louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06005675: User Acceptability Evaluation of Pseudophakic Patients Previously Implanted With the TECNIS Odyssey IOL
Official title: User Acceptability Evaluation of Pseudophakic Patients Previously Implanted With the TECNIS Odyssey IOL
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cataracts
Lead sponsor: Johnson & Johnson Surgical Vision, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-22
Enrollment: 44
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: Bilateral pseudophakic subjects previously implanted with the TECNIS Odyssey IOL

Brief summary: Prospective collection of data from medical records, multicenter, post-market clinical follow-up study.


Eligibility criteria: Inclusion Criteria:

1. Previously bilaterally implanted with TECNIS Odyssey IOL, following cataract extraction;
2. Enrollment at least 21 days after second eye surgery;
3. Clear intraocular media in each eye;
4. Signed informed consent and data protection documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries;
5. Availability, willingness, ability, and sufficient cognitive awareness to comply with examination procedures;
6. Ability to understand, read, and write in English

Exclusion Criteria:

1. Concurrent participation in an interventional clinical trial during the time from which the data will be collected;
2. Use of systemic or ocular medication that may affect vision
3. Prior corneal refractive surgery in each eye (i.e., LASIK, PRK, SMILE, RK, CK); NOTE: Limbal relaxing incisions (LRI) are permissible as planned at the time of surgery (intraoperatively) but not postoperatively until after completion of the study visits;
4. Ongoing adverse events that might impact study measurements, as determined by the investigator;
5. Acute or chronic disease or condition, ocular trauma, or surgery that may confound study measurements (e.g., clinically significant macular degeneration, glaucoma, cystoid macular edema, proliferative diabetic retinopathy, keratoconus, etc.);
6. Amblyopia, strabismus, nystagmus in each eye

Primary outcomes:
measure: Visual Acuities
timeFrame: 1-month postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Bakersfield
country: United States
facility: Empire Eye and Laser Center
state: California
city: Venice
country: United States
facility: Center For Sight
state: Florida
city: Mount Pleasant
country: United States
facility: Waring Vision Institute
state: South Carolina
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
Study officials:
affiliation: Johnson & Johnson Surgical Vision, Inc.
name: Johnson & Johnson, Surgical Vision Inc. Clinical Trial
role: STUDY_DIRECTOR
References:
Clinical trial NCT00524875: Effect of Intravitreal Bevacizumab on Early Post-Vitrectomy Hemorrhage in Diabetic Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetic Retinopathy
Keywords: Proliferative diabetic retinopathy
Bevacizumab
Early post-vitrectomy vitreous hemorrhage
Lead sponsor: Shahid Beheshti University of Medical Sciences
Sponsor class: OTHER
First posted: 2007-09-05
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether bevacizumab 1-2 weeks before vitrectomy is effective in lowering the rate of early post-vitrectomy vitreous hemorrhage in diabetic patients.

Detailed description: Diabetes is the leading cause of blindness in the age range of 20-64 years. Pars plana vitrectomy may be indicated for the management of advanced proliferative diabetic retinopathy. Early post-vitrectomy hemorrhage in diabetic patients is relatively common; it occurs in 29% -75% of patients in the first month after surgery. This may cause delayed visual rehabilitation and detection of surgical complications such as retinal break or detachment. Preliminary reports such as case series reported by Spaide RF, et al showed beneficial effect of bevacizumab in proliferative diabetic retinopathy complicated by vitreous hemorrhage.

Eligibility criteria: Inclusion Criteria:

* All eyes who are candidate for pars plana vitrectomy because of complications of diabetic retinopathy such as nonclearing vitreous hemorrhage, tractional retinal detachment threatening macula, active progressive PDR

Exclusion Criteria:

* One eye patient
* Best corrected visual acuity better than 20/50
* Pregnancy
* Use of internal tamponade such as silicone oil during surgery
* Concurrent ophthalmic surgery such as cataract extraction

Primary outcomes:
measure: early post-vitrectomy vitreous hemorrhage
Secondary outcomes:
measure: Visual improvement
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Hamid Ahmadieh, MD
Study officials:
affiliation: Ophthalmic Research Center of Shaheed Beheshti Medical University
name: Hamid Ahmadieh, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00608075: Neurofunctional and Neurochemical Markers of Treatment Response in Bipolar Disorder
Official title: Neurofunctional and Neurochemical Markers of Treatment Response in Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Bipolar I Disorder
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2008-02-06
Enrollment: 260
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the research is to study brain structure, function and chemistry of patients with bipolar disorder who are receiving lithium, an FDA-approved treatment for bipolar mania, in order to better understand who benefits from treatment and why they respond to medications. Studying this may help improve treatment and outcome in patients with bipolar disorder.


Eligibility criteria: Inclusion Criteria- bipolar patients (Manic=, depressed=60; 30 patients/year):

1. The patient meets DSM-IV criteria for type I bipolar disorder, manic or mixed, or depressed.
2. The patient has an index Young Mania Rating Scale (YMRS)total score \>15 or Montgomery Asberg Rating Scale (MADRS) total score \>20.
3. The patient is between 15 and 55 years old.

Inclusion Criteria- Healthy subjects (N=40):

1. Healthy subjects will be between the ages of 15 and 55 years.
2. Healthy subjects will have no history of any Axis I psychiatric disorder.
3. Healthy subjects will have no first-degree relatives with affective or psychotic disorders.

Exclusion criteria: All subjects will be excluded from participation for the following reasons.

1. Any medical or neurological disorder that could influence fMRI and MRS results.
2. A history of mental retardation or an estimated IQ total score \<85.
3. An MRI scan is contraindicated in the subject for any reason, including psychological impediments to being inside the MR scanner.
4. The patient cannot attend follow-up visits.

Primary outcomes:
measure: The purpose of the research is to study brain structure, function and chemistry of patients with bipolar disorder who are receiving lithium.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Caleb M Adler, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lei D, Li W, Tallman MJ, Strakowski SM, DelBello MP, Rodrigo Patino L, Fleck DE, Lui S, Gong Q, Sweeney JA, Strawn JR, Nery FG, Welge JA, Rummelhoff E, Adler CM. Changes in the structural brain connectome over the course of a nonrandomized clinical trial for acute mania. Neuropsychopharmacology. 2022 Oct;47(11):1961-1968. doi: 10.1038/s41386-022-01328-y. Epub 2022 May 18.
Clinical trial NCT04218175: Effects of Neuromobilization on Median Nerve Elasticity
Official title: Effects of Neuromobilization on Median Nerve Elasticity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Median Nerve Disease
Keywords: neuromobilization
elasticity
shear wave elastography
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The researcher who performed shear wave elastography did not know which group the case was evaluated during the measurement.
Primary purpose: TREATMENT

Brief summary: Purpose: The aim of this study was to investigate the effect of median nerve neuromobilization on median nerve elasticity using shear wave elastography.

Methods: The study included 36 healthy volunteers (72 upper extremities) aged 18-30 years. Inclusion criteria; no known systemic neuromuscular and metabolic diseases, no nerve impingement syndrome, and no upper extremity bone-tendon-muscle surgery in the last six months. Sociodemographic data of the participants were recorded. Wrist flexion and extension bilaterally with universal goniometer and finger grip strength bilaterally were measured with pinchmeter. Median Nerve Stress Test was performed. Median nerve elasticity was measured by Shear Wave Ultrasound Elastography. The extremity of the dominant side as a study group and the non-dominant side as a control group were measured bilaterally. Median nerve neuromobilization (stretching (n = 18) and shifting (n = 18)) was applied to the upper extremities of the dominant side. The application was carried out as 3 sets in one session. Evaluations were repeated after application.


Eligibility criteria: Inclusion Criteria:

* 18-30 years of age
* Healthy individuals without any known systemic disease

Exclusion Criteria:

* Those who have undergone an upper extremity bone-tendon-muscle operation in the last six months
* People with a systemic disease such as rheumatoid arthritis, diabetes mellitus
* Patients with any neuromuscular disease

Primary outcomes:
measure: Median Nerve Tension Test
timeFrame: 4 weeks
measure: Median nerve elasticity with Shear Wave Ultrasound Elastography
timeFrame: 4 weeks
measure: Bilaterally finger grip strength with pinchmeter
timeFrame: 4 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: İstinye University
Study officials:
References:
Clinical trial NCT01542775: Effects of Exercise on sRAGE Levels and Cardiometabolic Risk Factors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Korea University
Sponsor class: OTHER
First posted: 2012-03-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to examine the effects of exercise on diverse cardiometabolic risk factors and indicators of atherosclerosis in patients with type 2 diabetes mellitus (T2DM).


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes
* stable body weight
* sedentary lifestyle

Exclusion Criteria:

* smoked cigarettes
* cardiovascular disease
* chronic kidney
* chronic liver disease
* pregnant or breastfeeding
* any other major illness

Primary outcomes:
measure: change from baseline in soluble receptor for advanced glycation endproducts (sRAGE) after 12 weeks of aerobic exercise
timeFrame: 12 weeks
Secondary outcomes:
measure: anthropometric parameters
timeFrame: 12 weeks
measure: biochemical parameters
timeFrame: 12 weeks
measure: energy expenditure
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Eulji University School of Medicine
Study officials:
References:
Clinical trial NCT00497575: Diagnosis and Follow-up of Patients With Subclinical Hypothyroidism
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Hypothyroidism
L-Thyroxine
Follow-Up
Keywords: Congenital Hypothyroidism
diagnosis
L-thyroxine
newborn screening
Lead sponsor: Zhejiang University
Sponsor class: OTHER
First posted: 2007-07-06
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Observational model: DEFINED_POPULATION
Time perspective: PROSPECTIVE

Brief summary: Long term follow-up of the patients with delayed TSH elevation or subclinical hypothyroidism has been seldom reported. The purpose of this study was to explore the diagnostic criteria for subclinical hypothyroidism and the initial dosage of L-thyroxine through long-term follow up for infants with subclinical hypothyroidism ，and evaluate the curative effect.

Detailed description: Long term follow-up of the patients with delayed TSH elevation or subclinical hypothyroidism has been seldom reported. The purpose of this study was to explore the diagnostic criteria for subclinical hypothyroidism and the initial dosage of L-thyroxine through long-term follow up for infants with hyperthyrotropinemia，and evaluate the curative effect.All live-born neonates in province took part in the screening program from October, 1999 to September ,2006. Laboratory tests are performed as a time resolved fluoro-immunoassay (TRFIA). TSH is measured with a cut-off \> 9 mU/L. The diagnostic standard for subclinical hypothyroidism was: TSH ≥ 20 mU/L, T3 and T4 normal or low-normal ,or TSH \> 5.6 mU/L and \< 20 mU/L on initial determination and on follow-up or TSH levels increase on follow-up and/or gradually declining T4 levels.L-Thyroxine was administered for substitution therapy. After 2 years therapy，allround evaluation was performed. Compare the correlation to effects with different level of TSH、starting time of therapy and environment. Compare the effects between subclinical、temporary and permanent hypothyroidism.

Eligibility criteria: Inclusion Criteria:

* The diagnostic standard for manifest hypothyroidism and subclinical hypothyroidism was defined as follows:

  * Hypothyroidism - TSH \> 40 mU/L and T3 and T4 below the reference range or TSH \> 40 mU/L, T3 normal and T4 below the reference range \[2\]
  * Subclinical hypothyroidism - TSH ≥ 20 mU/L, T3 and T4 normal or low-normal or TSH \> 5.6 mU/L and \< 20 mU/L on initial determination and on follow-up or TSH levels increase on follow-up and/or gradually declining T4 levels.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Pediatric Society of the Chinese Medical Association
name: zhengyan Zhao, doctor
role: STUDY_DIRECTOR
References:
Clinical trial NCT06183775: Functional Magnetic Resonance Imaging Study on the Role of Awareness in Visual Perception in Healthy Adult Subjects.
Official title: Functional Magnetic Resonance Imaging Study on the Role of Awareness in Visual Perception in Healthy Adult Subjects.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Magnetic Resonance
Lead sponsor: IRCCS San Raffaele
Sponsor class: OTHER
First posted: 2023-12-28
Enrollment: 62
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Volunteers, enlisted among the students and workers of the San Raffaele Hospital and other universities.

Brief summary: The objective of the study concerns the investigation of the role of awareness in visual perception, highlighting the brain systems involved during non-processing Aware of stimuli belonging to different semantic categories. Specifically, the theoretical perspective of reference is that of the so-called "grounded cognition", according to which the representation of the concepts of semantic knowledge is conveyed by information sensorimotor and affective, introspective and social states. The main objective is therefore to evaluate whether the meaning of the stimulus can be extracted in the absence of awareness, investigating the neural response in the brain regions known to be involved in the conscious processing of stimuli belonging to the semantic categories in question.

To this end, two different experimental paradigms were implemented. A first paradigm aimed at investigating the unconscious representation of semantic knowledge in the context of language, therefore using visual stimuli in lexical mode (words). A second paradigm aimed at investigating the same phenomena in the field of visual perception of objects in space, using stimuli in iconic mode (images).


Eligibility criteria: Inclusion Criteria:

* aged between 20 and 65;
* Italian mother tongue.

Exclusion Criteria:

* clinical evidence of significant psychiatric or systemic neurological pathologies.

Primary outcomes:
measure: Magnetic resonance imaging for 62 healthy volunteers for measure the role of consciousness in visual perception.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Irccs San Raffaele
Study officials:
References:
Clinical trial NCT06935175: A Study of SHR-1826 Monotherapy or in Combination With Immunotherapy in the Treatment of Advanced Hepatocellular Cancer
Official title: A Study of SHR-1826 Monotherapy or in Combination With Immunotherapy in Patients With Advanced Hepatocellular Cancer
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Hepatocellular Cancer
Keywords: hepatocellular cancer
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2025-04-20
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study was designed to evaluate the efficacy and safety of SHR-1826 monotherapy or in combination with immunotherapy in the treatment of advanced hepatocellular cancer patients.


Eligibility criteria: Inclusion Criteria:

1.18-75 years old, male or female.

2.Hepatocellular carcinoma diagnosed histologically or cytologically, and not suitable for radical surgery;

3.Failure of at least one line of standard treatment (progression or intolerance);

4.According to the Response Evaluation Criteria in Solid Tumors (RECIST v1.1), there is at least one measurable lesion diagnosed by imaging (a lesion that has received local treatment needs to show clear progression to be considered a measurable lesion);

5.Expected survival time ≥ 12 weeks;

6.Normal function of major organs;

7.The subject voluntarily participates in this study, signs the informed consent form, has good compliance, and cooperates with the follow-up.

Exclusion Criteria:

1. Known or suspected to have a severe allergic history to the drugs related to this study (including drugs of the same type);
2. Evidence of liver decompensation: including but not limited to symptomatic ascites, esophageal-gastric variceal bleeding, hepatic encephalopathy, hepatorenaHave central nervous system metastasis;l syndrome, sepsis, etc.;
3. Have central nervous system metastasis;
4. Have a history of organ transplantation or are preparing for organ transplantation (including but not limited to liver transplantation);
5. Have a history of abdominal wall fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months before the start of treatment in the study;
6. Other situations in which the investigator deems that the subject should not be included.

Primary outcomes:
measure: Objective Response Rate (ORR) by RECIST V1.1
timeFrame: up 2 years
Secondary outcomes:
measure: Objective Response Rate (ORR) by mRECIST
timeFrame: up 2 years
measure: Disease control rate (DCR) by RECIST V1.1
timeFrame: up 2 years
measure: Progression-free survival (PFS)
timeFrame: up 2 years
measure: Overall survival (OS)
timeFrame: up 2 years
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Zhongshan Hospital
Study officials:
References:
Clinical trial NCT00910559: Phenotypic and Genetic Factors in Autism Spectrum Disorders
Official title: Phenotypic and Genetic Factors in Autism Spectrum Disorders
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Autism Spectrum Disorders
Keywords: Autism Spectrum Disorder
Autism
Asperger Syndrome
Pervasive Developmental Disorders- Not Otherwise Specified
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2009-06-01
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: FAMILY_BASED
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with ASDs and their parents and/or siblings

Brief summary: The purpose of the study is to collect phenotypic (observable characteristics) and genetic information about individuals with Autism Spectrum Disorders (ASDs) and their families.

Detailed description: Participation in this research study involves two research visits, at least one of which is at Children's Hospital Boston. The first visit lasts about 4-6 hours. On this visit, the child will work with a research assistant on a few different cognitive assessments while one or both parents answer interview questionnaires about the child's development, along with other family history information. The second visit at the hospital lasts about 2 and a half hours and involves medical history and family history questionnaires, as well as height, weight, and head circumference measurements and a blood draw from each family member. In addition, digital photographs will be taken of each family member and a 3-D picture of the child's face will be taken. Shortly after the visits, participants will receive a research report of our observations. These results include cognitive, behavioral, developmental, and social findings. The total time commitment for the study is 6 to 8 hours.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of autism spectrum disorder or suspected diagnosis based on clinical genetic test results (e.g., variant diagnosed via chromosomal microarray)
* Age ≥ 18 months

Exclusion Criteria:

* Presence of a metabolic disorder
* Acquired developmental disability (e.g., birth asphyxia, trauma-related injury, meningitis, etc.) or cerebral palsy

Primary outcomes:
measure: genotype-phenotype correlation
timeFrame: enrollment and sample analysis
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Children's Hospital Boston
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Christopher Walsh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: