louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02763124: Pseudophakic Astigmatic Reduction With Verion-LenSx Arcuate Incisions
Official title: Pseudophakic Astigmatic Reduction With Verion-LenSx Arcuate Incisions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Astigmatism
Keywords: Pseudophakic
Lead sponsor: Gainesville Eye Associates
Sponsor class: OTHER
Collaborators: name: Alcon, a Novartis Company
First posted: 2016-05-05
Enrollment: 18
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the effectiveness of the Verion-LenSx guided arcuate incision technique to reduce astigmatism in a pseudophakic population.

Detailed description: The purpose of this study is to evaluate the effectiveness of corneal arcuate incisions when they are performed with a femtosecond laser system on subjects who have had previous cataract surgery. The procedure to be used would not be different from that employed during cataract surgery, except that the only corneal incisions made would be the partial-depth arcuate incisions at the laser.

Eligibility criteria: Inclusion Criteria:

* Age 40 or older
* Willing and able to provide informed consent for participation in the study.

Exclusion Criteria:

-

Primary outcomes:
measure: Uncorrected Monocular Distance Visual Acuity
timeFrame: 60 days (+/- 10 days) after laser treatment
Secondary outcomes:
measure: Change in Corneal Astigmatism
timeFrame: 60 days (+/- 10 days) after laser treatment
measure: Change in Refractive Cylinder
timeFrame: 60 days (+/- 10 days) after laser treatment
measure: Spectacle Independence at Distance
timeFrame: 60 days (+/- 10 days) after laser treatment
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Gainesville Eye Associates
state: Georgia
Study officials:
affiliation: Gainesville Eye Associates
name: Clayton Blehm, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02274324: Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson&Apos;s Disease
Official title: Dietary Modifications Effect on Continuous LCIG Infusion Outcomes in Patients With Advanced Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Keywords: parkinson
duodopa
diet
proteins
amino acids
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Tel Aviv University
First posted: 2014-10-24
Enrollment: 20
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the role of dietary modifications of 3 different diets on clinical outcomes in patients with PD treated with Duodopa®. This is in search for an optimal diet that will accompany Duodopa® treatment and will optimize effect on fluctuations and dyskinesias and thus improve motor function and quality of life.

Detailed description: A prospective single-blind-crossover study in patients with PD regularly treated with Duodopa® (LICG) in which three different diets will be given. Diet A: Low fat western diet - traditional low-fat Western diet; a normal diet according to the recommendations of health organizations in which proteins consumed throughout the day, high-protein meal at noon and in the evening.

Diet B: Equal protein redistribution diet (EPRD) - proteins consumption is controlled and equally distributed over six meals throughout the day to minimize motor fluctuations.

Diet C: Protein redistribution diet (PRD) in which proteins are consumed in the morning prior to connection to the pump and in the evening after disconnecting from the . Carbohydrates and fats will be consumed during the day.

Following recruitment and study initiation patients will consume diet A for 3 weeks. Patients will then be randomized into either diet B or diet C for 3 additional weeks. At completion of this period patients will consume diet A for 2 weeks ("wash-out" period) and will then be "crosseovered" to get the third diet (B or C).

Eligibility criteria: Inclusion Criteria:

* Patients treated with Duodopa at least three months and are stable on medical therapy
* Patients should be not demented, able to fill diaries and to sign an informed consent

Exclusion Criteria:

* Severe dementia
* Inability to fill out diaries
* Unstable mediated condition
* Chronic renal failure

Primary outcomes:
measure: quality of life
timeFrame: 4 months
measure: dyskinesias
timeFrame: 4 months
Secondary outcomes:
measure: fluctuations
timeFrame: 4 months
measure: motor function
timeFrame: 4 months
Other outcomes:
Locations:
Study officials:
affiliation: Sheba Medical Center
name: Sharon Hassin, Dr
role: STUDY_DIRECTOR
affiliation: Sheba Medical Center
name: Oren Cohen, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01239524: The Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction
Official title: The Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Significance of Latissimus Dorsi Flap Innervation in Delayed Breast Reconstruction
Keywords: breast reconstruction, latissimus dorsi flap, thoracodorsal nerve, skeletal muscle disuse, breast MRI
Lead sponsor: Tampere University Hospital
Sponsor class: OTHER
First posted: 2010-11-11
Enrollment: 28
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Breast reconstruction with a pedicled myocutaneous latissimus dorsi (LD) flap is a widely used reconstruction method. It is controversial if surgical denervation by transecting the thoracodorsal nerve should be performed or not. It is assumed that after denervation the latissimus dorsi muscle will significantly atrophy and lose volume. On the other hand discomforting signs and symptoms from muscle contraction are believed to be prevented if flap is denervated. The aim of the study was prospectively evaluate the influence of LD-flap innervation on the functional and aesthetic outcome of delayed breast reconstruction, and to compare the change in muscle structure in breast MRI and histopathology.


Eligibility criteria: Inclusion Criteria:

* delayed LD-flap breast reconstruction, no recurrent disease observed

Exclusion Criteria:

* recurrent cancer, partial resection of the breast

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Kaariainen M, Giordano S, Kauhanen S, Helminen M, Kuokkanen H. No need to cut the nerve in LD reconstruction to avoid jumping of the breast: a prospective randomized study. J Plast Reconstr Aesthet Surg. 2014 Aug;67(8):1106-10. doi: 10.1016/j.bjps.2014.04.029. Epub 2014 May 13.
citation: Kaariainen M, Giordano S, Kauhanen S, Laaperi AL, Mattila P, Helminen M, Kalimo H, Kuokkanen H. The significance of latissimus dorsi flap innervation in delayed breast reconstruction: a prospective randomized study-magnetic resonance imaging and histologic findings. Plast Reconstr Surg. 2011 Dec;128(6):637e-645e. doi: 10.1097/PRS.0b013e318230c544.
Clinical trial NCT04912024: Comparative Outcome Measures of Patients Receiving Acute Renal ThErapy Study
Official title: Comparative Outcome Measures of Patients Receiving Acute Renal ThErapy Study (COMPARE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Kidney Disease
End Stage Renal Disease
Acute Kidney Injury
Keywords: Tablo
Outset Medical
ESRD
AKI
Lead sponsor: Outset Medical
Sponsor class: INDUSTRY
First posted: 2021-06-03
Enrollment: 458
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with AKI or ESKD who were prescribed acute intermittent Renal Replacement Therapy (RRT).

Brief summary: Retrospective, multicenter, comparative, post-market study of the Tablo Hemodialysis System in hospitalized participants with End-Stage Renal Disease or Acute Kidney Injury.


Eligibility criteria: Inclusion Criteria:

* Participant is 18 years of age.
* Participant weighs ≥ 34kg.
* Participant was hospitalized and had dialysis dependent End-Stage Renal Disease or Acute Kidney Injury and was prescribed acute intermittent renal replacement therapy.

Exclusion Criteria:

* Treatments isolated to ultrafiltration only.
* Any documented condition the Physician feels would prevent the participant from successful inclusion in the study.

Primary outcomes:
measure: BUN Lab Value
timeFrame: Change from baseline BUN measurement at 24 hours.
Secondary outcomes:
measure: Bicarbonate Lab Value
timeFrame: Change from baseline bicarbonate measurement at 24 hours.
measure: Potassium Lab Value
timeFrame: Change from baseline potassium measurement at 24 hours
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Adventist Health System
state: Florida
city: Fort Worth
country: United States
facility: Texas Health Harris Methodist Hospital Fort Worth
state: Texas
Study officials:
References:
Clinical trial NCT00193024: Epirubicin and Docetaxel in the Treatment of Patients With Metastatic Breast Cancer
Official title: A Phase II Trial of Epirubicin/Docetaxel in the First-Line Treatment of Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Aventis Pharmaceuticals
name: Pharmacia and Upjohn
First posted: 2005-09-19
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The epirubicin/docetaxel combination is one of the most active and best tolerated taxane/anthracycline combinations. In this phase II trial, we will further evaluate the feasibility, safety and effectiveness of the docetaxel/epirubicin combination, when administered as first-line treatment for metastatic breast cancer.

Detailed description: Upon determination of eligibility, all patients will receive:

Docetaxel + Epirubicin

Both drugs will be repeated at 21-day intervals

Eligibility criteria: Inclusion Criteria:

To be included in this study, you must meet the following criteria:

* Metastatic breast cancer confirmed by biopsy.
* Received no previous chemotherapy for metastatic breast cancer.
* Prior hormonal therapy is acceptable.
* Measurable or evaluable disease.
* Able to perform activities of daily living without considerable assistance
* Adequate bone marrow, liver and kidney function
* Must be able to understand the nature of this study and give written informed consent.

Exclusion Criteria:

You cannot participate in this study if any of the following apply to you:

* Age \< 18 years.
* Cardiac ejection fraction \< 45%.
* Women who are pregnant or lactating.
* Patients with meningeal metastases are ineligible.
* Moderate peripheral neuropathy
* History of hypersensitivity reaction to Taxotere
* Males with metastatic breast cancer

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

Primary outcomes:
measure: Clinical response rate of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer
Secondary outcomes:
measure: Safety of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer
Other outcomes:
Locations:
Study officials:
affiliation: SCRI Development Innovations, LLC
name: John D. Hainsworth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hainsworth JD, Yardley DA, Spigel DR, Meluch AA, Rinaldi D, Schnell FM, Greco FA. Docetaxel and epirubicin as first-line treatment for patients with metastatic breast cancer: a Minnie Pearl Cancer Research Network Phase II trial. Cancer Invest. 2006 Aug-Sep;24(5):469-73. doi: 10.1080/07357900600814060.
Clinical trial NCT05499624: POMCO2 Clinical Study MicroTrend System pCO2 Sensor
Official title: Safety & Efficacy of Oral Mucosal Carbon Dioxide Pressure (POMCO2) Measurement to Monitor Tissue Perfusion
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Hypoperfusion
Keywords: Oral mucosal carbon dioxide pressure
Lead sponsor: ExoStat Medical, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Bright Research Partners
First posted: 2022-08-12
Enrollment: 7
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The objective of this non-significant risk (NSR) study is to evaluate the safety and efficacy of the MicroTrend System by correlating POMCO2 data with relevant clinical metrics including arterial pressure and heart rate.

Detailed description: This is a prospective, single-center, non-randomized, non-significant risk (NSR) study evaluating the safety and efficacy of the MicroTrend System, which is indicated for monitoring oral mucosal carbon dioxide pressure (POMCO2) in hospital patients.

Eligibility criteria: Inclusion Criteria:

1. Hospitalized adult (age 22 years and older) in the critical care unit
2. Willing and able to provide independent written informed consent (or the patient's legal representative, if applicable)
3. Willing and physically able to comply with the study protocol and procedures

Exclusion Criteria:

1. Evidence of intra- or peri-oral, buccal, or gingival disease or trauma to the face or mouth that may interfere with MicroTrend System that is deemed clinically significant by the investigator
2. Any clinically significant medical health history or vital sign deemed by the investigator to potentially interfere with study conduct
3. Vulnerable subject populations (e.g., incarcerated or cognitively challenged adults)

Primary outcomes:
measure: Correlation between POMCO2
timeFrame: 4-6 hours
Secondary outcomes:
Other outcomes:
Locations:
city: North Chicago
country: United States
facility: Captain James A. Lovell Federal Health Care Center
state: Illinois
Study officials:
affiliation: Captain James A. Lovell Federal Health Care Center
name: Raul J Gazmuri, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00261924: Efficacy and Safety Study of Platelets Treated for Pathogen Inactivation and Stored for Up to Seven Days
Official title: Clinical Trial to Evaluate the Therapeutic Efficacy and Safety of INTERCEPT Platelets Stored for up to Seven Days After Collection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Thrombocytopenia
Keywords: Thrombocytopenic patients
Lead sponsor: Cerus Corporation
Sponsor class: INDUSTRY
First posted: 2005-12-06
Enrollment: 211
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Objective: To determine if platelets treated for pathogen inactivation and stored for 6 to 7 days are safe and effective compared to platelets collected by the same method, stored for the same amount of time and not treated for pathogen inactivation.

Detailed description: Although the European Commission directive 2004/33/EC states that platelet preparations may be stored for 7 days in conjunction with detection or reduction of bacterial contamination, most blood centers store platelets for only 4 or 5 days. Extending the storage time could greatly improve platelet availability for patients while decreasing wastage of this limited resource.

Eligibility criteria: Inclusion Criteria:

* At least 16 years old
* Written informed consent
* Thrombocytopenia, or expected to develop thrombocytopenia requiring platelet transfusion within 15 days of randomization
* Undergoing one haematopoietic stem cell transplantation and/or admitted for treatment of acute or chronic leukaemia, lymphoma, multiple myeloma or myelodysplasia

Exclusion Criteria:

* Refractoriness to platelet transfusion
* Immune-mediated thrombocytopenia, thrombotic thrombocytopenic purpura, or hemolytic uremic syndrome
* Use of IL-11 (Neumega®) or other investigational platelet growth factor
* Disseminated intravascular coagulation (DIC)
* Clinically or radiologically detectable splenomegaly
* Previous participation in the study

Primary outcomes:
measure: 1 hour corrected count increment for platelets
timeFrame: One hour after platelet transfusion
Secondary outcomes:
measure: Transfusion related adverse events
timeFrame: 24 hours after transfusion
Other outcomes:
Locations:
city: Edinburgh
country: United Kingdom
facility: SNBTS National Science Laboratory, Edinburgh and Western General Hospital
Study officials:
affiliation: Cerus Corporation
name: Larry Corash, M.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT04457024: Tennis Elbow Patients Undergoing Closed Therapy Can Easily Cause Tendon Tear
Official title: Tennis Elbow Patients Undergoing Closed Therapy Can Easily Cause Tendon Tear
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tennis Elbow
MRI
Hyperlipidemia
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2020-07-07
Enrollment: 108
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: In order to rule out the influence of the imbalance between height and weight on blood lipids, the difference between the case group and the control group was analyzed after adjusting the height and weight covariates using the Generalized Linear Model.

Brief summary: To explore whether there is a difference in the rate of tendon tear after hyperlipemia in tennis elbow patients and those with normal blood lipids after closed treatment, which provides clues for further exploration of its mechanism. 1. Collect data from 108 cases of tennis elbow patients treated at the Institute of Sports Medicine, Peking University Third Hospital from January 2010 to December 2018 at the Institute of Sports Medicine, Peking University Third Hospital. Statistics included the sex, age, BMI, number of closures, total cholesterol, triglycerides, low-density lipoprotein, high-density lipoprotein. 2. Retrieve the MRI imaging data of the above-mentioned patients, and use the extensor tendon at the humerus to see if there is a tear as an observation indicator. Analyze the difference of tendon tear after closed treatment in patients with high blood fat and normal blood fat.


Eligibility criteria: Inclusion Criteria:

* All patients with tennis elbows in our hospital

Exclusion Criteria:

* none

Primary outcomes:
measure: Use MRI to assess whether the tendon is torn
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Univerisity Third Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT00092924: Study of TRM-1(TRAIL-R1 Monoclonal Antibody) in Subjects With Relapsed or Refractory Non-Small Cell Lung Cancer (NSCLC)
Official title: A Phase 2, Multi-Center, Open-Label Study to Evaluate the Efficacy, Safety, and Tolerability of TRM-1 (Fully Human Monoclonal Antibody To TRAIL-R1) in Subjects With Relapsed or Refractory Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Non-Small-Cell Lung
Lead sponsor: Human Genome Sciences Inc.
Sponsor class: INDUSTRY
First posted: 2004-09-28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficacy and safety of TRM-1 in subjects with relapsed or refractory non-small cell lung cancer.


Eligibility criteria: Primary Inclusion Criteria:

* Relapsed or refractory histologically or cytologically confirmed Stage IIIB, IV, or recurrent NSCLC
* Previously treated and failed to respond to standard therapy or progressed after standard therapy
* 18 years of age or older

Primary Exclusion Criteria:

* Received a non-FDA approved investigational agent within the last 4 weeks.
* Previous cancer therapies (chemotherapy, hormonal therapy, monoclonal antibodies or radiation therapy) within the last 3 weeks, 8 weeks for fully human or humanized monoclonal antibodies
* Infection requiring antibiotics or hospitalization within the last 2 weeks
* HIV, Hepatitis-B, Hepatitis-C
* Pregnant or breast-feeding women
* Major surgery within the last 4 weeks
* History of other cancers within the past 5 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Denver
country: United States
facility: University of Colorado Cancer Center
state: Colorado
city: Chicago
country: United States
facility: Rush Medical College
state: Illinois
city: Durham
country: United States
facility: Duke Comprehensive Cancer Center
state: North Carolina
city: Nashville
country: United States
facility: Sarah Cannon Cancer Center
state: Tennessee
city: Houston
country: United States
facility: MD Anderson
state: Texas
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: