty of Dentistry
name: Mike Barczac, DDS
role: STUDY_CHAIR
References: