louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01560962: Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis
Official title: Efficacy of Over the Counter (OTC) Povidone-Ioldine 5% for Treatment of Acute or Chronic Blepharitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Blepharitis
Lead sponsor: Southern California Institute for Research and Education
Sponsor class: OTHER
First posted: 2012-03-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective: To determine the preliminary outcome of external over the counter (OTC) povidone iodine (PI) application in the management of chronic and acute blepharitis vs. currently clinically accepted medical regimen, i.e. eyelid hygiene, antibiotic drops, or antibiotic/steroid ointments.

Methodology: One hundred adult patients with chronic and acute blepharitis will be enrolled and randomized into four groups.

In group one, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI twice daily for 10 days and the other eye with no intervention.

In group two, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive warm soaked eyelid wash.

In group three, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive 1 drop of azithromycin ophthalmic solution twice daily for 10 days.

In group four, 25 patients will be instructed to scrub the lid margin of one eye with 5% PI and the other eye will receive tobradex ointment applied to the lid margin.

Subjective variables assessed included itchiness, foreign body sensation and eyelid edema (grade 0-4). Objective variables assessed included lid margin redness, meibomian gland plugging and presence/absence of collarets (grade 0-4). Cultures of lid margin at the initiation and at the cessation of treatment were obtained.

Detailed description: Final statiscial analysis for subjective and objective numerical values following treatment for each group of subjects (group 2,3,4) should show equal or almost equal efficacy in treatment of blepharitis.

Eligibility criteria: Inclusion Criteria:

* All potential subjects with symptomatic blepharitis examined to have blepharitis with healthy mental status, able to give consent, with/without co-existing medical consitions will be considered.

Exclusion Criteria:

* All subjects with history and/or probable history of allergic reaction to povidine-iodine, azithromycin, \& tobramycin/dexamethasone and all subjects who have mental disability and are unable to give direct consent will be excluded

Primary outcomes:
measure: meibomian gland plugging
timeFrame: 01/12 to 01/13
Secondary outcomes:
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Veterans Affairs Long Beach Healthcare System
state: California
Study officials:
References:
Clinical trial NCT02559362: Study on Breast Cancer Patient Perspectives of Exercise
Official title: Study on Breast Cancer Patient Perspectives of Exercise
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Abramson Cancer Center at Penn Medicine
Sponsor class: OTHER
First posted: 2015-09-24
Enrollment: 26
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast cancer subjects

Brief summary: The goal of the study is to establish the feasibility/willingness of breast cancer patients to delay surgery to do an exercise program, or be randomized to an exercise training program following treatment, and to see if that willingness correlates with prior physical activity history.


Eligibility criteria: Inclusion Criteria:

* women,
* breast cancer diagnosis,
* all races will be included.

Exclusion Criteria:

* men,
* those with no breast cancer (ductal carcinoma in situ),
* pregnant women,
* children

Primary outcomes:
measure: Number of subjects providing completed surveys
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Abramson Cancer Center of the University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: Abramson Cancer Center at Penn Medicine
name: Kathryn Schmitz, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05143762: Preemptive Dexamethasone , Paracetamol on Postoperative Period Following Adeno-tonsillectomy in Pediatric .
Official title: Effect of Preemptive Dexamethasone and Paracetamol on Postoperative Period Following Adeno-tosillectomy in Pediatric Age Group-: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Analgesia
Keywords: analgesia
dexamethasone
paracetamol
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2021-12-03
Enrollment: 90
Sex: ALL
Minimum age (years): 3
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tonsillectomy is one of the most common surgical operations performed on children, and it is frequently linked with an increased risk of complications such as acute discomfort when swallowing and postoperative nausea and vomiting (PONV).The most prevalent causes for postponing discharge home are poorly managed pain and PONV.

Detailed description: Tonsillectomy is one of the most common surgical operations performed on children, and it is frequently linked with an increased risk of complications such as acute discomfort when swallowing and postoperative nausea and vomiting (PONV). The most prevalent causes for postponing discharge home are poorly managed pain and PONV. As a result, these occurrences should be avoided and managed utilizing a multimodal strategy Because of its low cost and adequate safety profile in the treatment of post-tonsillectomy pain, acetaminophen is presently regarded the fundamental analgesic in this situation. Furthermore, acetaminophen has been recommended for use in children, and its pharmacological safety in this age group has been shown. Dexamethasone is another medication that is used to reduce postoperative pain and PONV in various procedures.

Eligibility criteria: Inclusion Criteria:

* children aged between 3 and 16 years.
* All patients are ASA physical status I or II scheduled to undergo a tonsillectomy with or without adenoidectomy using sharp dissection technique.

Exclusion Criteria:

* psychiatric illness.
* cardiac disease.
* renal or hepatic impairment.
* allergy dexamethasone , paracetamol and opioids.

Primary outcomes:
measure: Total opioid consumption at PACU
timeFrame: two hours postoperatively
Secondary outcomes:
measure: objective pain score
timeFrame: at 0 minute , 30 minutes ,1 hour and 2 hours at PACU
Other outcomes:
Locations:
city: Banha
country: Egypt
facility: Banha Faculity of Medicine
state: Elqalyoubea
Study officials:
affiliation: Benha University
name: fatma ahmed abdelfatah, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06259162: LAG3 Expression in Triple Negative Breast Cancer
Official title: The Evaluation the Relationship Between LAG-3 Expression / Immune Checkpoint Protein Expression and Neoadjuvant Chemotherapy Plus Immune Checkpoint Inhibitor in Triple Negative Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Triple Negative Breast Cancer
Immune Checkpoint Inhibitor
Lead sponsor: Samsung Medical Center
Sponsor class: OTHER
First posted: 2024-02-14
Enrollment: 128
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: This study is the experimental study for relationship between LAG-3 expression / immue checkpoint protein expression and neoadjuvant chemotherapy plus immune checkpoint inhibitor in triple negative breast cancer.


Eligibility criteria: Inclusion Criteria:

* Planned neoadjuvant chemotherapy
* Triple negative breast cancer

Exclusion Criteria:

* HER2-positive breast cancer
* Hormone receptor positive breast cancer

Primary outcomes:
measure: LAG-3 expression/immune checkpoint preotein expression
timeFrame: Before chemotherapy, 1 weeks & 3 weeks after chemotherapy, curative surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Ji-Yeon Kim
Study officials:
References:
Clinical trial NCT06498362: The "New" Place of LEVETIRACETAM in the Management of Status Epilepticus in Children
Official title: The "New" Place of LEVETIRACETAM in the Management of Status Epilepticus in Children: Multicenter Retrospective Study on 151 Children Over Three Months Old
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Epilepsy in Children
Keywords: Epilepsy
Epilepsy in Children
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2024-07-12
Enrollment: 151
Sex: ALL
Minimum age (years): 3
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Minor patient aged 3 months to 17 years having 2nd line treatment with LEVETIRACETAM or PHENYTOIN after failure of benzodiazepines

Brief summary: Status epilepticus is the leading neurological emergency in children, with mortality 2-7% and significant morbidity (10-20%). It is defined as the occurrence of a crisis lasting more than 5 minutes and requiring the implementation of treatment to stop it and thus limit the immediate and long-term consequences.

The research hypothesis is that LEVETIRACETAM is non-inferior to PHENYTOIN in terms of cessation and absence of recurrence of status epilepticus, with better clinical tolerance in children from 3 months to 17 years old, with or without epileptic disease, with or without a history of status epilepticus


Eligibility criteria: Inclusion Criteria:

* Minor patient aged 3 months to 17 years
* 2nd line treatment with LEVETIRACETAM or PHENYTOIN after failure of benzodiazepines
* Supported in one of the participating centers during the period from November 1, 2019 to May 31, 2023
* Subject or parents who have not expressed, after information, their opposition to the reuse of their data for the purposes of this research.

Exclusion Criteria:

* Patient or parents having expressed their opposition to participating in the study.

Primary outcomes:
measure: Highlight non-inferiority of LEVETIRACETAM compared to PHENYTOIN
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service pédiatrie 1 - CHU de Strasbourg - France
Study officials:
References:
Clinical trial NCT02820662: Study of the Implication of Omega-3 Polyunsaturated Fatty Acids in Retinopathy of Prematurity in New-born Infants
Official title: Study of the Implication of Omega-3 Polyunsaturated Fatty Acids in Retinopathy of Prematurity in Newborns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinopathy of Prematurity
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-07-01
Enrollment: 62
Sex: ALL
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The development of the retinal vascular network is generally complete during the 3rd trimester of pregnancy but may continue during the first 15 days of life. This late maturation may cause problems in pre-term births and may result in immature vascularization of the retina, a condition called retinopathy of prematurity. Among the different factors affecting the development of the retinal vasculature, the tissue level of omega-3 polyunsaturated fatty acids (PUFA) appears to be a crucial element, as does the form of the PUFA present in the tissues (nature of the phospholipids in their membranes). This project aims to show a possible association between levels of omega-3 PUFA and the onset of retinopathy of prematurity (ROP).


Eligibility criteria: Inclusion Criteria:

* Premature new-born infants born at less than 29 weeks of amenorrhea after informed consent has been obtained from a parent or the legal guardian of the infant

Exclusion Criteria:

* Premature new-born infants presenting a life-threatening condition. Persons without national health insurance cover

Primary outcomes:
measure: Stage of retinopathy of prematurity using a Retcam according to the ICROP classification (International Classification of Retinopathy of Prematurity) revised in 2005.
timeFrame: At 4 weeks of life or 31 weeks of amenorrhea
Secondary outcomes:
measure: Concentrations of omega-3 PUFA in Red Blood Cell (RBC) membranes.
timeFrame: At inclusion
Other outcomes:
Locations:
city: Dijon
country: France
facility: Centre Hospitalier Universitaire
Study officials:
References:
Clinical trial NCT05619562: Clinical Significance of Circulating Tumour Cells in Resectable Lung Cancer Patients
Official title: Clinical Significance of Circulating Tumour Cells in Resectable Lung Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Non Small Cell Lung Cancer
Circulating Tumor Cell
Lead sponsor: The Institute of Molecular and Translational Medicine, Czech Republic
Sponsor class: OTHER
First posted: 2022-11-17
Enrollment: 166
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: Patients with confirmed non-metastatic NSCLC undergoing radical surgery with curative intent.

Brief summary: To determine whether the presence of circulating/disseminated tumour cells (CTCs/DTCs) in the blood and bone marrow of the resectable lung cancer (NSCLC) patients is a negative prognostic factor, and to find correlations with other clinical/pathological disease characteristics.


Eligibility criteria: Inclusion Criteria:

Non-small cell lung cancer, non-metastatic

Exclusion Criteria:

Prior neoadjuvant chemoradiotherapy Prior lung cancer Cancer duplicity

Primary outcomes:
measure: CEA, EGFR, LunX, c-met and EpCAM mRNA positive circulating tumour cells in lung cancer patients
timeFrame: 30 days
Secondary outcomes:
measure: Cancer specific survival in CTC positive NSCLC patients
timeFrame: 5 years
Other outcomes:
Locations:
city: Olomouc
country: Czechia
facility: University Hospital Olomouc
state: Česká Republika
Study officials:
affiliation: Institute of Molecular and Translational Medicine, Faculty of Medicine and Dentistry, Palacky University
name: Marian Hajduch, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00883662: Mirena Observational Program
Official title: Mirena Observational Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Contraception
Menorrhagia
Endometrial Hyperplasia
Estrogen Replacement Therapy
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-04-20
Enrollment: 2725
Sex: FEMALE
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: Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications

Brief summary: Mirena is used for long-term in Kazakhstan, and in our observational program we would like to study patients distribution per indications of Mirena, and also patient compliance within a year after Mirena insertion. For patients with all approved indications for Mirena use: contraception, treatment of menorrhagia and protection from endometrial hyperplasia during estrogen replacement therapy


Eligibility criteria: Inclusion Criteria:

* Patients older than 18 years with previously taken decision of their gynecologist to insert Mirena according to registered indications

Exclusion Criteria:

* All patients with contraindications to Mirena insertion, according to approved prescribing information.

Primary outcomes:
measure: Patient distribution per indication
timeFrame: 12 months
Secondary outcomes:
measure: Patient compliance
timeFrame: 12 months
Other outcomes:
Locations:
city: Many Locations
country: Kazakhstan
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02976662: Artificial Shrinkage for Human Blastocyst Prior Vitrification
Official title: Removal of Blastocoel Fluid Before Blastocyst Vitrification by Laser Pulse and Its Effect on Clinical Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Vitrification
Lead sponsor: Dar AlMaraa Center
Sponsor class: OTHER
Collaborators: name: Benha University
First posted: 2016-11-29
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Investigators aim to investigate the effect of elimination of blastocoelic fluid by creating a large hole in the zona pellucida at the cellular junction of the trophectoderm cells located far away from the inner cell mass with a laser pulse before vitrification.

Detailed description: Human blastocyst formation begins about 5 days after injecting a single sperm into an oocyte in ICSI cycle or incubation of them in IVF cycle. Human blastocyst consists of cells forming an outer layer called trophotoderm that will form the placenta in case of successful implantation, an inner cell mass which become the fetus, a fluid-filled blastocoel cavity in the center, and a surrounding zone pellucida from which the embryo hatches to implant in the uterus. Human blastocyst contains a large amount of liquid in the blastocoel, which alters the infiltration of vitrification solution during the vitrification procedures leading to ice crystal formation. Therefore, investigators need to compare blastocyst survival, clinical pregnancy and implantation rates between vitrified untreated expanded blastocysts and vitrified blastocysts with artificially eliminated blastocoels by a laser pulse prior to vitrification

Eligibility criteria: Inclusion Criteria:

* BMI of ≤ 32

Exclusion Criteria:

* Non-expanded blastocysts.
* Women who had uterine pathology or abnormality.

Primary outcomes:
measure: Implantation rate
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Benha
country: Egypt
facility: Yasmin Magdi
Study officials:
References:
Clinical trial NCT05785962: Electromyographic Control of the Response in the Application of Vojta Therapy in People With Brain Injury.
Official title: Electromyographic Control of the Response in the Application of Vojta Therapy in People With Brain Injury.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Abdominal Muscles
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2023-03-27
Enrollment: 50
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
Intervention model description: Subjects in each group will be matched by age and sex.
Primary purpose: TREATMENT

Brief summary: A non-randomized clinical trial on a cohort of healthy subjects of legal age, both sexes, recruited from the university community and who will be randomly distributed into two groups (experimental and control). The objective will be to determine the feasibility of the standardized intervention protocol on the stabilizing muscles of the trunk (external oblique and internal oblique) before, during and after the application of Vojta Therapy, and to know the effects produced on the Musculature studied after performing the intervention.


Eligibility criteria: Brain injury group

Inclusion Criteria :

* Over 18 and under 80 years of age
* Persons with a medical diagnosis of brain damage secondary to stroke
* Have preserved the ability to walk, even with some type of orthopedic some type of orthopedic aid,

Exclusion Criteria:

* Over 80 years
* Healthy people

Group without brain damage

Inclusion Criteria :

* Over 18 and under 80 years of age
* Healthy people
* Full cognitive capacity.

Exclusion Criteria:

* Subjects with neuro-muscular pathologies that affect the abdominal muscles, previous surgeries in the area or any chronic neurological or organic disorder that may alter the results.
* Fever

Primary outcomes:
measure: Electromyographic activity in abdominal muscles
timeFrame: Change from Baseline electromyographic activity at 10 minutes.
Secondary outcomes:
measure: Date of birth
timeFrame: Baseline
measure: Sex
timeFrame: Baseline
measure: Height
timeFrame: Baseline
measure: Weight
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05572762: Assessing the Atraumatic Technique in Ophthalmic Patients
Official title: A Prospective Comparative Study Between an Atraumatic Peribulbar Block and the Traditional Peribulbar Needle Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intravenous Cannula Regional Ophthalmic Anesthesia
Lead sponsor: Research Institute of Ophthalmology, Egypt
Sponsor class: OTHER
First posted: 2022-10-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study is conducted to determine the efficacy of the cannula atraumatic technique as an alternative to the traditional needle penetrating technique to minimize the incidence of accidental globe penetration and/ or perforation, as the plastic part of the cannula is blunt and is difficult to perforate the normal globe being marble-like in consistency.

Detailed description: A prospective comparative single blinded randomized controlled clinical study was held in the operating theatre at Research institute of ophthalmology, on adult patients with age group between 18- 80 years of both sexes undergoing anterior, posterior segment or plastic surgeries. two techniques were used in comparison: the atraumatic technique, using a 20 or 22-gauge cannula advanced in the inferior-temporal peribulbar space after local infiltration. The skin and the conjunctiva will be pierced by the cannula and advanced for only 0.5 cm, then the cannula will be advanced blindly. Supplementation using the other sites (medial canthus and superior nasal) as needed.

Eligibility criteria: Inclusion Criteria:

1. Adult patients
2. Both
3. patients going to do anterior, posterior segment surgery or cornea surgeries.

Exclusion Criteria:

1. Pediatric population
2. Mentally retarded patients
3. Patients having Problems to lie flat, refused to take regional
4. Patients with communication problems as; language barrier, deaf and mute.
5. Patients with bleeding diathesis.

Primary outcomes:
measure: Safe Ophthalmic block using Globe Akinesia Score by Sarvela
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Research Institute of Ophthalmology
Study officials:
References: