louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01042223: Laryngomalacia Exposed
Official title: Laryngomalacia Exposed
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Complications
Keywords: Factors Predisposing or Causing
Lead sponsor: Boushahri Clinic Medical Center
Sponsor class: OTHER
First posted: 2010-01-05
Enrollment: 500
Sex: ALL
Minimum age (years): 14
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Primary care clinics

Brief summary: Laryngomalacia is the most common congenital laryngeal anomaly and the most frequent cause of stridor in infants and children. Symptoms usually appear within the first 2 weeks of life. Its severity increases up to 6 months. 15-60% of infants with laryngomalacia have synchronous airway anomalies.

Detailed description: The most common health complications associated with laryngomalacia were: 1. Gastroesophageal reflux which was presented by arching, choking, gagging, feeding aversion and continuous crying 2. Frequent unilateral eye infections 3. Repeated choking, frequent vomiting and poor weight gain 4. Repeated upper respiratory tract infections (viral and bacterial), coughing and cyanosis 5. Repeated secretory otitis media 6. Aspiration pneumonia

Eligibility criteria: Inclusion Criteria:

* 500 full term babies ≥ 37 weeks of both sexes were delivered by different modes of delivery, with birth weights of ≥ 2.5 kg, with no history of natal complications and from the same community.
* Mothers of these babies are from different socioeconomic standards with different educational levels.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Kuwait
country: Kuwait
facility: Boushahri Clinic Medical Center
state: P.O.Box :698 Salmiya
Study officials:
affiliation: New Children's Hospital, Cairo University
name: Mohamed S EL-Sayed, MBBCh, MSc, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04232423: Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis
Official title: Efficacy and Dosage of Olanzapine for Chemotherapy-induced Nausea and Vomiting Prophylaxis in Women With Gynecologic Cancers Receiving Carboplatin-based Regimen : a Double-blind, Placebo-controlled, Randomized Crossover Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Complete Response Rate to Chemotherapy-induced Nausea and Vomiting Prophylaxis
Keywords: Olanzapine
Chemotherapy-induced nausea and vomiting
Carboplatin
Gynecologic cancer
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2020-01-18
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A Double-Blind, Placebo-Controlled, Randomized Crossover Trial
Primary purpose: TREATMENT

Brief summary: To investigate that olanzapine can reduced side effect about nausea and vomiting in women with gynecologic cancers receiving carboplatin-based regimen by using olanzapine and placebo

Detailed description: A double-blind, placebo-controlled, randomized crossover trial

Eligibility criteria: Inclusion Criteria:

* Women with gynecological cancer receiving carboplatin-based chemotherapeutic regimen
* ECOG performance status 0-1
* Normal bone marrow, liver, and renal functions
* Can speak and write in Thai language

Exclusion Criteria:

* Women with nausea or vomiting prior to chemotherapeutic administration
* Pregnant women
* Women with active infection
* Women with bowel obstruction
* Women with symptomatic brain metastases
* Women who received dopamine receptor antagonists within 1 week before chemotherapeutic administration
* Women who received corticosteroid within 1 week before chemotherapeutic administration
* Women with past history of chemotherapy or radiotherapy
* Women with psychiatric disorders
* Women with poor controlled diabetes mellitus
* Women who received anticonvulsant medication
* Women with history of neuroleptic malignant syndrome
* Women with history of olanzapine allergy
* Women with history of lactose intolerance

Primary outcomes:
measure: Complete response rate of chemotherapy-induced nausea and vomiting prophylaxis
timeFrame: 5 days after chemotherapeutic administration
Secondary outcomes:
measure: Episodes of vomiting
timeFrame: 5 days after chemotherapeutic administration
measure: Severity of nausea
timeFrame: 5 days after chemotherapeutic administration
measure: Use of rescue drug
timeFrame: 5 days after chemotherapeutic administration
measure: Quality of life associated with nausea and vomiting measured using Functional Living Index-Emesis (FILE)
timeFrame: 5 days after chemotherapeutic administration
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi hospital
Study officials:
References:
Clinical trial NCT04835623: CEQUA for Sjogren's Syndrome Dry Eye
Official title: Effects of CEQUA™ on Objective and Subjective Dry Eye Findings Associated With Sjogren's Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Dry Eye
Dry Eye Syndromes
Sjogren's Syndrome
Lead sponsor: Center for Ophthalmic and Vision Research, LLC
Sponsor class: OTHER
Collaborators: name: Sun Pharmaceutical Industries Limited
First posted: 2021-04-08
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to show that CEQUA (cyclosporine 0.09% ophthalmic solution) improves symptoms of dry eye disease in a population of patients with Sjogren's Syndrome diagnosis.

Detailed description: After being informed about the study and potential risks, all participants giving informed consent will have an eye exam and will be asked about their medical history to determine eligibility for the study. Eligible participants will continue to the second visit the same day or up to 10 days later. During the second visit participants will answer questionnaires about their eyes and have their vision, eyes, and tears examined. All participants will be given CEQUA to use over the duration of the study. The same procedures will be repeated every four weeks for 3 months total.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Sjogren's Syndrome.
* Self-reported complaints of ocular dryness for a period of at least 3 months
* Best-corrected distance visual acuity of 20/25 or better in each eye.

Exclusion Criteria:

* Use of cyclosporine within the last 3 months.
* Use of ocular steroid within the 3 months.
* Previous history of treatment failure with cyclosporine.
* Known hypersensitivity or contraindication to the study medication or any of its ingredients.
* Use of any systemic or topical ocular medication that is known to cause or exacerbate dry eye.
* Any active ocular infection.
* Severe or serious ocular condition in either eye or any other unstable medical condition that may preclude study treatment or follow-up.
* History or presence of chronic generalized systemic disease that might increase the risk to the subject or confound the results of the study.
* Currently pregnant or lactating.

Primary outcomes:
measure: Mean change from baseline in total corneal staining
timeFrame: Baseline and week 12
Secondary outcomes:
measure: Mean change from baseline in total conjunctival staining
timeFrame: Baseline and week 12
measure: Mean change from baseline in the score of dry eye questionnaires
timeFrame: Baseline and week 12
Other outcomes:
Locations:
city: Manhattan
country: United States
facility: Center for Ophthalmic and Vision Recearch
state: New York
Study officials:
affiliation: Center for Ophthalmic and Vision Research
name: John Rocco Robilotto, OD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03651323: Latin America Registry on WatchmanTM Outcomes in Real Life
Official title: Left Atrial Appendage Closure for Stroke Prevention in Atrial Fibrillation: Latin America Registry on WatchmanTM Outcomes in Real Life
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Atrial Fibrillation
Keywords: Atrial fibrillation
Left atrial appendage
Stroke
Lead sponsor: Centro Medico Docente la Trinidad
Sponsor class: OTHER
Collaborators: name: Boston Scientific Corporation
First posted: 2018-08-29
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with atrial fibrillation and indication for left atrial appendage closure

Brief summary: Left atrial appendage (LAA) occlusion with WatchmanTM has emerged as viable alternative to anticoagulation therapy in randomized controlled trials. The device has FDA approved since 2015 and the firsts Latin American cases were performed in 2012. However, there is no real world data from Latin American experience in terms of success and outcomes.

Detailed description: Approximately 450 subjects will be enrolled in the study. Up to 50 sites in Latin America will participate in the study.

Primary analyses may include, but will not be limited to, the following: procedural complications, incidence of stroke and death. Descriptive statistics will be used for baseline, procedure and follow-up data collected through the registry.

Clinical history of each patient will be analyzed for a period of 6 months after the procedure according the standard practice at the enrolling centers. There will be no additional visits, nor procedures, for subjects in the registry.

Eligibility criteria: Inclusion Criteria:

* Patients who were eligible for a WatchmanTM device implantation according to current international and local guidelines and per physician and institution discretion.

Exclusion Criteria:

* Patient who were currently enrolled in another investigational study or registry that would directly interfere with the current study aims.

Primary outcomes:
measure: Incidence of Periprocedural complications
timeFrame: At implant
measure: Incidence of Stroke
timeFrame: 6 months follow up
measure: Incidence of Death
timeFrame: 6 months follow up
Secondary outcomes:
Other outcomes:
Locations:
city: Caracas
country: Venezuela
facility: Centro Medico Docente la Trinidad
state: Miranda
Study officials:
References:
Clinical trial NCT04157023: Simulator Training for Direct Ophthalmoscopy
Official title: Direct-Ophthalmoscopy-Simulator-Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Simulator-based Medical Skill Training
Keywords: simulator
medical skills
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2019-11-08
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups of participants are made. Group 1: Medical Students Group 2: Ophthalmologists Group 3: Neonatologists/Neurologists/Neurosurgeons
Primary purpose: DIAGNOSTIC

Brief summary: Evaluation of a digital simulator to train diagnostic skills in Ophthalmology

Detailed description: Direct Ophthalmoscopy is an important tool to detect pathologies e.g. on the optic nerve head. The training of the needed skills is made conventionally in most cases. In such the training sessions students examine each other after dilating one pupil. Examining of patients with pathologies is very important, but in many cases not very easy without any experience.

Simulators are of growing impact to teach diagnostic or surgical skills. A digital simulator with virtual reality technology is used to teach the skills to unexperienced examiners. The head-eye-hand-coordination can be trained without any stress.

Eligibility criteria: Inclusion Criteria:

* Medical student or Ophthalmologist or Neonatologist or Neurologist or Neurosurgeon
* Willing to participate to the study
* Consent to evaluate the measured data

Exclusion Criteria:

* age \<18 years

Primary outcomes:
measure: Total examined area
timeFrame: 1 hour
measure: Efficiency
timeFrame: 1 hour
Secondary outcomes:
measure: Learning effect
timeFrame: 1 hour
measure: Questionnaire
timeFrame: 1 hour
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05741723: OCS DCD Heart + CAP Continued Follow-Up
Official title: OCS DCD Heart + CAP Continued Follow-Up Post-Approval Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Heart Transplant
Lead sponsor: TransMedics
Sponsor class: INDUSTRY
First posted: 2023-02-23
Enrollment: 276
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients transplanted in the OCS DCD Heart Trial and OCS DCD Heart CAP will comprise the patient population for this PAS.

Brief summary: The objective of this post-approval study is to evaluate long-term outcomes of patients enrolled in the OCS DCD Heart and OCS DCD Heart CAP studies.


Eligibility criteria: Inclusion Criteria:

* Patients transplanted in the OCS DCD Heart Trial and OCS DCD Heart CAP trials.

Primary outcomes:
measure: Patient survival
timeFrame: 5 years post-transplant
Secondary outcomes:
Other outcomes:
measure: Cardiac related patient survival
timeFrame: 5 years post-transplant
measure: Graft survival
timeFrame: 5 years post-transplant
measure: Patient and graft survival
timeFrame: 5 years post-transplant
Locations:
city: La Jolla
country: United States
facility: University of California San Diago
state: California
city: Palo Alto
country: United States
facility: Stanford University
state: California
city: New Haven
country: United States
facility: Yale New Haven Hospital
state: Connecticut
city: Jacksonville
country: United States
facility: Mayo Clinic Florida
state: Florida
city: Orlando
country: United States
facility: AdventHealth Orlando
state: Florida
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern Medicine
state: Illinois
city: Indianapolis
country: United States
facility: St. Vincent Cardiovascular Research Institute
state: Indiana
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute
state: Minnesota
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
city: Omaha
country: United States
facility: University of Nebraska Medical Center
state: Nebraska
city: Bronx
country: United States
facility: Montefiore
state: New York
city: New York
country: United States
facility: Nyph/Cumc
state: New York
city: Durham
country: United States
facility: Duke University
state: North Carolina
city: Nashville
country: United States
facility: Vanderbilt Medical Center
state: Tennessee
city: Norfolk
country: United States
facility: Sentara
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert & the Medical College of Wisconsin
state: Wisconsin
Study officials:
References:
Clinical trial NCT05457023: Plasma Neurofilament Light and Its Relationship With Omega-3 Status and Soccer Heading in Women Soccer Players
Official title: A Blood Biomarker for Sports-Related Brain Injury and Its Relationship With Omega-3 Status and Purposeful Soccer Heading in Free-Living Collegiate Women Soccer Players During and After a Competitive Season
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Trauma
Keywords: Soccer, Heading, Omega-3, Neurofilament Light, Subconcussive, Women
Lead sponsor: University of Kansas Medical Center
Sponsor class: OTHER
First posted: 2022-07-13
Enrollment: 27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Collegiate women soccer players who actively compete at the NCAA Division 1-A competition level.

Brief summary: The purpose of this study is to (1) assess how a competitive season of purposeful gameplay soccer heading in collegiate women soccer players is related to a blood biomarker for sports-related brain injury, plasma neurofilament light (NF-L), and (2) examine how a player's omega-3 status is related to plasma NF-L concentration changes during and after a competitive season of gameplay soccer heading.


Eligibility criteria: Inclusion Criteria:

* At least 18 years of age.
* Active player on the university's current team roster for the upcoming competitive season.
* Is eligible to participate in games and is not redshirting.

Exclusion Criteria:

* Is recovering from a Physician diagnosed concussion.
* Is recovering from another injury prohibiting the study participant from participating in all sport-related activities.

Primary outcomes:
measure: Change in plasma neurofilament light concentrations from baseline, during, and after a competitive season.
timeFrame: Baseline, 1 Months, 2 Months, 3 Months, 6 Months
measure: Change in purposeful soccer heading frequencies from baseline, during, and after a competitive season.
timeFrame: Baseline, 2 weeks, 4 weeks, 6 weeks, 8 weeks, 10 weeks, 12 weeks, 14 weeks
measure: Change in Omega-3 status from baseline, during, and after a competitive season.
timeFrame: Baseline, 1 Months, 2 Months, 3 Months, 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Kansas City
country: United States
facility: University of Missouri Kansas City
state: Missouri
city: Kansas City
country: United States
facility: Rockhurst University
state: Missouri
Study officials:
affiliation: University of Kansas Medical Center
name: Aaron F Carbuhn, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06858423: Budesonide Nasal Irrigation Versus Fluticasone Propionate Nasal Spray in Treating Allergic Rhinitis Patients
Official title: Budesonide Nasal Irrigation Versus Fluticasone Propionate Nasal Spray in the Treatment of Adult Patients With Allergic Rhinitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Nasal Allergy
Keywords: allergic rhinitis
Budesonide
luticasone propionate
Lead sponsor: Benha University
Sponsor class: OTHER
First posted: 2025-03-05
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Budesonide is a medication of the corticosteroid type. Available as an inhaler, nebulization solution, The inhaled form is used in the long-term management of asthma and chronic obstructive pulmonary disease is used for allergic rhinitis and nasal polyps fluticasone propionate

Detailed description: The current study aims to compare between results of budesonid nasal irrigation and fluticasone nasal spray in the treatment of adult patients with Allergic Rhinitis.

Eligibility criteria: Inclusion Criteria:

* Adult age between 18 and 60 years old.
* Patients with allergic rhinitis evidence by past skin prick testing. Patients were given a skin prick test with a panel of dog, cat, Dermatophagoides farinae, D pteronyssinus, Alternaria, Penicillium, Hormodendron, Aspergillus, grass pollen mix, tree pollen mix, and ragweed allergen extracts (100,000 Allergen Unit/mL). Histamine, 10 mg/mL, was used as a positive control, and the diluent was used as the negative control. A positive reaction was defined as a wheal diameter at least 3 mm greater than the diluent control and/or at least a 50-mm flare (ie, erythema measured as the sum of the greatest diameter and the perpendicular diameter through the midpoint of the greatest diameter)

Exclusion Criteria:

* Patients who had autoimmune diseases or any immune compromised diseases including diabetes, chemotherapy.
* Patients with a history of nasal surgery.
* Patients who received systemic or topical corticosteroids, herbal drugs, beta blocking agent within the previous month of enrolment.
* Patients with asthma and COPD, nasal bleeding, obstructing nasal polyps, paranasal sinus.

Primary outcomes:
measure: Clinical improvement
timeFrame: 1 month
Secondary outcomes:
measure: Endoscopic examination improvement
timeFrame: 1 month
Other outcomes:
measure: Effects on serum cortisol level
timeFrame: 1 month
Locations:
city: Banhā
country: Egypt
facility: Benha University Hospitals - Otolaryngology department
state: Qalyobia
Study officials:
References:
Clinical trial NCT05338723: Possible Protective Effect of Rosuvastatin in Chemotherapy-induced Cardiotoxicity in HER2 Positive Breast Cancer Patients
Official title: Possible Protective Effect of Rosuvastatin in Chemotherapy-induced Cardiotoxicity in HER2 Positive Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chemotherapy-induced Cardiotoxicity
Breast Cancer
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2022-04-21
Enrollment: 50
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to investigate the possible role of rosuvastatin in protection against cardiotoxicity in HER2 positive breast cancer patients receiving doxorubicin sequential with trastuzumab.


Eligibility criteria: Inclusion Criteria:

* Age: 25-75 years old.
* Gender: female
* Newly diagnosed HER2 positive breast cancer patients who are scheduled to receive doxorubicin followed by trastuzumab adjuvant therapy.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) ≤ 2
* Preserved LV systolic function in which the left ventricular ejection fraction (LVEF)≥50%.
* Patients with normal renal and hematological functions.
* Alanine amino transferase (ALT ≤ 3 times ULN).

Exclusion Criteria:

* Pregnant or lactating females.
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) \> 2
* Patients with impaired LV systolic function in which the left ventricular ejection fraction (LVEF)\<50%.
* Patients with significant valvular heart disease, documented coronary artery disease, history of congestive heart failure or cardiomyopathy.
* Alanine amino transferase (ALT \> 3 times ULN).
* Patients already taking statins or other lipid lowering therapy.
* Patients with a known hypersensitivity to any of the used drugs.

Primary outcomes:
measure: change in left ventricular ejection fraction(LVEF) detected by electrocardiography transthoracic echocardiography
timeFrame: 6 months
Secondary outcomes:
measure: change of serum level of High sensitivity troponin I (hs-TnI).
timeFrame: 6 months
measure: change of serum level of Myeloperoxidase (MPO).
timeFrame: 6 months
measure: change of serum level of Interleukin-6 (IL-6). > Liver function test (ALT).
timeFrame: 6 months
measure: change of serum level of Liver function test (ALT).
timeFrame: 6 months
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: The Department of Clinical Oncology, Tanta University Hospital
Study officials:
affiliation: Tanta University
name: khlood m. kettana
role: PRINCIPAL_INVESTIGATOR
References: