louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00202956: Safety and Efficacy Study of Bugusan (BGS)to Treat Osteoporosis.
Official title: A Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Effects on Biomarkers and Safety of Bugusan (BGS) in Postmenopausal Patients With Osteoporosis.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Osteoporosis
Lead sponsor: Taichung Veterans General Hospital
Sponsor class: OTHER
First posted: 2005-09-20
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective is to evaluate the effects on biomarkers and safety of BGS in postmenopausal patients with osteoporosis.

Detailed description: The objective is to evaluate the effects on biomarkers and safety of BGS in postmenopausal patients with osteoporosis by a study of Randomized, Double Blind, Placebo-Controlled, Parallel Group.

Eligibility criteria: Inclusion Criteria:

1. Postmenopausal women between the ages of 45 and 75 years with a natural menopause ≧ 6 months and serum E2 values \< 20 pg/ml, serum FSH values ≧ 25 mIU/mL;
2. Patients have bone mineral density \<-2.5 SD of T score at the lumbar spine (L2-L4);
3. All patients must sign the informed consent form (ICF) prior to the trial.

Exclusion Criteria:

1. Any X-ray film that documents substantial scoliosis, or spinal secondary osteoporosis;
2. Any X-ray film that documents bone fracture within 3 month prior to the trial.
3. Medication such as estrogen, bisphosphonates, calcitonin, fluoride, glucocorticoids, ipriflavone intake within 3 weeks prior to the trial;
4. Use of other Chinese medicine within 2 weeks prior to the trial;
5. Patients with significant renal function impairment (Creatinine\>2mg/dl) and liver function impairment (AST and ALT \> 2 x the upper limit of normal range);
6. Patients have laboratory test abnormality, which in the investigator's opinion might confound the study;
7. Patients have severe cardiac disease, e.g. unstable angina pectoris, myocardial infarction, congestive heart failure (New York Heart Association Functional Classification III and IV);
8. Patients have life threatening disease;
9. Patients are allergic to any of the composition of Chinese medicine;
10. Significant concomitant disease or medical history that could interfere with the study as judged by the investigator;

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Taichung Veterans General Hospital
Study officials:
affiliation: Taichung Veterans General Hospital
name: Huey-Herng Sheu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00011856: Genetic Analysis of Familial Brain Aneurysms
Official title: Linkage Analysis of Familial Intracranial Aneurysms
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Aneurysm
Keywords: Intracranial Aneurysms
Cerebral
Loci
Susceptibility Genes
Cerebral Aneurysm
Familial Cerebral Aneurysm
Genetics
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 2001-03-02
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: This study will investigate cerebral (brain) aneurysms and their possible inheritance patterns in families. It will try to determine how often brain aneurysms occur in families in which more than one member has had an aneurysm and to find the gene or genes that contribute to their development.

People in families in which more than one family member had a cerebral aneurysm are eligible for this 1-day study. They will undergo the following procedures:

* Blood will be drawn (no more than 3 to 4 tablespoons) for research to identify genes that contribute to the development of brain aneurysms.
* A magnetic resonance angiograph (MRA) scan will be done to examine a specific brain area where aneurysms typically occur. Magnetic resonance imaging uses a strong magnetic field and radio waves to produce images of the brain and detect abnormalities.

If a more detailed picture of the brain is needed than can be obtained with MRA, a more specific MRA scan will be done using a contrast dye to enhance the images.

Patients may be invited to participate in related NIH research studies.

Detailed description: This study is designed to explore the genetics of familial cerebral aneurysms. Families in which more than one person has had a known cerebral aneurysm will be studied. Family histories will be obtained and participants identified who are willing to come to the NIH Clinical Center for an MRAngiograph and venipuncture. DNA will be isolated and linkage studies undertaken to identify loci involved in the etiology of familial cerebral aneurysms, using standard linkage approaches.

Eligibility criteria: INCLUSION CRITERIA:

Participants and their relatives that are affected or at a higher risk for cerebral aneurysms will be enrolled in this protocol.

EXCLUSION CRITERIA:

For the MR Angiograph portion of the study, any participant that is not able to sign the Clinical Center consent form due to metal implants, pregnancy, claustrophobia, or an allergy to gadolinium as a contrast will be excluded from the imaging part of the study.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Human Genome Research Institute (NHGRI)
state: Maryland
Study officials:
References:
Clinical trial NCT01870856: Lid Wiper Epitheliopathy Trial
Official title: Evaluation of Lid Wiper Epitheliopathy With and Without Daily Disposable Contact Lenses
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Lid Wiper Epitheliopathy
Keywords: Ocular discomfort
Contact lenses
Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-06-06
Enrollment: 187
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: The purpose of this study is to evaluate the effect of contact lens lubricity on lid wiper epitheliopathy (LWE) in symptomatic contact lens wearers. LWE is defined as an alteration of that portion of the marginal conjunctival epithelium of the upper eyelid that wipes the ocular surface during blinking.

Detailed description: This study will be conducted in two stages. In Stage 1, participants will wear either spectacles or contact lenses for two weeks to determine the impact of interruption of contact lens wear on LWE. In Stage 2, a second cohort of participants will wear one of two contact lens brands for two weeks, and LWE and ocular discomfort will be compared.

Eligibility criteria: Inclusion Criteria:

* Sign Informed Consent document.
* Severe lid wiper epitheliopathy (upper lid) in either eye.
* Currently wearing spherical daily disposable soft contact lenses or daily wear soft contact lenses in both eyes with at least 3 months of contact lens wearing experience.
* Symptomatic as determined by the SPEED questionnaire.
* Willing to follow visit schedule.
* Habitual contact lens power with the range of -1.00 to -6.00 diopters (D) with best corrected distance visual acuity greater than or equal to 20/25 in each eye.
* Astigmatism less than or equal to 0.75D.
* Possess spectacles which provide visual acuity of at least 20/25 in each eye.
* Willing and able to complete daily diaries.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Eye injury within 12 weeks immediately prior to enrollment.
* Any ocular condition that would contraindicate contact lens wear.
* Any use of systemic or ocular medications that would contraindicate contact lens wear, as determined by the investigator.
* Currently wearing toric or multifocal soft contact lenses.
* Participation in a clinical study (including contact lens or contact lens care product) within the previous 30 days.
* Routinely sleeps in lenses for at least 1 night per week.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Stage 1: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks
timeFrame: Baseline, Week 2
measure: Stage 2: Percent of Eyes Experiencing at Least 1 Grade Reduction in LWE at 2 Weeks
timeFrame: Baseline, Week 2
Secondary outcomes:
measure: Stage 2: Change From Baseline in Ocular Discomfort Score (as Measured by SPEED) at 2 Weeks
timeFrame: Baseline, Week 2
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Anne Brobst, OD, FAAO
role: STUDY_DIRECTOR
References:
Clinical trial NCT02246556: Dichoptic Virtual Reality Therapy for Amblyopia in Adults
Official title: Dichoptic Virtual Reality Therapy for Amblyopia in Adults
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Amblyopia
Anisometropia
Strabismus
Keywords: Amblyopia
Dichoptic
Virtual reality
Stereopsis
Stereo vision
Visual acuity
Binocular
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2014-09-22
Enrollment: 17
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This was a randomized, masked, controlled study of the effect of a virtual reality, binocular, 3-dimensional video game on visual acuity and stereopsis in adult patients with amblyopia. The trial has been halted as of June 2016 and will not be evaluating any new subjects for enrollment.


Eligibility criteria: Inclusion Criteria:

* Interpupillary distance of 60-66 mm
* Age 15-40
* Anisometropic amblyopia or strabismic amblyopia
* Best corrected visual acuity of 20/30 or worse in the amblyopic eye
* No prior therapeutic use of the software
* No other ongoing therapies including patching or recent eye muscle surgery
* No vested interest in the product
* Ability attend visits and complete the training session, and to stop the intervention after the specified intervention period

Exclusion Criteria:

* Stimulus-deprivation amblyopia.
* Organic lesions of the eye preventing the establishment of good vision (eg. media opacities, abnormalities in the fundus or optic nerve).
* Lesions of the brain preventing the establishment of good vision (eg. cortical visual impairment).
* Establishment of normal vision by refractive adaptation (wearing glasses after presentation).
* Patients diagnosed with Photosensitive Epilepsy.
* Inability to comply with the follow-up visits required.
* History of pathologic nystagmus (congenital or sensory).

Primary outcomes:
measure: Change in visual acuity
timeFrame: 3 weeks, 6 weeks, and 6 months
Secondary outcomes:
measure: Change in stereopsis
timeFrame: 3 weeks, 6 weeks, and 6 months
measure: Quality of life
timeFrame: 3 weeks, 6 weeks, and 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
References:
Clinical trial NCT01805856: Antimicrobial Prophylaxis in Thyroid and Parathyroid Surgery
Official title: Antimicrobial Prophylaxis for the Prevention of Surgical Site Infection in Thyroid and Parathyroid Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Thyroid Disease
Parathyroid Disease
Keywords: antimicrobial prophylaxis
AMP
surgical site infection
SSI
thyroid
thyroidectomy
parathyroid
surgery
Lead sponsor: Ito Hospital
Sponsor class: OTHER
First posted: 2013-03-06
Enrollment: 2164
Sex: ALL
Minimum age (years): 10
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The effectiveness of antimicrobial prophylaxis (AMP) for prevention of surgical site infection (SSI) following thyroid and parathyroid surgery remains uncertain. Present prospective randomized control study (Ito-RCT1) assessed the effectiveness of AMP in clean neck surgery associated with thyroid and parathyroid disease.

Detailed description: Between November 2010 and April 2012, 2164 consecutive patients who agreed to attend the randomized control study were enrolled. All the participants received surgery for thyroid and parathyroid disease at Ito Hospital and randomized in three groups; Group A (n=541): operation with AMP (PIPC, piperacillin sodium), Group B (n=541): operation with AMP (CEZ, cefazolin sodium), and Group C (n=1082): operation without AMP.

Exclusion criteria

* Patients who did not agree to attend the randomized control study.
* Patients who received the operation including mediastinum with sternotomy.
* Patients who received the operation including additional resection of trachea, esophagus and larynx.
* Patients who received the re-operation for post-operative bleedings.
* Patients who had known allergy to cephem or penicillin.

Eligibility criteria: Inclusion Criteria:

* Between November 2010 and April 2012, 2164 consecutive patients who agreed to attend the randomized control study were enrolled. All the participants received surgery for thyroid and parathyroid disease at Ito Hospital.

Exclusion Criteria:

* Patients who did not agree to attend the randomized control study.
* Patients who received the operation including mediastinum with sternotomy.
* Patients who received the operation including additional resection of trachea, esophagus and larynx.
* Patients who received the re-operation for post-operative bleedings.
* Patients who had known allergy to cephem or penicillin.

Primary outcomes:
measure: Surgical site infections after thyroid and parathyroid surgery
timeFrame: 1 month after operation
Secondary outcomes:
measure: Side effect of the drug for Antimicrobial prophylaxis
timeFrame: 4 days after operation
Other outcomes:
measure: Urinary tract infection after operation with or without antimicrobial prophylaxis
timeFrame: 1month after operation
Locations:
city: Tokyo
country: Japan
facility: Ito Hospital
Study officials:
affiliation: Ito Hospital
name: Takashi Uruno, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05410756: Relationship Between Dysphonia And Anxiety In Fibromyalgia
Official title: Relationship Between Dysphonia And Anxiety In Fibromyalgia Syndrome
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysphonia
Fibromyalgia
Anxiety Disorders
Keywords: anxiety
fibromyalgia
dysphonia
Lead sponsor: Umraniye Education and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2022-06-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 25 patients diagnosed with fibromyalgia syndrome

Brief summary: Our aim in conducting this study is to determine the relationship between voice disorders and anxiety in patients with fibromyalgia syndrome (FS).

Detailed description: This case controlled study was performed at the Physical Medicine and Rehabilitation outpatient clinic between April 2022 and June 2022. 25 patients who were diagnosed with FS according to the 2010 American College of Rheumatology (ACR) criteria were included in the study. For the control group 25 healthy volunteers with no previous chronic disease history were included . The investigators planed to investigate the relationship between the anxiety level of the FS patients and dysphonia. Thus an acoustic voice analysis (fundamental frequency (F0), jitter, shimmer, noise to harmonic ratio (NHR), harmonic to noise ratio (HNR)) and an aerodynamic analysis (maximal phonation time (MPT)) were performed by an experienced otolaryngologist specialized in voice disorders for evaluation of objective voice quality and function. These analyses were performed on all the volunteers from both groups, and the results obtained were compared between the groups.

Eligibility criteria: Inclusion Criteria:

* Diagnosed with Fibromyalgia syndrome for at least 1 year
* Minimum VAS score of 3

Exclusion Criteria:

* Patients with diabetes mellitus,
* other rheumatological diseases,
* malignancies,
* connective tissue disorders
* neuromuscular diseases and
* hereditary diseases.

Primary outcomes:
measure: Beck Anxiety Questionary Score
timeFrame: at the start of the study
measure: Visual Analogue Scale (VAS) Score
timeFrame: at the start of the study
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Umraniye Training and Research Hospital
Study officials:
affiliation: Umraniye Education and Research Hospital
name: Özlem Aslan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06622356: Multivariate Analysis and Machine Learning Model Risk Prediction of Recurrent Pain After PLIF Surgery for Degenerative Lumbar Spine Disease At Long-term Follow-up
Official title: Multivariate Analysis and Machine Learning Model Risk Prediction of Recurrent Pain After PLIF Surgery for Degenerative Lumbar Spine Disease At Long-term Follow-up
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lumbar Disc Herniation
Lumbar Degenerative Disease
Sarcopenia
Keywords: Lumbar Degenerative disease
PLIF
Sarcopenia
Sagittal balance
Machine learning
SVM
Cross Validation
Lead sponsor: First Affiliated Hospital of Suzhou Medical College
Sponsor class: OTHER
First posted: 2024-10-02
Enrollment: 452
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study retrospectively reviewed 452 patients suffering from degenerative lumbar spinedisorders in our institute between January 2019 and February 2023. The patients were separated into Recurrent pain group and Rehabilitation Group. Recurrent pain group (n = 268): mild/non pain group with VAS\<3 at 12-18 months after PLIF；Rehabilitation Group (n = 184): recurrent pain group with VAS≥3 at 12-18 months after PLIF.

Brief summary: The study was a clinical retrospective study designed to investigate risk factors for long-term recurrent pain after PLIF in patients with lumbar degenerative disease and to improve patient outcomes


Eligibility criteria: Inclusion Criteria:

1. confirmed diagnosis of lumbar degenerative disease (spinal stenosis, disc herniation with lumbar instability, and lumbar spondylolisthesis), with no significant symptomatic relief after conservative treatment for more than 3 months, and in need of surgical intervention;
2. lumbar spinal fusion surgical treatment with PLIF;
3. grouping based on the presence or absence of a lumbar or limb pain with VAS ≥3 at the 12-18 month postoperative follow-up;
4. observational indicators including individual factors, surgical factors, spine-pelvis sagittal balance parameters, and paravertebral muscle parameters.

Exclusion Criteria:

(1) those with a history of lumbar spine trauma, inflammation, tumor, or surgery; (2) those with congenital or acquired severe lumbar vertebral deformity; (3) those with severe neurological dysfunction; (4) those with incomplete baseline and follow-up data.

Primary outcomes:
measure: SAS（Pain rating scale）
timeFrame: 12-18 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Suzhou
country: China
facility: Medical record system and imaging system of the First Affiliated Hospital of Suzhou University
state: Jiangsu
Study officials:
References:
Clinical trial NCT01922609: Prediction of Carotid Occlusion Intolerance by Transcranial Doppler Evaluation in Patients Undergoing Carotid Artery Stenting With Proximal Flow Arrest Protection System.
Official title: Prediction of Carotid Occlusion Intolerance by Transcranial Doppler Evaluation in Patients Undergoing Carotid Artery Stenting With Proximal Flow Arrest Protection System.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carotid Occlusion Intolerance
Keywords: Carotid stenting
Proximal protection system
Transcranial Doppler ultrasound
Cerebrovascular reserve
Lead sponsor: University Hospital, Motol
Sponsor class: OTHER
First posted: 2013-08-14
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients with carotid artery stenosis indicated for carotid artery stenting with the use of proximal flow arrest protection device.

Brief summary: The aim of this observational pilot study is to determine whether intolerance of carotid occlusion during carotid artery stenting can be predicted with preprocedural transcranial Doppler evaluation.

Detailed description: Carotid artery stenting procedures are increasingly performed with devices that involve endovascular clamping of the common carotid artery, thus exposing the ipsilateral hemisphere to hypoperfusion. Approximately 5% of patients do not tolerate the clamp and are in increased risk of periprocedural cerebrovascular complication such as transient ischemic attack or stroke. To date, there is no method available that could be used to predict the risk of occlusion intolerance. The aim of this study is to determine whether preprocedural evaluation with transcranial Doppler ultrasonography can be effective in prediction of occlusion intolerance.

Eligibility criteria: Inclusion Criteria:

* Either \>50% symptomatic carotid artery stenosis (transient ischemic attack or ischemic stroke within 6 months before procedure) or \>70% asymptomatic carotid artery stenosis eligible for carotid artery stenting with proximal flow arrest protection
* Signed informed consent

Exclusion Criteria:

* Disagreement to be included in the study
* Inadequate acoustic window for transcranial Doppler ultrasound monitoring
* Carotid occlusion
* Significant extracranial artery stenosis (\>50%) other than target artery
* Inability to hold breath for sufficient time (approximately 30s)

Primary outcomes:
measure: Carotid occlusion intolerance
timeFrame: During carotid stenting procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Department of Cardiology, University Hospital Motol
Study officials:
affiliation: Department of cardiology, University Hospital Motol
name: Miloslav Spacek, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of cardiology, University Hospital Motol
name: Josef Veselka, MD, PhD
role: STUDY_CHAIR
References: