louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01069029: Combined Versus Successive Macular Hole and Cataract Surgery
Official title: Macular Hole and Cataract Extraction: Combined Surgery Versus Two Times Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Macular Hole
Visual Acuity
Keywords: Macular Hole
Cataract surgery
Vitreoretinal surgery
Combined surgery
Idiopathic
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2010-02-17
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with symptomatic visual loss and needed vitrectomy for Macular Hole treatment.

Brief summary: The purpose of this study is to compare functional and anatomical results of a combined surgery and two time surgery for macular hole and cataract extraction in one hundred and twenty patients (120 eyes) with idiopathic Macular Hole (MH) and cataract in two academic centers.

Detailed description: Main outcome measures were the assessment of visual acuity at 6 and 12 months,and the rate of closure of MH by OCT (optical coherence tomography).

Eligibility criteria: Inclusion Criteria:

* Macular Hole Stage 2,3,and 4
* Visual loss
* At least 18 years of age

Exclusion Criteria:

* Stage of Macular Hole Stage 1
* Macular hole post traumatism or associated with retinal detachment
* Diabetic retinopathy
* Glaucoma
* Age-related macular degeneration
* Myopia \> 6 diopters
* Preoperative pseudophakia

Primary outcomes:
measure: Post surgical procedure assessment of Visual acuity
timeFrame: 6 and 12 months post surgery
Secondary outcomes:
measure: Rate of closure of macular hole by OCT
timeFrame: at 6 and 12 months post surgery
Other outcomes:
Locations:
city: Dijon
country: France
facility: Ophthalmology Unit CHU Dijon
state: Burgundy
Study officials:
affiliation: Ophthalmology unit CHU Dijon
name: Catherine Creuzot-Gracher, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Muselier A, Dugas B, Burelle X, Passemard M, Hubert I, Mathieu B, Berrod JP, Bron AM, Creuzot-Garcher C. Macular hole surgery and cataract extraction: combined vs consecutive surgery. Am J Ophthalmol. 2010 Sep;150(3):387-91. doi: 10.1016/j.ajo.2010.04.008. Epub 2010 Jul 7.
Clinical trial NCT00195429: A Study Comparing the Withdrawal of Steroids or Tacrolimus in Kidney Transplant Recipients
Official title: A Randomized, Open-label and Multicenter Trial Comparing Withdrawal of Steroids or Tacrolimus From Sirolimus-based Immunosuppressive Regimen in de Novo Renal Allograft Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Kidney Failure
Graft vs Host Disease
Keywords: Kidney
Transplant
Lead sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-19
Enrollment: 47
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates two different immunosuppression drug regimens in patients with a recent kidney transplant. Patients initially received a regimen of Sirolimus, Tacrolimus and Prednisone and then randomized to discontinue either Tacrolimus or Prednisone.


Eligibility criteria: Inclusion Criteria:

* End-stage renal disease, with patients scheduled to receive a kidney transplant.
* Women who are of childbearing potential who are not pregnant and agree to use a medically acceptable method of contraception throughout the treatment period and for 3 months following discontinuation of study drugs. Any woman becoming pregnant during the treatment period must discontinue the use of study drugs;
* Signed informed consent.

Exclusion Criteria:

* Evidence of active systemic or localized major infection at the time of initial study drug administration;
* Multiple organ transplants;
* Any pathology or medical condition that can interfere with this protocol study proposal.

Other exclusion applies.

Primary outcomes:
measure: Number of Patients With Biopsy Confirmed Acute Rejection at 12 Months Follow up.
timeFrame: 12 months
Secondary outcomes:
measure: Creatinine Clearance Rate
timeFrame: 12 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
Study officials:
affiliation: Wyeth is now a wholly owned subsidiary of Pfizer
name: Medical Monitor
role: STUDY_DIRECTOR
affiliation: For Brazil, xavierl@wyeth.com
name: Trial Manager
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01223729: Acetyl-L-Carnitine Reduces Depression and Improves Quality of Life in Patients With Minimal Hepatic Encephalopathy
Official title: Acetyl-L-Carnitine Reduces Depression and Improves Quality of Life in Patients With Minimal Hepatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Minimal Hepatic Encephalopathy
Keywords: Acetyl-L-carnitine;
Minimal hepatic encephalopathy;
Quality of life;
Depression.
Lead sponsor: University of Catania
Sponsor class: OTHER
First posted: 2010-10-19
Enrollment: 67
Sex: ALL
Minimum age (years): 34
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Minimal hepatic encephalopathy represents a common complication present in well-compensated cirrhotic patients that impairs patients daily functioning and health-related quality of life. Acetyl-L-carnitine has been shown to be useful in improving blood ammonia and cognitive functions in cirrhotic patients with minimal hepatic encephalopathy. This study evaluated the effects of acetyl-L-carnitine treatment on health related quality of life and on depression in patients with minimal hepatic encephalopathy.


Eligibility criteria: Inclusion Criteria:

* All patients diagnosed as having cirrhosis at the outpatient Internal Medicine of the Department of Senescence of Cannizzaro Hospital (Catania) were candidates for enrolment. The diagnosis of cirrhosis was based on clinical, biochemical and ultrasonographic or liver histological data.

Exclusion Criteria:

* Exclusion criteria were overt hepatic encephalopathy or a history of overt HE; history of recent alcohol intake; infection; recent antibiotic use or gastrointestinal bleeding; history of recent use of drugs affecting psychometric performances like benzodiazepines, antiepileptics or psychotropic drugs; a history of shunt surgery or transjugular intrahepatic portosystemic shunt for portal hypertension; electrolyte imbalance; renal impairment; hepatocellular carcinoma; severe medical problems such as congestive heart failure, pulmonary disease or neurological or psychiatric disorder that could influence quality of life measurement; inability to perform neuropsycological tests.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Catania
country: Italy
facility: Cannizzaro Hospital
Study officials:
References:
citation: Malaguarnera M, Gargante MP, Cristaldi E, Vacante M, Risino C, Cammalleri L, Pennisi G, Rampello L. Acetyl-L-carnitine treatment in minimal hepatic encephalopathy. Dig Dis Sci. 2008 Nov;53(11):3018-25. doi: 10.1007/s10620-008-0238-6. Epub 2008 Mar 21.
Clinical trial NCT05764629: An Observational Study on Post-chronic Pancreatitis Diabetes Mellitus
Official title: An Observational Study of Risk Factors Influencing Glycemic Status and Optimized Treatment on Post-chronic Pancreatitis Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Chronic Pancreatitis
Diabetes Mellitus
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 324
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consequent patients with a diagnosis of PPDM-C in Changhai Hospital between 2018 to 2022

Brief summary: To explore the risk factors influencing glycemic status, optimized treatment, and prognosis of post-chronic pancreatitis diabetes mellitus (PPDM-C).

Detailed description: The present study was an observational study aimed to explore risk factors influencing glycemic status, optimized treatment, and prognosis of post-chronic pancreatitis diabetes mellitus. The observation items included clinical characteristics, blood glucose control and incidence of complications of PPDM-C.

Eligibility criteria: Inclusion Criteria:

1. patients with diagnosis of chronic pancreatitis and diabetes mellitus.
2. participants with painless chronic pancreatitis were diagnosed with diabetes within 2 years of the diagnosis of chronic pancreatitis.
3. participants with painful chronic pancreatitis were diagnosed with diabetes after the first attack of chronic pancreatitis.

Exclusion Criteria:

1. participants with suspected malignant tumors of the pancreas or other sites of body, or participants in the terminal stage of severe disease
2. serious mental illness, lesion of liver or kidney, pregnancy, breast-feeding or planning pregnancy
3. definitely diagnosed type 1 diabetes, type 2 diabetes, or other metabolic diseases that affect blood glucose
4. autoimmune pancreatitis
5. Scarcity of information related to HbA1c
6. death or loss of follow-up during follow-up

Primary outcomes:
measure: Hemoglobin A1c (HbA1c)
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Adverse events
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Changhai Hospital
Study officials:
References:
Clinical trial NCT02756429: Quantification of Endothelial Thrombogenicity in Patients With Atrial Fibrillation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation
stroke
thromboembolism
inflammation
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-04-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Atrial fibrillation (AF) is the most common cardiac arrhythmia. Because of its major impact on the general morbidity and risk of stroke, AF is a great concern for public health. Several mechanisms, including endothelial dysfunction and inflammatory processes, have been postulated as predisposing factors for AF, as well as for stroke.

Both clinical and experimental studies highlight inflammation as a predisposing factor for AF and its complications. Nevertheless, the source of high inflammatory proteins in patients with AF is still unknown. We hypothesized that multilevel intracardiac and extracardiac (left femoral vein, coronary sinus, left atrium, pulmonary vein) measurements of several inflammatory proteins (VEGF) would help assessing the extent and the source of inflammation in AF patients.

The measurement of von Willebrand factor (vWF) levels in multiple vascular sites would also help to define the site of endothelial dysfunction and of production of this thrombogenic factor.

Although AF is associated with an increased risk of stroke, the risk is not homogeneous. Permanent and persistent AF are associated with similar thromboembolic risk to that of paroxysmal AF.


Eligibility criteria: Inclusion Criteria:

* Patient for which an electrophysiology exploration or ablation is programmed;
* Patient who have given written informed consent.

Exclusion Criteria:

* Pregnant women;
* lung disease history (all sources);
* inflammatory disease history (all types);
* Anti-inflammatory treatment;
* left ventricular ejection fraction \<35%;
* history of stroke;
* Participation in other ongoing clinical trial.

Primary outcomes:
measure: VEGF concentration
timeFrame: Day one
measure: vWF concentration
timeFrame: Day one
Secondary outcomes:
Other outcomes:
Locations:
city: Bron
country: France
facility: Hospices Civils de Lyon
Study officials:
References:
Clinical trial NCT03442829: Repeated Sweet Breakfasts and Subsequent Sweet Food Preferences and Intakes
Official title: Impact of Repeated Sweet Breakfasts on Subsequent Sweet Food Preferences and Intakes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Repeated Sweet Food Consumption
Keywords: sweet taste, food preferences, food intake
Lead sponsor: Bournemouth University
Sponsor class: OTHER
Collaborators: name: University of Bristol
First posted: 2018-02-22
Enrollment: 54
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study will assess the impact of repeated sweet breakfast consumption versus repeated non-sweet breakfast consumption on subsequent sweet and non-sweet food preferences and intakes

Detailed description: Participants will be randomized to receive either sweet or non-sweet breakfasts for three consecutive weeks, and impacts on food preferences and intakes will be assessed at baseline (day 0), after 1 week (day 7), and after three weeks (day 21). Preferences for sweet and non-sweet foods will be assessed during two taste tests at each assessment time, where six different foods will be rated. Sweet and non-sweet food consumption will also be measured at two meals at each assessment time - breakfast and lunch. Identical buffet meals composed of sweet and non-sweet foods suitable for consumption at breakfast and lunch will be provided ad-libitum. Intervention breakfasts will only be consumed on the days between test days.

Eligibility criteria: Inclusion Criteria:

* No known food allergy
* No known taste or appetite abnormalities
* Non-smoker
* Habitually eats breakfast
* Able to provide consent and complete all study measures

Primary outcomes:
measure: Food Preferences
timeFrame: 3 weeks from baseline
measure: Food Intake
timeFrame: 3 weeks from baseline
Secondary outcomes:
measure: Hunger Ratings
timeFrame: 3 weeks from baseline
measure: Food Preferences at Lunch
timeFrame: 3 weeks from baseline
measure: Food Intake at Lunch
timeFrame: 3 weeks from baseline
Other outcomes:
Locations:
city: Bournemouth
country: United Kingdom
facility: Bournemouth University
state: US And Canada Only
Study officials:
affiliation: Bournemouth University, UK
name: Katherine Appleton, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bristol
name: Peter Rogers, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06894329: A Study for the PanCystPro Assay in the Management of Pancreatic Cystic Lesions
Official title: Clinical Utility Study to Determine Impact of PanCystPro Assay on Physician Decision-making in the Management of Pancreatic Cystic Lesions
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Pancreatic Cystic Lesions
Lead sponsor: Amplified Sciences Inc
Sponsor class: INDUSTRY
First posted: 2025-03-25
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with radiographically confirmed pancreatic cysts planned for EUS-FNA.

Brief summary: The purpose of this research is to learn if the PanCystPro assay can help doctors in making decisions about treatment and monitoring of pancreatic cysts. The PanCystPro test measures glucose, carcinoembryonic antigen (CEA), and gastricsin biomarkers on fluid obtained from a pancreatic cyst. The test reports if the cyst fluid should be considered "Non-mucinous" or "Mucinous". Mucinous pancreatic cysts are more likely to progress to cancer while non-mucinous cysts seldom progress to cancer.

Detailed description: A prospective observational study to assess the impact of PanCystPro in patients with radiographically confirmed pancreatic cysts planned for Endoscopic Ultra Sound (EUS) Fine Needle Aspirate (FNA). Eligible subjects will be enrolled after signing the ICF. One pancreatic cyst sample will be sent to the Amplified lab for PanCystPro testing.

The impact of PanCystPro on clinical management intention will be assessed after the PanCystPro result has been received by the physician. One year after enrollment the actual clinical management the patient received will be assessed.

Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older
* Cross sectional imaging studies demonstrating a pancreatic cyst at least 12 mm in size where fluid sampling can aid in patient's management
* Written informed consent.
* The patient will be undergoing EUS with anticipated FNA extraction as part of standard patient care.

Exclusion Criteria:

* Patients diagnosed with pancreatic cancer.
* Pregnant or lactating females.
* Patients with contraindications to moderate or deep procedural sedation (necessary for the conduct of the endoscopic ultrasound) like major cardiorespiratory illness.
* Patients with contraindications to FNA of a pancreatic cyst like being on blood thinners.

Primary outcomes:
measure: The percentage of subjects for which the providers indicated positive impact of the PanCystPro assay.
timeFrame: 1 month.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04043429: Restoration vs. Compensation in Neurovisual Rehabilitation of Visual Field Defects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hemianopia
Brain Injuries, Traumatic
Lead sponsor: University of Magdeburg
Sponsor class: OTHER
First posted: 2019-08-02
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Visual field defects (VFD) are a frequent effect of cerebral lesions especially after posterior cerebral artery stroke. The present study was conducted to compare effects of vision restoration training (VRT) and compensation training (Visual Exploration Training, VET) on visual field performance.


Eligibility criteria: Inclusion Criteria:

* Visual field defects after brain damage
* lesion age above 6 months
* documented brain lesions due to ischemic stroke, hemorrhage or tumor demonstrated by computer tomography or by magnet resonance imaging

Exclusion Criteria:

* hemispatial neglect
* complete blindness
* severe psychotic diseases
* serious drug abuse
* chronic degenerative diseases (dementia, multiple sclerosis)
* severe motor impairments
* noticeable low intelligence influencing proper comprehension of diagnostic and training instructions
* considerable impaired vision (visual acuity below 0.1 generated by amblyopia, opacity of cornea or lens, maculopathy and other retinal diseases where vision impairment is expected in the next month (e.g. subretinal neovascularisation, retinitis pigmentosa, diabetic retinopathy)
* inability to fixate due to central scotoma, pathological nystagmus or other forms of fixation disabilities

Primary outcomes:
measure: High Resolution Perimetry - Detectection performance change before vs. after training (%)
timeFrame: 3 months
measure: Humphrey Field Analyzer (Static Perimetry) - Detectection performance change before vs. after training (%)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Magdeburg
country: Germany
facility: Inst. f. Medical Psychology, Univ. of Magdeburg
Study officials:
References:
citation: Sabel BA, Gudlin J. Vision restoration training for glaucoma: a randomized clinical trial. JAMA Ophthalmol. 2014 Apr 1;132(4):381-9. doi: 10.1001/jamaophthalmol.2013.7963.
Clinical trial NCT04788329: The Effect of Mindfulness Programs on Postoperative Pain
Official title: The Effect of Mindfulness Programs on Postoperative Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post Operative Pain
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2021-03-09
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Participants undergoing hand surgery will be assessed and compared for postoperative pain. The patients' experience of going through surgery will be evaluated. The patient satisfaction and patient assessed outcomes will be measured.

Detailed description: Participants undergoing hand surgery will be randomized into either a control group or one of two groups that undergo mindfulness training during the perioperative period. One of the treatment groups will be enrolled in the program "Prepare for Surgery, Heal Faster" provided by NYU. The other treatment group will be enrolled in Wim Hof Method, a meditation program. This program is not provided by NYU, but instructions will be provided to the patient on how to complete the meditative exercises involved in this established method. Postop pain medication and pain scores will be monitored.

Eligibility criteria: Inclusion Criteria:

* Patient seen in Dr. Paksima's office
* Scheduled for hand surgery
* Aged 18+
* Able to provide consent

Exclusion Criteria:

* Less than 18 years old
* Inability to consent
* Not fluent in English

Primary outcomes:
measure: Change of Measured Pain
timeFrame: Day 0, 2 weeks, 6 weeks, 3 months, 1 year
Secondary outcomes:
measure: Change in Mindfulness Score of MAAS scale
timeFrame: Day 0, 2 weeks, 6 weeks, 3 months, 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: NYUSoM
state: New York
Study officials:
affiliation: NYU Langone Health
name: Nader Paksima
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00136929: Senior PAMI: Primary Angioplasty Versus Thrombolytic Therapy for Acute Myocardial Infarction in the Elderly
Official title: A Prospective Randomized Trial of Primary Angioplasty Versus Thrombolytic Therapy for Acute Myocardial Infarction in the Elderly "Senior PAMI"
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Infarction
Keywords: AMI
MI
Acute myocardial infarction (AMI), (MI)
Lead sponsor: PAMI Coordinating Center
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
name: Guidant Corporation
First posted: 2005-08-29
Enrollment: 530
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, randomized, multi-center, international trial comparing two reperfusion strategies in elderly (age \>= 70 years) patients with acute myocardial infarction: primary percutaneous coronary intervention (PCI) versus intravenous thrombolytic therapy. Clinical endpoints will be collected in the hospital, at 1 month, 6 months, and 1 year post-randomization. The primary endpoint is 30 day death or disabling stroke. The study null hypothesis is that there will be no significant difference in death or disabling stroke at 30 days post-randomization between patients treated with PCI versus thrombolytics.


Eligibility criteria: Inclusion Criteria:

* Age \>= 70
* Clinical symptoms \> 30 minutes
* Symptom onset \<= 12 hours
* ST segment elevation \>= 1 mm in 2 or more leads

Exclusion Criteria:

* Prior thrombolytics
* Cardiogenic shock
* Cerebrovascular accident (CVA)
* Prolonged cardiopulmonary resuscitation (CPR)
* Blood pressure (BP) \> 180/100 mm Hg
* Active bleeding
* International Normalized Ratio (INR) \> 1.4
* Acetylsalicylic acid \[aspirin\] (ASA) or heparin allergy
* History of neutropenia, thrombocytopenia, hepatic dysfunction, or renal insufficiency
* Peripheral vascular disease (PVD)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Ziekenhuis de Weezenlanden
name: Felix Zijlstra, M.D.
role: PRINCIPAL_INVESTIGATOR
References: