louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03908359: Comparison of the Effect of Minimal Invasive Lens Surgery and Traditional Cataract Surgery
Official title: Comparison of the Effect of Minimal Invasive Lens Surgery and Traditional Cataract Surgery for Treating Congenital Cataracts
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Congenital Cataract
Keywords: Congenital Cataract
minimal invasive surgery
secondary intraocular lens implantation
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2019-04-09
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 24
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Previously, the investigators have developed a minimal invasive lens surgery in the purpose of reduce post-operative complications of congenital cataract. This prospective, randomized controlled study aims at comparing the prognosis of the minimal invasive lens surgery and the traditional cataract surgery for treating congenital cataracts.

Detailed description: Patients with congenital cataract that requires surgical intervention are enrolled.

Then the participants are assigned to two groups: Group I: the participants receive a minimal invasive lens surgery, while in Group II, the participants receive a traditional cataract surgery. A secondary intraocular lens implantation is performed when the patient is two years old for both Group I and Group II. Investigators then compare the visual acuity, incidence of high intraocular pressure, incidence of visual axis opacification, uveitis and iris/pupil abnormality between two groups, to evaluate and compare the prognosis of minimal invasive lens surgery and traditional cataract surgery for treating congenital cataracts.

Eligibility criteria: Inclusion Criteria:

* Age between 1 month and 24 months
* Uncomplicated congenital cataract (≥ 3 mm central dense opacity) in one or both eyes with an intact non-fibrotic capsular bag
* Informed consent signed by a parent or legal guardian

Exclusion Criteria:

* confirmed or suspected hereditary cataract, including and not restricted to family history of congenital cataract
* Intraocular pressure \>21 mmHg
* Preterm birth (\<28 weeks)
* Presence of other ocular diseases (keratitis, keratoleukoma, aniridia, glaucoma) or systemic disease (congenital heart disease, ischemic encephalopathy)
* History of ocular diseases (any congenital eye diseases, such as, congenital cataract, congenital glaucoma, congenital aniridia) in the family
* History of ocular trauma
* Microcornea
* Persistent hyperplastic primary vitreous
* Rubella
* Lowe syndrome

Primary outcomes:
measure: Best corrected visual acuity
timeFrame: up to five years of age
Secondary outcomes:
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center,Sun Yat-sen U
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Yizhi Liu, M.D,Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02224170: Comparison of Effect on Quality of Recovery Outcome Between Systemic Lidocaine and Dexamethasone in Patients Undergoing Laparoscopic Cholecystectomy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Gallbladder Polyp
Asymptomatic Gallstones Without Cholecystitis
Keywords: Dexamethasone
Lidocaine
Quality of Recovery
Laparoscopic cholecystectomy
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2014-08-25
Enrollment: 8
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The primary purpose of this study is to compare the effect of lidocaine and dexamethasone on postoperative quality of recovery after laparoscopic cholecystectomy


Eligibility criteria: Inclusion Criteria:

* ASA I-II patients aged between 20 and 65 year undergoing laparoscopic cholecystectomy due to gallbladder polyp or asymptomatic gallstones without cholecystitis

Exclusion Criteria:

1. Steroid therapy or immunocompromised patients
2. Diabetes mellitus
3. Allergy to lidocaine or dexamethasone
4. Severe renal dysfunction (serum creatinine more than 1.6mg/dl)
5. Severe liver disease ( liver enzymes more than two times normal values)
6. History of atrioventricular block
7. Have a difficulty in understanding QoR-40 (40-item quality-of-recovery scoring system) or Korean language
8. History of physicologic disease

Primary outcomes:
measure: QoR-40 score
timeFrame: from baseline to 3 hours on the day after surgery
Secondary outcomes:
measure: Incidence and severity of postoperative nausea and vomiting
timeFrame: from baseline to 3 hours on the day after surgery
Other outcomes:
measure: Time to first analgesic request
timeFrame: from baseline to 3 hours on the day after surgery
measure: Number of rescue pain reliever
timeFrame: from baseline to 3 hours on the day after surgery
measure: Severity of postoperative pain
timeFrame: from baseline to 3 hours on the day after surgery
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Surgery, Yonsei University College of Medicine, Seoul, Korea
Study officials:
References:
Clinical trial NCT01996670: Early NCPAP Before Surfactant Treatment in Very Preterm Infants With RDS
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nasal Continuous Positive Airway Pressure,
Preterm Infants,
Surfactant Treatment,
Respiratory Distress Syndrome,
Bronchopulmonary Dysplasia
Lead sponsor: Xiangya Hospital of Central South University
Sponsor class: OTHER
First posted: 2013-11-27
Enrollment: 683
Sex: ALL
Minimum age (years): 30
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: inborn infants at 26-32 weeks gestation with RDS, whom received NCPAP as the initial treatment, followed by surfactant treatment within 24 h after birth

Brief summary: We hypothesis a period of early NCPAP before surfactant treatment is effective for treating RDS and preventing BPD in very premature infants.


Eligibility criteria: Inclusion Criteria:

* All enrolled infants were able to breathe at 5 min of age, had evidence of respiratory distress, unable to receive surfactant therapy, and were administrated with early NCPAP as the initial treatment

Exclusion Criteria:

* Exclusion criteria were endotracheal intubation for resuscitation or insufficient respiratory drive, died in the first 24 hours after birth, known genetic disorders, potentially life-threatening conditions unrelated to prematurity, and premature rupture of membranes (PROM) for \>3 weeks.

Primary outcomes:
measure: death or bronchopulmonary dysplasia
timeFrame: 24 hours after birth
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00827970: Randomized Population-Based Study on Chlamydia Trachomatis Screening
Official title: Populationbased Screening for Urogenital Chlamydia Trachomatis Infections by Use of Home-Obtained and Mailed Samples: A Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chlamydia Trachomatis
Infertility
Ectopic Pregnancy
Keywords: mass screening
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Aarhus County, Denmark
name: Novo foundation
name: The Danish Medical Research Council
First posted: 2009-01-23
Enrollment: 30000
Sex: ALL
Minimum age (years): 21
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief summary: 30,000 individuals living in Aarhus County, Denmark by Oct 1997 were randomized into two groups. The intervention group received an invitation to be tested for urogenital Chlamydia trachomatis by use of home-obtained and mailed sample (9,000 individuals). The control group received no intervention (21,000 individuals). Outcome measures: Number of tested individuals, number of detected infections, number of women developing PID, ectopic pregnancy or infertility, number of women giving birth to a child, number of women receiving IVF treatment and number of men developing epididymitis.

The hypothesis was that more individuals would be tested and treated for infections and that number of long term fertility complications would decline in the intervention group compared to control group.


Eligibility criteria: Inclusion Criteria:

* born in 1974, 1974 or 1976 AND living in Aarhus County October 1007

Exclusion Criteria:

-

Primary outcomes:
measure: Long term infertility complications
timeFrame: 2008
Secondary outcomes:
Other outcomes:
Locations:
city: Aarhus N
country: Denmark
facility: Department of Infectious Diseases, Aarhus University Hospital Skejby
Study officials:
affiliation: Aarhus University Hospital Skejby, Department of Infectious Diseases
name: Berit Andersen, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Andersen B, Olesen F, Moller JK, Ostergaard L. Population-based strategies for outreach screening of urogenital Chlamydia trachomatis infections: a randomized, controlled trial. J Infect Dis. 2002 Jan 15;185(2):252-8. doi: 10.1086/338268. Epub 2002 Jan 3.
citation: Andersen B, van Valkengoed I, Sokolowski I, Moller JK, Ostergaard L, Olesen F. Impact of intensified testing for urogenital Chlamydia trachomatis infections: a randomised study with 9-year follow-up. Sex Transm Infect. 2011 Mar;87(2):156-61. doi: 10.1136/sti.2010.042192. Epub 2010 Nov 20.
Clinical trial NCT04258670: Spontaneous Antigenemia in Loiasis
Official title: Spontaneous Antigenemia in Loiasis, A Study of the Loiasis Antigens Responsible for Cross-reactivity in the Rapid Diagnostic Test for Lymphatic Filariasis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Loiasis
Lymphatic Filariasis
Keywords: diagnostics
cross-reactivity
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Doris Duke Charitable Foundation
name: Centre for Research on Filariasis and other Tropical Diseases
First posted: 2020-02-06
Enrollment: 60
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: The study will be conducted in the Okola health district (Lékié Division, Centre Region, Cameroon), situated about 40km northeast of Yaoundé, the political capital city of Cameroon. The Okola health district is highly endemic for loiasis. Participant will be recruited among those excluded from an Onchocerciasis study due to high Mf counts \>20,000/mL.

Brief summary: This prospective study will enroll and follow 60 loiasis patients with high worm burden to monitor the spontaneous release of filarial antigen in peripheral blood. This study will define the cross-reactive antigen profile of persons with spontaneous loiasis antigenemia, and determine whether it varies with time.

Detailed description: Global efforts to eradicate lymphatic filariasis (LF) depend on rapid diagnostic tests (RDTs) that detect Wuchereria bancrofti circulating filarial antigen but these tests are unreliable in African nations where Loa loa is co-endemic because they yield false-positive results in some individuals with loiasis. The goals of this project are to define the cross-reactive antigen profile of persons with spontaneous antigenemia, how it varies over time, and to determine which L. loa antigens in cross-reactive sera best distinguish loiasis cross-reactivity from LF.

This prospective study will prospectively enroll 50 adults who presented with cross-reactive antigenemia at screening and 10 negative controls. Participants will followed for one year and tested every three months for persistence of antigenemia.

Eligibility criteria: Inclusion Criteria:

* Ability to give informed consent
* Loiasis Mf count \> 20,000 Mf/mL
* Resident of study area
* No evidence of severe or systemic comorbidities
* Consent to storage of blood samples for future study

Exclusion Criteria:

* Subject plans to move from the study area during subsequent 12 months

Primary outcomes:
measure: prevalence of specific cross-reactive L. loa antigens at baseline
timeFrame: 1 day
Secondary outcomes:
measure: Recurrence of cross-reactive antigenemia
timeFrame: quarterly for 1 year
Other outcomes:
Locations:
city: Yaoundé
country: Cameroon
facility: Centre for Research on Filariasis and other Tropical Diseases (CRFilMT)
Study officials:
affiliation: Washington University School of Medicine
name: Philip Budge, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02177370: Effect on Fenoterol Metered Dose Inhaler on the Beta-receptor Population on Lymphocytes in Patients With Bronchial Asthma
Official title: Effect of Fenoterol Metered Dose Inhaler (0.1 mg) on the Beta-receptor Population on Lymphocytes and the Clinical Findings Compared With Treatment With DSCG Metered Dose Inhaler in Patients With Bronchial Asthma.
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Asthma
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-06-27
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The aim of the study was to compare the effect of fenoterol metered dose inhaler with disodium cromoglycate (DSCG) metered dose inhaler on the lymphocyte β2-receptor population as well as on the clinical findings in patients with bronchial asthma over a two-week period of treatment.


Eligibility criteria: Inclusion Criteria:

* sex: male and female
* age: 18 years or over
* bronchial asthma, diagnosis confirmed by history and positive inhalation challenge test (unspecific challenge with carbachol, PD100SRaw))
* severity of asthma mild to moderate or asthmatic in symptom-free intervals
* Raw ≤ 5 cm H2O/l/s
* no antiasthmatic treatment in the week (steroid therapy: two weeks) before the start of the study

Exclusion Criteria:

* clinically significant, concomitant haematological, cardiac, renal, hepatic or metabolic diseases
* intercurrent diseases, e.g. severe respiratory infections
* patients who cannot do without the following preparations during the 5-week trial:

  * inhaled/oral steroids
  * theophylline
  * antihistamine, antiallergic drugs
  * inhaled/oral sympathomimetics
  * anticholinergics

Primary outcomes:
measure: Airway resistance (Raw)
timeFrame: after 2 weeks
measure: Number of binding sites of the β2 receptors per lymphocytes (BS/LY)
timeFrame: after 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02052570: School Reintegration After Pediatric Hematopoietic Stem Cell Transplant
Official title: School Reintegration After Pediatric Hematopoietic Stem Cell Transplant: Experiences of Children, Parents, Teachers and Providers
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Unspecified Complication of Bone Marrow Transplant
Keywords: School Reentry after pediatric HSCT
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-02-03
Enrollment: 0
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children transplanted in the PBMT (Pediatric Bone Marrow Transplant) program at DUMC (Duke University Medical Center) in the past 5 years for allogeneic HSCT to include diagnoses for malignancy, immunodeficiency, bone marrow failure and inherited metabolic disease. They must have previously attended school prior to transplant.

Brief summary: This is a qualitative study that will explore the experiences of school reentry following Hematopoietic Stem Cell Transplant (HSCT) in children ages 10-16 years of age, their parents, teachers and primary PBMT(Pediatric Bone Marrow Transplant) providers. This study will involve four focus groups: children post -transplant, parents, teachers and PBMT providers in an effort to understand the successes and challenges of returning to school following HSCT.

Detailed description: This is a qualitative descriptive study using purposive sampling to form the four focus groups to encourage diversity in diagnosis (immunodeficiency, malignancy, bone marrow failure and inherited metabolic diseases), age and location. Each group will participate via conference call due to difference in location. There will be semi-structured questions for each group but also allow flexibility by participants themselves.

Eligibility criteria: Inclusion Criteria:

* Children transplanted in the PBMT program at DUMC in the past 5 years for allogeneic HSCT to include diagnoses for malignancy, immunodeficiency, bone marrow failure and inherited metabolic disease. They must have previously attended school prior to transplant

Exclusion Criteria:

* Autologous transplants
* Significant developmental delays that would impair ability to communicate
* Inability to get full team (child, parent, teacher, provider) to participate
* Non-English speaking

Primary outcomes:
measure: Psychosocial issues
timeFrame: 90 minutes
measure: Cultural and environmental issues
timeFrame: 90 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Health Systems
state: North Carolina
Study officials:
affiliation: DUMC
name: Susan J Wood, MN
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00029770: Chiropractic Care, Medication, and Self-Care for Neck Pain
Official title: Chiropractic Care, Medication, and Self-Care for Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neck Pain
Lead sponsor: National Center for Complementary and Integrative Health (NCCIH)
Sponsor class: NIH
First posted: 2002-01-24
Enrollment: 270
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: This study will compare the effectiveness of chiropractic care, medications, and self-care on neck pain, a very common condition. The broad, long-term objective of this study is to identify effective therapies for neck pain sufferers and to increase understanding of neck pain conditions.

Detailed description: Neck pain is very common, with considerable socioeconomic consequences. Although some therapies appear promising, there are too few randomized clinical trials of sufficient quality to support the use of one therapy over another. This is especially true for acute/subacute neck pain. Although commonly treated with prescription medications, neck pain sufferers are increasingly seeking relief through complementary and alternative medicine therapies, such as chiropractic spinal manipulation. Little is known, however about the short- and long-term relative efficacy of these therapies and how they compare to giving patients simple advice on self-care.

The broad, long-term objective of this research is to identify effective therapies for neck pain sufferers and to increase our understanding of neck pain conditions. This randomized, observer-blinded clinical trial is a unique collaborative effort by experienced chiropractic and medical researchers and will focus on patients with acute/subacute neck pain (\<12 weeks duration). The study will determine the relative efficacy of chiropractic spinal manipulation, prescription medication, and self-care advice for neck pain in both the short term (after 6 weeks) and long term (after 52 weeks), using patient-rated neck pain as the main indicator of success.

Eligibility criteria: Exclusion Criteria:

* Pregnant women, due to use of diagnostic procedures (x-rays) and study treatments (NSAIDs and narcotic medications)

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bloomington
country: United States
facility: Northern Health Sciences University
state: Minnesota
Study officials:
References:
citation: Bronfort G, Evans R, Anderson AV, Svendsen KH, Bracha Y, Grimm RH. Spinal manipulation, medication, or home exercise with advice for acute and subacute neck pain: a randomized trial. Ann Intern Med. 2012 Jan 3;156(1 Pt 1):1-10. doi: 10.7326/0003-4819-156-1-201201030-00002.
Clinical trial NCT02373670: Parent Mentors Using Positive Deviance in Childhood Obesity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Positive deviance
Peer mentors
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
First posted: 2015-02-27
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A feasibility study randomizing participants (parents of children age 2-5 years old) to receive either education or a parent mentor with the aim of improving health behaviors and improving their body mass index z-score.


Eligibility criteria: Inclusion Criteria:

* BMI z-score \>2

Exclusion Criteria:

* Medical conditions or receiving medications affecting weight

Primary outcomes:
measure: Body mass index z-score
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
References:
citation: Hollister EB, Foster BA, Dahdouli M, Ramirez J, Lai Z. Characterization of the Stool Microbiome in Hispanic Preschool Children by Weight Status and Time. Child Obes. 2018 Feb/Mar;14(2):122-130. doi: 10.1089/chi.2017.0122. Epub 2017 Oct 13.
citation: Foster BA, Aquino CA, Gil M, Gelfond JA, Hale DE. A Pilot Study of Parent Mentors for Early Childhood Obesity. J Obes. 2016;2016:2609504. doi: 10.1155/2016/2609504. Epub 2016 Jun 9.
Clinical trial NCT00649870: Food Study of Valacyclovir Hydrochloride Tablets 1000 mg to Valtrex® Tablets 1000 mg
Official title: Single-Dose Food In Vivo Bioequivalence Study of Valacyclovir Hydrochloride Tablets (1000 mg; Mylan) to Valtrex® Tablets (1000 mg; GlaxoSmithKline) in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Viatris Inc.
Sponsor class: INDUSTRY
First posted: 2008-04-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: The objective of this study was to investigate the bioequivalence of Mylan's valacyclovir hydrochloride 1000 mg tablets to GlaxoSmithKline's Valtrex® 1000 mg tablets following a single, oral 1000 mg (1 x 1000 mg) dose administration under fed conditions.


Eligibility criteria: Inclusion Criteria:

* healthy, adult subjects, 18 years and older
* able to swallow medication

Exclusion Criteria:

* institutionalized subjects
* history of any significant disease
* use of any prescription or OTC medications within 14 days of start of study
* received any investigational products within 30 days prior to start of study

Primary outcomes:
measure: The 90% confidence interval for the LSMeans ratio of CPEAK, AUCL, and AUCI for the test and reference product should be between 80.00% and 125.00% for the natural log-transformed data.
timeFrame: blood collections through 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: Kendle International Inc.
state: West Virginia
Study officials:
affiliation: Kendle International Inc.
name: Dorian Williams, M.D.
role: PRINCIPAL_INVESTIGATOR
References: