louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01444313: Prospective Study of the Health Benefits of Ultra-Violet Filtering Contact Lenses
Official title: Prospective Study of the Health Benefits of Ultra-Violet Filtering Contact Lenses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Errors
Lead sponsor: Johnson & Johnson Vision Care, Inc.
Sponsor class: INDUSTRY
First posted: 2011-09-30
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to examine the short-term protective effect of Ultra-Violet filtering contact lenses on macular pigment ocular density.


Eligibility criteria: Inclusion Criteria:

* The subject is an adapted soft contact lens wearer
* The subject's spherical error equivalent (Best Sphere corrected for back vertex distance) must be from -0.50 diopters (D) to -6.00D or from +0.50D to +4.00D in each eye
* The subject must have a refractive astigmatism in each eye of -0.75D or less
* The subject must have a best corrected visual acuity of 6/9 or better in each eye.
* The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol
* The subject must read and sign the statement of informed consent
* The subject must be at least 18 years of age

Exclusion Criteria:

* Systemic or ocular allergies which might interfere with contact lens wear
* Systemic disease which might interfere with contact lens wear
* Ocular disease which might interfere with contact lens wear
* Grade 3 or 4 Slit Lamp Findings
* Greater than 0.1 difference in macular pigment optical density (MPOD) findings between right and left eye at baseline visit
* On changing stable medication or taking any medication known to affect tear film
* Active ocular surface pathology
* Use ocular medication
* Had had any anterior ocular surgery or other ocular surgery or injury within 8 weeks immediately prior to enrollment for this study
* Significant ocular tissue anomaly
* Presence of two or more corneal scars in either eye
* Pregnancy or lactation, or intends to become pregnant during the time period of the study
* Any medical condition that may be prejudicial to the study
* Diabetes
* Infectious diseases (e.g. Hepatitis, tuberculosis)
* Contagious immunosuppressive diseases (e.g. HIV)

Primary outcomes:
measure: Macular Pigment Optical Density at 9 months
timeFrame: baseline to 9 months
measure: Macular Pigment Optical Density at 15 months
timeFrame: baseline to 15 months
Secondary outcomes:
measure: Macular Pigment Optical Density at 3 months
timeFrame: baseline to 3 months
measure: Macular Pigment Optical Density at 6 months
timeFrame: baseline to 6 months
measure: Macular Pigment Optical Density at 12 months
timeFrame: baseline to 12 months
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
state: West Midlands
Study officials:
References:
Clinical trial NCT01989013: Effect on Parkinson's Disease After Therapeutic Induction of CranioSacral Integrated Therapy
Official title: Effect on Parkinson's Disease After Therapeutic Induction of CranioSacral Integrated Therapy
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
Craniosacral therapy
cranial osteopathy
Lead sponsor: Zia, Al Raza
Sponsor class: INDIV
First posted: 2013-11-20
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: We are studying \& researching the effect of CranioSacral Integrative therapy on Parkinson's Diseased Patients for 3 months. With a therapeutic induction via manual CranioSacral integrative therapy for 90 minutes per session with a total of 2 session divided equally in a month (biweekly intervention). At the end of 3 months each patient will have total of 9 hours of CranioSacral Integrative therapy induced, we will document the symptoms and shortcomings of the patients at evaluation, before and after therapeutic treatment on a measured scale ranging from 1-10. Finally graphically and statistically measure the quality of change in the symptoms at the end of 3 months and provide executive summary of the research finding, which the investigators expect to be a positive one.

Detailed description: We are studying \& researching the effect of CranioSacral I therapy on Parkinson's Disease

Eligibility criteria: Inclusion Criteria:

* must be Diagnosed with Parkinson's Disease

Exclusion Criteria:

* Anyone without Parkinson's Disease

Primary outcomes:
measure: reduction in tremors due to Parkinson's disease in the patient
timeFrame: 3 months
Secondary outcomes:
measure: Quality of Proprioception
timeFrame: 3 months
Other outcomes:
measure: Overall emotional State and sleep quality
timeFrame: 3 months
Locations:
city: Ann Arbor
country: United States
facility: Naturalmed therapy
state: Michigan
Study officials:
affiliation: IBR, Inc.
name: Al Raza, CST
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00949013: S9313B Study of Tumor Tissue Samples From Women With Early-Stage Breast Cancer Enrolled on Clinical Trial SWOG-9313
Official title: Evaluation of the Expression of the Cancer Stem Cell Marker ALDH1 as a Predictor of Adjuvant Chemotherapy Response in Breast Cancers of High Risk Women in SWOG-9313
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: stage IA breast cancer
stage IB breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
Lead sponsor: SWOG Cancer Research Network
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-07-30
Enrollment: 1600
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients enrolled to S9313 consenting to banking

Brief summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients enrolled on clinical trial SWOG-9313 will respond to doxorubicin and cyclophosphamide.

PURPOSE: This laboratory study is looking at tumor tissue samples from women with early-stage breast cancer enrolled on clinical trial SWOG-9313.

Detailed description: OBJECTIVES:

Primary

* To determine if ALDH1 positivity, as determined by IHC staining, identifies a poor prognostic subgroup of women with early-stage breast cancer who have been uniformly treated with adjuvant doxorubicin and cyclophosphamide on clinical trial SWOG-9313.

Secondary

* To determine associations of ALDH1 expression with other known factors that have been determined on clinical trial SWOG-9313, such as estrogen receptor (ER) status, HER2 status, TOPOII, cyclin E, and p27.
* To determine if ALDH1 positivity, as determined by IHC staining, identifies a poor prognostic subgroup within ER and HER2 subgroups in patients treated on clinical trial SWOG-9313.

OUTLINE: This is a multicenter study.

Tumor tissue samples from clinical trial SWOG-9313 are analyzed for ALDH1 expression by IHC.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Tumor samples collected from women diagnosed with early-stage breast cancer on clinical trial SWOG-9313 available

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Correlation of ALDH1 with disease-free survival and overall survival
timeFrame: Retrospectively
Secondary outcomes:
measure: Correlation of ALDH1 with other biomarkers (TOPOII, HER2, ER, PgR)
timeFrame: Retrospectively
Other outcomes:
Locations:
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Daniel F. Hayes, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00638313: Single-Dose Study Of PF-04603629 In Type 2 Diabetic Subjects
Official title: A Phase 1, Placebo-Controlled, Randomized Study To Assess The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Following Single, Escalating Subcutaneous Doses Of PF-04603629 In Type 2 Diabetic Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes Mellitus, Type 2
Keywords: GLP-1
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-03-19
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: PF 04603629 is a long acting exendin proposed for the treatment of Type 2 diabetes mellitus. The purpose of this study is to characterize the safety, tolerability, pharmacokinetics and glucose lowering capabilities following a single subcutaneous dose.


Eligibility criteria: Inclusion Criteria:

* Type 2 diabetes mellitus
* Hb A1c lower or equal to 11%

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* Evidence of diabetic complications with significant end-organ damage

Primary outcomes:
measure: To characterize the pharmacokinetics of PF-04603629 in serum after administration, under fasted conditions, of single, escalating, subcutaneous doses of PF-04603629 to adult subjects with T2DM.
timeFrame: 1 week per dose group
measure: To characterize the pharmacodynamic effect (glucose AUC lowering) of single, escalating, subcutaneous doses of PF-04603629 administered to adult subjects with T2DM.
timeFrame: 1 week per dose group
measure: To evaluate the safety and tolerability of escalating, single subcutaneous doses of PF-04603629 administered to adult subjects with T2DM.
timeFrame: 1 week per dose group
Secondary outcomes:
measure: No secondary outcomes listed in the protocol.
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Pfizer Investigational Site
state: Arizona
city: San Antonio
country: United States
facility: Pfizer Investigational Site
state: Texas
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT01760213: Brief Internet Based Treatment for PTSD
Official title: Internet Based Treatment Using Virtual Reality in the Prevention of PTSD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: PTSD
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
Collaborators: name: Bar-Ilan University, Israel
First posted: 2013-01-04
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of the project is to overcome some of the common barriers to treatment amongst recent survivors of traumatic events, by combining the world of evidence-based intervention with that of modern Internet technology. Specifically, it aims to test the feasibility and effectiveness of an Internet delivery of early-intervention trauma-focused cognitive behavioral therapy (CBT) for preventing post-traumatic stress disorder (PTSD). Over the course of the study the following objectives will be achieved:

1. The development of an Internet-based Virtual Reality intervention for preventing PTSD among patients who have recently experienced a traumatic event.
2. The evaluation of the feasibility of administering this intervention, and
3. The evaluation of the efficacy of this Internet based intervention in the prevention of PTSD in recent trauma survivors.


Eligibility criteria: Inclusion Criteria:

* Exposed to a traumatic event that meets DSM Criteria (objectively could cause physical injury;
* Subjectively involves helplessness or fear);
* Aged over 18; Aged under 65;
* Hebrew speaking; Suffering from PTSD (without the time criteria i.e. less than one month of symptoms);
* Able to give informed consent.

Exclusion Criteria:

* Suffering from, or have suffered from in the past, bipolar disorder;
* Suffering from, or have suffered from in the past, psychotic disorder;
* Suffering from, or have suffered from in the past, substance abuse;
* Suffering from PTSD;
* Suffering from another Axis I anxiety disorder that requires immediate treatment;
* Currently presents as a suicide risk, requiring hospitalization.

Primary outcomes:
measure: Levels of PTSD symptoms
timeFrame: 12 months after end of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: Hadassah medical organization
Study officials:
affiliation: HMO
name: Rena Cooper, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bar Ilan University
name: Sara Freedman, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT02893813: Comparison Between Two Surgical Methods for Eyelid Ectropion: Tarsal Strip Alone Versus Tarsal Strip With Punctoplasty (Three Snips With or Without Diamond-shaped Resection)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ectropion
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
First posted: 2016-09-09
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients underwent eyelid ectropion surgery

Brief summary: Ectropion of the eyelid can lead to skin retraction, stenosis of lacrimal point, chronic watering, visual discomfort or low visual acuity, mostly when it occurs with ectropion of lacrimal point. The objective of the study is to compare two surgical strategies for eyelid ectropion combined with ectropion of the lacrimal point

Detailed description: Were included patients underwent eyelid ectropion surgery in ophthalmology department from Oct 2014 to Oct 2015. The first procedure is lateral tarsal strip alone (group 1); the second one is lateral tarsal strip with three snips with or without diamond-shaped resection (group 2). The authors focused on the alteration of the quality of life related to watering, before and after operation. Quality of life related to discomfort due to watering was evaluated before and after surgery using a questionnaire. Informations have been gathered via phone with a ten items questionnaire, each item is worth 0 (no or minim discomfort due to watering) or 1 (discomfort due to more than moderated watering)

Eligibility criteria: Inclusion Criteria:

* patients underwent eyelid ectropion surgery

Exclusion Criteria:

-

Primary outcomes:
measure: Quality of life related to discomfort due to watering after eyelid ectropion surgery
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00169013: Gabapentin in Phantom and Stump Pain
Official title: Gabapentin in the Prevention of Phantom Limb Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Amputation of Lower Limb
Lead sponsor: Danish Pain Research Center
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2005-09-15
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: To investigate whether gabapentin can prevent phantom and stump pain after amputation.


Eligibility criteria: Inclusion Criteria:

1. Amputation of crus or femur

Exclusion Criteria:

1. Patients who cannot cooperate
2. Fertile women without sufficient contraceptives
3. Allergy to gabapentin
4. Earlier amputation of the same limb except toes
5. Serious lever, kidney, cardiac, respiratory, haematological disease.-

Primary outcomes:
measure: Primary outcome measures:
measure: Number of patients with phantom and stump pain 30 days and 6 months after amputation
measure: Average intensity of stump and phantom pain 30 days and 6 months after amputation
Secondary outcomes:
measure: Secondary outcome measures:
measure: Prevalence and severity of phantom and stump pain at controls day 7, 14 and 30, and 3 and 6 months
measure: McGill Pain Questionnaire day 7, 14 and 30, and 3 and 6 months
measure: Concurrent pain medication at day 7, 14 and 30, and 3 and 6 months
measure: Brush evoked allodynia, wind up like pain to repetitive pinprick, pressure pain threshold at day 14 and 30.
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Danish Pain Research Center, Aarhus University Hospital
Study officials:
affiliation: Danish Pain Research Center
name: Lone Nikolajsen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00217113: An Intervention to Preserve Functional Status and Independence Among Community Dwelling Elderly
Official title: An Intervention to Preserve Functional Status and Independence Among Community Dwelling Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Elderly
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Minnesota Department of Human Services
name: Elder Network
First posted: 2005-09-22
Enrollment: 100
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This is a study aimed at identifying Olmsted County senior citizens who are at risk for vulnerability. Those elders who screen "affirmatively" for vulnerability will be offered participation in a pilot intervention aimed at keeping seniors independent in the community. This intervention consists of a comprehensive geriatric home visit and the development of an individualized action plan aimed at preservation of function and independence. Participants will be followed for several months after their baseline assessment to evaluate implementation of recommendations.


Eligibility criteria: Age 65 or older Olmsted County Resident Able to provide own consent English speaking or with available translator

Primary outcomes:
measure: Change in VES-13 score (Pre/Post)
measure: Implementation of "Action Plan" Recommendations
measure: Frailty Domain Scores
Secondary outcomes:
measure: Hospitalization and Nursing home admissions
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Ericka E. Tung, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02362113: Glycemic Index/ Load and Mental Disorders
Official title: Glycemic Index, Glycemic Load and Common Psychological Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Depression
Anxiety
Psychological Distress
Lead sponsor: Isfahan University of Medical Sciences
Sponsor class: OTHER
First posted: 2015-02-12
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: non-academic staff of Isfahan University of Medical Sciences (IUMS), Isfahan, Iran, who were working in hospitals, university campus and health centers affiliated with IUMS

Brief summary: A total of 300 adults would be included in the present cross-sectional study. glycemic index (GI) and glycemic load (GL) would be assessed by using a validated self-administered dish-based semi-quantitative food frequency questionnaire. Validated Iranian versions of Hospital Anxiety and Depression Scale and General Health Questionnaire-12 would be used to assess anxiety, depression and psychological distress.

Detailed description: Frequency of 5 food groups will be asked in dish-based semi-quantitative food frequency questionnaire and they would be converted to grams. GI and GL will be estimated by using international table of GI and GL.

Validated Iranian versions of Hospital Anxiety and Depression Scale and General Health Questionnaire (GHQ)-12 were used to assess anxiety, depression and psychological distress.

Possible score range for anxiety and depression is from 0 to 21. Scores of 8 or higher on either section were considered as the presence of anxiety or depression and scores of 7 or less were considered as normal status. In the present study, participants who got scores of 4 or more from GHQ were considered to have psychological distress.

Eligibility criteria: Inclusion Criteria:

* Men and women aged 18-75 years of free-living individuals.

Exclusion Criteria:

* Over or underestimating of total energy intake
* Uncompleted questionnaire (more than 30% of questions)

Primary outcomes:
measure: odds ratio for having depression resulted from statistical analysis
timeFrame: up to 4 months
Secondary outcomes:
measure: depression score resulted from Hospital Anxiety and Depression Scale
timeFrame: up to 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Integrative Functional Gastroenterology Research Center, Isfahan University of Medical Sciences, Isfahan, Iran
name: Peyman Adibi, MD
role: STUDY_CHAIR
References:
citation: Haghighatdoost F, Azadbakht L, Keshteli AH, Feinle-Bisset C, Daghaghzadeh H, Afshar H, Feizi A, Esmaillzadeh A, Adibi P. Glycemic index, glycemic load, and common psychological disorders. Am J Clin Nutr. 2016 Jan;103(1):201-9. doi: 10.3945/ajcn.114.105445. Epub 2015 Nov 25.