louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05009810: Efficacy and Safety of Astaxanthin in Volunteer With Refraction Errors
Official title: Efficacy and Safety of Astaxanthin in Volunteer With Refraction Errors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Refractive Errors
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2021-08-18
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This study will investigate efficacy and safety of astaxanthin in 180 volunteers with refraction errors. Visual test, skin test, liver function test, renal function test, and adverse event will be evaluated before and after taking astaxanthin for 1 and 2 months.

Detailed description: This study will investigate efficacy and safety of astaxanthin in 180 volunteers with refraction errors. They will divided into 3 groups which are astaxanthin 4 mg group , astaxanthin 6 mg group, and placebo group. They will take the sample 1 capsule once daily for 2 months. Visual test, skin test, liver function test, renal function test, and adverse event will be evaluated before and after taking the sample for 1 and 2 months.

Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* Refraction errors, dry eye, or blurred vision
* Have a willingness to participate in the study

Exclusion Criteria:

* Uncontrolled disease
* Have complications during the study
* Have astaxanthin more than 2 weeks
* Allergic to astaxanthin, seafood, or seaweed
* Osteoporosis or thyroid disease
* Immunodeficiency or taking immunosuppressants
* Liver and kidney diseases
* A person with a brain disorder, vision or hearing unusual
* Pregnancy or lactation
* Cannot follow the protocol
* During participated in other studies

Primary outcomes:
measure: Visual acuity value
timeFrame: 2 months
Secondary outcomes:
measure: Refractive status
timeFrame: 2 months
measure: Eye fatigue status
timeFrame: 2 months
measure: Vision status
timeFrame: 2 months
measure: Skin erythema value
timeFrame: 2 months
measure: Skin melanin value
timeFrame: 2 months
measure: Skin humidity value
timeFrame: 2 months
measure: Skin transepidermal water loss value
timeFrame: 2 months
measure: Aspartate transaminase value
timeFrame: 2 months
measure: Alanine aminotransferase value
timeFrame: 2 months
measure: Alkaline phosphatase value
timeFrame: 2 months
measure: Blood urea nitrogen value
timeFrame: 2 months
measure: Creatinine value
timeFrame: 2 months
measure: Adverse events
timeFrame: 2 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03838510: Repeated-dose Behavioral Intervention to Reduce Opioid Overdose
Official title: Repeated-dose Behavioral Intervention to Reduce Opioid Overdose: A Two-Site Randomized-Controlled Efficacy Trial (REBOOT)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-Related Disorders
Drug Overdose
Lead sponsor: San Francisco Department of Public Health
Sponsor class: OTHER_GOV
First posted: 2019-02-12
Enrollment: 268
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: REBOOT is a randomized trial of a repeated-dose brief intervention to reduce overdose and risk behaviors among naloxone recipients with opioid use disorder. It includes an established overdose education curriculum within an Informational-Motivation-Behavior (IMB) model. This study will test the efficacy of REBOOT vs attention-control.


Eligibility criteria: Inclusion Criteria:

* Age 18-65 years
* Characteristics of opioid use history
* Previously received take-home naloxone
* No life-threatening illness likely to progress clinically during trial
* Able/willing to provide informed consent and locator information, communicate in English, and adhere to visit schedule

Exclusion Criteria:

* Suicidal ideation
* Participating in another interventional study that could possibly impact the study's outcomes of interest
* Planning to leave San Francisco/Boston metro area during study
* Previously exposed to REBOOT counseling intervention
* Any condition that, in the Principal Investigator's judgment, interferes with safe study participation or adherence to study procedures

Primary outcomes:
measure: Number of Overdose Events
timeFrame: 16 Months
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: San Francisco Department of Public Health
state: California
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: San Francisco Department of Public Health
name: Phillip O Coffin, MD, MIA
role: PRINCIPAL_INVESTIGATOR
References:
citation: McMahan VM, Arenander J, Matheson T, Lambert AM, Brennan S, Green TC, Walley AY, Coffin PO. "There's No Heroin Around Anymore. It's All Fentanyl." Adaptation of an Opioid Overdose Prevention Counseling Approach to Address Fentanyl Overdose: Formative Study. JMIR Form Res. 2022 Sep 7;6(9):e37483. doi: 10.2196/37483.
Clinical trial NCT02000310: Molecular and Cellular Mechanisms of Lysosomal Storage Diseases
Official title: Investigation of Molecular and Cellular Mechanisms of Lysosomal Storage Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lysosomal Storage Disorders
Keywords: Gaucher disease
Fabry disease
Pompe disease
Niemann-Pick disease
Lead sponsor: O & O Alpan LLC
Sponsor class: OTHER
First posted: 2013-12-04
Enrollment: 80
Sex: ALL
Minimum age (years): 1
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients or suspected carriers of a lysosomal storage disorders.

Brief summary: The lysosome is a specialized part of the cell that functions to degrade metabolic wastes in the cell. Defects in the functioning of the lysosome result in accumulation and subsequent storage of such metabolic wastes. These defects lead to conditions known as lysosomal storage diseases (LSD). LSDs are caused by inherited genetic mutations and there are over 40 genetically distinct lysosomal storage diseases. Within each specific lysosomal storage disease there are variances in severity of disease, age of onset, and clinical presentation. Though the genetic mutations contributing to the disease have been largely clarified, the molecular and cellular mechanisms that contribute to variations in each distinct LSD remain unclear. With this study we intend to better understand at the cellular and molecular level how the accumulation and storage of metabolic wastes in the lysosome affect the clinical manifestation of LSDs, to detect changes in these mechanisms upon treatment administration, and to correlate these results to genetic information. The knowledge obtained from this research study could lead to better ways to diagnose and treat lysosomal storage diseases.


Eligibility criteria: Inclusion Criteria:

* Subject is greater than or equal to 1 day of age and less than or equal to 100 years of age
* Signed Informed Consent/Assent
* Subject is able and willing to comply with study protocol requirements.
* From clinical or blood laboratory findings subject has evidence of a lysosomal storage disease or a family member of a patient with lysosomal storage disease

Exclusion Criteria:

* Pregnant woman

Primary outcomes:
measure: Correlating genetic mutations with clinical signs and symptoms
timeFrame: 5 years
Secondary outcomes:
measure: Associated Immune Pathophysiology
timeFrame: 5 years
Other outcomes:
Locations:
city: Fairfax
country: United States
facility: Lysosomal and Rare Disorders Research and Treatment Center, Inc (LDRTC)
state: Virginia
Study officials:
affiliation: Lysosomal & Rare Disorders Research & Treatment Center (LDRTC)
name: Ozlem Goker-Alpan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: LDRTC
name: Renuka Limgala, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06120010: Prevalence of Anatomical Variants of Dural Sinuses by MRV Evaluation in Sohag
Official title: Prevalence of Anatomical Variants of Dural Sinuses by MRV Evaluation in Sohag
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anatomical Variants of Dural Sinuses by MRV
Lead sponsor: Sohag University
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 169
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Sohag by nationality and residence, male or female by sex, having normal cerebral MRV reported and consented to participate in the research work will be included in this research.

Brief summary: The purpose of this study is to use the MRV to depict the prevalence of anatomical variants of dural venous sinuses in Sohag population, which can help to avoid potenital pitfalls in the diagnosis of dural venous sinus thrombosis, venous infarcts and venous hemorrhage.


Eligibility criteria: Inclusion Criteria:

* Sohag by nationality and residence, male or female by sex, having normal cerebral MRV reported and consented to participate in the research work will be included in this research.

Exclusion Criteria:

* Having the diagnosis of cerebral venous sinus thrombosis, congential or acquired intracranial abnormalities, ischemic or hemorrhagic stroke, intracranial hypertension, intracranial space occuping lesion, and previous head injury or neurosurgery, also patients with absolute or relative contraindications for imaging including claustrophobia, metallic implants, pacemaker and prosthetic heart valves for MRI.

Primary outcomes:
measure: Prevalence of anatomical variants of dural sinuses in Sohag population
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sohag
country: Egypt
facility: Sohag university Hospital
Study officials:
References:
citation: van Dam LF, van Walderveen MAA, Kroft LJM, Kruyt ND, Wermer MJH, van Osch MJP, Huisman MV, Klok FA. Current imaging modalities for diagnosing cerebral vein thrombosis - A critical review. Thromb Res. 2020 May;189:132-139. doi: 10.1016/j.thromres.2020.03.011. Epub 2020 Mar 19.
citation: Leach JL, Fortuna RB, Jones BV, Gaskill-Shipley MF. Imaging of cerebral venous thrombosis: current techniques, spectrum of findings, and diagnostic pitfalls. Radiographics. 2006 Oct;26 Suppl 1:S19-41; discussion S42-3. doi: 10.1148/rg.26si055174.
citation: Cure JK, Van Tassel P, Smith MT. Normal and variant anatomy of the dural venous sinuses. Semin Ultrasound CT MR. 1994 Dec;15(6):499-519. doi: 10.1016/s0887-2171(05)80019-8.
citation: Tubbs RS, Bosmia AN, Shoja MM, Loukas M, Cure JK, Cohen-Gadol AA. The oblique occipital sinus: a review of anatomy and imaging characteristics. Surg Radiol Anat. 2011 Nov;33(9):747-9. doi: 10.1007/s00276-011-0831-9. Epub 2011 May 29.
Clinical trial NCT01000610: A Study of MabThera (Rituximab) in Patients With Rheumatoid Arthritis and an Inadequate Response to Methotrexate
Official title: An Open Label Study to Evaluate the Safety and Efficacy of Rituximab in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Prior Treatment With Methotrexate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Rheumatoid Arthritis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-10-23
Enrollment: 18
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: In this open-label single arm study the safety and efficacy of Mabthera will be evaluated in patients with active rheumatoid arthritis who have had an inadequate response to methotrexate. Patients will receive MabThera (1000mg iv infusion) on days 1 and 15, and background methotrexate (10-25mg po or sc weekly). After the initial study period of 24 weeks, eligible patients may receive up to 3 re-treatments with MabThera. The anticipated time on study treatment is 1-2 years and target sample size is \<50


Eligibility criteria: Inclusion Criteria:

* adult patients \>/= 18 years of age
* rheumatoid arthritis DAS28 \>/= 3.2
* receiving treatment on an outpatient basis
* experienced an inadequate response to previous or current treatment with methotrexate

Exclusion Criteria:

* rheumatic autoimmune disease other than RA, or significant systemic involvement secondary to RA
* history of or current inflammatory joint disease other than RA
* previous treatment with any cell-depleting therapies

Primary outcomes:
measure: Number of Participants Reporting Adverse Events (AEs)
timeFrame: Days 1 and 15, every 8 weeks up to Week 24 and and then every 3 months up to 18 months for a total of 104 weeks
Secondary outcomes:
measure: Percentage Change in Disease Activity Score 28 (DAS28) From Baseline to Week 24
timeFrame: Baseline and Week 24
measure: Percentage of Participants Whose DAS28 Improved by >1.2 at Week 24
timeFrame: Baseline and Week 24
measure: Change in Bone Density (in Participants Untreated With Bisphosphonates)
timeFrame: Screening and Week 84
Other outcomes:
Locations:
city: Sousse
country: Tunisia
facility: Hopital Farhat Hached; Service Rhumatologie
city: Tunis
country: Tunisia
facility: Hopital Charles Nicole; Service Rhumatologie
city: Tunis
country: Tunisia
facility: Hopital La Rabta; Service Rhumatologie
city: Tunis
country: Tunisia
facility: Hopital Mongi Slim; Service Rhumatologie
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT05290610: Intracranial Stimulation Mapping In Epilepsy
Official title: Intracranial Stimulation Mapping In Epilepsy -The InStim Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Epilepsy
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2022-03-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a single group prospective feasibility study on adult epilepsy patients evaluating whether study tasks and workflow are feasible
Primary purpose: BASIC_SCIENCE

Brief summary: This is a single group prospective study to determine the feasibility for generating brain maps that localize cerebral functions and inter-regional information flow in partial epilepsy in adult patients.


Eligibility criteria: Inclusion Criteria:

* Male or female 18 years and older at screening.
* Written informed consent is obtained from the participant to comply with the requirements of the study.
* Stated willingness to comply with all study procedures and availability for the duration of the study
* Currently undergoing clinically indicated intracranial EEG monitoring for planning of epilepsy surgery in the University of Minnesota/MINCEP program.

Exclusion Criteria:

* Pregnancy ruled out prior to approval for intracranial EG monitoring.
* Persons who are rendered temporarily or permanently invulnerable by inability to understand the research due to study complexity, cognitive impairment, or by inability to make independent decisions owing to University of Minnesota or to Fairview health services.

Primary outcomes:
measure: The effect of prefrontal direct electrical brain stimulation on cognitive effort
timeFrame: Immediately after stimulation sessions
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: UMN
name: Alexander Herman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03091010: A Comparison of Fecal Microbiota Transplantation and Steroid Therapy in Patients With Severe Alcoholic Hepatitis.
Official title: A Comparison of Fecal Microbiota Transplantation and Steroid Therapy in Patients With Severe Alcoholic Hepatitis A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Alcoholic Hepatitis
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2017-03-27
Enrollment: 112
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study population: Patients attending the Out Patient Department and admitted to Institute of Liver and Biliary Sciences.

Study design: Prospective randomized controlled trial Study period: One year- January 2017- December 2018 Sample size: 130 (65 cases in each group) Intervention: The subjects will be given Fecal Microbiota Transplantation through a NJ tube placed after admission to the hospital. Participants will be administered the processed fecal microbiota sample collected from a related or unrelated healthy donor for a period of 7 days.

Monitoring and assessment:

The recipient will be monitored every day after Fecal Microbiota Transplantation therapy.

The recipient will undergo physical examination, complete blood counts, at baseline and a chest X ray, serum procalcitonin, CRP and Tumor Necrosis Factor alpha levels, Liver Function Tests, Kidney Function Tests, International Normalized Ratio and arterial ammonia, at day 0,4,7,14,28,90,180,270 and 365 from the start of therapy.

Microbiota analysis of the donors will be done at baseline and the recipients will be done on day 0,7,28,90 \& 180.


Eligibility criteria: Inclusion Criteria:

* Patients with severe alcoholic hepatitis .
* Eligible for steroid therapy.

Exclusion Criteria:

* Upper gastrointestinal bleed within the past one month.
* Active sepsis
* Serum creatinine \> 1.5 mg/dl (Hepato renal syndrome)
* Intestinal paralysis
* Hepatic or extrahepatic malignancy
* Disseminated intravascular coagulation
* Discriminant Function (DF) \>90

Primary outcomes:
measure: Proportion of participants with Overall Survival at 3 months
timeFrame: 3 months
Secondary outcomes:
measure: Improvement in Child Pugh Turcotte (score) severity in both groups
timeFrame: 6 months
measure: Improvement in Model for End Stage Liver Disease (MELD) of liver disease severity in both groups
timeFrame: 6 months
measure: Improvement in Glasgow Alcoholic Hepatitis (score) in both groups
timeFrame: 6 months
measure: Improvement in Maddrey's Discriminant Function (score) in both groups
timeFrame: 6 months
measure: Adverse events in both groups
timeFrame: 6 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of Liver and Biliary Sciences
state: Delhi
Study officials:
References:
Clinical trial NCT02398110: Transvaginal NOTES Nephrectomy Versus Conventional Laparoscopic Nephrectomy
Official title: Transvaginal NOTES Nephrectomy Versus Conventional Laparoscopic Nephrectomy: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Disease
Lead sponsor: First Affiliated Hospital of Gannan Medical University
Sponsor class: OTHER
First posted: 2015-03-25
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recent reports have suggested that transvaginal NOTES nephrectomy is feasible, yet comparative studies are lacking. The aim of this study was to compare the surgical outcomes of transvaginal NOTES nephrectomy to conventional laparoscopic nephrectomy.


Eligibility criteria: Inclusion Criteria:

* female sex,
* indication for nephrectomy due to benign or malignant kidney disease,
* age between 18 and 65 years, and
* legal competence

Exclusion Criteria:

* emergency surgery,
* contraindications to laparoscopic surgery,
* class IV or V as defined by the American Society for Anesthesiologists (ASA),
* body mass index (BMI) of \> 30 kg/m2,
* advanced TNM staging (≥ T3),
* history of major abdominal surgery,
* gravidity or breast-feeding, and
* no written informed consent signed

Primary outcomes:
measure: Intensity of pain in motion (Pain Scores on the Visual Analog Scale (0-10)
timeFrame: at postoperative day 1
Secondary outcomes:
measure: Cosmetic assessment (Patient Scar Assessment Questionnaire)
timeFrame: > 3 months after surgery
measure: Sexual function (Female Sexual Function Index)
timeFrame: Preoperatively, and 4, 8 and 12 months postoperatively
measure: Intraoperative complications (e.g. bleeding, organ-injury)
timeFrame: Evaluated at the operation day
measure: Duration of the operation
timeFrame: at the operation day
measure: Quality of life (SF-36)
timeFrame: on postoperative month 1
measure: Postoperative complication (classified using the Clavien-Dindo system)
timeFrame: early (≤ 1 month), or late (>1 month)
Other outcomes:
Locations:
city: Ganzhou
country: China
facility: First Affiliated Hospital of Gannan Medical University
state: Jiangxi
Study officials:
References:
Clinical trial NCT02153710: Speech Therapy for Aphasia: Comparing Two Treatments
Official title: A Prospective, Controlled Study of Rehabilitation of Anomia in Aphasia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Aphasia
Anomia
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Portland State University
name: University of Washington
First posted: 2014-06-03
Enrollment: 58
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: This is a behavioral speech therapy trial for individuals who have suffered a stroke on the left side of the brain and have difficulty speaking. The name of this disorder is called "aphasia." Individuals in this study will receive one of two treatments. The first is a phonological (sound level) treatment and the second is a semantic (word level) treatment. Individuals in both groups will receive 60 hours of therapy for free (2 hours/day, 5 days/week, 6 weeks).

Detailed description: Purpose: The ultimate goal of anomia treatment should be to achieve gains in exemplars trained in the therapy session as well as generalization to untrained exemplars and contexts. Phonomotor treatment (PMT) has shown such effects but has not yet been compared to a commonly used lexical/semantic based treatment (semantic feature analysis; SFA).

Methods: In a between group randomized controlled trial, 58 persons with aphasia characterized by anomia and phonological dysfunction were randomized to receive 56-60 hours of intensively delivered treatment over 6 weeks with testing pre-, post- and three-months post treatment termination.

Eligibility criteria: Inclusion Criteria:

* Single, left-hemisphere stroke
* English as primary language prior to stroke

Exclusion Criteria:

* Other neurological disorders
* Untreated depression

Primary outcomes:
measure: Spoken Word Production (Confrontation Naming)
timeFrame: Pretreatment to 3 months following treatment termination change
Secondary outcomes:
measure: Response Latency
timeFrame: Pretreatment to 3 months following treatment termination change
measure: Verbs Correctly Named
timeFrame: Pretreatment to 3 months following treatment termination change
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Diane L. Kendall, PhD
role: PRINCIPAL_INVESTIGATOR
References: