louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03757416: Flexor Tenosynovectomy to Treat Recurrent Carpal Tunnel Syndrome
Official title: Outcomes After Flexor Tenosynovectomy to Treat Recurrent Carpal Tunnel Syndrome: A Prospective Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Carpal Tunnel Syndrome
Keywords: recurrent
carpal tunnel release
flexor tenosynovectomy
Lead sponsor: University of Tennessee
Sponsor class: OTHER
First posted: 2018-11-28
Enrollment: 2
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: Adult patients of The Plastic Surgery Group/Hayes Hand Center at Erlanger Health System

Brief summary: The purpose of this study is to collect data on the clinical and functional outcomes of surgical management for recurrent carpal tunnel syndrome (CTS) using flexor tenosynovectomy. It is hypothesized that the outcomes of patients undergoing flexor tenosynovectomy for recurrent CTS will compare favorably to published data regarding alternative types of surgeries for the same condition.

Detailed description: Primary carpal tunnel release (CTR) is the most common surgical procedure of the hand, but reported rates of symptom recurrence are not uncommon. Many surgical techniques have been proposed and reported for management of carpal tunnel syndrome (CTS) symptom recurrence, however there is a paucity of data on flexor tenosynovectomy for management of recurrent CTS.

This study will evaluate clinical and functional outcomes using information from pre- and post-operative physical exams, surgery data, patient-reported satisfaction and symptoms, and scores on functional measures, such as the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.

Eligibility criteria: Inclusion Criteria:

* Adult patients (\> 18 years)
* Patient of The Plastic Surgery Group/Hayes Hand Center
* Previous diagnosis of Carpal Tunnel Syndrome
* Diagnosis of Recurrent Carpal Tunnel Syndrome
* Underwent primary carpal tunnel release
* Undergoing isolated flexor tenosynovectomy as secondary procedure

Exclusion Criteria:

* Had incomplete primary release of transverse carpal ligament
* Had documented neuroma upon re-exploration
* Had other soft tissue tumor within carpal tunnel or providing reasonable contribution to neurologic symptoms
* Experienced fracture or other traumatic injury to wrist after primary carpal tunnel release
* Diagnosis of osteomyelitis, infectious tenosynovitis or other infectious etiology to area of interest after primary procedure
* Diagnosis of rheumatoid arthritis, psoriatic arthritis, or other inflammatory arthropathy

Primary outcomes:
measure: Improvement of Symptoms
timeFrame: one year
Secondary outcomes:
measure: DASH (Disabilities of the Arm, Shoulder, and Hand) score
timeFrame: one year
measure: Patient 'satisfaction'
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: University of Tennessee College of Medicine Chattanooga
name: D M Jemison, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01873716: Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque
Official title: Indocyanine Green Fluorescence Uptake in Human Carotid Artery Plaque -- A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atherosclerosis
Atherosclerotic Plaque
Carotid Stenosis
Keywords: Atherosclerosis
Molecular Imaging
Vascular Biology
Inflammation
Fluorescence
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-06-10
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This will be a pilot study of 9 patients undergoing standard-of-care clinically indicated carotid endarterectomy. The nine patients will receive an injection of Indocyanine green (ICG) at a dose of 0.25 mg/kg (maximum 25 mg) as an intravenous bolus.

Immediately following endarterectomy, the resected specimen will be immersed in normal saline. Ex vivo fluorescence reflectance imaging (FRI) and immunohistochemistry will be performed.

The investigators hypothesize that compared to controls, ICG-injected patients will demonstrate increased ex vivo and microscopic ICG fluorescence signal within areas of plaque.


Eligibility criteria: Inclusion Criteria:

* Consecutive patients scheduled for elective carotid endarterectomy at Massachusetts General Hospital
* Age \> 18 years of age.
* Signed informed consent.

Exclusion criteria:

* Hemodynamic instability
* Any history of iodide allergy
* Any history of renal failure (estimated Glomerular Filtration Rate (eGFR) \<50 ml/min/1.73 m2)
* Any history of liver failure
* Any history of bleeding diathesis
* Any history of cerebral vascular accident in the preceding 3 months
* Pregnant or lactating females.
* Hx of seafood allergy

Primary outcomes:
measure: Tissue uptake of indocyanine green in carotid plaque
timeFrame: within 3 months after carotid endarterectomy
Secondary outcomes:
measure: Relationship of indocyanine green uptake to carotid plaque histology
timeFrame: within 3 months after carotid endarterectomy
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Farouc A Jaffer, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Vinegoni C, Botnaru I, Aikawa E, Calfon MA, Iwamoto Y, Folco EJ, Ntziachristos V, Weissleder R, Libby P, Jaffer FA. Indocyanine green enables near-infrared fluorescence imaging of lipid-rich, inflamed atherosclerotic plaques. Sci Transl Med. 2011 May 25;3(84):84ra45. doi: 10.1126/scitranslmed.3001577.
citation: Verjans JW, Osborn EA, Ughi GJ, Calfon Press MA, Hamidi E, Antoniadis AP, Papafaklis MI, Conrad MF, Libby P, Stone PH, Cambria RP, Tearney GJ, Jaffer FA. Targeted Near-Infrared Fluorescence Imaging of Atherosclerosis: Clinical and Intracoronary Evaluation of Indocyanine Green. JACC Cardiovasc Imaging. 2016 Sep;9(9):1087-1095. doi: 10.1016/j.jcmg.2016.01.034. Epub 2016 Aug 17.
Clinical trial NCT01057316: Formula PTX Renal Stent Clinical Study
Official title: Evaluation of Safety and Effectiveness of the Formula PTX Balloon-Expandable Stent for Renal Artery Stenosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Artery Stenosis
Lead sponsor: Cook Group Incorporated
Sponsor class: INDUSTRY
First posted: 2010-01-27
Enrollment: 120
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 the study is to evaluate the safety and effectiveness of the PTX-coating on the Formula PTX Balloon-Expandable Stent in treatment of renal artery stenosis.


Eligibility criteria: Inclusion Criteria:

* renal artery stenosis
* appropriate size and location of the lesion

Exclusion Criteria:

* pregnant or breast feeding
* failure or inability to give informed consent
* simultaneously participating in another drug or device study

Primary outcomes:
measure: Percent Diameter Stenosis of the Treated Renal Artery
timeFrame: 9 months
Secondary outcomes:
Other outcomes:
Locations:
city: Ostrava-Poruba
country: Czechia
facility: University Hospital Ostrava
city: Prague
country: Czechia
facility: Institute for Clinical and Experimental Medicine
city: Paris
country: France
facility: Hopital Europeen Georges Pomidou
city: Bad Krozingen
country: Germany
facility: Herz-Zentrum Bad Krozingen
city: Göttingen
country: Germany
facility: Krankenhaus Neu-Bethlehem
city: Heidelberg
country: Germany
facility: Uniklinik Heidelberg
city: Leipzig
country: Germany
facility: Universitatsklinikum Leipzig AoR
city: Lingen
country: Germany
facility: St. Bonifatius Hospital
city: Stade
country: Germany
facility: Klinik Dr. Hancken im Elbe Klinikum Stade
city: Brighton
country: United Kingdom
facility: Royal Sussex County Hospital
city: Canterbury
country: United Kingdom
facility: Kent & Canterbury Hospital
city: London
country: United Kingdom
facility: St. Mary's Hospital
Study officials:
References:
Clinical trial NCT02973516: Proof of Concept Study Concerning Efficacy of P03277 MR Imaging in HCC Diagnosis
Official title: Proof of Concept Study Concerning Efficacy of P03277 MR Imaging in HCC Diagnosis, Phase IIa Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Liver Disease
HepatoCellular Carcinoma
Lead sponsor: Guerbet
Sponsor class: INDUSTRY
First posted: 2016-11-25
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is an exploratory study aiming to collect data about diagnosis efficacy (sensitivity and specificity) of P03277 triphasic liver imaging for HCC in subjects with suspected small nodules and chronic liver disease. 30 subjects will be included, having HCC confirmed or not by previous enhanced CT and/or MRI and before any biopsy for histology analysis. The standard of reference for diagnosis will be given by the site according to their standard of care and adapted from EASL/EORTC diagnostic criteria (considering previous contrast enhanced imaging (CT and/or MRI) and/or biopsy specimen analysis given on-site and/or the more recent AFP results available). 10 additional subjects will be included to explore the diagnostic efficacy for HCC at half dose of P03277.


Eligibility criteria: Inclusion Criteria:

* Subject presenting with liver cirrhosis or chronic liver disease as shown by previous liver biopsy or by combination of clinical, endoscopic, biological, ultrasound parameters, and elastography
* Subject presenting with 1 to a maximum of 3 untreated hepatic nodule(s) of less than or equal to 3 cm (long axis) previously identified and/or characterized through enhanced CT and/or MRI within a maximum of 21 days before P03277 imaging, confirmed for HCC or not

Exclusion Criteria:

* Subject presenting with hepatic nodule more than 3 cm in addition to nodule(s) less than or equal to 3 cm
* Subject already treated for HCC by surgery or thermal ablation for which the resection or coagulation area is less than 2 cm from the new nodule(s)
* Subject previously treated by transarterial chemoembolization
* Subject with moderate or severe renal impairment (eGFR \< 60 mL/min/1.73 m2) based on measurement done or available within the 7 days before P03277 administration and assessed after any iodinated contrast agent administration, or with dialysis end stage renal disease (ESRD)

Primary outcomes:
measure: Diagnostic Value Evaluation for HCC
timeFrame: One day procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Clichy
country: France
facility: Hôpital Beaujon
Study officials:
affiliation: Guerbet
name: Clinical Project Manager
role: STUDY_DIRECTOR
References:
Clinical trial NCT00693316: Safety and Tolerability Study With Single Ascending Doses of ORM-12741
Official title: Phase I Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Study With Single Ascending Doses of ORM-12741
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy volunteer study
Lead sponsor: Orion Corporation, Orion Pharma
Sponsor class: INDUSTRY
First posted: 2008-06-09
Enrollment: 120
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and tolerability of escalating doses of ORM-12741 in healthy volunteers.


Eligibility criteria: Inclusion Criteria:

* Good general health ascertained by detailed medical history and physical examinations
* Males between 18 and 45 years
* Body mass index (BMI) between 18-30 kg/m2
* Weight 55-90 kg

Exclusion Criteria:

* Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease
* Any condition requiring regular concomitant treatment including herbal products or likely to need any concomitant treatment during the study
* Susceptibility to severe allergic reactions
* Regular consumption of more than 14 units of alcohol per week
* Current use of nicotine-containing products more than 5 cigarettes or equivalent/day
* Inability to refrain from using nicotine-containing products during the stay in the study centre
* Inability to refrain from consuming caffeine-containing beverages during the stay in the study centre
* Blood donation or loss of significant amount of blood within 3 months prior to the screening visit
* Abnormal finding in ECG, vital signs, laboratory tests or physical examination
* Participation in a drug study within 3 months prior to the start of this study

Primary outcomes:
measure: Safety measures, i.e. assessing adverse events, vital signs, ECG, safety laboratory values
timeFrame: About 8 weeks
Secondary outcomes:
measure: Pharmacokinetics
timeFrame: 5 days after each dose
Other outcomes:
Locations:
city: Rouffach
country: France
facility: Forenap Pharma
Study officials:
affiliation: Forenap Pharma
name: Déborah Metzger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06196216: Breast Lesion in CT Chest
Official title: Referal Features of Incidental Breast Masses in Chest CT
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Breast Cancer Female
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 100
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: adult female patients who underwent enhanced CT chest that incidentally revealed breast lesion(s) then referred to a specialized breast centre and had histopathological diagnosis.

Brief summary: The aims of this study are To evaluate the CT features of incidental breast lesions on chest CT and subsequently suggest useful criteria for referral to a specialized breast unit.

Detailed description: Enhanced chest CT examination reports containing the key word 'breast' well be reviewed retrospectively. Patients who had incidental breast lesion and were referred to a specialized breast unit and then underwent pathological confirmation well be included. Finally, 100 patients well be enrolled. Two radiologists well evaluate lesion characteristics including; size, shape, margins and enhancement. The correlations between the CT features and pathologies well be evaluated and the diagnostic accuracy of CT features in various combinations well be assessed.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria are patients who ex hibited incidental breast lesion(s) on enhanced chest CT and were referred to a specialized breast unit for assessment and then underwent pathological confirmation.

Exclusion Criteria:

* -Patients with known breast dis ease.
* Previous history of breast cancer or breast surgery.
* Patients who had undergone only non-enhanced CT examination.

Primary outcomes:
measure: detect useful CT criteria of breast lesions subsequently suggest criteria for referral to a specialized breast unit
timeFrame: 3years
Secondary outcomes:
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Assiut University
Study officials:
affiliation: Assiut University
name: Abo-Elhassan Hassib Mohamed, Associate professor
role: STUDY_DIRECTOR
References:
citation: Ibrahim AS, Khaled HM, Mikhail NN, Baraka H, Kamel H. Cancer incidence in egypt: results of the national population-based cancer registry program. J Cancer Epidemiol. 2014;2014:437971. doi: 10.1155/2014/437971. Epub 2014 Sep 21.
citation: Harish MG, Konda SD, MacMahon H, Newstead GM. Breast lesions incidentally detected with CT: what the general radiologist needs to know. Radiographics. 2007 Oct;27 Suppl 1:S37-51. doi: 10.1148/rg.27si075510.
Clinical trial NCT05700916: Evaluation of Milk Polar Lipids in Dyslipidemic Adults With Abdominal Obesity
Official title: Evaluation of Milk Polar Lipids on Lipoprotein Metabolism, Inflammation, and Gut Microbiota in Dyslipidemic Adults With Abdominal Obesity
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: EARLY_PHASE1
Conditions: Dyslipidemias
Obesity
Lead sponsor: University of Connecticut
Sponsor class: OTHER
Collaborators: name: Dairy Management Inc.
First posted: 2023-01-26
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The major objective of this project is to examine whether daily consumption of milk polar lipids (MPLs) influences cardiometabolic risk factors.

Detailed description: The investigators will conduct a randomized, double-blind, controlled, parallel, intervention study in dyslipidemic adults with abdominal obesity (n = 130). Participants will consume either a control dairy beverage (n = 65) or an MPL-rich dairy beverage (n = 65) for 8 weeks. The investigators plan to evaluate the following 4 specific objectives:

1. Determine the effects of MPLs on serum lipid concentrations and other cardiometabolic risk factors.
2. Evaluate the effects of MPLs on systemic biomarkers of low-grade inflammation.
3. Examine the effects of MPLs on lipoprotein metabolism and lipoprotein particle characteristics.
4. Evaluate the effects of MPLs on gut microbiota, gut permeability markers, and fecal lipids.

Eligibility criteria: Inclusion Criteria:

* LDL-C ≥ 130 mg/dL
* Waist circumference ≥ 88 cm for women, ≥ 102 cm for men
* Aged 18 to 70 years

Exclusion Criteria:

* Renal disease
* Liver disease
* Diabetes
* Heart disease
* Stroke
* Cancer
* Eating disorders
* Thyroid disease
* Gut-associated pathologies
* Autoimmune diseases
* Chronic inflammatory diseases
* Scleroderma
* Gallbladder disease
* Blood clotting disorders
* Intravenous drug use
* Fasting plasma/serum triglycerides \>500 mg/dL
* Fasting plasma/serum glucose \>126 mg/d
* Weight changes \>10% over last 4 weeks
* Oral antibiotics use up to 1 month prior to and during study
* Allergy or intolerance to milk products
* Taking lipid-lowering medications (e.g., statins, fibrates)
* Taking anti-inflammatory medications (e.g., corticosteroids)
* Taking medications which primarily affect blood clotting (e.g., warfarin).

Primary outcomes:
measure: Change from Baseline Serum LDL Cholesterol at 8 weeks
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Storrs
country: United States
facility: University of Connecticut
state: Connecticut
Study officials:
References:
Clinical trial NCT07020416: AutoSTEA for Adults With Functional Dyspepsia
Official title: Transcutaneous Electrical Acustimulation in Automatic Synchronization With Breathing for Treating Functional Dyspepsia: A Phase I Feasibility Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Functional Dyspepsia
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
First posted: 2025-06-13
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

Brief summary: The goal of this study is to assess how effective the AutoSTEA device is in treating functional dyspepsia (upper abdominal discomfort) in adults. It will also assess the safety and usability of the device. The main questions it aims to answer are:

* Does the AutoSTEA device ease dyspepsia symptoms?
* Is the AutoSTEA device safe and feasible for patients to use at their home?

Participants will:

* Use the device for half an hour every day for two weeks
* Have a phone check-in halfway through the trial
* Answer the daily and weekly questionnaires which consist of questions regarding symptoms, device usability, and adverse events experienced.


Eligibility criteria: Inclusion Criteria:

* 18 and older
* Must meet Rome IV criteria for functional dyspepsia

Exclusion Criteria:

* Patients with dyspepsia symptoms that have been fully resolved by antisecretory, antidepressant, or prokinetic therapy
* History of active NSAID use, unhealed esophagitis, unhealed ulcer disease, or other GI diseases that can explain their dyspepsia symptoms.
* History of upper GI surgeries and upper GI cancers, uncontrolled diabetes (type 1 and 2), severe psychiatric conditions, uncontrolled medical disorders, total knee replacement surgery, or above-the-knee amputation.
* Patients with H. pylori infection without confirmed eradication will also be excluded.

Primary outcomes:
measure: Determine the device safety when self-administered at home by patients
timeFrame: From enrollment to the end of treatment in two weeks
measure: Evaluate device usability
timeFrame: From enrollment to the end of treatment in two weeks
measure: Assess symptom responses to treatment
timeFrame: From enrollment to the end of treatment in two weeks
Secondary outcomes:
measure: Assess a diverse participant pool, especially overweight/obese female patients
timeFrame: From enrollment to the end of treatment in two weeks
measure: Assess patient's compliance to AutoSTEA treatment
timeFrame: From enrollment to the end of treatment in two weeks
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: MetroHealth Medical Center - Main Campus
state: Ohio
city: Parma
country: United States
facility: MetroHealth Parma Medical Center
state: Ohio
Study officials:
affiliation: MetroHealth Medical Center
name: Michael Kurin, MD
role: PRINCIPAL_INVESTIGATOR
References: