louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06401551: Clareon PanOptix Pro vs. Clareon PanOptix - Study B
Official title: Contralateral Study of Clareon PanOptix Pro vs. Clareon PanOptix
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aphakia
Presbyopia
Keywords: Cataract
IOL
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2024-05-06
Enrollment: 161
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Contralateral (split face) study design
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety and effectiveness of Clareon™ PanOptix™ Pro Trifocal Intraocular Lens (IOL) compared to Clareon™ PanOptix™ Trifocal IOL.

Detailed description: Subjects will attend 9 scheduled study visits for a total individual duration of participation of approximately 7 months. The primary endpoint will be assessed at the Month 2 follow-up visit. Both eyes of a subject must qualify for enrollment into this study.

Eligibility criteria: Key Inclusion Criteria:

* Understand and sign an ethics committee-approved informed consent form;
* Willing and able to attend all scheduled study visits as required by the protocol;
* Planned cataract surgery (both eyes);
* Preoperative corneal astigmatism less that 1.00 diopter in each eye.
* Other protocol-defined inclusion criteria may apply.

Key Exclusion Criteria:

* Women of childbearing potential if currently pregnant, intend to become pregnant during the study, or are breastfeeding;
* Ocular conditions as specified in the protocol;
* Subjects who desire monovision correction.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Mean Monocular Photopic Best Corrected Distance Visual Acuity (BCDVA)
timeFrame: Month 2 postoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Torrance
country: United States
facility: Wolstan & Goldberg Eye Associates
state: California
city: Bloomfield Hills
country: United States
facility: Grosinger, Spigelman & Grey Eye Surgeons, P.C.
state: Michigan
city: Kansas City
country: United States
facility: Moyes Eye Center
state: Missouri
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Charleston
country: United States
facility: Carolina Eye Care Physicians
state: South Carolina
city: Nashville
country: United States
facility: Vision for Life
state: Tennessee
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Salt Lake City
country: United States
facility: The Eye Institute of Utah
state: Utah
Study officials:
affiliation: Alcon Research, LLC
name: Principal Clinical Trial Lead
role: STUDY_DIRECTOR
References:
Clinical trial NCT00897351: Study of Tissue and Blood Samples From Patients With Recurrent Prostate Cancer Who Received Lapatinib on Clinical Trial ECOG-E5803
Official title: Evaluation of Polymorphisms, Mutations, and Protein Expression by Automated Quantitative Immunohistochemistry (AQUA) in the LapatinibTargets and Metabolic Pathway in Samples From E5803
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: recurrent prostate cancer
Lead sponsor: Eastern Cooperative Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 37
Sex: MALE
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Samples submitted for research from patients enrolled on E5803

Brief summary: RATIONALE: Studying samples of tumor tissue and blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is looking at tissue and blood samples from patients with recurrent prostate cancer who received lapatinib on clinical trial ECOG-E5803.

Detailed description: OBJECTIVES:

* To determine the association between polymorphisms in drug metabolizing enzymes and lapatinib ditosylate-associated toxicity in patients with hormone-sensitive recurrent prostate cancer receiving lapatinib ditosylate on clinical trial ECOG-E5803.
* To determine the association between mutations in EGFR, HER-2 and Kras; protein expression of HER2, EGFR, MAPK and AKT; polymorphism controlling androgen synthesis; and progression-free survival.

OUTLINE: Tissue and blood samples collected from patients enrolled on clinical trial ECOG-E5803 are analyzed for correlative studies. Samples are assessed for HER2, EGFR, MAPK, and Akt; EGFR mutations and polymorphisms in CYP3A4; Ras mutations; recently identified mutations in HER2-neu and Kras; and additional polymorphisms in the lapatinib ditosylate metabolic pathway by automated quantitative IHC. Predictors of efficacy and toxicity are analyzed, including markers in the EGFR pathway as predictors of progression-free survival.

Eligibility criteria: DISEASE CHARACTERISTICS:

* Diagnosis of prostate cancer

  * Recurrent disease
* Received lapatinib ditosylate on clinical trial ECOG-E5803

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Polymorphisms associated with toxicity
timeFrame: 1 month
measure: Association between mutations in EGFR, HER-2 and Kras; protein expression of HER2, EGFR, MAPK and AKT; polymorphism controlling androgen synthesis; and progression-free survival
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: University of Wisconsin, Madison
name: Jill Kolesar, PharmD
role: STUDY_CHAIR
References:
Clinical trial NCT06480851: Effectiveness of Percutaneous Neuromodulation in the Treatment of Cervical Pain in University Students.
Official title: Effectiveness of Percutaneous Neuromodulation in the Treatment of Cervical Pain in University Students.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Neck Pain
Keywords: pain
Ecoguided Percutaneous Neuromodulation
Lead sponsor: CEU San Pablo University
Sponsor class: OTHER
Collaborators: name: Universidad Católica de Ávila
First posted: 2024-06-28
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A non-randomized experimental study will be conducted to investigate the effect of Ecoguided Percutaneous Neuromodulation on patients with and without neck pain in college students. The sample will be collected in a non-probabilistic way at convenience among the students at the San Pablo-CEU University, with a sample that will be divided into two groups: group 1 (G1) with neck pain and group 2 (G2).


Eligibility criteria: Inclusion Criteria:

* Current Cervical Pain on a Visual Analog Scale (VAS) greater than 3.
* Neck pain in the last 12 weeks, and no treatment has been performed.
* Disability index of 8% or more on the Neck Disability Index.
* That they have undergone treatment.

Exclusion Criteria:

* Neck pain associated with vertigo.
* Osteoporosis (control X-ray).
* Diagnosed psychological disorders.
* Vertebral fractures (control X-ray).
* Tumors.
* Diagnosed metabolic diseases.
* Neck surgery.
* Belonephobia.

Primary outcomes:
measure: Pain threshold
timeFrame: up to 1 Week
Secondary outcomes:
measure: Pain by visual analog scale
timeFrame: Baseline
measure: Pain by visual analog scale
timeFrame: after intervention
measure: Pain by visual analog scale
timeFrame: Follow-up at 1 week
measure: Neck Disability Index Questionnaire.
timeFrame: Baseline
measure: Neck Disability Index Questionnaire.
timeFrame: after intervention
measure: Neck Disability Index Questionnaire.
timeFrame: Follow-up at 1 week
measure: Kinesiophobia
timeFrame: Baseline
measure: Kinesiophobia
timeFrame: after intervention
measure: Kinesiophobia
timeFrame: Follow-up at 1 week
measure: Pain Catastrophizing Scale
timeFrame: Baseline
measure: Pain Catastrophizing Scale
timeFrame: after intervention
measure: Pain Catastrophizing Scale
timeFrame: Follow-up at 1 week
measure: Health-related quality of life
timeFrame: Baseline
measure: Health-related quality of life
timeFrame: after intervention
measure: Health-related quality of life
timeFrame: Follow-up at 1 week
measure: Sonoelastography
timeFrame: Baseline
measure: Sonoelastography
timeFrame: after intervention
measure: Sonoelastography
timeFrame: Follow-up at 1 week
Other outcomes:
Locations:
city: Boadilla del Monte
country: Spain
facility: San Pablo CEU University
state: Madrid
Study officials:
References:
Clinical trial NCT03923751: Survey of Regional Anesthesia Practice in Poland
Official title: Survey of Regional Anesthesia Practice in Poland - National Survey 2018
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, Regional
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
Collaborators: name: Department of Anesthesiology and Intensive Care, Czerniakowski Hospital, Warsaw
name: Polskie Towarzystwo Znieczulenia Regionalnego i Leczenia Bólu (Polish ESRA)
name: Sekcja Znieczulenia Regionalnego i Terapii Bólu, Polskie Towarzystwo Anestezjologii i Intensywnej Terapii (PTAiIT)
First posted: 2019-04-23
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Anesthetists in Polish Hospitals

Brief summary: The study is being conducted to gain insight into regional anesthesia practice in polish hospitals specifically asking for methods used, accessibility to equipment and preference for regional blockade and perioperative analgesia.

Detailed description: In recent years, regional anesthesia has become one of the most dynamic parts of anesthesiology. This is in part due to less invasive surgical procedures, surgical enhanced recovery protocols as well as the incorporation of ultrasonography into the daily practice of regional anesthesia.

The aim of this retrospective survey is to track and analyse the changes in everyday practice of regional anesthesia in Poland that have occurred in the year 2018.

An invitation to the survey will be sent to all heads of anesthesiology departments in Poland. The answers to the survey will be collected using an internet based website created by the authors of the study.

Eligibility criteria: Inclusion Criteria:

* All Polish hospitals practising anesthesiology and intensive care in the national register of medical practices (www.rpwdl.csioz.gov.pl)

Exclusion Criteria:

* Hospitals and medical practices not practising anesthesiology or intensive care

Primary outcomes:
measure: Regional anesthesia practice
timeFrame: Up to 12 months practice in the year 2018
measure: Regional anesthesia practitioners
timeFrame: Up to 12 months in the year 2018
Secondary outcomes:
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: I Department of Anesthesiology and Intensive Care Warsaw Medical University
state: Mazowieckie
Study officials:
References:
Clinical trial NCT00069251: Bupropion for the Treatment of Methamphetamine Dependence - 1
Official title: Bupropion for the Treatment of Methamphetamine Dependence
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Amphetamine-Related Disorders
Keywords: amphetamine dependence
Lead sponsor: National Institute on Drug Abuse (NIDA)
Sponsor class: NIH
First posted: 2003-09-24
Enrollment: 150
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: The purpose of this study is to assess the efficacy and safety of bupropion in reducing methamphetamine use in subjects with methamphetamine dependence

Detailed description: A double-blind, placebo-controlled, parallel-group design study in which 100 subjects will be randomly assigned to placebo or bupropion for 12 weeks with follow-up assessments 4 weeks following treatment. Adaptive randomization will be used to balance treatment groups based on gender.

Eligibility criteria: Inclusion Criteria:

* Subject must have methamphetamine dependence as determined by the DSM-IV diagnosis
* Subject must be willing to comply with study procedures.
* Ability to verbalize understanding of consent form, provide written consent, and verbalize willingness to complete study procedures
* Be able to comply with protocol requirements

Exclusion Criteria:

* Please contact site for more information.

Primary outcomes:
measure: Severity addiction
measure: Methamphetamine use
Secondary outcomes:
Other outcomes:
Locations:
city: Costa Mesa
country: United States
facility: Matrix Institute on Addictions
state: California
city: San Diego
country: United States
facility: South Bay Treatment Center
state: California
city: Honolulu
country: United States
facility: Pacific Addiction Research Center
state: Hawaii
city: Des Moines
country: United States
facility: Powell Chemical Dependency Center
state: Iowa
city: Kansas City
country: United States
facility: University of Missouri - Kansas City
state: Missouri
Study officials:
affiliation: University of California, Los Angeles
name: Richard Rawson, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05959551: HD-tDCS to Modulate Connectivity
Official title: Modulating Functional Brain Connectivity Using High Definition Transcranial Direct Current Stimulation (HD-tDCS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Electricity; Effects
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Natural Sciences and Engineering Research Council, Canada
First posted: 2023-07-25
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 4 active treatment groups + 1 inactive treatment group
Primary purpose: BASIC_SCIENCE

Brief summary: The purpose of the proposed study is to broaden our understanding on the neural effects of High Definition Transcranial Direct Current Stimulation (HD-tDCS) so that its clinical effects can be further improved.

Detailed description: Normal healthy individuals will be recruited and undergo a standardized neuropsychological assessment (ANAM, MoCA, BDI-II, ToMS, and MAAS) and magnetic resonance imaging (MRI). During MRI, HD-tDCS will be applied. Four different stimulation targets will be investigated, and subjects will be randomly assigned for each target groups or sham group. After HD-tDCS/MRI session, subjects will be re-assessed with standardized neuropsychological tests.

Eligibility criteria: Inclusion Criteria:

- All other than excluded.

Exclusion Criteria:

* History or susceptibility to any neurological or psychiatric diseases, particularly seizures
* abnormal MRI
* metal implants or a cardiac pacemaker
* pregnant or breastfeeding women

Primary outcomes:
measure: change of functional connectivity
timeFrame: 0-11 minutes after the stimulation contrasting baseline (before stimulation)
Secondary outcomes:
measure: change of cerebral blood flow
timeFrame: 12-16 minutes after the stimulation contrasting baseline (before stimulation)
measure: Toronto Mindfulness Scale (curiosity)
timeFrame: Baseline, then within 1-2 hours from stimulation
measure: Toronto Mindfulness Scale (decentering)
timeFrame: Baseline, then within 1-2 hours from stimulation
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba
state: Manitoba
Study officials:
References:
Clinical trial NCT03445351: Quality of Life, Sleep, and Biomarkers in People With HIV/AIDS
Official title: Effect of Exercise on Quality of Life, Sleep, and Biomarkers in People With HIV/AIDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HIV/AIDS and Infections
Disorder Sleep
Lipodystrophy
Keywords: Exercise Therapy;
Sleep;
; Immune Markers;
HIV
Lead sponsor: Universidade Federal do Rio Grande do Norte
Sponsor class: OTHER
First posted: 2018-02-26
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Intervention study, prospective, a cohort with 17 PLHA participants of the exercise program
Primary purpose: PREVENTION

Brief summary: Aim: Evaluate the influence of exercise, in different times, on quality of life, sleep and clinical parameters in people living with HIV/AIDS (PLHA). Methods: Intervention study, prospective.

Detailed description: Aim: Evaluate the influence of exercise, in different times, on quality of life, sleep and clinical parameters in people living with HIV/AIDS (PLHA). Methods: Intervention study, prospective, a cohort with 17 PLHA participants of the exercise program, higher than 18 years, under antiretroviral therapy with CD4+ ≥ 350/mm3. Research Ethical Committee of the institution approved the study and the participants sign the informed consent and informed. All subjects underwent an exercise program in conformity to American College of Sports Medicine, 3 times per week during 40 minutes. Were evaluated the quality of life (QoL) with the Quality of Life - HAT - QoL and the sleep quality (SQ) with the Pittsburg questionnaire. The subjects were evaluated before the start of exercise program and in three times: short-term (2 to 4 months), medium-term (between 5 and 17 months) and long-term (between 18 to 25 months).

Eligibility criteria: Inclusion Criteria:

* Must have age ≥ 18 years old;
* diagnosis of HIV/AIDS;
* use of antiretroviral therapy;
* Must have lymphocyte T CD4+ cell count ≥ 350 cel/mm3
* Must have physical fitness by the assistant physician.

Exclusion Criteria:

* pregnancy;
* severe hearing deficiency.

Primary outcomes:
measure: Quality of life
timeFrame: 24 MONTHS
Secondary outcomes:
measure: Quality of sleep
timeFrame: 24 MONTHS
Other outcomes:
Locations:
Study officials:
affiliation: Universidade Federal do Rio Grande do Norte
name: RAFAELA MEDEIROS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03693651: Study of the Quality of Sleep of Parents of Premature Children Compared to Parents of Full-term Children
Official title: Prospective Study of the Quality of Sleep of Parents of Premature Children Hospitalized in Neonatology Compared to Parents of Full-term Children in Maternity
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Prematurity
Parenting
Sleep Deprivation
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 306
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Couple of Parents of child born at the CHRU of Brest (full-term in maternity or premature child (25-36 weeks) hospitalized in maternity, neonatalogy or unity of intensive neonatal care).

Both Parents will be included, each of them will have to fill the PSQI at 1, 3 and 6 months from the child birth.

Brief summary: This study evaluate the incidence of sleep disorders in parents of premature children hospitalized in unit care of neonatalogy or intensive unit care of neonatalogy, compared to parents of full-term child in maternity.


Eligibility criteria: Inclusion Criteria:

* Couple of parents of children born before term (between 25 and 36 weeks) and hospitalized at the CHRU de Brest.
* Parents of healthy full-term children born at Brest CHRU (\> 37 weeks) without neonatal hospitalization.
* Having formulated their agreement

Exclusion Criteria:

* Parents whose child died in the neonatal period.
* Couple whose one parents are minors at the birth of the child.
* Parents of children with malformation and /or genetic anomaly.
* Parents with known addiction, depressive syndrome or known psychiatric condition before birth.
* Single parent family.
* Non-French speaking parents.
* Refusal of participation of one of the parents.

Primary outcomes:
measure: Scale Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 6 months from child Birth
Secondary outcomes:
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 1 month from child birth
measure: The Pittsburgh Sleep Quality Index (PSQI)
timeFrame: 3 months from child birth
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
Study officials:
References:
Clinical trial NCT02944851: Comparison of the Accuracy of Non-invasive Hemoglobin Measurement (SpHb) and Vena Cava Inferior Ultrasound
Official title: Comparison of Noninvasive Two Methods to Monitoring Blood Loss; Inferior Vena Cava (IVC) Ultrasound - Non-invasive Hemoglobin Measurement (SpHb)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Blood Donors, Traumatic Blood Loss
Keywords: Blood donors
blood donation
traumatic blood loss
Trauma
Lead sponsor: Haseki Training and Research Hospital
Sponsor class: OTHER
First posted: 2016-10-26
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Voluntary donors for blood donation.

Brief summary: The aim of this work is determine the more successful noninvasive method by comparison of two noninvasive methods ( IVC ultrasound - noninvasive hemoglobin measurement (SpHb)) that used in the detection of patients with blood loss.

The works were completed in 6 months. The study was conducted at the blood donation center and in Emergency department. Vital parameters were measured and recorded before making the voluntary blood donation. Following Masimo brand portable device fingers SpHb value was measured.Then IVC diameter of patients in the supine position were measured using ultrasonography. Then he left to donors return in routine blood donation programme. A unit (500ml) of blood were drawn from each donor. After the blood donation process measured and recorded the vital signs again. SpHb was measured noninvasively from finger again. Following these measurements were recorded again by measuring the diameter of IVC.


Eligibility criteria: Inclusion Criteria:

* Who have volunteered to donate blood
* Older than 18 years
* Both sexes

Exclusion Criteria:

* Known tricuspid valve regurgitation and right heart failure
* Oral intake or the fluid loss (diarrhea and vomiting-urination) between the two measurements during the blood donation
* Inappropriate echogenicity for vena cava inferior diameter measurement

Primary outcomes:
measure: Diagnosis of stage 1 hemorrhagic shock
timeFrame: 30 minute (15 minute blood donation, 15 minute rest time ).
measure: Diagnosis of stage 1 hemorrhagic shock
timeFrame: 30 minute (15 minute blood donation, 15 minute rest time ).
Secondary outcomes:
measure: Diagnosis of stage 1 hemorrhagic shock
timeFrame: 30 minute (15 minute blood donation, 15 minute rest time ).
measure: Diagnosis of stage 1 hemorrhagic shock
timeFrame: 30 minute (15 minute blood donation, 15 minute rest time ).
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Haseki Training and Reseurch Hospital
Study officials:
affiliation: The health ministry, Haseki Training and Research Hospital
name: Adnan Yamanoğlu, MD
role: STUDY_DIRECTOR
References: