louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01077804: A Study to Evaluate Long-term Impact of VARIVAX Among Children and Adolescents (V210-036)(COMPLETED)
Official title: Fifteen Year Follow-up to Evaluate Long-term Effectiveness of VARIVAX Among Children and Adolescents
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Varicella
Herpes Zoster
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Kaiser Permanente
First posted: 2010-03-01
Enrollment: 7585
Sex: ALL
Minimum age (years): 12
Maximum age (years): 23
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 15 years prospective follow-up of the original study cohort

Brief summary: The purpose of these continuing post-licensure studies is to evaluate the long-term effectiveness of VARIVAX® \[Varicella Virus Vaccine Live (Oka/Merck)\] and to assess the impact of the vaccine on the epidemiology of varicella and herpes zoster.

Detailed description: Parents/guardians of the cohort of children vaccinated between 12 and 23 months of age during a six-month period in 1995 (June-November) at KPMCP Northern California were interviewed by telephone at 6-month intervals to ascertain whether their child had varicella or herpes zoster in the 6 months prior to interview. Follow-up continued for a minimum of 14 years after vaccination.

Eligibility criteria: Inclusion Criteria:

* Subject was a member of Kaiser Permanente Northern California, age 12-23 months, received a dose of varicella vaccine between June and November 1995, and parents accepted to participate in 15-year follow-up

Exclusion Criteria:

* Subjects diagnosed with varicella before study enrollment
* Subject's parents unable to complete telephone interviews in English, Spanish, or Cantonese

Primary outcomes:
measure: Number of Participants With an Occurrence of Breakthrough Varicella
timeFrame: From 6 weeks to 168 months (14 years) post vaccination
measure: Incidence Rate of Breakthrough Varicella
timeFrame: From 6 weeks to 168 months (14 years) post vaccination
Secondary outcomes:
measure: Number of Participants With an Occurrence of Herpes Zoster Infection
timeFrame: From 6 weeks to 168 months (14 years) post vaccination
measure: Incidence Rate of Herpes Zoster Infection
timeFrame: From 6 weeks to 168 months (14 years) post vaccination
Other outcomes:
Locations:
Study officials:
affiliation: Kaiser Permanente
name: Roger Baxter
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baxter R, Ray P, Tran TN, Black S, Shinefield HR, Coplan PM, Lewis E, Fireman B, Saddier P. Long-term effectiveness of varicella vaccine: a 14-Year, prospective cohort study. Pediatrics. 2013 May;131(5):e1389-96. doi: 10.1542/peds.2012-3303. Epub 2013 Apr 1.
Clinical trial NCT02055404: On-Eye Evaluation of Contact Lens Rotation Marks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Refractive Error
Keywords: astigmatism
toric
contact lenses
daily disposable contact lenses
molded mark
rotation mark
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2014-02-05
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The purpose of this study was to select the size of the molded rotation mark for a new toric contact lens by comparing the visibility of various molded rotation marks.

Detailed description: Participants wore the test and control products contralaterally (in each eye separately) for 2 hours, during which the Investigator assessed the various molded rotation marks for visibility. Each participant was assessed by 10 investigators.

Eligibility criteria: Inclusion Criteria:

* Sign Informed Consent document.
* Best corrected distance visual acuity (VA) greater than or equal to 20/25 in each eye.
* Other protocol-defined inclusion criteria may apply.

Exclusion Criteria:

* History of any ocular surgery or ocular injury within 12 weeks of study enrollment.
* Any ocular disease, infection, inflammation, or abnormality that contraindicates contact lens (CL) wear.
* History of herpetic keratitis.
* Slit-lamp findings greater than grade 2 at baseline.
* Any use of systemic or ocular medications for which CL wear could be contraindicated.
* Inactive corneal neovascularization greater than 1 millimeter of penetration.
* A clinically significant dry eye not responding to treatment.
* History of refractive surgery.
* Participation in a clinical study within the previous 30 days.
* Other protocol-defined exclusion criteria may apply.

Primary outcomes:
measure: Visibility of Rotation Mark (Clearly Visible, Slightly Visible Acceptable)
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Alcon Research
name: Joachim Nick, Dipl. Ing.
role: STUDY_DIRECTOR
References:
Clinical trial NCT01319604: SENSIMED Triggerfish
Official title: Randomized Clinical Investigation to Assess the Efficacy of SENSIMED Triggerfish Continuous IOP Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma
Lead sponsor: Sensimed AG
Sponsor class: INDUSTRY
First posted: 2011-03-21
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the investigation is to investigate the relationship between the study device output and tonometric assessments.

Detailed description: 60 subjects will be enrolled in total. Enrolled patients will be randomized into one of 8 device groups of 6 subjects each or into the control group containing 12 subjects. Patients in the device arm will receive one session of 3-to 24-hour continuous IOP monitoring with SENSIMED Triggerfish®. SENSIMED Triggerfish® monitoring will begin at 18h ± 2 hours for all patients. SENSIMED Triggerfish® will be installed randomly on right or left eyes. During SENSIMED Triggerfish® monitoring on one eye, GAT and/or Perkins IOP measurements will be taken in the fellow eye every 3 hours. Outside this time they will receive GAT and/or IOP measurements every 3 hours in both eyes until the end of the 24-hours period. Patients in the control group will receive GAT and/or ICare PRO IOP measurements every 3 hours for 24 hours in both eyes.

Eligibility criteria: Inclusion Criteria:

* Signed informed consent for the investigation
* Confirmed diagnosis of primary open angle glaucoma or normal tension glaucoma of similar degree in both eyes
* Age 18-85
* Stable anti-glaucomatous therapy 4 weeks before and throughout the investigation

Exclusion Criteria:

* Patients not able to understand the character and individual consequences of the investigation
* Patients with contraindications for silicone contact lens wear
* Wear of full frame metallic glasses during SENSIMED Triggerfish® monitoring
* Diagnosis of pseudoexfoliation syndrome / pseudoexfoliative glaucoma and of pigment dispersion syndrome / pigmentary glaucoma
* Severe dry eye
* Patients who have had ocular surgery within the last 3 months
* Corneal or conjunctival abnormality or irregularity hindering correct contact lens adaptation
* Allergy to corneal anaesthesia
* Simultaneous participation in other clinical research

Primary outcomes:
measure: Relationship between study device signal and tonometer reading
timeFrame: during 24 hours of study device wear
Secondary outcomes:
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Glostrup
country: Denmark
facility: University Hospital Glostrup
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: Valencia
country: Spain
facility: Hospital Universitari i Politècnic la Fe
city: Bern
country: Switzerland
facility: Inselspital
Study officials:
affiliation: University of Bern
name: Milko Iliev, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05921604: Baclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve Gastrectomy
Official title: Baclofen Versus Gabapentin in Preventing Postoperative Pain After Laparoscopic Sleeve
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Post Operative Pain
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2023-06-27
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this study is to compare the possible efficacy of baclofen and gabapentin on postoperative pain in patient with morbid obesity who will undergo laparoscopic sleeve gastrectomy.


Eligibility criteria: Inclusion Criteria:

* - Age between 18-60 years old.
* Both male and female patients will be included.
* Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥35 kg/m2 with the presence of comorbidity such as hypertension, arthritis, and diabetes.
* Morbidly obese patients scheduled for sleeve gastrectomy with BMI ≥ 40 kg/m2 without comorbidity.
* Patients fit for anesthesia and surgery.

Exclusion Criteria:

* Patients with BMI \>55 kg/m2.
* Patients with previous procedures for the treatment of obesity.
* Pregnant females and lactating women.
* Patients with psychological or psychiatric disease
* Administration of antiemetic medication or systemic corticosteroids within 24 hours before surgery
* Patients who experienced vomiting within 24 hours before surgery.
* Patients with history of alcohol or drug abuse.
* Patients with hypersensitivity or contraindications to any of the drugs used in this study.

Primary outcomes:
measure: visual analog scale (VAS) score
timeFrame: The first 48 hours after surgery.
Secondary outcomes:
measure: sedation score
timeFrame: The first 48 hours after surgery.
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Gastrointestinal and Laparoscopic Surgery Unit, General Surgery Department, Tanta University Hospital, Tanta, Egypt
state: Gharbiya
Study officials:
References:
Clinical trial NCT00322504: Acupuncture for Anxiety in Women With Breast Cancer: A Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: University of New Mexico
Sponsor class: OTHER
First posted: 2006-05-08
Enrollment: 10
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: To assess the efficacy of acupuncture treatment in reducing symptoms of anxiety in women recently diagnosed with cancer.

• To assess the efficacy of acupuncture treatment on improving perceived quality of life in women recently diagnosed with cancer.

Detailed description: This is a feasibility study of acupuncture for anxiety reduction in women with breast cancer. Ten patients will be recruited at the UNM Cancer Research Treatment Center via the Breast Clinic and screened for anxiety. Treatment will consist of 10 acupuncture sessions over 5 weeks. Measures (Hopkins Symptom Checklist, Sheehan Disability Index) will be administered and analyzed for treatment effect on scores.

Eligibility criteria: Inclusion Criteria:

* Woman age 18 years or older excluding the need for parental/guardian permission.
* Histologic diagnosis of breast cancer.
* Having a minimum anxiety score of 1.75 on the Hopkins Symptom Checklist (HSCL) with sufficient English language proficiency for the investigators to make this determination.
* Able to give informed consent.
* Willingness to participate in the study and receive 10 acupuncture treatments in 5 weeks.
* Ability to fill out questionnaires and communicate with the research staff

Exclusion Criteria:

* Males with breast cancer
* Psychoses or a major personality disorder
* Current use of opiates,

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Albuquerque
country: United States
facility: University of New Mexico
state: New Mexico
Study officials:
affiliation: University of New Mexico
name: Brian Shelley
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03340701: Pharmacokinetics of Progesterone in Pregnancy
Official title: Pharmacokinetics of Vaginal Progesterone in Pregnancy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Progesterone
Keywords: progesterone
pharmacology
pharmacokinetics
Lead sponsor: Thomas Jefferson University
Sponsor class: OTHER
First posted: 2017-11-13
Enrollment: 6
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pharmacokinetic study to assess plasma concentration time profile of vaginal progesterone in pregnant women.
Primary purpose: OTHER

Brief summary: Pharmacokinetic analysis of 200mg vaginal progesterone suppository in women with singleton pregnancies between 18 0/7- 23 6/7 weeks' gestation

Detailed description: Prospective study of 6 women with singleton pregnancies 18 0/7- 23 6/7 weeks' gestation with no prior preterm birth or short cervix who are administered a single dose of 200mg vaginal progesterone suppository. Serum progesterone levels will be drawn serially from pre-dose to 24 hours post-dose.

Eligibility criteria: Inclusion Criteria:

* ≥18 years old pregnant with singleton gestation 16 0/7 - 23 6/7 weeks
* pre-pregnancy BMI 20-40
* no history of prior preterm birth

Exclusion Criteria:

* history of an adverse reaction to progesterone
* contraindication to progesterone treatment including prior or active thrombus, active hepatic disease, known adverse reaction to progesterone
* medical comorbidity requiring medication including: hypertension, diabetes, substance abuse/methadone maintenance therapy, asthma, thyroid disease
* major fetal anomaly diagnosed on ultrasound or known chromosomal disorder
* multifetal gestation
* vaginal bleeding, preterm labor, premature rupture of membranes, or clinical chorioamnionitis, at the time of enrollment or on Day 1 of study
* any progesterone use of any form previously during the pregnancy
* active vaginitis
* Illicit substance use in pregnancy including cocaine, opiates, marijuana
* abnormal pap smear/+HPV on most recent pap smear
* known or suspected malignancy of the breast or genital organs
* cervical length ≤25mm

Primary outcomes:
measure: Pharmacokinetic model
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Thomas Jefferson University Hospital
state: Pennsylvania
Study officials:
affiliation: Thomas Jefferson University
name: Rupsa C Boelig, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Boelig RC, Zuppa AF, Kraft WK, Caritis S. Pharmacokinetics of vaginal progesterone in pregnancy. Am J Obstet Gynecol. 2019 Sep;221(3):263.e1-263.e7. doi: 10.1016/j.ajog.2019.06.019. Epub 2019 Jun 15.
Clinical trial NCT03386201: FLuorescence Cholangiography Using Methylene Blue
Official title: FLuorescence Cholangiography Using Methylene Blue
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bile Duct Injury
Keywords: Laparoscopic cholecystectomy
Fluorescence
Lead sponsor: University of Oxford
Sponsor class: OTHER
Collaborators: name: Oxford University Hospitals NHS Trust
First posted: 2017-12-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Open label prospective, non-randomised proof of principle study assessing the use of methylene blue fluorescence cholangiography.


Eligibility criteria: Inclusion Criteria:

* Participant is willing and able to give informed consent for participation in the study.
* Male or Female, aged 18 years or above.
* Undergoing laparoscopic cholecystectomy

Exclusion Criteria:

* Patient who is unable or unwilling to give informed consent
* Known allergy to methylene blue
* Risk of serotonin syndrome (taking SSRI / G6PD deficiency / previous serotonin syndrome)
* Significant renal failure
* Pregnant / planning pregnancy or breastfeeding

Primary outcomes:
measure: Concordance of surgeon anatomy definition with fluorescence outline
timeFrame: Intraoperative (At end of laparoscopic cholecystectomy)
Secondary outcomes:
measure: Signal to background ratio over time throughout laparoscopic cholecystectomy
timeFrame: 0, 10, 20, 30, 40, 50, 60, minutes and at 10 minute intervals thereafter post injection of methylene blue
Other outcomes:
Locations:
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
Study officials:
References:
Clinical trial NCT00908401: Analgesic Effect of Breastmilk for Procedural Pain in Preterm Infants
Official title: Breastmilk or Oral Sucrose Solution in Preterm Neonates for Procedural Pain: a Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Procedural Pain
Keywords: breastmilk
oral sucrose
analgesia
preterm neonates
Neonates
Lead sponsor: Centre Hospitalier Intercommunal Creteil
Sponsor class: OTHER
First posted: 2009-05-25
Enrollment: 42
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Hypothesis: Breastmilk has a more powerful analgesic effect than oral sucrose to avoid procedural pain in preterm neonates.

The objective is to test this hypothesis in a randomized, controlled study using a standardized and validated pain scale (DAN). The sample size is 21 preterm infants in each two groups. The main end point is a reduction of the risk to have a DAN superior to 1 from 80% with oral sucrose to 40% with breastmilk.


Eligibility criteria: Inclusion Criteria:

* preterm neonates born before 27 and 29+6 weeks GA
* blood sampling procedure
* obtention of parental consent

Exclusion Criteria:

* congenital malformation
* intravenous continuous analgesia
* contraindications to feed
* high grade intracerebral hemorrhage

Primary outcomes:
measure: Decrement from 80 to 40% of frequency of DAN's scale score superior to 1 using breastmilk instead of oral sucrose
timeFrame: One time during day 3 or 4 then day 7 to 10
Secondary outcomes:
Other outcomes:
Locations:
city: Creteil
country: France
facility: Centre Hospitalier Intercommunal de Creteil
Study officials:
affiliation: Centre Hospitalier Intercommunal Creteil
name: Elodie Zana, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schollin J. Analgesic effect of expressed breast milk in procedural pain in neonates. Acta Paediatr. 2004 Apr;93(4):453-5. doi: 10.1080/08035250410027959.
citation: Carbajal R, Veerapen S, Couderc S, Jugie M, Ville Y. Analgesic effect of breast feeding in term neonates: randomised controlled trial. BMJ. 2003 Jan 4;326(7379):13. doi: 10.1136/bmj.326.7379.13.
citation: Carbajal R, Paupe A, Hoenn E, Lenclen R, Olivier-Martin M. [APN: evaluation behavioral scale of acute pain in newborn infants]. Arch Pediatr. 1997 Jul;4(7):623-8. doi: 10.1016/s0929-693x(97)83360-x. French.
Clinical trial NCT02161601: Effect of Incorrectly Applied Cricoid Pressure During Rapid Sequence Induction. Evaluation With High-resolution Manometry.
Official title: Effect of Incorrectly Applied Cricoid Pressure During Rapid Sequence Induction. Evaluation With High-resolution Manometry
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cricoid Pressure
Keywords: Cricoid pressure
Rapid Sequence Induction
Lead sponsor: Örebro University, Sweden
Sponsor class: OTHER
First posted: 2014-06-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: During emergency anesthesia (rapid sequence induction) , a firm pressure is applied to the cricoid cartilage of the patient in order to prevent passive regurgitation of gastric content into the pharynx. This maneuver is called cricoid pressure.

Cricoid pressure is often performed incorrectly, due to difficulties to locate the cricoid cartilage in many patients. Despite this, the effectiveness of an incorrectly applied cricoid pressure has not been investigated. In this study we have used high-resolution manometry (HRM) to evaluate pressures in the upper esophagus during correctly applied cricoid pressure (against the cricoid cartilage) compared to incorrectly applied cricoid pressure (against the thyroid cartilage and against the trachea) during a rapid sequence induction.


Eligibility criteria: Inclusion Criteria:

* Elective surgery and Anesthesia with intubation,
* ASA physical status I-II (American Society of Anesthesiologist classification system = system for assessing the fitness of cases before surgery)
* Body Mass Index \> 18,5 and \< 30
* Informed, signed and dated consent

Exclusion Criteria:

* Suspected difficult airway,
* Pharyngoesophageal dysfunction,
* Body Mass Index \< 18,5 or \> 30,

Primary outcomes:
measure: difference in pressure (mmHg), detected by high resolution solid state manometry, between correctly vs incorrectly applied cricoid pressure
timeFrame: 15 sec. during ongoing cricoid pressure application
Secondary outcomes:
Other outcomes:
Locations:
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
References: