louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01131481: Evaluation of Glistenings in Intraocular Lenses Implanted in Normal Patients Following Routine Cataract Extraction.
Official title: Evaluation of Glistenings in Intraocular Lenses AVS Model X-60 Vs AcrySof MA50-BM.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Glistenings
Keywords: cataracts,glistenings,intraocular lenses.
Lead sponsor: Fry Eye Associates and Fry Eye Surgery Center
Sponsor class: OTHER
Collaborators: name: Bausch & Lomb Incorporated
First posted: 2010-05-27
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Evaluation of glistenings in intraocular lenses implanted in normal patients following routine cataract surgery. The lenses used will be Model X-60 made by the AVS company Vs AcrySof MA50BM made by the Alcon company.


Eligibility criteria: Inclusion Criteria:

* 18 years or older
* Bilateral cataracts requiring surgery
* Potential visual acuity of 20/40 or better in both eyes
* Require IOL power in range of 15-25 diopters
* Pupillary dilation of at least 6mm
* Willing and able to provide informed consent and attend follow-up appointments to 3 years

Exclusion Criteria:

* Any co-existing ocular disease or previous ocular surgery that would confound findings in the study, especially those effecting quality of vision. Examples include Macular degeneration amblyopia and prior epiretinal membrane peel.

Primary outcomes:
measure: Evaluation of Glistenings between the Model X-60 made by the AVS company and AcrySof MA50BM made by the Alcon company.
timeFrame: The patient will be followed 1-2 days after surgery on the first eye and 1-2 days after surgery on the second eye,1-2 months after surgery on both eyes,4-6 months after surgery on both eyes and 1,2 and 3 yrs after surgery on both eyes.
Secondary outcomes:
Other outcomes:
Locations:
city: Garden City
country: United States
facility: Fry Eye Associates
state: Kansas
Study officials:
affiliation: Fry Eye Associates
name: Luther Fry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03700281: Investigating the Effectiveness of a Seasonal Influenza Vaccination Promotion Campaign for Members of a Non-Profit, Community-Based Health Insurance Plan: 2018-2019
Official title: Investigating the Effectiveness of a Seasonal Influenza Vaccination Promotion Campaign for Members of a Non-Profit, Community-Based Health Insurance Plan: 2018-2019
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Influenza, Vaccination
Lead sponsor: The University of Texas Health Science Center at Tyler
Sponsor class: OTHER
Collaborators: name: Sendero Health Plans, Inc.
First posted: 2018-10-09
Enrollment: 22584
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: • This study will assess the effect of promotional messaging and incentives encouraging influenza vaccination in the Sendero IdealCare policy holders during the 2018-2019 Flu Season. The intervention will consist of influenza vaccination promotion/reminders from Sendero Health Plans to subscribers, including text messages, emails, and tailored direct mail outs, i.e. postcard or a personalized letter, and incentive. The study population consists of approximately 22,500 subscribers enrolled in Sendero IdealCare Plan. The intervention will last approximately four months. The primary endpoints, assessed through administrative claims data, will be getting a flu shot during the 2018-2019 season. Data collected through this study will be used to determine effective components of influenza vaccination promotion campaigns used by a health insurance plan.


Eligibility criteria: Inclusion Criteria:

* Enrollment in Sendero IdealCare health plan as of August 1, 2018
* Age 18 years or older

Exclusion Criteria:

* A coverage termination date listed prior to December 31, 2018.
* Sendero member records lack both a phone number and email address.

Primary outcomes:
measure: Influenza vaccination
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
city: Austin
country: United States
facility: The University of Texas System Population Health
state: Texas
Study officials:
References:
Clinical trial NCT03549481: Predictive Value of Risk Scores in Acute Coronary Syndrome
Official title: Role of TIMI, PURSUIT and GRACE Risk Scores in Predicting LV Remodeling in Patients With Acute Coronary Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Left Ventricle Remodeling
Risk Scores
Keywords: risk score
acute coronary syndrome
left ventricular remodelng
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: adult patients of both gender with acute coronary syndrome

Brief summary: role of different risk scores in acute coronary syndrome to predict left ventricular remodeling

Detailed description: patients with acute coronary syndrome (STEMI, NSTEMI, UA) will be included and different risk scores will be calculated for each patient.

after that in-hospital and short-term outcome beside left ventricular systolic and diastolic functions (at admission and 3m later) will be assessed to be correlated with different risk scores to determine which score system was able to predict left ventricular remodeling and what was the cut off value, sensitivity, and specificity of the score

Eligibility criteria: Inclusion Criteria:

* patients with acute coronary syndrome

Exclusion Criteria:

* previous acute coronary syndrome previous PCI or CABG chronic renal disease decompensated liver disease patient refusal to participate patients dropped during follow up

Primary outcomes:
measure: left ventricular remodeling
timeFrame: 3 months
measure: in hospital and short term outcme
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: shaimaa Mostafa
Study officials:
References:
Clinical trial NCT04186481: A Study of the Safety and Performance of the MINITAC◊ Titanium 2.0 Suture Anchor
Official title: Safety and Performance of MINITAC◊ Ti 2.0 Suture Anchor in Extremities
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hallux Valgus Repairs
Medial or Lateral Instability Repairs/Reconstructions
Achilles Tendon Repairs/Reconstructions
Midfoot Reconstructions
Metatarsal Ligament/Tendon Repairs/Reconstructions
Scapholunate Ligament Reconstructions
Ulnar or Radial Collateral Ligament Reconstructions
Lateral Epicondylitis Repair
Biceps Tendon Reattachment
Lead sponsor: Smith & Nephew, Inc.
Sponsor class: INDUSTRY
First posted: 2019-12-04
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: This is a retrospective study evaluating the safety and performance of the MINITAC Suture anchors for extremities repair. Data will be used to support Notified Body (BSI) requirements for extremities repair indications.

Detailed description: Up to 3 sites will participate in the study across Australia and the EU, collectively enrolling a minimum of 30 and a maximum of 50 subjects into the study.

Eligibility criteria: Inclusion Criteria:

1. Subject has undergone extremities repair using the MINITAC◊ Ti 2.0 Suture Anchor.
2. Subject was ≥ 18 years of age at time of surgery.
3. Subject status is \> 12 months post-operative.

Exclusion Criteria:

Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.

Primary outcomes:
measure: Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 6 Months Post-operative
timeFrame: 6 months
Secondary outcomes:
measure: Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 12 Months Post-operative
timeFrame: 12 months
Other outcomes:
measure: Range of Motion (ROM)
timeFrame: 6 and 12 months
Locations:
city: Ashtonfield
country: Australia
facility: Maitland Hand and Othopaedic surgery
state: New South Wales
Study officials:
affiliation: Maitland Hand and Othopaedic surgery
name: Thomas Thorvaldson, B.Med.Sc (Syd), B.Med.(Newc)
role: PRINCIPAL_INVESTIGATOR
affiliation: Clinical Director, Global Clinical Strategy, Sports Med and ENT Smith & Nephew
name: Stephan Mangin
role: STUDY_CHAIR
References:
Clinical trial NCT05037981: Effect of Early Systemic Stabilization Therapy on Recent Onset Vitiligo
Official title: Evaluation of Early Systemic Stabilization Therapy on Recent Onset Localized Non-segmental Vitiligo
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vitiligo
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2021-09-08
Enrollment: 25
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with active localized vitiligo

Brief summary: Vitiligo is a distressing disorder of depigmentation. In spite of multiple successful therapeutic regimens, disease relapse remains a challenge to patients and physicians. Most guidelines consider systemic treatments only in rapidly progressive disease with wider surface areas. This delay in halting the immune attack, may give the chance for further disease progression as well as establishment of resident memory T cell population predisposing to future disease relapses. The aim of this study was to assess the ability of early systemic therapy of localized (\<2% BSA), recent onset (\<6 months) vitiligo to control disease activity and minimize the possibility of recurrence.


Eligibility criteria: Inclusion Criteria:

* Patients ≥ 6 years old of both genders
* Early onset vitiligo (˂6m duration)
* Body surface area (BSA) affected ≤2%

Exclusion Criteria:

* Patients who received any previous treatment for vitiligo
* Pregnant and lactating females
* Patients with other cutaneous or systemic autoimmune diseases
* Patients with contraindication to systemic corticosteroids

Primary outcomes:
measure: Duration needed to arrest of vitiligo activity
timeFrame: 6 months
measure: Duration of maintaining vitiligo stability
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Samia Esmat, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Rania Mogawer, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Cairo University
name: Dalia Bassiony, MD
role: STUDY_DIRECTOR
affiliation: Cairo University
name: Suzan Shalaby, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Rehab Hegazy, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Nanis Ragab, MD
role: STUDY_CHAIR
affiliation: Cairo University
name: Sarah Ibrahim
role: STUDY_CHAIR
References:
Clinical trial NCT00980681: Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time-Of-Flight (TOF)
Official title: Evaluation of Dotarem-enhanced Magnetic Resonance Angiography (MRA) Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Renal Arterial Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Renal Disease
Keywords: Renal disease
Contrast agent
MRA
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2009-09-21
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.

Detailed description: Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.

Eligibility criteria: Inclusion Criteria:

* Male or female, aged more than 18 years
* Strongly suspected of having renal arterial disease
* Scheduled (or to be scheduled) to undergo arterial catheter-based X-ray angiography examination

Exclusion Criteria:

* Known grade IV or V chronic kidney disease (GFR\<30 mL/min/1.73m²)
* Contraindication to MRI
* Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination

Primary outcomes:
measure: Percent of Non Assessable Renal Artery Segments
timeFrame: 1 to 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Guerbet LLC
state: Indiana
Study officials:
affiliation: Guerbet
name: Pierre DESCHE, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05223881: Gastroparesis in Cystic Fibrosis
Official title: 13^C-Spirulina Platensis Gastric Emptying Breath Test for Diagnosis of Gastroparesis in Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Gastroparesis
Keywords: Cystic Fibrosis
Pediatrics
Altered lung function
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2022-02-04
Enrollment: 0
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this research is to determine if an investigational device called the 13C-Spirulina Gastric Emptying Breath Test (GEBT), can accurately diagnose gastroparesis (delayed emptying of the stomach) in patients with Cystic Fibrosis (CF).


Eligibility criteria: Inclusion Criteria:

* Patients age 4 years\* and above with a genetically confirmed diagnosis of CF (\*This age was chosen as patients younger than 4 years rarely undergo GES)
* Actively being followed at the University of Miami CF Center (i.e. seen within the past 5 years at a University of Miami pediatric or adult pulmonology clinic)

Exclusion Criteria:

* History of abdominal surgeries involving gastrointestinal luminal resection (i.e. small bowel or colonic resection that increases risk of post-operative strictures or narrowing of the lumen). Nissen fundoplication, gastrostomy tube placement, gynecologic surgeries, appendectomy, and/or cholecystectomy are not excluded.
* Gastrointestinal comorbidities that impact absorption such as Inflammatory Bowel Disease and Celiac Disease
* Known hypersensitivity to Spirulina, egg, milk or wheat allergens
* Patients not able to consume at least 50% of a standard test meal
* Pregnant women
* Adults unable to consent
* Prisoners

Primary outcomes:
measure: Rate of gastric emptying
timeFrame: 4 hours
Secondary outcomes:
measure: Rate of gastric emptying over time
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: University of Miami
name: Daphna Katz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00010881: Oregon Center for Complementary and Alternative Medicine in Neurological Disorders
Official title: Oregon Center for Complementary and Alternative Medicine in Neurological Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurological Disorders
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2001-02-05
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The mission of the Oregon Center for Complementary and Alternative Medicine in Neurological Disorders (ORCCAMIND) is to facilitate research and education on the effectiveness and mechanisms of action of complementary and alternative medicine (CAM) therapies in the treatment of neurological disorders. The integration of conventional medicine and CAM communities is critical for the success of ORCCAMIND. Thus, ORCCAMIND is composed of six institutions: Oregon Health Sciences University; National College of Naturopathic Medicine; Western States Chiropractic College; Oregon College of Oriental Medicine; the Linus Pauling Institute at Oregon State University; and the Portland Veterans Affairs Medical Center.

ORCCAMIND will initially focus on the use of CAM antioxidants and stress reduction as treatments for neurodegenerative and demyelinating diseases because many of these diseases have oxidative injury as a causative or contributory factor and several CAM approaches have direct or indirect anti-oxidant effects. Through the Career Development Program the Developmental Research Program and the activities of the Education and Information Core, we will also foster and promote research into other CAM approaches for neurologic diseases that extend beyond anti-oxidant therapies. ORCCAMIND will achieve its goals by carrying out 4 Research Projects and maintaining 4 Core facilities that integrate the research strengths of conventional medicine and CAM practitioners and researchers. ORCCAMIND draws its strength from the multi-institutional support and the quality of all its investigators. The investigators join ORCCCAMIND with extensive experience with clinical trials, patient care, externally funded basic and clinical neuroscience research, and training programs, including federally-funded training grants. ORCCAMIND is a bold initiative that integrates basic and clinical research scientists, conventional neurologists and CAM practitioners. It will promote the exploration of new areas of CAM research and lead research on CAM therapies for neurological disorders.

Detailed description: See brief summary

Eligibility criteria: Inclusion Criteria:

* written informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health Sciences Univ./Neurology
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Dr. Barry S. Oken
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01301781: BLI801 Laxative in Constipated Adults
Official title: A Pilot Efficacy Evaluation of BLI801 Laxative in Constipated Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Constipation
Lead sponsor: Braintree Laboratories
Sponsor class: INDUSTRY
First posted: 2011-02-23
Enrollment: 52
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: A pilot study to evaluate the safety and efficacy of BLI801 vs. placebo in constipated adults.


Eligibility criteria: Inclusion Criteria:

* Constipated, defined by ROME III definition
* Subject has \< 3 satisfactory BMs during the run-in period

Exclusion Criteria:

* Subjects with known or suspected ileus, gastrointestinal obstruction, gastric retention, bowel perforation, toxic colitis, toxic megacolon
* Subjects taking laxatives or prokinetic agents that refuse to discontinue these treatments.
* Subjects who are allergic to any BLI801 component
* Subjects taking narcotic analgesics or other medications known to cause constipation.
* Subjects who, in the opinion of the Investigator, should not be included in the study for any reason, including inability to follow study procedures
* Subjects who have participated in an investigational clinical, surgical, drug, or device study within the past 30 days
* Subjects with an active history of drug or alcohol abuse

Primary outcomes:
measure: percentage of patients experiencing a bowel movement within 3 hours of the first study medication dose
timeFrame: 3 hours
Secondary outcomes:
measure: percentage of patients experiencing a complete/satisfactory bowel movement (BM) within 3 hours of first dose
timeFrame: 3 hours
measure: serum chemistry
timeFrame: 7 days
Other outcomes:
Locations:
city: Anaheim
country: United States
facility: Advanced Clinical Research Institute
state: California
city: Jupiter
country: United States
facility: Jupiter Research
state: Florida
city: New Smyrna Beach
country: United States
facility: United Medical Research
state: Florida
city: Great Neck
country: United States
facility: Long Island GI Research Group
state: New York
Study officials:
References:
Clinical trial NCT05634681: Plan of the Day Radiotherapy
Official title: Plan-of-the-day Radiotherapy for Patients With Locally Advanced Cervical Cancer - a Prospective Randomized Controlled Trial (the POD-protocol)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cervix Cancer
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2022-12-02
Enrollment: 190
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 study objectives are to improve the treatment of LACC patients and to increase knowledge of the potential benefit of the plan-of-the-day concept on side effects during and after radiotherapy.


Eligibility criteria: Inclusion Criteria:

* Histologically confirmed cervical cancer eligible for definitve radiochemotherapy
* FIGO stage IB1-IVa
* Over 18 years
* Speaks and understands Norwegian or English.
* ECOG 0-2
* Histology: Squamous cell carcinoma, adenocarcinoma, adenosquamous carcinoma
* Ability to understand and fill in patient questionnaires, and willing to sign a written informed consent
* Large movers (LM), fundus movement ≥2,5 cm.

Exclusion Criteria:

* Evidence of distant metastasis. Suspicious paraaortic lymphnodes below the renal vessels is allowed if they are covered by the radiation field
* Patients with previous surgery for their cervical cancer
* Uncontrolled intercurrent somatic illness.
* Psychiatric illness /social situations limiting study compliance
* Prior radiotherapy to the pelvis
* Patients who are pregnant or breastfeeding is excluded due to risk of teratogenic and abortifacient effects of radiotherapy and cisplatin, and the potential risk of adverse effect of nursing infants
* Patients under current treatment for other invasive s except non-melanoma skin cancers
* Nephrostomy
* Patients with inflammatory bowel disease

Primary outcomes:
measure: To investigate whether implementation of the plan of the day concept results in less gastro-intestinal toxicity.
timeFrame: 5 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Oslo University Hospital
name: Kjersti Bruheim, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: