louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02240758: Confocal Laser Endomicroscopy for Brain Tumors
Official title: INTRA-OPERATIVE CONFOCAL LASER ENDOMICROSCOPY FOR BRAIN TUMORS: A FEASIBILITY STUDY IN HUMAN
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Low Grade Glioma (LGG), High Grade Glioma (HGG)
Keywords: glioma, confocal laser endomicroscopy
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2014-09-16
Enrollment: 10
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: Confocal Laser Endomicroscopy (CLE) could be a useful tool for real-time diagnosis of brain lesions (initial diagnosis or follow-up post resection to check for residual dysplasia) and real-time assessment of resections margins during surgery. Probe-based CLE using the CELLVIZIO® has never been used for glioma surgical guided resection. Before assessing the potential of this technique in improving surgical resection outcome, a feasability study has to be performed.


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years old
* Clinical signs and history of the disease in favor of a HGG, LGG
* MRI study in favor of a HGG, LGG, meningioma or brain metastasis
* Affiliated to or beneficiary of a social security system (or equivalent).
* Patients who have provided written informed consent for the study

Exclusion Criteria:

* - Allergy to fluorescein
* Previous life-threatening allergic reactions and known hypersensitivity
* Pregnant or lactating or not using effective contraception;
* Restricted renal function define by a creatinine clearance \< 30ml/min
* Patients under a beta-blockers treatment
* Contraindication to do an MRI (pace-maker)
* Contraindication to the use of 5-ALA : known hypersensibility to 5-ALA or to porphyrin, acute or chronic porphyria
* Minor or adult ward of court (under guardianship or trusteeship)
* No affiliation to a social security system (or equivalent).
* Patients who express opposition to participation in the study.

Primary outcomes:
measure: To demonstrate the technical feasibility of endomicroscopic imaging during brain tumors (gliomas) removal with an open approach (classic neurosurgical procedures) and biopsies.
timeFrame: End of the surgical procedure
Secondary outcomes:
measure: To demonstrate the safety of endomicroscopic imaging during brain tumors (gliomas, meningiomas, metastasis) removal with an open approach (classic neurosurgical procedures) and biopsies.
timeFrame: 14 days after inclusion
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civils de Lyon
Study officials:
affiliation: Hospices Civils de Lyon
name: GUYOTAT JACQUES, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01481558: Effects of Transcranial Direct Current Stimulation on the Apathy of Alzheimer's Disease
Official title: Effects of Transcranial Direct Current Stimulation on the Apathy of Alzheimer's: a Randomized, Sham-controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Apathy
Alzheimer's Disease
Keywords: Apathy
Alzheimer's Disease
Dementia
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2011-11-29
Enrollment: 40
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase 2 double-blind, randomized, sham-controlled study to investigate the effects of repeated transcranial direct current stimulation for the treatment of apathy in moderate Alzheimer's Disease in patients selected from an outpatient clinics in São Paulo, Brazil.

Detailed description: Forty patients were randomized to receive either active or sham-tDCS over the left dorsolateral prefrontal cortex (DLPFC). Patients received six sessions of intervention during two weeks and were evaluated at baseline, at week one and two, and after one week without intervention. Clinical raters, patients, and caregivers were blinded. The primary outcome was apathy. Global cognition and neuropsychiatric symptoms were examined as secondary outcomes.

Eligibility criteria: Inclusion criteria:

1. Dementia defined by DSM-IV (Diagnostic and Statistical Manual version IV)
2. Possible Alzheimer's Disease defined by NINCDS-ADRDA (National Institute for Neurological and Communicative Disorders and Stroke and the Alzheimer's Disease and Related Disorders Association)
3. Mini Mental State Examination scores from 10 to 20
4. Apathy defined by a score equal or higher to 14 in Apathy Scale

Exclusion criteria:

1. Clinical instability
2. Epilepsy
3. Metallic clip in the head
4. Use of alcohol and psychotropic drugs

Primary outcomes:
measure: Apathy Symptoms
timeFrame: Differences in outcome measure comparing second week to baseline
Secondary outcomes:
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo Medical School
Study officials:
affiliation: Harvard Medical School (HMS and HSDM)
name: Felipe Fregni, MD, PhD, MPH
role: STUDY_DIRECTOR
affiliation: University of Sao Paulo
name: Ricardo Nitrini, MD, PhD
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Claudia K Suemoto, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Federal University of Espirito Santo
name: Ester Nakamura-Palacios, MD, PhD
role: STUDY_CHAIR
affiliation: University of Sao Paulo
name: Daniel Apolinário, MD
role: STUDY_CHAIR
References:
citation: Suemoto CK, Apolinario D, Nakamura-Palacios EM, Lopes L, Leite RE, Sales MC, Nitrini R, Brucki SM, Morillo LS, Magaldi RM, Fregni F. Effects of a non-focal plasticity protocol on apathy in moderate Alzheimer's disease: a randomized, double-blind, sham-controlled trial. Brain Stimul. 2014 Mar-Apr;7(2):308-13. doi: 10.1016/j.brs.2013.10.003. Epub 2013 Oct 25.
Clinical trial NCT06442358: Self Biophysical Profile Using a Home Ultrasound Device Proof of Concept
Official title: BPP for ME: Self Biophysical Profile Proof of Concept
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Perinatal Care
Lead sponsor: PulseNmore
Sponsor class: INDUSTRY
Collaborators: name: University of Michigan
First posted: 2024-06-04
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this study is to assess if patients presenting for antenatal testing can complete a Bio Physical Score (BPP) with a home-use ultrasound with remote clinician guidance.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* Singleton pregnancy
* Gestational age ≥ 24 0/7 weeks
* No known major fetal or genetic anomalies (may include: isolated pyelectasis, isolated --VSD, multicystic dysplastic kidney, cleft lip/palate, club foot, etc.)
* Ability to understand and sign informed consent in English
* Ability to read and understand instructions in English
* Ability to hold an ultrasound probe and respond to clinician instructions
* BMI less than 40 at initial prenatal visit
* Scheduled biophysical profile (BPP)
* Any maternal/pregnancy complications requiring antenatal testing, including but not limited to intrauterine growth restriction, chronic or gestational hypertension, preexisting or gestational diabetes, autoimmune disorder, etc.

Exclusion Criteria:

* Multiple gestation
* Known major fetal structural anomaly or aneuploidy
* Known fetal or genetic anomalies
* Ruptured membranes
* Uterine complaints, such as painful contractions
* Maternal concern for decreased fetal movement
* Not evaluated vaginal bleeding (not including spotting)
* Fetal or maternal criteria that require urgent delivery
* BMI ≥ 40 at initial prenatal visit

Primary outcomes:
measure: Assess feasibility and proof of concept that the Pulsenmore home ultrasound device can be used to complete the biophysical profile (BPP) for fetal well being
timeFrame: One day
Secondary outcomes:
measure: Assess preliminary effectiveness and compare participant results to standard of care BPP
timeFrame: One day
measure: Assess patient reported experience measures and patient reported outcomes with using the Pulsenmore home ultrasound device.
timeFrame: One day
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
Study officials:
affiliation: University of Michigan
name: Alex Peahl, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00154258: A Long Term Study of Clozapine in Patients With Treatment-resistant Schizophrenia
Official title: An Open Extension Study to Phase IIb Study of Clozapine in Patients With Treatment-resistant Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Schizophrenia
Keywords: Schizophrenia, treatment-resistant, clozapine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-12
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Clozapine is an antipsychotic. This open study will evaluate the safety and efficacy of long term treatment of clozapine in patients with treatment-resistant schizophrenia.

Detailed description: Clozapine is an antipsychotic. This open study will evaluate the safety and efficacy of long term treatment of clozapine in patients with treatment-resistant schizophrenia.

Eligibility criteria: Inclusion Criteria:

* Attended the previous Phase IIb (core) study
* Improved during the core study
* No safety issues during the core study

Exclusion Criteria:

* Discontinued the core study
* Pregnant or nursing (lactating) women

Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Adverse events during the long term treatment (until NDA approval)
timeFrame: Baseline to 52 weeks
measure: Vital signs at every 4 weeks
timeFrame: Baseline to 52 weeks
measure: Laboratory tests (hematology: at every 1 - 2 weeks, others: at every 4 weeks)
timeFrame: Baseline to 52 weeks
measure: ECG at every 12 weeks
timeFrame: Baseline to 52 weeks
measure: Echo cardiogram at every 24 weeks
timeFrame: Baseline to 52 weeks
Secondary outcomes:
measure: Changes in the symptoms of psychosis at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks
timeFrame: Baseline to 52 weeks
measure: Motor side effects at every 8 weeks up to 52 weeks of treatment, thereafter at every 16 weeks
timeFrame: Baseline to 52 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_CHAIR
References:
Clinical trial NCT01937858: The Correlation Between HbA1c and Mean Blood Glucose in Patients With Diabetes and Renal Failure
Official title: The Correlation Between HbA1c and Mean Blood Glucose in Patients With Diabetes and Renal Failure
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetes
Renal Failure
Keywords: HbA1c
glycated hemoglobin
correlation
diabetes
renal failure
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
First posted: 2013-09-10
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Our target population is patients with diabetes and impaired renal function. This study will include 80 adult patients with type1 or type 2 diabetes; 20 with normal serum creatinine, 40 with renal failure in the predialysis stage (20 with stage 3 and 4 CKD \[GFR 0f 20-40\] and 20 with stage 5 CKD not yet on hemodialysis \[GFR \<20\]), and 20 on hemodialysis. All patients should be comfortable and committed to doing self-glucose monitoring.

Brief summary: The value of HbA1c as a tool to determine glycemic control in patients with diabetes and renal failure has not been well studied, the same accepted normal ranges for HbA1c are applied to all patients with diabetes regardless of their renal function. We would like to evaluate the use of HbA1c as a tool of assessing long term glycemic control in this subgroup of patients with diabetes and evaluate the effect of dialysis on HbA1c


Eligibility criteria: Inclusion Criteria:

All patients \>18 years of age with type 1 or 2 diabetes who show competence in home glucose monitoring and are willing to commit to doing the testing

Exclusion Criteria:

* Pregnancy
* Having received a blood transfusion with in the preceding three months
* Known to have any hereditary or hemolytic anemia
* On a medication known to interfere with HbA1c assay (opiates, acetaminophen, vitamin C, vitamin E) - we will allow patients to be on asprin as almost all patients with diabetes are on this drug.
* Having a blood hemoglobin \<7 mg/dl
* Bilirubin level \>20mg/dL or a triglyceride level \> 250mg/dL
* Alcohol addiction

Primary outcomes:
measure: Correlation
timeFrame: three months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01116258: A Study in Healthy Volunteers to Assess Safety and Blood Levels of AZD5847 After Multiple Doses Over 14 Days
Official title: A Phase I, Single-center, Double-blind, Randomized, Placebo-controlled, Parallel-group, Multiple Ascending Dose Study to Assess the Safety, Tolerability, and Pharmacokinetics of AZD5847 Following Oral Administration to Healthy Male Subjects and Female Subjects of Non-childbearing Potential
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Safety
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-05-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the safety, tolerability and blood levels of AZD5847 after daily oral dosing for 14 days.


Eligibility criteria: Inclusion Criteria:

* BMI between 18-30

Exclusion Criteria:

* Use of drugs that inhibit or induce cytochrome P450 3A4 enzymes
* History of presence of gastrointestinal, hepatic or renal disease

Primary outcomes:
measure: Safety variables (adverse events, vital signs, physical examinations, clinical laboratory assessments, 12-lead ECG, digital ECG, telemetry)
timeFrame: collected prior to treatment, during treatment, and follow-up for a total of 25 to 52 days(includes upto 28 days for screening)
Secondary outcomes:
measure: characterize the Pharmacokinetics of AZD9742 in blood and urine
timeFrame: PK-sampling during 14 pre-defined study days for PK profiling
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Research Site
state: Kansas
Study officials:
affiliation: AstraZeneca
name: Andrew Shaw
role: STUDY_DIRECTOR
affiliation: AstraZeneca
name: Brendan Smyth
role: STUDY_CHAIR
affiliation: AstraZeneca
name: David Melnick
role: STUDY_DIRECTOR
affiliation: Quintiles, Inc.
name: Eleanor Lisbon
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04045158: Diaphragm Ultrasound in Neuromuscular Disorders
Official title: Diaphragm Ultrasound in Neuromuscular Disorders
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Muscular Dystrophies
Keywords: diaphragm
ultrasound
echocardiography
Lead sponsor: Centre d'Investigation Clinique et Technologique 805
Sponsor class: OTHER
First posted: 2019-08-05
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with neuromuscular diseases admitted for a cardio-respiratory function evaluation

Brief summary: Muscular dystrophies are neurologic disease with higher morbidity and mortality. Cardiac function and respiratory muscles can be affected, in addition with skeletal muscle deficiency . Lung function is classically assessed with functionnal pulmonary tests (FPT) . Ultrasound recently emerged as a non-invasive tool to assess diaphragm function.

The aims of the study are:

* to provide the spectrum of diaphragm ultrasound in patients with muscular dystrophies
* to assess the correlation between diaphragm ultrasound and FPT
* to assess the correlation between diaphragm ultrasound and cardiac function


Eligibility criteria: Inclusion Criteria:

* Duchenne muscular dystrophy,
* Becker muscular dystrophy,
* LGMD,
* myotonic dystrophy type 1 and type 2,
* metabolic myopathy,
* mitochondrial myopathy,
* FSHD1 and 2,
* myasthenia

Exclusion Criteria:

* history of cardiac surgery
* history of thoracic surgery
* brain traumatism

Primary outcomes:
measure: diaphragm ultrasound motion
timeFrame: 1 year
Secondary outcomes:
measure: correlation between diaphragm motion (mm) and forced vital capacity(ml)
timeFrame: 1 year
measure: correlation between diaphragm motion (mm) and inspiratory capacity (ml)
timeFrame: 1 year
measure: diaphragm thickness (mm)
timeFrame: 1 year
measure: correlation between diaphargm thickness and maximal inspiratory pressure (cmH20)
timeFrame: 1 year
Other outcomes:
Locations:
city: Garches
country: France
facility: Hopital Raymond Poincare
Study officials:
References:
citation: Fayssoil A, Nguyen LS, Stojkovic T, Prigent H, Carlier R, Amthor H, Bergounioux J, Zini J, Damez-Fontaine S, Wahbi K, Laforet P, Nicolas G, Behin A, Bassez G, Leturcq F, Ben Yaou R, Mansencal N, Annane D, Lofaso F, Orlikowski D. Determinants of diaphragm inspiratory motion, diaphragm thickening, and its performance for predicting respiratory restrictive pattern in Duchenne muscular dystrophy. Muscle Nerve. 2022 Jan;65(1):89-95. doi: 10.1002/mus.27432. Epub 2021 Oct 25.
Clinical trial NCT01979458: Photometric Stereo Endoscopy (PSE) as a Tool for Imaging the Rectum and Colon
Official title: Pilot Study to Evaluate Photometric Stereo Endoscopy (PSE) as a Tool for Imaging the Rectum and Colon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Colonic Polyps
Keywords: Colonoscopy
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2013-11-08
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The goal of this research is to assess photometric stereo endoscopy (PSE) as an endoscopic imaging technique. Specifically, topographical surface contrast reconstructed from the PSE data will be compared to conventional imaging contrast to assess if PSE provides enhanced contrast of abnormal tissue.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing a routine colonoscopy screening
* Patients must be over the age of 18
* Patients must be able to give informed consent

Exclusion Criteria:

* Patients with bleeding/hemostasis disorders
* Patients that are pregnant
* Patients taking any anti-coagulants that would preclude them from undergoing a standard of care colonoscopy, such as Coumadin and Plavix, at the time of the study
* Patients with known colitis or active bleeding will be excluded

Primary outcomes:
measure: Image Contrast
timeFrame: Immediate
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
References:
Clinical trial NCT02552758: The Influence of Omega-3 Fatty Acid on the Violence of Schizophrenia Patient and the Possible Mechanism
Official title: The Influence of Omega-3 Fatty Acid on the Violence of Schizophrenia Patient and the Possible Mechanism
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Schizophrenia
Keywords: violence
PET
omega-3 fatty acid
schizophrenia
patient
Lead sponsor: Shanghai Mental Health Center
Sponsor class: OTHER
First posted: 2015-09-17
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators plan to explore whether Omega-3 fatty acid have effect on the violent behavior of the schizophrenia patients. Investigators will use PET to explore the influence on serotonin function of the brain to understand the mechanism of how Omega-3 fatty acid works. This study will enroll 100 patients of schizophrenia with violent behavior.Participants will be split into two groups randomly. In one group, participants will receive one pill of placebo per day, and in the other, participants will have one pill of 900mg Omega-3 fatty acid per day. This intervention will last 3 months.At week 0, week 4, week 8 and week 12, some scales will be evaluated. Meanwhile, the density of eicosapentaenoic acid(EPA),docosahexaenoic acid (DHA),noradrenalin(NE), dopamine(DA) and serotonin(5-HT) in blood will be tested.At week 0 and week 12, 10 patients of each group will be randomly selected to have the exam of PET.


Eligibility criteria: Inclusion Criteria:

* the sore of MOAS scale \>=4 more than 2 violent behavior in recent 6 months by self repot

Exclusion Criteria:

* serious diseases,such as cardiovascular diseases,nervous system disease. allergy to fish oil

Primary outcomes:
measure: violent behavior of Participants as Assessed by Modified Overt Aggression Scale(MOAS)
timeFrame: up to 24 months
measure: psychiatry symptoms of participants as assessed by Positive and Negative Syndrome Scale (PANSS)
timeFrame: up to 24 months
measure: blood level of eicosapentaenoic acid(EPA), docosahexaenoic acid (DHA), noradrenalin(NE), dopamine(DA) and serotonin(5-HT) of participants
timeFrame: up to 24 months
measure: the density of 5-HT1A receptor in brain tested by positron emission tomography (PET)
timeFrame: up to 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Mental Health Center
state: Shanghai
Study officials:
affiliation: Shanghai Mental Health Center (China)
name: Yi Qiao, phD
role: PRINCIPAL_INVESTIGATOR
References: