louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00987623: Clinical Evaluation of Two Daily Disposable Lenses in Neophytes
Official title: Clinical Evaluation of Two Daily Disposable Lenses in Neophytes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-10-01
Enrollment: 326
Sex: ALL
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the performance of two daily disposable contact lenses in a population of neophytes (new wearers).


Eligibility criteria: Inclusion Criteria:

* No previous contact lens experience or attempts to try contact lenses (neophytes).
* Currently wearing spectacles or needing vision correction in both eyes.
* No older than 45 years of age.
* Able to achieve visual acuity of at least 20/40 in each eye with study lenses in the available parameters.
* Interested in wearing contact lenses.
* Willing to wear study lenses for at least 8 hours/day, at least 5 days/week.
* Other protocol-defined inclusion/exclusion criteria may apply.

Exclusion Criteria:

* Eye injury or surgery within twelve weeks prior to enrollment.
* Pre-existing ocular irritation that would preclude contact lens fitting.
* Previous corneal or refractive surgery.
* Currently enrolled in any Clinical Trial.
* Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Overall Lens Satisfaction
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Washington
country: United States
facility: The Research Intelligence Group (TRiG)
state: Pennsylvania
Study officials:
References:
Clinical trial NCT03131323: Nasal Findings in Reactive Airway Diseases
Official title: Nasal Findings in Reactive Airway Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Reactive Airway Disease
Wheezing
Keywords: delineate the prevalence of abnormal nasal finding in wheezy child
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-04-27
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: children aged from 2years to 18 years with recurrent wheezy ches

Brief summary: Reactive airway diseases is a common respiratory diseases affecting 1-18% of the population in different countries. It carries a significant burden to children, their families, the healthcare system and the overall community.The purpose of the study is to delineate the prevalence of abnormal nasal finding in wheezy children and evaluate the role of the endoscopic examination of the nose in evaluation and management of a wheezy child.Patients and methods:The study will be conducted as a prospective case series including all children having chest wheezes, aged from two years to eighteen years, attending emergency unit of assuit university children hospital

Detailed description: Reactive airway diseases is a common respiratory diseases affecting 1-18% of the population in different countries. The worldwide increasing incidence of asthma continues to make it a global health problem . It is one of the major causes of hospitalization among children younger than 15 years of age . It carries a significant burden to children, their families, the healthcare system and the overall community. When combined with shortness of breath, chest tightness and/or cough, it is a bronchial asthma .

Pediatric wheeze be triggered by upper respiratory tract infections . The adenoids are a prominent contributor to chronic rhinitis in the pediatric population. Clinical control of chronic rhinosinusitis may be important to optimize the control of difficult-to-treat asthma. However, the relationship between chronic rhinosinusitis and asthma in children remains largely descriptive .

Eligibility criteria: Inclusion Criteria:

* All children having chest wheezes, aged from two years to eighteen years, attending emergency unit of Assiut University Pediatric Hospital, during the period 1⁄6∕2017 to 1∕6⁄2018. They will be examined in Otolaryngology Department, Assiut University Hospital

Exclusion Criteria:

* Refusal of endoscopic nasal examination by care givers.and patients with definite diagnosis of wheeze (bronchiolitis,pneumonia)

Primary outcomes:
measure: nasal findings in reactive airway diseases
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00731523: Pharmacokinetics (PK) and Metabolism of FTY720 in Patients With Severe Renal Impairment and Healthy Matched Subjects.
Official title: An Open-label, Single-dose, Parallel-group Study to Compare the Pharmacokinetics of FTY720 and Metabolites in Subjects With Severe Renal Impairment With That in Matched Healthy Control Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Renal Insufficiency
Keywords: FTY720, Pharmacokinetics, Renal insufficiency
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2008-08-11
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The purpose of this study is to compare the pharmacokinetics of FTY720 and its metabolites in patients with severe renal insufficiency and in matched, healthy volunteers. This study will allow a better understanding of the effects of renal insufficiency on the disposition of FTY720.


Eligibility criteria: Inclusion Criteria:

Healthy Subjects:

* Subjects must have a calculated glomerular filtration rate (GFR) by Cockcroft-Gault Equation ≥80 mL/min.

Severe Renal Impaired Patients:

* Patients not on dialysis with severe renal failure with a creatinine clearance \< 30 mL/min as determined by Cockcroft-Gault Equation.
* Renal function should have been stable within the 3 months prior to study start.
* Patients with diabetes and/or hypertension who are in otherwise in good health may be included. However patients with diabetes must not have clinical evidence of gastropathy or enteropathy.

Exclusion Criteria:

All Subjects/Patients:

* History of multiple and recurring allergies or allergy to the investigational compound/compound class being used in this study
* History of retinal macular edema.
* History of any significant cardiovascular events such as myocardia infarction, valvular disease, angina, ischemic heart disease, dilated cardiomyopathy, dysrhythmia.
* History of immunocompromise, including a positive HIV (ELISA and Western blot) test result.

Severe Renal Impaired Patients:

* Use of any highly potent CYP3A4 inhibitor (e.g. erythromycin, ketoconazole, itraconazole) within 2 weeks prior to dosing.
* Use of beta blocker therapy within two (2) weeks prior to dosing.

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: PK profile comparison between healthy volunteers and severe renal impaired patients, 3 weeks
Secondary outcomes:
measure: Assess the safety and tolerability, 3 weeks
measure: Assess the influence of renal function on the pharmacokinetics of FTY720 metabolites M2 and M3, 3 weeks
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Novartis Investigator Site
Study officials:
affiliation: Novartis investigator site
name: Novartis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03594123: A 12-week Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Official title: A 12-week, Multicenter, Active-treatment Extension Trial to Evaluate the Safety and Tolerability of Brexpiprazole in the Treatment of Subjects With Agitation Associated With Dementia of the Alzheimer's Type
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Alzheimer's Disease
Keywords: Agitation
Lead sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Sponsor class: INDUSTRY
Collaborators: name: H. Lundbeck A/S
First posted: 2018-07-20
Enrollment: 259
Sex: ALL
Minimum age (years): 55
Maximum age (years): 91
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Active treatment extension study of the 331-14-213 trial, to assess the long-term safety and tolerability of oral brexpiprazole as treatment in adult participants with agitation associated with dementia of the Alzheimer's type (AAD).


Eligibility criteria: Inclusion Criteria:

* Participants must have participated in the 331-14-213 study.
* Participants must have an identified caregiver who has contact, at a minimum of 2 hours per day, 4 days per week to describe the participant's symptoms and can observe participant behavior.

Exclusion Criteria:

* Participants with a substantial protocol violation during the course of their participation in the double-blind trial 331-14-213.

Primary outcomes:
measure: Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) by Severity
timeFrame: From first dose through 30 days after last dose of study drug (Up to approximately Week 16)
Secondary outcomes:
Other outcomes:
Locations:
city: Miami
country: United States
facility: For additional information regarding sites, contact 844-687-8522
state: Florida
Study officials:
References:
Clinical trial NCT04960423: Clinical Study of Imaging and Endoplant-related Mechanical Complications After Long Segment Fixation and Fusion of Degenerative Lumbar Scoliosis (DLS)
Official title: Clinical Study of Imaging and Endoplant-related Mechanical Complications After Long Segment Fixation and Fusion of Degenerative Lumbar Scoliosis (DLS)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Degenerative Scoliosis
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-13
Enrollment: 200
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From April 2009 to May 2019, patients with degenerative lumbar scoliosis (DLS) underwent posterior selective decompression and long segment fixation and fusion surgery in the Department of Orthopaedic Lumbar Surgery of our hospital

Brief summary: There is a high probability of mechanical complications in patients with degenerative lumbar scoliosis after long segment fixation and fusion, and there are few studies on distal borderline kyphosis deformity/failure. This study was designed to retrospectively analyze the patients with degenerative lumbar scoliosis (DLS) who underwent posterior selective decompression and long segment fixation and fusion surgery in the lumbar spine department of our hospital from April 2009 to May 2016. Patients' basic data, surgical data and preoperative, immediate postoperative and follow-up imaging data were collected to study the incidence of distal mechanical complications, risk factors and their relationship with clinical symptom scores in DLS patients undergoing posterior selective decompression and long segment fixation and fusion. It has guiding significance for clinical operation decision making.


Eligibility criteria: Inclusion Criteria:

* Age ≥45 years old;
* The number of fixed vertebral bodies ≥5, and the upper instrumented vertebra (UIV) is located in the thoracolumbar segment;
* Third generation total pedicle screw internal fixation system;
* Follow-up time ≥24 months;
* Complete clinical and imaging data.

Exclusion Criteria:

* Idiopathic scoliosis, neuromuscular scoliosis, non-structural scoliosis, spinal tumors, spinal tuberculosis, ankylosing spondylitis, humman's disease, history of spinal surgery, history of spinal trauma, and history of hip surgery

Primary outcomes:
measure: Imaging and Endoplant-related Mechanical Complications
timeFrame: 2019.1.1-2025.12.31
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University of Third Hospital
state: Beijing
Study officials:
References:
Clinical trial NCT01909323: Digestive Tolerance of Maltitol and FOS
Official title: Digestive Tolerance and Postprandial Glycaemic and Insulinaemic Responses Evaluation of Different Maltitol/FOS Mixtures in Healthy Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Digestive Tolerance in Healthy Adults
Lead sponsor: Syral
Sponsor class: INDUSTRY
Collaborators: name: Beghin-Meiji
First posted: 2013-07-26
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Digestive symptoms following consumption of low digestibe carbohydrates are generally assessed product by product but several ingredients can be used simultaneously. The study aimed at evaluating to digestive tolerance of maltitol and FOS used in a same food.


Eligibility criteria: Inclusion Criteria:

* BMI between 18.5 and 30
* normal and regular stool frequency: at least 3 stools per week and no more than 3 per days
* subjects not sufferinf from a metabolic, functional or inflammatory disease affecting intestinal transit and nutrients absorption
* subjects not sufferinf from IBS according to Rome III criteria
* subjects not using mdeiction which could affect nutrients absoprtion

Exclusion Criteria:

-

Primary outcomes:
measure: Composite score of gastrointestinal symptoms in the 24h following the consumption of products
timeFrame: 24 hours
Secondary outcomes:
measure: Individual scores of gastrointestinal symptoms: bloating, abdominal discomfort, borborygms, flatulences
timeFrame: 24 and 48 hours
measure: Stool frequcency and consistency
timeFrame: 24 & 48 hours
measure: Glycaemic response
timeFrame: 2 hours
Other outcomes:
Locations:
city: Saint-Herblain
country: France
facility: Biofortis SAS
Study officials:
affiliation: Biofortis SAS
name: David Gendre, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00184223: Motivational Interviewing to Acutely Admitted Psychiatric Patients With Comorbid Substance Use
Official title: Motivational Interviewing to Acutely Admitted Psychiatric Patients With Comorbid Substance Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Substance-Related Disorders
Keywords: Motivational Interviewing
Substance abuse
Acuteley admitted psychiatric patients
Emergency Services, Psychiatric
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: St. Olavs Hospital
First posted: 2005-09-16
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose for this study is to determine whether 2x45 minutes Motivational Interviewing given during hospital stay to acutely admitted psychiatric patients with substance use problems, can reduce substance use after discharge.

Detailed description: The aims of the study are in a randomized controlled trial to compare the effects of 2 x 45 minutes Motivational Interviewing and standard treatment with standard treatment alone.All patients acutely admitted to Østmarka Psychiatric Hospital are evaluated for substance use, and all patients with substance use that give their consent to participate are randomized to Motivational Interviewing and standard treatment or standard treatment alone.

Substance use and function will be followed for two years.Admittances to hospital and contacts with primary health care for five years.

Eligibility criteria: Inclusion Criteria:

* substance use
* acutely admitted to psychiatric hospital

Exclusion Criteria:

* dementia
* serious brain damage
* not speaking Norwegian or English

Primary outcomes:
measure: Substance use and function questionnaire
timeFrame: 2 years
Secondary outcomes:
measure: Admissions to hospital
timeFrame: 2 years
measure: Number of contacts with primary ealth care
timeFrame: 2 years
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Østmarka Psychiatric Department, St. Olavs Hospital, University Hospital of Trondheim
Study officials:
affiliation: Norwegian University of Science and Technology
name: Gunnar Morken, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bagoien G, Bjorngaard JH, Ostensen C, Reitan SK, Romundstad P, Morken G. The effects of motivational interviewing on patients with comorbid substance use admitted to a psychiatric emergency unit - a randomised controlled trial with two year follow-up. BMC Psychiatry. 2013 Mar 21;13:93. doi: 10.1186/1471-244X-13-93.
Clinical trial NCT03244423: Tranexamic Acid in Cyanotic Heart Defects
Official title: Tranexamic Acid in Cyanotic Heart Defects: a Risk-benefit Analysis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Postoperative Hemorrhage
Keywords: Pediatric
Cyanotic heart disease
Tranexamic acid
Postoperative blood loss
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 120
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The use of antifibrinolytic agents such as to reduce blood loss in congenital cardiac surgery has been described in many studies

Detailed description: 40 patients in each one of the three groups; In control group will receive normal saline, Intravenous Tranexamic acid group received 50 mg / kg intravenousely followed by of 1 mg/kg/hr.for six hours. The topical Tranexamic acid group will have 50 mg / kg of tranexamic poured into the pericoredial cavity. in the first 24 hours we will measure the total blood loss and transfusion requirements. Complate blood picture and coagulation studies will be recorded. the occurrence of re-exploration for excess bleeding, or adverse events.

Eligibility criteria: Inclusion Criteria:

2 to 12 years cyanotic cardiac disease with cardio pulmonary bypass

Exclusion Criteria:

Previous cardiac surgery any operation within 48 hr., previous inotropes or mechanical vention aprotinin exposure Liver or renal impairment Coagulation or hemostatic dysfunction within the last 7 days before surgery.

Primary outcomes:
measure: postoperative blood loss
timeFrame: within the first 24 hours
Secondary outcomes:
measure: total blood transfusion
timeFrame: within the first 24 hours
measure: the interval from protamine to skin closure
timeFrame: within the first 24 hours
measure: the length of ICU stay
timeFrame: within the first month
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: Associate profossor of anesthesiology
name: Sayed k Abd-Elshafy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06030323: Validation of AI Models to Measure Physical Activity After a Stroke
Official title: Validation and Testing of Artificial Intelligence Models to Measure Physical Activity in Patients Admitted to Hospital Following a Stroke
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Stroke
Lead sponsor: Cambridge University Hospitals NHS Foundation Trust
Sponsor class: OTHER
First posted: 2023-09-11
Enrollment: 34
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: Acute and sub-acute stroke inpatients

Brief summary: The research team are developing algorithms using artificial intelligence that use information collected by accelerometers to detect a person's position, such as whether an individual is lying, sitting, or standing, and the individual's movements, such as whether they are taking steps or standing up.

Sensor location will affect the accuracy of the model and acceptability of the method. The research team are therefore developing algorithms for four different locations.

The purpose of the research is for the development of the algorithms and check whether they accurately recognise different positions and movements in people whose movement is affected by a stroke, and by being in a hospital environment (e.g. using a profiling bed).

The research team plan to recruit between 34 and 50 participants who are admitted hospital due to having a stroke. After providing informed consent, participants will be asked to complete a one-off assessment with a member of the research team and a ward physiotherapist. Participants will be asked to wear the four sensors, and move through a series of postures, walk for up to six minutes, and stand as many times as they feel able in one minute.


Eligibility criteria: Inclusion Criteria:

* admitted to hospital with a diagnosis of an acute stroke.

Exclusion Criteria:

* unable to provide informed consent;
* receiving end-of-life care;
* the consultant in charge of their care disagrees with their inclusion

Primary outcomes:
measure: Sensitivity and specificity of AI models
timeFrame: Collected during hospitalisation (up to 12 weeks)
Secondary outcomes:
Other outcomes:
Locations:
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospital NHS Foundation Trust
state: Cambridgeshire
Study officials:
References: