louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02053064: Long-term Follow-up of Sanfilippo Type A Patients Treated by Intracerebral SAF-301 Gene Therapy
Official title: Long-term Follow-up of Patients With Sanfilippo Type A Syndrome Who Have Previously Been Treated in the P1-SAF-301 Clinical Study Evaluating the Tolerability and Safety of the Intracerebral Administration of SAF-301.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Mucopolysaccharidosis Type III A
Sanfilippo Disease Type A
Keywords: Neurodegenerative diseases
Nervous systems diseases
Genetic diseases, Inborn
Metabolic diseases
Gene therapy
Adeno Associated Virus (AAV)
Lead sponsor: LYSOGENE
Sponsor class: INDUSTRY
First posted: 2014-02-03
Enrollment: 4
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: P2-SAF-301 is an open-label interventional study without administration of investigational product, evaluating the long-term safety and tolerability of intracerebral SAF-301 previously administered to 4 patients with Sanfilippo type A syndrome.

The primary objective is to collect additional safety and tolerability data on intracerebral SAF-301 previously administered to 4 patients with Sanfilippo type A syndrome.

The secondary objective is to further collect data to assess the effects of SAF-301 on neurological and psychological status, and potential biological markers.


Eligibility criteria: Inclusion Criteria:

* Patients having completed the previous phase I/II study (P1-SAF-301),
* Family understanding the follow-up procedures and the informed consent,
* Patient's parents having signed the informed consent form.

Exclusion Criteria:

* Participation in any other clinical trial.

Primary outcomes:
measure: Checking of adverse events
timeFrame: until 60 months after SAF-301 administration
Secondary outcomes:
measure: Information on neurological and cognitive changes based on clinical status, standardized neurocognitive and behavioral assessments
timeFrame: 5 years after the injection of SAF-301
measure: Information on changes in potential biomarkers of the disease
timeFrame: 5 years after the injection of SAF-301
measure: Information to further evaluation of immune response
timeFrame: 5 years after the injection of SAF-301
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: Hôpitaux Universitaires Paris Sud (Bicêtre)
Study officials:
affiliation: AP-HP Hôpital Bicêtre
name: Kumaran DEIVA, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01492764: Ablation of Ventricular Fibrillation by Accurate Targeting of Arrhythmogenic Regions (AVATAR)
Official title: Ablation of Ventricular Fibrillation by Accurate Targeting of Arrhythmogenic Regions (AVATAR)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ventricular Tachyarrhythmias
Keywords: Ventricular Tachyarrhythmia
Ablation
Electrophysiology
Human
Mapping
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
First posted: 2011-12-15
Enrollment: 2
Sex: ALL
Minimum age (years): 21
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with documented rapid heart rhythms involving the bottom chambers of the heart.

Brief summary: This study will test the hypothesis that many human heart rhythm disorders are caused by small localized sources, where brief ablation may successfully eliminate the heart rhythm disorder.

Detailed description: The investigators will enroll patients with documented rapid heart rates from the bottom chambers of the heart (ventricular tachyarrhythmias).

During electrophysiological study, the investigators will map the localized sources of these heart rhythm disorders.

1. The 'active' group will prospectively receive brief ablation at localized sources (Focal Impulse and Rotor Modulation, FIRM).
2. The control group will be a historical cohort who have received traditional ablation for this disorder.

All patients will be followed for up to 1 year to ensure that they have no recurrent arrhythmias.

Eligibility criteria: Inclusion Criteria:

1. Documented ventricular tachyarrhythmias.
2. Undergoing clinically indicated EP study with ablation.

Exclusion Criteria:

1. Unwillingness or inability to provide informed consent.

Primary outcomes:
measure: reduction in ventricular tachyarrhythmias events
timeFrame: 3 months
measure: safety of ventricular basket mapping in patients undergoing ablation
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: University of California, San Diego Medical Center
state: California
city: San Diego
country: United States
facility: Veterans Affairs San Diego Medical Center
state: California
Study officials:
affiliation: University of California, San Diego
name: Sanjiv Narayan, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02445664: Effect of a Tablet-administered Educational Video on Patients´ Knowledge on Osteoporosis and Treatment
Official title: Effect of a Tablet-administered Educational Video on Patients´ Knowledge on Osteoporosis and Treatment - a Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: Patient education
Video intervention
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
First posted: 2015-05-15
Enrollment: 67
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Osteoporosis is a highly prevalent disease in which non-adherence is a well-recognized problem. Non-adherence may be due to patients´ lack of knowledge, understanding, and involvement. In this study the investigators aimed to determine the effect of an educational video displayed on a tablet-device. The investigators hypothesized that an educational video would increase patients´ knowledge on osteoporosis and treatment at a two week follow up.


Eligibility criteria: Inclusion Criteria:

* Scheduled for at DXA scan at the osteoporosis clinic
* Currently on once-weekly alendronate treatment
* Informed consent

Exclusion Criteria:

* Patients that do not understand Danish
* Patients having hearing impairments (unable to hear the video)
* Patients having visual impairments (unable to watch the video)
* Patients diagnosed with dementia
* Patients unable to give written informed consent.

Primary outcomes:
measure: Change in knowledge score
timeFrame: Baseline and 2-week follow up
Secondary outcomes:
measure: Change in "confidence to treatment" score, as indicated by participant response to questionnaire.
timeFrame: Baseline and 2-week follow up
measure: Change in "satisfaction with the amount of information" score, as indicated by participant response to questionnaire.
timeFrame: Baseline and 2-week follow up
measure: Change in "understandability of the information" score, as indicated by participants response to questionnaire.
timeFrame: Baseline and 2-week follow up
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02008864: Evaluating the Effect of Senna in Uremic Pruritus
Official title: Phase II Study of the Effect of Senna Alexandrina Mill. on Uremic Pruritus and Serum IL-2, INF-δ and TNF-α Levels of Hemodialysed Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: End Stage Renal Disease
Pruritus
Keywords: End stage renal diseases
Hemodialysis
Uremic pruritus
Iranian traditional medicine
Cassia angustifolia
Lead sponsor: Shiraz University of Medical Sciences
Sponsor class: OTHER
First posted: 2013-12-11
Enrollment: 60
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: Uremic pruritus remains one of the most frustrating and potentially disabling symptoms in patients with end stage renal disease. It affect up to 90 percent of patients with end stage renal disease. Several hypotheses have been postulated for the possible underlying etiology, but none is conclusive. Aside from kidney transplantation, which is only definitive treatment, therapeutic approaches have largely been empirical, and no firm evident-base treatments are available. The main goal of therapy remains to minimize severity of pruritus. In Iranian traditional medicine Cassia senna L. is used for healing uremic pruritus . In this study investigators considered to evaluate effect of Cassia senna L. in uremic pruritus by a double blind placebo control clinical trial. It is hypothesized that oral Cassia senna L. may attenuate uremic pruritus by decreasing serum IL-2, IFN-γ and TNF-α.


Eligibility criteria: Inclusion Criteria:

* Hemodialysis patients
* Suffering from pruritus for at least 6 weeks
* Have not responded to other drugs

Exclusion Criteria:

* Dermatological disease
* Liver disease
* Metabolic disease

Primary outcomes:
measure: Severity of Pruritis, as measured by a visual analogue scale
timeFrame: 3 months
Secondary outcomes:
measure: Serum IL-2 level
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
affiliation: Shiraz University of Medical Sciences
name: Jamshid Roozbeh, MD
role: STUDY_CHAIR
affiliation: Shiraz University of Medical Sciences
name: Abdolali Mohagheghzadeh, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shiraz University of Medical Sciences
name: Mohammad Mehdi Sagheb, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Shiraz University of Medical Sciences
name: Arian Kamali-Sarvestani, Pharm D
role: STUDY_DIRECTOR
affiliation: Shiraz University of Medical Sciences
name: Pouya Faridi, PhD
role: STUDY_DIRECTOR
References:
citation: Hercz D, Jiang SH, Webster AC. Interventions for itch in people with advanced chronic kidney disease. Cochrane Database Syst Rev. 2020 Dec 7;12(12):CD011393. doi: 10.1002/14651858.CD011393.pub2.
Clinical trial NCT03811964: Photomotor Reflex to Evaluate the Role of the Non-visual Effects of Light in Neurological, Psychiatric and Ophthalmological Pathologies
Official title: Study of the Photomotor Reflex to Evaluate the Role of the Non-visual Effects of Light in Neurological, Psychiatric and Ophthalmological Pathologies
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Sleep Disorders
Neurological Pathologies
Psychiatric Pathologies
Ophthalmological Pathologies
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 726
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The light has visual and non-visual effects on organism and can act on the behavior, the mood, the cognition and the sleep. These effects are mediated by "classical" retina photoreceptors which allow vision (rods, cones) but also melanopsin cells. The non-visual effects of light seems to be altered in many neurological, psychiatric or ophtalmological conditions but their exact role in the pathogenesis remains poorly understand. The purpose of the study is to increase our knowledge of the non-visual effects of light and establish new therapeutic applications


Eligibility criteria: Inclusion Criteria:

* Man or woman
* Aged 18 years or older
* Subject having signed a free and informed consent
* Subject affiliated to a social protection scheme Arm 1 :Subjects with primary sleep-wake disorder Arm 2 : subjects presenting a neurological pathology with disorder of the controls of the wake and the sleep Arm 3 : subject presenting a psychiatric pathology pathology with disorder of the controls of the wake and the sleep Arm 4 : subject presenting an ophthalmological pathology with possible alteration of the photoreception and / or phototransduction Arm 5 : subjects with photosensitivity with regulation disorder of sleep and wake Arm 6 : healthy subject

Exclusion Criteria:

Age-Related Macular Degeneration (AMD) and all maculopathies (retinopathies pigmentosa, macular involvement of diabetes)

* Cataract with significant vision loss \<5/10
* Chorioretinal neovascularization
* Subject in exclusion period determined by previous or current study
* Impossibility to give the subject information enlightened (subject in emergency situation, difficulties of understanding the subject, ...)
* Subject under the protection of justice
* Subject under guardianship or curatorship
* Pregnancy / Breastfeeding

Primary outcomes:
measure: PIPR : Post-Illumination Pupil Response
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: University Hospital, Strasbourg, France
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Bourgin Patrice, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05482464: Effect of Daily Consumption of Glycomacropeptide on Gut Microbiome and Blood Functional Proteome of Subjects With Irritable Bowel Syndrome
Official title: Effect of Daily Consumption of Glycomacropeptide on Gut Microbiome and Blood Functional Proteome of Subjects With Irritable Bowel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Inflammatory Bowel Syndrome
Lead sponsor: Oregon State University
Sponsor class: OTHER
Collaborators: name: BUILD Dairy
name: Agropur
First posted: 2022-08-01
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: single group assignment
Primary purpose: BASIC_SCIENCE

Brief summary: This study investigates the use of glycomacropeptide (GMP) as a means to manipulate the gut microbiome, metabolome and protein profile of subjects with irritable bowel syndrome (IBS).

Detailed description: In vitro assays show that GMP strongly promotes the growth of beneficial bacteria including Bifidobacterium breve, B. bifidum, B. infantis and Lactococcus lactis. GMP also binds to pathogenic bacteria and prevents their adhesion to intestinal cells, which could prevent enteric infection. GMP also modulates the inflammatory response of key gut immune cells called macrophages. However, the extent to which daily consumption of GMP alters the gut microbiome, metabolome and protein profile of subjects with IBS remains unknown.

This study will investigate how daily GMP consumption can alter the gut microbiome, metabolome and protein profile of subjects with IBS.

Eligibility criteria: Inclusion Criteria:

* Fluent in English
* IBS diagnosis with Rome IV criteria
* People who have a primary care provider

Exclusion Criteria:

* Lactose or milk protein intolerance
* Any known other gastrointestinal disease or disorder beyond IBS, or major gastrointestinal surgery
* Habitual use of laxatives or antacids
* Pregnant or nursing.
* Use of pre or probiotics within one month prior to the study
* Use of antibiotics within one month prior to the study

Primary outcomes:
measure: Measure the inflammatory markers in stool and blood using immunology multiplex assay
timeFrame: Baseline, GMP feeding week 1, 2 and 3 and post study without GMP feeding week 1, 2 and 3
measure: Stool sample based gut microbiome composition using 16S rRNA gene sequencing
timeFrame: Baseline, GMP feeding week 1, 2 and 3 and post study without GMP feeding week 1, 2 and 3
Secondary outcomes:
Other outcomes:
Locations:
city: Corvallis
country: United States
facility: Milam Hall, Room 001
state: Oregon
Study officials:
References:
Clinical trial NCT06380764: Greater Occipital Nerve Block Value in Management of Postdural Puncture Headache
Official title: Greater Occipital Nerve Block at Two-levels Spares the Need for Epidural Blood Patch for Management of Postdural Puncture Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postdural Puncture Headache
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 152
Sex: ALL
Minimum age (years): 25
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Neuraxial techniques are well tolerated and effective options for labor analgesia and anesthesia for caesarean section, and may protect high risk women against severe maternal morbidity. However, neuraxial techniques still have drawbacks especially postdural puncture headache (PDPH) and may be associated with chronic headache, back pain and postnatal depression. PDPH is a relatively common acute complication of neuraxial techniques that was traditionally considered benign and self-limiting, but it significantly impacts patients' general health and quality of life.

Greater Occipital Nerve (GON) originates from C2-3 segments and through its muscular relations it is divided as proximal and distal parts; the most proximal part lies between obliquus capitis inferior and semispinalis and then passes through the semispinalis to pierce the trapezius muscle. In distal region of trapezius fascia, the GON is crossed by the occipital artery and exits the trapezius fascia into the nuchal line about 5-cm lateral to midline. Functionally, GON provides motor supplies to the muscles while passing through it and its main sensory supply is in the occipital region.


Eligibility criteria: Inclusion Criteria:

* Patients with postdural puncture headache;
* Patients partially improved on conservative treatment and required a definitive pain relieving management;
* Patients who were intolerant to conventional analgesics;
* Patients who did not receive or did not improve on conservative therapies.

Exclusion Criteria:

* Patients had postdural puncture headache who were improving on conservative treatment and refused further interventions;
* Patients who had headache secondary to local or systemic disease, cervical radiculopathy, manifest diabetes mellitus;
* Patients dependent on routine analgesia for other causes were excluded from the study;
* Patients refused to participate in the study or to sign the written consent;
* Patients missed during follow-up were not included in the study.

Primary outcomes:
measure: The extent of reduction of consumed analgesia
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
city: Banhā
country: Egypt
facility: Benha university
state: El Qalyoubia
Study officials:
References:
Clinical trial NCT04274764: Screening and Intervention for Glaucoma and Eye Health Through Telemedicine
Official title: Sustainable Community Clinic Telemedicine-Based Glaucoma Screening
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: Telemedicine
Motivational interviewing
Health Coaching
Lead sponsor: University of Michigan
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2020-02-18
Enrollment: 622
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be assigned at a 1:1 ratio to the study intervention.
Primary purpose: PREVENTION

Brief summary: This is a multiple site, randomized study that will assess the effects of personalized eHealth education and motivational-interviewing-based counseling on patient adherence to physician follow-up appointments.

Detailed description: The primary objective of this study is to evaluate the effects of personalized eHealth education and motivational-interviewing-based counseling on adherence to glaucoma follow-up care compared to standard education delivered by a trained staff member. Participants will be randomized in a 1:1 ratio to either standard education and care navigation or eHealth education, counseling and care navigation. The outcome measure of the participant seeing an Ophthalmologist for follow up care within 3 months was increased to 6 months. This modification was made due to ophthalmology visit appointments not being available within the 3-month timeframe.

This study is embedded in a CDC-funded program to engage people from medically underserved areas in glaucoma screening. Participants who screened positive for glaucoma or suspected glaucoma were randomized in a 1:1 ratio to either the standard education and care navigation arm or the eHealth education, counseling, and care navigation arm.

Eligibility criteria: Inclusion Criteria:

- \> or = to 18 years of age

Exclusion Criteria:

* Sudden vision changes
* Significant eye pain
* Pregnant women
* Prisoners
* Cognitive impairment

Primary outcomes:
measure: Physician Follow up
timeFrame: Up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Flint
country: United States
facility: Hamilton Community Health Clinic
state: Michigan
city: Ypsilanti
country: United States
facility: Hope Clinic
state: Michigan
Study officials:
affiliation: University of Michigan
name: Paula Anne Newman-Casey, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Newman-Casey PA, Killeen O, Miller S, MacKenzie C, Niziol LM, Resnicow K, Creswell JW, Cook P, Heisler M. A Glaucoma-Specific Brief Motivational Interviewing Training Program for Ophthalmology Para-professionals: Assessment of Feasibility and Initial Patient Impact. Health Commun. 2020 Feb;35(2):233-241. doi: 10.1080/10410236.2018.1557357. Epub 2018 Dec 20.
Clinical trial NCT00569764: Effect on Metabolic Parameters of Abilify in SPR
Official title: The Effects of Metabolic Parameters of Aripiprazole in Patients With Schizophrenia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Schizophrenia
Metabolic Syndrome
Keywords: schizophrenia
metabolic syndrome
aripiprazole
Lead sponsor: Seoul National Hospital
Sponsor class: OTHER_GOV
Collaborators: name: Korea Otsuka Pharmaceutical Co., Ltd.
First posted: 2007-12-07
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: patients with schizophrenia who want to change an antipsychotics due to metabolic side effects

Brief summary: To measure the long-term changes in weight and plasma lipids after switching antipsychotic treatment to aripiprazole

Detailed description: To measure the long-term changes in weight, plasma lipids and fasting blood glucose after switching antipsychotic treatment to aripiprazole, 1 year, open label studies in out and in-patients with schizophrenia.

The measurement of weight and lipid profile and fasting blood glucose will be measured at baseline and every 3 months for 1 year.

Eligibility criteria: Inclusion Criteria:

* DSM-IV diagnosis with schizophrenia
* who signed an informed consent

Exclusion Criteria:

* comorbid with substance abuse or substance dependence
* pregnancy or lactation

Primary outcomes:
measure: weight lipid profile : HDL, LDL, total-cholesterol, triglyceride fasting blood glucose
timeFrame: 1 year
Secondary outcomes:
measure: prolactin ECG
timeFrame: 1 year
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National Hospital
city: Seoul
country: Korea, Republic of
facility: Seoul National Hospital
Study officials:
affiliation: Seoul National Hospital
name: Jong-il Lee, M.D.
role: STUDY_DIRECTOR
References: