louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06831019: The ROAR Study: Reactive Oxygen Species and Reproduction
Official title: The ROAR Study: Reactive Oxygen Species and Reproduction
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Ovarian Aging
IVF Outcome
Oxidative Stress
Keywords: oxidative stress
ovarian aging
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
First posted: 2025-02-17
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 43
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heterosexual couples undergoing fresh IVF cycle

Brief summary: This is a prospective cohort study characterizing follicular fluid and serum levels of oxidative stress in women with various infertility diagnoses undergoing in vitro fertilization, and assessing the relationship of oxidative stress to oocyte competence as determined by embryo development outcomes. Furthermore, we will measure oxidative stress in sperm and correlate the overall oxidative stress within the couple with IVF and pregnancy outcomes of the resultant embryos.


Eligibility criteria: Inclusion Criteria:

1. Female age 18-43 years
2. Subjects planning blastocyst culture for preimplantation genetic screening (PGS) for aneuploidy.
3. Male partners 18 years of age or older.

Exclusion Criteria:

* Female partner age 44 or older
* Planning fresh transfer (hybrid PGS cycle)
* Cleavage stage biopsy

Primary outcomes:
measure: Implantation rate
timeFrame: From enrollment to transfer of all embryos - can be anywhere from 8 weeks to 1 year (or sometimes longer if pregnancy is achieved)
Secondary outcomes:
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: University of California, San Francisco
state: California
Study officials:
affiliation: University of California, San Francisco
name: Mitchell Rosen, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01823419: Omega-6 to Omega-3 Fatty Acid Ratio and Higher Order Cognitive Function in 7-to 9-year-olds
Official title: Omega-6 to Omega-3 Fatty Acid Ratio and Higher Order Cognitive Function in 7-to 9-year-olds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Typical Development
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
First posted: 2013-04-04
Enrollment: 70
Sex: ALL
Minimum age (years): 7
Maximum age (years): 9
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 7-9 year olds

Brief summary: The purpose of this study is to investigate the role of the ratio of omega-6 to omega-3 fatty acids on executive functions. The investigators hypothesize that participants ages 7-9 years with a ratio closer to 4:1 will do better on tests of executive function than participants with a ratio closer to the purported Western diet norm of 15:1.


Eligibility criteria: Inclusion Criteria:

* typically-developing

Exclusion Criteria:

* not fluent in English

Primary outcomes:
measure: Relation between executive function and n-6/n-3 fatty acid intake
timeFrame: up to 10 days
Secondary outcomes:
measure: Temperament
timeFrame: Baseline
measure: Socioeconomic status
timeFrame: Baseline
Other outcomes:
Locations:
city: Kannapolis
country: United States
facility: UNC at Chapel Hill Nutrition Research Institute
state: North Carolina
Study officials:
affiliation: UNC-Chapel Hill
name: Carol L Cheatham, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: UNC-Chapel Hill
name: Kelly W Sheppard, BS
role: STUDY_DIRECTOR
References:
citation: Sheppard KW, Cheatham CL. Omega-6/omega-3 fatty acid intake of children and older adults in the U.S.: dietary intake in comparison to current dietary recommendations and the Healthy Eating Index. Lipids Health Dis. 2018 Mar 9;17(1):43. doi: 10.1186/s12944-018-0693-9.
citation: Sheppard KW, Cheatham CL. Omega-6 to omega-3 fatty acid ratio and higher-order cognitive functions in 7- to 9-y-olds: a cross-sectional study. Am J Clin Nutr. 2013 Sep;98(3):659-67. doi: 10.3945/ajcn.113.058719. Epub 2013 Jul 3.
Clinical trial NCT06312319: Home-based Respiratory Training on Swallowing in Stroke
Official title: Effects of a Home-based Respiratory Muscle Training on Swallowing Function in Patients With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Stroke
Lead sponsor: Universidad de Granada
Sponsor class: OTHER
First posted: 2024-03-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to evaluate the effects of a home-based respiratory muscle training on swallowing function in patients with chronic stroke. The patients will be included in a experimental or a control group. The patients in the experimental group will receive a home-based respiratory training using respiratory devices added to standard treatment, while the participants in the control group will only receive the standard treatment.

Detailed description: This study aims to evaluate the effects of a home-based respiratory muscle training on swallowing function in patients with chronic stroke. The patients will be included in a experimental or a control group. The patients in the experimental group will receive home-based respiratory training using respiratory devices added to standard treatment, while the participants in the control group will only receive the standard treatment. The swallowing function will be assessed using specific tools and questionnaires. Secondary outcomes will evaluate the respiratory function. The intervention will have a duration of 6 weeks.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of stroke
* 18 years of age or more

Exclusion Criteria:

* Cognitive impairment or aphasia that prevents the understanding of instructions.
* Tracheostomy.
* Presence of cancer.
* Patients who present another disease of the central nervous system
* Absence of neuromotor competence to carry out the respiratory function tests.
* Central apnea.
* Hypoventilation-obesity syndrome.
* Severe cardiorespiratory impairment (hemodynamic instability, pulmonary embolism, recent pneumonothorax, acute hemoptysis, active respiratory infections, recent myocardial infarction, unstable angina, pulmonary hypertension, uncontrolled asthma, or severe chronic obstructive pulmonary disease).
* Patients with recent otorhinolaryngological, abdominal, or thoracic surgery.

Primary outcomes:
measure: Gugging Swallowing screen
timeFrame: Baseline, 6 weeks
measure: Swallowing quality of life questionnaire
timeFrame: Baseline, 6 weeks
measure: cough peak flow
timeFrame: Baseline, 6 weeks
Secondary outcomes:
measure: Forced vital capacity
timeFrame: Baseline, 6 weeks
measure: Forced expiratory volumen in the first second
timeFrame: Baseline, 6 weeks
measure: FEV1/FVC ratio
timeFrame: Baseline, 6 weeks
measure: Respiratory Pressure Meter
timeFrame: Baseline, 6 weeks
Other outcomes:
Locations:
city: Granada
country: Spain
facility: Faculty of Health Sciences
Study officials:
affiliation: UGR
name: Irene Cabrera Martos
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01017419: Orientation for Hearing Aid Users: Information Retention
Official title: Orientation for Hearing Aid Users: Information Retention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hearing Loss
Keywords: hearing aids
counseling
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-11-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 88
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 30 adults (18 female and 12 male) with age varying from 18 to 88 years, with post lingual uni or bilateral hearing loss of various degrees and types.

Brief summary: Aim: To verify how much of the orientation provided at diagnosis and hearing aid fitting are retained by new hearing aid users and analyze whether age, degree of hearing loss, academic and socio-economics status have an influence on this

Detailed description: Introduction: The understanding and retention of orientations provided by the health professional increases patient's satisfaction and compliance to treatment and reduces treatment duration and costs. Aim: To verify how much of the orientation provided at diagnosis and hearing aid fitting are retained by new hearing aid users and analyze whether age, degree of hearing loss, academic and socio-economics status have an influence on this. Methods: Participated in this study 30 adults (18 female and 12 male) with age varying from 18 to 88 years, with post lingual uni or bilateral hearing loss of various degrees and types. Orientations were offered at the time of diagnosis and hearing aid fitting. At the first follow up visit patients were interviewed regarding their hearing loss' characteristics as well as hearing aid care and use (probed recall task). It was also evaluated how participants manipulated their devices. A protocol was used to score participant's responses. Results: on average participants could retain 31,6% and 83,6% of the orientation provided regarding their hearing loss and hearing aid care and use. There was a negative correlation between age and amount of information retained. There was no influence of degree of hearing loss, academic and socio-economic statues. Conclusion: The hearing impaired patients have difficulty to recall orientation provided therefore the use of facilitation strategies to information retained is necessary.

Eligibility criteria: Inclusion Criteria:

* older than 18 years old
* sensorineural hearing loss, hearing aid candidate

Exclusion Criteria:

* severe dexterity or visual problems. Cognitive or memory disorders

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: Hrac - Usp
state: Sao Paulo
Study officials:
affiliation: University of Sao Paulo
name: Deborah V Ferrari, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00969319: Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America
Official title: Effekt-2 - Efficacy and Safety of Long-term Treatment With KOGENATE® FS in Latin America
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Coagulation Disorders
Hemophilia A
Keywords: Octocog alfa
Hemophilia A
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-09-01
Enrollment: 105
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will consist of patients with a diagnosis of hemophilia A. Physicians should consult the full prescribing information for KOGENATE® FS before enrolling patients and familiarize themselves with the safety information in the product package label.

Brief summary: The aim of this international prospective post-marketing surveillance study is to obtain data on treatment procedures, long-term safety and efficacy and patient acceptance of KOGENATE Bayer/FS in treatment of patients with haemophilia A under daily-life treatment conditions.


Eligibility criteria: Inclusion Criteria:

* Patients with diagnosis of hemophilia A, independent of age, treated with KOGENATE® FS as their only source of FVIII, decision taken by the investigator to administer KOGENATE® FS. For pretreated patients with more than 100 exposure days an inhibitor assessment within three months prior to enrollment should be available; for pretreated patients with less than 100 exposure days an inhibitor assessment at baseline should be available.

Primary outcomes:
measure: Total consumption of FVIII
timeFrame: After 12 months and after 24 months
measure: Number of bleedings
timeFrame: After 12 months and after 24 months
measure: Kind of bleedings
timeFrame: After 12 months and after 24 months
measure: Continuation of therapy
timeFrame: After 12 months and after 24 months
measure: Overall assessment by the physician
timeFrame: After 12 months and after 24 months
Secondary outcomes:
measure: Adverse event collection
timeFrame: After 12 months and after 24 months
Other outcomes:
Locations:
city: Many locations
country: Mexico
city: Many locations
country: Venezuela
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT02327819: The Effect of Branched-chain Amino Acid (BCAA) on the Progression of Primary Liver Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Primary Liver Cancer
Lead sponsor: Tel-Aviv Sourasky Medical Center
Sponsor class: OTHER_GOV
First posted: 2014-12-30
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: Supplementation of BCAA found to reduce the risk of developing liver cancer, but the affect of BCAA on existing liver cancer is unknown.

The participants (post curative intent surgery) will be supplemented with either BCAA/non-BCAA-enriched protein supplement. The intervantion will go on for 2 years or until a new liver tumor is found.


Eligibility criteria: Inclusion Criteria:

* diagnosed primary liver cancer
* viral or Nonalcoholic Steatohepatitis Cirrhosis
* Cirrhosis rated Child-Pugh A
* liver cancer rated Barcelona Clinic Liver Cancer (BCLC) A

Exclusion Criteria:

* Age (over 65)
* liver condition rated Child-Pugh B/C
* GI/Absorption issues
* patients given a treatment before surgery

Primary outcomes:
measure: time until a new liver tumor is found
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Tel Aviv
country: Israel
facility: Clinical Nutrition Unit, Sourasky Medical Center
Study officials:
References:
Clinical trial NCT06148519: Comparing Preschool-Aged Refractive Measurements and Amblyopia Risks Using the 2WIN-S Portable Refractor with Vision Screening by Cycloplegic Refraction in Bangkok
Official title: Comparing Preschool-Aged Refractive Measurements and Amblyopia Risks Using the 2WIN-S Portable Refractor with Vision Screening by Cycloplegic Refraction in Bangkok
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: 2WIN-S Portable Refractor
Keywords: Refraction
vision screening
preschool aged children
Lead sponsor: Department of Medical Services Ministry of Public Health of Thailand
Sponsor class: OTHER_GOV
First posted: 2023-11-28
Enrollment: 250
Sex: ALL
Minimum age (years): 3
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: The goal of this diagnostic test is to compare the results of refraction and amblyopia risks between using 2WIN-S portable refractor and cycloplegic refraction in pre-school age.

All participants will be tested by 2WIN-S portable refractor.


Eligibility criteria: Inclusion Criteria:

* corrected visual acuity 0.1 logMAR (Snellen 20/25) or better
* Age 3-6 years old who studies in the kindergarten school that joins the study
* Parents sign informed consent form about allowing their child to join the study

Exclusion Criteria:

* other eye conditions causing visual and 2WIN-S portable refractor working disturbance such as media opacity, history of ocular surgery, strabismus, etc.

Primary outcomes:
measure: Significant refractive errors defined by AAPOS
timeFrame: At baseline.
Secondary outcomes:
measure: Diagnostic accuracy for Amblyopia
timeFrame: At baseline.
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Rajavithi Hospital
Study officials:
References:
Clinical trial NCT03267719: Intravaginal Laser Treatment of Mild and Moderate Stress Incontinence
Official title: Intravaginal Laser Treatment of Mild and Moderate Stress Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress Incontinence, Female
Lead sponsor: University Hospital Tuebingen
Sponsor class: OTHER
First posted: 2017-08-30
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim of the study is to evaluate the effectiveness of laser therapy as a non-surgical treatment option in patients with mild and moderate stress incontinence.

Detailed description: The aim of the study is to evaluate the effectiveness of laser therapy as a non-surgical treatment option in patients with mild and moderate stress incontinence.

Eligibility criteria: Inclusion Criteria:

* Light or moderate stress incontinence
* mixed urine incontinence with predominance of the stress component
* written informed consent

Exclusion Criteria:

* Pregnancy
* patients treated radiotherapy in the small basin
* connective tissue disorders (e.g., Ehlers-Danlos syndrome, Marfan syndrome)
* patient with or after malignant disease of the uterus, ovaries, vagina and vulva
* former surgery due to stress incontinence (except for the patients who had a TVT insert with removal of the TVT)
* Descensus genitalis\> POPQ Stage 1
* former surgery due to a genital lowering with vaginal netting

Primary outcomes:
measure: Quality of life
timeFrame: 6 month
Secondary outcomes:
Other outcomes:
Locations:
city: Tübingen
country: Germany
facility: Department for Women's Health
Study officials:
affiliation: University Women's Hospital Tübingen
name: Christl Reisenauer, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06688019: A Comparison of High-flow Nasal Oxygen and Conventional Nasal Cannula in Monitored Anesthesia Care for Endoscopic Submucosal Dissection
Official title: A Comparison of High-flow Nasal Oxygen and Conventional Nasal Cannula in Monitored Anesthesia Care for Endoscopic Submucosal Dissection
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Patients Undergoing Endoscopic Submucosal Dissection
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2024-11-14
Enrollment: 200
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Arm 1: conventional nasal cannula group Arm 2: high-flow humidified oxygen-delivery system (OptiFlow THRIVE) group
Primary purpose: PREVENTION

Brief summary: Sedation for endoscopic submucosal dissection places patients at risk of desaturation, and high-flow nasal oxygen may reduce the risk. The aim of this study is to evaluate the role of high-flow nasal oxygen during endoscopic submucosal dissection. We will compare the incidence of hypoxemia (defined as SpO2 lower than 90%) of conventional nasal oxygen cannula group and that of high-flow humidified oxygen-delivery system group during the procedure.


Eligibility criteria: Inclusion Criteria:

* patients who will undergo endoscopic sumucosal dissection under remimazolam-based sedation

Exclusion Criteria:

* dementia or cognitive dysfunction
* altered mental status
* intubated patients or tracheostomy
* pregnancy
* recent history of nasal bleeding
* contraindication for positive pressure ventilation
* patients under oxygen therapy
* illiteracy or foreigner

Primary outcomes:
measure: The incidence of hypoxemia (SpO2 lower than 90%) measured with pulse oximetry during the procedure
timeFrame: during the procedure (from the start to the end of the endoscopic submucosal dissection), 1hour
Secondary outcomes:
measure: the number and duration of hypoxemia
timeFrame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour
measure: the lowest SpO2 during procedure
timeFrame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour
measure: need for airway intervention
timeFrame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour
measure: the end tidal CO2 at the end of the procedure
timeFrame: during the procedure (from the start to the end of the endoscopic retrograde cholangiopancreatography), 1hour
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03165019: Time Course and Prognostic Significance of Pulmonary Artery Pressure in Highlanders.
Official title: Time Course and Prognostic Significance of Pulmonary Artery Pressure in Highlanders.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Altitude Pulmonary Hypertension
Sleep Apnea
Keywords: high altitude illness
pulmonary hypertension
sleep apnea
disease progression
hypoxia
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
First posted: 2017-05-24
Enrollment: 165
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Highlanders with high altitude pumonary hypertension living at an altitude of 2500-4000 m; healthy highlanders living at an altitude of 2500-4000 m; healthy lowlanders living at an altitude of \<1000 m.

Brief summary: The purpose of the current study is to evaluate the clinical and physiologic course of Kyrgyz highlanders with high altitude pulmonary hypertension (HAPH) by performing a longitudinal cohort study. To this end, the investigators will invite the same highlanders who participated in the study in 2012 to undergo follow-up examinations in 2017, in order to allow comparisons of current results with baseline data from 2012.


Eligibility criteria: Inclusion Criteria:

* high altitude pulmonary hypertension confirmed by clinical presentation and mean pulmonary artery pressure \>30 mmHg measured by echocardiography at altitude of residence.
* healthy subjects (high altitude controls)
* Both genders
* Age \>16 y
* Kyrgyz ethnicity
* born, raised and currently living at \>2500 m
* healthy subjects currently living at \<1000 m (low altitude controls)

Exclusion Criteria:

* Pulmonary hypertension from other causes, in particular from left ventricular failure as judged clinically and by echocardiography
* Excessive erythrocytosis
* Other coexistent disorders that may interfere with the cardio-respiratory system and sleep
* Regular use of medication that affects control of breathing
* Heavy smoking

Primary outcomes:
measure: Changes in pulmonary artery pressure
timeFrame: Year 2012 to 2017
Secondary outcomes:
measure: Changes in nocturnal arterial oxygen saturation
timeFrame: Year 2012 to 2017
measure: Survival
timeFrame: Year 2012 to 2017
measure: Progression of oxygen desaturation index
timeFrame: Year 2012 to 2017
measure: Progression of quality of life
timeFrame: Year 2012 to 2017
measure: Progression of cognitive performance
timeFrame: Year 2012 to 2017
measure: Exercise performance
timeFrame: Year 2012 to 2017
measure: Arterial blood gas analysis
timeFrame: Year 2012 to 2017
Other outcomes:
Locations:
city: Bishkek
country: Kyrgyzstan
facility: National Center for Cardiology and Internal Medicine
Study officials:
affiliation: NCCIM
name: Talant M Sooronbaev, MD
role: PRINCIPAL_INVESTIGATOR
References: