louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01150396: Prognosis of Extremely Premature Birth
Official title: Mortality and Morbidity of Infants Born With Gestational Age Less Than 28 Weeks
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Infant, Premature, Diseases
Perinatal Morbidity
Development
Problem;Growth
Keywords: extremely premature infant
outcome
follow-up
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Haukeland University Hospital
name: Helse Stavanger HF
First posted: 2010-06-25
Enrollment: 160
Sex: ALL
Minimum age (years): 22
Maximum age (years): 27
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants born before 28 weeks' gestational age

Brief summary: Pregnant women at risk of giving birth before 28 weeks' gestational age will be enrolled. Fetal circulation will be studied and blood for inflammatory parameters will be collected. If birth occurs before 28 weeks, detailed information on clinical course of the newborn until discharge from the neonatal intensive care unit will be recorded,and specimens of amniotic fluid, placenta, blood and urine will be collection for inflammatory parameters. After discharge the children will be followed according to a specific protocol until 5 years of age.

Detailed description: The study includes a regional cohort (Western Norway) of approximately 50 extremely preterm infants born per year over a three year period. Detailed information on fetal condition (growth, circulation, infection), neonatal resuscitation and clinical course (details on ventilatory support, circulation, pulmonary function as assessed with a neonatal spirometry technique, cerebral imaging, nutrition, growth) will be recorded. Biobank samples of blood and amniotic fluid from the mother, and from placenta, blood, urine, and tracheal aspirates will be collected form the infant, primarily to examine for inflammatory parameters. After discharge, follow-up at 6, 12, 36 and 56 months will be conducted using standardized tests (Ages \& Stages, INFANIB, Denver Developmental Screening test, Bayley scales, WPPSI and ABC movement tests).

Eligibility criteria: Inclusion Criteria:

* Born with gestational age less than 28 weeks

Exclusion Criteria:

* None

Primary outcomes:
measure: Health
timeFrame: 40 weeks
Secondary outcomes:
measure: Health
timeFrame: 1 year
measure: Health
timeFrame: 3 years
measure: Health
timeFrame: 5 years
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Stavanger
country: Norway
facility: Stavanger University Hospital
Study officials:
affiliation: University of Bergen, Faculty of Medicine
name: Trond Markestad, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bentsen MH, Markestad T, Oymar K, Halvorsen T. Lung function at term in extremely preterm-born infants: a regional prospective cohort study. BMJ Open. 2017 Oct 25;7(10):e016868. doi: 10.1136/bmjopen-2017-016868.
Clinical trial NCT01411696: Retrospective Study in Patients Receiving Two or More OZURDEX® Injections for Retinal Vein Occlusion (RVO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Retinal Vein Occlusion
Macular Edema
Lead sponsor: Allergan
Sponsor class: INDUSTRY
First posted: 2011-08-08
Enrollment: 289
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who received at least 2 injections of OZURDEX® to treat macular edema due to RVO in at least one eye.

Brief summary: This is a retrospective data collection study to evaluate the efficacy, safety, and re-injection interval of OZURDEX® in the treatment of macular edema due to RVO. Following informed consent, there were no patient study visits. All data was collected via chart review.


Eligibility criteria: Inclusion Criteria:

* Macular edema
* Received at least 2 OZURDEX® injections

Exclusion Criteria:

* Received OZURDEX® injections as part of a clinical study

Primary outcomes:
measure: Change From Baseline in Best Corrected Visual Acuity (BCVA) 4 to 20 Weeks Following the Last OZURDEX® (Dexamethasone Intravitreal Implant) Injection
timeFrame: Baseline, 4 to 20 weeks after last injection (Up to 6 months)
Secondary outcomes:
measure: Percentage of Participants With an Increase of 2 Lines or More in BCVA
timeFrame: Baseline, Up to 6 months
measure: Percentage of Participants With an Increase of 3 Lines or More in BCVA
timeFrame: Baseline, Up to 6 months
measure: Change From Baseline in Central Retinal Thickness by Optical Coherence Tomography (OCT) 4 to 20 Weeks After Each Injection
timeFrame: Baseline, 4 to 20 Weeks after Each injection (up to 6 months)
Other outcomes:
Locations:
city: San Antonio
country: United States
state: Texas
Study officials:
affiliation: Allergan
name: Medical Director
role: STUDY_DIRECTOR
References:
citation: Dugel PU, Capone A Jr, Singer MA, Dreyer RF, Dodwell DG, Roth DB, Shi R, Walt JG, Scott LC, Hollander DA; SHASTA Study Group. Two or more dexamethasone intravitreal implants in treatment-naive patients with macular edema due to retinal vein occlusion: subgroup analysis of a retrospective chart review study. BMC Ophthalmol. 2015 Sep 4;15:118. doi: 10.1186/s12886-015-0106-z.
citation: Singer MA, Capone A Jr, Dugel PU, Dreyer RF, Dodwell DG, Roth DB, Shi R, Walt JG, Scott LC, Hollander DA; SHASTA Study Group. Two or more dexamethasone intravitreal implants as monotherapy or in combination therapy for macular edema in retinal vein occlusion: subgroup analysis of a retrospective chart review study. BMC Ophthalmol. 2015 Apr 1;15:33. doi: 10.1186/s12886-015-0018-y.
Clinical trial NCT00328796: Acupuncture for Pain Relief During Perineal Repair After Childbirth
Official title: Acupuncture or Local Anaesthetics for Pain Relief During Perineal Repair After Vaginal Delivery: A Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Birth Injuries
Lacerations
Pain
Keywords: Perineal
repair
episiotomies
midwives
pain relief
Episiotomy
Lead sponsor: Sonderborg Hospital
Sponsor class: OTHER_GOV
Collaborators: name: The Danish Midwifery Organization
name: Aase and Ejnar Danielsens Foundation
name: The Augustinus Foundation, Denmark.
First posted: 2006-05-22
Enrollment: 207
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Midwives and obstetricians are currently using acupuncture for several health problems during pregnancy and childbirth. The investigators wish to determine whether acupuncture can be used as pain relief during the repair of lacerations in the female pelvic floor following childbirth.

Three acupuncture points in the ear have been reported highly effective for perineal pain relief. A scientific trial will compare acupuncture with traditional local anaesthetics when midwives conduct perineal repair just after delivery in the hospitals of Southern Denmark.

Detailed description: A randomised trial has been initiated. 226 healthy primipara are invited to participate if they deliver a child after gestation week 36 and sustain a perineal laceration or an episiotomy during childbirth.

The randomisation is done using a computer-controlled voice response system and the compared treatments are:

A: Acupuncture in Shen Men, GV20, BL36 and 2 needles in the upper ear.

B: Local anaesthetics (lidocaine 10 ml/mg) directly in the wound area.

Primary outcomes are:

1. Need for additional pain relief during the perineal repair.
2. Pain experienced during perineal repair reported 1 day after delivery.
3. Wound healing evaluated 1 and 14 days after delivery.
4. Patient satisfaction with the given pain relief.

Eligibility criteria: Inclusion Criteria:

* Primipara
* Healthy mother and child
* Danish speaking
* Perineal laceration or episiotomy that can be sutured by a midwife.

Exclusion Criteria:

* Large perineal lacerations
* Heavy bleeding after childbirth
* No need for pain relief

Primary outcomes:
measure: Need for additional pain relief during the perineal repair
measure: Pain experienced during perineal repair reported 1 day after delivery
measure: Wound healing evaluated 1 and 14 days after delivery
Secondary outcomes:
measure: Patient satisfaction with the given pain relief
Other outcomes:
Locations:
city: Sønderborg
country: Denmark
facility: Obstetric Departments in the Hospitals of Southern Denmark
state: Region South Denmark
Study officials:
affiliation: Aarhus University, Perinatal Epidemiological Unit
name: Sara Kindberg, PhD Student
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00452296: Tight Glycemic Control in Acute Exacerbations of COPD
Official title: Tight Glycemic Control in Acute Exacerbations of COPD
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: COPD
Hyperglycemia
Keywords: inpatients with COPD
glucose control
Lead sponsor: Soroka University Medical Center
Sponsor class: OTHER
First posted: 2007-03-27
Enrollment: 84
Sex: ALL
Minimum age (years): 45
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Glucose control has been shown as an important and independent prognostic factor in several acute conditions in hospitalized patients, including Acute MI, stroke, cardiac surgery and in critical care units.

Patients with acute exacerbation of COPD (AECOPD)and diabetes treated with insulin had a longer in-patient stay and more frequent isolation of Gram negative bacteria from sputum than those without diabetes.Hyperglycemia (\>11 mmol/l) on admission predicted failure of non-invasive ventilation and infectious pulmonary complications in patients admitted to the ICU with acute respiratory failure caused by severe AECOPD.

The primary goal of this study is to test the hypothesis that in AECOPD, tight glycemic control during hospital stay will improve outcome of hospitalization.

The secondary goal of this study is to test new ways in controlling patients in the internal medicine ward.


Eligibility criteria: Inclusion Criteria:

* current or past smokers (at least 20 py)
* patient with COPD be ATS criteria
* hospitalized with acute exacerbation, 2/3 criteria:1- worsening of SOB 2-change in sputum volume 3- change in sputum color
* signed informed concent

Exclusion Criteria:

* respiratory failure (pH\<7.35 ו Pco2\>60 )
* pneumonia
* pneumothorax
* bronchiectasis
* lung collapse
* congestive heart failure
* lung cancer
* suspected pulmonary emboli
* immune deficiency (acquired 0r congenital)
* cystic fibrosis
* post lung implantation
* asthma/ non smokers

Primary outcomes:
measure: mortality
timeFrame: one year
Secondary outcomes:
measure: hospialization
timeFrame: one year
Other outcomes:
Locations:
Study officials:
affiliation: Soroka University Medical Center
name: Idit F Liberty
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00444496: SPHERE Hypertension Baseline Data Study
Official title: SPHERE Hypertension Baseline Data Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2007-03-07
Enrollment: 470
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: People seen by Renton, Bellevue, and Shoreline fire departments with blood pressure higher than 160/100.

Brief summary: We are collecting baseline data on patients who have high blood pressure readings (160/100 or higher) at a 9-1-1 response by an EMT.

Detailed description: We are collecting baseline data on patients who have high blood pressure readings (160/100 or higher) at a 9-1-1 response by an EMT. We want to understand what these patients currently remember occurring during the 9-1-1 response around their high blood pressure measure; if the patients seek a second reading; if the patients seek follow-up care as a result of the high blood pressure measure. We are also interested if patients trust EMTs as a provider of preventive health care. This baseline data will also allow us to more accurately measure the success of a future intervention study aimed at motivating subjects to receive a follow-up hypertension assessment from a physician after receiving a high blood pressure reading from an EMT.

Eligibility criteria: Inclusion Criteria:

* Systolic blood pressure greater than or equal to 160 and/or diastolic blood pressure greater than or equal to 100
* Patient is at least 18 years old
* Patient was not transported by paramedics
* Patient was not admitted to a hospital
* Patient is not a nursing home/adult family home resident
* Patient's phone number is listed in the MIRF database

Exclusion Criteria:

* not meeting inclusion criteria

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Hendrika Meischke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06884696: Study of Placental Inflammation in Gestational Diabetes
Official title: Study of Placental Inflammation in Gestational Diabetes: the Role of the Inflammosome NLRP3 and the Scavenger Receptor of Inflammatory Chemokines D6
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Gestational Diabetes Mellitus (GDM)
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2025-03-19
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to investigate the placental inflammation in women with gestational diabetes mellitus, in particular the role of inflammasome NLRP3 and the chemokine scavenger decoy receptor D6

Detailed description: The aim of this study is to investigate systemic and placental inflammation in women with gestational diabetes mellitus, in particular the role of inflammasome NLRP3 and the chemokine scavenger decoy receptor D6, compared to women with uncomplicated pregnancy

Eligibility criteria: Inclusion Criteria:

* Women with gestational diabetes mellitus
* Women with uncomplicated pregnancy
* Age \>18 years
* Singleton pregnancy

Exclusion Criteria:

* Age \< 18 years
* Infections (HIV,HCV)
* Multiple pregnancy
* Cancer

Primary outcomes:
measure: Placental inflammation
timeFrame: At delivery/birth
Secondary outcomes:
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Fondazione Policlinico Universitario Agostino Gemelli
Study officials:
affiliation: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
name: Chiara Tersigni
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00000196: Neurobiology of Opioid Dependence: 5 - 5
Official title: Neurobiology of Opioid Dependence: 5
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Opioid-Related Disorders
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 1999-09-21
Enrollment: 0
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effect of acute naltrexone pretreatment on the response to yohimbine in healthy volunteers.


Eligibility criteria: Please contact site for information.

Primary outcomes:
measure: Behavioral, physiological, neuroendocrine response to yohimbine
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: VA Connecticut Healthcare System
state: Connecticut
Study officials:
affiliation: VA Connecticut Healthcare System
name: Marc I Rosen, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04417296: IMPACTS OF BRAXTON-HICKS CONTRACTIONS ON COMPUTERISED CARDIOTOCOGRAPHY PARAMETERS: A POTENTIAL LINK.
Official title: IMPACTS OF BRAXTON-HICKS CONTRACTIONS ON COMPUTERISED CARDIOTOCOGRAPHY PARAMETERS: A POTENTIAL LINK.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Braxton Hicks' Contractions
Keywords: Braxton Hicks' contractions
uterine contractions
fetal well-being
Computerized cardiotocography (cCTG)
Fetal heart rate (FHR)
Pregnancy
Lead sponsor: University of Campania Luigi Vanvitelli
Sponsor class: OTHER
First posted: 2020-06-04
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 48
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We included pregnant who were referred for the fetal antepartum cardiotocography monitoring to the outpatient clinic of the "Luigi Vanvitelli" University of Campania in Naples, Italy. All patients had an uncomplicated pregnancy and to define a pregnancy uncomplicated we adopted Chappell's definition: "a normotensive pregnancy, delivered at \>37 weeks, ending in a live-born baby who was not small for gestational age and did not have any other notable pregnancy complications"

Brief summary: Several types of research examined the relationship of Braxton-Hicks contractions and uterine flow. Nevertheless, no one considered the relationship of the maternal perception of Braxton-Hicks contractions with the fetal wellbeing quantifies through computerised cardiotocography. Our study wants to estimate the correlation between the maternal perception of Braxton-Hicks contractions and antepartum computerised cardiotocography parameters.


Eligibility criteria: Inclusion Criteria:

* Nonlaboring women with a term uncomplicated singleton pregnancy

Exclusion Criteria:

* complicated singleton pregnancy

Primary outcomes:
measure: the comparison of the antepartum computerised cardiotocography between the patients with Braxton-Hicks contractions and the patients without uterine activity
timeFrame: pre-intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Napoli
country: Italy
facility: Università degli studi della Campania "Luigi Vanvitelli"- OB & Gyn -
state: Italia
Study officials:
References:
Clinical trial NCT03607396: Study for Evaluating the Real Use of Inhaled Aztreonam Lysine in Patients With Cystic Fibrosis
Official title: Study for Evaluating the Real Use of Inhaled Aztreonam Lysine in Patients With Cystic Fibrosis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cystic Fibrosis
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
Collaborators: name: Gilead Sciences
First posted: 2018-07-31
Enrollment: 75
Sex: ALL
Minimum age (years): 6
Maximum age (years): 65
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Cystic fibrosis patients colonized by Pseudomonas aeruginosa

Brief summary: The aim of this observational trial is to evaluate the pulmonary function in cystic fibrosis patients that have been treated with inhaled aztreonam lysine comparing the previous 12 months before the treatment and the forward 12 months after initiating the treatment.


Eligibility criteria: Inclusion Criteria:

* Patients above 6 years old that have been treated with Aztreonam Lysine (AZLI) at any time within 12 months before starting the treatment
* Diagnosis of Cystic Fibrosis confirmed
* Chronic infection by Pseudomonas aeruginosa
* Patients can be treated with any inhaled antibiotic before or after AZLI treatment
* Patients have to have the following FEV1 measures: 12 months before starting AZLI; at AZLI initiation; 12 months after starting AZLI
* For lung transplant patiens, only data before the transplant will be collected.

Exclusion Criteria:

* Non applicable

Primary outcomes:
measure: FEV1
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
state: Catalunya
city: Valencia
country: Spain
facility: Hospital La Fe
state: Comunidad Valenciana
city: Madrid
country: Spain
facility: Hospital 12 de Octubre
Study officials:
References:
Clinical trial NCT01467596: Ultrasound-guided Supraclavicular Brachial Plexus Block in Elderly
Official title: Effects of Age on Minimum Effective Volume of Local Anesthetic for Ultrasound-guided Supraclavicular Brachial Plexus Block (US-SCB)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arm Injuries
Anesthesia
Keywords: Ultrasound
Brachial block
Levobupivacaine
Minimum
Volume
Minimum volume of Levobupivacaine 0,5%
Lead sponsor: Šarić, Jadranka Pavičić, M.D.
Sponsor class: INDIV
First posted: 2011-11-08
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this study is to determine the minimum effective volume of local anesthetic (50:50 mixture of 0.5% levobupivacaine and 2% lidocaine) required to produce an effective US-SCB for surgical anesthesia in 50% of patients and to calculate the effective volume required to produce an effective US-SCB in 95% of the patients (MEAV95) in elderly group (\>65 years) and in middle aged group (\<45years) of patients.

Detailed description: We believe that known data regarding the minimum anesthetic volume required for effective US-SCB from middle age population can not be applicable to the elderly population since our preliminary data, presented at Euroanesthesia meeting in Amsterdam, 2011, and published in abstract form in the European Journal of Anaesthesiology, showed that involutional changes of brachial plexus in elderly, assessed by measuring the cross-sectional area (CSA) of brachial plexus at the first rib, allowed a 35% reduction in local anesthetic volume for an effective US-SCB for surgical anesthesia in elderly patients in comparison with the younger patients.

Eligibility criteria: Inclusion Criteria:

* ASA 1 - 3 elderly patients (\>65 years) scheduled for hand surgery
* ASA 1-3 middle aged patients (\<45 years)

Exclusion Criteria:

* Cognitive impairment
* Coagulopathy
* Allergy to local anesthetics
* Infection at the puncture site,
* Body mass index \> 35 kg/m2

Primary outcomes:
measure: Ultrasound-guided Supraclavicular Brachial Plexus Block in Elderly
timeFrame: A blinded Assistant assess sensory and motor blockade in a 5-min intervals up to 30 minutes
Secondary outcomes:
measure: Ultrasound-guided Supraclavicular Brachial Plexus Block in...
timeFrame: A blinded Assistant assess onset (in a 5-min intervals up to 30 minutes after completion of US-SCB) ) and duration of sensory and motor blockade (in a 30-min intervals after the completion of surgery).
Other outcomes:
Locations:
city: Zagreb
country: Croatia
facility: University Hospital Merkur
Study officials:
name: Jadranka Pavičić Šarić, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tomulic K, Pavicic Saric J, Acan I.Effect of age on anaesthetic volume for ultrasound guided supraclavicular brachial plexus block: 8AP2-8 June 2011 - Volume 28 - Issue - p 113 European Journal of Anaesthesiology