louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00268645: Insulin Glargine in Type 2 Diabetes
Official title: Open Trial of the Safety and Efficacy of Lantus for Insulin Naive Type 2 Diabetes Mellitus Patients or Patients Who Use Insulin Combined With 1 or More Oral Antidiabetic Drugs and Don't Have Good Glycemic Control.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2005-12-22
Enrollment: 534
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of this project is to confirm the efficacy and safety profile of Insulin glargine in daily practice and to improve the physicians' knowledge and experience concerning Insulin glargine


Eligibility criteria: Inclusion Criteria:

* Type 2 Diabetes Mellitus patients,
* Diabetic patients receiving insulin or patients who are insulin-naive and whose glycemic control cannot be sufficiently maintained with single or combined oral antidiabetic agents,
* Patients with HbA1C\>8
* Patients able to self-measure its blood glucose levels.

Exclusion Criteria:

* According to package insert information (Summary of Product Characteristics)

Primary outcomes:
measure: For efficacy: FBG (Fasting Blood Glucose), HbA1c
Secondary outcomes:
measure: For safety: ICA (Insulin Cell Antibody)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Sanofi-Aventis
Study officials:
affiliation: Sanofi
name: Edibe Taylan
role: STUDY_DIRECTOR
References:
Clinical trial NCT02361645: NSAIDs and PGE2 Levels in Vitrectomy Patients
Official title: Vitreous Nonsteroidal Antiinflammatory Drus Concentrations And Prostaglandin E2 Levels in Vitrectomy Patients Treated With Indomethacin 0.5%, Bromfenac 0.09%, and Nepafenac 0.1%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vitreous Inflammation
Keywords: nonsteroidal antiinflammatory drugs
prostaglandin E2
vitrectomy
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
First posted: 2015-02-12
Enrollment: 70
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 assess vitreous concentrations of nonsteroidal antiinflammatory drugs (NSAIDs) and prostaglandin E2 in patients treated with NSAIDs before vitrectomy.

A total of 0.5 to 1 mL undiluted vitreous was removed from the midvitreous cavity at the beginning of the surgery before infusion with balanced salt solution. Samples were immediately frozen and stored at -40°C until analysis. Samples were evaluated in a masked fashion. Vitreous concentrations of the study drugs were quantified using a reverse-phase liquid chromatography mass spectroscopy system. The minimum quantification limit for ketorolac, bromfenac, nepafenac, and amfenac was 0.8 ng/mL. Prostaglandin E2 concentrations were determined using a commercially available competitive enzyme immunoassay kit (R \& D Systems, Minneapolis, MN).


Eligibility criteria: Inclusion Criteria:

* patients with pucker scheduled for vitrectomy

Exclusion Criteria:

* diabetes
* active inflammation

Primary outcomes:
measure: Prostaglandin E2 levels in the vitreous (pg/mL)
timeFrame: 7 days after NSAID TID administration, following vitrectomy
Secondary outcomes:
measure: NSAIDs concentration (ng/mL) into the vitreous
timeFrame: 7 days after NSAID TID administration, following vitrectomy
measure: Adverse events
timeFrame: 7 days after NSAID TID administration, following vitrectomy
Other outcomes:
Locations:
Study officials:
References:
citation: Morescalchi F, Russo A, Semeraro F. SURGICAL OUTCOMES OF VITREOMACULAR TRACTION TREATED WITH FOVEAL-SPARING PEELING OF THE INTERNAL LIMITING MEMBRANE. Retina. 2021 Oct 1;41(10):2026-2034. doi: 10.1097/IAE.0000000000003139.
Clinical trial NCT01530945: Mapping Multidimensional Illness Trajectories of Patients With End-stage Kidney Disease
Official title: Mapping Multidimensional Illness Trajectories of Patients With ESKD
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Kidney Disease
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: National Institute of Nursing Research (NINR)
First posted: 2012-02-10
Enrollment: 227
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: ESKD patients who have been on dialysis

Brief summary: Patients with end-stage kidney disease (ESKD) must manage not only the demands of dialysis and comorbid conditions but also associated symptoms and acute life-threatening events that contribute to functional limitations and increased risk of mortality. Yet little is known about the trajectories of quality of life dimensions in patients with ESKD when they experience acute life-threatening episodes, to guide palliative care for this population. In this prospective, descriptive study, we will identify trajectories of symptoms, physical functioning, psychosocial needs, and emotional and spiritual well-being in 200 patients with ESKD who are at a high risk of experiencing acute life-threatening events and mortality within 12 months.


Eligibility criteria: Inclusion Criteria:

* aged 18 years or older;
* receiving either Hemodialysis or Peritoneal dialysis
* on dialysis either \< 3 months or ≥ 6 months with a Charlson Comorbidity Index (CCI) score ≥ 5

Exclusion Criteria:

* Patients who are enrolled in hospice or too sick to participate in questionnaire completion will not be eligible.
* Kidney transplant candidates will be excluded because their illness trajectories after transplant are likely to differ.

Primary outcomes:
measure: Symptoms, physical functioning, psychosocial needs, spiritual well-being, cognitive functioning
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: UNC Hospitals and outpatient dialysis clinics
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Mi-Kyung Song, PhD, RN, FAAN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05303545: Physical Activity in People With Sequelae of Poliomyelitis
Official title: Physical Activity in People With Sequelae of Poliomyelitis : a Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Poliomyelitis
Keywords: Exercise
Disabled persons
Rehabilitation
Cross sectional studies
Social inclusion
Lead sponsor: Institut de Sante Parasport Connecte Synergies
Sponsor class: OTHER
Collaborators: name: Assistance Publique - Hôpitaux de Paris
First posted: 2022-03-31
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects with poliomyelitis sequelae.

Brief summary: People with disabilities are less physically active than the general population. At present, the physical activity level of people with poliomyelitis sequelae and their barriers to physical activity are unknown.

The aim of this study is to describe the physical activity level of people with poliomyelitis sequelae and their barriers to physical activity.

Detailed description: This is a cross-sectional, monocentric, cohort study of subjects with poliomyelitis sequelae followed in a Physical Medicine and Rehabilitation Department.

All consecutive eligible outpatient subjects consulting to the Physical Medicine and Rehabilitation Department of our university hospital will be included.

Data will be collected from the patients' medical records, in particular data related to their clinical, radiological, biological and physiological examinations.

It is an ancillary study to the NO-AGING study.

Eligibility criteria: Inclusion Criteria:

* Consulting to the Physical Medicine and Rehabilitation Department of our university hospital
* Having poliomyelitis sequelae
* No opposition to be enrolled in the study from the patient
* Affiliation to a social security scheme

Exclusion Criteria:

* Disability that does not allow the completion of questionnaires
* Acute intercurrent medical situation
* Use of electric wheelchair
* Under court protection.

Primary outcomes:
measure: Physical activity level
timeFrame: Baseline
Secondary outcomes:
measure: Barriers of physical activity
timeFrame: Baseline
Other outcomes:
Locations:
city: Garches
country: France
facility: Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France
name: François Genêt, MD-PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Physical Medicine and Rehabilitation, Raymond Poincaré Hospital, AP-HP, 92380 Garches, France
name: Vincent T Carpentier, MD-MSc
role: STUDY_CHAIR
References:
Clinical trial NCT02625545: Study of Median Lobe Prostatic UroLift Procedure
Official title: Study of Median Lobe Prostatic UroLift Procedure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Benign Prostatic Hyperplasia (BPH)
Lead sponsor: NeoTract, Inc.
Sponsor class: INDUSTRY
First posted: 2015-12-09
Enrollment: 45
Sex: MALE
Minimum age (years): 50
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 evaluate the safety and effectiveness of using UroLift in subjects with a prostatic median lobe enlargement due to benign prostatic hyperplasia (BPH).

Detailed description: Study Objectives: Evaluate the safety and effectiveness of the UroLift® System when used in symptomatic benign prostatic hyperplasia (BPH) subjects with an enlarged median lobe.

Study Design: Prospective, multicenter, non-blinded, single arm (non-randomized) study.

Sample Size: A total of no more than 48 subjects will be enrolled. Subject Population: Males age of 50 years or older diagnosed with lower urinary tract symptoms (LUTS) with enlarged median lobe.

Eligibility criteria: Inclusion Criteria:

* Enlarged median lobe (ML) contributing to obstruction of the prostate
* BPH

Exclusion Criteria:

-

Primary outcomes:
measure: At 6 Months, the 95% Lower Confidence Limit of the Mean Percent Improvement in IPSS Over Baseline for the UroLift System Must be ≥ 25%.
timeFrame: 6 months
Secondary outcomes:
measure: Intent to Treat Population International Prostate Symptom Scores at Baseline and 12 Month Follow-up
timeFrame: 12 Months
measure: Intent to Treat Population International Prostate Symptom Score Percent Change From Baseline to 12 Month Follow-up
timeFrame: 12 Months
measure: Intent to Treat Population Quality of Life Scores at Baseline and 12 Month Follow-up
timeFrame: 12 Months
measure: Intent to Treat Population Quality of Life Score Perfect Change From Baseline to 12 Month Follow-up
timeFrame: 12 Months
measure: Intent to Treat Population BPHII Scores at Baseline and 12 Month Follow-up
timeFrame: 12 Months
measure: Intent to Treat Population BPHII Score Percent Change From Baseline to 12 Month Follow-up
timeFrame: 12 Months
measure: Intent to Treat Population Peak Flow Rate Scores at Baseline and 12 Month Follow-up
timeFrame: 12 Months
measure: Intent to Treat Population Peak Flow Rate Percent Change From Baseline to 12 Month Follow-up
timeFrame: 12 Months
measure: Intent to Treat Population Post Void Residual Measurement at Baseline and 12 Month Follow-up
timeFrame: 12 Months
measure: Intent to Treat Population Post Void Residual Change From Baseline to 12 Month Follow-up
timeFrame: 12 Months
Other outcomes:
Locations:
Study officials:
affiliation: Wake Forest
name: Dan B. Rukstalis, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01840345: The Role of N-acetyl-l-cysteine (NAC) as an Adjuvant to Opioid Treatment in Patients With Chronic Neuropathic Pain
Official title: The Role of N-acetyl-l-cysteine (NAC) as an Adjuvant to Opioid Treatment in Patients With Chronic Neuropathic Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neuropathic Pain
Keywords: uncontrolled
neuropathic pain
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2013-04-25
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will test whether treatment with N-acetyl-L-cysteine (NAC) is safe and decreases pain in patients with chronic neuropathic pain. The investigators hypothesize that NAC will be a useful adjunct to opioid treatment in chronic neuropathic pain.

Detailed description: This is an open-label study to evaluate the safety and efficacy of N-acetyl-L-cysteine in patients with Chronic neuropathic pain.

Eligibility criteria: Inclusion Criteria:

* 18-65 years old
* non-cancer neuropathic pain
* stable dose of opioids for pain
* using breakthrough pain meds
* still with persistent pain per VAS

Exclusion Criteria:

* pregnant or nursing
* serious medical or psychiatric illness (including uncontrolled hypertension)
* active stomach ulcer, history or seizures or asthma
* breakthrough pain meds other than opioids
* using illicit drugs

Primary outcomes:
measure: Opioid Use
timeFrame: Baseline, 4 weeks
Secondary outcomes:
measure: Pain
timeFrame: Baseline, 4 weeks
measure: Mood
timeFrame: Baseline, 4 weeks
measure: Stress
timeFrame: Baseline, 4 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: Virginia Commonwealth University
name: Dace S Svikis, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03409445: Validation of a Food Frequency Questionnaire for the Assessment of Omega-3 Fatty Acid Intake
Official title: Validation of a Food Frequency Questionnaire for the Assessment of Omega-3
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Lead sponsor: Swiss Federal Institute of Technology
Sponsor class: OTHER
Collaborators: name: University Children's Hospital, Zurich
First posted: 2018-01-24
Enrollment: 152
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults

Brief summary: As essential nutrients omega 3 fatty acids contribute to normal growth and development. Inadequate intake is linked to the development of chronic diseases such as coronary heart disease, high blood pressure, cancer, arthritis, psychological illnesses and allergies. Therefore, it is important to be able to reliably detect the intake of these fatty acids. Due to eating habits varying in different countries the questionnaire documenting dietary habits needs to be adapted to the situation in question. Based on a US version the investigators developed a questionnaire suitable for Switzerland and now wish to validate it by measuring the fatty acid composition of red blood cells, which will provide information on the intake of the various fatty acids.


Eligibility criteria: Inclusion Criteria:

* healthy males and females aged 18 to 60

Exclusion Criteria:

* known disorders of the gastrointestinal tract which can lead to malabsorption
* intake of medication which could affect the absorption of any nutrients
* Pregnant or breast-feeding women

Primary outcomes:
measure: Fatty acid composition of red blood cells due to dietary habits
timeFrame: 1 day ( first visit)
Secondary outcomes:
Other outcomes:
Locations:
city: Zürich
country: Switzerland
facility: ETH Zurich
Study officials:
References:
Clinical trial NCT06651645: Pre- vs Post-Pandemic Risk-adjusted Survival Rates in the US Hospitals
Official title: Pre- vs Post-COVID-19 Pandemic Risk-adjusted Survival Rates in the US Hospitals: Retrospective Cohort Study of Hospital Performance
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: In-hospital Mortality
Non-COVID Deaths
Surge
Keywords: In-hospital mortality
Post pandemic hospital performance
Surge
Hospital recovery
Hospital performance
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2024-10-22
Enrollment: 30000000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult inpatients admitted to a hospital represented with the PINC-AI hospital database.

Brief summary: This study aims to perform a retrospective cohort study of administrative health data to understand how care delivery performance varies across US hospitals post-COVID-19 pandemic compared to the pre-pandemic performance. We also hope to identify which factors contribute to performance changes.


Eligibility criteria: The study cohort will include one random encounter per patient for all adult (age ≥18years) encounters. All inpatients with the Premier healthcare database (PINC-AI) and those patients who were admitted under observation status and expired in the hospital or those who presented acutely to the emergency department and died in the emergency department will be considered as inpatients for the purpose of this study as per prior precedence in including such patients.

All pediatric inpatients, skilled nursing facilities inpatients, long term acute care inpatients, rehabilitation facility inpatients, psychiatric inpatients, hospice inpatients, chemical dependency unit inpatients and deceased organ donor inpatients are excluded after applying encounter level exclusion criteria from this inpatient cohort. Application of this encounter level exclusion will also preferentially exclude any children hospitals, skilled nursing facilities, acute long term care facilities, psychiatry hospitals, inpatient hospices and chemical dependency units.

Primary outcomes:
measure: Adjusted in-hospital mortality
timeFrame: During hospital admission
Secondary outcomes:
measure: Rates of potential inpatient complications (PICs)
timeFrame: During hospital admission
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health
state: Maryland
Study officials:
affiliation: Grand Island Regional Medical Center
name: Maniraj Neupane, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06231745: Paroxetine Safety and Efficacy in Rheumatoid Arthritis
Official title: The GRK2 Inhibitor Paroxetine as a Novel Adjunct to Conventional Therapy in Rheumatoid Arthritis Patients.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Rheumatoid Arthritis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 100
Sex: ALL
Minimum age (years): 23
Maximum age (years): 57
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rheumatoid arthritis (RA) is a systemic chronic auto-inflammatory disorder which imposes a remarkable burden of morbidity and mortality on global health. The complex interaction between genetics, environment, and immunological response contribute to RA pathogenesis. Current treatment comprises conventional disease-modifying anti-rheumatic drugs (DMARDs) followed by biological DMARDs, if necessary, to achieve low disease activity or remission. Therapeutics used in RA had limitations in tolerability, access, and response duration and magnitude. Consequently, implementation of safe adjunctive treatment for RA is urgently needed to boost the therapeutic response.


Eligibility criteria: Inclusion Criteria:

* Aged 23-57 years fulfilling 2010 American College of Rheumatology - European League against Rheumatism (ACR-EULAR) classification criteria for RA (12) and had active inflammatory RA with no limit in disease duration.
* Patients received MTX, nonsteroidal anti-inflammatory drugs, selective cyclooxygenase-2 inhibitors, acetaminophen, and low dose of oral corticosteroids will be allowed to enroll the trial
* Intravenous, intra-articular or intramuscular corticosteroids; intra-articular hyaluronate sodium; biological DMARDs; and other DMARDs will not be permitted less than 4 weeks before the first dose of paroxetine.

Exclusion Criteria:

* patients refusing to give informed consent, diabetes, congestive heart failure, previous adverse reaction to paroxetine, oral prednisolone greater than 10 mg/day, receiving biological DMARDs, severe anemia, active infection, pregnancy or lactation, and clinically significant renal or hepatic disease.

Primary outcomes:
measure: The primary efficacy end point will be the change in the 28-joints disease activity score (DAS28).
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Damietta
country: Egypt
facility: Mostafa Bahaa
state: New Damietta
Study officials:
References:
Clinical trial NCT05776745: Study of Speech Function in Epileptic Patients Based on Stereoelectroencephalography Signal
Official title: Study of Speech Function in Epileptic Patients Based on Stereoelectroencephalography Signal
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Epilepsy
Keywords: Epilepsy
Stereoelectroencephalography
Speech
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 5
Sex: ALL
Minimum age (years): 16
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Based on stereoelectroencephalography model in the treatment of epilepsy patients, this study conducted language-related experimental studies without interfering with normal monitoring treatment. Meanwhile, voice data and intracranial electrophysiological data were collected for analysis. To study the mechanism related to the language function of patients, try to establish a model to decode the intracranial electrophysiological data related to language.


Eligibility criteria: Inclusion Criteria:

* Patients with focal refractory epilepsy also need preoperative evaluation with SEEG

Exclusion Criteria:

* History of major depression or psychiatric disorders and medication that causes symptoms of psychiatric disorders
* Patients with severe cognitive impairment (MMSE score ≤15), unable to complete the language function test

Primary outcomes:
measure: Phonetic Feature Encoding in Human Superior Temporal Gyrus
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang University School of Medicine Second Affiliated Hospital
state: Zhejiang
Study officials:
References: