louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01396616: Clinical Evaluation of Toric Intraocular Lens Made by Aurolab
Official title: Clinical Evaluation of Toric Intraocular Lens Made by Aurolab
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Astigmatism
Lead sponsor: Aurolab
Sponsor class: OTHER
First posted: 2011-07-19
Enrollment: 120
Sex: ALL
Minimum age (years): 40
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to measure visual acuity and Intraocular Lens (IOL) rotational stability after implantation of TORIC IOL and to assess the post operative complications after implantation of TORIC IOL.

Detailed description: Among available methods for treating astigmatism in cataract surgery, the implantation of toric IOLs is an emerging technology that shows promising results. Similar to implanting a one-piece acrylic lens, toric IOLs provide good distance vision and, in many patients, freedom from spectacles for distance vision. A low absolute residual refractive cylinder has been associated with the implantation of toric IOLs, and the safety profile for toric IOLs has been good. As improvements with regard to rotational stability and treatment and cylinder power range are made, toric IOLs will emerge as an effective, safe treatment option for correcting astigmatism during cataract surgery.

Further, to evidence on the safety and efficacy of TORIC IOL for patients having cataract associated with astigmatism served as the basis for us to identify the published literature on the safety and efficacy of TORIC IOL implantation in the treatment of cataract associated with astigmatism, thus provide a background for the development of clinical investigation plan for the present study.

Eligibility criteria: Inclusion Criteria:

* Age 40 to 65
* Senile cataract
* Posterior Sub Capsular Cataract (PSCC)
* Astigmatism 1.25 D or more
* Residence within 100 kms of Madurai

Exclusion Criteria:

* Traumatic \& Complicated cataract
* Poor mydriasis
* Amblyopia
* Severe Pseudo exfoliation (PXF)
* Dense posterior polar cataract (PPC)
* One eyed patients
* Uveitis
* Corneal pathology / Scar
* Retinal Pathology contributing to visual loss
* Intraoperative complication like PC rupture, Zonular dialysis

Primary outcomes:
measure: vision improvement
timeFrame: 150 days
Secondary outcomes:
measure: Refractive error correction
timeFrame: 150 days
Other outcomes:
Locations:
city: Madurai
country: India
facility: Aravind Eye Hospital
state: Tamilnadu
Study officials:
affiliation: HOD of IOL & Cataract clinic, Aravind Eye Hospital, Tirunelveli
name: Dr. SHIVKUMAR CHANDRASHEKAR, MBBS., MS.,
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00618124: A Study To Find The Best Doses Of SU011248 (Sunitinib) And Capecitabine When These Drugs Are Administered Together
Official title: A Phase 1 Safety And Pharmacokinetic Study Of SU011248 And Capecitabine In Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Solid Tumors
Breast Cancer
Neoplasms
Keywords: solid tumor malignancy, SU011248, sunitinib, capecitabine, Phase 1
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2008-02-18
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study assesses the maximum tolerated dose, overall safety and antitumor activity of SU011248 in combination with capecitabine in patients with advanced solid tumors


Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of a solid cancer which is not responsive to standard therapy or for which no standard therapy exists
* Patient has good performance status (ECOG 0 or 1)

Exclusion Criteria:

* Prior treatment with either SU011248 or capecitabine.
* Hypertension that cannot be controlled by medications

Primary outcomes:
measure: To determine the maximally tolerated dose of SU011248 (dosed continuously or on a 4/2 or 2/1 Schedule) when given in combination with capecitabine.
timeFrame: From Screening until disease progression or discontinuation of the study
Secondary outcomes:
measure: To evaluate the pharmacokinetics of SU011248 and capecitabine when these drugs are co-administered
timeFrame: From Cycle 1, Day 1 until discontinuation of the study
measure: To preliminarily assess the antitumor activity of SU011248 and capecitabine in patients with measurable disease
timeFrame: From screening until disease progression or discontinuation of the study
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Pfizer Investigational Site
state: Indiana
city: Albuqurque
country: United States
facility: Pfizer Investigational Site
state: New Mexico
city: Nashville
country: United States
facility: Pfizer Investigational Site
state: Tennessee
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03424824: Randomized Clinical Trial Evaluating BP1.3656 Versus Placebo For Alcohol Use Disorder Treatment
Official title: A Multisite Randomized Clinical Trial Evaluating BP1.3656 Vs Placebo For Alcohol Use Disorder Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Alcohol Use Disorder
Lead sponsor: Bioprojet
Sponsor class: OTHER
First posted: 2018-02-07
Enrollment: 210
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Multisite Randomized Clinical Trial Evaluating BP1.3656 Vs Placebo For Alcohol Use Disorder Treatment.

Detailed description: Proof of concept study evaluating in alcohol use disorder, the ability of psychosocial support in combination with BP1.3656 to reduce alcohol consumption. The study will be a multicenter, randomized, double-blind, placebo-controlled phase II trial with parallel groups to evaluate the effectiveness and the safety of BP1.3656.

Eligibility criteria: Inclusion Criteria:

* Male or female alcohol use disorder
* Ages 18-65
* Absent or minimal alcohol withdrawal symptoms assessed
* 18 kg/m2 ≤ BMI ≤ 35 kg/m2
* Excessive alcohol use during the 2 weeks between screening and baseline
* Voluntarily expressed willingness to participate in the study, understanding protocol procedures and having signed and dated an informed consent prior to the start of protocol required procedures while not intoxicated (BAC\<0.05).

Exclusion Criteria:

* History of delirium tremens, epilepsy, or withdrawal seizures
* Clinical depression or suicidality: Beck Depression Inventory (BDI) ≥ 16 and suicidality (Item G ≠ 0)
* Recent illicit drug use, i.e. cannabis, cocaine, amphetamines or opioids
* Clinically significant cardiovascular, hematologic, severe hepatic impairment
* History of psychosis, or current severe psychiatric disorder, e.g. schizophrenia, bipolar disorder, severe depression or organic brain syndrome unrelated to alcohol abuse
* Physical dependence on sedatives or hypnotics that requires pharmacologically supported detox
* Receiving ongoing alcohol use disorder medication (e.g. Baclofen)

Primary outcomes:
measure: Decrease in number of monthly Heavy Drinking Days (HDDs/month)
timeFrame: 12 weeks
Secondary outcomes:
measure: Total daily alcohol consumption (TAC)
timeFrame: 12 weeks
measure: Percent of patients without Heavy Drinking Days (HDDs)
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: State Psychiatric Hospital for Treatment of Drug Addiction and Alcoholism
city: Amiens
country: France
facility: CHU Amiens Picardie
city: Leningrad
country: Russian Federation
facility: Leningrad Regional Narcology Dispensary
Study officials:
affiliation: Leningrad Regional Narcology Dispensary, Russia
name: Evgeny Krupitsky, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01480024: Effect of Body Composition and Metabolism on Oocyte Gene Expression
Official title: Effect of Body Composition and Metabolism on Oocyte Gene Expression
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: healthy women
oocytes
in vitro fertilization
pregnancy
childbearing-age
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
First posted: 2011-11-28
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 38
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: women of childbearing age undergoing fertility treatment

Brief summary: The investigators will test the hypothesis that obese women have a unique oocyte gene expression profile that differs significantly from that of normal weight women.


Eligibility criteria: Inclusion Criteria:

* BMI \< 25 (N=35) or BMI ≥ 30 (N=35)
* Seeking fertility treatment at the Arkansas Fertility and Gynecology Associates Clinic
* Assisted reproduction will include the oocyte retrieval technique
* 18 to 38 years of age

Exclusion Criteria:

* Any health condition or medication that may interfere with the study outcome as determined by the investigators

Primary outcomes:
measure: oocyte gene expression profile
timeFrame: 1-2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Nutrition Center
state: Arkansas
Study officials:
References:
citation: Ruebel ML, Cotter M, Sims CR, Moutos DM, Badger TM, Cleves MA, Shankar K, Andres A. Obesity Modulates Inflammation and Lipid Metabolism Oocyte Gene Expression: A Single-Cell Transcriptome Perspective. J Clin Endocrinol Metab. 2017 Jun 1;102(6):2029-2038. doi: 10.1210/jc.2016-3524.
Clinical trial NCT04087824: Deep Learning Algorithm for Recognition of Colonic Segments.
Official title: Development and Validation of a Deep Learning Algorithm for Real-time Recognition of Colonic Segments.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colonic Diseases
Keywords: Deep learning
Colonoscopy
Central Neural Networks
Lead sponsor: Shandong University
Sponsor class: OTHER
First posted: 2019-09-12
Enrollment: 60
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: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study is to develop and validate a deep learning algorithm to realize automatic recognition of colonic segments under conventional colonoscopy. Then, evaluate the accuracy this new artificial intelligence(AI) assisted recognition system in clinic practice.

Detailed description: Colonoscopy is recommended as a routine examination for colorectal cancer screening. Complete inspection of all colon segments is the basis of colonoscopy quality control, and furthermore improves the detection rates of small adenomas. Recently, deep learning algorithm based on central neural networks (CNN) has shown multiple potential in computer-aided detection and computer-aided diagnose of gastrointestinal lesions. However, there is still a blank in recognition of anatomic sites, which restricts the realization of AI-aided lesions detection and disease severity scoring. This study aim to train an algorithm to recognize key colonic segments, and testify the accuracy of each segments recognition as compared to endoscopic physicians.

Eligibility criteria: Inclusion Criteria:

* Patients aged 18-70 years undergoing conventional colonoscopy

Exclusion Criteria:

* Known or suspected bowel obstruction, stricture or perforation
* Compromised swallowing reflex or mental status
* Severe chronic renal failure(creatinine clearance \< 30 ml/min)
* Severe congestive heart failure (New York Heart Association class III or IV)
* Uncontrolled hypertension (systolic blood pressure \> 170 mm Hg, diastolic blood pressure \> 100 mm Hg)
* Dehydration
* Disturbance of electrolytes
* Pregnancy or lactation
* Hemodynamically unstable
* Unable to give informed consent

Primary outcomes:
measure: The accuracy of each colonic segment real-time recognition with deep learning algorithm.
timeFrame: 3 months.
Secondary outcomes:
measure: The accuracy of total colonic segments recognition with deep learning algorithm as compared to endoscopic experts group.
timeFrame: 3 months.
Other outcomes:
Locations:
Study officials:
affiliation: Qilu Hospital of Shandong University
name: Xiuli Zuo, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00397124: The Role of the Vagus Nerve in Tumor-to-Brain Communication in Lung Cancer Patients
Official title: Does the Vagus Nerve Play a Role in Tumor-to-Brain Communication? a Preliminary Study in Patients With Newly Diagnosed Lung Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lung Cancer
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2006-11-08
Enrollment: 40
Sex: ALL
Minimum age (years): 35
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: the aim of this study is to measure brain metabolism in patients with lung cancer.FDG uptake in the brain in patients with malignant tumors will be compared to the amount of tracer activity found in patients who have benign pulmonary process. if differences between the brain uptake of FDG in the two groups will be found, further assessment will be performed in order to evaluate if such differences could be attributed and specifically localized to the brain regions innervated by the vagus


Eligibility criteria: Inclusion Criteria:

* patients with SPN referred for routine whole body FDG-PET imaging
* patients with NSCLC and patients with no evidence of lung cancer on further follow up

Exclusion Criteria:

* patients with a clinical history of vagotomy, abdominal surgery. brain tumor, brain trauma or CVA. or those with a systemic inflammatory disease

Primary outcomes:
measure: the impact of the imaging modality on patients management
Secondary outcomes:
measure: the impact of the imaging modality on patients management
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Medical Center
Study officials:
affiliation: Rambam Health Care Campus
name: Ora Israel, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04590924: HAFAI Cohort 5 Year Follow up of Patients With Femoroacetabular Impingement Undergoing Hip Arthroscopy
Official title: Pain, Function and Hip Osteoarthritis 5 Years After Hip Arthroscopic Surgery in Patients With Femoroacetabular Impingement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Femoro Acetabular Impingement
Lead sponsor: Horsens Hospital
Sponsor class: OTHER
First posted: 2020-10-19
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: Patients included in the HAFAI cohort 5 years ago.

Brief summary: Patients included in the HAFAI cohort will be invited for 5 year follow up.

Detailed description: Patients with femoroacetabular impingement will be investigated 5 years after surgery. We will used the Copenhagen Hip and Groin Score to evaluate pain, activities of daily living, sport, participation in sport and hip-related quality of life. Furthermore, degree of hip osteoarthritis will be evaluated using standing x-rays. Last, we will investigate number of re-operations and conversions to total hip replacement.

Eligibility criteria: Inclusion Criteria:

* Included in the HAFAI cohort

Exclusion Criteria:

* Non

Primary outcomes:
measure: Pain 5 years after surgery
timeFrame: Score at 5 years and change from before surgery to 5 years after surgery
measure: Sports function 5 years after surgery
timeFrame: Score at 5 years and change from before surgery to 5 years after surgery
measure: Development of osteoarthritis 5 years after surgery
timeFrame: Score at 5 years and change from before surgery to 5 years after surgery
measure: Re-operation
timeFrame: From date of initial surgery until the date of first documented re-operation or total hip replacement, whichever came first, assessed up to 6 years after initial surgery
Secondary outcomes:
measure: Activities of daily living 5 years after surgery
timeFrame: Score at 5 years and change from before surgery to 5 years after surgery
measure: Hip related quality of life 5 years after surgery
timeFrame: Score at 5 years and change from before surgery to 5 years after surgery
measure: Participation in sport 5 years after surgery (HAGOS)
timeFrame: Score at 5 years and change from before surgery to 5 years after surgery
measure: Participation in sport 5 years after surgery (HSAS)
timeFrame: Score at 5 years and change from before surgery to 5 years after surgery
Other outcomes:
Locations:
city: Horsens
country: Denmark
facility: Signe Kierkegaard
state: Danmark
Study officials:
affiliation: Horsens Hospital
name: Signe Kierkegaard, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kierkegaard S, Mechlenburg I, Dalgas U, Lund B. Five-Year Follow-up After Hip Arthroscopic Surgery in the Horsens-Aarhus Femoroacetabular Impingement (HAFAI) Cohort. Orthop J Sports Med. 2022 Mar 8;10(3):23259671221075653. doi: 10.1177/23259671221075653. eCollection 2022 Mar.
Clinical trial NCT01790724: Regulating Efficacy and Wellness in Diabetes
Official title: Social Cognitive and Neuropsychological Influences on Physical Activity Behavior in Type II Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Type 2
Metabolic Syndrome
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2013-02-13
Enrollment: 125
Sex: ALL
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The propose of the study is to test the hypothesis that an eight week program consisting of walking exercise and social cognitive theory based group workshops will increase physical activity adherence six months later in older adults with type 2 diabetes or metabolic syndrome.


Eligibility criteria: Inclusion Criteria:

* adults between the ages of 50-75 years
* individuals diagnosed with type 2 diabetes or metabolic syndrome (presence of 3 of the 5 criteria)
* physician consent to participate.

Exclusion Criteria:

* below age 50 or above age 75 at the beginning of the intervention
* exercising regularly more than twice per week for the last six months
* diagnosis of type 1 diabetes mellitus
* failing the Telephone Interview of Cognitive Status
* inability to communicate in English

Primary outcomes:
measure: Physical Activity
timeFrame: Month 6
Secondary outcomes:
measure: Self-efficacy
timeFrame: Month 6
measure: Executive function
timeFrame: Month 6
measure: Self-regulatory strategy use
timeFrame: Month 6
measure: Physical function
timeFrame: Month 6
measure: Psychosocial outcomes
timeFrame: Month 6
Other outcomes:
Locations:
city: Urbana
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Edward McAuley, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Olson EA, Mullen SP, Raine LB, Kramer AF, Hillman CH, McAuley E. Integrated Social- and Neurocognitive Model of Physical Activity Behavior in Older Adults with Metabolic Disease. Ann Behav Med. 2017 Apr;51(2):272-281. doi: 10.1007/s12160-016-9850-4.
Clinical trial NCT01314924: Effects of Acute Ingestion of Dark Chocolate on Endothelial Function in Hypertensive Patients
Official title: Featuring Treated Hypertensive Patients Who Improve Endothelial Function After Dark Chocolate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: Hypertension
Endothelial dysfunction
Vascular stiffness
Use of one or two antihypertensive drugs
Lead sponsor: Hospital Universitario Pedro Ernesto
Sponsor class: OTHER
Collaborators: name: Rio de Janeiro State Research Supporting Foundation (FAPERJ)
First posted: 2011-03-15
Enrollment: 21
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: We aimed to identify clinical and vascular parameters of treated hypertensive patients who present beneficial effects of dark chocolate for one-week period on vascular function.

Detailed description: Recent findings indicate an inverse relationship between cardiovascular disease and consumption of flavonoids. We aimed to identify clinical and vascular parameters of treated hypertensive patients who present beneficial effects of dark chocolate for one-week period on vascular function. Twenty-one hypertensive patients in drug therapy, both genders, aged 40-65 years, were included in a prospective study with measurement of blood pressure, brachial flow-mediated dilatation (FMD), peripheral arterial tonometry (EndoPAT) and central hemodynamic parameters by SphygmoCor. After seven days of eating dark chocolate (70% cocoa) 75g/day, the clinical and vascular evaluation were repeated. Patients were divided into two groups according to the response in FMD: responders (increase in FMD, n=12) and non-responders (no improvement in FMD, n=9).

Eligibility criteria: Inclusion Criteria:

* Previous diagnosis of hypertension
* Use of one or two antihypertensive drugs
* Systolic blood pressure between 130 and 160 mmHg
* Diastolic blood pressure between 85 and 100 mmHg

Exclusion Criteria:

* Secondary hypertension
* Diabetes mellitus
* Body mass index \> 35kg/m2
* Chronic kidney disease
* Known coronary artery disease
* Previous stroke

Primary outcomes:
measure: Endothelial function
timeFrame: One week
Secondary outcomes:
measure: Blood pressure
timeFrame: One week
measure: Central hemodynamic parameters
timeFrame: One week
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitario Pedro Ernesto
state: RJ
Study officials:
affiliation: State University of Rio de Janeiro
name: Jenifer d"El-Rei, MSc
role: PRINCIPAL_INVESTIGATOR
References: