louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00878839: Investigation of Corneal Aberrations and Visual Outcomes in Patients Implanted With an AcrySof Toric Intraocular Lens (IOL)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Cataracts
Astigmatism
Keywords: Cataract
Toric IOL
Corneal Aberration
Astigmatism
AcrySof
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2009-04-09
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: A prospective evaluation of postoperative corneal aberrations and visual parameters (e.g. visual acuity) in patients implanted with an AcrySof Toric IOL.


Eligibility criteria: Inclusion Criteria:

* Operable cataracts;
* Good ocular health;
* Qualifies for AcrySof Toric IOL via AcrySof Toric Calculator (1.03-2.06 D cylinder at corneal plane)

Exclusion Criteria:

* \>2.06 D astigmatism at corneal plane;
* irregular astigmatism;
* prior or ongoing corneal disease or scarring;
* history of ocular disease

Primary outcomes:
measure: Corneal Aberration
timeFrame: 3 months
Secondary outcomes:
measure: Visual acuity, residual refractive cylinder, lens alignment
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02731339: Spinal Curvature, Mobility, and Low Back Pain Relationship in Women With and Without Urinary Incontinence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Incontinence
Lead sponsor: Ataturk Training and Research Hospital
Sponsor class: OTHER
First posted: 2016-04-07
Enrollment: 73
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study was to investigate the relationship among sagittal spinal curvatures, mobility, and low back pain in women with and without urinary incontinence.


Eligibility criteria: Inclusion Criteria:

* aged between 20 and 65 years,
* diagnosed with stress and mixed urinary incontinence
* healthy women

Exclusion Criteria:

* Women with prior history of injury or surgery related to spine,
* spinal deformity,
* systemic pathology,
* any rheumatologic disease,
* neurologic condition,
* symptomatic pelvic organ prolapse,
* malignancy,
* pregnancy

Primary outcomes:
measure: Spinal curve and mobility, as measured by Spinal Mouse® device
timeFrame: spinal curve and mobility will be followed through study completion, an average of 3 months
Secondary outcomes:
measure: Low back pain, as measured by Visual Analog Scale
timeFrame: Low back pain will be followed through study completion, an average of 3 months
measure: Disability caused by low back pain, as measured by Oswestry Disability Index
timeFrame: Disability will be followed through study completion, an average of 3 months
measure: Urogenital symptoms, as measured by Urogenital Distress Inventory-6
timeFrame: Urogenital symptoms will be followed through study completion, an average of 3 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05570539: Assessment of the Pharmacokinetics of BLU-5937 Extended Release Prototypes and a BLU-5937 Immediate Release Reference Formulation
Official title: A Phase 1, Single-Centre, Open-Label, Two-Part, Sequential Cross-Over Study Designed to Assess the Pharmacokinetic Profile of BLU-5937 Following Administration of Extended Release Formulation Prototypes and an Immediate Release Reference Formulation in Healthy Male and Female Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Cough
Healthy
Lead sponsor: Bellus Health Inc. - a GSK company
Sponsor class: INDUSTRY
First posted: 2022-10-06
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a Phase 1, Single-Centre, Open-Label, Two-Part, Sequential Cross-Over Study Designed to Assess the Pharmacokinetic Profile of BLU-5937 Following Administration of Extended Release Formulation Prototypes and an Immediate Release Reference Formulation in Healthy Male and Female Subjects


Eligibility criteria: Inclusion Criteria:

* Healthy males or non-pregnant, non-lactating healthy females

Exclusion Criteria:

* History of clinically significant cardiovascular, renal, hepatic, metabolic, dermatological, respiratory, GI, neurological, endocrine, haematological, immunological or psychiatric disorder, as judged by the investigator.

Primary outcomes:
measure: Measurement of the maximum observed plasma drug concentration (Cmax)
timeFrame: Pre dose up to 36 hours post-dose
measure: Measurement of the minimum observed plasma drug concentration (Cmin)
timeFrame: Pre dose up to 36 hours post-dose
measure: Measurement of the area under the plasma drug concentration by time curve AUC
timeFrame: Pre dose up to 36 hours post-dose
measure: Measurement of the observed plasma drug concentration 24 hours post-dose (C24)
timeFrame: 24 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT02817139: Transcranial Direct Current Simulation in Chronic Migraine
Official title: Transcranial Direct Current Simulation Over Primary Motor vs Prefrontal Cortex in Chronic Migraine: a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Migraine Disorders
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2016-06-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a pilot, double-blind, placebo-controlled, randomized trial aiming to compare the effects of transcranial direct current stimulation in Chronic Migraine.

Detailed description: The patients will be randomized into 1 of 3 groups: active tDCS over primary motor cortex, active tDCS over prefrontal cortex, sham tDCS. Each group will receive treatment for 20 minutes a day, 3 days a week for 4 weeks.

Eligibility criteria: Inclusion Criteria:

* patients with a clinical diagnosis of chronic migraine according to the International Classification of Headaches Disorders (ICHD-3 beta) of the International Headache Society, with an established headache history occurring on 15 or more days per month-however, for at least 1 year, instead of only 3 months, as defined in the International Headache Society (IHS) guidelines.

Exclusion Criteria:

* headache attributable to some pathological condition, associated neurologic or neuropsychiatric disease, use of central nervous system modulating drugs, pregnancy, metallic head implants, and use of a cardiac pacemaker.

Primary outcomes:
measure: Change in quality of life associate to migraine assessed on the Headache Impact Test-6 (HIT-6)
timeFrame: Baseline (week 1) and Endpoint (week 4)
Secondary outcomes:
measure: Change in pain assessed on the Visual Analogue Scale (VAS)
timeFrame: Baseline (week 1) and Endpoint (week 4)
measure: Change in quality of life assessed on the Medical Outcomes Study 36 - Item Short - Form Health Survey(SF-36)
timeFrame: Baseline (week 1) and and Endpoint (week 4)
measure: Side Effects Questionnaire
timeFrame: From date of first neurostimulation until the date of last neurostimulation, , assessed up to 1 month
Other outcomes:
Locations:
city: João Pessoa
country: Brazil
facility: Suellen Andrade
state: PB
Study officials:
References:
Clinical trial NCT02545439: A Drug-drug Interaction Study of ALKS 5461 in Healthy Volunteers
Official title: A Phase 1 Study to Evaluate the Impact of CYP3A4 Induction on the Single Dose Pharmacokinetics of ALKS 5461
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteers
Keywords: Alkermes
Samidorphan
ALKS 5461
Healthy Volunteer
Pharmacokinetics
Lead sponsor: Alkermes, Inc.
Sponsor class: INDUSTRY
First posted: 2015-09-10
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will evaluate the impact of CYP3A4 induction on the single-dose pharmacokinetics of ALKS 5461.


Eligibility criteria: Inclusion Criteria:

* Has a body mass index (BMI) of 18.0 - 30.0 kg/m\^2
* Is in good physical health
* Agrees to use an approved method of contraception for the duration of the study
* Additional criteria may apply

Exclusion Criteria:

* Is currently pregnant or breastfeeding
* Has a lifetime history of substance abuse disorder
* Has used nicotine within 90 days prior to the study or anticipates a need to use nicotine during the study period
* Has used any prescription or over-the-counter medication, including natural health products or dietary supplements (with the exception or prescription contraceptives or hormonal replacements, acetaminophen, ibuprofen, or multivitamins) within 14 days prior to study start
* Has used opioids within 30 days prior to screening, or has an anticipated need for opioid medication at any point during the study
* Has used alcohol within 72 hours prior to any inpatient period
* Is a heavy caffeine drinker (regularly consuming 5 or more caffeinated beverages per day)
* Has a history of intolerance or hypersensitivity to opioids (buprenorphine) or opioid antagonists (naltrexone, naloxone)
* Additional criteria may apply

Primary outcomes:
measure: AUCinf
timeFrame: Up to 72 hours
measure: AUClast
timeFrame: Up to 72 hours
measure: Cmax
timeFrame: Up to 72 hours
Secondary outcomes:
measure: Safety and tolerability will be measured by the incidence of Adverse Events
timeFrame: UP to 27 days
Other outcomes:
Locations:
city: Overland Park
country: United States
facility: Alkermes Investigational Site
state: Kansas
Study officials:
affiliation: Alkermes, Inc.
name: Arielle Stanford, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT06870539: Feasibility of Saliva and Remote Monitoring of Active Cytomegalovirus (CMV) Infection and Symptoms During Ovarian Cancer Treatment
Official title: Feasibility of Saliva and Remote Monitoring of Active Cytomegalovirus (CMV) Infection and Symptoms During Ovarian Cancer Treatment
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer-related Cognitive Dysfunction
Cytomegaloviral Infection
Fallopian Tube Carcinoma
Ovarian Carcinoma
Primary Peritoneal Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2025-03-11
Enrollment: 28
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with ovarian cancer undergoing active treatment at the Mayo Clinic

Brief summary: This study evaluates the feasibility and accuracy of using saliva to remotely monitor cytomegalovirus (CMV) infection in individuals receiving treatment for ovarian cancer.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18
* Ability to read and write in English
* Diagnosed with ovarian cancer (ovarian, primary peritoneal, fallopian tube)
* Receiving care from providers at Mayo Clinic
* Regardless of diseases status, actively receiving treatment for ovarian cancer (frontline, maintenance, progression, recurrence)

Exclusion Criteria:

* Pregnant at the time of study participation
* Inability to provide informed written consent
* History of dementia, stroke, brain tumors or other condition which may impair cognitive functioning

Primary outcomes:
measure: Using saliva and blood samples to remotely monitor cytomegalovirus (CMV) infection
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota/Masonic Cancer Center
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Amanika Kumar, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02811939: Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone: Sub-Study I
Official title: Testing the Interactive Effects of Delta-9-Tetrahydrocannabinol and Pregnenolone: Sub-Study I
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Cannabis
Marijuana
THC
Dronabinol
Pregnenolone
PREG
Psychotic Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2016-06-23
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: The overall purpose of this study is to examine the effect of Pregnenolone (PREG) on the acute psychosis-like and cognitive effects of Delta-9-Tetrahydrocannabinol (THC). This will be tested by pretreating healthy individuals with PREG, and then assessing their responses to Dronabinol (THC).


Eligibility criteria: Inclusion Criteria:

* Exposed to cannabis at least once in lifetime

Exclusion Criteria:

* Cannabis naïve
* Individuals with a documented reaction/allergy to Pregnenolone
* Individuals with a documented reaction/allergy to Sesame oil

Primary outcomes:
measure: Change from Baseline: Positive and Negative Syndrome Scale (PANSS)
timeFrame: baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo
Secondary outcomes:
measure: Change from Baseline: Clinician Administered Dissociative Symptoms Scale (CADSS)
timeFrame: baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo
measure: Change from Baseline: Visual Analog Scale (VAS)
timeFrame: Baseline; 30 minutes and 10 minutes prior to administration of oral dronabinol or placebo; 20, 90, 110, 150, 180, and 240 minutes after the administration of oral dronabinol/placebo
measure: Change from Baseline: Psychotomimetic States Inventory (PSI)
timeFrame: baseline, 30, 110, 180, and 240 minutes after the administration of oral dronabinol/placebo
measure: Cognitive Test Battery
timeFrame: 25 minutes after Dronabinol is given orally
Other outcomes:
Locations:
city: West Haven
country: United States
facility: Biological Studies Unit at the VA Connecticut Healthcare System, Yale School of Medicine
state: Connecticut
Study officials:
affiliation: Yale Univerisity, School of Medicine
name: Deepak Cyril D'Souza, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04977739: Research on the Application and Mechanism of New Biological Probes in Biomedicine
Official title: Research on the Application and Mechanism of New Biological Probes in Biomedicine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tumors
Cardiovascular Diseases
Respiratory System Diseases
Digestive System Diseases
Endocrine System Diseases
Metabolic Diseases
Immune System Diseases
Urinary System Diseases
Nervous System Diseases
Blood Diseases
Infectious Diseases
Lead sponsor: Nanfang Hospital, Southern Medical University
Sponsor class: OTHER
First posted: 2021-07-27
Enrollment: 737
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: NanFang Hospital samples

Brief summary: Fluorescence is one of the most commonly used research and detection techniques in the field of biomedical science. The characteristics of fluorescent probe directly affect the performance and application of fluorescence analysis and imaging. Aggregation-Caused Quenching has limited the application of traditional fluorescent probes to some extent. This project intends to systematically evaluate the detection efficiency of new methods through the detection of biomarkers in clinical samples and the comparison with the detection methods of traditional biomarkers, so as to provide theoretical and experimental basis for the establishment of fast and simple biomarker detection technologies with new biological probes.


Eligibility criteria: Inclusion Criteria:

* Sign the informed consent form voluntarily.
* Age 18-70 years old.
* High expression (positive) group: The results of multiple laboratory tests indicate that the marker is higher than the normal range.
* Low expression (negative) healthy volunteer group: those with no underlying diseases and no abnormalities in the physical examination.
* Have routine examination to check the remaining body fluid samples, and the body fluid samples are not contaminated.

Exclusion Criteria:

* Accompanied by other inflammations.
* The data of the subject is not complete, or the collection of cases is incomplete due to other reasons.
* The researcher judged that it was not suitable to participate in this research.

Primary outcomes:
measure: signal intensity of the probes
timeFrame: one day
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Nanfang Hospital
state: Guangdong
Study officials:
affiliation: Nanfang Hospital, Southern Medical University
name: Bo Situ
role: STUDY_DIRECTOR
References:
Clinical trial NCT00482339: PCR-Based Detection of Bacterial Agents in Platelet Concentrates and Whole Blood
Official title: PCR-Based Detection of Bacterial Agents in Platelet Concentrates and Whole Blood (First Study)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: bacterial contamination
platelet concentrates
blood donation
looxster
pureprove
bacterial genomic DNA
bacterial contamination of platelet concentrates
Preparation of "bacterial DNA" in blood
comparison of blood culture versus NAT
Lead sponsor: University of Jena
Sponsor class: OTHER
First posted: 2007-06-05
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: OTHER

Brief summary: Using methods of molecular biology bacteria can be detected in blood. In comparison to conventional blood cultures "bacterial DNA" is isolated using a new sample preparation system in platelet apheresis concentrates and in the predonation whole blood of donors.

Detailed description: Bacterial contamination of platelet concentrates is discussed worldwide and according to literature occuring in 1:1000 to 1:5000 concentrates. Bacterial contaminated concentrates can in fact cause severe infections in patients. therefore this study initially intends to detect contamination with "bacterial DNA" in platelet aphereses concentrates. All sample donations are also examined by blood culture for contamination. To exclude already existing "infection" of the donor one tube of whole blood is taken in addition to the other legally required samples for the production of pharmaceutical medicine. All samples are anonymised before passed on for analysing.

Eligibility criteria: Inclusion Criteria:

* healthy platelet apheresis donor

Exclusion Criteria:

* Missing health clearance for blood donation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Jena
country: Germany
facility: Institute for Transfusion Medicine, University Hospital Jena
state: Thuringia
Study officials:
affiliation: University Hospital Jena, Germany
name: Dagmar Barz, Prof Dr med.
role: STUDY_DIRECTOR
References:
Clinical trial NCT05816239: LUng voluMe reductIoN by DuAl ENergy CT Evaluation (LUMINANCE) Study
Official title: LUng voluMe reductIoN by DuAl ENergy CT Evaluation (LUMINANCE) Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Lung Perfusion
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2023-04-18
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Up to 30 patients within the University Hospitals Health System

Brief summary: The purpose of this research study is to see if a special CT scan (dual-energy CT) provides useful information in patients undergoing bronchsoscopic lung volume reduction (valve placement for emphysema). The investigators will enroll up to 30 participants in this study from University Hospitals Cleveland Medical Center. All of the participants from this study will undergo their valve procedure at University Hospitals Cleveland Medical Center.


Eligibility criteria: Inclusion Criteria:

* Adult patients (≥ 18 years of age at the time of written informed consent) with emphysema who have been deemed appropriate candidates for bronchoscopic lung volume reduction

Exclusion Criteria:

* Patients unable to provide consent
* Patients who are pregnant or nursing
* Women of child-bearing age will undergo pregnancy tests based on University Hospital (UH) standard bronchoscopy pre-procedural testing
* Patients unable to undergo a DECT chest (contraindications to a CT chest with intravenous contrast such as a reported or documented allergy to intravenous (IV) contrast or impaired renal function, defined as the following:
* Glomerular filtration rate (GFR) \<90 ml/min/1.73 m2 at the time of initial evaluation if patient age is ≤ 59 years
* GFR \<85 ml/min/1.73 m2 if patient age is 60-69 years
* GFR \<75 ml/min/1.73 m2 if patient age is ≥70 years

Primary outcomes:
measure: Change in lung perfusion as measured by duel-energy computed tomography
timeFrame: Baseline, 8 weeks
measure: Change in walk distance as measured by six-minute walk test
timeFrame: Baseline, 8 weeks
measure: Change in FEV1 as measured by pulmonary function test
timeFrame: Baseline, 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals
name: Sameer Avasarala, MD
role: PRINCIPAL_INVESTIGATOR
References: