louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06041763: Bridge-Enhanced ACL Repair (BEAR) in Meniscus Repair
Official title: Outcomes Following Meniscal Repair With the BEAR Implant: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Meniscus Tear
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2023-09-18
Enrollment: 80
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: The bridge-enhanced ACL repair (BEAR) implant is a collagen-based scaffold loaded with whole blood. It is designed to promote healing in the setting of intraarticular knee pathology. This study would compare clinical outcomes and synovial fluid cytokine profiles in patients who undergo isolated meniscal repair with or without the BEAR implant.


Eligibility criteria: Inclusion Criteria:

• History of meniscus injury indicated for isolated repair, without concomitant ligament reconstruction or repair, cartilage repair procedure, or osteotomy.

Exclusion Criteria:

* Patients who are undergoing meniscal repair for displaced bucket-handle meniscal tears
* Patients with a history of blood-borne diseases including HIV, hepatitis B virus, hepatitis C virus, human T-lymphotropic virus, and syphilis

Primary outcomes:
measure: Change in International Knee Documentation Committee (IKDC) Subjective Knee Form Score
timeFrame: Baseline, 1 Year Post-Procedure
measure: Change in Lysholm Scale Score
timeFrame: Baseline, 1 Year Post-Procedure
measure: Change in Visual Analogue Scale (VAS) Score
timeFrame: Baseline, 1 Year Post-Procedure
measure: Incidence of Repair Failure
timeFrame: Up to 1 Year Post-Procedure
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Guillem Gonzalez-Lomas, MD Gonzalez-Lomas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02118363: INTERACTION, Monitoring of Stroke Patients in Hospital and Home Environment
Official title: Proof of Concept Study of the INTERACTION Technology, Monitoring of Stroke Patients in Hospital and Home Environment
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: upper limb
lower limb
monitoring
assessment
sensor
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: University of Twente
name: University of Pisa
name: Roessingh
name: XSens technologies B.V.
name: Smartex S.r.l.
First posted: 2014-04-21
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: subakut or chronic stroke patients

Brief summary: Clinical assessment and monitoring of balance and arm function in stroke patients with sensor based measurement, in clinical and home environment.


Eligibility criteria: Inclusion Criteria:

* Age: 18 or above
* Previous Stroke in the personal history
* Able to walk 10 meters. A walking aid (unilateral or bilateral) is permitted
* Able to walk without special shoes
* Able to raise the arm against gravity
* Able to read and understand questionnaires and able to execute commands
* Able and willing to participate in the study
* Singed Informed Consent

Exclusion Criteria:

* Contraindications on ethical grounds (vulnerable persons)
* known or suspected non-compliance, drug or alcohol abuse,
* Severe aphasia
* Severe dementia
* Severe depression
* Relevant medical disease or increased risk of rehospitalization
* Severe sensory deficits
* Severe neglect

Primary outcomes:
measure: proof of concept
timeFrame: 3 month
Secondary outcomes:
Other outcomes:
Locations:
city: Vitznau
country: Switzerland
facility: Cereneo
Study officials:
References:
citation: Held JPO, Klaassen B, Eenhoorn A, van Beijnum BF, Buurke JH, Veltink PH, Luft AR. Inertial Sensor Measurements of Upper-Limb Kinematics in Stroke Patients in Clinic and Home Environment. Front Bioeng Biotechnol. 2018 Apr 12;6:27. doi: 10.3389/fbioe.2018.00027. eCollection 2018.
Clinical trial NCT04100863: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Autism
Official title: A Non-Interventional Pilot Study to Explore the Role of Gut Flora in Autism
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Autism
Autism Spectrum Disorder
Autistic Disorder
Autism, Akinetic
Autism; Atypical
Autism; Psychopathy
Autism Fragile Syndrome X
Autism With High Cognitive Abilities
Autism-Related Speech Delay
Autism, Susceptibility to, 6
Autism Spectrum Disorder High-Functioning
Autistic Thinking
Autism, Susceptibility to, X-Linked 6
Autistic Behavior
Lead sponsor: ProgenaBiome
Sponsor class: OTHER
First posted: 2019-09-24
Enrollment: 0
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Individuals ages 6 and older who have been diagnosed with Autism

Brief summary: This study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding autism.

Detailed description: The goal of this Research Study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding autism.

Eligibility criteria: Inclusion Criteria:

1. Signed informed consent by parent or legally authorized representative
2. Male or female patients age 6 and older.
3. Diagnosis of autism per DSM-V criteria (See appendix)

Exclusion Criteria:

1. Refusal by parent or legally authorized representative to sign informed consent form
2. Treatment with antibiotics within 2 weeks prior to screening
3. Treatment with probiotics within 6 weeks prior to screening
4. History of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy.
5. Postoperative stoma, ostomy, or ileoanal pouch
6. Participation in any experimental drug protocol within the past 12 weeks
7. Treatment with total parenteral nutrition
8. Any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial
9. Inability of parent or legally authorized representative to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study

Primary outcomes:
measure: Correlation of Microbiome to Autism via Relative Abundance Found in Microbiome Sequencing
timeFrame: 1 year
Secondary outcomes:
measure: Validation of Sequencing Methods
timeFrame: 1 year
Other outcomes:
Locations:
city: Ventura
country: United States
facility: ProgenaBiome
state: California
Study officials:
affiliation: ProgenaBiome
name: Sabine Hazan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00594763: Venous Thrombosis in Turner Syndrome
Official title: The Risk of Venous Thrombosis in Women With Turner Syndrome
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thromboembolic Disease
Keywords: Turner syndrome
Thromboembolic disease
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2008-01-16
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with Turner syndrome

Brief summary: In the literature, cases of thrombosis in the venous system have been described in girls and women with Turner syndrome. By screening a group of women with Turner syndrome, the researchers wish to find out if this condition is more frequent in this patient population.

Detailed description: In the literature cases of thrombosis in the venous system has been described in girls and women with Turner syndrome. By screening a group of women with Turner syndrome we wish to find out if this condition is more frequent in this patient population. Participants are examined with screening blood tests evaluating thromboembolic disturbances.

Eligibility criteria: Inclusion Criteria:

* Turner syndrome verified by karyotyping
* Aged 18 or above

Exclusion Criteria:

* Malignant disease
* Treatment with anticoagulants

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Medical Department M (Endocrinology and Diabetes), Aarhus University Hospital
state: Aarhus C
Study officials:
affiliation: Medical Department of Endocrinology, Aarhus University Hospital, 8000 Aarhus, Denmark
name: Jens Sandahl Christiansen, MD, dr.med, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01353963: Desvenlafaxine Succinate (Pristiq): Postmarketing Surveillance Study Among Filipino Patients
Official title: An Open Label, Non-interventional Study Of The Safety Of Desvenlafaxine Succinate (Pristiq) In The Treatment Of Major Depressive Disorder (Mdd) And Vasomotor Symptoms (Vms) Associated With Menopause In Filipino Adult Patients: A Post Marketing Surveillance Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Major Depressive Disorder
Vasomotor Symptoms
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2011-05-16
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with major depressive disorder and vasomotor symptoms secondary to menopause prescribed with desvenlafaxine succinate

Brief summary: This is a non-interventional study to review safety data on administration of desvenlafaxine succinate among Filipino patients with MDD and VMS per usual clinical practice within the first three years post commercial distribution.

Detailed description: post marketing surveillance none

Eligibility criteria: Inclusion Criteria:

Patients diagnosed with major depressive disorder and vasomotor symptoms secondary to menopause prescribed with desvenlafaxine succinate

Exclusion Criteria:

Hypersensitivity to desvenlafaxine succinate

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) or Serious Adverse Events (SAEs), or Discontinuation Due to Adverse Events (AEs)
timeFrame: Week 4 to Week 8
measure: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 4.
timeFrame: Week 4
measure: Change From Baseline in Systolic Blood Pressure (BP) and Diastolic BP at Week 8.
timeFrame: Week 8
measure: Change From Baseline in Heart Rate at Week 4.
timeFrame: Week 4
measure: Change From Baseline in Heart Rate at Week 8.
timeFrame: Week 8
measure: Change From Baseline in Weight at Week 4.
timeFrame: Week 4
measure: Change From Baseline in Weight at Week 8.
timeFrame: Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Las Pinas
country: Philippines
facility: Private Clinic
city: Manila
country: Philippines
facility: Private Clinic
city: Pasay City
country: Philippines
facility: Private Clinic
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT05188963: RCT About Two Different Regimens of Clean Intermittent Catheterization in Women With Overt Postpartum Urinary Retention
Official title: A Randomized Control Trial About Two Different Regimens of Clean Intermittent Catheterization in Women With Overt PUR: the DICOPUR Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Urinary Retention
Postpartum Period
Keywords: postpartum urinary retention
intermittent catheterization
postvoid residual volume
postpartum
Lead sponsor: Medical University of Vienna
Sponsor class: OTHER
First posted: 2022-01-12
Enrollment: 96
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: A randomized controlled trial of two different regimens of intermittent catheterization in women with overt postpartum urinary retention.

Participants will be randomized to one of two groups with different cut-offs for accepted postvoid residual urine (150 ml vs 250 ml).

Primary endpoint is be the time to regain normal bladder function in each group. Secondary endpoints are 1) presence/absence of bacteriuria or urinary tract infections, 2) the duration of hospital stay, 3) scores on the adapted version of the German pelvic floor questionnaire section about bladder function and postpartum symptoms.

The calculated sample size is 96 (48 in each group).


Eligibility criteria: Inclusion Criteria:

* Diagnosed overt postpartum urinary retention.
* Age ≥ 18 years at delivery date.
* Delivery at study site.
* signed informed consent.

Exclusion Criteria:

* Refusal to participate.
* Language barrier.

Primary outcomes:
measure: Time to regain normal bladder function
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Vienna
country: Austria
facility: Medical University of Vienna/Allgemeines Krankenhaus Wien
Study officials:
References:
Clinical trial NCT00992563: WALTZ - Wet Age-Related Macular Degeneration (AMD) AL-39324 Treatment Examination
Official title: A Dose-Escalation Study of AL-39324 Suspension Versus Lucentis® for the Treatment of Exudative Age-Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Age Related Macular Degeneration
Keywords: wet age-related macular degeneration, exudative
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-10-09
Enrollment: 35
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, and effects of investigational drug AL-39324 for the treatment of wet AMD.

Detailed description: Following a single administration, patients will be followed for 6 months postinjection.

Eligibility criteria: Inclusion Criteria:

* Willing to give written informed consent, make the required study visits and follow instructions;
* The study eye:

  * must have a primary diagnosis of choroidal neovascularization (CNV) secondary to AMD;
  * lesion must be no larger than 30 mm2;
  * must have edema measuring greater than 340 μm;
  * must have a visual score between 73 and 34 letters, inclusive;
  * must be able to have clear picture taken of the back of the eye;
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* The study eye must not have been treated for exudative AMD previously;
* The study eye must not have any other ocular disease, condition, infection, or recent surgery that would interfere with vision or examination of the back of the eye;
* The study eye must not have uncontrolled glaucoma;
* The study eye must not be missing a lens;
* Must not be taking any medication that is toxic to the lens;
* Must not be taking oral or ocular corticosteroids;
* Must not have an unstable or progressive condition that would interfere with study visits;
* Must not have allergies to any component of the test article or sensitivity to fluorescein dye;
* If female, must not be pregnant or nursing and must agree to adequate birth control;
* Must not be participating in another drug or device study within 30 days of screening for this study;
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Incidence of targeted adverse events occurring in the study eye
timeFrame: Up to Day 7 after injection
Secondary outcomes:
measure: Mean change from baseline in central foveal thickness (CFT) at Month 1
timeFrame: Baseline (Day 0), Month 1
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Jennifer M. Kissner, Ph.D.
role: STUDY_DIRECTOR
References:
Clinical trial NCT02049463: Advanced Analysis of the Carotid Phonoangiography and Diseases
Official title: Advanced Analysis of the Carotid Phonoangiography and Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Carotid Atherosclerosis
Seeing Sounds as Colors
Stenosis
Stroke
Keywords: carotid artery
sound
stenosis
wall
stroke
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2014-01-30
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: the patients who is going to have carotid angiography study and with informed consent signed.

Brief summary: Purpose: To investigate the different sound spectrum of carotid arteries and to analyze its relationship to the vessel disease, and to build a new biomarker about vascular disorder.

Methods: To record the carotid phonoangiography with digital stereoscopy and analysis the spectrum with different algorithm such as FFT, wavelet, entropy, complexity, and HHT. The results will be correlated and comparison to the finding in clinical, carotid Doppler and duplex, CTA, MR, and catheter angiography.

Statistics:

The significance of difference between parameters was computed using t-tests or paired t-test etc. A p value \<0.05 is defined as significant.

Detailed description: The investigators plan to recruit data from patients that come to their department for angiography study and intervention (n=300) with different disease entity such as atherosclerosis, tumor, aneurysm, arteriovenous malformation or fistula, and other vascular disorders. A period of about 20 seconds of the carotid phonoangiography was recorded.

Standard for comparison: catheter angiography, CTA, MRI/MRA. The degree of stenosis, the wall thickness, SI and density change was clustered and compared. The clinical and laboratory data will be reviewed and the vascular risk factors will be calculated.

Spectrum analysis: The sound spectrum will be analysis with the FFT, wavelet, entropy, complexity, and HHT algorithms.

The correlation between change of spectrums and also the correlated clinical, images, and laboratory change will be further analysis by statistic method.

Eligibility criteria: Inclusion Criteria:

1. Age: 20 years old to 99 years old
2. Gender: Unlimited
3. Because different types of brain diseases, those who received conventional catheter vascular examination.

Exclusion Criteria:

1. Neck inflammation locally who can not admit the sound.
2. Due to inability to cooperate to accept those recordings.

Primary outcomes:
measure: progression of stenosis
timeFrame: three years
Secondary outcomes:
measure: wall change
timeFrame: three years
Other outcomes:
Locations:
city: Taiwan
country: Taiwan
facility: Hon-Man Liu
Study officials:
affiliation: National Taiwan University Hospital
name: Hon-man Liu, MD, MBA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06365463: Telerehabilitation to Improve Balance and Mobility in Patients After Stroke
Official title: Telerehabilitation to Improve Balance and Mobility in Patients After Stroke: Group Physiotherapy Performed in Individuals' Homes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hemorrhagic Stroke
Ischemic Stroke
Keywords: Stroke
Telerehabilitation
Balance
Mobility
Lead sponsor: University Rehabilitation Institute, Republic of Slovenia
Sponsor class: OTHER
First posted: 2024-04-15
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Telerehabilitation is an effective rehabilitation method that allows patients to receive physiotherapy remotely in their homes. The purpose of this study was to investigate the effects of home-based remote group training for balance and mobility on activities and body functions.

Detailed description: Patients in the chronic post-stroke phase will be assessed for balance and mobility before and after remotely conducted group training. The training will last for 6 weeks, with two 60-minute sessions of balance and mobility training per week. Two consecutive groups will participate. The participants's balance and weight-bearing symmetry will be comprehensive assessed, as well their sit-to-stand ability, walking speed, and satisfaction with the remote training. Detailed inclusion and exclusion criteria are specified in the appropriate section.

Eligibility criteria: Inclusion Criteria:

* chronic phase of ischemic or haemorrhagic stroke (\>6 months after stroke)
* ability to walk independently on level ground or on all surfaces with or without a walking aid
* mild balance deficit
* sufficient cognitive and communicative abilities for participation
* access to a personal computer with a camera, connected to the Internet

Exclusion Criteria:

* stroke in the brainstem or cerebellum
* additional neurological condition
* musculoskeletal impairments that would interfere with the training
* advanced heart failure

Primary outcomes:
measure: Change in balance
timeFrame: Assessment 1-5 days before and 1-5 days after the training
measure: Change in limits of stability
timeFrame: Assessment 1-5 days before and 1-5 days after the training
measure: Change in weight-bearing symmetry
timeFrame: Assessment 1-5 days before and 1-5 days after the training
Secondary outcomes:
measure: Change in mobility
timeFrame: Assessment 1-5 days before and 1-5 days after the training
measure: Change in walking speed
timeFrame: Assessment 1-5 days before and 1-5 days after the training
Other outcomes:
measure: Satisfaction with the remote training
timeFrame: Assessed 1-5 days after the training
Locations:
city: Ljubljana
country: Slovenia
facility: University Rehabilitation Institute, Republic of Slovenia
Study officials:
affiliation: University Rehabilitation Institute, Rehabilitation of Slovenia
name: Urška Puh, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03033563: ICSI Outcome of Ejaculated Versus Extracted Testicular Spermatozoa
Official title: ICSI Outcome of Ejaculated Versus Extracted Testicular Spermatozoa in Cryptozoospermic or Severe Oligozoospermic Men
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracytoplasmic Sperm Injection
Lead sponsor: Adam International Hospital
Sponsor class: OTHER
First posted: 2017-01-27
Enrollment: 430
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infertile couples

Brief summary: The study is retrospective to compare ICSI outcome of patients with cryptozoospermia or severe oligozoospermia after use of ejaculated versus extracted testicular sperms in different cycles for the same patient.

Detailed description: The study was carried out on couples who underwent ICSI in period 2012-2014 for male factor infertility.Patients with semen showing cryptozoospermia were candidates for inclusion in this study.

First cycle was done as ICSI with priority to ejaculated sperm; testicular sperm was used if no motile sperm was available. For failed cases a second cycle was repeated using either testicular sperm or ejaculated sperm.

Keywords:Cryptozoospermia, ejaculated spermatozoa, testicular spermatozoa, ICSI.

Eligibility criteria: Inclusion Criteria:

* Couples seeking ICSI.

Exclusion Criteria:

* Couples not seeking ICSI.

Primary outcomes:
measure: Intracytoplasmic sperm injection outcome
timeFrame: three years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: