louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02753803: Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5 mg and Pioglitazone 30 mg
Official title: A Randomized, Open-label, Multiple Dosing, Three-way Crossover Clinical Trial to Investigate the Pharmacokinetic/Pharmacodynamic Drug-drug Interaction of Evogliptin 5 mg and Pioglitazone 30 mg
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Type 2 Diabetes
Lead sponsor: Dong-A ST Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2016-04-28
Enrollment: 36
Sex: MALE
Minimum age (years): 19
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: A randomized, open-label, multiple dosing, three-way crossover clinical trial to investigate the pharmacokinetic/pharmacodynamic drug-drug interaction of evogliptin 5 mg and pioglitazone 30 mg after oral administration in healthy male subjects

Detailed description: A randomized, open-label, multiple-dose, three-treatment, three-period, six-sequence, crossover study

Eligibility criteria: Inclusion Criteria:

* Healthy Male Volunteers (Age: 19\~45years)
* 55\<Body Weight\<90, 18\<BMI\<27
* FPG: 70-125 mg/dL

Exclusion Criteria:

* galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Clinically significant Medical History
* Allergy or Drug Hypersensitivity
* AST(SGOT), ALT(SGPT) \> Upper Normal Range\*1.5, eGFR\<80 mL/min
* Drink during clinical trial period
* Smoking during clinical trial period
* Grapefruit/Caffeine intake during clinical trial period
* No Contraception

Primary outcomes:
measure: AUC
timeFrame: 1d~6d pre-dose, 15d~20d pre-dose, 29~34d pre-dose, 7d/21d/35d pre-dose and post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Clinical Trials Center, Seoul National University Hospital
Study officials:
affiliation: Clinical Trials Center, Seoul National University Hospital
name: Kyung-Sang Yu, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06253403: Sexual Dysfunction and Anorexia Nervosa
Official title: Exploring Sexual Dysfunction in Women Affected by Anorexia Nervosa: Initial Insights
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Anorexia Nervosa
Keywords: sexual dysfunction, anorexia nervosa, women, libido
Lead sponsor: Comenius University
Sponsor class: OTHER
First posted: 2024-02-12
Enrollment: 89
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects within the clinical group are women diagnosed with either AN or a history of anorexia nervosa

Brief summary: The objective of this observational study is to investigate the potential influence of anorexia nervosa on the sexual health of women. The primary focus is to determine the presence of sexual dysfunction in individuals with anorexia nervosa and explore any potential correlation between eating disorders and sexual dysfunction. To facilitate comparison, data from a control group comprising healthy women is incorporated alongside the clinical group data.

Detailed description: numerous studies indicate that women diagnosed with anorexia nervosa experience a discernible impact on their sexual well-being, often accompanied by symptoms of sexual dysfunction (SD). Such dysfunction may manifest as a diminished libido, reduced sexual desire, and challenges in achieving orgasm

Eligibility criteria: Inclusion Criteria:

clinic group :

* adult
* women
* diagnosis of anorexia nervosa
* from Slovakia and Czech Republic

control group:

* health women
* adult
* from Slovakia and Czech Republic

Exclusion Criteria:

clinic group:

* health women
* other diagnosis or disorder
* other country

control group:

* presence of some mental illness
* other country

Primary outcomes:
measure: Female Sexual function index (FSFI)
timeFrame: 1 day
Secondary outcomes:
measure: The Eating Disorder Examination - Questionnaire Short (EDE-QS
timeFrame: 1 day
Other outcomes:
Locations:
city: Bratislava
country: Slovakia
facility: Tatiana Hess
Study officials:
References:
Clinical trial NCT00320203: Anecortave Acetate in Patients With Open-angle Glaucoma
Official title: A Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Open-angle Glaucoma
Keywords: open-angle
glaucoma
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2006-05-03
Enrollment: 86
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: The purpose of this study is to evaluate the safety, efficacy, and duration of effect of a single administration of Anecortave Acetate Depot for treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma.


Eligibility criteria: Inclusion Criteria:

* Patients 18 years of age or older with open-angle glaucoma.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* Patients with open-angle glaucoma with a pseudoexfoliation or pigment dispersion component.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean change in intraocular pressure at 9 am from baseline
timeFrame: Weeks 2 and 6, Months 2, 3, 4, 5, 6, 7.5, 9, 10.5, and 12
Secondary outcomes:
measure: Time to treatment failure
timeFrame: At time point
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Theresa Landry
role: STUDY_DIRECTOR
References:
Clinical trial NCT01556503: Sensitivity/Specificity Study of Non-invasive Imaging for Melanoma Diagnosis
Official title: Sensitivity/Specificity Study of Non-invasive Imaging for Melanoma Diagnosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Melanoma
Lead sponsor: OHSU Knight Cancer Institute
Sponsor class: OTHER
First posted: 2012-03-16
Enrollment: 24
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: The purpose of this study is to show how well a new device, confocal microscope, works to detect malignant melanoma, a type of skin cancer.


Eligibility criteria: Inclusion Criteria:

* Age 12 or older
* Patient who has already been selected by their dermatologist for biopsy of a suspicious pigmented lesion and who consents to participate in the study
* Signed informed consent

Exclusion Criteria:

* Age \< 12 years

Primary outcomes:
measure: Sensitivity of confocal microscope to improve melanoma detection
timeFrame: Up to 1 year
measure: Specificity of the confocal microscope to improve melanoma detection
timeFrame: Up to 1 year
Secondary outcomes:
measure: Patterns seen on the confocal image
timeFrame: Up to 1 year
Other outcomes:
Locations:
city: Portland
country: United States
facility: OHSU Knight Cancer Institute
state: Oregon
Study officials:
affiliation: OHSU Knight Cancer Institute
name: Eric Simpson
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06439303: Analysis and Evaluation of Smoking Treatment With Cytisine
Official title: Analysis and Evaluation of Smoking Treatment With Cytisine: Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Moderate or Severe Tobacco Use Disorder
Lead sponsor: Regina Elena Cancer Institute
Sponsor class: OTHER
First posted: 2024-06-03
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who have referred to the Anti-smoking Center of the IRE, National Cancer Institute "Regina Elena", and that meet the following criteria.

Brief summary: The lack of clinical studies on the use of Cytisine in the treatment of the cessation of smoking, the need to find effective therapeutic alternatives and the opportunity to reduce costs related to the complications of cigarette smoking, represent the main reasons that led to the design of this study.

Detailed description: The study is observational, retrospective and monocentric, and aims to evaluate patients who performed an initial pneumological examination at the Anti-Smoking Center of the National Institute Regina Elena tumors due to smoking cessation in the reference period. To such patients, affected of moderate or severe tobacco use disorder, drug therapy was prescribed with Cytisine 1.5 mg, with the aim of evaluating treatment adherence, efficacy and tolerability of Cytisine as monotherapy in the treatment of moderate or moderate tobacco use disorder serious. Responding patients will be taken into consideration for the study consecutively to the criteria established and pertaining to the Anti-Smoking Center of the National Cancer Institute Regina Elena in the period between 02/01/2023 and 11/30/2023 on first and subsequent visits controls.

Eligibility criteria: Inclusion Criteria:

* patients aged \> 18 years;
* patients suffering from moderate or severe tobacco use disorder;
* prescription of pharmacological therapy with Cytisine;
* patients returned to the 1st check-up on schedule;

Exclusion Criteria:

* Patients with contraindications to taking Cytisine and partial receptor agonists nicotinic cholinergics;
* Patients undergoing pharmacological or physical treatment for neoplastic pathology;
* Pregnant or breastfeeding women;
* Patients for whom specific information for objective assessments is not available;

Primary outcomes:
measure: Therapeutic adherence
timeFrame: 3 months
Secondary outcomes:
measure: Evaluation of the effectiveness of the therapy.
timeFrame: 3 months
measure: Evaluation of therapeutic adherence in relation to motivation.
timeFrame: 3 months
measure: Assessment of adherence in relation to the dependency score physics.
timeFrame: 3 months
measure: Safety and Tolerability assessment.
timeFrame: 3 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: "Regina Elena" National Cancer Institute
Study officials:
References:
Clinical trial NCT00708903: Study to Examine the Effect of HKI-272 on Rhythms of the Heart (Cardiac Repolarization)
Official title: A Single Dose, Crossover, Placebo- and Moxifloxacin-Controlled Study of the Effects of HKI-272 on Cardiac Repolarization in Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: Thorough QTc study
Lead sponsor: Puma Biotechnology, Inc.
Sponsor class: INDUSTRY
First posted: 2008-07-02
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether HKI-272 affects the rhythms of the heart (cardiac repolarization).


Eligibility criteria: Inclusion Criteria:

* Men or women of nonchildbearing potential,
* 18-50 years old.
* Healthy as determined by the investigator, including physical examination, laboratory test results, and medical history.

Primary outcomes:
measure: QTc interval
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tacoma
country: United States
state: Washington
Study officials:
affiliation: Biotechnology
name: Puma
role: STUDY_DIRECTOR
References:
Clinical trial NCT05412303: Vaso-inotropic Score and ECMO-VA Support in Post-cardiotomy Cardiogenic Shock.
Official title: Vaso-inotropic Score and ECMO-VA Support in Post-cardiotomy Cardiogenic Shock.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: EMCO-VA
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2022-06-09
Enrollment: 2769
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Post cardiotomy cardiogenic shock

Brief summary: Veno-arterial extracorporeal membrane oxygenation (VA-ECMO) is a well-established lifesaving treatment for refractory cardiogenic shock, with or without concomitant respiratory failure. VA-ECMO is usually started in presence of refractory low cardiac output syndrome following CPB weaning. Currently, there is no consensus about the best timing for implantation and initiation of VA-ECMO in this setting. Some publications have suggested that VIS score could be used to determine the necessity of VA-ECMO in cardiologic area. It was demonstrated that a VIS score between 20 and 40 may be a cut-off value to discuss the implantation of VA-ECMO. Post cardiotomy shock is a very interesting setting because the timing of cardiogenic shock is known and several bias are more controlled than in medical area.

Based on the well-established ability of VIS Score in predicting mortality, we will investigate the role of the VIS Score as a determinant for early VA-ECMO implantation in patients suffering of post-cardiotomy cardiogenic shock.


Eligibility criteria: Inclusion Criteria:

* age over 18 years
* Cardiac surgery with cardiopulmonary bypass
* Post cardiotomy cardiogenic shock
* ECMO-VA implanted in OR

Exclusion Criteria:

* LVAD
* Heart transplantation
* Incomplete data in relation to outcomes
* Cardiac arrest

Primary outcomes:
measure: Pourcentage of death
timeFrame: Day 30
Secondary outcomes:
measure: 1 - Number of complications
timeFrame: Day 30
measure: 2 - number of days in intensive care
timeFrame: through study completion, up to 15 days
measure: 3 - number of days in hospital
timeFrame: through study completion, up to 3 months
Other outcomes:
Locations:
city: Dijon
country: France
facility: Chu Dijon Bourogne
Study officials:
References:
Clinical trial NCT03858543: Fractional Laser Assisted Delivery of Sculptra® for the Treatment of Striae
Official title: Fractional Laser Assisted Delivery of Sculptra® for the Treatment of Striae: FADeS Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Striae Distensae
Keywords: Stretch marks
Fractional laser therapy
Poly-L lactic acid
Sculptra
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
Collaborators: name: Galderma R&D
First posted: 2019-02-28
Enrollment: 10
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: This study evaluates the efficacy of treatment of striae distensae using the combined modality of fractional laser and poly-L lactic acid (Sculptra).

Detailed description: Striae Distensae (SD) is a form of scarring that can oftentimes be quite disfiguring and emotionally distressing to individuals.

Fractional laser therapy has been used by doctors to treat stretch marks by stimulating collagen growth.

Poly-L lactic acid also promotes collagen growth in the areas injected.

The combination of laser and poly-L lactic acid might provide the optimal treatment modality for SD by decreasing the appearance of atrophic scars.

Eligibility criteria: Inclusion Criteria:

* Subject has bilateral striae alba
* Subject has stable body weight for at least 6 months with Fitzpatrick skin type 1-4

Exclusion Criteria:

* Subject has striae rubra
* Pregnant
* History of adverse effects to phototherapy
* Subject has single sided lesions
* Subject has immunosuppression
* Subject has radiation therapy to the study area
* Subject has topical or oral steroid use or chemotherapy within the last 6 months
* History of keloids or hypertrophic scar

Primary outcomes:
measure: Change in Stretch Mark Size
timeFrame: Baseline (Pre-treatment) vs. 3 Months, 4 Months, 5 Months, 6 Months
Secondary outcomes:
measure: Treatments Superiority Assessment
timeFrame: 3 Months
measure: Treatments Superiority Assessment
timeFrame: 4 Months
measure: Treatments Superiority Assessment
timeFrame: 5 Months
measure: Treatments Superiority Assessment
timeFrame: 6 Months
Other outcomes:
Locations:
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
Study officials:
References:
Clinical trial NCT05670743: Pharmacokinetics of Advantage Arrest in Healthy Children 13-Months to 13-Years of Age
Official title: Pharmacokinetics of Advantage Arrest in Healthy Children 13-Months to 13-Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Dental Caries in Children
Keywords: pharmacokinetics
Lead sponsor: Advantage Silver Dental Arrest, LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Washington
First posted: 2023-01-04
Enrollment: 23
Sex: ALL
Minimum age (years): 13
Maximum age (years): 13
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: This is a topical agent where the active ingredients are applied to the teeth and eventually swallowed and may be absorbed through the GI tract or excreted. Minimal amounts are absorbed through the oral mucosa. Serum concentrations of silver and fluoride will be be proportional to the dose of silver and fluoride administered topically to the teeth as part of Advantage Arrest.
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to further characterize basic pharmacokinetic (PK) parameters in healthy children to contribute to evidence for the safety of silver diamine fluoride (SDF; Advantage Arrest). Children with at least one active cavity will be treated and then have blood draws at random time points afterwards.

Detailed description: The FDA requested additional data to evaluate the pharmacokinetics of silver diamine fluoride (SDF, Advantage Arrest) in children 13 months to 13 years old. The first request is for children under 36 months of age to be included in a study. The second request is for serum silver concentration be evaluated for a longer duration post-application to better estimate the half-life of silver and return of serum silver to baseline levels in children.

Eligibility criteria: Inclusion Criteria:

* At least one untreated caries lesion into the dentin
* Live within 10 miles of study site

Exclusion Criteria:

* oral mucositis
* ulcerative oral lesions
* hypersensitivity to silver or fluoride
* history of treatment with silver diamine fluoride within 3 months

Primary outcomes:
measure: Fluoride Cmax
timeFrame: 21 days
measure: Silver Cmax
timeFrame: 21 days
measure: Fluoride Tmax
timeFrame: 21 days
measure: Silver Tmax
timeFrame: 21 days
measure: Area Under Curve, Fluoride
timeFrame: 21 days
measure: Area Under Curve, Silver
timeFrame: 21 days
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Center for Pediatric Dentistry
state: Washington
Study officials:
affiliation: University of Washington
name: Travis Nelson, DDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02675543: Vitreous Inflammation in Standard and Heavy Silicone Oil
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Vitreous Inflammation
Lead sponsor: Università degli Studi di Brescia
Sponsor class: OTHER
First posted: 2016-02-05
Enrollment: 70
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: The inflammatory response after prolonged retinal detachment and after vitreoretinal surgery has its apex in the development of PVR that occurs when retinal cells are exposed to the inflammatory milieu in the humor vitreous.

This situation is common in complicated retinal detachment, but is amplified after invasive surgery and by the use of intraocular tamponades that float over a subtle film of liquid where the inflammatory cytokines and growth factors reach the critical concentration over the inferior retina.

Many authors have noted that the heavy tamponade are more prone to cause intraocular inflammation compared to standard silicone oil, especially if they remain for several months in the eye.

The purpose of this study is to measure the vitreous concentration of some of the most important cytokines involved in the inflammatory vitreal response.


Eligibility criteria: Inclusion Criteria:

* patient scheduled for vitrectomy

Exclusion Criteria:

* diabetic retinopathy
* uveitis

Primary outcomes:
measure: Vitreous Prostaglandin E2 Levels
timeFrame: intraoperarive
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Schwartz SG, Flynn HW Jr, Wang X, Kuriyan AE, Abariga SA, Lee WH. Tamponade in surgery for retinal detachment associated with proliferative vitreoretinopathy. Cochrane Database Syst Rev. 2020 May 13;5(5):CD006126. doi: 10.1002/14651858.CD006126.pub4.
Clinical trial NCT04079543: NPO and Patient Satisfaction in the Cath Lab
Official title: Randomized Controlled Trial of Liberalized NPO Status to Improve Patient Satisfaction in Patients Undergoing Procedures in the Cardiac Catheterization Lab
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Patient Satisfaction
Dehydration
Physiological Effects Secondary to Dehydration
Keywords: Nil per os (NPO)
TAVR
arrhythmia ablation
Lead sponsor: Stony Brook University
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized (1:1) into one of the two groups: Strict NPO (NPO after midnight) or liberal NPO (clear liquids up to 2 hours prior to procedure).
Primary purpose: TREATMENT

Brief summary: The purpose of this randomized, control study is to compare liberal vs strict nil per os (NPO) policies on patients undergoing transcatheter aortic valve replacement (TAVR) or arrhythmia ablation. The primary objective of this study is to determine if allowing clear liquids up to 2 hours prior to elective TAVR or elective arrhythmia ablation procedure improves patient satisfaction.

Detailed description: After informed written consent, patients will be randomized into one of the two groups: Strict NPO (NPO after midnight) or liberal NPO (clear liquids up to 2 hours prior to procedure). All patients, regardless of study arm, will be allowed to take medications with a sip of water. All other peri-operative care will be routine. On the day of the procedure, a patient satisfaction survey will be completed and the procedure will be performed as routine.

Eligibility criteria: Inclusion Criteria:

* 18 years of age or older,
* patients planned to undergo trans-catheter aortic valve replacement or arrhythmia ablation at Stony Brook University Hospital
* ability to provide written informed consent

Exclusion Criteria:

* Age less than 18 years
* emergency procedure, dysphasia, nutrition administered via feeding tube (NG, PEG, etc.) or intravenously (total parenteral nutrition), gastroparesis,
* patients not alert and oriented to person, place, and date,
* concurrent surgical procedures on the day of TAVR or arrhythmia ablation.

Primary outcomes:
measure: Patient Satisfaction: survey
timeFrame: Up to 24 hours
Secondary outcomes:
measure: Exploratory Analyses
timeFrame: Through the end of hospitalization, usually 2 days.
Other outcomes:
Locations:
Study officials:
References: