louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05201573: DIAM™ Spinal Stabilization System Long Term Follow up Clinical Plan
Official title: DIAM™ Spinal Stabilization System Long Term Follow up Clinical Plan
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Low Back Pain
Lead sponsor: Companion Spine, LLC
Sponsor class: OTHER
Collaborators: name: MCRA
First posted: 2022-01-21
Enrollment: 175
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Data will be collected from up to 8 sites that participated in the DIAM Pivotal Study.

There is no randomization for this study. The goal is to collect long-term follow-up data on patients who participated in the DIAM™Spinal Stabilization System - Pivotal Study and were randomized to the DIAM arm or who were randomized to the control arm AND crossed over to receive DIAM treatment.

Brief summary: A hybrid prospective/retrospective, multicenter, single-arm, data collection study.

Detailed description: Collect long-term follow-up data with x-rays and CT on subjects who received the DIAM™ Spinal Stabilization System through the original IDE protocol.

Data collected at one-time point from subjects with at least 5 years of follow-up data.

Eligibility criteria: Inclusion Criteria:

* Subject randomized to the DIAM arm and treated with the DIAM™Spinal Stabilization System in the IDE study OR randomized to the Control arm and crossed over to receive treatment with the DIAM™ Spinal Stabilization System in the IDE study.
* Willing and able to consent to study procedures

Exclusion Criteria:

* NA

Primary outcomes:
measure: Evaluate the safety associated with the use of the investigational implant during long term follow up
timeFrame: 5-10 years after implantation
Secondary outcomes:
measure: Back Pain evaluation
timeFrame: 5-10 years after implantation
measure: Back Pain evaluation
timeFrame: 5-10 years after implantation
measure: Back Pain evaluation
timeFrame: 5-10 years after implantation
measure: Back Pain evaluation
timeFrame: 5-10 years after implantation
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00101673: Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%
Official title: Efficacy and Safety of Vildagliptin in Patients With Type 2 Diabetes With HbA1c 9-11%
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Diabetes Mellitus, Type 2
Keywords: type 2 diabetes
vildagliptin
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-01-13
Enrollment: 251
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 study was not conducted in the United States. The purpose of this study was to assess the safety and effectiveness of two doses of vildagliptin, an unapproved drug, in lowering overall blood glucose levels in people with type 2 diabetes who had not previously been treated with drug therapy to lower their blood sugar and whose blood sugar levels were in a specified range.


Eligibility criteria: Inclusion Criteria:

* Blood glucose criteria must be met
* Not currently on drug therapy for type 2 diabetes
* Body mass index (BMI) in the range 22-45

Exclusion Criteria:

* Pregnancy or lactation
* Type 1 diabetes
* Evidence of serious diabetic complications
* Evidence of serious cardiovascular conditions
* Laboratory value abnormalities as defined by the protocol
* Other protocol-defined exclusion criteria may apply

Primary outcomes:
measure: Change from baseline in HbA1c at 12 weeks
Secondary outcomes:
measure: Adverse event profile after 12 weeks of treatment
measure: Patients with reduction in HbA1c >/= 0.7% after 12 weeks
measure: Change from baseline in fasting plasma glucose at 12 weeks
measure: Change from baseline in HOMA-B at 12 weeks
measure: Change from baseline in body weight at 12 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Pratley RE, Schweizer A, Rosenstock J, Foley JE, Banerji MA, Pi-Sunyer FX, Mills D, Dejager S. Robust improvements in fasting and prandial measures of beta-cell function with vildagliptin in drug-naive patients: analysis of pooled vildagliptin monotherapy database. Diabetes Obes Metab. 2008 Sep;10(10):931-8. doi: 10.1111/j.1463-1326.2007.00835.x. Epub 2007 Dec 17.
citation: Pratley RE, Rosenstock J, Pi-Sunyer FX, Banerji MA, Schweizer A, Couturier A, Dejager S. Management of type 2 diabetes in treatment-naive elderly patients: benefits and risks of vildagliptin monotherapy. Diabetes Care. 2007 Dec;30(12):3017-22. doi: 10.2337/dc07-1188. Epub 2007 Sep 18.
Clinical trial NCT04078373: Urinary Disorders in Subacute Patients After Stroke
Official title: Assessment and Treatment of Urinary Disorders in Patients in the Subacute Phase After Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke, Ischemic
Stroke Hemorrhagic
Urinary Incontinence
Keywords: stroke
inpatient rehabilitation
urinary disorders
treatment
Lead sponsor: University Rehabilitation Institute, Republic of Slovenia
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subacute patients after ischaemic or hemorrhagic stroke directly transferred from an acute hospital to complex inpatient rehabilitation

Brief summary: This observational study will address urinary disorders in subacute stroke patients. Patients without and with urinary disorders will be compared, and treatment outcome will be assessed among the latter.

Detailed description: This prospective observational study will include 100 patients after first ischaemic or hemorrhagic stroke directly transferred from an acute hospital to our Institute for inpatient rehabilitation. Within admission assessment, patients will be classified according to stroke type, stroke localisation and time since stroke. Comorbidities will be recorded and associated neurological deficits will be assessed. Post mictional residue will be determined in all patients one day after admission. The patients with urinary disorders will be treated according to the published official protocol, either using the immediate urination approach or the bladder diary approach. Continence will be regularly assessed by the nursing staff. Urination-disorder-related complications (pressure ulcers, falls and urinary infections), drug therapy and the use of continence aids will also be followed.

Eligibility criteria: Inclusion Criteria:

* subacute patients after ischaemic or hemorrhagic stroke;
* direct transfer from acute hospital to complex inpatient rehabilitation at our Institute.

Exclusion Criteria:

* incontinence before stroke;
* previous brain injury or other brain disease;
* previous bladder or prostate surgery;
* inability to ambulate before stroke;
* terminal disease with expected survival less than three months.

Primary outcomes:
measure: Degree of urinary continence
timeFrame: Through study completion, for an average of 6 weeks
Secondary outcomes:
measure: Presence of urinary-disorders-related complications
timeFrame: Through study completion, for an average of 6 weeks
Other outcomes:
Locations:
city: Ljubljana
country: Slovenia
facility: University Rehabilitation Institute, Republic of Slovenia
Study officials:
affiliation: University Rehabilitation Institute, Republic of Slovenia
name: Nataša Bizovičar, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02179073: Health-related Quality of Life of Patients With Neurogenic Bladder
Official title: Effects of Bladder Management on Health-related Quality of Life in Patients With Neurogenic Bladder
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurogenic Bladder Dysfunction
Lead sponsor: Swiss Paraplegic Research, Nottwil
Sponsor class: NETWORK
First posted: 2014-07-01
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: individuals with neurogenic bladder dysfunction

Brief summary: Bladder management has a major impact on the quality of life in patients with neurogenic bladder dysfunction. This a prospective investigation of the effects of the method for bladder evacuation on the health-related quality of life in patients with neurogenic bladder dysfunction. The changes in health-related quality of life over time (longitudinal investigation) and the differences between the different methods for bladder evacuation will be investigated. Patients will be given a standardized and validated questionnaire annually for 10 years.


Eligibility criteria: Inclusion Criteria:

* Individuals with neurogenic bladder dysfunction

Exclusion Criteria:

* Insufficient dexterity to fill in the questionnaire
* Insufficient proficiency in the German or French language

Primary outcomes:
measure: quality of life
timeFrame: up to year 10
Secondary outcomes:
measure: bladder evacuation method
timeFrame: year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
measure: urinary tract infections
timeFrame: year 1, 2, 3, 4, 5, 6, 7, 8, 9, 10
measure: patient characteristics
timeFrame: time 0
Other outcomes:
Locations:
city: Nottwil
country: Switzerland
facility: Swiss Paraplegic Centre
state: LU
Study officials:
References:
Clinical trial NCT03542773: Targeted Imaging of Glutamate Carboxypeptidase II With DCFPyL-PET
Official title: Targeted Imaging of Glutamate Carboxypeptidase II With DCFPyL-PET
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Schwannomas
Malignant Tumors
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-05-31
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: To use 18F-DCFPyL imaging agent and PET/CT to detect none prostate cancer solid malignancies and schwannoma tumors.

Detailed description: The purpose of this protocol is to extend our existing patient base from those with prostate cancer to those with any solid malignancy - as well as patients with schwannoma, a non-malignant solid tumor that also over-expresses GCP II. Using our first generation imaging agent, \[18F\]DCFBC, we have shown that we could detect GCP II in tissue specimens of patients with a variety of cancers, and vestibular schwannoma. We have also shown that GCP II may not only be present in the neovasculature of solid (non-prostate) tumors, but also reside within the tumor epithelium itself. We have shown that to be the case for melanoma, in particular. Our goal is to leverage the broad utility of our GCP II targeted imaging agents for managing other cancers. In addition to schwannoma, the cancers we intend to target include but will not be restricted to: head and neck cancer, salivary gland tumors, renal cell carcinoma, transitional cell carcinoma, colorectal cancer, gastric cancer, neuroendocrine cancer, glioblastoma, melanoma, pancreatic cancer, non-small cell lung cancer, soft tissue sarcoma, breast cancer, endometrial cancer, ovarian cancer, lymphoma and multiple myeloma.

Eligibility criteria: Inclusion Criteria:

1. Greater than or equal to 18 years of age
2. Biopsy-proven cancer or Schwannoma diagnosis
3. No contraindications to PET scanning to include pregnancy, etc. For females of childbearing potential, negative serum pregnancy test obtained within a 10-day period prior to PET study
4. Patients or their legal representatives must have the ability to read, understand and provide written informed consent for the initiation of any study related procedures.

Exclusion Criteria:

1. Administered a radioisotope within 5 physical half-lives prior to PET imaging
2. In female subjects pregnancy.

Primary outcomes:
measure: Determine feasibility of using 18F-DCFPyL to detect cancer
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
name: Steven Rowe, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06015373: The Impact of Carvedilol Posology on Clinically Significant Portal Hypertension
Official title: The Impact of Carvedilol Posology on Clinically Significant Portal Hypertension: Insights From Elastography Measurements
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Clinically Significant Portal Hypertension
Keywords: portal hypertension
carvedilol
elastography
Lead sponsor: Centro Hospitalar De São João, E.P.E.
Sponsor class: OTHER
First posted: 2023-08-29
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 77
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Carvedilol has emerged as the preferred non-selective β-blocker (NSBB) for treating portal hypertension. However, there is still a debate in dosing regimen, specially regarding dose interval, with a potential lower bioavalability in once daily regimens. The aim of this study is to assess the acute effects of carvedilol posology in patients with clinically significant portal hypertension (CSPH), as a surrogate marker of bioavailability.

In this experimental study, patients with CSPH receiving carvedilol twice daily were asked to supress the night dose of carvedilol, in order to have a dose interval of approximately 24 hours. Spleen stiffness measurement (SSM) by transient elastography (TE) was performed and compared with SSM prior or under treatment. Same procedure was applied to liver stiffness measurement (LSM).


Eligibility criteria: Inclusion Criteria:

* patients with CSPH (defined as a LSM 25 kPa or SSM over 45kPa prior to introduction of carvedilol)

Exclusion Criteria:

* Non-responders to non-selective β-blockers (NSBB)
* NSBB other than carvedilol
* Dosing regimen other than twice daily
* No SSM or LSM within 3 months prior to the beginning of the study
* Body mass index (BMI) \> 30 m/kg2
* Contraindications to NSBB use
* Portal venous thrombosis
* Refusal to participate in the study
* Failure to comply to the study regimen

Primary outcomes:
measure: spleen stiffness measurement (SSM)
timeFrame: Baseline SSM measured up to 3 months before enrolment, and measured at 24 hours after suspending carvedilol
Secondary outcomes:
measure: liver stiffness measurement (LSM)
timeFrame: Baseline LSM measured up to 3 months before enrolment, and measured at 24 hours after suspending carvedilol
Other outcomes:
Locations:
city: Vila Real
country: Portugal
facility: Centro Hospitalar de Trás os Montes e Alto Douro
state: Lordelo
Study officials:
References:
Clinical trial NCT00509873: A Study of the Safety and Efficacy of Gatifloxacin in Patients With Bacterial Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Conjunctivitis
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2007-08-01
Enrollment: 578
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study will determine the safety and efficacy of gatifloxacin eye drops in patients with bacterial conjunctivitis


Eligibility criteria: Inclusion Criteria:

* Clinically diagnosed with bacterial conjunctivitis

Exclusion Criteria:

* Signs and/or symptoms of conjunctivitis for more than 96 hours
* Signs and/or symptoms suggestive of fungal, viral, or allergic conjunctivitis
* Clinical diagnosis of chlamydia in either eye

Primary outcomes:
measure: Percentage of Patients With Clearing (Clinical Success) of Conjunctival Hyperemia and Conjunctival Discharge at Day 6
timeFrame: Day 6
Secondary outcomes:
measure: Percentage of Patients With Microbiological Cure at Day 6
timeFrame: Day 6
measure: Percentage of Patients With Clinical Improvement of Ocular Signs at Day 6
timeFrame: Day 6
measure: Percentage of Patients With Clinical Improvement of Ocular Symptoms at Day 6
timeFrame: Day 6
Other outcomes:
Locations:
city: Gretna
country: United States
state: Louisiana
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Heller W, Cruz M, Bhagat YR, De Leon JM, Felix C, Villanueva L, Hollander DA, Jensen H. Gatifloxacin 0.5% administered twice daily for the treatment of acute bacterial conjunctivitis in patients one year of age or older. J Ocul Pharmacol Ther. 2014 Dec;30(10):815-22. doi: 10.1089/jop.2014.0040.
Clinical trial NCT06155773: Clinical Performance of Onlay Restorations After Cervical Margin Relocation (CMR)
Official title: Effect of Cervical Margin Relocation With Different Restorative Materials on Three-year Clinical Performance and In-Vitro Fracture Resistance of Indirect Hybrid Ceramic Onlay Restorations
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2023-12-04
Enrollment: 64
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The current study intends to evaluate the effect of cervical margin relocation with different restorative materials on three-year clinical performance of indirect Computer-Aided-Design (CAD)/ Computer-Aided-Manufacture (CAM) onlay restorations. This study is designed to test the null hypothesis that the three-year clinical performance of onlay restorations is significantly affected by cervical margin relocation with different restorative materials.


Eligibility criteria: Inclusion Criteria:

* Good general health
* Good oral hygiene
* Patient aging 20-40 y
* Patients with proximal deep carious lesion
* International caries detection and assessment system (ICDAS) 4 or 5 that diagnosed clinically and radiographically.
* Normal response to a vitality test.

Exclusion Criteria:

* poor general health
* poor oral hygiene
* Teeth would need direct pulp capping
* Teeth act as abutment for fixed or removable prosthesis.
* patients with excessive parafunctional habits
* Patient potentially unable to be compliant to recall visits

Primary outcomes:
measure: Gingiva
timeFrame: three year follow up
measure: Modified World Dental Federation (FDI) clinical Criteria
timeFrame: three year follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Faculty of dentistry , Mansoura University
state: Dakahlia
Study officials:
References:
Clinical trial NCT05894473: Effects of Telerehabilitation Based Motor and Cognitive Dual Task Exercises in Patients With Parkinson's Disease
Official title: Comparison of the Effects of Telerehabilitation Based Motor and Cognitive Dual Task Exercises in Patients With Parkinson's Disease - A Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Yeditepe University
Sponsor class: OTHER
First posted: 2023-06-08
Enrollment: 45
Sex: ALL
Minimum age (years): 40
Maximum age (years): 87
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The ability to respond to multiple stimuli is impaired in Parkinson's patients. Traditional rehabilitation approaches focus only on balance and gait training, but individuals with Parkinson's disease need to perform multiple tasks in daily life.

Detailed description: The dual-task (DT) methodology aims to perform two tasks simultaneously. There is no study in which motor and cognitive dual-task exercises are given together and followed up remotely in elderly individuals with PD.

Therefore, it was aimed to compare the effects of telerehabilitation method and motor and cognitive dual-task exercises on cognitive function, balance, walking, fall risk and quality of life in individuals with Parkinson's Disease.

Eligibility criteria: Inclusion Criteria:

* Being diagnosed with idiopathic Parkinson's Disease

  * Getting at least 21 points from the Montreal Cognitive Assessment Scale test
  * Stability of drug therapy taken in the last 1 month
  * Being in the "ten" period of the patients
  * Being able to walk independently on flat ground (3 and above according to Functional Ambulation Classification)

Exclusion Criteria:

* • Serious hearing or vision problems

  * Having other neurological, cardiovascular or orthopedic disorders that may prevent walking
  * Any other neurological disorder (eg dementia, cerebrovascular disease)
  * Having an education level of less than 5 years
  * Patients with a pacemaker
  * Having vascular lower extremity pathologies
  * Not having internet access with a smart phone or computer

Primary outcomes:
measure: Parkinson's Disease Quality of Life Questionnaire
timeFrame: 8 weeks
measure: Montreal Cognitive Assessment Scale (MoCA)
timeFrame: 8 weeks
measure: Berg Balance Scale (BBS)
timeFrame: 8 weeks
measure: 10 meter walking speed test
timeFrame: 8 weeks
measure: Timed Up And Go Test
timeFrame: 8 weeks
measure: Fall Efficiency Scale - International
timeFrame: 8 weeks
measure: Five Times Sit to Stand Test
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Yeditepe University
Study officials:
affiliation: Yeditepe University
name: Yeditepe University
role: PRINCIPAL_INVESTIGATOR
References: