louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03185442: Cerebral Effects of Pulsed Radiofrequency on the Lumbar Dorsal Root Ganglion With Functional Magnetic Resonance Imaging.
Official title: Evaluation of Central Cerebral Effects of Pulsed Dosed Radiofrequency (PRF) on the Lumbar Dorsal Root Ganglion (DRG) Using Functional Magnetic Resonance Imaging (fMRI).
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lumbar Radiculopathy
Chronic Disease
Keywords: fMRI
PRF
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2017-06-14
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: Evaluation of central (cerebral) effects of Pulsed RadioFrequency (PRF) on the lumbar DRG (Dorsal Root Ganglion), using fMRI (functional Magnetic Resonance Imaging ). Feasibility study (after which an interim analysis is done): 5 subjects in order to detect measurable central effects inducted by PRF on DRG, follow up study 20. Total amount of subjects 25.

Detailed description: Detect and prove the central effects of PRF and show the objective working mechanism.

PRF is often used technique to alleviate chronic radicular neuropathic pain, although good clinical results are observed the precise (central ) working mechanism is still unknown. This study aims to find the central working mechanism.

The investigator postulate the existence of central -cerebral effect of PRF on the DRG (dorsal root ganglion). If the investigator can detect the effect using fMRI and demonstrate the objective unequivocal proof that PRF on the DRG works than the investigator will be able to promote this technique for further use in the chronic pain states.

Eligibility criteria: Inclusion Criteria:

* 18-75 y
* Radicular pain in lumbar region more than 6 weeks, neuropathic

Exclusion Criteria:

* Coagulopathy
* Implanted PM or SCS device
* Pregnancy
* Unwilling to undergo MRI
* Psychiatric disorders

Primary outcomes:
measure: Central working mechanism
timeFrame: 6 weeks
Secondary outcomes:
measure: Central working mechanism
timeFrame: 3 times in 6 weeks
measure: Central working mechanism
timeFrame: 2 times in 6 weeks
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Pain Clinic Universitair Ziekenhuis Brussel
state: Vlaams Brabant
Study officials:
affiliation: Universitair Ziekenhuis Brussel
name: Olivier De Coster, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Universitair Ziekenhuis Brussel
name: Patrice Forget, PhD MD
role: STUDY_DIRECTOR
affiliation: Universitair Ziekenhuis Brussel
name: Jan Poelaert, PhDMD
role: STUDY_CHAIR
References:
Clinical trial NCT00070642: CPG 7909 Injection in Melanoma
Official title: ProMune™ (CPG 7909 Injection) With or Without Chemotherapy for the Treatment of Stage III b/c or IV Melanoma: A Randomized, Multi-Center, Open Label, Parallel Group, Active-Controlled, Phase II/III Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Carcinoma, Melanoma
Keywords: Immunotherapy, skin cancer
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2003-10-08
Enrollment: 184
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: To determine the safety, tolerability and effects of CPG 7909 (the study drug) when given with chemotherapy to patients with melanoma.


Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed melanoma that is metastatic.
* Measurable disease according to the RECIST criteria.
* Karnofsky Performance Status of \> 70.

Exclusion Criteria:

* Prior treatment with anti-neoplastic biologic or chemotherapy for recurrent or metastatic disease (except one course of adjuvant immunotherapy and/or adjuvant chemotherapy other than DTIC).
* Suspected or known CNS metastases.

Primary outcomes:
measure: Phase II: Assess the anti-neoplastic activity, as determined by overall response rate (complete plus partial responses) according to the RECIST criteria.
timeFrame: indeterminate
measure: Phase III: Evaluate and compare the survival time of the two treatment groups, as selected in Phase II.
timeFrame: Indeterminate
Secondary outcomes:
measure: Phase III: Assess the overall response rate
timeFrame: indeterminate
measure: Asses the degree of clinical benefit defined as the proportion of patients experiencing complete and partial responses as well as stable disease.
timeFrame: indeterminate
measure: Determine the duration of response.
timeFrame: indeterminate
measure: Determine the time to progression
timeFrame: indeterminate
measure: Assess the pharmacokinetic profile and immunopharmacodynamic response to CPG 7909 Injection alone or in combination with DTIC, or DTIC alone (immunopharmacodynamic response only).
timeFrame: indeterminate
measure: Describe the tolerability of CPG 7909 Injection alone, CPG 7909 Injection in combination with DTIC vs. DTIC alone
timeFrame: indeterminate
Other outcomes:
Locations:
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05122442: Multicenter, Non-interventional Study, Describing Patients With Inherited Retinal Disease (IRD) in France
Official title: Multicenter, Non-interventional Study, Describing Patients With Inherited Retinal Disease (IRD) in France
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Inherited Retinal Disease
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-11-16
Enrollment: 1000
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with inherited retinal disease

Brief summary: Genetic diagnostic testing becomes increasingly important for enhancing our understanding of the disease notably the genetics and providing the best care to the patients, and several initiatives seek to gather more data in order to better understand and treat those diseases.

Within this context, Novartis and SENSGENE/Strasbourg University Hospitals (HUS) want to set up, through a research collaboration, a non-interventional study in France to better understand the epidemiology of IRDs, particularly the distribution of pathogenic variants in patients. This study aims to serve as a starter study to implement an IRD national registry led by SENSGENE/Strasbourg University Hospitals (HUS). The data collected might also be used to populate global European registries. The primary objective has been defined in a sufficient broad way to address this perspective of registries.

As IRDs can present from birth to late middle age, this study will include both children and adult patients regardless of age, sex, and the type of IRD.


Eligibility criteria: Inclusion criteria:

* All patients, whatever age or gender, clinically diagnosed with IRD or with high suspicion for IRDs based on clinical examination and functional tests (such as fundus exam and ERG), regardless of genetic testing
* Patients who attended a consultation at one of the participating centers from SENSGENE network over the inclusion period starting from sites initiation
* Patients who had been prescribed a genetic test for IRD prior to or at the date of inclusion.

Exclusion criteria:

* Patients/Parents/Legally authorized representatives (LAR) opposed to the collection and processing of their medical data/the medical data of their children/the medical data of the person for whom they are LAR;
* Patients who are suffering from any other retinal disorder or optic neuropathy that may clinically or genetically overlap with IRD or non-genetic (phenocopy);
* Patients/parents/Legally authorized representatives (LAR) refusing genetic testing;
* Patients lacking decision-making capacity: Mental incapacity, unwillingness, or language barriers precluding adequate understanding or cooperation.

Primary outcomes:
measure: Proportion of patients with IRD by clinical presentation
timeFrame: 12 month
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Les Hôpitaux Universitaires
Study officials:
References:
Clinical trial NCT02250742: The Effect of Dry Needling on Trunk Muscle Function in Low Back Pain Patients
Official title: The Effect of Dry Needling on Trunk Muscle Function in Low Back Pain Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: ultrasound imaging
acupuncture
back muscles
spine
muscle strength
Lead sponsor: University of Haifa
Sponsor class: OTHER
First posted: 2014-09-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The study will establish data on the function of trunk muscles in healthy and low back pain patient's pre and post dry needling treatment. This will help in understanding the underlying mechanism of this treatment and reveal the effect of dry needling on muscle performance.

Study hypothesis is that an improvement of back muscle function following dry needling procedure will be found.

Detailed description: Dry needling of muscles is mainly used for the management of pain in musculoskeletal disorders. Yet, the association between dry needling and motor performance of muscles is still unclear.

This study aims to investigate the immediate effect of dry needling on lumbar multifidus muscles' function in healthy and low back pain subjects.

The sample will be divided into: low back pain group and control (healthy) group. Both groups will receive dry needling to the lumbar multifidus muscles using a deep insertion technique with 4 needles (2 on each side of the spine). The needles will be left in situ for 10 minutes. Ultrasound imaging will be used to measure multifidus muscles' thickness, pre and post- procedure during rest in a prone position and during contralateral active straight leg extension.

Eligibility criteria: Inclusion Criteria:

* Age: 18-60 years.
* Healthy individuals or individuals with main complaint of low back pain (LBP)

Exclusion Criteria:

* Patients with "red flags" for a serious spinal condition, for example: tumor, compression fractures, infection, cancer.
* Signs of nerve root compression (positive straight leg raise \<45 degrees, decreased reflexes, decrease sensation or decreased strength in the lower extremities).
* Pregnancy.
* Previous surgery to the lumbar spine
* History of congenital lumbar or pelvic anomalies
* Physical therapy for LBP was provided in the 6 months prior to participation in the study
* Patients who are unable to lie prone for 30 minutes.

Primary outcomes:
measure: Change in Multifidus muscle thickness
timeFrame: baseline and Immediately after dry needling procedure at the same session
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: University of Haifa
Study officials:
affiliation: University of Haifa, Department of Physical Therapy
name: Gali Dar, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05810142: Clinical Study on Third-line Treatment of Advanced Duodenal Adenocarcinoma by Fuquinitinib Combined With Sindillimab
Official title: Clinical Study on Third-line Treatment of Advanced Duodenal Adenocarcinoma by Fuquinitinib Combined With Sindillimab
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Third-line Treatment
Dvanced Duodenal Adenocarcinoma
Furquinelone Combined With Sintilimab
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-04-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will include patients with advanced duodenal adenocarcinoma who received third-line or above treatment with the combination of furquimatinib and sintilimab in Renji Hospital from January 2019 to the present.

Brief summary: This research project is a single-center, retrospective clinical exploration study. It aims to retrospectively analyze data from 20 patients with advanced duodenal adenocarcinoma who received third-line treatment with furquinelone combined with sintilimab, in order to determine the clinical efficacy and safety of this combination therapy in advanced duodenal cancer.


Eligibility criteria: Inclusion Criteria:

* Patients must meet all of the following criteria to be eligible for inclusion:

Age between 18 and 80 years (inclusive); Imaging findings consistent with unresectable local advanced, recurrent or metastatic duodenal adenocarcinoma; Histologically confirmed unresectable local advanced, recurrent or metastatic duodenal adenocarcinoma; ECOG performance status 0-2; At least one measurable or evaluable lesion according to RECIST v1.1; Third-line or above treatment with the combination of sintilimab and furquimatinib.

Exclusion Criteria:

-

Patients meeting any of the following criteria will be excluded:

Patients with incomplete clinical data or laboratory examination that affects statistical analysis; Patients who have had other malignant tumors in the past 5 years; Patients who have had arterial thrombotic diseases such as angina, myocardial infarction, and transient ischemic attack in the past 6 months; Patients who have received other types of anti-tumor or experimental treatment; Pregnant or lactating women; Patients with other diseases or abnormal mental status that may affect the patient's treatment; Patients who have received other types of immune therapy, anti-angiogenic drugs, or small-molecule tyrosine kinase inhibitors.

Primary outcomes:
measure: Primary efficacy endpoint: Objective Response Rate (ORR)
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02863042: Is Deltoid Ligament Repair for Ankle Fracture Necessary?
Official title: Is Deltoid Ligament Repair in Supination-external Rotation Ankle Fractures Necessary? A Prospective Cohort Study.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Ankle Fracture
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2016-08-11
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigator hypothesizes that primary acute ankle deltoid ligament repair can help restore ankle radiographic congruity and functional outcomes.

Detailed description: The purpose of this study is to evaluate whether stabilization with anatomic ankle deltoid ligament repair can help restore ankle congruity and improve functional outcome in patients with unstable supination-external rotation ankle fractures.

Eligibility criteria: Inclusion criteria:

* Supination-external rotation ankle fracture with deltoid ligament incompetency
* Minimum of 2 year clinical follow up

Exclusion criteria:

* Non-supination-external rotation ankle fracture
* Medial malleolus fracture
* Incomplete clinical or radiographic followup.

Primary outcomes:
measure: Change in Functional Improvement as measured by the Short Musculoskeletal Function Assessment (SMFA)
timeFrame: baseline, 6 month post-operative visit
Secondary outcomes:
measure: Mean Score on American Orthopaedic Foot and Ankle Society (AOFAS) Hindfoot Scale
timeFrame: 2 year postoperative visit
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Glenn G Shi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04257942: Pathological Crystallization of Cholesterol in Atherosclerosis
Official title: Pathological Crystallization of Cholesterol in Atherosclerosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Crystallization of Cholesterol in Atherosclerosis
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Weizmann Institute of Science
First posted: 2020-02-06
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with carotid stenosis - symptomatic and asymptomatic

Brief summary: Endarterectomy of the carotid artery procedure will be performed at Sheba Medical center vascular surgery department, followed by fixation and histology. Tissues will then be transferred to Weizmann Institute of Science for observation implementing advanced electron microscopy techniques. Finally, joint evaluation of the results will be carried out, in relation to the patient clinical history.

Detailed description: Human atherosclerotic tissues will be obtained from the Department of Vascular Surgery, Sheba Medical Center. Tissues will be taken from donors undergoing routine endarterectomy procedures.We chose carotid artery as the source for the atheromas, due to its high prevalence and its considerable size.All speciemnts will be studied in Cryo-Scanning Electron Microscopy (Cryo-SEM). Tissues will be observed in hydrated vitrified state, after High Pressure Freezing (HPF) and freeze fracture, as well established in the WIS group. Samples will be observed at -120°C. Cathode-Luminescence (CL) detects a luminescence signal induced by electrons in cholesterol crystals and CE condensed states. It will be implemented herein under cryogenic conditions. Sample preparation is as for cryo-SEM. Cryo-FIB-SEM block face serial imaging allows the acquisition of serial images over large volumes (tens of cubed micrometers), at a relatively high imaging resolution (up to 5nm3 voxel size). Volumes of up to 40x40x40 ml will be imaged with a resolution of up to 10nm. The data will be minimally processed and aligned using FIJI, reconstructed and manually segmented using Avizo Lite 9.2.0 software.

Eligibility criteria: Inclusion Criteria:

* all patients that are being operated on for carotid endarterctomy due to carotid stenosis

Exclusion Criteria:

* none

Primary outcomes:
measure: crystallization of cholesterol in atherosclerosis
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05087342: Latino Semaglutide Study
Official title: A Randomized Latino Semaglutide 2.4mg Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Obesity
Obesity; Drug
Overweight or Obesity
Weight Loss
Weight Loss Trajectory
Weight, Body
Keywords: obesity
obesity; drug
overweight
weight loss
weight
Lead sponsor: Loma Linda University
Sponsor class: OTHER
Collaborators: name: Novo Nordisk A/S
First posted: 2021-10-21
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study to understand better how this anti-obesity medication works to assist individuals to lose weight and maintain weight loss. This study may lead to the development of other related medications for assisting people with the disease of obesity.


Eligibility criteria: Inclusion Criteria:

* Self-identify as being of Hispanic/Latino ethnicity
* BMI \>30
* Age 18-75 years old
* Able to provide informed consent before any trial related activities

Exclusion Criteria:

* Current cancer treatment
* Diabetes, Type 1 or Type 2
* Eating disorders
* Medication use targeting the GPL-1 system
* In the last 30 days, attempted to lose weight by lifestyle modification alone or with the use of anti-obesity medications resulting in more than 5 pounds of weight loss.
* History of bariatric surgery
* Use of obesogenic medications (including but not limited to steroids, haloperidol, clozapine, risperidone, olanzapine, amitriptyline, imipramine, paroxetine, and lithium) which cannot be substituted or stopped.
* Pregnant or planning to become pregnant in the next 8 months
* Genetic disorders and/or physical or mental handicaps that would limit participation in the study and/or the intensive lifestyle intervention.
* Any contraindication to semaglutide 2.4 mg including personal or family history of medullary thyroid carcinoma or Multiple Endocrine Neoplasia Syndrome Type 2, hypersensitivity to semaglutide 2.4 mg or any product components.
* Any known or suspected allergy to semaglutide 2.4 mg or related products
* Previous participation in this trial, either initial screening or group randomization

Primary outcomes:
measure: Assessment of weight loss.
timeFrame: Change between baseline and final study visit, seven months post baseline.
Secondary outcomes:
measure: Food Addiction Assessment
timeFrame: Change between baseline and month four of treatment.
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Loma Linda University Health
state: California
Study officials:
affiliation: Loma Linda University
name: Warren Peters, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01644942: Identification in Obese Patients of the Mechanism Involved in Intramuscular Lipid Accumulation
Official title: Identification in Obese Patients of the Mechanisms Involved in Intramuscular Lipid Accumulation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Insulin Resistance
Hyperlipidemia
Keywords: Obese
insulin sensitive
insulin resistant
myotubes
lipid accumulation
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
First posted: 2012-07-19
Enrollment: 33
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL

Brief summary: The study aims to determine in obese patients the implication of intramuscular lipid accumulation in relation with insulin resistance and defect in lipid oxidation.

Detailed description: Obese insulin sensitive and obese insulin resistant patients undergo a glucose tolerance test, indirect calorimetry during exercise and muscular biopsy.

Eligibility criteria: Inclusion Criteria:

* Obese patients with a Body Mass Index (BMI) between 30 and 40 kg/m2
* Patients who do not practice physical exercise (Voorips index \< 9)
* Age between 40 and 70 years- Male gender
* Fast blood glucose \<1,10 g/l and no hypoglycemic treatment
* Signed informed consent
* Social security affiliation
* Absence of anti VIH, anti hepatitis C antibodies, and HBS antigen
* Normal biological tests
* Non smoking persons

Exclusion Criteria:

* Patients who refuse the anti-VIH, anti-hepatitis C antibodies, and HBS antigens tests
* Patients treated by anticoagulant, b blockers, lipopenic, or anti-inflammatory.
* Patients with a contraindication to muscular exercise (retinopathy, coronaropathy, nephropathy) and to muscular biopsy
* Allergy to local anaesthetic

Primary outcomes:
measure: lipid accumulation in skeletal muscle
timeFrame: 1 month
Secondary outcomes:
measure: lipid accumulation in myotubes from obese patients
timeFrame: 1 month
Other outcomes:
Locations:
city: Montpellier
country: France
facility: CHRU Montpellier
Study officials:
References: