louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02466607: Study of Stimulus Parameters in Flicker Electroretinogram (ERG)
Official title: Study of Stimulus Parameters in Flicker Electroretinogram (ERG)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retinopathy
Keywords: Retinal function
Lead sponsor: LKC Technologies, Inc.
Sponsor class: INDUSTRY
First posted: 2015-06-09
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: The electroretinogram (ERG) is a diagnostic test that measures the electrical activity generated by cells in the retina in response to a light stimulus. Typically, an ERG is recorded with white flash when the pupil is dilated. RETeval Visual Diagnostic Device (RETeval) generates an array of color flashes, which allows studying whether color flash would be a useful diagnostic tool.

Full pupil dilation is required to obtain a response from the whole retina. However, this requirement often limits a patient's flow in the clinic and increases the overall time patients spend at the eye practitioner. RETeval provides the possibility of recording ERGs in un-dilated pupils therefore making the whole exam easier and shorter. These results need to be compared to the classic, fully dilated ERG and evaluated for efficiency.

The purpose of this research study is to use the RETeval device to measure the eye's electrical response and how it changes with different stimuli such as changing flash color or pupil dilation.


Eligibility criteria: Inclusion Criteria:

* healthy adult volunteers
* volunteers able to get their pupil fully dilated

Exclusion Criteria:

* pregnant women
* children
* subjects with
* light sensitivity
* photosensitive epilepsy
* allergies or sensitivity to pupil dilation ophthalmic solutions
* history of glaucoma
* cardiac dysrhythmia will not be invited to participate in this study.
* Pregnancy status, light sensitivity and photosensitive epilepsy will be based on volunteer's providing this information at the time of signing the consent form

Primary outcomes:
measure: Flicker harmonic amplitude
timeFrame: up to 2 mnths
measure: Flicker harmonic implicit time
timeFrame: up to 2 months
measure: Flicker fundamental amplitude
timeFrame: up to 2 months
measure: Flicker fundamental implicit time
timeFrame: up to 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Wedgwood Optometry
state: Texas
Study officials:
affiliation: LKC Technologies
name: Olga Kraszewska, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davis CQ, Kraszewska O, Manning C. Constant luminance (cd.s/m2) versus constant retinal illuminance (Td.s) stimulation in flicker ERGs. Doc Ophthalmol. 2017 Apr;134(2):75-87. doi: 10.1007/s10633-017-9572-3. Epub 2017 Feb 3.
Clinical trial NCT02425007: Efficacity of Incentive Spirometry in Elderly People
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Lead sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Sponsor class: OTHER
First posted: 2015-04-23
Enrollment: 32
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the efficiency of incentive spirometry in elderly. Outcomes are lung function and chest expansion.


Eligibility criteria: Inclusion Criteria:

* Healthy

Exclusion Criteria:

* Pulmonary disease
* Cognitive disorders

Primary outcomes:
measure: lung function will be measured by spirometry
timeFrame: 1 month
Secondary outcomes:
measure: Chest expansion will be measured by a tape measure
timeFrame: One month
Other outcomes:
Locations:
city: Brussel
country: Belgium
Study officials:
References:
Clinical trial NCT01529307: First in Human Trial of TAS266 in Patients With Advanced Solid Tumors
Official title: A Phase I, Open-label Dose Escalation Study With Safety Expansion of TAS266 Administered by IV Infusion to Patients With Advanced Solid Tumors
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Advanced Solid Tumors
Keywords: Biologic,
solid tumors,
Death Receptor 5 agonist,
caspase-8
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-02-08
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess safety, tolerability, maximum tolerated dose or recommended dose for expansion of TAS266 administered by IV infusion to patients with advanced solid tumors.


Eligibility criteria: Inclusion Criteria:

* Confirmed diagnosis of solid tumors
* 18 years or older
* ECOG performance status of 0, 1 or 2
* Adequate bone marrow, hepatic and renal function
* Obtained written informed consent

Exclusion Criteria:

* Patients with primary CNS tumor or CNS tumor involvement. However patients with CNS metastases may be allowed if certain conditions are met.
* Major surgery within 4 weeks before study treatment
* Prior anaphylactic or other severe infusion reactions to human immunoglobulin or antibody formulations
* Impaired cardiac functions
* Previous hepatitis viral infection such as hepatitis B or hepatitis C
* Diagnosis of HIV infection
* Pregnant or nursing (lactating) women

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Frequency and characteristics of Dose limiting toxicities at each dose level
timeFrame: 2 years
Secondary outcomes:
measure: Type, frequency, and severity of AEs, changes in laboratory and clinical assessments
timeFrame: 2 years
measure: TAS266 serum concentrations and PK parameters: Cmax, Tmax, AUC0-tlast, Tlast, T1/2 and accumulation ratio of TAS266
timeFrame: 8 timepoints each for Cycles 1 and 2, prior to dosing on Day 1 of Cycles 3, 4, 5 and 6, at End of Treatment
measure: Presence and concentration of anti-TAS266 antibodies
timeFrame: 2 Years
measure: Tumor response
timeFrame: 2 Years
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center/University of South Florida Moffitt SC
state: Florida
city: San Antonio
country: United States
facility: South Texas Accelerated Research Therapeutics START
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah / Huntsman Cancer Institute Huntsman UT
state: Utah
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02765607: Circulatory Oscillations in Post Cardiac Surgery Patients
Official title: Circulatory Oscillations in Post Cardiac Surgery Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Disease
Keywords: Blood circulation
Cardiac surgical procedures
Homeostasis
Lead sponsor: St. Olavs Hospital
Sponsor class: OTHER
Collaborators: name: Norwegian University of Science and Technology
First posted: 2016-05-06
Enrollment: 20
Sex: ALL
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 scheduled for routine coronary artery bypass graft (CABG) surgery.

Brief summary: In this observational study investigators examine the presence of circulatory oscillations in blood pressure, heart rate, and doppler laser flow before and after planned cardiac surgery.


Eligibility criteria: Inclusion Criteria:

* patients scheduled for routine coronary artery bypass graft (CABG) surgery, single procedure only

Exclusion Criteria:

* no sinus or pacemaker rhythm
* ejection fraction below 0.5
* serious valvular disease
* right ventricular failure
* pulmonary hypertension
* serious postoperative bleeding

Primary outcomes:
measure: Frequency and amplitude of oscillations of electrocardiogram (ECG)
timeFrame: First day
Secondary outcomes:
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: Trondheim University Hospital
Study officials:
affiliation: Trondheim University Hospital
name: Nils K Skjaervold, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05369507: Eliminating HCV in Rural South Carolina Utilizing NP Led Mobile Clinics and Virtual Care Coordination
Official title: Eliminating HCV in Rural South Carolina With Smart Phone Virtual Care Coordination Deployed in NP Led Mobile Clinics
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis C
Substance Use Disorders
Keywords: Mobile health
Nurse practitioner
Care coordination
Virtual care coordination
People who inject drugs
Rural health
Lead sponsor: Prisma Health-Upstate
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2022-05-11
Enrollment: 146
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Up to 150 individuals with current hepatitis C (HCV) will be recruited from mobile health clinics in rural South Carolina - sites will be selected based on HCV prevalence rates and lack of current HCV screening/treatment resources. NPs will provide HCV care through mobile health units. Participants will be randomized (1:1) to either mobile health clinic treatment as usual or virtual care coordination. Virtual care coordination designed to move people along HCV care cascade will be conducted by the Emocha smartphone platform - an adaptable platform designed by emocha to link patients to care. Using quantitative methods, associations between psychosocial factors such as homelessness, mental illness, provider mistrust, poor social support, high levels of shame and stigma with HCV outcomes including SVR will be examined. Investigators hypothesize that SVR rate among the HCV-infected individuals treated (and with follow-up SVR determination) will be 90% with the Clopper-Pearson 95% CI having a width of 13%.


Eligibility criteria: Inclusion Criteria:

* Not previously treated with HCV direct-acting antiviral medications OR treatment-experienced and eligible for treatment with sofosbuvir/velpatasvir
* Age 18+
* Willing to be randomized to either emocha versus TAU arms
* Able to provide informed consent

Exclusion Criteria:

* Pregnant or breastfeeding

Primary outcomes:
measure: HCV Treatment Initiation Rates
timeFrame: 27 months
Secondary outcomes:
measure: HCV Treatment Adherence
timeFrame: 12 weeks
measure: HCV Treatment Completion
timeFrame: 12 weeks
measure: Rate of Sustained Virologic Response
timeFrame: 6 months
Other outcomes:
Locations:
city: Greenville
country: United States
facility: Prisma Health Upstate
state: South Carolina
Study officials:
References:
Clinical trial NCT06910007: Accuracy of Various Advanced Treatment Planning Software for Static Computer Guided Surgery in Dental Implant
Official title: Accuracy of Advanced Treatment Planning Software for Static Computer Guided Surgery ( Blue Sky Plan Bio, Exoplan, Real Guide Computer Software)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Implant
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2025-04-04
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study will be conducted to investigate the accuracy of Blue sky plan bio , exoplan ,and real guide advanced treatment planning software required for static computer guided surgery designing and manufacturing.


Eligibility criteria: Inclusion Criteria:

1. partially edentulous adults with at least three teeth remaining.
2. an expected sufficient bone volume to perform implant insertion with at least a 3.5mm Cybermed dental implant without simultaneous bone augmentation.
3. extractions performed at least 3 months earlier.
4. potential earlier sinus grafting was performed at least 6 months prior to implant placement.
5. Patients with absence of any periodontal problems in the adjacent teeth.

7- stable medical condition to undergo implant surgery (ASA 1 or 2).

Exclusion Criteria:

1. Physical or psychological disorders generally prohibiting implant therapy. After initial screening.
2. Patients with a history of bruxism
3. Patients with over eruption of the opposing tooth.

Primary outcomes:
measure: deviation between planned and actual implant position when using different planning software
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00809107: Frozen Embryo Transfer (FET) in Natural Cycles or in Natural Cycles Controlled by Human Chorionic Gonadotropin (hCG) Administration
Official title: Cryopreserved-Thawed Embryo Transfer in Natural Cycle or in Natural Cycles Controlled by External Administration of hCG: a Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility
Keywords: natural cycle
FET
spontaneous LH pic
HCG
Lead sponsor: Universitair Ziekenhuis Brussel
Sponsor class: OTHER
First posted: 2008-12-17
Enrollment: 150
Sex: FEMALE
Minimum age (years): 17
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The rational of the study is to assess the implantation, pregnancy and live birth rates after the transfer of frozen- thawed embryos in natural cycles with spontaneous Luteinizing Hormone (LH)/Progesterone rise or in natural cycles controlled by human chorionic gonadotropin (hCG) for final oocyte maturation and ovulation.


Eligibility criteria: Inclusion Criteria:

* age \<40
* BMI:18-29Kg/m2
* day 3 embryo transfers
* previously IVF or ICSI

Exclusion Criteria:

* irregular cycles
* oocyte donation cycles

Primary outcomes:
measure: Implantation rate
timeFrame: 2 years
Secondary outcomes:
measure: Ongoing pregnancy rate
timeFrame: 2 years
Other outcomes:
Locations:
city: Brussel
country: Belgium
facility: Centre of Reproductive Medicine
Study officials:
References:
citation: Gelbaya TA, Nardo LG, Hunter HR, Fitzgerald CT, Horne G, Pease EE, Brison DR, Lieberman BA. Cryopreserved-thawed embryo transfer in natural or down-regulated hormonally controlled cycles: a retrospective study. Fertil Steril. 2006 Mar;85(3):603-9. doi: 10.1016/j.fertnstert.2005.09.015.
Clinical trial NCT05786807: Effect of H. Pylori Eradication on Alleviating Symptoms in Functional Dyspepsia Patients
Official title: Effect of H. Pylori Eradication on Alleviating Symptoms in Functional Dyspepsia Patients: A Multicenter, Comparative Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Helicobacter Pylori-positive With Functional Dyspepsia
Lead sponsor: Wonkwang University Hospital
Sponsor class: OTHER
First posted: 2023-03-28
Enrollment: 315
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In patients with Helicobacter pylori-positive functional dyspepsia, long-term follow-up for 6 months after standard triple therapy first-line eradication treatment, the rate of symptom disappearance and degree of improvement of functional dyspepsia were confirmed through changes in symptom scores and changes in drug usage, and eradication treatment The purpose of this study is to confirm the rate of symptom disappearance according to the results.


Eligibility criteria: Inclusion Criteria:

* Male and female outpatients between the ages of 19 and 75
* Who have symptoms of functional dyspepsia (early fullness, postprandial discomfort, epigastric pain, epigastric soreness) that correspond to Rome criteria 4 (diagnostic criteria questionnaire)

Exclusion Criteria:

* Small intestine and large intestine disease within 6 months of the screening visit (Visit 1)
* liver, pancreatobiliary disease within 6 months of the screening visit (Visit 1)
* peptic ulcer within 6 months of the screening visit (Visit 1)

Primary outcomes:
measure: Rate of disappearance of dyspepsia symptoms
timeFrame: Day 176
Secondary outcomes:
measure: Improvement rate of dyspepsia symptoms
timeFrame: Day 92, Day 176
measure: Number of days of dyspepsia drug administration
timeFrame: Day 92, Day 176
Other outcomes:
Locations:
city: Iksan
country: Korea, Republic of
facility: Wonkwang University Hospital
state: Jeollabuk
Study officials:
affiliation: Wonkwang University Hospital
name: Suck Chei Choi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02521207: Pilot Study of OXP001(2) and Brufen in Healthy Subjects
Official title: A Two-Part, Randomised, Open-Label, Evaluator-Blinded, Multiple-Dose, Phase I Pilot Study With OXP001 Ibuprofen 400 mg Tablets and Brufen® 400 mg Tablets to Assess the Comparative Bioavailability (Part 1) and Effects on Gastroduodenal Irritation (Part 2) in Healthy Human Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Gastroduodenal Erosions
Lead sponsor: Oxford Pharmascience Ltd
Sponsor class: INDUSTRY
Collaborators: name: Quotient Clinical
First posted: 2015-08-13
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The study will compare the study drug to an already marketed formulation of prescription strength ibuprofen (Brufen® the reference product) by looking at how the drug is taken up by the body and also by performing a specialist procedure called an endoscopy (or more specifically, a gastroscopy). The safety and tolerability of the study drug will also be assessed.

The study will consist of 2 parts involving up to 54 healthy male and female subjects. Subjects will be randomly assigned to receive either the study drug or reference product. Part 1 will be a cross over study in which up to 10 subjects will receive a single dose of 800 mg study drug OXP001 or Brufen® on Day 1, then a single dose of 800 mg study drug OXP001 or Brufen® on Day 4. Part 1 will assess bioavailability and involve an interim decision on progression to Part 2. In Part 2, up to 44 subjects will receive a dose of 800 mg OXP001 or Brufen® three times daily for 7 days in order to assess pharmacokinetics and stomach irritation using endoscopy.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female subject
* Healthy, normal upper GI tract as indicated by no ulcers or erosions at baseline, as assessed by the gastroenterologist conducting the endoscopy (ie Lanza score of 0 in both the stomach and duodenum) (Part 2 only)
* H. pylori negative

Exclusion Criteria:

* Clinically significant abnormal laboratory parameters
* Any clinically significant diseases or conditions affecting the haematopoietic, cardiovascular, renal, hepatic, endocrine, pulmonary, central nervous, immunological, dermatological, GI or any other body system

Primary outcomes:
measure: Part 1: Comparison of Peak Plasma Concentration (Cmax)
timeFrame: Part 1; Day 1 and Day 4
measure: Part 2: Comparison of Average Lanza Score
timeFrame: Part 2; Day 8
measure: Part 2: Comparison of Average Number of Erosions
timeFrame: Day 8
measure: Part 1: Comparison of Area Under the Curve (AUC)
timeFrame: Part 1; Day 1 and Day 4
Secondary outcomes:
Other outcomes:
Locations:
city: Nottingham
country: United Kingdom
facility: Quotient Clinical Ltd
state: Notts
Study officials:
affiliation: Quotient Clinical Ltd
name: Stuart Mair
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03479307: A Study Evaluating Bilastine Ophthalmic Solution 0.6% in the Conjunctival Allergen Challenge (Ora-CAC®) Model.
Official title: A Multi-Center, Double-Masked, Randomized, Vehicle- and Active-Controlled, Phase 3 Study Evaluating the Efficacy and Safety of Bilastine Ophthalmic Solution 0.6% Compared to Vehicle and Zaditen (Ketotifen Ophthalmic Solution 0.025%) for the Treatment of Allergic Conjunctivitis in the Conjunctival Allergen Challenge (Ora-CAC®) Model
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Allergic Conjunctivitis
Lead sponsor: Faes Farma, S.A.
Sponsor class: INDUSTRY
Collaborators: name: ORA, Inc.
First posted: 2018-03-27
Enrollment: 228
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 evaluate the efficacy of Bilastine ophthalmic solution 0.6% compared to vehicle and Zaditen (Ketotifen ophthalmic solution 0.025%) for the treatment of the signs and symptoms of allergic conjunctivitis.


Eligibility criteria: Inclusion Criteria:

* be at least 18 years old
* be willing and able to avoid all disallowed medications and contact lenses
* must have a pregnancy test if of childbearing potential
* must be able to read an eye chart from 10 feet away

Exclusion Criteria:

* must not have any allergies to the study medications
* must not have any ocular or non ocular condition that investigator feels will interfere with study parameters
* must not have used immunotherapy in the last 2 years
* must not have used an investigational drug or device in the past 30 days or concurrently enrolled in another investigational trial

Primary outcomes:
measure: Ocular Itching
timeFrame: The outcome measure was assessed at Visit 4b (Day 1: 16h post-treatment) and Visit 5 (Day 8 ±3, 15 minutes post-treatment).
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Cornea Consultants of AZ
state: Arizona
city: Torrance
country: United States
facility: East West Eye Institute
state: California
city: Andover
country: United States
facility: Andover Eye Associates
state: Massachusetts
city: Mason
country: United States
facility: Apex Eye
state: Ohio
city: Philadelphia
country: United States
facility: Philadelphia Eye Associates
state: Pennsylvania
city: Memphis
country: United States
facility: Total Eye Care, P.A.
state: Tennessee
Study officials:
References: