louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01586052: Erythropoietin Therapy for Children With Cerebral Palsy: Phase 1
Official title: A Phase 1 Clinical Research of Erythropoietin Therapy for Children With Cerebral Palsy: Safety and Efficacy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cerebral Palsy
Keywords: Cerebral Palsy
Erythropoietin
Rehabilitation
Lead sponsor: Bundang CHA Hospital
Sponsor class: OTHER
Collaborators: name: LG Life Sciences
First posted: 2012-04-26
Enrollment: 11
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This purpose of this phase 1 study is to investigate the safety and efficacy of erythropoetin for children with cerebral palsy.

Detailed description: Cerebral palsy is a disorder of movement and posture resulted from a nonprogressive lesion or injury of the immature brain. It is a leading cause of childhood onset disability.

Many experimental animal studies have revealed that erythropoietin is useful to repair neurological injury in brain. The main mechanism of erythropoietin is supposed as follows; neuroprotection effect, angiogenesis, and anti-inflammation.

On the basis of many experimental studies, erythropoietin is suggested as a potential therapy for cerebral palsy.

Eligibility criteria: Inclusion Criteria:

* Cerebral Palsy
* Abnormal Muscle Tone
* GMFCS (Gross Motor Functional Classification System): II to IV
* Age: 6 months \~ 3 years
* Abnormal Brain MRI compatible to clinical features and non-progressive
* Willing to Comply with All Study Procedure

Exclusion Criteria:

* Known Genetic Disorder
* Baseline Erythropoietin level \> 45 mU/mL
* Presence of Drug Hypersensitivity Related to the Study Remedy
* Previous Erythropoietin Treatment before 3 months
* Coagulopathy:

Family History, Unknown Cerebral Infarction, Thromboembolic Events History

* Intractable Seizure Disorder
* Poor Cooperation of Guardian including Inactive Attitude for Rehabilitation
* Uncontrolled Hypertension
* Liver Dysfunction
* Renal Dysfunction
* Absolute Neutrophil Count \< 500/dL
* Intracerebral or Intraventricular Hemorrhage
* Malignancy

Primary outcomes:
measure: Adverse Events
timeFrame: 8 weeks
Secondary outcomes:
measure: Changes in Quality of Movement
timeFrame: Baseline - 8 weeks
measure: Changes in Gross Motor Function
timeFrame: Baseline - 8 weeks
measure: Changes in Neurodevelopmental Outcomes
timeFrame: Baseline - 8 weeks
measure: Changes in Motor Development
timeFrame: Baseline - 8 weeks
measure: Changes in Spasticity
timeFrame: Baseline - 8 weeks
Other outcomes:
Locations:
city: Seongnam-si
country: Korea, Republic of
facility: CHA Bundang Medical Center, CHA University
state: Gyeonggi-do
Study officials:
affiliation: CHA University
name: Minyoung Kim, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02041052: The Size of the Gastric Remnant as Determinant for Delayed Gastric Emptying After Whipple Resection.
Official title: Phase Two Randomized Study of The Size of the Gastric Remnant as Determinant for Delayed Gastric Emptying After Whipple Resection.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: 50 % Reduction of Delayed Gastric Emptying
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: Ralf Segersvärd
name: Afshin Noorani
name: John Blomberg
First posted: 2014-01-20
Enrollment: 7
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A small gastric remnant after whipple resection improves gastric emptying and therefore prevents the development of delayed gastric emptying.

Detailed description: Every patient submitted to a whipple resection and at the same time present with characteristics suggestive of minimal risk for leakage from the pancreaticojejunostomy will be included in the study. At the time of reconstruction the patient will be randomized to either conventional size of the stomach or to a subtotal gastrectomy containing a small upper gastric pouch only.

Eligibility criteria: Inclusion Criteria:

All patients undergoing whipple procedure with preoperative assignment as low risk for leakage from the pancreaticojejunal anastomosis.

* Signed informed consent.

Exclusion Criteria:

* High and intermediate risk pancreaticojejunal anastomosis. Unwillingness to participate.

Primary outcomes:
measure: Postoperative delayed gastric emptying
timeFrame: Postoperative recovery period in days (on an average <20 days)
Secondary outcomes:
measure: Quality of life
timeFrame: during three first postoperative months
measure: Postoperative hospital stay
timeFrame: In hospital stay in days (on an average <20 days)
measure: Total Gastric emptying as measured by the paracetamol test
timeFrame: three months postoperatively
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital Gastrocentrum
Study officials:
affiliation: Karolinska University Hospital
name: Lars Lundell, professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02857452: Transcultural Validation in French of the Systemic Lupus Activity Questionnaire (SLAQ) and the Lupus Quality Of Life (LupusQoL) Questionnaire
Official title: Transcultural Validation in French of the Systemic Lupus Activity Questionnaire (SLAQ) and the Lupus Quality Of Life (LupusQoL) Questionnaire
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lupus
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-05
Enrollment: 162
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with lupus meeting the 1997 classification criteria of the American College of Rheumatology for systemic lupus erythematous

Brief summary: The evaluation of lupus patients must include several approaches, in particular disease activity and quality of life.

The Systemic Lupus Activity Questionnaire (SLAQ) is a validated self-questionnaire to evaluate disease activity. It has the advantage of being inexpensive, easy to use in large cohorts and has been used in several studies. It has never been validated in French. The Lupus Quality Of Life (LupusQoL) is a self-questionnaire to evaluate quality of life and is specific to systemic lupus erythematous; it was developed from interviews with patients.

This tool, validated in a British population, has never been validated in French.


Eligibility criteria: Inclusion Criteria:

* Patients with lupus meeting the 1997 classification criteria of the American College of Rheumatology for systemic lupus erythematous.
* Patients able to understand written and spoken French.
* Patients who have been informed about the research

Exclusion Criteria:

* Severe mental retardation.
* Any impairment of ability to understand making self-evaluation impossible.
* Age \< 18 years.
* Age \> 75 years.

Primary outcomes:
measure: Answers in French to the au Systemic Lupus Activity Questionnaire (SLAQ)
timeFrame: Evolution of answers between D0, D15, M3 and M6
Secondary outcomes:
measure: Answers in French to the Lupus Quality of Life (Lupus QoL) questionnaire
timeFrame: Evolution of answers between D0, D15, M3 and M6
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT01921452: Study to Verify Clinical Utility of Point-of-Care (POC) Thyroid Stimulating Hormone (TSH) Test Kits as Compared to Third Generation TSH Test Kit
Official title: A Single-center Interventional Study to Verify Clinical Utility of the Quantitative and the Qualitative POC TSH Test Kits Compared With the Third Generation TSH Test Kit
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypothyroidism
Keywords: Hypothyroidism
Third generation TSH kit
Quantitative POC TSH kit
Qualitative POC TSH kit
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2013-08-13
Enrollment: 283
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This is a Phase 4, single-center, open-label, interventional study, wherein all enrolled subjects will be tested for Thyroid Stimulating Hormone (TSH) by using the quantitative and the qualitative Point-of-Care (POC) TSH test kits and the third generation TSH test kit at the same time.


Eligibility criteria: Inclusion Criteria:

* Suspected hypothyroidism subject
* Willing to comply with the trial protocol
* Signed informed consent document

Exclusion Criteria:

* Menstrual period, bleeding hemorrhoids, hematuria
* Drinking or taking aspirin within 48 hours
* Subjects with partially or completely restricted consciousness and behavioral ability, who do not have independent decision-making ability.
* Subjects who are unwilling or unable to complete the trial
* Subjects who do not sign informed consent form

Primary outcomes:
measure: Number of Participants With Positive and Negative TSH Test Result
timeFrame: Day 1 up to Day 5
measure: Concentration of TSH in Whole Blood
timeFrame: Day 1 up to Day 5
Secondary outcomes:
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Research site
Study officials:
affiliation: Merck Serono Limited, UK
name: Medical Responsible
role: STUDY_DIRECTOR
References:
citation: Wang T, Sheng S, Ruan M, Yan J, Gu J, Jiang Y, Gao Y, Lu H. Clinical Evaluation of the Immune Colloidal Gold Method for Rapid Qualitative and Quantitative Measurement of Thyroid-Stimulating Hormone as an Assay for Hypothyroidism. Adv Ther. 2016 Nov;33(11):2001-2011. doi: 10.1007/s12325-016-0401-y. Epub 2016 Sep 7.
Clinical trial NCT01987752: Safety and Efficacy of Combigan® Ophthalmic Solution in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma, Open-Angle
Ocular Hypertension
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2013-11-19
Enrollment: 732
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Open Angle Glaucoma or Ocular Hypertension treated with Combigan® Ophthalmic Solution in Clinical practice.

Brief summary: This study is a Post-Marketing Surveillance study in Korea to evaluate the safety and efficacy of Combigan® (brimonidine tartrate/timolol maleate) Ophthalmic Solution in patients with Open Angle Glaucoma or Ocular hypertension with insufficient response to local beta blockers treated as per standard of care in clinical practice.


Eligibility criteria: Inclusion Criteria:

* Patients with Open Angle Glaucoma or Ocular Hypertension treated with Combigan® Ophthalmic Solution as standard of care in clinical practice.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Percentage of Participants Reporting Adverse Events
timeFrame: Up to 2.6 Years
measure: Percentage of Participants With Overall Improvement From Baseline in Intraocular Pressure (IOP)
timeFrame: Baseline, Week 4
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT04377152: Expanded Access 68Gallium-PSMA-11 PET for Prostate Cancer
Official title: Expanded Access: 68Gallium-PSMA-11 for PET Imaging of Prostate Cancer
Study type: EXPANDED_ACCESS
Overall status: APPROVED_FOR_MARKETING
Conditions: Prostate Cancer
Prostate
Prostate Adenocarcinoma
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2020-05-07
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT

Brief summary: This expanded access protocol provides eligible participants with investigational 68Ga-PSMA-11 PET imaging to detect and localize prostate cancer for initial and subsequent treatment strategy.


Eligibility criteria: Biochemical recurrent and pre-prostatectomy staging participants will be eligible and must meet the following criteria:

Inclusion Criteria:

1. Age ≥ 18 years
2. Histopathologically confirmed or biopsy proven prostate adenocarcinoma.
3. Concern for metastatic disease in one of the following settings:

   1. Initial staging with intermediate to high risk prostate cancer.
   2. Biochemical recurrence after initial therapy.
4. Ability to understand a written informed consent document, and the willingness to sign it

Exclusion Criteria:

1. Unlikely to comply with protocol procedures, restrictions and requirements and judged by the Investigator to be unsuitable for participation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Thomas Hope, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00659152: Morphofunctional Lung Analysis by Positron Emission Tomography
Official title: Morphofunctional Lung Analysis by Positron Emission Tomography in ALI-ARDS Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Lung Injury
Acute Respiratory Distress Syndrome
Keywords: ALI/ARDS
Lead sponsor: Policlinico Hospital
Sponsor class: OTHER
First posted: 2008-04-16
Enrollment: 30
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: ALI/ARDS ICU patients

Brief summary: Patients affected by acute lung injury-acute respiratory distress syndrome (ALI-ARDS) undergo a positron emission tomography (PET) scan in order to analyse lung function.


Eligibility criteria: Inclusion Criteria:

* Ali-ards
* Age \> 18yrs

Exclusion Criteria:

* COPD

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Milano
country: Italy
facility: Davide Chiumello
Study officials:
affiliation: Policlinico Hospital
name: Davide Chiumello, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06542952: Statistical Analysis of Prevalence, Incidence, Comorbidities and Medical Expense in Epileptic Children in Taiwan Based on National Health Research Insurance Database.
Official title: Statistical Analysis of Prevalence, Incidence, Comorbidities and Medical Expense in Epileptic Children in Taiwan Based on National Health Research Insurance Database
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Neurologic Disorder
Seizure Disorder
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2024-08-07
Enrollment: 169026
Sex: ALL
Minimum age (years): 0
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from epilepsy

Brief summary: Epilepsy is a common disease in pediatric neurology. In recent years, due to the promotion of Taiwan's health insurance and the advancement of related medical treatments and anti-epileptic drugs, the prevalence, incidence, and related comorbidities of childhood epilepsy in Taiwan are expected, as well as the number of epilepsy patients in different regions or different age groups. and medical costs may change. This study aims to collect data from the National Health Insurance Database through the National Institutes of Health, review relevant data on childhood epilepsy patients from 2001 to 2013, and analyze trends to discuss the impact of universal health insurance and medical progress on childhood epilepsy patients. Impact.


Eligibility criteria: Inclusion Criteria:

1. Targets aged 0\~19 (\<=19) in the home country
2. Diagnosis code includes ICD9: 345.XX, ACODE:A225 (including outpatient and inpatient)
3. Between 2001 and 2013, those who had seen a doctor three times in a row with epilepsy diagnosis codes and used anti-epileptic drugs

Exclusion Criteria:

* Exclude those who sought medical treatment for epilepsy from 2001 to 2013, but the number of medical visits (outpatient + hospitalization) \<3 times, and exclude those who did not take medication from 2001 to 2013.

Primary outcomes:
measure: Statistical Analysis of prevalence, incidence, comorbidities and medical expense medical expense in epileptic children in Taiwan based
timeFrame: 2001-2013
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Department of Pediatrics, National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Mei Lan Liou, master
role: STUDY_DIRECTOR
References:
Clinical trial NCT02858752: Memory and Attention in Healthy Children
Official title: Memory, Auditory and Visual Attention in Healthy Children: Neurophysiological and Electrophysiological Aspects
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy Volunteers
Keywords: Attention
Short-term memory
Aural Memory
Visual Memory
Child
EEG
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2016-08-08
Enrollment: 400
Sex: ALL
Minimum age (years): 5
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This project studies memory and attention in healthy children aged from 5 to 17 years. The processes investigated are short term memory (auditory and visual) and attention.

To characterize these processes involved in childhood, neuropsychological and neurophysiological assessments will be performed (using Electro-encephalography measures, behavioural responses and questionnaires).


Eligibility criteria: Inclusion Criteria:

* Normal or corrected vision
* No neurological and psychiatric antecedent.
* No neuro-developmental disorder (dysphasia, dyslexia, dyspraxia, attention deficit disorder...)
* Motivation to participate to the study
* Signed parental informed consent authorizing their child to participate to the study

Exclusion Criteria:

* Children educated in a specialized institution.
* Subjects diagnosed with a neurological, psychiatric or neuro-developmental disorder
* Subjects with hearing loss
* Subjects with a visual impairment that cannot be corrected
* Subjects with an organic or chronic disease that can affect cognitive functions.
* Subjects who do not benefit from social security.

Primary outcomes:
measure: Neuropsychological tests: Proportion of accurate answers
timeFrame: 2 months
measure: Neuropsychological tests: reaction time of answers (seconds)
timeFrame: 2 months
measure: Neurophysiological tests: Event-related potentials in response to auditory and visual stimulations
timeFrame: 2 months
Secondary outcomes:
measure: Proportion of accurate answers according to age range of children
timeFrame: 2 months
measure: reaction time of answers (seconds) according to age range of children
timeFrame: 2 months
measure: Event-related potentials in response to auditory and visual stimulations according to age range of children
timeFrame: 2 months
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hopital Femme Mère Enfant
Study officials:
References:
Clinical trial NCT02336152: Use of Onepiece Suit or Forced Warm Air for Perioperative Temperature Conservation.
Official title: Use of Onepiece Suit or Forced Warm Air for Perioperative Temperature Conservation.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Surgery
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2015-01-12
Enrollment: 30
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: PREVENTION

Brief summary: To study if a one piece body suite (T-balance, Telespro, Finland) is equally effective in maintaining peri-operative body temperature as forced air warming, during open low-back surgery of medium duration.


Eligibility criteria: Inclusion Criteria:

* ASA 1-3
* Approved consent
* Expected duration of open back surgery of 60-120 min
* Prestudy core temperature (oral) of at least 36 degrees C

Exclusion Criteria:

* Known diabetes mellitus
* Any known illness or use of pre-op drugs which may interfere with normal temperature regulation
* Body mass index less than 17 or more than 35
* Pregnancy
* Any contraindication for warming device or temperature monitor

Primary outcomes:
measure: Body core temperature
timeFrame: 30 minutes after anaesthesia induction
Secondary outcomes:
measure: Body core temperature
timeFrame: 1 hr before - intraoperative - 3 hrs postoperative
measure: Patient termal satisfaction
timeFrame: 1 hr before - intraoperative - 3 hrs postoperative
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Dept of Anesthesiology, Oslo University Hospital, Ullevaal
Study officials:
References:
Clinical trial NCT02457052: Impact of a Transportable Customizable and Scalable Sitting Positioning Device on Swallowing Disorders
Official title: Impact of a Transportable Customizable and Scalable Sitting Positioning Device on Swallowing Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Deglutition Disorders
Keywords: Medical device
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2015-05-29
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: When the seat is a vehicle for disabled person, postural adaptation methodology is known and, on prescription, there is possibility of financial support for technical posture assists. For people who use a standard seat, a chair for example, there is no satisfactory existing hardware.

A transportable customisable and scalable sitting positioning device (DATP device), to be placed on a standard seat, is a solution that might fit in the home, in specialized foster homes or in institutions for the elderly. Such a device has been developed but earnings on swallowing disorders have to be validated.


Eligibility criteria: Inclusion Criteria :

* Present a swallowing disorder authenticated by a score Dysphagia Handicap Index above 11
* Postural disorder authenticated by a score greater than 0 to at least 1 of the following 3 items to MCPAA: retroversion, obliquity and rotation of the pelvis
* Autonomy Conservation compatible with the use of different seats including standard seats
* Signing of informed consent

Exclusion Criteria:

* Postural disorder requiring the use of only one type of installation (wheelchair or hull)
* Spinal stiffness or non-reducible hips (spondylitis, osteosynthesis rod)
* Not included anthropometric dimensions between:

  * Basin with between 39 and 50 cm
  * femoral length between 42 and 52 cm
  * tibial length between 39 and 44 cm (46.5 with femoral recharge), measured with the shoes.
* Pregnant or lactating women

Primary outcomes:
measure: Change from baseline in laryngeal movement during swallowing
timeFrame: One month
Secondary outcomes:
measure: NIH Swallowing Safety Scale
timeFrame: One month
measure: Functional oral intake scale (FOIS)
timeFrame: One month
measure: Adult sitting postural control measure (MCPAA)
timeFrame: One month
measure: Quality questionnaire of patient's life
timeFrame: One month
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital, Toulouse
state: Midi-Pyrénées
Study officials:
affiliation: University Hospital, Toulouse
name: Virginie WOISARD, MD; PHD
role: PRINCIPAL_INVESTIGATOR
References: