louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03011047: Efficacy of Endoscopic Transantral Surgical Approach in the Repair of Orbital Blow-Out Fractures
Official title: Efficacy of Endoscopic Transantral Versus Transorbital Surgical Approaches in the Repair of Orbital Blow-Out Fractures-Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Orbital Floor Fracture
Keywords: endoscopic, trans-antral, subciliary
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2017-01-05
Enrollment: 38
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Aim of this study is to assess the efficacy of endoscopic trans-maxillary surgical approach versus traditional trans-orbital surgical approach (control group) in orbital blow out fractures in terms of postoperative clinical and digital radio-graphical assessments.

Detailed description: (N.M) Operator, data entry \& corresponding author; Assistant lecturer , surgery department .

(I.E) Main supervisor, data monitoring \& auditing; Professor, surgery department.

(R.H) Co-supervisor, data entry \& auditing; Lecturer, surgery department . (AM) Assistant lecturer, surgery department .Faculty of Oral \& Dental Medicine Cairo University outcome assessors and data collection.

(YA) Assistant Lecturer of Surgery department , faculty of oral and dental medicine - Cairo University , for baseline data collection, recruitment, sequence generation, allocation concealment, patient retention and taking participants consents.

intervention:

Preoperative preparation:

Preoperative cone beam CT. A clearance from the ophthalmology department after examination of papillary reflexes, motility restriction and measurement of the visual acuity.

Laboratory Investigations: blood picture, liver functions, kidneys functions,coagulation profile Informed consent signed by the patient. (NM and RH) will perform all procedures under general anesthesia . Intervention :Endoscopic trans-maxillary (through the maxillary sinus) surgical approach.

control group: Traditional trans-orbital surgical approaches. follow up clinically and radio-graphically for 6 months.

Eligibility criteria: Inclusion Criteria:

1. Patients with unilateral/bilateral orbital blow out fractures.
2. Positive forced-duction test. ( to ensure the muscular entrapment).

Exclusion Criteria:

1. Medical condition affecting bone healing.
2. Medically compromised conditions, not proper candidate for general anesthesia.
3. Tumor case encroaching on the orbital floor.
4. Pathological orbital blow out fractures.
5. Allergy/ metal hypersensitivity.

Primary outcomes:
measure: Diplopia resolution using Forced duction test positive/negative
timeFrame: 6 months
Secondary outcomes:
measure: Fracture reduction Digital radiography (Cone beam CT)
timeFrame: 6 months
measure: Enophthalmus correction. Digital radiography (Cone beam CT)
timeFrame: 6 months
Other outcomes:
Locations:
Study officials:
affiliation: Cairo University
name: Ahmed elkhadem, PHD
role: STUDY_CHAIR
References:
Clinical trial NCT03475147: Smartphone Flicker Fusion Test for Patients With Optic Disorders.
Official title: Validation of a Smartphone-Based Flicker Fusion Test
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Scotoma
Lead sponsor: University of Iowa
Sponsor class: OTHER
First posted: 2018-03-23
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: The purpose of this project is to validate a quick, easy-to-use and administer smartphone flicker fusion test. The app (called eyeFusion) can potentially be used to easily and quickly collect critical flicker fusion measurements on patients admitted with optic disorders as part of the clinical care process.

Detailed description: The smartphone app developed is a flicker fusion that presents the subject with a series of stimuli consisting of a flickering pattern of bars above or below a static rectangle. For each stimulus presentation, the user has to tap the region that is flickering. The duration of the app is less than 2 minutes.

This study will assess the validity of the test construct in measuring flicker fusion thresholds, and serve as a foundation for further iterative designs of the app and future validation and characterization studies.

Eligibility criteria: Inclusion Criteria:

Control

* Age matched 18-80 years of age.
* Healthy normal controls with no known eye disorders.

Exclusion Criteria:

* Scotoma or any other ocular disorder

Inclusion Criteria - Patients

* Age 18-80
* Clinically associated scotoma

Exclusion Criteria - Patients

-Any other ocular disorder

Primary outcomes:
measure: Assess Validity of the test construct measuring flicker fusion thresholds.
timeFrame: 1/1/2020
Secondary outcomes:
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Randy Kardon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03915847: Evaluation of Cesarean Scar After Three Different Uterine Closure Technis
Official title: Evaluation of Cesarean Scar After Three Different Uterine Closure Technis: A Randomised Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cesarean Section, Repeated
Cesarean, Uterine Scar Thickness
Cesarean, Residual Myometrial Thickness
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2019-04-16
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study compares three techniques of uterine closure on myometrium thickness at the site of uterine scar of women who underwent repeated cesarean section. Cesarean scar will be evaluated by transvaginal ultrasound six months after cesarean.


Eligibility criteria: Inclusion Criteria:

* Previous two or three cesarean
* Gestational weeks \>=36 weeks

Exclusion Criteria:

* Risk of obstetric haemorrhage
* Suspicion or diagnosis placenta previa or accrete syndrome
* Chorioamnionitis
* Uterine myoma in the anterior uterine segment
* Hysterotomy other than lower segment uterine incision at previous cesarean

Primary outcomes:
measure: Residual myometrial thickness
timeFrame: 6 months after cesarean
Secondary outcomes:
measure: Existence of cesarean scar defect
timeFrame: 6 months after cesarean
measure: Width of defect
timeFrame: 6 months after cesarean
measure: Depth of defect (niche)
timeFrame: 6 months after cesarean
measure: Operation time
timeFrame: 10 minute after cesarean completed
measure: Change in hemoglobin
timeFrame: 48 hours after cesarean
measure: Blood product transfusion
timeFrame: One week after cesarean
measure: Maternal infectious morbidity
timeFrame: Six weeks after cesarean
measure: Length of hospitalization
timeFrame: One month after cesarean
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University Hospital
Study officials:
References:
Clinical trial NCT04678947: The BARF Project: A Pilot Study Using the BARF Scale to Assess CINV in Children
Official title: The BARF Project: A Pilot Study Using the BARF Scale to Assess CINV in Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Nausea
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2020-12-22
Enrollment: 6
Sex: ALL
Minimum age (years): 4
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: In this pilot study, the Baxter Retching Faces (BARF) Scale will be used to assess chemotherapy induced nausea and vomiting (CINV) in the pediatric cancer population during chemotherapy admissions, and the corresponding administration of anti-emetic medications will be reviewed.


Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with cancer of any kind.
* Patients receiving inpatient chemotherapy at SLCH on the general pediatric oncology service
* Patients admitted for a course of inpatient chemotherapy scheduled to last at least 24 hours and but no more than 7 days.
* Patients who have received any prior cancer treatment, including radiation therapy, and/or surgery.
* Patients ages 4 to 12 years of age.
* Patient with a guardian who has the ability to understand English and the willingness to sign an IRB approved written informed consent document.

Exclusion Criteria:

* Any patient who is not undergoing inpatient chemotherapy on the general pediatric oncology service, including patients undergoing chemotherapy as conditioning for hematopoietic stem cell transplantation or other cellular therapy.
* Any patient who is receiving their first cycle of inpatient chemotherapy (however, they can be included during a future cycle).
* Any patient who is blind or unable to communicate by speaking or pointing.

Primary outcomes:
measure: Doses of anti-emetic medication administered during inpatient chemotherapy admissions
timeFrame: 24 hours - 7 days (estimated)
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Amy Armstrong, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02193477: Effect of TEAS on the Incidence Rate of SIRS in Patients Undergoing Abdominal Surgery
Official title: Effect of Transcutaneous Electrical Acupoint Stimulation (TEAS)on the Incidence Rate of Systemic Inflammatory Response Syndrome (SIRS) in Patients Undergoing Radical Surgery for Gastric Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Systemic Inflammatory Response Syndrome
Inflammation
Lead sponsor: Air Force Military Medical University, China
Sponsor class: OTHER
First posted: 2014-07-17
Enrollment: 105
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to access the effect of Transcutaneous Electrical Acupoint Stimulation(TEAS) on the Incidence rate of Systemic Inflammatory Response Syndrome (SIRS) in patients undergoing radical surgery for gastric cancer

Detailed description: Patients undergoing elective radical surgery for gastric cancer under general anesthesia were randomly assigned to three groups, control group , TEAS group and sham TEAS group.

TEAS group receiving TEAS before general anesthesia induction , 1th day and 2nd day after surgery. TEAS was given through electrodes attached to specific acupoints. The time for TEAS was 30min.

Sham TEAS group receiving sham TEAS before general anesthesia induction , 1th day and 2nd day after surgery. Sham TEAS was given through electrodes attached to non-acupoints. The time for sham TEAS was also 30min.

Control group were given no TEAS. Incidence rates of SIRS in each group were compared .Venous blood samples from all groups(control group , TEAS group and sham TEAS group) were collected before general anesthesia induction,1th day and 3rd day after surgery. Inflammatory cytokines index including interleukin-6,interleukin-10,Tumor Necrosis Factor- alpha(TNF-α),Interferon-γ(IFN-γ),Monocyte Chemotactic Protein 1(MCP-1),IgG,IgM were measured.

Eligibility criteria: Inclusion Criteria:

* Age\>30yrs,\<75yrs
* ASA 1-2
* Scheduled for radical surgery for gastric cancer under general anesthesia；
* Informed consented

Exclusion Criteria:

* Patients with implanted pacemakers
* Patients with severe hypertension or cardiac dysfunction；
* Patients with severe pulmonary disease
* Patients with hemoglobin\<90g/L

Primary outcomes:
measure: Incidence rate of SIRS
timeFrame: 1st day after surgery
Secondary outcomes:
measure: Change of Inflammatory cytokines
timeFrame: 30 minutes before general anesthesia induction and 1st and 3rd day after the surgery
measure: Incidence rate of SIRS
timeFrame: 3rd day after surgery
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Fourth Military Medical University
state: Shanxi
Study officials:
affiliation: Air Force Military Medical University, China
name: Qiang Wang, MD
role: STUDY_CHAIR
References:
Clinical trial NCT00725777: Treatment of Non-falciparum Malaria
Official title: Efficacy and Safety of Artemether Lumefantrine Combination Therapy for the Treatment of Malaria Due to Plasmodium Ovale, Plasmodium Malariae, and Mixed Plasmodium Infections in Gabon
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Non-falciparum Malaria
Lead sponsor: Albert Schweitzer Hospital
Sponsor class: OTHER
First posted: 2008-07-30
Enrollment: 40
Sex: ALL
Minimum age (years): 6
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients with non-falciparum infection will be given artemether-lumefantrine for three days and will be followed up for 28 days. Besides efficacy and safety evaluations a substudy on immunology will be performed.


Eligibility criteria: Inclusion Criteria:

* Male or female patients between the age of 6 months and 60 years and with a minimum of 5kg bodyweight
* Presence of uncomplicated malaria confirmed by: i)fever or history of fever in the previous 4 days, and ii)positive microscopy of P. malariae or P. ovale or mixed infection with P.falciparum with parasite density \> 50-200000/μl of blood
* Written informed consent

Exclusion Criteria:

* Patients with presence of other clinical conditions requiring hospitalization
* Presence of other febrile conditions
* Presence of significant anemia, defined by hemoglobin \< 7g/dl
* Known history of hypersensitivity,allergic or adverse reactions to artemether or lumefantrine
* Intake of any antimalarial or antibiotics with known antimalarial activity in the preceding 2 weeks
* Pregnant and breast feeding females

Primary outcomes:
measure: Parasitological cure rate on day 28
timeFrame: D28
Secondary outcomes:
measure: Frequency and severity of drug related adverse events
timeFrame: D28
Other outcomes:
Locations:
city: Lambaréné
country: Gabon
facility: Medical Research Unit of the Albert Schweitzer Hospital
state: Moyen Ogooue
Study officials:
affiliation: Medical Research Unit of the Albert Schweitzer Hospital in Lambaréné
name: Sabine Bélard, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mombo-Ngoma G, Kleine C, Basra A, Wurbel H, Diop DA, Capan M, Adegnika AA, Kurth F, Mordmuller B, Joanny F, Kremsner PG, Ramharter M, Belard S. Prospective evaluation of artemether-lumefantrine for the treatment of non-falciparum and mixed-species malaria in Gabon. Malar J. 2012 Jul 10;11:120. doi: 10.1186/1475-2875-11-120.
Clinical trial NCT06072677: Adolescent Mood During Puberty and Testosterone
Official title: Probing the Neurophysiological Mechanisms Underlying Sex-specific Testosterone-mood Relationships During Puberty: A Randomized Controlled Trial Using a Smartphone-based Training Program
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Adolescent Depression
Keywords: Puberty
Depression
Mood disturbance
Adolescence
Stress
Peripubertal Transition
Hormones
EEG
Sex differences
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: Foundation of Hope, North Carolina
First posted: 2023-10-10
Enrollment: 60
Sex: ALL
Minimum age (years): 11
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: Starting at puberty, female adolescents are nearly three-times more likely to develop internalizing disorders, like depression, while male adolescents are two-times more likely to develop externalizing disorders, like attention deficit hyperactivity disorder (ADHD). This divergence between the sexes during puberty suggests sex-specific pathways of risk and differential effects of sex hormones. The purpose of this research is to determine: 1) sex-specific neural and endocrine features of the pubertal transition that may mediate sex differences in adolescent mood disorders, and 2) the neurophysiological basis of susceptibility to hormone change during puberty.


Eligibility criteria: Inclusion Criteria:

* Between the ages of 11 and 14
* Have their own personal mobile device and capability to download the MyCap and Healthy Minds apps
* Experienced a stressful life event within the last year, or endorse moderate depression (defined by a CES-DC score 16 or higher)

Exclusion Criteria:

* Previous experience with the Healthy Minds Program
* Regular meditation practice
* Current or history of manic episodes, psychotic symptoms, or current suicidal intent
* Taking any form of exogenous hormones or intrauterine device (IUD) within one month of participation in the study
* Taking medications that directly alter cardiovascular or neurological function

Primary outcomes:
measure: CES-DC Score Over Time
timeFrame: up to Week 8
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Carolina Crossing B, Suite 1
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Elizabeth Andersen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03645577: Phrenic Nerve Injury During Pulmonary Vein Isolation With the Second-generation Cryoballoon.
Official title: Phrenic Nerve Injury During Pulmonary Vein Isolation With the Second-generation Cryoballoon: Clinical, Procedural, and Anatomical Characteristics
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Phrenic Nerve Palsy
Keywords: Pulmonary vein isolation
Phrenic nerve palsy
Paroxysmal atrial fibrillation
Persistent atrial fibrillation
Lead sponsor: University of Luebeck
Sponsor class: OTHER
Collaborators: name: Principal Investigator: Roland Richard Tilz, MD
First posted: 2018-08-24
Enrollment: 731
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients who underwent a PVI by the second generation Cryoballoon.

Brief summary: To determine the most frequent complication associated with cryoballoon PVI. The main hypothesis is to explore the incidence of phrenic nerve palsy.


Eligibility criteria: Inclusion Criteria:

* age 18 years or older
* Cryoballoon PVI
* Periprocedural phrenic lesion

Exclusion Criteria:

- Non

Primary outcomes:
measure: Incidence of phrenic nerve palsy
timeFrame: 06/2012 until 04/2018
Secondary outcomes:
measure: Predictors of phrenic nerve palsy
timeFrame: 06/2012 until 04/2018
measure: Clinical course of phrenic nerve palsy
timeFrame: 06/2012 until 04/2018
Other outcomes:
Locations:
city: Luebeck
country: Germany
facility: University Heart Center Luebeck, Electrophysiology
Study officials:
References:
citation: Heeger CH, Sohns C, Pott A, Metzner A, Inaba O, Straube F, Kuniss M, Aryana A, Miyazaki S, Cay S, Ehrlich JR, El-Battrawy I, Martinek M, Saguner AM, Tscholl V, Yalin K, Lyan E, Su W, Papiashvili G, Botros MSN, Gasperetti A, Proietti R, Wissner E, Scherr D, Kamioka M, Makimoto H, Urushida T, Aksu T, Chun JKR, Aytemir K, Jedrzejczyk-Patej E, Kuck KH, Dahme T, Steven D, Sommer P, Richard Tilz R. Phrenic Nerve Injury During Cryoballoon-Based Pulmonary Vein Isolation: Results of the Worldwide YETI Registry. Circ Arrhythm Electrophysiol. 2022 Jan;15(1):e010516. doi: 10.1161/CIRCEP.121.010516. Epub 2021 Dec 28.
Clinical trial NCT02479477: Impact of Labour Kinesiotherapy in the Quality Life of Auxiliary Nursing in the Surgery Center
Official title: Impact of Labour Kinesiotherapy in the Quality Life of Auxiliary Nursing in the Surgery Center
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Quality of Life
Pain
Keywords: Public Health
Nursing Staff, Hospital
Lead sponsor: Faculdade de Ciências Médicas da Santa Casa de São Paulo
Sponsor class: OTHER
First posted: 2015-06-24
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The quality of life and daily activities can be affected by muscleskeletal pain and one of the forms of assessment is through the SF-36 questionnaire. The investigators know that the working kinesitherapy is a way to improve the quality of life.

Detailed description: The activities in the work routine can cause pain and negatively affect quality of life. There is the hypothesis that gymnastics may be used for pain and injuries relating to repetitive movement at work. Objective the study is assess the impact of labor kinesiotherapy in the quality of life of the operating room nursing assistants.

Eligibility criteria: Inclusion Criteria:

* professional nursing assistants allocated in the surgical center at least one year
* both genders
* who agreed to participate in the study by signing the informed consent

Exclusion Criteria:

* persons submitted on any surgery in the last six months
* with illness or muscle-skeletal disabilities
* or who couldn't attend all sessions for vacations or scale

Primary outcomes:
measure: change in questionnaire score after the intervention (minimum 0, maximum 100)
timeFrame: two months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03782077: Change of Optic Nerve Sheath Diameter After Deflation of Pneumatic Tourniquet
Official title: Effect of Deflation of Pneumatic Tourniquet on the Change of Optic Nerve Sheath Diameter in Patients Undergoing Knee Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intracranial Pressure Increase
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergoing knee surgery using pneumatic tourniquet

Brief summary: The purpose of this study is to evaluate the change of the optic nerve sheath diameter after deflation of pneumatic tourniquet.

Detailed description: Deflation of pneumatic tourniquet could induces many changes in various organ systems. It has been shown to affect intracranial pressure. Thus, the investigators evaluate the change of optic nerve sheath diameter using ultrasound after deflation of pneumatic tourniquet in patients undergoing knee surgery.

Eligibility criteria: Inclusion Criteria:

* ASA physical status 1-4
* patients undergoing knee surgery using pneumatic tourniquet

Exclusion Criteria:

* patients who refuse to participate in this study
* patients with history of cerebrovascular disease
* patients who are judged ineligible by the medical staff to participate in the study for other reasons

Primary outcomes:
measure: change of optic nerve sheath diameter
timeFrame: 5 minutes before deflation and at 5-minute intervals for 10 minutes after deflation
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
Study officials:
affiliation: Asan Medical Center
name: Won Uk Koh, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim HJ, Kim YJ, Kim J, Kim H, Ro YJ, Koh WU. Change in the optic nerve sheath diameter after deflation of a pneumatic tourniquet: a prospective observational study. Sci Rep. 2022 Jan 11;12(1):521. doi: 10.1038/s41598-021-04457-4.