louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05800639: Frontal Alpha Asymmetry and Pediatric Emergence Delirium
Official title: Mediation Role of Perioperative Electroencephalogram Frontal Alpha Asymmetry to Pediatric Emergence Delirium
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Emergence Delirium
Lead sponsor: Gangnam Severance Hospital
Sponsor class: OTHER
First posted: 2023-04-05
Enrollment: 80
Sex: ALL
Minimum age (years): 2
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Children aged 2-8 year with an American Society of Anesthesiologists (ASA) physical status of I-II who are undergoing elective ophthalmological requiring general anesthesia in Gangnam Severance Hospital will be eligible.

Brief summary: This study aimed to investigate whether the association between the preoperative anxiety level and emergence delirium involves EEG frontal alpha asymmetry in pediatric patients undergoing ophthalmic surgery under general anesthesia. The investigators hypothesized that EEG frontal alpha asymmetry contributes a significant portion of the preoperative anxiety - emergence delirium association in pediatric patients. Mediation analysis will be performed to estimate the relationships between preoperative anxiety of children (modified Yale Preoperative Anxiety Scale (mYPAS)), EEG frontal alpha asymmetry, and emergence delirium (Pediatric Assessment of Emergence Delirium (PAED) scale).


Eligibility criteria: Inclusion Criteria:

* Children aged 2-8 year
* Children with an American Society of Anesthesiologists (ASA) physical status of I-II
* Children who are scheduled to undergo elective ophthalmological requiring general anesthesia

Exclusion Criteria:

* Emergency surgery
* Patients with developmental delays
* Patients with neurological or psychiatric diseases associated with symptoms of agitation, anxiety, attention deficit, sleep disturbances
* Patients with autism
* Patients with a recent history (within one month) of receiving general anesthesia
* Patients with congenital or genetic diseases that may influence brain development

Primary outcomes:
measure: The peak PAED score
timeFrame: After the completion of surgery, during the PACU stay. PAED score will be measured every 10 minutes during the PACU stay.
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Gangnam Severance Hospital
Study officials:
affiliation: Gangnam Severance Hospital
name: Young Song
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00807339: CyberKnife for Unresectable Renal Tumors
Official title: CyberKnife Stereotactic Radiation for Unresectable Renal Tumors/PhaseI Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Cancer
Keywords: CyberKnife
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
First posted: 2008-12-11
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a dose escalation study using the CyberKnife radiotherapy device for small surgical or medically untreatable renal tumors. Patients with renal tumors 5cms or less in diameter will be accrued onto this study. The ability of CyberKnife to ablate these renal tumors and maintain renal function with dose escalation will be assessed.

Detailed description: The CyberKnife Robotic Radiosurgery System is a unique radiosurgical system capable of treating tumors anywhere in the body noninvasively and with sub-millimeter accuracy. The CyberKnife System delivers radiation using a precise targeting methodology allowing a focal treatment margin around the target, thus limiting the volume of adjacent tissue receiving high doses radiation. This in turn allows the delivery of high doses of radiation to the prostate over a short series of treatments.

Eligibility criteria: Inclusion Criteria:

* Tumor size 5 cm or less
* Radiographic evidence of malignancy or Histologically verified primary renal malignancy.
* If the kidney biopsy is inconclusive but the radiologist determines that the tumor based on the CT/MRI is highly suspicious for cancer, you may participate
* Patients with highly suspicious lesions on CT or MRI
* One -three gold fiducials placed in or around tumor
* Contradiction or patient refusal to partial or complete nephrectomy
* Age 18 or greater
* KPS score 70 or greater

Exclusion Criteria:

* Irreversible coagulopathies that preclude fiducial placement

Primary outcomes:
measure: To determine the maximum tolerated dose of CyberKnife radiation
timeFrame: 2 years
Secondary outcomes:
measure: To evaluate local control, overall survival and late toxicity including preservation of renal function
timeFrame: 2 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
References:
Clinical trial NCT02522039: Pupillary Response After Glaucoma Medication
Official title: Effect of Topical Anti-glaucoma Medications on Late Pupillary Light Reflex, as Evaluated by Pupillometry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Effect (Glaucoma Drugs)
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2015-08-13
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Investigation of the effect on the pupillary constriction by latanoprost, dorzolamide,timolol in healthy subjects. The pupillary constriction is compared to no drug.


Eligibility criteria: Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* ophthalmological diseases
* systemic disease
* smoking
* refractive error \>= 6 diopters

Primary outcomes:
measure: pupillary constriction measured as the post-illimination pupillay response (PIPR)
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Glostrup University Hospital
Study officials:
affiliation: Head of the project
name: Henrik Lund-Andersen, Professor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05057039: The Study of Gut Microbiota in Hypertensive Patients
Official title: The Study of Gut Microbiota in Hypertensive Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Hypertension
Gut Microbiota
Diet
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
Collaborators: name: Cathay General Hospital
First posted: 2021-09-27
Enrollment: 70
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: People who join the Elderly Health Examination Program in Cathay General Hospital in 2021

Brief summary: Recent animal and human studies have found the relationship between the composition of the gut microbiota and hypertension, but some studies did not have a detailed evaluation of the diet content, which could be an important effect on gut microbiota. Moreover, most of these studies were finished in Western countries, in which the dietary patterns were significantly different from those in Chinese regions. This study intends to establish Taiwanese local data to explore the differences in the composition of gut microbiota among hypertensive patients and normotensive subjects.

Detailed description: The investigators plan to enroll total 70 hypertensive and normotensive cases from the elderly health examination in Cathay General Hospital, who are aged from 65 to 80 years. Body mass index and blood samples for biochemical analysis such as blood sugar and cholesterol levels are taken, and fecal samples are collected for analysis of gut microbiota, which is characterized by 16S ribosomal RNA gene sequencing. Besides, the diet and nutrients intake are recorded and calculated by licensed dietitian. Through the exploration of gut microbiota in hypertensive patients, the results can be the reference for clinical treatment.

Eligibility criteria: Inclusion Criteria:

1. Age 65\~80 years old
2. People who join the Elderly Health Examination Program in Cathay General Hospital in 2021

Exclusion Criteria:

1. Antibiotics use within one month
2. Acute gastrointestinal illness within one week, such as vomiting and diarrhea
3. History of gastrointestinal surgery
4. History of inflammatory bowel disease
5. Chronic gastrointestinal disease under medication treatment
6. Cannot finish dietary record

Primary outcomes:
measure: The difference of gut microbiota composition between the two groups
timeFrame: immediately after the enrollment completes
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Taipei Medical University
Study officials:
References:
Clinical trial NCT00305539: HECTHOR: Humira to Spare Steroids in Giant Cell Arteritis
Official title: HECTHOR: A Pilot Multicenter Double-blind Randomised Study of 3 Months Treatment With Humira Added to Steroids in Giant Cell Arteritis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Giant Cell Arteritis
Keywords: Giant Cell Arteritis
Placebo
Anti-TNF
Multicenter-randomized-trial
Proved GCA according to ACR criteria (HUNDER et al 1990)
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
Collaborators: name: Abbott
First posted: 2006-03-22
Enrollment: 69
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: In giant cell arteritis (GCA), a short initial treatment with anti-TNF may allow a faster decrease of steroids dosage and therefore avoid some of the adverse events of steroids.

Detailed description: The protocol consists of a SC injection of adalimumab or placebo every 2 weeks for 10 weeks added to steroids

Eligibility criteria: Inclusion Criteria:

* Age ≥ 50 years
* ACR criteria for Giant cell arteritis (HUNDER 1990)
* Positive Temporal artery biopsy
* Plus standard inclusion criteria for Humira protocols

Exclusion Criteria:

* Prednisone treatment for a different disease at a dose \>15 mg/day
* Corticoid treatment for GCA more than 10 days
* GCA treatment with prednisone \> 1 mg/kg whatever period of time
* GCA treatment with an anti-TNF, MTX, cyclosporine, cyclophosphamide, dapsone or steroid bolus
* Recent, permanent or transient visual loss due to GCA and the presence of any specific visual abnormality (diplopia, hallucination)
* Plus standard exclusion criteria for Humira protocols

Primary outcomes:
measure: To determine the influence of an initial treatment of 3 months with adalimumab, 40 mg every other week, in the percentage of patients achieving at 6 months (week 26), a decrease in their corticosteroid treatment to a dose equal or lower than 0,1 mg/kg
timeFrame: 1 year
Secondary outcomes:
measure: To determine the influence of an initial treatment of 3 months with adalimumab on the total dose of corticosteroids determined by AUC (area under the curve)
timeFrame: 1 year
measure: To determine the influence of an initial treatment of 3 months with adalimumab on the percentage of patients relapsing at one year
timeFrame: 1 year
Other outcomes:
Locations:
city: Kremlin Bicêtre
country: France
facility: Hôpital Bicêtre
Study officials:
affiliation: Hôpital Bicêtre, APHP, France
name: Xavier Mariette, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Seror R, Baron G, Hachulla E, Debandt M, Larroche C, Puechal X, Maurier F, de Wazieres B, Quemeneur T, Ravaud P, Mariette X. Adalimumab for steroid sparing in patients with giant-cell arteritis: results of a multicentre randomised controlled trial. Ann Rheum Dis. 2014 Dec;73(12):2074-81. doi: 10.1136/annrheumdis-2013-203586. Epub 2013 Jul 29.
Clinical trial NCT05877339: The Effect of Exercise on Fatigue in White-collar Workers
Official title: The Effect of Exercise on Fatigue in White-collar Workers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Exercise
Fatigue
Lead sponsor: Sisli Hamidiye Etfal Training and Research Hospital
Sponsor class: OTHER
First posted: 2023-05-26
Enrollment: 307
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 20-75 years old white-collar worker

Brief summary: A survey will be conducted on the Internet for desk workers. The questionnaire; International Physical Activity Questionnaire will be filled out to evaluate the exercise level of the participants, the visual analog scale to question the general pain levels, and the fatigue severity questionnaire to investigate the fatigue levels. The patients will also be divided into the presence of osteoarthritis, the presence of fibromyalgia, and healthy group, and an evaluation will be made between the groups.

Detailed description: A survey will be conducted on the Internet for desk workers. The questionnaire; International Physical Activity Questionnaire will be filled out to evaluate the exercise level of the participants, the visual analog scale to question the general pain levels, and the fatigue severity questionnaire to investigate the fatigue levels. The patients will also be divided into the presence of osteoarthritis, the presence of fibromyalgia, and healthy group, and an evaluation will be made between the groups.

Eligibility criteria: Inclusion Criteria:

* 20-75 years old
* white-collar worker
* agree to participate in the study

Exclusion Criteria:

* history of musculoskeletal surgery
* the presence of illness that will prevent him/her from exercising

Primary outcomes:
measure: Survey
timeFrame: through study completion, an average of 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: University of Health Sciences, Şişli Hamidiye Etfal Training and Research Hospital
Study officials:
References:
Clinical trial NCT02245139: Surveillance Study of Acute Gastroenteritis in Hospitalized Children
Official title: Surveillance Study of Acute Gastroenteritis Etiologies in Hospitalized Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Gastroenteritis
Diarrhea
Dehydration
Keywords: diarrhea
vomiting
fever
abdominal pain
oliguria
Lead sponsor: Shaikh Ragheb Harb Hospital
Sponsor class: OTHER
First posted: 2014-09-19
Enrollment: 198
Sex: ALL
Minimum age (years): 1
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: male and female patient from 1 month to 13 YO admitted to pediatric floor with acute gastroenteritis

Brief summary: Acute gastroenteritis is a common cause of hospital admission and health office visits and have a huge burden on the economy of developing countries. The investigators proposed this observational prospective study during summer period in a community and tertiary care hospital in a rural area of Lebanon to investigate the etiologies and age distribution of admitted cases to general pediatric floor from the age of 1 month up to the age of 14 years.


Eligibility criteria: Inclusion Criteria:

* acute gastroenteritis

Exclusion Criteria:

* immunodeficiency
* malnutrition

Primary outcomes:
measure: etiologies
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01504139: The Luteal Phase After GnRHa Trigger - a Proof of Concept Study
Official title: The Luteal Phase After GnRHa Trigger - a Proof of Concept Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Progesterone Levels
Infertility
Lead sponsor: Regionshospitalet Viborg, Skive
Sponsor class: OTHER
First posted: 2012-01-05
Enrollment: 93
Sex: FEMALE
Minimum age (years): 25
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 investigate levels of progesterone in the luteal phase after various stimulations in the follicular phase and treatment with GnRH antagonist protocol followed by GnRHagonist as induction of ovulation.

Detailed description: The purpose of this study is to investigate levels of progesterone in the luteal phase after various stimulations in the follicular phase and treatment with GnRH antagonist protocol followed by GnRHagonist as induction of ovulation. Furthermore the aim is to explore whether the luteal phase can be supported with small daily boluses of hCG without the administration of exogenous P, while maintaining good reproductive outcome.

Eligibility criteria: Inclusion Criteria:

* women from the age of 25 up to 40
* Serum-FSH and serum-LH levels under 12 IU/L
* Length of period between 25 and 34 days
* BMI between 18 and 30

Exclusion Criteria:

* less than 2 ovaries
* uterine abnormalities
* PCOS or UL-PCO (more than 11 follicles over 12 mm in 1 ovary

Primary outcomes:
measure: Levels of progesterone in the mid-luteal phase.
timeFrame: up to 1-1½years.
Secondary outcomes:
Other outcomes:
Locations:
city: Skive
country: Denmark
facility: the Fertility clinic, Regional Hospital Skive
state: Central Jutland
Study officials:
affiliation: The Fertility Clinic, Skive Regional Hospital, Denmark
name: Helle Olesen Elbaek
role: STUDY_DIRECTOR
References:
citation: Andersen CY, Elbaek HO, Alsbjerg B, Laursen RJ, Povlsen BB, Thomsen L, Humaidan P. Daily low-dose hCG stimulation during the luteal phase combined with GnRHa triggered IVF cycles without exogenous progesterone: a proof of concept trial. Hum Reprod. 2015 Oct;30(10):2387-95. doi: 10.1093/humrep/dev184. Epub 2015 Jul 23.
Clinical trial NCT03136939: Study of IGRP-specific T Cell in Peripheral Blood of Type 1 Diabetes Mellitus
Official title: Study of IGRP-specific T Cell in Peripheral Blood of Type 1 Diabetes Mellitus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes Mellitus
Lead sponsor: First Affiliated Hospital of Zhejiang University
Sponsor class: OTHER
First posted: 2017-05-02
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patients of diabetes and healthy controls

Brief summary: 10 type 1 diabetes, 10 type 2 diabetes and 10 healthy controls matched with age and sex were enrolled in our study and their periphera blood mononuclear cells (PBMC) were isolated. We implemented ELISPOT(Enzyme-linked Immunospot Assay) to detect the interferon-γ (IFN-γ）which secreted by IGRP-specific T cell. Results were compared between these groups.


Eligibility criteria: Inclusion Criteria:

* the criteria of type 1 and type 2 diabetes

Exclusion Criteria:

* no diabetes

Primary outcomes:
measure: the rate of positive reactivation against the IGRP epitopes
timeFrame: 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Department of Endocrinology, the First Affiliated Hospital to Zhejiang University School of Medicine
state: Zhejiang
Study officials:
References:
Clinical trial NCT06267339: Effects of Transcranial Random Noise Stimulation on Motor Learning in Typically Developing Adolescents
Official title: Effects of Transcranial Random Noise Stimulation on Motor Learning in Typically Developing Adolescents
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Children
Keywords: typically developing children
motor learning
controls
grasp
reach
Lead sponsor: Burke Medical Research Institute
Sponsor class: OTHER
First posted: 2024-02-20
Enrollment: 40
Sex: ALL
Minimum age (years): 10
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The goal of this study is to compare motor learning rates on two different tasks, when combined with non-invasive brain stimulation.

Detailed description: We will apply transcranial random noise stimulation or sham stimulation. During tRNS, participants will complete a grasping task or a reaching task. Each participant will complete both tasks, with a wait period between each task. Task order will be randomized, such that half the group will begin with each task. We will compare task scored before vs. after tRNS, for each task. This will be a measure of motor learning.

Eligibility criteria: Inclusion Criteria:

* Age 10-17 years
* Ability to follow two-step instructions
* Provides informed consent

Exclusion Criteria:

* Presence of illness, disease

Primary outcomes:
measure: Change in Grasp score
timeFrame: Immediately before vs. Immediately after brain stimulation
measure: Change in Reach score
timeFrame: Immediately before vs. Immediately after brain stimulation
Secondary outcomes:
measure: Change in Graded Redefined Assessment of Strength, Prehension assessment (GRASSP)
timeFrame: Immediately before vs. Immediately after brain stimulation
measure: Change in score on second reaching task
timeFrame: Immediately before vs. Immediately after brain stimulation
Other outcomes:
Locations:
city: White Plains
country: United States
facility: Burke Neurological Institute
state: New York
Study officials:
affiliation: Burke Neurological Institute
name: Kathleen Friel, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00656539: Safety and Efficacy Pilot Study of AzaSite® for Four Weeks in Subjects With Blepharitis
Official title: A Single-Center, Open-Label, Randomized Pilot Study of the Safety and Efficacy of AzaSite® Ophthalmic Solution, 1% in Combination With Mechanical Therapy Versus Mechanical Therapy Alone for Four Weeks in Subjects With Posterior Blepharitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Blepharitis
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2008-04-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and efficacy of AzaSite® ophthalmic solution, 1% on signs and symptoms of blepharitis.


Eligibility criteria: Inclusion Criteria:

* diagnosis of moderate to severe chronic posterior blepharitis
* If female of childbearing potential, are non-pregnant and non-lactating

Exclusion Criteria:

* had ocular surface surgery (LASIK, refractive, pterygium) within the past year
* unwilling to discontinue use of contact lenses during the study
* have glaucoma
* unable or unwilling to withhold the use of eyelid scrubs during the study
* have a serious systemic disease or uncontrolled medical condition that in the judgment of the investigator could confound study assessments or limit compliance
* currently using any preserved topical ocular medications (with the exception of unpreserved tear substitutes) at the time of entry into the study or during study participation

Primary outcomes:
measure: Change in clinical signs and symptoms associated with blepharitis
timeFrame: 4 weeks
Secondary outcomes:
measure: Standard ocular safety assessments
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Lynbrook
country: United States
facility: Ophthalmic Consultants of Long Island
state: New York
Study officials:
affiliation: Medical Monitor
name: Reza Haque, MD
role: STUDY_DIRECTOR
References: