louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00131118: Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta
Official title: Efficacy and Safety of Zoledronic Acid in Children (1 -17 Years) With Severe Osteogenesis Imperfecta
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Osteogenesis Imperfecta
Keywords: Osteogenesis Imperfecta, Brittle bone disease, bisphosphonate, children
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-08-17
Enrollment: 127
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is an extension study to examine the long-term safety and efficacy of zoledronic acid in patients who have completed the core CZOL446H2202 study.


Eligibility criteria: Inclusion Criteria:

* Have completed the core CZOL446H2202 study
* Males or females between 1-17 years of age

Exclusion Criteria:

* Deformity or abnormality which would prevent spine bone density from being done
* Any surgical bone-lengthening procedure
* Any kidney diseases or abnormalities
* Low calcium or vitamin D levels in the blood

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Long-term safety of two different zoledronic acid doses over an additional 12 months in patients who have completed one year treatment in CZOL446H2202
Secondary outcomes:
measure: Measure percentage change of lumbar spine bone mineral density at month 18 and 24 compared to baseline in the core study.
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: UCLA Medical Center-Dept of Pediatric Nephrology
state: California
city: Wilmington
country: United States
facility: Alfred Dupont Hospital for Children
state: Delaware
city: Boise
country: United States
facility: Intermountains Orthopedics
state: Idaho
city: Omaha
country: United States
facility: Children's Hospital
state: Nebraska
city: Multiple Locations
country: United States
facility: For information regarding facilities, please contact the Central Contact
state: New Jersey
city: Cincinnati
country: United States
facility: Children's Hospital Medical Center
state: Ohio
city: Columbus
country: United States
facility: Children's Hospital
state: Ohio
city: Portland
country: United States
facility: Oregon Health Sciences University
state: Oregon
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: Texas Children's Hospital
state: Texas
Study officials:
References:
Clinical trial NCT00535418: Optimal Duration of Pre-operative Treatment With Letrozole and to Correlate Clinical Efficacy With Appropriate Surrogate Markers
Official title: Pre-operative Hormone Therapy for Postmenopausal Women With ER and/or PgR Positive Breast Cancer: An Uncontrolled Phase IIb/III Trial to Assess Optimal Duration of Pre-operative Treatment With Letrozole and to Correlate Clinical Efficacy With Appropriate Surrogate Markers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Breast Cancer
Keywords: Breast cancer
neoadjuvant treatment
treatment duration
Primary hormone receptor positive
breast cancer in postmenopausal women
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-09-26
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess optimal duration of pre-operative treatment with letrozole and to correlate clinical efficacy with appropriate surrogate markers.


Eligibility criteria: Inclusion criteria:

1. Female Breast Cancer patients with primary invasive breast cancer, histologically confirmed by core needle biopsy, whose tumors are estrogen (ER) and / or progesterone (PgR) positive (Clinical Stage \*T2, T3, T4a,b,c, N0, M0)
2. Patients after menopause
3. Tumor measurable by clinical examination, mammography and ultrasound
4. Adequate bone marrow, renal and hepatic function
5. A life expectancy of at least 6 months.

Exclusion criteria:

1. Prior treatment with aromatase inhibitors or antiestrogens.
2. Uncontrolled endocrine disorders such as diabetes mellitus, confirmed hypo- or hyperthyroidism, Cushing´s Syndrome, Addison´s disease (treated or untreated), Patients with unstable angina, uncontrolled cardiac disease (e.g. Class II or IV New York Heart Association's Functional Classification).
3. Patients with tumors in both breasts, evidence of inflammatory breast cancer or distant metastasis
4. Patients who are eligible for breast conserving surgery.
5. Concomitant anti-cancer treatments such as chemotherapy, immunotherapy/biological response modifiers (BRM's), endocrine therapy (including steroids), bisphosphonate therapy and radiotherapy. Patients who have received HRT will NOT be excluded, provided that HRT is discontinued at least 2 weeks prior to entry into the study.

Other protocol defined inclusion/exclusion criteria may apply

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Krainick-Strobel UE, Lichtenegger W, Wallwiener D, Tulusan AH, Janicke F, Bastert G, Kiesel L, Wackwitz B, Paepke S. Neoadjuvant letrozole in postmenopausal estrogen and/or progesterone receptor positive breast cancer: a phase IIb/III trial to investigate optimal duration of preoperative endocrine therapy. BMC Cancer. 2008 Feb 26;8:62. doi: 10.1186/1471-2407-8-62.
Clinical trial NCT00179218: The Effects of Resistance Exercise and Protein Supplementation in Hemodialysis Patients
Official title: The Effects of Resistance Exercise and Protein Supplementation in Hemodialysis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: End Stage Renal Disease
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study is to determine how protein supplementation, with or without exercise, affects functional capacity, strength, body composition, and physical activity in hemodialysis patients.


Eligibility criteria: Inclusion Criteria:

* On hemodialysis for more than 3 months, on a thrice weekly hemodialysis program;
* Adequately dialyzed (Kt/V ≥ 1.2).
* Age ≥ 18 years old.

Exclusion Criteria:

* Patients unable to perform exercise due to cardiovascular disease, osteoarthritis, etc., as determined by the PI and the primary physician of the subject.
* Pregnant women.
* Patients hospitalized within the last month prior to the study.

Primary outcomes:
measure: increase in lean body mass
timeFrame: 12 months
Secondary outcomes:
measure: increase in physical functioning
timeFrame: 12 months
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Vanderbilt University Medical Center
name: Alp Ikizler, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02190318: Residual Renal Function Preservation in Peritoneal Dialysis Patients
Official title: The Effects of Losartan and Spironolactone on Residual Renal Function Preservation in Peritoneal Dialysis Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Renal Disease
Keywords: peritoneal dialysis；
residual renal function；
RAAS
Lead sponsor: Second Xiangya Hospital of Central South University
Sponsor class: OTHER
Collaborators: name: Baxter Healthcare Corporation
First posted: 2014-07-15
Enrollment: 96
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: Aldosterone blockade is useful in preserving residual renal function in patients on PD.The long term efficacy of dual blockade of the RAAS is better than monotherapy.

Detailed description: Residual renal function has been proven to contribute to improved survival and quality of life of dialysis patients. It is now recognized as an important factor in the prognosis of PD.The RAAS system is involved in the development of renal diseases. Angiotensin II and aldosterone are vital in this process. The beneficial effect of angiotensin-converting enzyme inhibitor or angiotensin receptor blocker on residual renal function has been demonstrated in peritoneal dialysis patients. Unfortunately, neither ACE inhibition nor angiotensin receptor blocker fully supprsses aldosterone production. Now much focus has been placed on aldosterone antagonist.

Eligibility criteria: Inclusion Criteria:

* Patients who having been on PD continuously for one month, urine volume\>600 ml/d, residual renal function\>2ml/min/1.73m2, blood pressure\>120/70mmHg, serum potassium levels\<5.5mmol/l, stable clinical condition.

Exclusion Criteria:

* Patients with infectious systemic disease, peritonitis during the preceding 1 month, who had taken ACEI/ARBs in the 3 preceding months, spirolactone in the 2 preceding weeks, intolerance to ACEI/ARBs, CHF, MI, malignant hypertension and stroke within the preceding 6 months.

Primary outcomes:
measure: residual renal function of peritoneal dialysis patients
timeFrame: From date of randomization until the date of dropping out of the study or death from any cause, whichever came first, assessed up to 12 months.
Secondary outcomes:
measure: peritoneal membrane function
timeFrame: From date of randomization until the date of dropping out of the study or death from any cause, whichever came first, assessed up to 12 months.
Other outcomes:
Locations:
city: Changsha
country: China
state: Hunan
Study officials:
References:
citation: Hasegawa T, Nishiwaki H, Ota E, Levack WM, Noma H. Aldosterone antagonists for people with chronic kidney disease requiring dialysis. Cochrane Database Syst Rev. 2021 Feb 15;2(2):CD013109. doi: 10.1002/14651858.CD013109.pub2.
Clinical trial NCT01839318: Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses
Official title: Subjective Comparison of Pre-Lens Tear Film Stability With Daily Disposable Contact Lenses Using Ring Mire Projection
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Hyperopia
Refractive Error
Keywords: Soft contact lenses
Daily disposable contact lenses
Tear Film Break Up Time
Contact lens wettability
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2013-04-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The purpose of this study was to compare three CE-marked daily disposable contact lenses for tear film stability as measured by pre-lens non-invasive keratograph break up time (PL NIK-BUT). Secondarily, contact lens surface wettability was assessed.

Detailed description: Each participant wore 3 brands of contact lenses in a randomized, cross-over fashion, with a washout phase of at least 1 night between brands.

Eligibility criteria: Inclusion Criteria:

* Sign Informed Consent.
* Adapted soft contact lens wearer.
* Willing to wear contact lenses up to 12 hours and attend all study visits.
* Vision correctable to 0.1 (logMAR) or better in each eye at distance with pre-study lenses at Visit 1.
* Contact lens prescription within the power range specified in the protocol.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Any ocular infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear.
* Any use of systemic or ocular medications that would contraindicate contact lens wear.
* Any ocular finding observed during the Visit 1 examination that would contraindicate contact lens wear.
* Monocular (only 1 eye with functional vision) or fit with only 1 lens.
* History of herpetic keratitis, ocular surgery, or irregular cornea.
* Known pregnancy.
* Unstable tear film with a NIK-BUT value below 13 seconds in either eye without lenses.
* Participation in any clinical study within 30 days of Visit 1.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Pre-Lens Non-Invasive Keratograph Break Up Time (PL NIK-BUT) at 8 Hours
timeFrame: Hour 8
Secondary outcomes:
measure: Total Wettability Score
timeFrame: Hour 8
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Jessie Lemp, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01537718: Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker
Official title: Evaluation of the Performances of the Sleep Disordered Breathing Monitoring Function in Pacemaker
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bradycardia
Lead sponsor: LivaNova
Sponsor class: INDUSTRY
First posted: 2012-02-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The IBSY04 clinical investigation is an European, prospective, multi-centre, non-randomized, longitudinal study.

Detailed description: The purpose of this study is to assess the performance of Sleep Disordered Breathing Monitoring function (SDB) in pacemakers by comparing device diagnostic data to the results of in-lab PolySomnoGraphy (PSG) recording during the same night

Eligibility criteria: Inclusion Criteria: Any patient enrolled in the study must fulfil all of the following criteria:

* Patients eligible for implantation of a single or dual-chamber pacemaker according to current available guidelines
* Patients who are scheduled for implant of a REPLY 200 SR; or REPLY 200 DR pacemaker
* Patients who provide signed and dated informed consent

Exclusion Criteria:

* Inability to understand the purpose of the study or refusal to co-operate
* Unavailability for scheduled follow-ups at the implanting centre
* Already included in another clinical study that could affect the results of this study
* Inability or refusal to provide informed consent
* Patient is minor (less than 18-years old)
* Patient is pregnant (women of childbearing potential should have a negative pregnancy test prior to enrolment)
* Patient is forfeiture of freedom or under guardianship

Primary outcomes:
measure: Event-based sensitivity of breathing troubles
timeFrame: 1 day
measure: Event-based Positive Predictive Value of breathing troubles
timeFrame: 1 day
Secondary outcomes:
measure: Apnea Index-based Positive Predictive Value
timeFrame: 1 day
measure: Apnea Index-based Negative Predictive Value
timeFrame: 1 day
measure: Safety based on Adverse events
timeFrame: 3 months
Other outcomes:
Locations:
city: Creteil
country: France
city: Grenoble
country: France
city: La Rochelle
country: France
city: Barcelona
country: Spain
city: Sevilla
country: Spain
Study officials:
affiliation: CHU Grenoble, France
name: PASCAL DEFAYE, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00004418: Effect of Glycerol Trierucate on Clinical Course of Adrenoleukodystrophy
Official title: Study of Glyceryl Trierucate and Glyceryl Trioleate (Lorenzo's Oil) Therapy in Male Children With Adrenoleukodystrophy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Adrenoleukodystrophy
Keywords: adrenoleukodystrophy
inborn errors of metabolism
rare disease
sphingolipidoses
Lead sponsor: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
Sponsor class: OTHER
First posted: 1999-10-19
Enrollment: 126
Sex: MALE
Minimum age (years): 18
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: OBJECTIVES: I. Evaluate the clinical efficacy of combination glyceryl trierucate and glyceryl trioleate (Lorenzo's Oil) therapy in boys with X-linked adrenoleukodystrophy.

II. Compare the frequency and severity of neurological disability of study patients with untreated historical controls.

Detailed description: PROTOCOL OUTLINE: This is an open label study. Patients must follow dietary instructions as provided by the investigator. Patients receive 2-4 tablespoons of a mixture of glyceryl trierucate and glyceryl trioleate oil once daily. Patients complete a neuropsychological scoring scale questionnaire to measure neurological disability. Patients undergo physical examinations including magnetic resonance imaging and magnetic resonance spectroscopy of the head.

Patients are followed monthly for 6 months, then every 3 months until they reach the age of 13 years or death.

Eligibility criteria: Inclusion criteria.

1. Boys between the age of 18 months and 8 years of age
2. Biochemically proven asymptomatic X-linked adrenoleukodystrophy determined by elevation of very long chain fatty acids or DNA analysis.
3. Platelet count in normal range

Exclusion criteria.

1. Abnormal MRI consistent with childhood cerebral disease
2. Boys who have undergone bone marrow transplantation
3. Other medical condition which in the opinion of the investigator prevents evaluation or treatment

Primary outcomes:
measure: Change From Baseline in Very Long Chain Fatty Acids (VLCFA) Blood Levels
timeFrame: Baseline, an average of 10 years, up to age 13
Secondary outcomes:
measure: Number of Participants With T2 MRI Abnormality
timeFrame: 10 years
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Kennedy Krieger Institute
state: Maryland
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
name: Gerald V Raymond, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03759418: Left Atrial Appendage Ligation Using the Atriclip Device
Official title: Left Atrial Appendage Ligation Using the Atriclip Device; Single Center Study of Device Safety and Efficacy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Left Atrial Appendage Ligation
Keywords: Left Atrial Appendage Ligation
Atriclip
atrial fibrillation
Lead sponsor: St. Helena Hospital Coon Joint Replacement Institute
Sponsor class: OTHER
Collaborators: name: AtriCure, Inc.
name: Adventist Heart and Vascular Institute
First posted: 2018-11-30
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients who had an Atriclip placed to exclude the left atrial appendage.

Brief summary: The purpose of the study is to collect data regarding ligation of the left atrial appendage at least 12 months after surgery for patients that had exclusion of the left atrial appendage as a primary minimally invasive procedure or in conjunction with other open cardiac or minimally invasive cardiac procedures.

Detailed description: The purpose of this study is to collect data regarding ligation of the left atrial appendage at least 12 months after surgery for patients that had exclusion of the left atrial appendage as a primary minimally invasive procedure or in conjunction with other open cardiac or minimally invasive cardiac procedures. The patient will undergo a transesophageal echocardiogram (TEE) to collect the following data: Left Ventricular Ejection Fraction; Left Atrial diameter size; confirmation of Left Atrial Appendage exclusion defined by the absence of left atrial to LAA (left atrial appendage) communication measured in millimeters and absence of LAA pocket measured in millimeters; presence of thrombus in left atrium.

Eligibility criteria: Inclusion Criteria:

* All adult patient who had a heart procedure where an Atriclip device was deployed as the primary or secondary procedure between 3/2013-12/20/2016
* Patient is willing to undergo a trans esophageal echocardiogram, or if unable a CT angiogram
* If female, must be of non-childbearing potential or have a negative pregnancy test within 7 days prior to the procedure
* Patient is willing to sign an IRB approved Informed Consent

Exclusion Criteria:

* Patient did not have an Atriclip device as part of the surgical procedure between 3/2013 and 12/2016.
* Patient is unwilling or unable to undergo trans esophageal echocardiogram with general anesthesia or a CT angiogram

Primary outcomes:
measure: 12 month follow up with complete exclusion of the Left Atrial Appendage
timeFrame: 365 days to complete
Secondary outcomes:
measure: Any signs of thrombus in the left atrium
timeFrame: 365 days to compete
measure: Occurrence of Cerebrovascular accident/transient Ischemic Attack
timeFrame: 365 days to complete
Other outcomes:
Locations:
Study officials:
affiliation: St. Helena Hospital Adventist Heart Institute
name: Gansevoort Dunnington, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06562218: The Effectiveness of Cross-training on an Immobilised Forearm
Official title: The Effectiveness of Cross-training on an Immobilised Forearm Due to Fracture
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Forearm Fracture
Keywords: fracture
immobilisation
cross-education
muscle strength
Lead sponsor: Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization
Sponsor class: OTHER
First posted: 2024-08-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized controlled double-blind clinical trial
Primary purpose: PREVENTION

Brief summary: The cross-training phenomenon is the increase in muscle strength in the contralateral limb when one limb is exercised. Limited studies have shown that it prevents immobilisation-induced muscle weakness in healthy volunteers. The aim of this study was to evaluate the effect of strengthening the contralateral extremity on muscle strength and range of motion in the immobilised extremity in patients who had undergone immobilisation for forearm fractures.


Eligibility criteria: Inclusion Criteria:

* Traumatic unilateral forearm fracture (treated surgically or conservatively and immobilised in a cast)

Exclusion Criteria:

* Previous upper limb surgery/joint disease - deformity affecting hand-wrist function
* Any neurological condition affecting the upper extremity (stroke, Parkinson's disease; multiple sclerosis, reflex sympathetic dystrophy, peripheral nerve injury)

Primary outcomes:
measure: Wrist isometric flexion muscle strength
timeFrame: 1 year
measure: Wrist isometric extansion muscle strength
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Prof. Dr. Cemil Taşçıoğlu City Hospital
Study officials:
References: