louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02552927: Chest Shielding in Premature Infants During Phototherapy
Official title: Effect of Chest Shielding on the Incidence of Patent Ductus Arteriosus in Premature Infants Undergoing Phototherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Patent Ductus Arteriosus in Premature Infants
Keywords: PDA
Jaundice
Phototherapy
Lead sponsor: University of Rochester
Sponsor class: OTHER
First posted: 2015-09-17
Enrollment: 50
Sex: ALL
Minimum age (years): 23
Maximum age (years): 33
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This is a feasibility study where Infants will be randomized to either chest shielding with aluminum foil or chest shielding without aluminum foil while undergoing phototherapy for premature infants. The primary outcome is patent ductus arteriosus.


Eligibility criteria: Inclusion Criteria:

* less or equal to 29 weeks or 1000g at birth
* Admitted to the NICU (Neonatal intensive care unit) within 24 hours after birth
* English speaking parents

Exclusion Criteria:

* Congenital abnormalities
* Chromosomal disorders
* Cyanotic heart defects
* Nitric oxide
* Prophylactic phototherapy
* Unlikely to survive beyond 72 hours according to the attending neonatologist
* Do not require phototherapy

Primary outcomes:
measure: Incidence of symptomatic Patent ductus arteriosus
timeFrame: During first 2 weeks
Secondary outcomes:
measure: Urinary Nitric oxide level
timeFrame: During first 2 weeks
Other outcomes:
measure: Incidence of Chronic lung disease
timeFrame: at 36 weeks post-menstrual age
measure: Incidence of Retinopathy of Prematurity
timeFrame: up to 44 weeks post-menstrual age
measure: Peak level of total serum bilirubin
timeFrame: First 2 weeks
measure: Duration of Phototherapy
timeFrame: First 2 weeks
measure: Incidence of intraventricular hemorrhage
timeFrame: First 2 weeks
measure: Incidence of surgical ligation for patent ductus arteriosus
timeFrame: First 4 weeks
Locations:
city: Rochester
country: United States
facility: University of Rochester
state: New York
Study officials:
affiliation: University of Rochester
name: Javed Mannan, MD, MPH
role: STUDY_DIRECTOR
References:
Clinical trial NCT04548427: Study to Evaluate the Efficacy and Safety of CKD-352
Official title: Active Controlled, Randomized, Double-blind, Multi-center, Phase 3 Trial to Evaluate the Efficacy and Safety of CKD-352 Eye Drops in Patients With Dry Eye Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Dry Eye Disease
Keywords: Dry Eye Disease
CKD-352
Lead sponsor: Chong Kun Dang Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2020-09-14
Enrollment: 283
Sex: ALL
Minimum age (years): 19
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 compare the efficacy and safety of CKD-352 in patients with dry eye disease

Detailed description: Active controlled, randomized, double-blind, multi-center, phase 3 trial to evaluate the efficacy and safety of CKD-352 eye drops in patients with dry eye disease

Eligibility criteria: Inclusion Criteria:

1. More than the age of 19 years old
2. Subjects with dry eye symptoms for at least 3 month
3. Subjects who sign on an informed consent form willingly

Exclusion Criteria:

1. Subjects who have clinically significant ocular surface diseases, abnormal corneal susceptibility and abnormal epiphora
2. Subjects who have clinically significant medical history of ocular disability
3. Subjects who have malignant tumor within 5 years
4. Subjects with known hypersensitivity to investigational product
5. Women who are nursing, pregnant or planning pregnancy during the study
6. Subjects who have received any other investigational product
7. Impossible subjects who participate in clinical trial by investigator's decision

Primary outcomes:
measure: Changes in Corneal Staining from Baseline and at Week 4
timeFrame: Baseline, Week 4
Secondary outcomes:
measure: Changes in Corneal Staining from Baseline and at Week 2
timeFrame: Baseline, Week 2
measure: Changes in Conjunctival Staining from Baseline and at Week 2,4
timeFrame: Baseline, Week 2,4
measure: Changes in Tear Break-up Time from Baseline and at Week 2, 4
timeFrame: Baseline, Week 2,4
measure: Changes in Schirmer I Test from Baseline and at Week 2, 4
timeFrame: Baseline, Week 2,4
measure: Changes in Ocular Surface Disease Index from Baseline and at week 2, 4
timeFrame: Baseline, Week 2,4
Other outcomes:
Locations:
city: Pusan
country: Korea, Republic of
facility: Pusan National University Hospital
Study officials:
affiliation: Pusan National University Hospital
name: Jong Su Lee, M.D, Ph.D
role: STUDY_CHAIR
References:
Clinical trial NCT01013727: Functional Neuroimaging of Postural Reconstruction
Official title: Functional Neuroimaging of Postural Reconstruction: Preliminary Study on a Dorsiflexion Motion of the Ankle and Comparison Between an Arm Following Postural Reconstruction Program and a Comparator Arm Following a Muscular Stretching Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: Volunteers
healthy subjects
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2009-11-16
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: To study in two cross-sections of healthy volunteers, with single photon emission computed tomography (SPECT), the possible changes generated in the mid-term by two rehabilitation techniques: the postural reconstruction and the muscular stretching. The changes in the cortical activation patterns will be estimated during a non-specific position of the ankle, held static.

The influence of each technique will be estimated though the evidence of a change in the functional mapping of the areas activated during the defined motor task on healthy volunteers.

Detailed description: This is a monocentre, randomized study.

Eligibility criteria: Inclusion Criteria:

* male or female 18 to 35 years old

Exclusion Criteria:

* pregnant, lactating

Primary outcomes:
measure: Change in the functional mapping of the areas activated during the defined motor task on healthy volunteers.
timeFrame: 8 months
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: University Hospital Strasbourg
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Izzie Jacques Namer, Md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01054027: Study on Effective Mydriasis in Premature Infants
Official title: A Randomized Controlled Trial to Determine the Lowest Effective Dose for Adequate Mydriasis in Premature Infants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Retinopathy of Prematurity (ROP)
Keywords: Retinopathy of Prematurity (ROP)
Eye exams
Premature infants
cyclomydril
Lead sponsor: Georgetown University
Sponsor class: OTHER
First posted: 2010-01-22
Enrollment: 15
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SCREENING

Brief summary: The purpose of this study is to compare the dilating effect of 0, 1, 2 or 3 drops of mydriatic (pupil dilating) in premature infants undergoing routine retinal (eye) screening exams for Retinopathy of Prematurity (ROP).

Detailed description: Premature infants need to have eye exams starting at about 4 weeks of age and continuing until their retinas (membrane at the back of the eye which collects and transfers light) is fully grown. These exams are done to see if they have developed ROP, a disease which can lead to blindness if not treated.

The ophthalmologist (eye doctor) looks through the enlarged pupil (opening at the front of the eye) to see the retina. The drug that is used to dilate the pupil, Cyclomydril, has been shown to have side effects in premature infants. No literature has shown what the optimal dose is for premature babies. Nursery policy is to give 3 drops of Cyclomydril in each eye, at 5 minute intervals, 45-60 minutes before a scheduled eye exam. We sought to reduce the dose without delaying the exam for an under-sized pupil.

In the study, each infant is randomized at the time of the exam to receive either 0, 1 or 2 drops of Cyclomydril in the left eye and 3 drops in the right eye to serve as their own control. The zero-drop group was created to test the contralateral (opposite eye) effect of 3 drops in the right eye. Pupil dilation size is measured using the Colvard pupillometer by a Pediatric Ophthalmologist examiner (G.V.V.) who was not masked to study group assignment.

Measures of pupil size are done at baseline (before any drops given), 45, 90 and 120 minutes after the first drop was given. ROP screening exam is done at the first opportunity to visualize the posterior and peripheral retina.

Additional drops are given at 120 minutes if the observer is unable to complete the exam prior to that point.

Eligibility criteria: Inclusion Criteria:

* Premature infants undergoing clinically indicated retinal exams

Exclusion Criteria:

* Ocular congenital anomalies
* Pre-threshold ROP

Primary outcomes:
measure: dilation of the pupil in millimeters
timeFrame: at baseline (no drops yet instilled), 45, 90 and 120 minutes after drops instilled
Secondary outcomes:
Other outcomes:
Locations:
city: Washington
country: United States
facility: Georgetown University Hospital
state: District of Columbia
Study officials:
affiliation: Georgetown University Hospital
name: Monisha Bahri, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04970927: The Effect of Pandemic on Children With Cerebral Palsy
Official title: Investigation of the Effect of Covid-19 Pandemic on Children With Cerebral Palsy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cerebral Palsy
Covid19
Keywords: Cerebral Palsy
Covid19
Pandemics
Lead sponsor: Afyonkarahisar Health Sciences University
Sponsor class: OTHER
First posted: 2021-07-21
Enrollment: 300
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: -Parents of children under the age of 18 with cerebral palsy who applied to our hospital between 01.01.2014-31.01.2021

Brief summary: Cerebral Palsy (CP), is the most common cause of physical disability that begins in childhood and lasts throughout life, affecting 1 in 500 newborns, with an estimated prevalence of 17 million worldwide.

Social isolation, economic conditions, interruption of treatments, etc. may cause physical, mental, behavioral and psychosocial changes in children with cerebral palsy. Discontinuing regular physiotherapy can worsen functional skills and cause complications in children with cerebral palsy. Our aim in this study is to investigate the sustainability of the treatments of children with cerebral palsy during the pandemic period, their physical and psychosocial effects, and the relationship between their parents' fear of covid-19.


Eligibility criteria: Inclusion Criteria:

* Parents of children under the age of 18 with cerebral palsy who applied to our hospital between 01.01.2014-31.01.2021

Exclusion Criteria:

* Parents of Cerebral Palsy Patients over 18 years of age
* Parents who cannot be reached by phone
* Parents who do not agree to fill out the questionnaire

Primary outcomes:
measure: Evaluation Survey
timeFrame: First day
Secondary outcomes:
measure: Covid-19 Fear Scale
timeFrame: First day
Other outcomes:
Locations:
city: Merkez
country: Turkey
facility: Sevda Adar
state: Afyon
Study officials:
affiliation: Afyonkarahisar Health Sciences University
name: SEVDA ADAR
role: PRINCIPAL_INVESTIGATOR
affiliation: Afyonkarahisar Health Sciences University
name: PETEK ŞARLAK KONYA
role: STUDY_CHAIR
affiliation: Afyonkarahisar Health Sciences University
name: ALİ İZZET AKÇİN
role: STUDY_CHAIR
References:
Clinical trial NCT06735027: Corticosteroid Injection Versus Nerve Block
Official title: A Randomized Comparative Cohort Study of the Use of Intra-articular Corticosteroid Injection Compared to Suprascapular Nerve Block for Treatment of Shoulder Pain
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glenohumeral Arthritis
Rotator Cuff Arthropathy
Keywords: osteoarthritis
glenohumeral arthritis
rotator cuff arthropathy
corticosteroid injection
suprascapular nerve block
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-12-16
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two study arms, with each arm receiving one of two interventions: corticosteroid shoulder injection or suprascapular nerve block
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate conservative pain relief measures for patients suffering from glenohumeral arthritis or rotator cuff arthropathy. Conservative management of osteoarthritis is often first line treatment, and while a corticosteroid injection is frequently used, suprascapular nerve blocks have not often been described as an analgesic option in this population.


Eligibility criteria: Inclusion Criteria:

* diagnosis of glenohumeral osteoarthritis, rheumatoid arthritis, or rotator cuff arthropathy who are being offered injection

Exclusion Criteria:

* uncontrolled diabetes (patients will be excluded if no HbA1c within a year or if it is 8 or greater"
* known allergy to steroid or anesthetic
* pregnant women
* prisoners
* patients with diminished capacity to consent to participation
* children under 18 years of age
* non-English speakers

Primary outcomes:
measure: change in visual analog scale (VAS) for pain
timeFrame: preintervention, 24 hours, 3 days, 1 month, and 3 months postintervention
measure: single assessment numerical evaluation (SANE) of the shoulder
timeFrame: preintervention, 24 hours, 3 days, 1 month, and 3 months postintervention
measure: Oxford shoulder score (OSS)
timeFrame: preintervention, 24 hours, 3 days, 1 month, and 3 months postintervention
measure: American shoulder and elbow surgeons (ASES) score
timeFrame: preintervention, 24 hours, 3 days, 1 month, and 3 months postintervention
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Allison Rao, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04809727: Histopathological Findings in Symptomatizing Patients After Supracervical Hysterectomy
Official title: Histopathological Findings in Symptomatizing Patients After Supracervical Hysterectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: CIN
Cancer of Cervix
Cervicitis
Lead sponsor: Tanta University
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 88
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All patients suffering after supracervical hysterectomy
Primary purpose: DIAGNOSTIC

Brief summary: Supracervical hysterectomy is widely common and had many complications either immediate or delayed. In these patients bleeding, infection, chronic pelvic pain are common. In these patients cervical biopsy was done and histopathological examinations were done to evaluate the pathology in these patients.

Detailed description: * Study design and settings: Cross sectional descriptive studies conducted from December 2017 till January 2021.
* Patients: 80 patients with supracervical hysterectomy recruited at Tanta University Hospital, gynecology clinics will be recruited according inclusion and exclusion criteria. Inclusion criteria include all symptomatizing patients following supracervical hysterectomy, of any age, of any complaints. The exclusion criteria were patients with total hysterectomy, hysterectomies for malignant indications, and refusal to participate.
* Methods: All patients' demographic data, history, indication of hysterectomy, duration since operation, postoperative complications and their main complaint.

Intervention: under general anesthesia cervical biopsy (4 quadrants) were taken from all patients and was sent for histopathological examinations.

Eligibility criteria: Inclusion Criteria:

* all symptomatizing patients following supracervical hysterectomy,

Exclusion Criteria:

* with total hysterectomy,
* hysterectomies for malignant indications,
* refusal to participate.

Primary outcomes:
measure: Detection of cervical neoplasia or cancer incidence
timeFrame: 1 year
measure: Detection of chronic cervicitis incidence
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Tanta
country: Egypt
facility: Ayman Shehata Dawood
state: Gharbia
Study officials:
References:
Clinical trial NCT05294627: Validation of the Stockholm3 Test for Detection of Prostate Cancer in the Swiss Population
Official title: Validation of the Prostate Cancer Biomarker Stockholm3 for Improved Disease Detection and Classification in the Swiss Population
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Localized Carcinoma
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Department of Urology, University Hospital Freiburg, Freiburg, Germany
name: Department of Urology, Kantonsspital Graubünden, Chur, Switzerland
First posted: 2022-03-24
Enrollment: 380
Sex: MALE
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Men with suspicion of prostate cancer (usually due to a combination of elevated PSA levels \[e.g. \>2.5 ng/ml\] and/or pathological digital rectal examination and/or MRI-findings)

Brief summary: The purpose of this study is to collect blood samples to investigate the prognostic performance of the STHLM3 test in a population of Swiss and German men suspected of harbouring prostate cancer based on a combination of elevated PSA levels (e.g. \>2.5 ng/ml) and/or pathological digital rectal examination and/or MRI-findings.


Eligibility criteria: Inclusion Criteria:

* Planned prostate biopsy due to suspicion of prostate cancer (usually due to a combination of elevated PSA levels \[e.g. \>2.5 ng/ml\] and/or pathological digital rectal examination and/or MRI-findings)
* Written informed consent by the participant

Exclusion Criteria:

* Severe anemia (Hb \<60g/l)
* Previously already established diagnosis of prostate cancer.

Primary outcomes:
measure: Cancer detection
timeFrame: 2020-2022
Secondary outcomes:
measure: Disease state
timeFrame: 2020-2022
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel, Urology
Study officials:
affiliation: Universitätsspital Basel
name: Ashkan Mortezavi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00951327: Cholangioscopy Using Narrow Band Imaging (NBI) in Patients With Primary Sclerosing Cholangitis (PSC) Undergoing Endoscopic Retrograde Cholangiopancreatogram (ERCP)
Official title: Cholangioscopy Using Narrow Band Imaging (NBI) in Patients With Primary Sclerosing Cholangitis (PSC) Undergoing ERCP.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Sclerosing Cholangitis
Keywords: Primary sclerosing cholangitis
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2009-08-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients presenting for ERCP with history of Primary Sclerosing Cholangitis

Brief summary: Patients with primary sclerosing cholangitis (PSC) are affected by an inflammatory condition of the bile ducts. Unfortunately, patients with PSC have a 10 to 15 percent lifetime risk of developing gallbladder and bile duct cancers. Gallbladder and bile duct cancers have a five-year survival of only 5 to 10 percent. Surgery to provide a cure must remove all cancer confined to one area.

In order to increase survival rates there is a need to identify cancer and pre-cancer early. This has been difficult to do.

Patients who have lab tests, positive imaging tests or obstructions will usually have a test called ERCP (Endoscopic Retrograde Cholangiopancreatogram) to take biopsies and enlarge bile ducts or opening bile ducts with stents. Patients usually have cells in the bile ducts removed and analyzed, but there are not studies to show how sensitive this may be to determine if the cells are cancer or pre-cancerous. A new scope with a system using light filters called Narrow Band Imaging (NBI) may help detect cancer and pre-cancer more often and at an earlier stage.


Eligibility criteria: Inclusion Criteria:

* Patients with PSC presenting for ERCP where tissue sampling is indicated
* Adults age 18 to 75 years old
* Able to give informed written consent
* Either male or female

Exclusion Criteria:

* PSC with acute cholangitis
* Patients with acute or chronic, debilitating cardiopulmonary disease who are unable to safely undergo prolonged conscious sedation
* Patients with a prior history of liver transplant
* Prisoners
* Unable or unwilling to give informed consents

Primary outcomes:
measure: Cholangioscopy with NBI will enhance the ability to identify sites of potential dysplasia or malignancy in patients with PSC and will be more sensitive in identifying dysplasia than ERCP with biliary brushing and fluoroscopy-guided forceps biopsy.
timeFrame: One year
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic Rochester
state: Minnesota
Study officials:
References:
citation: Azeem N, Gostout CJ, Knipschield M, Baron TH. Cholangioscopy with narrow-band imaging in patients with primary sclerosing cholangitis undergoing ERCP. Gastrointest Endosc. 2014 May;79(5):773-779.e2. doi: 10.1016/j.gie.2013.09.017. Epub 2013 Oct 24.