louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00191204: Open Label Phase III Duloxetine Study for Stress Urinary Incontinence
Official title: Long Term Monitoring of Safety in Subjects Treated With Duloxetine for Stress Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Urinary Incontinence Stress
Lead sponsor: Eli Lilly and Company
Sponsor class: INDUSTRY
Collaborators: name: Boehringer Ingelheim
First posted: 2005-09-19
Enrollment: 363
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to monitor the long term safety of duloxetine in the treatment of stress urinary incontinence.


Eligibility criteria: Inclusion Criteria:

* Female out patients
* Are ambulatory and are able to use a toilet independently and without difficulty.

Exclusion Criteria:

* Use of monoamine oxidase inhibitors (MAOIs)

Primary outcomes:
measure: The primary objective of this study is to generate long-term safety data for duloxetine in the treatment of women with stress urinary incontinence.
Secondary outcomes:
measure: The secondary objective of this study is to collect data to demonstrate the maintenance of effect of duloxetine on patients quality of life, measured by Patient Impression of Improvement questionnaire.
Other outcomes:
Locations:
city: Peterborough
country: United Kingdom
facility: For additional information regarding investigative sites for this trial contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours EST), or speak with your personal physician.
Study officials:
affiliation: Eli Lilly and Company
name: Call 1-877-CTLILLY (1-877-285-4559) OR 1-317-615-4559 Mon - Fri 9am - 5pm Eastern Time (UTC/GMT - 5 hours, EST)
role: STUDY_DIRECTOR
References:
Clinical trial NCT01255904: A Trial Of Oral Chloral Hydrate Versus Intranasal Dexmedetomidine For Sedated Abr Exams
Official title: A RANDOMIZED CONTROLLED TRIAL OF ORAL CHLORAL HYDRATE VERSUS INTRANASAL DEXMEDETOMIDINE FOR SEDATED ABR EXAMS.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Sedation
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
First posted: 2010-12-08
Enrollment: 90
Sex: ALL
Minimum age (years): 6
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy of oral chloral hydrate to intranasal dexmedetomidine for the successful completion of a sedated ABR exam (hearing exam).


Eligibility criteria: Inclusion Criteria:

* Patient scheduled for ABR exam with sedation to be administered according to protocol by nurse in keeping with standard practice at the TCH Audiology clinic.

Exclusion Criteria:

* Patients younger than 6 months or older than 8 years
* Previously failed sedation
* Weight greater than 25 kg
* Weight less than 5 kg
* BMI above 30
* Diagnosis of ADHD
* Any patient deemed inappropriate for nurse administered sedation
* Patients with any cardiac disease
* Obstructive sleep apnea

Primary outcomes:
measure: Time to Complete Study
timeFrame: 60-180 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Childrens Hospital
state: Texas
Study officials:
References:
citation: Fong CY, Lim WK, Li L, Lai NM. Chloral hydrate as a sedating agent for neurodiagnostic procedures in children. Cochrane Database Syst Rev. 2021 Aug 16;8(8):CD011786. doi: 10.1002/14651858.CD011786.pub3.
Clinical trial NCT01220804: Evaluation of Blood-retinal Barrier Functional Alterations by Optical Coherence Tomography
Official title: Evaluation of Blood-retinal Barrier Functional Alterations by Optical Coherence Tomography
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetic Retinopathy
Lead sponsor: Association for Innovation and Biomedical Research on Light and Image
Sponsor class: OTHER
Collaborators: name: Fundação para a Ciência e a Tecnologia
name: Instituto Financeiro para o Desenvolvimento Regional
First posted: 2010-10-14
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Type 2 diabetic patients with nonproliferative diabetic retinopathy (NPDR) (study population) and healthy volunteers (control population).

Brief summary: The purpose of this study is to identify alterations of the blood-retinal barrier (BRB) in diabetic retinas using a novel non-invasive approach based on the Fourier domain high-definition optical coherence tomograph (OCT).

Detailed description: Type 2 diabetic patients with nonproliferative diabetic retinopathy (NPDR) (study population) and healthy volunteers (control population).

Inclusion Criteria:

Age over 18 years; type-2 diabetes; NPDR levels 10, 20 and 35/47 (ETDRS severity scale); and an area of retinal leakage of at least 25% of the RLA map (macular area).

Exclusion Criteria:

Presence of media opacity; vitreous syneresis or posterior vitreous detachment, and; previous photocoagulation treatments or any type of intraocular surgery or intravitreal medications; and other retinal pathologies.

Eligibility criteria: Inclusion Criteria:

* Age over 18 years; type-2 diabetes; NPDR levels 10, 20 and 35/47 (ETDRS severity scale), and area of retinal leakage of at least 25% of the RLA map (macular area).

Exclusion Criteria:

* Presence of media opacity; vitreous syneresis or posterior vitreous detachment, and; previous photocoagulation treatments or any type of intraocular surgery or intravitreal medications.

Primary outcomes:
measure: Optical reflectivity as measured by optical coherence tomography
timeFrame: 14 months
Secondary outcomes:
Other outcomes:
Locations:
city: Coimbra
country: Portugal
facility: AIBILI
Study officials:
References:
Clinical trial NCT06407804: Effects of Thrower's Ten and Routine Physical Therapy in Patients With Shoulder Impingement Syndrome
Official title: Effects of Thrower's Ten and Routine Physical Therapy on Pain, Range of Motion and Functional Disability in Patients With Shoulder Impingement Syndrome
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Shoulder Impingement Syndrome
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-05-09
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the effects of thrower's ten and routine physical therapy on pain, range of motion and functional disability in patients with shoulder impingement syndrome

Detailed description: Shoulder impingement is a common cause of shoulder pain. It's also known as impingement syndrome or swimmer's shoulder, since it's common in swimmers. It occurs when there is impingement of tendons or bursa in the shoulder from bones of the shoulder. A randomized clinical trial will be conducted at Ibne Sina Hospital,Multan . Non probability convenience sampling technique will be applied on 46 patients who will be allocated through computerized randomization into group A \& group B to collect data. Group A will be given Throwers ten Program and group B will be given routine physical therapy along with baselines. The study will be completed within the time duration of nine months. Primary Outcome measures of the research will be pain, range of motion,function and disability . Data will be analyzed using SPSS software version 25. After assessing normality of data by Shapiro-wilk test, it will be decided either parametric or non-parametric test will be used within a group or between two groups.

Eligibility criteria: Inclusion Criteria:

* Age group 18-35 years
* Male and female
* Shoulder or neck pain within the prior 6month
* 3 positive tests out of 5: Positive Neer's test, positive Hawkins test, positive Jobe's test, painful arc, and pain on resisted external rotation of the arm.

Exclusion Criteria:

* History of surgery of the affected shoulder
* Fractures in around the shoulder
* Neurological disorders leading to altered muscle activity
* Systemic arthritic conditions (RA, Osteoporosis)
* Disorders of the cervical spine

Primary outcomes:
measure: Numeric Pain Rating Scale
timeFrame: 6 weeks
measure: Range of Motion
timeFrame: 6 weeks
measure: Shoulder pain and disability index (SPADI)
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Johar Pain Relief Center
state: Punjab
Study officials:
affiliation: Riphah International University
name: Rabiya Noor, PHD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04412304: Anticoagulant Therapy and 28-days Mortality in Critically Ill COVID-19 Patients
Official title: Patient Characteristics, Outcome and Thromboembolic Events Among Adult Critically Ill COVID-19 Patients With Different Anticoagulant Regimes at One of the Biggest Emergency Hospitals in Northern Europe, Sweden
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid-19
Thromboembolic Events
Bleeding
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
First posted: 2020-06-02
Enrollment: 166
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A cohort study of the Covid-19 patients admitted to an ICU at Stockholm South General Hospital from March 6th 2020 to April 30 2020

Brief summary: The aims of the study are to to associate anticoagulation (AC) regime with outcome in critically ill patients with Covid-19. This will be done by describe baseline characteristics and comorbidities before hospital admission, level of organ support and dose of AC treatment and associate this with 28 days survival, survival outside ICU, thromboembolic event and bleeding complications.


Eligibility criteria: Inclusion Criteria:

* laboratory confirmed positive test for SARS-CoV-2
* admitted to ICU because of critical illness due to covid-19

Exclusion Criteria:

* patients with treatment for thromboembolic complications at arrival to the ICU
* short ICU length of stay defined as discharged the same or the following day as ICU admission

Primary outcomes:
measure: 28-days ICU mortality
timeFrame: 28 days from ICU-admission
Secondary outcomes:
measure: Incidence of thromboembolic events
timeFrame: 28 days from ICU-admission
measure: Incidence of bleeding events
timeFrame: 28 days from ICU-admission
measure: ICU-free days alive from ICU-admission.
timeFrame: 28 days from ICU-admission
Other outcomes:
measure: D-dimer levels in the three groups groups
timeFrame: 28 days from ICU-admission
Locations:
city: Stockholm
country: Sweden
facility: South General Hospital
state: Stockholms Län
Study officials:
affiliation: Karolinska Institutet, Department of Clinical Science and Education
name: Maria Cronhjort, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jonmarker S, Hollenberg J, Dahlberg M, Stackelberg O, Litorell J, Everhov AH, Jarnbert-Pettersson H, Soderberg M, Grip J, Schandl A, Gunther M, Cronhjort M. Dosing of thromboprophylaxis and mortality in critically ill COVID-19 patients. Crit Care. 2020 Nov 23;24(1):653. doi: 10.1186/s13054-020-03375-7.
Clinical trial NCT00963404: Image-Guided Tumorboost of Bladder Cancer
Official title: Image-guided Tumorboost of Localized Unifocal Bladder Cancer: A Phase I/II Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Bladder Neoplasms
Keywords: Image-guided Radiotherapy
Fiducial marker
Adverse effects
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus University Hospital
First posted: 2009-08-21
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to increase the radiation dose (Boost) to the bladder tumor. The bladder cancer patients included in the study will undergo tumor demarcation. The bladder demarcations will then be the target for an image-guided boost delivered precisely to the expected tumor site.


Eligibility criteria: Inclusion Criteria:

* Muscle invasive bladder cancer (transitional carcinoma)
* Unifocal
* TNM stage T2a-4a, N0-1, M0
* unfit for radical cystectomy

Exclusion Criteria:

* Hyperthyroidism
* Multinodular goiter
* Pregnancy
* Breast feeding
* WHO preformance status more than 2
* Iodine allergy
* MRI or CT contrast media allergy
* Bi-lateral hip-prosthesis

Primary outcomes:
measure: Local tumor control
timeFrame: One year
Secondary outcomes:
measure: Acute and late adverse effects of the radiotherapy treatment
timeFrame: 3 years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: The department of Oncology, Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: The department of Oncology, Rigshospitalet
city: Herlev
country: Denmark
facility: The department of Oncology, Herlev University Hospital
city: Odense
country: Denmark
facility: The department of Oncology, Odense University Hospital
Study officials:
affiliation: The department of Oncology, Aarhus University Hospital
name: Jimmi Sondergaard
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01288404: Randomized Controlled Trial of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium
Official title: A Pilot Study of Subconjunctival Bevacizumab Injection in Impending Recurrent Pterygium
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pterygium of the Conjunctiva and Cornea
Keywords: Bevacizumab, impending recurrent pterygium
Lead sponsor: Ramathibodi Hospital
Sponsor class: OTHER
First posted: 2011-02-02
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Hypothesis: Subconjunctival bevacizumab injection may potentially suppress neovascularization in pterygium, preventing or retarding the progression of recurrence.

Detailed description: 1. Impending recurrent pterygium
2. Anti-VEGF therapy

   * Bevacizumab
   * Subconjunctival injection
   * Suppress neovascularization

Eligibility criteria: Inclusion Criteria:

1. Impending recurrent pterygium developed within 6 months following pterygium surgery either simple excision or excision with grafting.
2. Failure of conventional topical anti-inflammatory therapy for impending recurrent pterygium which was defined by the progression of fibrovascular tissue over the excised area despite receiving treatment.
3. No history of any adjunctive treatment such as MMC, 5-FU, periocular injection of corticosteroids and beta radiation.
4. No other ocular surface pathologies or coexisting ocular diseases.
5. No other ocular surgeries within the previous 6 months.
6. No history of allergy to the medications used in this study.
7. Good compliance with the study regimen and availability for the duration of the entire study period.

Exclusion Criteria:

1. Platelet disorders
2. Hypertension
3. Pregnant or lactating women

Primary outcomes:
measure: Severity of impending recurrent pterygium
timeFrame: 3 months
Secondary outcomes:
measure: Visual analog scales
timeFrame: 3 months
measure: Adverse reactions
timeFrame: 3 months
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Ramathibodi Hospital
Study officials:
affiliation: Ramathibodi Hospital
name: Kaevalin Lekhanont, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02739204: Concurrent Radiotherapy and/or Cisplatin With or Without Celecoxib in Patients With Primary Oral Squamous Cell Carcinoma
Official title: Development of Novel Diagnostic Tools and Therapeutic Strategies for Oral Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Oral Squamous Cell Carcinoma
Keywords: Celecoxib
Relapse-free OSCC patient
Recurrence
Survival
Prognosis
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Welfare, Taiwan
First posted: 2016-04-15
Enrollment: 270
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The research and development of novel anti-tumor agents in oral cancer is slow, the investigation of repositioning use of currently available drugs in clinical, such as a selective cyclooxygenase-2 (COX-2) inhibitor (Celebrex/Celecoxib) maybe a potential alternative strategy.

Detailed description: Celebrex (Celecoxib) is a form of non-steroidal anti-inflammatory drug that directly targets COX-2 enzyme to block the inflammatory signaling and has been approved to treat colon cancer. In our preliminary findings, Celecoxib significantly inhibited cell growth,proliferation, migration, invasion and epithelial-mesenchymal transition programs in oral squamous cell carcinoma cell (OSCC) lines. The Institutional Review Board in China Medical University Hospital (CMUH) has approved the combination treatment of concurrent radiotherapy (RT) and/or Cisplatin with or without Celecoxib in a phase II clinical trial for relapse-free primary OSCC patients.

Eligibility criteria: Inclusion Criteria:

1. OSCC patients with T1,2/ N0 and without pathological risk features
2. OSCC patients with T1,2/ N0,1 and pathological risk features
3. OSCC patients with T4a/ N2,3

Exclusion Criteria:

1. Pregnant women paitents
2. Taiwanese aboriginal patients
3. Not primary OSCC patients
4. OSCC patients with dysfunction of liver and/or kidneys

Primary outcomes:
measure: Relapse-free recurrence
timeFrame: 3 year relapse-free recurrence
Secondary outcomes:
measure: Relapse-free survival
timeFrame: 3 year relapse-free survival
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: Department of Otolaryngology
Study officials:
affiliation: Graduate Institute of Clinical Medical Science, China Medical University, Taiwan
name: Ying-Chin Ko, MD-PhD
role: STUDY_CHAIR
References:
Clinical trial NCT00700804: Meat Protein and Calcium: Do They Interact Synergistically or Antagonistically?
Official title: Meat Protein and Calcium: Do They Interact Synergistically or Antagonistically?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dietary Proteins
Keywords: Calcium retention
dietary protein
dietary calcium
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
Collaborators: name: National Cattlemen's Beef Association
First posted: 2008-06-19
Enrollment: 34
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The primary objective is to determine whether meat interacts positively with calcium to improve calcium retention. The secondary objective is to determine whether any interaction between dietary protein and calcium affects biomarkers of bone metabolism.

Detailed description: This study tests the effects of dietary protein and calcium on calcium retention and indices of bone metabolism. It is a controlled feeding trial with a randomized crossover design (2x2 Factorial), studying 34 healthy post-menopausal women. The women are blocked on Body Mass Index (weight in kilograms divided by height in meters squared)and randomly assigned to a high calcium (HC,1500 milligrams per day) or low calcium (LC, 600 milligrams per day) group, and consume both low protein (LP,10% protein) and high protein (HP, 20% protein) diets for 7 weeks each. There is a 3-week "washout" between dietary periods, during which the subjects consume self-selected diets. After 3 week equilibration to each diet, the 2-day rotating menu is extrinsically labeled with a Calcium-47 radiotracer and retention is monitored for 28 days by whole body scintillation counting. In addition to Calcium retention, other endpoints include urinary indices of acid excretion and urine serum indices of bone resorption.

Eligibility criteria: Inclusion Criteria:

* at least 3 years since last menses
* bone mineral density equal to or greater than 2.5 standard deviations from average bone mineral density for young adults,
* body mass index equal to or less than 35 kilograms/meter squared

Exclusion Criteria:

* taking prescription medication other than hormone replacement therapy

Primary outcomes:
measure: Calcium Absorption
timeFrame: 17 weeks
Secondary outcomes:
measure: Serum Insulin-like Growth Factor 1 (IGF-1)
timeFrame: 7 weeks
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: Janet R Hunt, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05343104: Osteoarthrosis on 7.0T Magnetic Resonance Imaging
Official title: Osteoarthrosis on 7.0T Magnetic Resonance Imaging
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: MRI
Osteoarthrosis
Keywords: MRI
Osteoarthrosis
Lead sponsor: Chinese PLA General Hospital
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients with clinical diagnosis of patellar chondromalacia were continuously included.

Brief summary: This clinical trial studies the use of 7-Tesla (7T)and 3T magnetic resonance imaging (MRI) in detecting osteoarthrosis. 7T MRI has increased detection sensitivity, including more accurate lesion delineation, higher inter-rater agreement. Diagnostic procedures such as 7T MRI may help ultimately improved diagnostic and therapies confidence to inform decision making than standard 3T MRI.

Detailed description: 7T MRI increased detection sensitivity, attain superior anatomic resolution, higher spatial and spectral specificity of advanced quantitative techniques, and shorter scan times than 3T MRI. When applied clinically, these benefits translate to increased detection sensitivity, and ultimately improved diagnostic and therapies confidence to inform decision making. This study aim to detect the image characteristics and diagnostic accuracy of osteoarthrosis on 7T MRI.

Eligibility criteria: Inclusion Criteria:

* Age≥18 and ≤80
* Having no contraindications against MRI
* Clinically stable

Exclusion Criteria:

* Age#18 or #80
* Pregnancy and other contraindication to MRI scan
* Informed consent not obtained

Primary outcomes:
measure: The thickness of the cartilage of patellar on 7T MRI scan
timeFrame: baseline
measure: The T2 mapping value of the patellar cartilage on 7T MRI scan
timeFrame: baseline
measure: The abnormal signal in the infrapatellar fat pad
timeFrame: baseline
Secondary outcomes:
measure: Signal change of the patellar chondral before and after rehabilitation
timeFrame: 1 month after rehabilitation
measure: Signal change of the infrapatellar fat pad before and after rehabilitation
timeFrame: 1 month after rehabilitation
Other outcomes:
Locations:
city: Beijing
country: China
facility: Chinese PLA General Hospital
Study officials:
References: