louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03476538: Bariatric Surgery and Pharmacokinetics of Gabapentin
Official title: Bariatric Surgery and Pharmacokinetics Gabapentin: BAR-MEDS Gabapentin
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity, Morbid
Keywords: Bariatric surgery
Gastrointestinal tract
Biological availability
Pharmacokinetics
Gabapentin
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
name: Volvat Medisinsk Senter Stokkan
name: Namsos Hospital
name: Alesund Hospital
First posted: 2018-03-26
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients referred for bariatric surgery (gastric bypass or sleeve gastrectomy)

Brief summary: Changes to gastric pH, gastric emptying time, gastrointestinal transit-time or the pre-systemic metabolizing effect of enzymes secreted in the mucosa may all alter the pharmacokinetics of medicines. These factors are potentially influenced by bariatric surgery. Little is so far known about how gastric bypass and sleeve gastrectomy impacts the biological availability of medication. In this study the pharmacokinetic effects of bariatric surgery on gabapentin are investigated.


Eligibility criteria: Inclusion Criteria:

* Preparing to undergo gastric bypass or sleeve gastrectomy in Central Norway
* Being a Norwegian citizen

Exclusion Criteria:

* Having previously undergone resections in the GI-tract

Primary outcomes:
measure: gabapentin concentration in blood serum (area under curve (AUC))
timeFrame: From baseline to 1 year postoperatively
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St. Olavs University Hospital
Study officials:
affiliation: St. Olavs University Hospital
name: Magnus Strømmen, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06907238: The Value of Novel Thrombus Markers in the Diagnosis and Treatment of Acute Pulmonary Embolism
Official title: The Value of Novel Thrombus Markers in the Diagnosis and Treatment of Acute Pulmonary Embolism
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Acute Pulmonary Embolism
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2025-04-02
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 200 patients in APE group and 200 patients in non APE group each

Brief summary: In response to the high mortality rate of patients with acute pulmonary embolism (APE) and the fact that only a small proportion of deceased patients can receive correct diagnosis, this study will use a sensitive, non-invasive, and feasible new thrombus molecular marker (TAT/PIC/TM/t-PAIC) to detect and evaluate the activation of the coagulation and fibrinolysis systems and endothelial system damage in patients, in order to monitor the early diagnosis and treatment of APE, reduce mortality, and improve patient quality of life. Therefore, this study intends to include 200 newly diagnosed APE patients to evaluate the sensitivity and specificity of the single and combined application of novel thrombus molecular markers for APE diagnosis; Detect the biomarker results of patients at different time points before and after treatment, and evaluate their value in APE treatment monitoring; Track and follow up on patients after discharge to explore the prognostic value of biomarkers for APE.


Eligibility criteria: Inclusion Criteria:

* 1.Patients diagnosed with APE for the first time through CTPA in clinical practice and who have not received anticoagulant therapy in the past month; 2.Age ≥ 18 years old.

Exclusion Criteria:

* 1. Complicated with other thrombotic diseases, complicated with important organ damage such as heart, liver, kidney, and previous history of pulmonary embolism; 2. Malignant tumors; 3. Renal dialysis patients; 4. Antiphospholipid syndrome; 5. Immune system diseases; 6. Hematological diseases; 7. DIC caused by severe infection; 8. Patients judged by clinicians to be unfit for clinical practice.

Primary outcomes:
measure: New thrombusmarkers (TAT/PIC/TM/t-PAIC)
timeFrame: Data of patients on the first, the fourth day, seventh and tenth days after admission for diagnosis. If the duration of hospitalization is ≤ 7 days, data will be collected only three times
Secondary outcomes:
measure: Conventional coagulation indicators, PT、APTT、FIB、D-Dimer and FDP
timeFrame: Data of patients on the first, the fourth day, seventh and tenth days after admission for diagnosis. If the duration of hospitalization is ≤ 7 days, data will be collected only three times
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00130338: Rivastigmine Capsules in Patients With Probable Vascular Dementia
Official title: An Open-label Extension to Evaluate the Efficacy and Safety of Rivastigmine Capsules in Patients With Probable Vascular Dementia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Vascular Dementia
Keywords: Dementia
Vascular
Rivastigmine
Stroke
Memory loss
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-15
Enrollment: 521
Sex: ALL
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this research study is to evaluate, in the open-label extension phase, the effectiveness, tolerability and safety of rivastigmine capsules in males and females between the ages of 50 and 85 years old with probable vascular dementia.


Eligibility criteria: Inclusion Criteria:

* Patients who complete the double-blind treatment phase or those who have dropped out early in the study, but have returned for all the remaining scheduled efficacy assessments (retrieved drop-out patients) without significant protocol violations are eligible to participate.

Exclusion Criteria:

* Retrieved drop-out patients, who have been treated with other cholinergic drugs during the past 4 weeks

Primary outcomes:
measure: Safety and tolerability of rivastigmine for up to 52 weeks of treatment in patients with VaD and probable VaD
Secondary outcomes:
measure: 52 week's treatment with rivastigmine on cognition, activities of daily living, behavior and clinical staging in patients with VaD and probable VaD
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02817438: Research on Anxiety and Depression: Computer-Assisted Therapy
Official title: Research on Anxiety and Depression: Computer-Assisted Therapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mood Disorders
Anxiety Disorders
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study examines how online self-guided programs can improve mood and anxiety symptoms. These programs use exercises from Cognitive-Behavioral Therapy, which is an evidence-based treatment for depression and anxiety. The purpose of this study is to learn who will do best with the online format. Our aim is to learn for whom online self-guided interventions are most efficacious. This knowledge is important because it will help inform clinicians and patients about who might benefit from this type of intervention versus who would need the assistance of a therapist. More specifically, we hope to figure out who would benefit from solely an online intervention and who would benefit from an online intervention in addition to other treatment.


Eligibility criteria: Inclusion Criteria:

* Previous participation in the RAD study in our laboratory

RAD study inclusion criteria are:

* 18+ years of age
* Fluent and literate in English
* Can provide informed consent
* fMRI scanning eligibility, including no evidence of any form of metal embedded in the body (e.g., metal wires, nuts, bolts, screws, plates, sutures)

Exclusion Criteria:

* Anyone who has not already completed the RAD study will be excluded.

RAD study exclusion criteria are:

* Presence of suicidal ideations representing imminent risk
* General medical condition, disease, or neurological disorder that interferes with the assessments
* Mild traumatic brain injury (history of physical brain injury or blow to the head resulting in loss of consciousness greater than five minutes) and which could interfere with doing the assessments
* Severe impediment to vision, hearing and/or hand movement, likely to interfere with ability to complete the assessments
* Unable and/or unlikely to follow the study protocols
* Pregnant or breastfeeding

Primary outcomes:
measure: Depression and Anxiety Composite Score
timeFrame: 12 weeks
Secondary outcomes:
measure: Quality of Life
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Tali Ball, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00506038: Efficacy Study of Fine Needle Technique on Calcific Tendinitis
Official title: Phase 2 Study of the Fine Needle Technique on Calcific Tendinitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Tendinitis
Keywords: Calcific Tendinitis
Lead sponsor: Hadassah Medical Organization
Sponsor class: OTHER
First posted: 2007-07-25
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Background: Calcific tendinitis of the rotator cuff may cause chronic pain at the shoulder. Sometimes the pain can lead to a serious impairment in the daily life.

One of the most efficient treatments is percutaneous needle aspiration using ultrasound guidance.

This treatment includes identification the tendonitis with US or screening , local anesthesia and then puncturing the calcium in the rotator cuff many times. The treatment is short 5-10 minutes, relatively cheap ,safe and usually with good outcomes. However in the literature there is a lack of controlled prospective trials.

Our goal is to set a study that will evaluate this treatment between two groups:

1. Puncturing the calcium in the rotator cuff 15 times (the experiment group)
2. Puncturing the calcium in the rotator cuff twice (the controlled group)


Eligibility criteria: Inclusion Criteria:

1. Age 18 and above.
2. 6 months of pain in the shoulder.
3. Positive IMPING and sensitivity on SST.
4. Calcification above 1 cm in one of the dimensions by US or aray of the shoulder.
5. Completed conservative treatment: physiotherapy or analgesics.

Exclusion Criteria:

1. Diabetes, Nephrological diseases
2. RC tear according to US.
3. Prior operation in this shoulder
4. Steroids injection in the last three months.
5. A patient that is in the absorption phase of the tendinitis
6. Pregnancy
7. Coagulation System impairments

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hadassah Medical Organization
name: Ori Safran, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hadassah Medical Organization
name: Charles Milgrom, Prof.
role: STUDY_CHAIR
References:
Clinical trial NCT01962038: A Combined Training Program for Veterans With Amnestic Mild Cognitive Impairment
Official title: A Combined Training Program for Veterans With Amnestic Mild Cognitive Impairment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Amnestic Mild Cognitive Impairment
Keywords: Mild Cognitive Impairment
Aging
Lead sponsor: Palo Alto Veterans Institute for Research
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2013-10-14
Enrollment: 72
Sex: ALL
Minimum age (years): 50
Maximum age (years): 90
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 examine the efficacy of a combination physical exercise and cognitive training program on improving memory in older Veterans with amnestic Mild Cognitive Impairment.


Eligibility criteria: Inclusion Criteria:

* diagnosis of amnestic Mild Cognitive Impairment
* available informant
* visual and auditory acuity to allow neuropsychological testing
* willingness to participate in exercise training + cognitive training for 8 months
* approval of primary provider to participate in exercise trial

Exclusion Criteria:

* current severe psychiatric disorder
* diagnosis of dementia
* history of neurological or system illness affecting CNS function
* acute illness or unstable chronic illness
* current severe cardiac disease
* inability to exercise consistently because of orthopedic or musculoskeletal problems
* morbid obesity
* inability to read, verbalize understanding and voluntarily sign the informed consent

Primary outcomes:
measure: Change from Baseline to 28 weeks in delayed recall of a word list
timeFrame: Baseline, 24 weeks, 28 weeks
measure: Change from Baseline to 28 weeks in Delayed Recall of Names-Face Task
timeFrame: Baseline, 24 weeks, 28 weeks
Secondary outcomes:
measure: Non-Cognitive Outcomes (Depression, Sleep, Quality of Life)
timeFrame: Baseline, Time 2, Time 3
Other outcomes:
measure: Exercise Assessment
timeFrame: Baseline, Time 2, and Time 3
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System
state: California
Study officials:
affiliation: VA Palo Alto Health Care System
name: Jennifer K Fairchild, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02678390: Medium Chain Triglycerides and Aerobic Exercise on Ketone Production in Women With or Without Prediabetes
Official title: Stimulating the Production of Ketones Through the Combined Use of Aerobic Exercise (AE) and Dietary a Medium Chain Triglycerides (MCT) Supplement
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prediabetic State
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2016-02-09
Enrollment: 20
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to compare the effect on ketone production of dietary an MCT supplement combined or not with physical exercise in two groups of women (N=10/group), healthy adults and patients with prediabetes. After an evaluation of the metabolism (a 4-hour visit with multiple blood samples) at the beginning of the study, all the participants are taken for one-week the MCT supplement alone follow by a one-week period of taking the MCT supplement in combination with physical exercise. At the end of each period of time, the 4-hour visit for the evaluation of the metabolism is repeated.


Eligibility criteria: Inclusion Criteria:

* Healthy women group: fasting blood glucose \< 6.1 mmol/L and HbA1c \< 6.0 %.
* Women with prediabetes: fasting blood glucose between 6.1 and 6.9 mmol/L and HbA1c between 6.0 and 6.4 %

Exclusion Criteria:

* Structured physical activity (more than 2 times per week)
* Inability to practice physical exercise
* Diabetes (fasting glucose ≥ 7.0mmol/L or HbA1c ≥ 6.5%)
* Uncontrolled dyslipidemia or hypertension
* Use of medications known to affect the metabolism of lipids and carbohydrates (steroids, beta-blockers, diuretics, insulin sensitizers, etc.)
* Severe infections or inflammations

Primary outcomes:
measure: Plasma Ketone Concentrations
timeFrame: 5 days
Secondary outcomes:
measure: Plasma Glucose Concentrations
timeFrame: 5 days
measure: Plasma Triglyceride Concentrations
timeFrame: 5 days
measure: Plasma Free Fatty Acid Concentrations
timeFrame: 5 days
measure: Plasma Insulin Concentrations
timeFrame: 5 days
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Research Centre on Aging - CSSS-IUGS - CIUSSS de l'Estrie - CHUS
state: Quebec
Study officials:
affiliation: Research Centre on Aging, CIUSSS de l'Estrie-CHUS
name: Stephen Cunnane, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03834090: Effectiveness of Radial Extracorporeal Shock Wave Therapy and Supervised Exercises in Lateral Epicondylitis
Official title: Comparison of the Effectiveness of Radial Extracorporeal Shock Wave Therapy and Supervised Exercises in the Treatment of Lateral Epicondylitis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lateral Epicondylitis
Lead sponsor: Istanbul University
Sponsor class: OTHER
First posted: 2019-02-07
Enrollment: 41
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: No consensus has yet been built on the treatment of lateral epicondylitis (LE) due to the lack of evidence. Although conflicting results are present, radial extracorporeal shock wave therapy (rESWT) has increasingly been used in the treatment of tendinopathy

Detailed description: ESWT and exercise have beneficial effects on the management of tendinopathies owing to their various mechanisms that showed therapeutic efficacy. Owing to its positive outcomes, extracorporeal shock wave therapy (ESWT) has recently been used in the treatment of musculoskeletal system diseases such as plantar fasciitis, Achilles tendinopathy, calcific rotator cuff tendinopathies, and patellar tendinopathy

Eligibility criteria: Inclusion Criteria:

* The diagnosis of LE was made in the clinical examination, and the diagnosis was confirmed with the Southampton Diagnostic Criteria of "the presence of epicondyle pain, and epicondyle pain and tenderness on resisted extension of the wrist.
* Patients with symptoms lasting longer than 3 months
* with average pain in the previous week detected as 3 or above on a 10-cm visual analogue scale (VAS)
* who were aged over 18 years

Exclusion Criteria:

* pain in the proximal part of the affected extremity (e.g. shoulder pain, neck pain)
* abnormal neurogenic symptoms (e.g. radicular pain, numbness) on the affected extremity
* presence of posterior interosseous nerve entrapment
* congenital or acquired upper extremity deformities that might affect grip strength
* systemic musculoskeletal system or neurologic disorders
* systemic rheumatologic disease or systemic infection
* presence of malignancy, coagulation disorders, and anticoagulant use
* inserted cardiac pacemaker
* history of surgical treatment on the elbow of the affected extremity
* pregnancy.
* patients who were administered other treatments such as physical therapy or steroid injections in the last 3 months

Primary outcomes:
measure: Change Patient-rated Tennis Elbow Evaluation score
timeFrame: Change from Baseline at 1 month and 3 months after treatment.
Secondary outcomes:
measure: Change Visual Analogue Scale score
timeFrame: Change from Baseline at 1 month and 3 months after treatment.
measure: Change Roles and Maudsley Score
timeFrame: Change from Baseline at 1 month and 3 months after treatment.
measure: Change Grip Strength score
timeFrame: Change from Baseline at 1 month and 3 months after treatment.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03445390: The Effect of Intravenous Acetaminophen on Post-Operative Pain After Craniotomy
Official title: The Effect of Intravenous Acetaminophen on Post-Operative Pain After Craniotomy: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Patients selected for this study were being treated for Moyamoya disease and required two operations, scheduled 1-2 weeks apart. With random assignment, patients were administered 1 gram of intravenous acetaminophen at the beginning and end of surgery, and placebo during the other operation.
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to determine the efficacy of IV acetaminophen when administered to neurosurgical patients at the beginning and end of their surgery. If the result is improved pain control with less opioid consumption postoperatively, then those patients may also experience less opioid related side effects such as nausea/vomiting, pruritus, and sedation. While numerous other studies have failed to show a benefit of IV acetaminophen after neurosurgical procedures, we are studying the administration of 1 g in two doses over the course of the operation.


Eligibility criteria: Inclusion Criteria:

* Patients with a diagnosis of bilateral moyamoya disease scheduled for bilateral external-carotid to internal-carotid bypass surgery to be done in two stages.

Exclusion Criteria:

* Allergy or history of reaction to acetaminophen. Patients with liver disease. Anyone not able to provide informed consent.

Primary outcomes:
measure: Post-operative Opioid Consumption
timeFrame: Up to 24 hours post-operative
measure: Post-operative Pain
timeFrame: Up to 24 hours post-operative
Secondary outcomes:
measure: Count of Participants Requiring Anti-emetic Administration
timeFrame: Up to 24 hours post-operative
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University Medical Center
state: California
Study officials:
References: