louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00199264: Efficacy Vulvovaginitis Candida
Official title: A Single-Blind, Randomized, Dose-Finding Study Versus Fluconazole to Assess the Efficacy and Tolerability of Five Single Doses of Albaconazole in the Treatment of Acute Non-Recurrent Candida Spp Vulvovaginitis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Candidiasis Vulvaginitis
Keywords: antifungal oral therapy
efficacy acute candidiasis vulvaginitis
Lead sponsor: J. Uriach and Company
Sponsor class: INDUSTRY
First posted: 2005-09-20
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To compare the therapeutic efficacy of 10 mg, 40 mg, 80 mg, 160 mg and 320 mg of albaconazole, as a single oral dose, in women affected by acute non-complicated vulvovaginitis due to Candida spp.

Detailed description: Multi-center, open-label, randomized study, controlled with fluconazole.

Eligibility criteria: Inclusion Criteria:

* Ambulatory patients over 18 years of age, with a vaginal score sum ³ 2 and KOH fresh examination positive for yeasts (hyphae, pseudohyphae). The diagnosis must be later confirmed with a positive Candida spp. culture.

Exclusion Criteria:

* Patients with recurrent disease, prior treatment with antifungal agents within the last 7 days, immunosuppression, pregnant or lactating women, other vulvovaginal diseases, other systemic diseases, hypersensitivity to azole derivatives.Number of patients: 78 patients included to obtain 60 evaluable patients

Primary outcomes:
measure: Primary Efficacy VariableThe primary efficacy assessment will be carried out 24 ± 4 (FV) days following treatment or at the last patient's.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hosp Infecciosas F J Muñiz, Buenos Aires. Argentina
name: Ricardo Negroni, Dr
role: STUDY_CHAIR
References:
Clinical trial NCT04289064: Artificial Intelligence System for Assessing Image Quality of Fundus Images and Its Effects on Diagnosis
Official title: Artificial Intelligence System for Assessing Image Quality of Fundus Images and Its Effects on Diagnosis: A Clinical Trial
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Retinal Diseases
Artificial Intelligence
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2020-02-28
Enrollment: 300
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inclusion Criteria:

* Patients should be aware of the contents and signed for the informed consent.

Exclusion Criteria:

* 1. Patients who cannot cooperate with a photographer such as some paralytics, the patients with dementia and severe psychopaths.
* 2. Patients who do not agree to sign informed consent.

Brief summary: Fundus images are widely used in ophthalmology for the detection of diabetic retinopathy, glaucoma and other diseases. In real-world practice, the quality of fundus images can be unacceptable, which can undermine diagnostic accuracy and efficiency. Here, the researchers established and validated an artificial intelligence system to achieve automatic quality assessment of fundus images upon capture. This system can also provide guidance to photographers according to the reasons for low quality.


Eligibility criteria: Inclusion Criteria:

* Patients should be aware of the contents and signed for the informed consent.

Exclusion Criteria:

* 1. Patients who cannot cooperate with a photographer such as some paralytics, the patients with dementia and severe psychopaths.
* 2. Patients who do not agree to sign informed consent.

Primary outcomes:
measure: Performance of artificial intelligence system for distinguish between good image quality and poor image quality
timeFrame: 3 months
Secondary outcomes:
measure: The comparison of the performance for previous artificial intelligence diagnostic system with fundus images of different image quality
timeFrame: 3 months
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun Yat-sen University
state: Guangdong
Study officials:
References:
Clinical trial NCT01460264: An Open Prospective Longitudinal Pulmonary-cardiovascular Cohort Study
Official title: BIG3 - An Open Prospective Longitudinal Pulmonary-cardiovascular Cohort Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Chronic Obstructive Pulmonary Disease
Cardiovascular Diseases
Lung Cancer
Keywords: Prospective Cohort Study
Respiratory Function Tests
Computed Tomography
Electrocardiography
Peripheral Arterial Disease
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2011-10-26
Enrollment: 10000
Sex: ALL
Minimum age (years): 45
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Community sample,residents in Skåne county Sweden.

Brief summary: This is an observational study aiming to identify and validate biomarkers (including imaging and clinical descriptors) for chronic obstructive pulmonary disease (COPD), cardiovascular disease (CVD) and lung cancer.


Eligibility criteria: Inclusion Criteria:

* 45-75 years

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Lund
country: Sweden
facility: Skåne University Hospital
Study officials:
affiliation: Skane University Hospital
name: Louise Hagman Bennet, MD, PhD
role: STUDY_CHAIR
affiliation: Skane University Hospital
name: David Erlinge, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skane University Hospital
name: Claes-Göran Löfdahl, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Skane University Hospital
name: Maria Planck, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gerhardsson de Verdier M. The big three concept: a way to tackle the health care crisis? Proc Am Thorac Soc. 2008 Dec 1;5(8):800-5. doi: 10.1513/pats.200806-058TH.
Clinical trial NCT02068664: An Assessment of the Prevalence of Spatial Neglect in Stroke Survivors With Aphasia
Official title: An Assessment of the Prevalence of Spatial Neglect in Stroke Survivors With Aphasia With Option of Prism Adaptation Treatment (PAT) Protocol
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Spatial Neglect
Aphasia
Stroke
Keywords: spatial neglect
aphasia
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2014-02-21
Enrollment: 60
Sex: ALL
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: Stroke survivors with aphasia and spatial neglect

Brief summary: The purpose of this study is to determine if stroke survivors with aphasia have spatial neglect (Phase 1). If they are determined to have the condition Phase 2 will be offered: which is prism adaptation treatment. This is a pilot study that will be performed with 4-5 subjects.

Detailed description: Spatial neglect is a disorder that may occur after a brain injury such as stroke. Spatial neglect may affect stroke recovery. One example of this heterogeneous condition: Individuals with spatial neglect often pay more attention to one side of what they are looking at, even though they have no difficulty seeing. The study investigators would like to screen stroke survivors with aphasia because they may also have spatial neglect (right neglect after left hemisphere stroke), which is said by the literature to occur in 25% of cases. If it is identified, a treatment approach will be offered, to attempt to remediate the condition using prism goggles, following a prism treatment protocol based on previous studies.

Eligibility criteria: Inclusion Criteria:

* A stroke survivor with aphasia who is a member at the Adler Aphasia Center

Exclusion Criteria:

* Has a history of brain tumor, head injury with loss of consciousness, dementia, alzheimers

Primary outcomes:
measure: Kessler Foundation Neglect Assessment Process
timeFrame: 2 weeks
Secondary outcomes:
measure: Behavior Inattention Test
timeFrame: 2 weeks
measure: Barthel Index
timeFrame: 2 weeks
measure: University of Alabama at Birmingham (UAB) Life Space assessment
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Maywood
country: United States
facility: Adler Aphasia Center
state: New Jersey
Study officials:
affiliation: Kessler Foundation/Kessler Institute for Rehabilitation
name: Kimberly Hreha, OT
role: PRINCIPAL_INVESTIGATOR
affiliation: Kessler Foundation
name: A.M. Barrett, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05217264: Adaptation of High Activity Arthroplasty Score to Turkish
Official title: Reliability and Validity of the Turkish Version of the High Activity Arthroplasty Score
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arthropathy
Surgery--Complications
Physical Disability
Lead sponsor: Harran University
Sponsor class: OTHER
First posted: 2022-02-01
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The patients with a total or unicompartmental knee prosthesis.

Brief summary: The objectives of this study were the translation, cross-cultural adaptation, and assessment of the psychometric properties of the Turkish High-Activity Arthroplasty Score (HAAS) in patients with primary TKA.

Detailed description: The purpose of this study is to translate and cross-culturally adapt the HAAS instrument into Turkish and investigate its psychometric properties. For cross-cultural adaptation, two bi-lingual translators used the back-translation procedure. Within a 5-to-7-day period after the first assessment, the participants will complete the Turkish version of HAAS to evaluate test-retest reliability. Cronbach's alpha (α) will use to assess internal consistency. The correlations with the Turkish version of the KOOS, SF-36 and FJS-12 will determine to check the validity.

Eligibility criteria: Inclusion Criteria:

1. Primary THA/TKA due to primary osteoarthritis for \>6 months,
2. Age \<65
3. To be able to communicate in Turkish
4. Agree to participate in the study

Exclusion Criteria:

1. who do not agree to participate in the study 2- who will undergo 2nd revision TKA 3- who have undergone lower extremity surgery and thus have sequelae 4-having cognitive impairment

Primary outcomes:
measure: High-Activity Arthroplasty Score
timeFrame: Baseline,
Secondary outcomes:
measure: The Knee Injury and Osteoarthritis Outcome Score (KOOS)
timeFrame: Baseline
measure: SF-36
timeFrame: Baseline
measure: Forgotten Joint Score
timeFrame: Baseline
measure: High-Activity Arthroplasty Score
timeFrame: Within a 3-to-5-day period after the first assessment (Second assessment)
Other outcomes:
Locations:
city: Şanlıurfa
country: Turkey
facility: Harran University
Study officials:
affiliation: Harran University
name: Zeynal YASACI, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06382064: Evaluation of Wear Experience With One Week Reusable Contact Lenses in Habitual Two Week Reusable Lens Wearers
Official title: Evaluation of Wear Experience With PRECISION7® Contact Lenses in Habitual Acuvue® Oasys® Lens Wearers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Myopia
Keywords: Contact Lenses
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2024-04-24
Enrollment: 71
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects will be fit into Acuvue Oasys contact lenses at the first visit to wear for 2 weeks. Subjects will then be fit into PRECISION7 lenses at the second visit to wear for 2 weeks.
Primary purpose: TREATMENT

Brief summary: This open-label study is of current Acuvue® Oasys® wearers (2 - week replacement, reusable lenses) who are satisfied with their current lenses. Subjects will be refit into one week reusable contact lenses and will wear lenses for approximately 2 weeks. Subjects will return for vision and lens fit assessments and will complete surveys about their wear experience.


Eligibility criteria: Inclusion Criteria:

1. At least 18 years of age
2. Ability to give informed consent
3. Current Acuvue® Oasys® spherical lens wearer.
4. Distance visual acuity of 20/25 or better with current contact lenses in each eye.
5. Good general health defined by, medication use that has not changed within the last 30 days and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the Investigator.
6. Willing to spend time for the study, which includes: attend three study visits and wear contact lenses on days between study visits.

Exclusion Criteria:

1. Current or active ocular inflammation or infection as determined by the Investigator.
2. Currently pregnant or lactating. (Participants will be asked to self-report these conditions).
3. Systemic inflammatory disease (i.e. Diabetes, etc.) that could confound study results in the opinion of the investigator.

Primary outcomes:
measure: Subjective Assessment of Lens Wear Experience
timeFrame: After 2 weeks of wear in the 1-week replacement reusable lenses.
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University College of Optometry
state: Ohio
Study officials:
References:
Clinical trial NCT01405664: the Effect of Weight Bearing Status on Healing and Pain Outcomes After Surgery for Osteochondral Defects of the Ankle
Official title: A Randomized, Controlled Clinical Trial to Evaluate the Effect on Patient Outcomes of Weight Bearing Status After Forage of Osteochondral Defects of the Ankle
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteochondritis Dissecans of Ankle and Joints of Foot
Lead sponsor: Nova Scotia Health Authority
Sponsor class: OTHER
First posted: 2011-07-29
Enrollment: 68
Sex: ALL
Minimum age (years): 16
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The rationale for this research study is to evaluate the effect on clinical outcomes of weight bearing as tolerated after forage surgery for the treatment of osteochondral defects of the ankle, thus potentially eliminating the need for a period of immobilisation or non-weight bearing after surgery.

The investigators hypothesize that their will be no difference in functional outcomes between weight bearing as tolerated as compared to non-weight bearing for six weeks after forage surgery for OCD of the ankle.

Detailed description: The hypothesis for advantage of the investigational post-operative therapy is based on:

Equivalent clinical outcomes to non-weight bearing; Similar radiographic findings on CT at follow-up visit between the two groups; reduced morbidity and disability to subjects through elimination of a period of non-weight bearing; reduction of cost to patients by eliminating need for adjuvant walking and mobility aids (crutches, taxis) and time off work.

Eligibility criteria: Inclusion Criteria:

* Patients aged 16-60 years
* No prior ankle surgery
* Able and willing to comply with follow-up
* Capable of provide informed consent
* Medically fit for surgery
* Lesions on preoperative CT Scan \< 1.5cm
* Symptomatic (ie:pain, restricted activities, inability to WB, decreased ROM)
* Single Isolated lesion
* Failure of conservative treatment (3 months of limited activities and/or weight bearing and/or immobilization)

Exclusion Criteria:

Age less than 16 years or greater than 60 years

* Inflammatory arthritis
* Diffuse osteoarthritis of affected joint
* Associated fracture
* Prior ankle surgery for current injury (including arthroscopy)
* Unable to comply with follow-up
* Unable to provide informed consent
* Bernt \& Hardy class IV (amenable to ORIF)
* Multiple osteochondral defects in one ankle or touching osteochondral lesions of tibia and talus
* Prior osteochondral defects of the affected ankle

Primary outcomes:
measure: Ankle Osteoarthritis Scale
timeFrame: 12 months
Secondary outcomes:
measure: CAT Scan
timeFrame: 12months
Other outcomes:
Locations:
city: Halifax
country: Canada
facility: Queen Elizabeth II Health Sciences Centre, Halifax Infirmary
state: Nova Scotia
Study officials:
affiliation: Nova Scotia Health Authority
name: Mark Glazebrook, MD,FRCSC
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02569164: Cardiovascular Risks and Urinary Albumin Excretion(UAE) in Polycystic Ovarian Syndrome (PCO)
Official title: Urinary Albumin Excretion in Women With Polycyclic Ovary Syndrome and it's Relation to Cardiovascular Risk Factors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Urinary Albumin Excretion
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2015-10-06
Enrollment: 50
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: PCO patients

Brief summary: PCO patients will be assessed clinically,urine \& blood samples will be tested. Systolic \& diastolic blood pressure, serum glucose \& insulin levels, lipid profile, C-reactive protein, complete hormonal profile, and Urinary albumin excretion will be measured.

Detailed description: PCO patients with 2 of 3 criteria: oligo- or anovulation ; hyperandrogenism \&polycystic ovaries. Exclusion criteria: pregnancy, diabetes, hypertension , adrenal \& thyroid dysfunction.

Blood samples after overnight fast (8hrs) at day 2 or 3 of menstrual cycle. Serum concentration of follicle stimulating hormone (FSH), luteinizing hormone (LH), prolactin, total testosterone \& sex hormone binding globulin, serum 17-hydroxy (OH) progesterone \& dehydroepiandrosterone sulfate will be measured.

Oral glucose tolerance test \& plasma insulin levels will be measured. Total cholesterol, triglycerides, high\& low density lipoproteins. Urinary albumin will be measured\& all the data will be analysed.

Eligibility criteria: Inclusion Criteria:

* PCO patients

Exclusion Criteria:

* pregnancy
* diabetes
* hypertension
* adrenal dysfunction
* thyroid dysfunction

Primary outcomes:
measure: Number of patients with hyperinsulinemia (uIU/ml)
timeFrame: 3 months
measure: Number of patients with hyperlipidemia (mg/dl).
timeFrame: 3 months
measure: Number of patients with albuminuria(ug/ml)
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: kasrelaini
name: suzy abdelaziz, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03286764: Use of Peppermint Oil During Screening Colonoscopy to Improve Visibility
Official title: Use of Peppermint Oil During Screening Colonoscopy to Improve Visibility
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enhancement of the ADR During Colonoscopy
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2017-09-18
Enrollment: 48
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The investigators hypothesize that spraying peppermint oil containing L-menthol onto the colonic mucosa during colonoscopy will relax smooth muscle allowing better colonic visualization.


Eligibility criteria: Inclusion Criteria:

* Screening colonoscopy
* Age 50 years and older
* Able to give consent

Exclusion Criteria:

* No consent obtained or adult lacking capacity to consent
* Do not reach cecum on colonoscopy
* Renal impairment (defined as CrCl \<30 ml/min)
* Allergy to study peppermint oil solution
* History of colon resection
* Inflammatory bowel disease
* Known colorectal neoplasia
* Non-correctable coagulopathy
* Pregnancy or lactating
* Prisoners

Primary outcomes:
measure: Determination of Adenoma Detection Rate during Colonoscopy Procedure
timeFrame: 2 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Kevin C Ruff
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06701864: Palpation Versus Ultrasonography for Identifying the Cricothyroid Membrane of Distorted Neck-anatomy
Official title: Palpation Versus Ultrasonography for Identifying the Cricothyroid Membrane of Distorted Neck-anatomy
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Airway Management
Identification of the Cricothyroid Membrane
Keywords: Airway Management
Ultrasound
Palpation
Cricothyroid membrane
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised to either "palpation" or "ultrasonography"

The participants are thus randomised to use either "palpation" or to use "ultrasonography" to DIAGNOSE the position of the cricothyroid membrane
Primary purpose: DIAGNOSTIC

Brief summary: Participants will be anesthesiologists, who will identify the cricothyroid membrane on a silicone model of the neck with either palpation or ultrasonography.

The participants can choose either the "String of pearls" or Thyroid-Airline-Cricoid-Airline (TACA) for the ultrasonographic method to be used .

The silicone model of the neck is distorted with with the larynx deviated to one of the sides to simulate a patient with neck pathology.

Detailed description: Participants will be anesthesiologists, who will identify the cricothyroid membrane on a silicone model of the neck with either palpation or ultrasonography.

The participants can choose either the "String of pearls" or Thyroid-Airline-Cricoid-Airline (TACA) for the ultrasonographic method to be used .

The silicone model of the neck is distorted with with the larynx deviated to one of the sides to simulate a patient with neck pathology.

The test persons are randomized to use other palpation or ultrasonography. All attempts are video-taped.

Eligibility criteria: Inclusion Criteria:

* Participants in a airway management course

Exclusion Criteria:

* Unwillingness to participate

Primary outcomes:
measure: Correct identification of the cricothyroid membrane within a minute
timeFrame: Within 1 minute during procedure
Secondary outcomes:
measure: Correct identification of the sagittal plane within the airway
timeFrame: Within 1 minute during procedure
Other outcomes:
Locations:
Study officials:
References: