louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05368870: Accuracy of Intra Ocular Lens CARLEVALE Calculation
Official title: Refractive Outcomes After Scleral Fixation of the Carlevale Intraocular Lens: Retrospective Study of Power Calculation Accuracy.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lens Diseases
Lead sponsor: Poitiers University Hospital
Sponsor class: OTHER
First posted: 2022-05-10
Enrollment: 40
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: All patients who underwent implantation of Carlevale between Octobre 2019 and Avril 2022 in the ophtalmologie department of Poitiers hospital and La Rochelle hospital

Brief summary: The purpose of this study is to assess the accuracy of intra ocular lens power calculation using the new Carlevale sutureless scleral fixation posterior chamber intra ocular lens.

Detailed description: Retrospective comparison of refractive spherical equivalent predicted before surgery and measured after surgery in patient who underwent implantation of an sutureless scleral fixation posterior chamber intra ocular lens between October 2019 and Avril 2022 in the ophthalmology department of Poitiers Hospital and La Rochelle Hospital.

Eligibility criteria: Inclusion Criteria:

* All patients who underwent implantation of Carlevale between Octobre 2019 and Avril 2022 in the ophtalmologie department of Poitiers hospital and La Rochelle hospital

Exclusion Criteria:

* Post surgery best corrected visual acuity worse than 20/40
* Keratoconus
* Macular oedema

Primary outcomes:
measure: Prediction error
timeFrame: Between Month 1 and Month 6
Secondary outcomes:
Other outcomes:
Locations:
city: Poitiers
country: France
facility: Centre hospitalier universitaire
state: Vienne
Study officials:
References:
Clinical trial NCT00988975: Trial to Determine Which of Two Surgical Techniques Works Better to Correct Vaginal Bulging
Official title: Does Pelvicol Graft in the Posterior Compartment Offer Any Benefit to Surgical Outcomes During Laparoscopic Sacral Colpoperineopexy?
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Rectocele
Lead sponsor: Urogynecology Associates, Indiana
Sponsor class: OTHER
First posted: 2009-10-02
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Women with vaginal bulging who are undergoing laparoscopic sacrocolpopexy at Clarian Health are eligible to enroll in this study. Two different methods of correcting rectocele at the time of sacrocolpopexy will be compared for surgical outcome, surgical complications, and patient satisfaction with intercourse and bowel function. One of the surgical methods uses an additional graft material and one surgical method does not. It is hypothesized that the method which uses an additional graft material to strengthen the patient's tissues will have a better outcome.


Eligibility criteria: Inclusion Criteria:

* women with stage 2 pelvic organ prolapse undergoing laparoscopic sacrocolpopexy

Exclusion Criteria:

* concomitant colo-rectal procedure
* allergy to pork
* any contraindication to laparoscopic sacrocolpopexy

Primary outcomes:
measure: Anatomic success of rectocele repair
timeFrame: 6 months
Secondary outcomes:
measure: change in patient symptomatology post-operatively
timeFrame: 6 months
Other outcomes:
Locations:
city: Carmel
country: United States
facility: Clarian North
state: Indiana
city: Indianapolis
country: United States
facility: Clarian Methodist
state: Indiana
Study officials:
References:
Clinical trial NCT03380975: Role of Montelukast in Asthma and Allergic Rhinitis Patients
Official title: Role of Montelukast in Asthma and Allergic Rhinitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Asthma and Allergic Rhinitis
Keywords: MAAP
Asthma
Allergic rhinits
Lead sponsor: Clinision
Sponsor class: OTHER
First posted: 2017-12-21
Enrollment: 600
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Montelukast is an orally active compound which binds with high affinity and selectivity to the CysLT1 receptor. Montelukast inhibits physiologic actions of LTD4 at the CysLT1 receptor without any agonist activity. As a result, bronchoconstriction is inhibited with decreased airway and blood eosinophil's leading to improved control over asthma and allergic rhinitis
Primary purpose: TREATMENT

Brief summary: To determine the effect of Montelukast in Asthma and Allergic rhinits patients

Detailed description: Montelukast is a potent and selective blocker of the CysLT1 receptor. Accordingly, a recent study has shown that Montelukast can improve symptoms of seasonal allergic rhinitis and asthma in patients with both diseases. For treatment of asthma, Montelukast is administered once daily to adults as a 10-mg film-coated tablet, to children aged 6-14 years as a 5-mg chewable tablet, and to children aged 2-5 years as a 4-mg chewable tablet form. Asthma and allergic rhinitis have been linked clinically for many years as "one airway one diseases". Patients with allergic asthma and rhinitis are significantly more likely to experience asthma attacks compared to patients with asthma alone. Side effects most commonly reported above placebo included headache, otitis media, upper respiratory infection, and pharyngitis

Eligibility criteria: Inclusion Criteria:

* Age \>18 years
* Signed Informed Consent
* Clinical diagnosis of Asthma and Allergic Rhinitis

Exclusion Criteria:

* Previous adverse reaction to Montelukast
* History of hyper-eosinophilic disorder other than atopic disease
* Female subjects who are pregnant, breast-feeding
* Any significant and active pulmonary pathology other than asthma

Primary outcomes:
measure: Efficacy of montelukast on asthma day and night symptoms changes from baseline after 4 weeks of treatment
timeFrame: 4 weeks
Secondary outcomes:
measure: Efficacy of montelukast on allergic rhinitis symptoms changes from baseline after 4 weeks of treatment
timeFrame: 4 weeks
measure: Effect of montelukast in change in individual quality of life using Quality of life questionnaire after 4 weeks of treatment
timeFrame: 4 weeks
measure: Proportion of participants experiencing an adverse event (AE)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Dr. Faisal Faiyaz Zuberi
state: Sindh
Study officials:
affiliation: Dow University of Health Sciences
name: Faisal Faiyaz, FCPS,FCPS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04670575: Vivity Outcomes in Patients With Early Stage Glaucoma
Official title: Vivity Outcomes in Patients With Early Stage Glaucoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Cataract
Presbyopia
Keywords: Extended Range of Vision, Intraocular Lens Technology, Glaucoma
Lead sponsor: Vance Thompson Vision
Sponsor class: OTHER
First posted: 2020-12-17
Enrollment: 27
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with early stage glaucoma with cataracts in both eyes who are planned to have bilateral cataract surgery with implantation of Vivity or Vivity Toric intraocular lens.

Brief summary: The goal of the study is to determine the visual outcomes in patients with mild, pre-perimetric glaucoma who undergo cataract surgery with implantation of the Alcon Vivity Extended Range Intraocular Lens (IOL).


Eligibility criteria: Inclusion Criteria:

1. Patients at least age 45 years of age undergoing uncomplicated cataract surgery with optional concomitant minimally invasive glaucoma surgery (MIGS)
2. Subjects with documented diagnosis of pre-perimetric glaucoma
3. Calculated lens power within Vivity/Vivity toric range
4. Willing and able to comprehend informed consent and complete 4-6 month post-op visit
5. Potential postoperative BCDVA of 20/20 or better in each eye based on Investigator's medical opinion

Exclusion Criteria:

1. Ocular comorbidity, other than pre-perimetric glaucoma, that could reduce the potential postoperative BCDVA
2. Previous ocular surgery including refractive surgery
3. Subjects who are pregnant or plan to become pregnant during the course of the study.

Primary outcomes:
measure: Uncorrected Distance Visual Acuity
timeFrame: 4-6 months
measure: Uncorrected Intermediate Visual Acuity
timeFrame: 4-6 months
measure: Uncorrected Near Visual Acuity
timeFrame: 4-6 months
Secondary outcomes:
measure: Contrast Sensitivity
timeFrame: 4-6 months
measure: Patient Satisfaction and Spectacle Independence Survey Results
timeFrame: 4-6 months
measure: Mean Refractive Spherical Equivalent
timeFrame: 4-6 months
Other outcomes:
Locations:
city: Sioux Falls
country: United States
facility: Vance Thompson Vision
state: South Dakota
Study officials:
affiliation: Vance Thompson Vision
name: Brian M Shafer, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03115775: CLA and Vitamin D on Protein Turnover
Official title: Randomized Controlled Trial to Evaluate the Independent and Combined Effects of Conjugated Linoleic Acids and Vitamin D on Muscle Protein Turnover in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Protein
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: BASF
First posted: 2017-04-14
Enrollment: 40
Sex: ALL
Minimum age (years): 65
Maximum age (years): 85
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized, double-blind, controlled clinical trial
Primary purpose: OTHER

Brief summary: To conduct a randomized, double-blind, controlled clinical trial to determine the independent and combined effects of dietary conjugated linoleic acid (CLA) and vitamin D supplementation on anabolic signaling, the expression of growth regulatory factors, and muscle protein turnover in older adults.


Eligibility criteria: Inclusion Criteria:

* BMI \>/= 18.5 and \</= 35.0
* Serum 25OH-VitD3 \< 35 ng/ml

Exclusion Criteria:

* Diabetes
* COPD

Primary outcomes:
measure: Change in post-absorptive muscle protein synthesis
timeFrame: Baseline and 8 weeks
measure: Change in combined amino acid and insulin stimulated muscle protein synthesis
timeFrame: Baseline and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Bettina Mittendorfer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: van Vliet S, Fappi A, Reeds DN, Mittendorfer B. No independent or combined effects of vitamin D and conjugated linoleic acids on muscle protein synthesis in older adults: a randomized, double-blind, placebo-controlled clinical trial. Am J Clin Nutr. 2020 Nov 11;112(5):1382-1389. doi: 10.1093/ajcn/nqaa240.
Clinical trial NCT02127775: Lesinurad Tablet Bioequivalence
Official title: A Phase 1, Randomized, Open-Label, Crossover Study to Assess the Bioequivalence of Lesinurad Tablets From Two Manufacturing Sites in Healthy Adult Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Ardea Biosciences, Inc.
Sponsor class: INDUSTRY
First posted: 2014-05-01
Enrollment: 54
Sex: MALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: This study will assess the bioequivalence of lesinurad tablets manufactured at two different sites.

Detailed description: This study is intended to evaluate the clinical comparability of lesinurad tablets manufactured at the 2 different sites by assessing relevant clinical Pharmacokinetics (PK) parameters.

Eligibility criteria: Inclusion Criteria:

* Subject has a body weight ≥ 50 kg (110 lbs.) and a body mass index ≥ 18 and ≤ 40 kg/m2.
* Subject has a Screening serum urate level ≤ 7 mg/dL. ˗ Subject is free of any clinically significant disease or medical condition, per the Investigator's judgment.

Exclusion Criteria:

* Subject has any gastrointestinal disorder that affects motility and/or absorption.
* Subject has a history or suspicion of kidney stones.
* Subject has undergone major surgery within 3 months prior to Screening.
* Subject has donated blood or experienced significant blood loss (\> 450 mL) within 12 weeks prior to Day 1 or gave a plasma donation within 4 weeks prior to the Screening visit.
* Subject has inadequate venous access or unsuitable veins for repeated venipuncture.

Primary outcomes:
measure: PK profile of lesinurad from plasma
timeFrame: Day 1 and Day 5
Secondary outcomes:
measure: Incidence of Adverse Events
timeFrame: 5 weeks
Other outcomes:
Locations:
city: Austin
country: United States
state: Texas
Study officials:
affiliation: Ardea Biosciences, Inc.
name: J. Hall
role: STUDY_DIRECTOR
References:
Clinical trial NCT03573375: Barriers Affecting Physical Activity
Official title: Cancer Patients' Reported Frequency and Barriers to Physical Activity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer Patients and Physical Activity
Keywords: Questionnaires
Surveys
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
First posted: 2018-06-29
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this research study is learn about how often cancer patients engage in physical activity using the exercise behavior questionnaire.

This is an investigational study.

Up to 200 participants will be enrolled in this study. All will take part at MD Anderson.

Detailed description: If participant agrees to take part in this study, participant will complete a series of questionnaires about exercise and participant's symptoms and physical abilities. These should take about 5 minutes to complete.

Additionally, demographic information (such as participant's age, race, sex, zip code, specifics about participant's cancer type and care) will be collected from participant's medical record.

Participant will complete the questionnaires 1 time, and participation in this study will be over after that.

Eligibility criteria: Inclusion Criteria:

1. Patient must be 18 years of age or older.
2. Patient must be able to understand, read, write and speak English.
3. Patient must be able to sign an Informed Consent Form.

Exclusion Criteria:

1. Patients with physical limitations (visual, cognitive, motor impairment) causing inability to read, complete or sign the consent form and survey.
2. Wheelchair bound patients who spend all of their day in bed or wheelchair
3. Patients who the attending physician deems unable to participate due to acute physical distress.
4. Previously filled out (EBBS and Stanford) surveys in the Supportive Care Clinic

Primary outcomes:
measure: Percentage of Cancer Patients Who Report Engaging in Physical Activity Using the Stanford Patient Education Research Center Exercise Behaviors Survey
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Amy Ng, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00487175: Tramadol and Pain Sensitization
Official title: Tramadol and Pain Sensitization
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Pain
Keywords: Pain
sensitization
analgesia
Healthy volunteers and pain
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2007-06-15
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: Tramadol is a largely used analgesic drug. Its role however on sensitization as occurs for example in neuropathic pain is not very well known. This protocol aims therefore at studying the effect of tramadol in a human pain model with sensitization induced by a cold stimulus, using evoked potentials to elucidate how pain is modified when tramadol is administered.

Detailed description: The study is a comparison of the analgesic of tramadol versus placebo in a pain model using evoked potentials. Evaluation criteria will be the amplitude of the evoked potential obtained defore and after treatment

Eligibility criteria: Inclusion Criteria:

* Healthy men
* Between 18 and 40 years old
* Written consent given

Exclusion Criteria:

* Concomitant medication
* Tramadol hypersensibility
* Excessive consumption of alcohol, tobacco, coffee, tea or toxicomania

Primary outcomes:
measure: Amplitude of the evoked potential elicited by a thermal stimulus on the arm with an induced hyperalgic area
timeFrame: with an induced hyperalgic area
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CIC
Study officials:
name: PICKERING Gisèle, MCU-PH, pharmacology
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06277375: The Effect of Slow Stroke Back Massage on Pain and Fatigue in Women With Fibromyalgia
Official title: Fibromiyalji Tanılı Kadınlarda Uygulanan Yavaş Vurumlu Sırt Masajının Ağrı ve Yorgunluk Üzerine Etkisi: Randomize Kontrolü Çalışma
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Massage Intervention
Keywords: pain
Fatigue
Fibromyalgia
Lead sponsor: TC Erciyes University
Sponsor class: OTHER
First posted: 2024-02-26
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Fibromyalgia syndrome (FM) is defined as a non-inflammatory chronic pain syndrome with widespread pain in the musculoskeletal system, tender points (PINs) on physical examination and no specific laboratory findings. T Sampling was calculated using Power power (G Power 3.1.9.4) analysis. The effect size of the study was calculated based on the mean pain scores and standard deviations of the control and experimental groups taken from the study conducted by Field, et al. (2002). Accordingly, when 25 patients were included in each group, it was determined that the power was 85% at 5% Type I error level. The application to the experimental group will be done 3 days a week for 10 minutes for a total of 30 minutes. data will be collected with patient information form, fatigue severity scale and vas.

Detailed description: he research will be conducted experimentally with the aim of evaluating the effects of slow-stroke back massage in patients followed up in the physical therapy and rehabilitation unit with the diagnosis of fibromyalgia.

Eligibility criteria: Inclusion Criteria:

* Able to communicate verbally,
* Over 18 years of age,
* no vision and hearing loss
* who have received medical treatment,
* who have never received a slow-stroke back massage before

Exclusion Criteria:

* Initially volunteered to participate in the study, but did not like the application of slow-stroke back massage
* who wants to leave the study for another reason

Primary outcomes:
measure: VAS
timeFrame: The scale was filled in the baseline
measure: Fatigue
timeFrame: The scale was filled in the baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Dilek Efe Arslan
state: Melikgazi
Study officials:
affiliation: ERCİYES UNİVERSİTY
name: DİLEK EFE ARSLAN
role: STUDY_DIRECTOR
References:
Clinical trial NCT03630575: Study of Psychoactive Substances in Newborns' Hair Whose Mothers Were Treated and Followed at the Nice University Hospital - New Born Hair Study
Official title: Study of Psychoactive Substances in Newborns' Hair Whose Mothers Were Treated and Followed at the Nice University Hospital - New Born Hair Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Newborn
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2018-08-15
Enrollment: 30
Sex: ALL
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Hair toxicological analysis is nowadays a complementary technique to blood and urinary analyses because it allows a better detection of xenobiotics in time.

The detection of xenobiotics is expressed in hours in blood and in days in urines; it is several months in the hair. So, hair makes it possible to establish a retrospective timetable of consumption and exposure to xenobiotics.

In newborns, hair has different morphological characteristics than adults' hair. It is thinner, more porous and the development phases are not the same.

Nevertheless, it is recognized that the absorption mechanisms of xenobiotics in newborns' hair are similar to those of adults. On the other hand, some difficulties of interpretation and discernment are observed between in utero exposure and environmental exposure after birth.

It is interesting to have data to estimate the absorption of psychoactive substances in newborns' hair following an utero exposure.

The main objective of this project is to study the mechanisms of incorporation of psychoactive substances administered to the mothers during pregnancy in newborns' hair.


Eligibility criteria: Inclusion Criteria:

* Newborns of mothers treated with known doses of psychoactive drugs during pregnancy or exposed to cannabinoids during pregnancy
* Full-term newborns (≥37 weeks)
* Informed consent signed by the child's legal representatives
* Affiliation to Social Security

Exclusion Criteria:

* Newborns of mothers exposed to unknown doses of psychoactive substances (excluding cannabis) during pregnancy
* One of the child's legal representatives hasn't signed the informed consent
* Premature delivery \<37 weeks of amenorrhea
* Newborns who can't be followed at T 4-6 months.

Primary outcomes:
measure: Change of psychoactive substances concentration in newborn's hair at 6 months
timeFrame: At 6 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: Hôpital Archet 2 - Service de Gynécologie - Obstétrique - Reproduction
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: André BONGAIN, PU-PH
role: PRINCIPAL_INVESTIGATOR
References: