louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02331953: Predictors of Postoperative Delirium in Elder Patients After Spine Surgery: Regional Cerebral Oxygen Saturation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postoperative Delirium in Elder Patients After Spine Surgery
Keywords: spine surgery
cerebral oximetry
postoperative delirium
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2015-01-06
Enrollment: 109
Sex: ALL
Minimum age (years): 60
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients undergoing spine surgery

Brief summary: Postoperative delirium is an important problem in patients undergoing major surgery. The incidence of delirium was 12.5% in the patients over 70 years old undergoing spine surgery. A study shows that a low preoperative regional cerebral oxygen saturation (rSO2) is associated with postoperative delirium after on-pump cardiac surgery. This same perturbation likely also increases the risk for postoperative delirium after spine surgery, although there are little data that have evaluated this hypothesis. Therefore, this observational study was designed to explore the relationship between perioperative rSO2 and the delirium in elderly patients undergoing spine surgery.


Eligibility criteria: Inclusion Criteria:

1. Patients in the study will be 60 or older undergoing elective major spine surgery (expected operative time is more than 2 hrs).
2. Patients who can do the mini-mental state examination (MMSE), Confusion Assessment Method for the ICU (CAM-ICU) and Intensive Care Delirium Screening Checklist (ICDSC).
3. Patients who understand the nature of the study and are willing to sign the consent form

Exclusion Criteria:

1. Emergency surgery
2. Patients diagnosed with neurocognitive disorders or psychiatric diseases, thus, cannot check MMSE or communicate with other people (e.g. Alzheimer's dementia, alcohol abuse)
3. Patients diagnosed with cerebrovascular disorders (e.g. stroke, atherosclerotic stenosis of carotid artery, TIA)
4. Patients who cannot be followed up until 2 days after surgery

Primary outcomes:
measure: the predictive power of periopertiver rSO2 regarding postoperative delirium
timeFrame: up to 2days postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Anesthesiology and Pain Medicine, Anesthesia and Pain Research Institute, Yonsei University College of Medicine
Study officials:
References:
Clinical trial NCT00619853: The Influence of MCIMT (Modified Constrained Induced Movement Therapy), Bilateral Intensive Treatment, and NDT Approach on the UL Function in Children With Hemiplegic Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hemiplegic Cerebral Palsy
Keywords: Improving the assisting hand function in children with Hemiplegic Cerebral palsy
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2008-02-21
Sex: ALL
Minimum age (years): 18
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this pilot study was to compare unimanual training (CIMT) and bimanual training (HABIT) protocols aimed to improve ability of the involved hand in children with hemiplegia. Both protocols were conducted in an educational setting for 2 hours a day for 2 months, one-hour group session and one-hour individual therapy session conducted by occupational therapists or assistants.

The children in the CIMT group practiced various tasks using their involved hand with the contralateral hand constrained with a mitt. The children at the HABIT group practiced various bimanual tasks without constraint.

Twelve children (2 - 6.5 yrs.) participated in this study. The inclusion criterion included minimal extension movement of the involved wrist, and for the CIMT group, the ability to of tolerates the mitt. The children were matched in relation to cognitive level and MACS score and randomly divided into the two intervention groups.

Each child's assessment included the Quality of Upper Extremity Skills Test (QUEST), the Assisting Hand Assessment (AHA), and the Blocks and Box for children above age 5 yrs old. Range of motion (ROM) was assessed using an electronic gonimeter, and muscle tone was recorded using surface EMG and the Tardiue scale. The Child Health Questioner (CHQ) was completed by the parents before, and 6 months after, the intervention. Children were assessed starting two month before, and two month after, the intervention.


Eligibility criteria: Inclusion Criteria:

* Children with Hemiplegia

Exclusion Criteria:

* No ability for a minimal extension movement in the wrist

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jerusalem
country: Israel
facility: MESHI kindergarten
Study officials:
References:
Clinical trial NCT00517153: Miglustat in Niemann-Pick Type C Disease
Official title: A Phase II Randomized Controlled Study of Miglustat in Adult and Juvenile Patients With Niemann-Pick Type C Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Niemann-Pick Type C Disease
Keywords: Zavesca
miglustat
Niemann-Pick Type C
Actelion
Lead sponsor: Actelion
Sponsor class: INDUSTRY
First posted: 2007-08-16
Enrollment: 29
Sex: ALL
Minimum age (years): 4
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a phase II randomized controlled study of miglustat in adult and juvenile patients with Niemann-Pick Type C disease. Up to 42 patients will be randomised in a 2:1 ratio to either treatment with miglustat or to a non-treatment group. Both groups will follow an identical visit schedule.


Eligibility criteria: Inclusion Criteria:

1. Patients with Niemann-Pick Type C disease confirmed by abnormal cholesterol esterification and abnormal filipin staining.
2. Patients who can ingest a capsule.
3. Patients who are above the age of four (4) years of age.

Exclusion Criteria:

1. Patients younger than 18 years who are unable to give informed assent and/or whose legal guardian is unable to provide informed consent.
2. Patients aged 18 and over who cannot provide informed consent and/or whose legal guardian is unable to provide witnessed informed consent.
3. Sexually active and fertile patients who do not agree to use adequate contraception throughout the study and for three months after cessation of OGT 918 treatment.
4. Patients who cannot tolerate the study procedures or who are unable to travel to the study center as required by this protocol.
5. Patients currently undergoing therapy with other investigational agents or patients taking drugs or food supplements which may interfere with gastrointestinal absorption or motility.
6. Patients suffering from clinically significant diarrhea (\>3 liquid stools per day for \>7 days) without definable cause within 3 months of Screening Visit, or who have a history of significant gastrointestinal disorders.
7. Patients with an intercurrent medical condition that would render them unsuitable for the study e.g. HIV, hepatitis infection.
8. Patients who in the opinion of the Investigator (for whatever reason) are thought to be unsuitable for the study.
9. Patients with an adjusted Creatinine Clearance of less than 70 ml/min/1.73m2 (CrCl \<70).
10. Patients younger than four (4) years of age.

Primary outcomes:
measure: The primary endpoints will be two parameters - Horizontal Saccadic α and Horizontal Saccadic β - which are estimated for each patient from their saccadic eye movement data
timeFrame: Baseline to Month 12
Secondary outcomes:
measure: Highest amplitude for which a velocity measurement is obtained
timeFrame: Baseline to Month 12
Other outcomes:
Locations:
Study officials:
affiliation: Columbia University
name: Claudia Chiriboga, Assoc. Prof. MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05349253: Effect of Garlic Extracts on Changes in Cerebral Blood Flow
Official title: Effect of Garlic Extracts on Changes in Cerebral Blood Flow: Randomized, Double-blind, Placebo-controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Pusan National University Yangsan Hospital
Sponsor class: OTHER
First posted: 2022-04-27
Enrollment: 30
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the safety and efficacy of Garlic extracts for improving of cerebral blood flow.


Eligibility criteria: Inclusion Criteria:

1. Healthy adults 19 years of age or older as of the screening date
2. Those with no history of treatment for hypertension within the last 3 months
3. A person who voluntarily decides to participate and agrees in writing to abide by the precautions after hearing and fully understanding the detailed explanation of this study

Exclusion Criteria:

1. Those with systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher
2. Those who have had a stroke, myocardial infarction, percutaneous coronary angioplasty or surgery for coronary angioplasty within the past 6 months
3. Persons with acute and severe cardiovascular diseases such as heart failure, myocardial infarction, and stroke
4. Those with acute/chronic inflammation such as cancer, rheumatic disease, autoimmune disease, gastrointestinal disease, etc.
5. Those who have a history of gastrointestinal diseases (eg Crohn's disease) or gastrointestinal surgery (except simple appendicectomy or hernia surgery) that may affect the absorption of the product for human application testing
6. Persons who have taken prohibited concomitant drugs within the last 3 months
7. Persons with a history of clinically significant hypersensitivity reactions to drugs and health functional foods
8. Those who have received antipsychotic drug treatment within 2 months before the screening test
9. Persons with a history of drug or alcohol abuse
10. Pregnant or lactating women
11. When women of childbearing potential of childbearing potential do not accept the implementation of appropriate contraceptive methods (except for women who have undergone sterilization)
12. Subjects who have participated in health functional food related research or clinical trials within the last 3 months
13. In case the principal investigator judges that it is not appropriate to participate in this study

Primary outcomes:
measure: Change of Cerebral blood flow
timeFrame: Change of Cerebral blood flow before and after 60 minutes garlic extract intake basis in the experimental group
Secondary outcomes:
Other outcomes:
Locations:
city: Gyeongsang
country: Korea, Republic of
facility: Pusan national university Yangsan Hospital
state: Yangsan
Study officials:
References:
Clinical trial NCT00912353: AZD7268 Single Ascending Dose Study in Healthy Japanese Subjects
Official title: A Phase I, Single Center, Randomized, Double-Blind, Placebo-Controlled Single Ascending Oral Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7268 in Healthy Japanese Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Phase I
Japanese healthy volunteer
AZD7268
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-06-03
Enrollment: 56
Sex: ALL
Minimum age (years): 20
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: This is a Phase I, single center, randomized, double-blind, placebo-controlled single ascending oral dose study to assess the safety, tolerability and pharmacokinetics of AZD7268 in healthy Japanese subjects.


Eligibility criteria: Inclusion Criteria:

* Healthy Japanese male and female (of non-child bearing potential) subjects 20 to 45 years of age, inclusive
* Body weight between 50 and 90 kg, inclusive, with a Body Mass Index (BMI)

  * 18 to ≤ 27 kg/m2

Exclusion Criteria:

* Clinically relevant disease or disorder (past or present), which in the opinion of the investigator, may either put the subject at risk because of participation in the study or influence the results or the subject's ability to participate in the study
* Any clinically significant abnormalities in physical examination, vital signs, clinical chemistry, hematology or urinalysis results as judged by the investigator and/or sponsor
* Smoking in excess of 5 cigarettes per day or equivalent within 30 days of Day 1

Primary outcomes:
measure: To asses the safety nature and incidence of adverse events, blood pressure, pulse rate, body temperature, physical examination, laboratory assessments (clinical chemistry, hematology, and urinalysis parameters), effects on ECG parameters, EEG recordings,
timeFrame: From screening period to follow-up, 44 days (maiximum).
Secondary outcomes:
measure: To characterize the pharmacokinetics of AZD7268 and its metabolite(s) in plasma and urine.
timeFrame: Blood and urine sampling from pre-dose until 72 hrs post dose.
measure: To collect and store DNA for future exploratory research
timeFrame: One blood sampling after randomisation
Other outcomes:
Locations:
city: Gelndale
country: United States
facility: Research Site
state: California
Study officials:
affiliation: California Clinical Trials
name: Mark Yen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06971653: Effect of Piezoelectric Surgery on Pain, Comfort, and Patient Satisfaction in Third Molar Surgery
Official title: Piezoelectric Versus Conventional Surgical Approaches in Third Molar Removal: A Focus on Pain, Comfort, and Patient Satisfaction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Complication
Lead sponsor: Ege University
Sponsor class: OTHER
First posted: 2025-05-14
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effects of piezoelectric surgery on postoperative pain, comfort and patient satisfaction with conventional bur method applied in surgical extraction of impacted mandibular third molars.

The main question it aims to answer is:

Is piezoelectric surgery effective on reducing pain and increasing comfort and patient satisfaction in impacted third molar surgery? Pain levels were assessed using the Visual Analog Scale (VAS), and patient satisfaction was measured with functional evaluations conducted on the 1st, 3rd, and 7th postoperative days.


Eligibility criteria: Inclusion Criteria:

* Patients with mesioangular, distoangular, vertical or horizontal, fully impacted and fully bone retained impacted lower wisdom teeth
* Patients without any systemic disease
* Patients who have been informed about the duration, purpose and requirements of the study and who have signed the informed consent form voluntarily.

Exclusion Criteria:

* Patients with any systemic contraindication, infection in the area of the tooth to be extracted, anamnesis of sensitivity to paracetamol derivatives or aspirin, pregnant or breastfeeding patients, and patients using antibiotics or anti-inflammatory drugs in the last 3 weeks
* In addition, smokers or alcohol addicts were not included in the study.

Primary outcomes:
measure: Postoperative pain with Routine and Piezoelectric Surgery
timeFrame: The postoperative outcomes including pain are clinically assessed at different-time intervals (6th and 12th hours after the operation, 1st, 2nd, 3rd and 7th days after the operation).
Secondary outcomes:
measure: Chewing, Swallowing and Speaking Functions with Routine and Piezoelectric Surgery
timeFrame: The postoperative outcomes including chewing, swallowing and speaking are clinically assessed at different-time intervals (1st, 2nd, 3rd, 4th, 5th, 6th and 7th days postoperative days).
Other outcomes:
Locations:
Study officials:
affiliation: Ege University
name: Mert Zeytinoğlu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00709553: Drug Interaction Study to Asses Multiple Doses of ZD4054 (Zibotentan)
Official title: A Randomised, Open-label, Crossover, Phase I Study to Assess the Effect of Multiple Oral Doses of ZD4054 (Zibotentan) on the Pharmacokinetics of a CYP450 3A Probe (Midazolam) in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: ZD4054
Healthy Volunteers
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-07-03
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the study is to to assess the effect of multiple oral doses of ZD4054 (Zibotentan) on the pharmacokinetics of a CYP450 3A Probe (midazolam) in healthy male subjects.


Eligibility criteria: Inclusion Criteria:

* BMI between 18 and 30 kg/m2
* Medical and surgical history and physical examination without any clinically significant findings
* Normal resting ECG with QTcB interval \<450ms

Exclusion Criteria:

* Definite or suspected personal history or family history of hypersensitivity to drugs that are endothelin antagonists; ie, ambrisentan, artrasentan, sitaxsetan and bosentan
* Healthy volunteer has a known hypersensitivity to midazolam or any of the excipients of the midazolam tablet
* Medical diagnosis of migraine with an attack during the 12 months prior to Screening

Primary outcomes:
measure: PK variables
timeFrame: Frequent sampling occasions during study
Secondary outcomes:
measure: Safety variables (adverse events, ECG, blood pressure, pulse, safety lab)
timeFrame: During the whole treatment period
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Research Site
Study officials:
affiliation: AstraZeneca, Medical Science Director
name: Thomas Morris
role: STUDY_DIRECTOR
affiliation: Parexel
name: Dago Mazur
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tomkinson HK, Kemp JV, Wollseifen T, Morris T, Oliver SD. An open-label, randomized, single-center, two-period, phase I, crossover study of the effect of zibotentan (ZD4054) on the pharmacokinetics of midazolam in healthy male volunteers. Clin Ther. 2010 Jul;32(7):1372-86. doi: 10.1016/j.clinthera.2010.07.013.
Clinical trial NCT01320553: Effect of Different Concentrations of SPARC1102 on Allergic Conjunctivitis
Official title: Effect of Different Concentrations of SPARC1102 on Allergic Conjunctivitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Conjunctivitis
Lead sponsor: Sun Pharma Advanced Research Company Limited
Sponsor class: INDUSTRY
First posted: 2011-03-22
Enrollment: 122
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The present study will test if administration of different concentrations of 1334H eyedrops will be effective in treatment of allergic conjunctivitis in people with 10 yrs of age or older.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent form and HIPAA document
* Willing and able to comply with all study procedures
* Be at least 10 years of age at the time of enrollment
* LogMar 0.7 or better, in each eye
* History of ocular allergies, and a positive skin and ocular allergic reaction to allergens
* A negative urine pregnancy test if female of childbearing potential and must use adequate birth control throughout the study period

Exclusion Criteria:

* have known contraindications or sensitivities to the use of any of the study medications(s) or their components;
* have any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters (including but not limited to narrow angle glaucoma, clinically significant blepharitis, follicular conjunctivitis, iritis, pterygium or a diagnosis of dry eye);
* have a current diagnosis or history of open angle glaucoma or ocular hypertension;
* have had ocular surgical intervention within three (3) months prior to Visit 1 or during the study and/or a history of refractive surgery within the past 6 months;
* have a known history of retinal detachment, diabetic retinopathy, or progressive retinal disease;
* have the presence of an active ocular infection (bacterial, viral or fungal), positive history of an ocular herpetic infection, or preauricular lymphadenopathy at any visit;
* manifest signs or symptoms of clinically active allergic conjunctivitis in either eye at screening or during study
* have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device study within 30 days of the study

Primary outcomes:
measure: Ocular Itching
timeFrame: Up to 28 days
Secondary outcomes:
measure: Ciliary Redness Evaluated by the Investigator
timeFrame: Up to 4 weeks
Other outcomes:
Locations:
city: Andover
country: United States
facility: ORA Inc
state: Massachusetts
Study officials:
References: