louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05524831: Kinesio Taping Versus Oromotor Training on Drooling in Children With Spastic Cerebral Palsy
Official title: Kinesio Taping Versus Oromotor Training on Drooling in Children With Spastic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drooling
Kinesiotape
Cerebral Palsy
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2022-09-01
Enrollment: 30
Sex: ALL
Minimum age (years): 4
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 2
Primary purpose: TREATMENT

Brief summary: Statement of the problem :

Which is more effective for treatment of drooling in children with spastic cerebral palsy; kinesio taping or oromotor training?

Null Hypothesis:

There will be no difference between the effectiveness of kinesio taping and oromotor training on drooling in children with spastic cp.

Detailed description: Subjects:

The Study targets the children with spastic cerebral palsy from both sexes , sample size estimation will be carried out to determine the recruited number of children ,Children participating in this study will be selected randomly from Cairo pediatric physical therapy centers to participate in this study.

Study Design:

A comparative experimental design (Prospective pre-test post-test design with 2 months follow-up evaluation) .

Children will be assessed by measuring the drooling before and after two months of receiving intervention.

Eligibility criteria: Inclusion Criteria:

1. A diagnosis of spastic cerebral palsy with drooling problem.
2. The age of the selected children will range from 4to 8 years old.
3. Severe degree of drooling according to Drooling Severity and Frequency Scale.
4. Child with good head control

Exclusion Criteria:

1. Congenital problems of mouth and soft palate such as cleft lip and palate, jaw anomalies and salivary gland pathologies.
2. Epilepsy.
3. Child receiving drugs that could affect saliva production or other treatments to control drooling just before or during the study.
4. Allergic reactions to the kinesio tape.

Primary outcomes:
measure: assessment of drooling severity
timeFrame: 2 months for each participant
measure: assessment of drooling severity and frequency
timeFrame: 2months for each participant
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of physical therapy ,cairo university
Study officials:
affiliation: Cairo University
name: Hagar Awaad
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02096731: Combined Bronchodilators in Chronic Obstructive Pulmonary Disease and the Risk of Adverse Cardio-pulmonary Events
Official title: Combined Bronchodilators in Chronic Obstructive Pulmonary Disease and the Risk of Adverse Cardio-pulmonary Events: A Population-based Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pulmonary Disease, Chronic Obstructive
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-03-26
Enrollment: 115397
Sex: ALL
Minimum age (years): 55
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Users of tiotropium or long-acting beta agonists

Brief summary: Background: Recent observational studies have reported possible arrhythmogenic effects with long-acting beta-agonists (LABA), while the long-acting anticholinergic tiotropium has been associated with cardiovascular and cerebrovascular events. Finally, pneumonia was the object of a recent signal in trials of LABAs submitted for marketing approval.

Aim: To assess the potential cardio-pulmonary risk arising from the concurrent use of two long-acting bronchodilators as well as from monotherapy use of each of the long-acting bronchodilators.

Methods: A series of population-based cohort studies, using both cohort and nested case-control analyses will be conducted using data from the United Kingdom's Clinical Practice Research Datalink (CPRD). The base cohort will consist of new users of long-acting bronchodilators from Jan 2002 until Aug 2012, age \>= 55 with chronic obstructive pulmonary disease (COPD) and at least two years of baseline medical history information. The high-dimensional propensity score technique will be used to match new users of each long-acting bronchodilator and new users of two bronchodilators with comparable subjects from the base cohort, with one-year follow-up for outcomes of acute myocardial infarction, stroke, heart failure, arrhythmia and community acquired pneumonia. Data will be analysed using time-dependent Cox proportional hazard regression models and conditional logistic regression models.

Detailed description: Purpose:

Eligibility criteria: Inclusion criteria:

* New users of long-acting bronchodilators, either a LABA or tiotropium, between January 2002 and August 2012
* Age \>= 55 years

Exclusion criteria:

- Use of LABA or tiotropium in the two years prior to cohort entry

Primary outcomes:
measure: Myocardial Infarction
timeFrame: Up to 12 months
measure: Stroke
timeFrame: Up to 12 months
measure: Heart Failure
timeFrame: Up to 12 months
measure: Cardiac Arrhythmia
timeFrame: Up to 12 months
measure: Community Acquired Pneumonia
timeFrame: Up to 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Montreal
country: Canada
facility: Boehringer Ingelheim Investigational Site
state: Quebec
Study officials:
affiliation: Boehringer Ingelheim
name: Boehringer Ingelheim
role: STUDY_CHAIR
References:
Clinical trial NCT00961831: Radiation Dosimetry, Metabolism, Safety, Tolerability and Positron Emission Tomography/Computed Tomography (PET/CT) Imaging With BAY 85-8050 in Healthy Volunteers and Patients
Official title: Open-label, Multicenter Study for an Evaluation of Radiation Dosimetry, Metabolism, Safety and Tolerability of the [F18] Labeled PET (Positron Emission Tomography) Tracer BAY 85-8050 Following a Single Intravenous Administration in Healthy Volunteers, as Well as the Investigation of Safety, Tolerability and Diagnostic Performance of the Tracer in PET/CT (Computer Tomography) in Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Neoplasm
Keywords: Neoplasm
PET/CT diagnosis
PET tracer
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-08-19
Enrollment: 20
Sex: ALL
Minimum age (years): 35
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: This study is a visual assessment of diagnostic PET/CT images obtained after a single intravenous injection of BAY85-8050 in patients with cancer


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers only
* Males/females, \>/=50 and \</= 65 years of age
* Cancer patients only
* Males/females \>/= 35 years and \</= 75 years of age
* Patient had an FDG PET/CT for detection, or staging, or restaging, or therapy response assessment that still showed tumor mass

Exclusion Criteria:

* Concurrent severe and/or uncontrolled and/or unstable other medical disease (e.g. poorly controlled diabetes, congestive heart failure, myocardial infarction within 12 months prior to planned injection of BAY85-8050, unstable and uncontrolled hypertension, chronic renal or hepatic disease, severe pulmonary disease) which could compromise participation in the study
* Known sensitivity to the study drug or components of the preparation

Primary outcomes:
measure: Visual assessment of lesions
timeFrame: Within up to 2 hours after treatment
Secondary outcomes:
measure: Quantitative analysis of BAY 85-8050 uptake into lesions (Standardized Uptake Values, SUVs)
timeFrame: Within up to 2 hours after treatment
measure: Serum chemistry:Glutamate pyruvate transaminase (GPT/ALAT), gamma-glutamyl transferase (gamma-GT), glutamate-oxaloacetate transaminase (GOT), alkaline phosphatase, total bilirubin, creatinine, total protein
timeFrame: At least 2 times within 8 days after treatment
measure: Electrocardiogram (ECG)
timeFrame: at least 2 times within 8 days after treatment
measure: Vital signs: Heart rate, blood pressure
timeFrame: at least 2 times within 8 days after treatment
measure: Adverse events collection
timeFrame: continuously for at least 8 days after treatment
Other outcomes:
Locations:
city: München
country: Germany
state: Bayern
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02893631: Assessment of Hemostasis Disorders in rtPA-treated Patients Requiring Endovascular Treatment for Ischemic Stroke
Official title: Assessment of Hemostasis Disorders in Tissue Plasminogen Activator Treated (rtPA-treated) Patients Requiring Endovascular Treatment for Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke, Acute
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2016-09-08
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: rtPA-treated patients requiring endovascular treatment for ischemic stroke

Brief summary: Stroke treatment includes thrombolysis, thrombectomy for patients with proximal artery occlusion and sometimes neurosurgery. It rises questions regarding hemostasis: thrombolysis induces fibrinolysis but its effects on coagulation, fibrinogen and platelets and duration of these effects are unknown. Thus management of antithrombotics and hemostasis during thrombectomy and surgery is an issue.

Objectives : to describe thrombolysis-induced hemostatic disorders (fibrinolysis, coagulation, fibrinogen, platelets) in patients requiring thrombectomy for stroke and to evaluate the time required for the normalization of these disorders.

Methods : Observational monocentric study including rtPA-treated patients requiring endovascular treatment for stroke. Blood sampling within the first 48 hours after rtPA administration to assess of fibrinolysis, coagulation and platelet functions with point of care devices and specific laboratory tests. Record of clinical and biological data.


Eligibility criteria: Inclusion Criteria:

* patient over 18
* treatment with rtPA for an acute stroke
* endovascular treatment required

Exclusion Criteria:

* opposition to participate in the study
* long term anticoagulant-treated patient
* pregnant patient

Primary outcomes:
measure: fibrinolysis activity
timeFrame: until normalization of fibrinolytic activity, up to 48 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation Ophtalmologique Adolphe de Rothschild
Study officials:
affiliation: Fondation OPH A de Rothschild
name: Marie-Claire NGHE, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05038631: Managed Access Programs for LEE011, Ribociclib
Official title: Managed Access Programs for LEE011, Ribociclib
Study type: EXPANDED_ACCESS
Overall status: AVAILABLE
Conditions: Breast Cancer
Keywords: MAP
Manage access program
Breast Cancer
CLEE011
Ribociclib
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2021-09-09
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no

Brief summary: The purpose of this registration is to list Managed Access Programs (MAPs) related to LEE011, Ribociclib

Detailed description: CLEE011A2408 - No longer available - Managed Access Program (MAP) Cohort to provide access to ribociclib (LEE011, Kisqali®), for locally advanced or metastatic cancer resistant or refractory to available treatment options and candidate for therapy with a CDK inhibitor (including tumors with D-cyclin-CDK4/6-INK4a-Rb pathway abnormalities)

CLEE011A2006M - Available - Managed Access Program (MAP) Cohort to provide access to Ribociclib for patients diagnosed with early-stage HR+HER2 (stages II and III) - breast cancer requiring adjuvant treatment with an ET based regimen

Eligibility criteria: Inclusion Criteria:

1. An independent request was received from a licensed physician.
2. The patient has a serious or life-threatening disease or condition and there is no comparable or satisfactory alternative therapy available for diagnosis, monitoring, or treatment.
3. The patient is not eligible or able to enroll in a clinical trial or continue participation in such trial.
4. There is a potential patient benefit to justify the potential risk of the treatment use, and the potential risk is not unreasonable in the context of the disease or condition to be treated.
5. The patient must meet any other medical criteria established by the medical experts responsible for the product or by the health authority in the country of request (as applicable).
6. Provision of the product will not interfere with the initiation, conduct, or completion of a Novartis clinical trial or overall development program.
7. Managed Access provision is allowed per local laws/regulations.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05163431: Dimensional Validation of the Hallux Valgus Orthosis
Official title: Dimensional Validation of the Hallux Valgus Orthosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hallux Valgus
Lead sponsor: TOPMED
Sponsor class: OTHER
Collaborators: name: Natural Sciences and Engineering Research Council, Canada
name: Orthèse Hallux Valgus Inc.
First posted: 2021-12-20
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The goal of this project is to optimize the design of the orthosis by establishing the key volumetric characteristics of the custom iterations in order to subsequently transpose them to a standard model and establish the increment proportions of the different sizes. The final product should reduce the pain by repositioning the phalanges of the first toe with the first metatarsal in its axis.


Eligibility criteria: Inclusion Criteria:

* Painful hallux valgus
* three people maximum per shoe size

Exclusion Criteria:

* People with diabetes ;
* People with severe obesity ;
* People with hallux rigidus;
* People wearing full-time foot orthosis;
* People wearing high heel shoes regularly ;
* People with degenerative disease ;
* People with neuromuscular pathology ;
* People with a circulatory disorder ;
* People who have had major lower body surgery;
* People with epilepsy or with a history of epilepsy.

Primary outcomes:
measure: Change in big toe deviation angle during gait at 1 month
timeFrame: At baseline and 1 month
measure: Change in pain at 1 month
timeFrame: At baseline and 1 month
measure: Change in comfort at 1 month
timeFrame: At baseline and 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Québec
country: Canada
facility: TOPMED
state: Quebec
Study officials:
affiliation: TOPMED
name: Edith Martin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04703231: Comparison of Ocular Findings in Patients Between Surgical and Natural Menopause
Official title: Comparison of Ocular Findings in Patients Between Surgical and Natural Menopause
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Menopause Surgical
Macula Edema
Visual Acuity Reduced Transiently
Keywords: menopause
Eye disease
Macular changes
Lead sponsor: Batman Training and Research Hospital
Sponsor class: OTHER_GOV
First posted: 2021-01-11
Enrollment: 60
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Will be studied in a patient population with low sociocultural level.

Brief summary: It is aimed to compare the ocular findings in patients with natural and surgical menopause.

Detailed description: To compare the parameters such as fundus examination, macular thickness, visual acuity and lens opacities among female patients diagnosed with menopause between the ages of 40-65.The criteria for exclusion from the study are the presence of a history of illness, drug use, smoking and alcohol use.Inclusion criteria were female patients who were in menopause and who did not use any medications. For surgical menopause, the uterus and ovaries were surgically removed at least 3 months ago.

Eligibility criteria: Inclusion Criteria:

* Newly diagnosed menopause (Natural or Surgical Menopause( At least 3 months after surgery),
* No history of illness(Diabetes,Heart disease,Kidney disease etc.)
* Not Smoking
* Did not use alcohol
* Have not use any medication
* Age between 45-65 years
* BMI between 20-25 kg/m

Exclusion Criteria:

* Smoking or Alchohol consumption
* Age before 45 and after 65 years
* Have chronic disease
* Using any medication
* Have not diagnosed Menopause
* BMI greater than 30 kg/m

Primary outcomes:
measure: Macular thickness measurement
timeFrame: 3 months after menopause
measure: Detecting lens opacities
timeFrame: 3 months after menopause
measure: Intraocular pressure measurement
timeFrame: 3 months after menopause
measure: Comparison of all detected data
timeFrame: 3 months after menopause
Secondary outcomes:
Other outcomes:
Locations:
city: Batman
country: Turkey
facility: Batman Maternity and Child Health Hospital
Study officials:
References:
Clinical trial NCT04913831: Effects of Cerebrolysin on Level of Consciousness and Brain Metabolism in Disorder of Consciousness After Stroke: Single Center Randomized Controlled Study
Official title: Effects of Cerebrolysin on Level of Consciousness and Brain Metabolism in Disorder of Consciousness After Stroke: Single Center Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Stroke
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2021-06-04
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study was to determine the effect of stroke on post-stroke level of consciousness through a double-blind, placebo-controlled, randomized study design. And Brain 18F-FDG PET was used to reveal the mechanism of recovery after cerebrolysin administration.

Thirty patients with chronic stroke patients with minimal consciousness (MCS) or vegetative human (VS) level of consciousness disorder in the revised coma recovery scale were enrolled. Thirty patients were randomly divided into a Cerebrolysin group and a placebo group.


Eligibility criteria: Inclusion Criteria:

* Ischemic or hemorrhagic stroke patients
* Stroke with CT or MRI diagnosis
* Chronic patients with more than 3 months of stroke onset
* Patients with vegetative status or minimal consciousness (Coma Recovery Scale -revised: CRS-R)
* Age: 19 to 90 years old
* A person who voluntarily consents to the clinical trial in writing by the principal or legal representative

Exclusion Criteria:

* In case of contraindications, including allergies to cerebrolysin
* Patients with contraindications to PET
* Progressive or unstable stroke
* In case of accompanying serious neurogenic disease
* Major depressive disorder, schizophrenia, bipolar disorder, dementia, and other serious psychiatric diseases.
* History of alcohol or other drug addiction within 3 years of onset
* In case of accompanying serious liver, kidney, heart, or respiratory disease
* If you have the following medical abnormalities (Total serum bilirubin\> 4 mg/dL, alkaline phosphatase\> 250 U/L, SGOT/AST\> 150 U/L, SGPT/ALT\> 150 U/L, or creatinine) \> 3.5 mg/dL)
* In case of having a medical disease that is less than 1 year old
* During pregnancy or lactation
* Participating in other therapeutic research

Primary outcomes:
measure: CRS-R (JFK Coma recovery scale-revised)
timeFrame: up to 11 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
Study officials:
affiliation: Department and Research Institute of Rehabilitation Medicine, Yonsei University College of Medicine, Seoul, Yonsei University College of Medicine
name: Deog Young Kim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01247831: The Effect of Selective Laser Trabeculoplasty (SLT) on Ocular Rigidity
Official title: The Effect of Selective Laser Trabeculoplasty (SLT) on Ocular Rigidity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Keywords: glaucoma, selective laser trabeculoplasty, ocular rigidity
Lead sponsor: Technische Universität Dresden
Sponsor class: OTHER
First posted: 2010-11-24
Enrollment: 150
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 this study is to examine the influence of selective laser trabeculoplasty (SLT) on ocular rigidity in glaucoma patients.

Detailed description: Ocular Rigidity (corneal hysteresis and corneal resistance factor) is measured with the Ocular Response Analyzer (Reichert) before and 4 weeks after SLT (Q-switched 532 nm frequency doubled neodymium yttrium aluminium garnet laser with a spot size of 400 µm and a 3-ns pulse duration). The trabecular meshwork is treated with 100 spots over 360° and an energy of 0,8 mJ.

The purpose is to examine if selective laser trabeculoplasty changes ocular rigidity.

Eligibility criteria: Inclusion Criteria:

glaucoma patients (primary open angle glaucoma, ocular hypertension) over the age of 18 who need further IOP reduction to control their glaucoma

Exclusion Criteria:

other forms of glaucoma (angle closure, secondary glaucoma, congenital, juvenile), acute psychosis, epilepsy

Primary outcomes:
measure: change in ocular rigidity
timeFrame: 4 weeks
Secondary outcomes:
measure: IOP reduction
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Dresden
country: Germany
facility: University Eye Clinic Dresden
state: Saxonia
Study officials:
affiliation: University Eye Clinic Dresden
name: Karin R Hornykewycz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01419431: Attenuated Inflammatory Response in Laparoscopic Colon Surgery
Official title: Increased SOCS 3 mRNA in Monocytes From Patients Subjected to Laparoscopic Colon Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Regulation of Inflammatory Response
Keywords: Colon cancer
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2011-08-18
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Colon cancer stage I-III

Brief summary: Pro-inflammatory responses following laparoscopic surgery.

Detailed description: Blood samples from 20 patient with colon cancer collected before and in 3 days following laparoscopic surgery. Analyzed for inflammatory cytokines and corresponding SOCS3 mRNA.

Eligibility criteria: Inclusion Criteria:Colon cancer stage I-III -

Exclusion Criteria:Colon cancer stage IV

-

Primary outcomes:
measure: Inflammatory values for laparoscopic resection for colon cancer.
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: OUS
name: Dag T. Førland, MD
role: PRINCIPAL_INVESTIGATOR
References: