louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02569892: Non-Damaging Photothermal Therapy of Non-exudative Age Related Macular Degeneration
Official title: Non-Damaging Photothermal Therapy of Non-exudative Age Related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Macular Degeneration
Retinal Drusen
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: Bascom Palmer Eye Institute
First posted: 2015-10-07
Enrollment: 19
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a randomized controlled study of non-damaging photothermal macular grid laser versus sham laser therapy in patients with dry age-related macular degeneration (AMD) and large high-risk drusen. The goal of the study is to determine if this treatment will reduce macular drusen volume and also whether this might improve visual acuity or reduce the risk of conversion to advanced age-related macular degeneration defined as development of choroidal neovascularization or geographic atrophy.


Eligibility criteria: Inclusion Criteria

1. Older than 60 years of age.
2. Male or female patients with nonexudative AMD with a drusen volume of of at least 0.03mm3 in the central 3mm circle
3. Adequate pupil dilatation and clear media to perform colour, red-free imaging and fundus fluorescein angiography, fundus autofluorescence imaging and OCT.
4. Able to give an informed consent.

Exclusion Criteria:

1. Presence of signs of advanced AMD, such as CNV, haemorrhages or macular atrophy based on OCT and fundus autofluorescence photography (FAF).
2. Previous macular laser treatment.
3. Any previous ocular condition that may be associated with a risk of developing macular oedema.
4. Vitreomacular traction determined clinically and /or by OCT, which in the opinion of the investigator, contributes to the macular oedema (associated or causing a detachment of the fovea).
5. Presence of other macular disease such as epiretinal membrane, macular telangiectasia.
6. Important known allergies to sodium fluorescein dye used in angiography.
7. Ocular or periocular infections.
8. Planned intra-ocular surgery within one year.
9. Patient is unavailable for follow-up visits.

Primary outcomes:
measure: Change in Macular Drusen Volume
timeFrame: baseline, 6, 12, and 24 months
Secondary outcomes:
measure: Change in Visual Acuity
timeFrame: baseline, 6, 12, and 24 months
measure: Development of Geographic Atrophy (GA) or Choroidal Neovascularization (CNV)
timeFrame: 2 years
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Byers Eye Institute at Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Steven Sanislo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00320892: "Death Rattle" - A Double Blind, Randomly Controlled, Crossover Trial
Official title: "Death Rattle" - A Double Blind, Randomly Controlled, Crossover Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Noise
Death
Keywords: Death Rattle
Noise level
Primary Care
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
Collaborators: name: Ben-Gurion University of the Negev
First posted: 2006-05-03
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Dying patients are often unable to clear secretions from their large airways, resulting in noisy breathing usually described as "death rattle." While there is no evidence that patients find this condition disturbing, the noises may be disturbing to the patient's visitors and caregivers who may fear that the patient is choking to death.

In Israel none of the pharmaceutical drugs listed in the literature exist. Thus, Atropine drops which have been noted in the literature as being used, though according to our knowledge no evidence of clinical trials using sublingual Atropine were conducted.

The study is designed as a randomly controlled, double blind crossover trial. The patient will serve as control for himself, as crossover between placebo and drug (randomly chosen) will take place. The administrator of the drug will be blinded to the medication, each time randomly beginning with a different drug (placebo or Atropine).

We will evaluate Atropine Sulphate 1% ophthalmic drops effect on 33 patients using a noise score scale of 0-3. Noise scores will be taken at the start; 30 min after drug/placebo administration and every hour thereafter. After 4-hours crossover will take place and evaluation will follow the same protocol.


Eligibility criteria: Inclusion Criteria:

* : Patients belonging to Home Palliative Care Unit of Clalit Health Services - Southern District, and the Oncology Department of Soroka University Medical Center and suffering from "death rattle" will be recruited for the study.

Exclusion Criteria:

-

Primary outcomes:
measure: Noise Level
timeFrame: 8 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Beer-Sheva
country: Israel
facility: Ben-Gurion University of the Negev, Sial Research Center for Family Medicine and Primary Care
Study officials:
affiliation: Ben-Gurion University of the Negev
name: Pesach Shvartzman
role: STUDY_CHAIR
References:
Clinical trial NCT02515292: Evaluation of Infants With Intrauterine Growth Restriction
Official title: Multidimensional Modeling in Evaluation of Infants With Intrauterine Growth Restriction
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intrauterine Growth Restriction
Keywords: IUGR (intrauterine growth restriction)
IGF2 (insulin-like growth factor 2)
morbidity
Lead sponsor: Iuliu Hatieganu University of Medicine and Pharmacy
Sponsor class: OTHER
First posted: 2015-08-04
Enrollment: 60
Sex: ALL
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Population with IUGR from a 3rd level maternity from Nord-West of Romania

Brief summary: Purpose: Clinical assessment (anthropometric) and paraclinical (biochemical and immunological by dosing serum insuline growth factors IGF1 and IGF2 and their receptors) of neonates with intrauterine growth restriction (IUGR) and the integration in a multidimensional statistical model .

Objectives:

1. IGF1 and IGF2 evaluation of serum and IGF1 receptor, IGF2 receptor and IGF2 receptor gene expression in cord blood from newborns with intrauterine growth restriction (IUGR). (Prospective)
2. Evaluation and monitoring of anthropometric, clinical (non-cardiac morbidity) and paraclinical. (Retrospective \& prospective)
3. Evaluation and monitoring of morphological and functional by echocardiography. (Prospective)
4. Integrating multidimensional clinical and paraclinical parameters in a statistical model for evaluating newborn with intrauterine growth restriction.


Eligibility criteria: Inclusion Criteria:

* newborns with intrauterine growth restriction (IUGR): weight below the 10th percentile for gestational age
* parental consent for enrollment

Exclusion Criteria:

* IUGR neonates in the context chromosomopathies: trisomy 21, trisomy 18.
* neonates with congenital heart disease
* twins
* refusal of parents for participation to the study

Primary outcomes:
measure: Evaluation of serum IGF2
timeFrame: baseline
measure: Evaluation of IGF2 receptors
timeFrame: baseline
Secondary outcomes:
measure: Genetic evaluation
timeFrame: baseline
measure: Clinical assessment
timeFrame: baseline
measure: Cardiac morphological and functional evaluation
timeFrame: baseline and follow-up (1 month and/or 6 months)
Other outcomes:
Locations:
city: Cluj-Napoca
country: Romania
facility: Neonatal-Ward, 1st Gynecology Clinic
state: Cluj
Study officials:
affiliation: Iuliu Hațieganu Medicine and pharmacy University
name: Gabriela Zaharie, PhD, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00541944: Establishment of an Algorithm for a Clinical Classfication of Hypoosmolar Hyponatremia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hyponatremia
Keywords: hyponatremia
diagnosis and treatment of hyponatremia
classification of hyponatremia
Lead sponsor: University of Wuerzburg
Sponsor class: OTHER
First posted: 2007-10-10
Enrollment: 138
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated in an University Hospital in Germany

Brief summary: The prospective clinical diagnosis of hyponatremia is often very difficult- but requirement for an appropriate and riskless treatment of hyponatremia. This study try to establish an algorithm handling a prospective clinical categorization of hyponatremia and approving together the start of an appropriate symptomatic therapy.


Eligibility criteria: Inclusion Criteria:

* hypoosmolar hyponatremia with serum sodium concentration ≤129 mmol/l and serum osmolality ≤ 280 mosm/kg;
* age \> 18 years;
* letter of agreement.

Exclusion Criteria:

* gravidity and lactation;
* restricted decision-making-ability

Primary outcomes:
measure: Establishment of an clinical algorithm to differentiate the different causes of hyponatremia
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Wuerzburg
country: Germany
facility: University of Wuerzburg
Study officials:
affiliation: Universtiy of Wuerzburg
name: Bruno Allolio, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fenske W, Stork S, Koschker AC, Blechschmidt A, Lorenz D, Wortmann S, Allolio B. Value of fractional uric acid excretion in differential diagnosis of hyponatremic patients on diuretics. J Clin Endocrinol Metab. 2008 Aug;93(8):2991-7. doi: 10.1210/jc.2008-0330. Epub 2008 May 13.
Clinical trial NCT06180044: Physiologic Burden to the Surgeon During Orthopaedic Surgery
Official title: Quantification of Physiologic Burden to the Surgeon During Orthopaedic Surgery
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Physiological Stress
Keywords: Surgeon
Orthopaedic surgery
Hexoskin Smart Vest
Physiologic data
Lead sponsor: University of Utah
Sponsor class: OTHER
First posted: 2023-12-22
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Orthopaedic surgeons, orthopaedic fellows, and orthopaedic residents performing surgery.

Brief summary: The investigator's plan to quantify the physiologic impact of orthopaedic surgery on the surgeon and operating team.

Detailed description: The prevalence of musculoskeletal pain among orthopaedic surgeons is inordinately high. Poor surgical ergonomics and physiological stress have been shown to impair surgical performance and cause injuries. Various approaches, techniques and instruments have been designed to improve surgical outcomes for patients. There has been nominal research in the area of occupational hazards such surgeries impose upon the surgeon. Several studies have demonstrated a higher risk of cervical spondylosis and rotator cuff tears amongst surgeons. However, little has been studied on the impacts of some of these approaches, techniques, and instruments on surgeons' physiologic measures.

The investigator's will use The Hexoskin Smart Vest to capture physiological data from surgeons during the study.

Eligibility criteria: Inclusion Criteria:

* Orthopaedic surgeons, orthaopedic fellows, and orthopaedic residents.
* Up to 750 surgical patients of the participating surgeons will be included for demographic chart review.

Exclusion Criteria:

* Non-surgeons, fellows, or residents.
* Female participants that are or become pregnant.

Primary outcomes:
measure: Average Heart Rate (beats per minute, bpm)
timeFrame: 30 minutes before surgery
measure: Average Heart Rate (beats per minute, bpm)
timeFrame: During entire surgical procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Orthopedics
state: Utah
Study officials:
affiliation: University of Utah
name: Christopher Pelt, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03217344: Conservative Treatment of Proximal Humeral Fractures
Official title: Conservative Treatment of Proximal Humeral Fractures - Immobilization for 1 Week Compared to Three Weeks: Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Shoulder Fractures
Lead sponsor: Hospital del Mar
Sponsor class: OTHER
First posted: 2017-07-14
Enrollment: 130
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: prospective randomized without restrictions
Primary purpose: TREATMENT

Brief summary: Optimal treatment of proximal humeral fractures is yet to be defined. Many of them can be treated non-operatively. The question remains on how long do we have to immobilize non-operatively treated proximal humeral fractures?

Detailed description: There is still controversy on best treatment of proximal humeral fractures. While some authors propose surgical treatment other advocate for conservative treatment. Traditionally, fractures treated non-operatively undergo a 3-week period of immobilization followed by progressive rehabilitation program. Nevertheless, there is little evidence to support a 3-week immobilization period. The purpose of this study is to bring evidence to support either a 1-week immobilization or 3-week immobilization period in non-operatively treated proximal humeral fractures.

Eligibility criteria: Inclusion Criteria:

* Patients ≥ 60 yo and \< 85 yo
* Acute fractures less than 1 week evolution
* Conservative treatment decided by orthopedic surgeon
* Contact between humeral head and humeral shaft.
* No gleno-humeral dislocation
* No previous surgery

Exclusion Criteria:

* Cognitive impairment

Primary outcomes:
measure: pain (analogical pain scale)
timeFrame: 1 year
Secondary outcomes:
measure: fragment displacement assessed through X-Ray exam
timeFrame: 3 months
measure: functional outcome
timeFrame: 1 year
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Carlos Torrens
Study officials:
affiliation: Hospital Mar
name: Carlos Torrens, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Handoll HH, Elliott J, Thillemann TM, Aluko P, Brorson S. Interventions for treating proximal humeral fractures in adults. Cochrane Database Syst Rev. 2022 Jun 21;6(6):CD000434. doi: 10.1002/14651858.CD000434.pub5.
Clinical trial NCT01367340: Effect of Physical Activity Intervention Children With Spastic Diplegia After Resistance Training
Official title: Effect of Physical Activity Intervention on Mobility Changes and Participation for School-Age Children With Spastic Diplegia and After Resistance Training
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cerebral Palsy
Spastic Diplegia
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2011-06-07
Enrollment: 32
Sex: ALL
Minimum age (years): 5
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to investigate the effects of a 6-month physical activity intervention program on mobility and participation after the termination of a 6-week functional strengthening program for school-age children with spastic diplegia cerebral palsy. The primary outcomes are gross motor function, participation, and physical activity behavior.


Eligibility criteria: Inclusion Criteria:

* children with spastic diplegia, aged 6 to 12 year-old, and Gross Motor Function Classification System (GMFCS) level between I to III
* able to stand up from a chair independently and maintain standing for more than 2 seconds without falling
* able to answer questionnaire designed for school-age children
* able to follow verbal instructions

Exclusion Criteria:

* have orthopedic surgery, selective dorsal rhizotomy, or use of a baclofen pump within 6 months
* have orthopedic problems or other medical conditions preventing the child from joining the resistance exercise program, such as obvious LE joint contractures, uncontrolled epilepsy, or cardiopulmonary problems
* hearing loss or using hearing aid

Primary outcomes:
measure: Gross Motor Function Measure
timeFrame: 1.5 months
Secondary outcomes:
measure: One-repetition maximum of loaded sit-to-stand
timeFrame: 1.5 months
measure: Gait speed
timeFrame: Week 0, 6, 12, 18, 24, 36, 42, 48, 72
measure: 1-minute walk test
timeFrame: 1.5 months
measure: School Function Assessment
timeFrame: 3 months
measure: Pediatric Evaluation of Disability Inventory
timeFrame: 1.5 months
measure: Physical activity status by International Physical Activity Questionnaire and accelerometer
timeFrame: 3 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Institute of Physical Therapy, National Taiwan University
Study officials:
affiliation: Institute of Physical Therapy, National Taiwan University
name: Hua-Fang Liao, MS
role: STUDY_CHAIR
References:
citation: Liao HF, Liu YC, Liu WY, Lin YT. Effectiveness of loaded sit-to-stand resistance exercise for children with mild spastic diplegia: a randomized clinical trial. Arch Phys Med Rehabil. 2007 Jan;88(1):25-31. doi: 10.1016/j.apmr.2006.10.006.
Clinical trial NCT02854644: Study of the Anti-tumoral Immune Response
Official title: Study of the Anti-tumoral Immune Response T Cells Cluster of Differentiation 4 (TCD4): Proof of the Concept in Breast Cancer and Glioma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Glioma
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This study evaluates the frequency of the spontaneous T cells specific CD4 answers of tumoral antigens breast cancer and glioma.


Eligibility criteria: Inclusion Criteria:

* Performance status 0,1 or 2
* breast cancer or glioma
* Arm glioma: patients without anti-tumoral treatment
* Arm breast cancer: inclusion before treatment
* Arm breast cancer HER2: patients with current therapy

Exclusion Criteria:

* Psychiatric disease compromising the understanding of the information or the realization of the study
* vulnerable People according to the law (minors, adults under protection, private persons of freedom ...)
* Unaffiliated People to the Social Security
* People being for the period of exclusion from another study
* Life expectancy estimated unless 3 months.
* For patients in Arm glioma: patients having already begun a systematic treatment.
* For patients with a breast cancer: patient already under current therapy

Primary outcomes:
measure: Spontaneous immune responses of T cells CD4 specific tumor antigens
timeFrame: 15 months
Secondary outcomes:
measure: T cells level
timeFrame: 15 months
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Régional Universitaire
Study officials:
References:
Clinical trial NCT00730444: Expanded Access Protocol for [123I]mIBG for Patients With Known or Suspected Neuroblastoma
Official title: Expanded Access Protocol for [123I]mIBG for Patients With Known or Suspected Neuroblastoma
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Neuroblastoma
Keywords: Neuroblastoma
Nuclear medicine
Diagnostic scintigraphy
Known and suspected neuroblastoma
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2008-08-08
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: GE Healthcare has recently submitted a New Drug Application (NDA) for Iobenguane I 123 Injection (\[123I\]mIBG (AdreView)) as a diagnostic nuclear imaging agent for the detection of primary or metastatic neuroblastoma and pheochromocytoma. The present protocol establishes an Expanded Access program to provide AdreView to pediatric medical centers and hospitals that treat neuroblastoma patients. AdreView will be provided for use in diagnostic assessment of patients with known or suspected neuroblastoma for whom there is an appropriate clinical indication for \[123I\]mIBG imaging.

Detailed description: The sponsor will provide \[123I\]mIBG as a single dose in a ready-to-use vial. All patients greater than or equal to 18 years of age and children with a weight of greater than or equal to 70 kg will receive an intravenous injection of 370 ±10% MBq (333 to 407 MBq \[9.0 to 11 mCi\]) of \[123I\]mIBG. Children \<16 years of age (with a weight of 8-70 kg) will receive an activity of \[123I\]mIBG calculated on the basis of a reference activity for an adult scaled to body weight. Each investigator is responsible for obtaining the appropriate thyroid blockade agent and for its administration in accordance with national and local regulations and guidelines. Approximately 24 (± 6) hours following administration of \[123I\]mIBG all patients will return to the clinic for scintigraphic imaging. Imaging will be performed as per the standard procedures of the investigational site. This should include at a minimum total body planar scintigraphy. Single photon emission computed tomography (SPECT) may be performed following planar scintigraphy, as appropriate.

Eligibility criteria: Inclusion Criteria:

* The patient has known or suspected neuroblastoma and is undergoing evaluation of disease status (for which a mIBG scintigraphic examination is clinically appropriate).
* The patient is able and willing to comply with study procedures and a signed and dated informed consent is obtained from the patient (or their legal guardian.

Exclusion Criteria:

* The patient uses medications that are known to interfere with \[123I\]mIBG uptake and these medications cannot be safely withheld for a least 24 hours before study procedures.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: GE Healthcare
state: New Jersey
Study officials:
affiliation: GE Healthcare
name: Arnold Jacobson, MD
role: PRINCIPAL_INVESTIGATOR
References: