louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00303407: Prophylaxis of Venous Thrombo-Embolism in Cancer Patients Under Palliative Care
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cancer
Venous Thromboembolism
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
First posted: 2006-03-16
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: To determine the efficacy and to measure the complications of prophylactic anticoagulation using low-molecular weight heparin in adult cancer patients under palliative care


Eligibility criteria: Inclusion Criteria:

* Cancer patients in palliative care
* Patients fully informed about their condition
* Signed informed consent
* No exclusion criteria

Exclusion Criteria:

* Absence of advanced cancer
* Cancer previously cured
* Venous thromboembolism diagnosed within 6 months prior to inclusion
* Absence of discerning capacity
* Active anti-thrombotic treatment with heparins or coumarines
* Thrombocytopenia \<50G/l
* PTT \>45sec
* TP\<35%
* Active bleeding
* Renal failure \<20ml/min
* Past history of heparin-induced thrombocytopenia

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Collonge-Bellerive (Geneva)
country: Switzerland
facility: Center of Continuous Care, chemin de la Savonnière
state: Geneva
Study officials:
affiliation: Center of Continuous Care, chemin de la Savonnière 11, CH-1245 Collonge-Bellerive
name: Catherine Weber, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Prandoni P. Antithrombotic strategies in patients with cancer. Thromb Haemost. 1997 Jul;78(1):141-4.
Clinical trial NCT00716807: Efficacy of Nalbuphine and Naloxone Administered as Nose Sprays in the Treatment of Orofacial Pain
Official title: Modeling Kappa Opioid Analgesic Mechanisms in Chronic Orofacial Pain Disorders
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Temporomandibular Joint Dysfunction Syndrome
Burning Mouth Syndrome
Keywords: BMS
TMD
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2008-07-16
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Patients with chronic masticatory muscle pain (i.e., pain greater than three months) or patients with burning mouth syndrome participate in this study. The aim of the study is to compare the pain killing effectiveness of nalbuphine, a narcotic pain killer, administered with either placebo or naloxone, a drug used to treat opiate overdose. A second goal is to determine if there are sex differences in these two drug regimens. Drugs will be administered with single-use intranasal spray devices. All participants will receive two sprays (one spray per nostril). One of the two sprays will be nalbuphine (5 mg). The other spray will be naloxone in half the participants and placebo in the other half.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of temporomandibular muscle pain OR
* Clinical diagnosis of burning mouth syndrome
* Pain duration: at least 3 months
* Pain severity: 2 or greater on a 0 - 10 scale

Exclusion Criteria:

* No adverse reaction to study drugs
* Not currently using narcotic analgesic drugs

Primary outcomes:
measure: Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100.
timeFrame: 20 minute intervals for three hours.
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Jon D Levine, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01270607: Acupuncture and Pain Processing
Official title: Acupuncture and Pain Processing
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2011-01-05
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to test the hypothesis that acupuncture will reduce Fibromyalgia pain, via alterations in the processing of pain in the central nervous system.

Detailed description: Patients and healthy controls will be enrolled in the study for a total of 6 weeks. This includes a screening and baseline visit, 8 acupuncture treatments (2 per week for 4 weeks), and a follow-up visit and treatment 1 week after completion of the study treatment sessions. To determine the effects of acupuncture on pain, patients and healthy controls will undergo psychophysical pain testing at four points throughout the study: Baseline (appointment 1), post-treatment 1 (appointment2), post treatment 8 (appointment 9), and at the final follow-up session (1 week from last treatment - appointment 10).Participants will also fill out a brief report on pain, sleep, and functioning on a palm pilot. This is expected to take less than 2 minutes per day and will occur throughout the 6 week study period.

Eligibility criteria: Inclusion Criteria:

1. Age 18-50
2. Fibromyalgia patient OR healthy control
3. No current opioid use
4. Patients: must have had Fibromyalgia for 6 months or longer

Exclusion Criteria:

1. Inflammatory disorder (lupus, rheumatoid arthritis)
2. Current untreated depression
3. Active infection
4. Healthy controls: pain disorder or major medical condition that in the discretion of the investigator interfere with the validity of the study
5. Heart disease or use of a cardiac pacemaker

Primary outcomes:
measure: Pain rating to Temporal Summation and Diffuse Noxious Inhibitory Control (DNIC) as measured by a visual analogue scale
timeFrame: Measured at last study acupuncture session (6 weeks post enrollment)
Secondary outcomes:
measure: Change in Fibromyalgia Impact Questionnaire
timeFrame: Change from first to last study treatment session (6 weeks)
measure: Change in Brief Pain Inventory
timeFrame: Change from first to last treatment session (6 weeks)
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University School of Medicine
state: California
Study officials:
affiliation: Stanford University
name: Sean Mackey
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03518307: Epidemiology of Merkel Carcinomas in the Bas-Rhin
Official title: Epidemiology of Merkel Carcinomas in the Bas-Rhin From 1983 to 2011: General Population Study Based on the Bas-Rhin Cancer Registry
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Merkel Carcinoma
Keywords: Merkel carcinoma
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-05-08
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients residing in the Bas-Rhin and diagnosed between 1983 and 2011 as having primitive Merkel arcinoma (topographic code C44 morphological code 8247/3)

Brief summary: The aim of this work is to study demographic, clinical, management (diagnostic and therapeutic) and survival data concerning patients with Merkel's carcinoma in the Lower Rhine, thus obtaining the first French data.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Diagnosis of primary Merkel carcinoma (topographic code C44 morphological code 8247/3)
* Diagnosis made between 1983 and 2011
* Patient residing in the Bas-Rhin at the date of diagnosis
* Patient who has given his consent for the use of his data for research purposes

Exclusion Criteria:

- Refusal to participate in research

Primary outcomes:
measure: Retrospective study of demographic, clinical, management (diagnostic and therapeutic) and survival data for patients with Merkel carcinoma in the Lower Rhine region
timeFrame: The period from from January 1st, 1983 to December 31st, 2011 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de Dermatologie
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Dan LIPSKER, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01364207: The Effects of Caffeinated Coffee on Intraocular Pressure
Official title: The Effects of Caffeinated Coffee on Intraocular Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Primary Open Angle Glaucoma
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
First posted: 2011-06-02
Enrollment: 112
Sex: ALL
Minimum age (years): 40
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: High intraocular pressure (IOP) is a known risk factor for developing primary open-angle glaucoma (POAG). There is controversy in the literature regarding the degree to which caffeine influences IOP, with some studies reporting minimal changes in IOP while others report up to 4 mmHg increases. To date there are no double-masked randomized controlled trials that examine acute caffeinated coffee's effects on IOP in patients with or at risk for primary open-angle glaucoma. The investigators aim to better understand the relationship between acute caffeinated coffee (vs decaffeinate coffee) consumption and IOP in a double-masked, crossover randomized controlled clinical trial.


Eligibility criteria: Inclusion Criteria:

* 40-89 yrs
* POAG for cases or no forms of glaucoma for controls
* Willingness to drink coffee
* Consent signed

Exclusion Criteria:

* Age less than 40 or greater than 89 yrs
* all forms of glaucoma other than POAG
* any condition inappropriate for tonometry (ie corneal disease, LASIK)
* unable or unwilling to give consent
* unable or unwilling to drink coffee
* pregnancy

Primary outcomes:
measure: Change in Intraocular Pressure at 60 Minutes
timeFrame: Prior to coffee ingestion (baseline), 60 minutes post coffee ingestion
measure: Change in Intraocular Pressure at 90 Minutes
timeFrame: Prior to coffee ingestion (baseline), 90 minutes post coffee ingestion
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts Eye and Ear Infirmary
state: Massachusetts
Study officials:
affiliation: Massachusetts Eye and Ear Infirmary
name: Louis R Pasquale, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04794907: Retinal Care Data Repository
Official title: Retinal Care Data Repository
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Diabetic Retinopathy
Age Related Macular Degeneration
Lead sponsor: Retinal Care Inc.
Sponsor class: INDUSTRY
First posted: 2021-03-12
Enrollment: 1000
Sex: ALL
Minimum age (years): 0
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The DR cohort includes any patient with diabetes. The AMD cohort includes patients 55 years and older.

Brief summary: The Retinal Care Data Repository's primary objective is to make data available for Retinal Care to develop algorithms that improve the care of people with retinal diseases.

Detailed description: The initial focus is to develop algorithms that prevent, delay the progression, or improve treatment of diabetic retinopathy (DR) and age-related macular degeneration (AMD). Examples include but are not limited to: describing the incidence, prevalence, and severity distribution of DR and AMD in the overall population and subgroups; diagnosing specified severity thresholds for DR and AMD; predicting the development and progression of DR and AMD for the overall population, subgroups, and individuals; and recommending tests and treatments to prevent or delay the progression of DR and AMD for the overall population, subgroups, and individuals.

Data will be collected retrospectively and prospectively.

Eligibility criteria: Inclusion Criteria:

* Diabetes or age 65 years and older

Exclusion Criteria:

* None

Primary outcomes:
measure: Risk Stratification
timeFrame: Decade
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Retinal Care Inc.
name: Stephen R Fransen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01130207: Microbes and Bariatric Surgery
Official title: Effects of Bariatric Surgery on the Gastro-intestinal Microflora
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Diabetes
Periodontal Disease
Keywords: Obesity
Diabetes
Periodontal disease
Lead sponsor: State University of New York - Upstate Medical University
Sponsor class: OTHER
First posted: 2010-05-25
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with obesity who are already accepted for treatment by bariatric surgery in Syracuse NY

Brief summary: The investigators will study people who are obese and will be treated by bariatric surgery. The investigators will test the hypothesis that some of the features of obesity are related to the bacteria in the gastro-intestinal tract.


Eligibility criteria: Inclusion Criteria:

* Ages 18-65
* Will undergo bariatric surgery for treatment of obesity in Syracuse NY
* Willingness to participate

Exclusion Criteria:

* Any previous gastrointestinal surgery
* Use of antibiotics in the previous 3 months

Primary outcomes:
measure: Changes in microflora after bariatric surgery
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Syracuse
country: United States
facility: Upstate Medical University
state: New York
Study officials:
References:
Clinical trial NCT04047407: Suprathreshold Pressure Pain Stimulation in Fibromyalgia
Official title: Pain Response Characteristics to Different Doses of Suprathreshold Pressure Stimulation in Fibromyalgia Subjects
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Fibromyalgia
Keywords: Reffered pain
Pain sensitivity
Fibromyalgia
Suprathreshold
Central sensitization
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2019-08-06
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subject recruitment will be carried out in a local fibromyalgia association. Healthy volunteers will be recruitment among hospital and university workers.

Brief summary: The purpose of this study is to investigate the induced-pain characteristics after suprathreshold pressure stimulation at different intensities in fibromyalgia subjects, compared with healthy volunteers.

Detailed description: Fibromyalgia syndrome is a chronic painful, non-inflammatory rheumatic disease with a high negative impact on the quality of life, and is characterized by widespread pain, fatigue and generalised hyperalgesia on examination, symptoms that can be the consequence of central sensitization.

Despite several methods have successfully addressed this increased responsiveness of nociceptive neurons in the central nervous system, there is a lack of consensus about how to systematically perform them and those that are more appropriated for different syndromes. Therefore, investigating appropriate simple methods to assess clinical manifestations of central sensitization is relevant in the assessment of fibromyalgia.

The present study aims to investigate the pain response after suprathreshols pressure stimulation in fibromyalgia subjects compared with healthy volunteers.

Eligibility criteria: Inclusion Criteria:

* Age between 18 and 80 years
* Fullfilled the American Collegue of Rheumathology criteria for fibromyalgia.
* Understanding of spoken and written Spanish.

Exclusion Criteria:

* Diagnosed psychiatric pathology.
* Rheumatic pathology not medically controlled.

Primary outcomes:
measure: Referred pain induced area after suprathreshold pressure stimulation
timeFrame: Inmediately after each stimulation
Secondary outcomes:
measure: Pain intensity
timeFrame: Inmediately after each stimulation
measure: Body regions afected by pain after suprathreshold pressure stimulation
timeFrame: Inmediately after each stimulation
Other outcomes:
Locations:
city: Talavera De La Reina
country: Spain
facility: Hospital General Nuestra Señora del Prado
state: Toledo
Study officials:
affiliation: University of Castilla-La Mancha
name: Rubén Arroyo Fernández, MsC, PT
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04918407: Effects of Empagliflozin in Reducing Oxidative Stress After Kidney Transplantation
Official title: Effects of Empagliflozin in Reducing Oxidative Stress of Diabetic Recipients After Kidney Transplantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Kidney Transplant; Complications
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 40
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: The purpose of this study is to investigate the effect of empagliflozin on oxidative stress in patients with type 2 diabetes after kidney transplantation. The association is examined by comparing the difference in oxidative modifications before and after 90 days treatment with 25 mg empagliflozin plus insulin compared to insulin treatment. The study is randomised and double-blinded. Each treatment group consists of 20 patients. Oxidative stress markers are measured by serum level of superoxide dismutase activity ,lipid peroxidation assay kit, glutathione assay, glutathione peroxidase activity , total antioxidant capacity assay oxidant status , carbonyl content assay and bca protein assay . . A student t-test will be performed to compare adding empagliflozin . The results will be published in a peer-review journal.

Detailed description: With the purpose of studying the antioxidant activity of empagloflozin 25mg will add on insulin in 20 patients after kidney transplant and will compare with 20 diabetic recipient of kidney transplant on insulin therapy alone.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with type 2 diabetes
* HbA1c: 6.5-9.0%
* post kidney transplant
* stable graft function

Exclusion Criteria:

* pancreas and kidney transplant
* history of recurrent urinary tract infection

Primary outcomes:
measure: serum level of superoxide dismutase
timeFrame: Change from baseline after 90 days of intervention
Secondary outcomes:
measure: Plasma levels of malondialdehyde
timeFrame: Change from baseline after 90 days of intervention
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Labbafinezhd Hospital
city: Tehran
country: Iran, Islamic Republic of
facility: SBMU
Study officials:
affiliation: Shahid Beheshti University of Medical Sciences
name: Nooshin Dalili
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05944107: Anticoagulation Management in Complex Cardiac Surgery
Official title: Impact on Anticoagulation Management When Activated Clotting Time is Combined With Heparin Concentration Monitoring in Cardiac Surgery: a Randomised Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Extracorporeal Circulation
Keywords: anticoagulation
cardiopulmonary bypass
heparin
titration
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2023-07-13
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this clinical trial is to compare the anticoagulation management with or without heparin concentration level guidance, in patients undergoing valve or complex cardiac surgery during cardiopulmonary bypass using closed, coated circuits. The main questions it aims to answer are:

* initial heparin bolus, subsequent supplementary doses and total heparin variance among groups.
* protamine dose among groups.

Participants are adult patients scheduled for valve or complex cardiac surgery. They are randomised to either Activated Clotting Time guided management alone or combined with heparin level concentration monitoring.


Eligibility criteria: Inclusion Criteria:

* elective procedures
* cardiac surgery, except for Coronary Artery Bypass Grafting
* Cardiopulmonary bypass under Minimally Invasive Extracorporeal Circulation

Exclusion Criteria:

* known allergy to heparin or protamine
* hematological disease

Primary outcomes:
measure: Heparin dose
timeFrame: Bolus dose before cardiopulmonary bypass
measure: Heparin dose
timeFrame: Total dose after cardiopulmonary bypass
measure: Protamine dose
timeFrame: Total dose after cardiopulmonary bypass
Secondary outcomes:
measure: Platelet count
timeFrame: Immediately after surgery
measure: Platelet count
timeFrame: 24 hours after surgery
measure: Platelet count
timeFrame: 48 hours after surgery
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: AHEPA University Hospital, Aristotle University of Thessaloniki
Study officials:
affiliation: AHEPA University Hospital, Aristotole University of Thessaloniki
name: Helena Argiriadou, Dr
role: STUDY_DIRECTOR
References:
Clinical trial NCT03159507: Effect of Omega-3 Index on Cellular Metabolism and Quality of Life
Official title: Effect of Omega-3 Index on Cellular Metabolism and Quality of Life Following the Administration of a Customized Dose of Omega-3 Oil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Omega-3 Index
Cellular metabolism
EPA Monoglyceride
Quality of life
Lead sponsor: SCF Pharma
Sponsor class: INDUSTRY
Collaborators: name: Université du Québec à Rimouski
First posted: 2017-05-18
Enrollment: 16
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, single arm trial where each participant receives a personalized dose
Primary purpose: BASIC_SCIENCE

Brief summary: Determine whether personal optimization of the Omega-3 index improves cellular metabolism and quality of life (according to the SF-36 form).


Eligibility criteria: Inclusion Criteria:

* Participant aged 19 or over
* Available for the entire duration of the study and willing to participate on the basis of the information provided in the FIU duly read and signed.

Exclusion Criteria:

* Allergy known to fish
* Pregnant women who breast-feed or test positive for pregnancy

Primary outcomes:
measure: Omega-3 Index
timeFrame: 8 weeks
Secondary outcomes:
measure: Cellular metabolism
timeFrame: 8 weeks
measure: Quality of life
timeFrame: 8 weeks
measure: Heart rate
timeFrame: 8 weeks
measure: Total Cholesterol
timeFrame: 8 weeks
measure: Triglycerides
timeFrame: 8 weeks
measure: HDL-cholesterol
timeFrame: 8 weeks
measure: LDL-cholesterol
timeFrame: 8 weeks
measure: Alanine aminotransferase
timeFrame: 8 weeks
measure: Aspartate aminotransferase
timeFrame: 8 weeks
measure: Bilirubin
timeFrame: 8 weeks
measure: Albumin
timeFrame: 8 weeks
measure: C-reactive protein
timeFrame: 8 weeks
measure: Apolipoprotein B
timeFrame: 8 weeks
measure: Erythrocyte sedimentation rate
timeFrame: 8 weeks
measure: Systolic blood pressure
timeFrame: 8 weeks
measure: Diastolic blood pressure
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Rimouski
country: Canada
facility: SCF Pharma
state: Quebec
Study officials:
affiliation: SCF Pharma
name: Anne-Julie Landry, MSc
role: STUDY_DIRECTOR
References: