louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03045042: Search for Serum/Plasma Biomarkers in Pompe's Disease
Official title: Search for Serum/Plasma Biomarkers in Pompe's Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Late Onset Pompe Disease
Pompe Disease
Keywords: Pompe
microRNA
biomarker
muscle MRI
glycogenosis
Lead sponsor: Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
Sponsor class: OTHER
Collaborators: name: Genzyme, a Sanofi Company
First posted: 2017-02-07
Enrollment: 35
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Late onset Pompe patiens

Brief summary: This study aims to analyze serum and plasma samples from patients with late onset Pompe disease treated and not treated with enzyme replacement therapy (ERT) to identify microRNA that could be specific of the disease. The investigators will correlate the concentration of these microRNA with several muscle function tests and quantitative muscle MRI to know whether they are good biomarkers of progression.


Eligibility criteria: Inclusion Criteria:

* Genetic confirmation of Pompe disease

Exclusion Criteria:

* Pregnancy

Primary outcomes:
measure: MicroRNA in serum samples
timeFrame: Baseline
Secondary outcomes:
measure: Muscle function test
timeFrame: Baseline and one year
measure: Whole body muscle MRI
timeFrame: Baseline a and one year
measure: Changes in microRNA concentration
timeFrame: One year period
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
Study officials:
References:
Clinical trial NCT00153842: A Study of Paclitaxel and Carboplatin in Combination With Bexarotene Oral Capsules in Patients With Advanced Lung Cancer
Official title: Phase I and II Clinical Studies of Paclitaxel and Carboplatin in Combination With Bexarotene Oral Capsules for the Treatment of Patients With Advanced Non-Small Cell Lung Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Carcinoma, Non-small-cell Lung
Keywords: NSCLC
Bexarotene
Targretin
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: Bristol-Myers Squibb
name: Ligand Pharmaceuticals
First posted: 2005-09-12
Enrollment: 33
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary aim is to evaluate the safety (Phase I components) of administering bexarotene (Targretin®, LGD1069) oral capsules in combination with two Taxol® and carboplatin (Paraplatin®) schedules to patients with stage IIIB and IV non-small cell lung cancer. This study will also evaluate the preliminary efficacy (Phase II component) of bexarotene oral capsules in combination with the weekly Taxol® schedule and carboplatin in these patients.

Detailed description: The phase I portion of the study will evaluate the safety of administering bexarotene oral capsules daily at two dose levels (300 mg/m2 and 400 mg/m2) in combination with carboplatin and Taxol®. At least 6 patients will be entered onto each dose level. Doses will not be escalated over the course of treatment of an individual patient. The recommended Phase II dose is defined as the highest dose of bexarotene oral capsules (300 mg/m2 or 400 mg/m2) in combination with carboplatin and Taxol® that induces DLT in fewer than or equal to 33% of patients.

The sequential phase II portion of the study will evaluate the efficacy of bexarotene oral capsules in combination with carboplatin and weekly Taxol® in patients with advanced non-small cell lung cancer. The efficacy will be gauged according to the rate of major response where, by definition, a major response occurs if a patient achieves either complete remission (CR) or partial remission (PR). For these patients a true response rate of 20% or greater is sufficiently large to warrant further investigation. A true response rate of 10% or less indicates that the combination is less active.

Eligibility criteria: Inclusion Criteria:

* unresectable stage IIIB or IV NSCLC
* adequate bone marrow, hepatic, thyroid and renal function

Exclusion Criteria:

* peripheral neuropathy \>= grade 2
* gastrointestinal abnormalities
* known hypersensitivity to retinoids

Primary outcomes:
measure: Bexarotene Oral Capsules Safety at Two Dose Levels (300 mg/m2 and 400 mg/m2) in Combination With Carboplatin and Taxol®.
timeFrame: 36 months
Secondary outcomes:
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Norris Cotton Cancer Center
state: New Hampshire
Study officials:
affiliation: Norris Cotton Cancer Center
name: James R Rigas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06196242: Deep Brain Stimulation Lead Localization After Implantation
Official title: Research on Lead Localization for Deep Brain Stimulation After Implantation
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: Deep Brain Stimulation
Lead Localization
MRI
Lead sponsor: Tsinghua University
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Deep brain stimulation (DBS) is an effective treatment for a variety of neurological and psychiatric disorders, with more than 200,000 patients implanted with DBS devices worldwide. Parkinson's disease is one of the typical indications.The clinical outcomes of DBS depends on the accurate implantation of the lead, and the identification of the lead locations is the basis for evaluating the effectiveness of the treatment. The aim of this study is to localize the implantation position of the lead based on postoperative MRI images and to reconstruct the relative spatial relationship between the lead and the stimulation target. By comparing with the lead position identified based on postoperative CT, this study will evaluate the accuracy of identifying the DBS lead position directly from MRI. This study may help to optimise the stimulation parameters and investigate the best stimulation targets for DBS patients.


Eligibility criteria: Inclusion Criteria:

* Parkinson's disease patients with DBS devices, DBS implanted for at least 1 month.
* Ability to tolerate DBS turn-off for at least 30 minutes.
* DBS devices do not contain the ferromagnetic material.
* The patients can fully understand the content of the trial and sign the informed consent form.
* Able to comply to the requirements of this study.

Exclusion Criteria:

* Presence of other concomitant diseases that have or require implantation of pacemakers, defibrillators, cochlear implants, or other neurostimulation devices.
* Patients who are abnormally sensitive to temperature or allergic to heat.
* Patients with severe psychiatric disorders or cognitive impairment.

Primary outcomes:
measure: Lead position
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: National Engineering Research Center of Neuromodulation
state: Beijing
Study officials:
References:
Clinical trial NCT00043342: Study of Interferon Gamma-1b by Injection for the Treatment of Patients With Cystic Fibrosis
Official title: A Phase I/II Study of Interferon Gamma-1b by Subcutaneous Injection for the Treatment of Patients With Cystic Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Cystic Fibrosis
Keywords: cystic fibrosis
pulmonary impairment
Lead sponsor: InterMune
Sponsor class: INDUSTRY
First posted: 2002-08-12
Enrollment: 51
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to evaluate the safety, tolerability, and efficacy of Interferon gamma-1b (IFN-gamma 1b) when administered by subcutaneous injection over a period of 4 weeks to patients with mild-to-moderate cystic fibrosis. Additionally, preliminary assessments on the effects of IFN-gamma 1b on lung function and other indicators of health will be made.


Eligibility criteria: * At least 6 years of age
* Diagnosis of cystic fibrosis (against certain criteria)
* Able to perform pulmonary (lung) function tests and participate in induced sputum procedures
* Pulmonary function values must meet certain minimal requirements
* Must have acceptable laboratory test results
* Cannot be on certain medications during and immediately prior to study
* Cannot have a history of unstable or deteriorating cardiac or neurologic disease

Primary outcomes:
measure: change in sputum neutrophil count
timeFrame: 4 weeks
Secondary outcomes:
measure: change in predicted FEV1, sputum bacterial density, sputum levels of free neutrophil elastase, DNA and IL-8
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
affiliation: InterMune
name: Steven Porter, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01854242: Study of the Relationship Between Glycogen Storage Disease Type Ia and Inflammatory Bowel Disease
Official title: Glycogen Storage Disease Type Ia and Inflammatory Bowel Disease: A New Comorbidity or Secondary Consequence
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Inflammatory Bowel Disease
Glycogen Storage Disease Type Ia
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Prometheus Laboratories
First posted: 2013-05-15
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Glycogen storage disease (GSD) type I is an autosomal recessive disorder of glycogen metabolism that affects approximately 1 in 100,000 live births (1). Mutations of the genes that encode glucose 6-phosphatase \[type Ia\] (2) and glucose 6-phosphate translocase \[type Ib\] (3) have been isolated. Diagnosis is usually suspected in infants with fasting hypoglycemia, lactic acidosis, hyperlipidemia, and hepatomegaly. Other features include stomatitis, growth retardation, osteopenia and hyperuricemia.

Brief summary: The purpose of this research study is to understand the relationship between inflammatory bowel disease (IBD) and Glycogen storage disease (GSD)type Ia. GSD type Ib has been established to have an association with IBD with clinical and histologic features that mirror those of Crohn disease. Development of the disease seems to be related to the defect of neutrophil function in individuals with GSD type Ib and subsequent colonic inflammation. In the last decade, it has become a standard for patients with GSD type Ib and gastrointestinal symptoms to be evaluated for IBD. Patients with GSD type Ia were not recognized to have similar gastrointestinal symptoms until recently. The prevalence of IBD is greater in patients with GSD type Ia versus the general population.

Detailed description: The purpose of this research study is to understand the relationship between IBD and GSD type Ia. The Investigators will be attempting to develop a blood test which will be aimed at the participants diagnosis of IBD.

As a participant in this research study, a blood sample will be collected during your admission to the University of Florida. This will not affect the length of stay of your scheduled visit. There will be no scheduled clinic follow-up.

Eligibility criteria: Inclusion Criteria:

* Anyone with Glycogen Storage Disease type Ia

Exclusion Criteria:

* Anyone where the amount of blood needed to complete the Prometheus test exceeds 3ml/kg.

Primary outcomes:
measure: Serologic, Genetic and Inflammatory Markers Consistent With Inflammatory Bowel Disease
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida and Shands
state: Florida
Study officials:
affiliation: University of Florida
name: Nicole T Lawrence, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Florida
name: David A Weinstein, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01869842: Randomized Controlled Study of the Traditional Percutaneous Coronary Intervention and Intervention Using Optical Coherence Tomography of Incomplete Stent Adhesion and Extent of the Formation of Neointima by Resolute Zotarolimus-eluting Stent Insertion
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
Stable Angina
Unstable Angina
Keywords: Resolute zotarolumus-eluting stent
optical coherence tomography
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2013-06-05
Enrollment: 115
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Optical coherence tomography (OCT) after the stent procedure to improve the adhesion and expansion, or incomplete uncovered struts attached to the main track. OCT in clinical areas by improving the parameters of the best stent will be useful. However, for better results for optical coherence tomography in percutaneous interventions have little useful data on the role. Randomized controlled study of the traditional percutaneous coronary intervention and intervention using optical coherence tomography.


Eligibility criteria: Inclusion Criteria:

* Single lesion in a Single vessel
* Reference vessel diameter 2.5 - 3.5 mm
* Lesion length ≤ 34 mm and ≤ 34 mm stent length
* Stable angina requiring revascularization, patients with unstable angina
* The patient has no difficulty to enforce the follow-up angiography
* Patient is ≥ 20 years old

Exclusion Criteria:

* Lesions with graft vessel, thrombosis, restenosis, and bifurcation requiring 2 stents
* Reference vessel diameter \< 2.5 mm or \> 4.0mm
* Contraindication to anti-platelet agents
* Treated with any DES within 3 months at other vessel
* Creatinine level ≥ 2.0 mg/dL or ESRD
* Severe hepatic dysfunction (3 times normal reference values)
* Patients with LVEF \< 30%
* Life expectancy 1 year
* Lesions with CTO or left main
* Target vessel of ST-elevation MI
* Lesions requiring overlapped stenting or more than 2 DES in each vessel
* Heavy calcified lesions (definite calcified lesions on angiogram)
* Far distal or tortuous lesions having difficulties in OCT evaluation or follow-up OCT
* Pregnant women or women with potential childbearing

Primary outcomes:
measure: ratio of the stent strut
timeFrame: Angiographic follow-up with OCT at 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT02612142: Physical EXercise as an Adjunct Treatment for Depression
Official title: Efficacy of Exercise as an Adjunct Treatment for Clinically Depressed Inpatients During the Initial Stages of Antidepressant Therapy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Lead sponsor: Université de Reims Champagne-Ardenne
Sponsor class: OTHER
First posted: 2015-11-23
Enrollment: 48
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: 35 participants diagnosed with major depressive disorder were randomized in 3 intervention groups: (1) aerobic exercise (AE) ; (2) placebo (stretching) exercise (ST); and (3) no intervention (control group; NI). The intervention length was 10 consecutive days. In groups 1 (aerobic exercise) and 2 (sham exercise), participants exercised for 30 minutes each day. Depressive symptoms were assessed the day before the beginning of intervention and the day after the end of intervention for participants of both groups.

Detailed description: In the aerobic exercise (AE) group, the intervention consisted of 30 minutes of daily brisk walking or jogging. This was done individually and supervised. Participants who missed \> 2 training sessions were considered as non-completers. Exercise intensity had to be maintained within 65%-75% of age-predicted maximal heart rate, as commonly prescribed in studies using aerobic exercise to alleviate depression. Heart rate monitoring devices were used.

Participants in the stretching (ST) group also performed a daily 30 minutes exercise program but this was "sham" exercise, consisting of stretching exercises. Several muscle groups (thighs, calves, gluteal, shoulders, back) were stretched for 60 seconds, with equivalent resting intervals between stretching series. These activities were also individual and supervised. As was the case for the AE intervention, participants who missed \> 2 training sessions were considered as non-completers.

Participants in the control (NI) group received no intervention other than prescribed medication.

All participants started antidepressants within less than 2 weeks before study entry.

Eligibility criteria: Inclusion Criteria:

* diagnosis of major depressive disorder (MDD)
* antidepressant drug therapy initiated for less than 2 weeks
* score of 29 or more on the Beck depression inventory

Exclusion Criteria:

* medical contraindication for exercise practice
* inability to understand written French
* beta-blocking drugs or another forms of antidepressant therapy (sleep deprivation, electroconvulsive therapy)

Primary outcomes:
measure: Score change on the 21-item Beck depression inventory (BDI-II). Each item has a set of severity-graded self-evaluative statements that are rated 0 (neutral) to 3 (maximum severity).
timeFrame: Baseline and 10 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Etablissement Public de Santé Mentale de la Marne
name: Zodi Imad, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06449742: A Prospective Observational Study of Artificial Intelligence Morphometric Evaluation of Vertebral Fractures
Official title: A Prospective Observational Study of Artificial Intelligence Morphometric Evaluation of Vertebral Fractures
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Vertebral Fracture
Osteoporosis
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2024-06-10
Enrollment: 250
Sex: MALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male patients, with an age ≥ 50 years old, that perform CT scan, without osteo-metabolic conditions.

Brief summary: The study will be conducted as a monocentric observational prospective study design wants to evaluate the prevalence of vertebral fractures in the cohort of patients that perform a chest-abdomen CT for medical indication other than osteometabolic pathologies.

Detailed description: This study aimed to evaluate the prevalence of vertebral fractures in a cohort of patients that perform a chest-abdomen CT for medical indication other than osteometabolic pathologies.It is estimated that 250 patients will be enrolled (Patients will be enrolled in retrospective and prospective way between 01/03/2025 and 28/02/2026. The presence of one or more vertebral fractures will be evaluated through the radiological medical assessment with automatic 3D reconstruction of the thoracic and lumbar spine and by application of the AI software NanoxAIHealthVCF NANO-X IMAGING LTD on abdomen-chest CT studies.

Clinical, anthropometric, and anamnestic data will be collected from patients undergoing CT assessments. These data will be collected on the day of the radiological examination.

There will be only one evaluation at the time of the CT scan. Only in case of fracture detection, via radiological medical assessment and/or via AI software, the patient will be subsequently evaluated in the Endocrinology Unit as for standard of care.

Eligibility criteria: Inclusion Criteria:

1. Male subjects
2. Age ≥ 50 years
3. Clinical and medical history data available at abdomen-chest CT evaluation
4. Signature of informed consent to the study

Exclusion Criteria:

1. Hospitalized patients
2. Patients known to have osteo-metabolic diseases.
3. with primary and/or acquired immunodeficiency states, and/or severe impairment of general clinical condition (e.g. metastatic neoplasms; immunosuppressive therapies; worsening/reacute/compensated chronic diseases; moderate-severe renal failure)
4. Patients unable to understand and sign the Informed Consent.

Primary outcomes:
measure: Number of fractures detected with CT scans trough AI software and 3D reconstruction
timeFrame: from 01/03/2025 to 28/02/2026
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01103999: Prospective Evaluation of Spleen Injury Treatments in Languedoc Roussillon
Official title: Prospective Evaluation of Spleen Injury Treatments in Languedoc Roussilon, France
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Trauma
Keywords: spleen
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2010-04-15
Enrollment: 93
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population includes patients hospitalized for trauma to the spleen.

Brief summary: Descriptive, prospective, multicenter evaluation of spleen injury treatment in the Languedoc Roussilon region according to trauma severity, morbi-mortality and length of hospitalization.


Eligibility criteria: Inclusion Criteria:

* Hospitalized for abdominal trauma
* diagnosis of splenic contusion confirmed by scanner or during surgery for hemodynamically unstable cases
* patient has signed a consent form
* patient is a beneficiary of or affiliated with a social security program

Exclusion Criteria:

* Refuses to participate
* Pregnant or breastfeeding
* Patient under guardianship

Primary outcomes:
measure: Number of deceased participants
timeFrame: 1 year
Secondary outcomes:
measure: Number of participants with certain morbidities
timeFrame: 3 months of follow up
measure: Days in hospital
timeFrame: 1 year of follow up
measure: Direct costs (euros per patient)
timeFrame: 1 year of follow up
Other outcomes:
Locations:
city: Alès
country: France
facility: Centre Hospitalier d'Alès
city: Avignon
country: France
facility: CH d'Avignon - Centre Hospitalier Henri Duffaut
city: Bagnols sur Ceze
country: France
facility: Centre Hospitalier Général Louis Pasteur
city: Beziers
country: France
facility: Centre Hospitalier Général
city: Carcassonne Cedex 9
country: France
facility: Centre Hospitalier Antoine Gayraud
city: Marseille Cedex 20
country: France
facility: APHM - Hôpital Nord
city: Mende
country: France
facility: Centre Hospitalier de Mende
city: Montpellier
country: France
facility: Hôpital Saint Eloi
city: Narbonne
country: France
facility: Centre Hospitalier de Narbonne
city: Nîmes
country: France
facility: Centre Hospitalier Universitaire de Nîmes
city: Perpignan
country: France
facility: Centre Hospitalier Saint Jean
city: Sete
country: France
facility: Centre Hospitalier du bassin de Thau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Marie-Christine Le Moine, MD
role: PRINCIPAL_INVESTIGATOR
References: