louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03511742: Functional ICUS in Uganda and Their Survival Outcomes
Official title: Functional Characteristics of ICUs in Uganda and Their 28-day Patient Mortality
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Critical Illness
Lead sponsor: Makerere University
Sponsor class: OTHER
First posted: 2018-04-30
Enrollment: 367
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Target population Critically ill patients in all Intensive care units in Uganda Accessible population. All ICUs in Uganda. All patients admitted to the intensive care units in Uganda during the study period.

Brief summary: Aim of the study is to describe the functional characteristics of Icus in Uganda and their @8-day patient characteristics it is a prospective cohort study .All Icus in Uganda will be included and their admitted patients followed upto 28 days in the ICU for mortality

Detailed description: Intensive Care units are specialized units with expertise to provide organ support for the critically ill patients. There's a growing global burden of critical illness especially in the low-income coun-tries where critical care services are limited. Despite advances in critical care, the mortality in Uganda remains very high, with sepsis and trauma as the major contributors. There's paucity of literature regarding ICUs characteristics, disease burden and patient characteristics which could be contributing to the high mortality.

Objectives To describe the functional characteristics of the ICUs in Uganda. To determine the ICU mortality of critically ill patients in Uganda. To determine the risk factors of mortality of patients admitted in the ICU Methods A prospective cohort study will be carried out in all ICUs in Uganda. All new patients in the ICUs will be recruited into the study. Data will be collected onto two separate questionnaires, one for patient characteristics and the second for ICU functional characteristics. The patient's data will be collected within the first 24 hours and patients will be followed up for death\\discharge within 28 days in the ICU. The data will be collected from the patients' charts and entered into Epidata.

Eligibility criteria: Inclusion Criteria:

All new patients admitted to Uganda's Intensive Care Units ICUs in Uganda whose unit heads verbally consent to participate in the study.

Exclusion Criteria:

Patients transferred in from another unit will not be re recruited. ICUs that don't consent to the study.

Primary outcomes:
measure: 28 day mortality
timeFrame: 3 months
measure: functional characteristics of ICUs in Uganda
timeFrame: 3 months
Secondary outcomes:
measure: factors associated with mortality
timeFrame: 3 months
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Atumanya Patience
Study officials:
References:
Clinical trial NCT04646070: Superomedial Pedicle Versus Inferior Pedicle Techniques in Wise Pattern Reduction Mammaplasty :A Comparison Study
Official title: Superomedial Pedicle Versus Inferior Pedicle Techniques in Wise Pattern Reduction Mammaplasty :A Comparison Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: To Compare Complications of Both Techniques in Wise Pattern Reduction Mammaplasty and to Correlate Between Complications and Patient Mediated Factors
Lead sponsor: Kafrelsheikh University
Sponsor class: OTHER
First posted: 2020-11-27
Enrollment: 30
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A comparison study between superomedial and Inferior pedicle techniques in wise pattern reduction mammaplasty

Detailed description: To compare complications of both techniques in wise pattern reduction mammaplasty and to correlate between complications and patient mediated factors

Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

* previous extensive breast surgery Breast cancer

Primary outcomes:
measure: To compare complications of both techniques including nipple areola complex necrosis
timeFrame: 30 days postoperative
Secondary outcomes:
measure: To correlate between complications and patient mediated factors
timeFrame: 30 days postoperative
Other outcomes:
Locations:
city: Kafr Ash Shaykh
country: Egypt
facility: Kafr Elsheikh University Hospital
Study officials:
affiliation: Kafr Elsheikh University
name: Safwat Adel hegazy, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT04703270: Understanding COVID-19 Infection in Pregnant Women and Their Babies
Official title: Understanding COVID-19 Infection in Pregnant Women and Their Babies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Corona Virus Infection
Pregnancy Related
Neonatal Infection
Breastfeeding
Lead sponsor: St George's, University of London
Sponsor class: OTHER
First posted: 2021-01-11
Enrollment: 881
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All pregnant women ≥ 24 weeks gestation in England.

Brief summary: This national study will recruit expectant mothers with and without positive nasopharyngeal swabs for SARS-CoV-2, and aims to determine the seroepidemiology of SARS-CoV-2 amongst expectant mothers and their infants in the U.K.


Eligibility criteria: Inclusion Criteria:

* Signed informed consent form
* Any woman pregnant in selected hospitals in England who has no signs or symptoms of COVID-19 disease during pregnancy and is rtPCR negative at delivery
* Any woman pregnant in any hospital in England who tests positive by rtPCR at any point during pregnancy from 24 weeks gestation onwards, regardless of signs and symptoms

Exclusion Criteria:

* If the pregnant woman is under 18 years in prison or unable to make an informed consent for other reasons (e.g. learning difficulties, language barriers)

Primary outcomes:
measure: Antibody Concentrations in Maternal Blood in Pregnant Women in England
timeFrame: Delivery
measure: Antibody Concentrations in Cord/Infant Blood at Delivery
timeFrame: Delivery
Secondary outcomes:
measure: Number of Participants With Breastmilk Samples Positive for Antibodies Specific to SARS-CoV-2
timeFrame: At birth
measure: Number of Mother-infant Pairs Who Are Both rtPCR Positive for SARS-CoV-2 in Blood at Delivery
timeFrame: Delivery
measure: Number of Mother-infant Pairs Who Are Both rtPCR Positive for SARS-CoV-2 in Secretions at Delivery
timeFrame: Delivery
measure: Breastmilk Samples That Are rtPCR Positive
timeFrame: Delivery
measure: Placental Samples That Are rtPCR Positive
timeFrame: Delivery
measure: Number of Participants in Whose Placental Sample the Virus Can be Grown in Vitro
timeFrame: Delivery
measure: Number of Participants in Whose Breast Milk Sample the Virus Can be Grown in Vitro
timeFrame: Delivery
measure: Number of Mother-baby Pairs in Whom the Virus Can be Grown in Vitro
timeFrame: 6 weeks post delivery
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: St George's, University of London
Study officials:
References:
Clinical trial NCT00785070: Pre and Post Orthopedic Surgery Sleep and Cardiac Testing (PROSPECT)
Official title: Pre and Post Orthopedic Surgery Sleep and Cardiac Testing (PROSPECT)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obstructive Sleep Apnea
Keywords: Perioperative
Obstructive Sleep Apnea
Screening
Home Sleep Testing
Lead sponsor: Memorial Health System
Sponsor class: OTHER
Collaborators: name: Nexan Inc
First posted: 2008-11-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Orthopedic Total Hip or Knee Joint Replacement

Brief summary: * Evaluate sleep disordered breathing before and after orthopedic surgery utilizing a FDA cleared to market (510k) home sleep study device (Nexan Inc., ClearPath System)
* Compare Berlin Questionnaire and Epworth Sleep Scale questionnaires to the home sleep study device results.
* Evaluate effectiveness of the home sleep study testing in the orthopedic presurgical population.


Eligibility criteria: Inclusion Criteria:

* Undergoing knee or hip total joint replacement
* Answer Yes to any PROSPECT health history questions and/or score Positive on the sleep questionnaires

Exclusion Criteria:

* Tape Allergy
* Previous Diagnosis Of Obstructive Sleep Apnea

Primary outcomes:
measure: Comparison of objective sleep data to standardized sleep questionnaires
timeFrame: Pre and Post Operative
Secondary outcomes:
measure: Compare Pre and Post Operative Objective sleep data
timeFrame: Pre and post operative
Other outcomes:
Locations:
city: Colorado Springs
country: United States
facility: Memorial Health System
state: Colorado
Study officials:
affiliation: Memorial Health System
name: Clayton B. Carr, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02793570: Non-contrast 3D MR Angiography for Assessment of the Thoracic Aorta in Pregnancy
Official title: Native High-resolution 3D SSFP MR Angiography for Assessment of the Thoracic Aorta in Pregnant Subjects With Familial Aortopathies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Magnetic Resonance Imaging
Pregnancy
Lead sponsor: University Hospital Birmingham NHS Foundation Trust
Sponsor class: OTHER
First posted: 2016-06-08
Enrollment: 15
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant subjects in mid-trimester with familial aortopathy

Brief summary: Introduction: Native magnetic resonance angiography (MRA) is recommended to assess the thoracic aorta during pregnancy, avoiding the risks of ionising radiation and contrast agent administration. This guidance is however, based only on consensus opinion supported by limited case reports (level of evidence C).

Aim: To evaluate the feasibility of performing native 3D steady-state free-precession (SSFP) MRA in pregnant subjects with inherited aortopathy to guide timing and mode of delivery.


Eligibility criteria: Inclusion Criteria:

* Any pregnant subject with a history of familial aortopathy

Exclusion Criteria:

* None

Primary outcomes:
measure: Gestation at delivery
timeFrame: 40 weeks
measure: Completion of non-contrast 3D MRA aorta
timeFrame: 40 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United Kingdom
facility: QEHB
Study officials:
References:
Clinical trial NCT03671070: Role of Low Dose Epinephrine Boluses In Acute Hypotension
Official title: Role of Low Dose Epinephrine Boluses For Acute Hypotension in The Pediatrics ICU
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hypotension and Shock
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 50
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Study evaluates the role of low dose epinephrine boluses in management of acute hypo-tension VS The Traditional management of acute hypo-tension.

Half of the participants suffering from acute hypo-tension will receive low dose epinephrine boluses (≤ 5 µg/kg/dose) and the other half will receive traditional management of shock

Detailed description: Epinephrine, due to its alpha-1 and beta-adrenergic effects, is considered an important part of the management of children with hypo-tension. Epinephrine is typically used as a continuous infusion (0.02-0.5 μg/kg/min) for severe sustained hypo-tension and as a bolus (0.01 mg/kg, maximum dose = 1 mg) for bradycardia, asystole, or pulse-less arrest. There are, however, clinical conditions that may benefit from smaller doses of bolus epinephrine. For example, brief periods of hypo-tension during medical procedures, intermittent hemodynamic instability, and augmentation of low blood pressure in a pre-arrest condition. While a resuscitation (or code) dose of epinephrine would be inappropriate (as it would cause an unacceptable large increase in blood pressure and heart rate \[HR\]), a smaller dose may be particularly useful.

Low-dose bolus vasopressors have been used for decades by anaesthesiologists to prevent post-re-perfusion injury after solid organ transplant, control cerebral oxygenation during anaesthesia and manage acute hypo-tension during spinal surgery. Recently, use of bolus dose phenyl-ephrine has been described in the emergency department setting to augment blood pressure during periods of hypo-tension surrounding intubation. Finally, free open access medical publications have provided some insight into using bolus dose pressors for acute hypotensive episodes in adults. However, there is few published data describing the use of low-dose vasopressor boluses in children.

Eligibility criteria: Inclusion Criteria:

* Patients experiencing acute hypotensive episodes whether brief or during or after medical or surgical procedures

Exclusion Criteria:

* Patients experiencing acute hypotensive episodes in arrest or pre-arrest situations

Primary outcomes:
measure: change of mean value of blood Pressure both systolic and diastolic according to age group
timeFrame: within 1 Hours after injection
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Reiter PD, Roth J, Wathen B, LaVelle J, Ridall LA. Low-Dose Epinephrine Boluses for Acute Hypotension in the PICU. Pediatr Crit Care Med. 2018 Apr;19(4):281-286. doi: 10.1097/PCC.0000000000001448.
Clinical trial NCT03838770: tDCS for the Management of Multiple Sclerosis Related Fatigue
Official title: Transcranial Direct Current Stimulation (tDCS) for the Management of Multiple Sclerosis Related Fatigue
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: National Multiple Sclerosis Society
First posted: 2019-02-12
Enrollment: 122
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a pragmatic clinical trial that aims to determine the effect of tDCS on symptomatic fatigue in Multiple Sclerosis (MS) patients. This is a randomized, blinded, sham-controlled study design to determine the effect of Transcranial Direct Current Stimulation (tDCS) on MS participants to reduce feelings of fatigue.120 participants with MS and clinically-significant fatigue (as defined by a score of \>36 on the Fatigue Severity Scale) will be recruited to participate in either an active or sham treatment condition.


Eligibility criteria: Inclusion Criteria:

* Definite MS diagnosis, all subtypes
* Fatigue Severity Scale score of 36 or greater
* Score of 7.5 or less on the Expanded Disability Status Scale (EDSS) (with caregiver proxy required for those with scores of 7.5 or greater)
* Ability to understand the informed consent process and provide consent to participate in the study

Exclusion Criteria:

* Primary neurologic, psychiatric or other medical disorder other than MS
* History of seizures or seizure disorder
* History of head trauma or medical device in head or neck
* Clinically significant abnormality on EKG
* Current symptomatic treatment for fatigue
* Symbol Digit Modalities Test or SDMT score≥3.0 SD from published norms
* WRAT-4 reading level below average (\<85) (estimated general intellectual function)
* Beck Depression Inventory-Fast Screen (BDI- FS) score ≥10
* Current chronic headaches or migraines
* Skin disorder/sensitive near stimulation locations

Primary outcomes:
measure: change from baseline in the self-reported Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue instrument.
timeFrame: 7 Days post end of Treatment
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: New York Langone Medical Center
name: Leigh Charvet, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03665870: Prevention Through Intervention: Telehealth Solution to Deter 911 Calls Due to Hypoglycemia
Official title: Prevention Through Intervention: Telehealth Solution to Deter 911 Calls Due to Hypoglycemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Hypoglycemia Unawareness
Hypoglycemia
Hypoglycemia Acute
Keywords: Telehealth
Emergency Medicine
Paramedicine
Diabetes
Hypoglycemia
Telecoaching
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: Birmingham Fire and Rescue Service
First posted: 2018-09-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm pre-post study.
Primary purpose: PREVENTION

Brief summary: This study aims to standardize and evaluate the benefits of the Prevention to Intervention program offered by the Birmingham Fire and Rescue Service. This will accomplished by standardizing the educational materials used, offering phone based follow-up and pre-post data collection.


Eligibility criteria: Inclusion Criteria:

1. Be a citizen of Birmingham
2. Be 18 years or older
3. Receive Dextrose-50 IV (intravenous treatment provided by EMS personnel for hypoglycemia)
4. Understand and speak English

Exclusion Criteria:

a) Enrolled currently in any diabetes related educational programs

Primary outcomes:
measure: Fear of Hypoglycemia
timeFrame: Through study completion, an average of 8 weeks
Secondary outcomes:
measure: Self Efficacy
timeFrame: Pre and Post (after 8 weeks)Through study completion, an average of 8 weeks
measure: Knowledge of Diabetes
timeFrame: Through study completion, an average of 8 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Birmingham Fire and Rescue Service
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Mohanraj Thirumalai, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Thirumalai M, Zengul AG, Evans E. Challenges and Lessons Learned From a Telehealth Community Paramedicine Program for the Prevention of Hypoglycemia: Pre-Post Pilot Feasibility Study. JMIR Diabetes. 2021 Aug 3;6(3):e26941. doi: 10.2196/26941.
Clinical trial NCT02300870: Myocardial Perfusion Echocardiography to Detect Human Heart Transplant Rejection
Official title: Myocardial Perfusion Echocardiography to Detect Human Heart Transplant
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Heart Transplantation
Keywords: Acute rejection, myocardial blood flow
Lead sponsor: Brigham and Women's Hospital
Sponsor class: OTHER
Collaborators: name: General Electric
First posted: 2014-11-25
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Heart Transplant patients

Brief summary: The primary objective of this proposal is to show the efficacy of contrast enhanced ultrasonography in detecting heart transplant rejection in humans. The secondary objective is to demonstrate the efficacy of this technique in generating data which allow for the assessment of short and long term outcomes.


Eligibility criteria: Inclusion Criteria:

* All adult subjects (ages 18 to 75) who have undergone heart transplant at Brigham and Women's Hospital

Exclusion Criteria:

* hemodynamic instability (e.g., systolic blood pressure \< 90 mmHg)
* atrial fibrillation with rapid ventricular response (e.g., heart rate \> 120 bpm)
* premature atrial or ventricular complexes of a frequency that will not allow adequate echocardiographic assessment
* poor acoustic windows
* inability to provide informed consent
* any contraindication listed in the Optison package insert (i.e., history of an allergic reaction)

Primary outcomes:
measure: Global and regional microvascular myocardial perfusion
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Brigham and Women's Hospital
name: Michael Givertz, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04841070: NEURodevelopmental Outcome After Persistent Pulmonary Hypertension Of the Newborn
Official title: NEURodevelopmental Outcome in Children Between One and Five Years After Persistent Pulmonary Hypertension Of the Newborn
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Persistent Pulmonary Hypertension of the Newborn
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 55
Sex: ALL
Minimum age (years): 1
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Neonatal pulmonary hypertension is a rare but serious condition resulting from a lack of adaptation to extra-uterine life in some newborns. In the short term, the risk of death requires rapid and appropriate management of this transient pathology.

In the long term, these newborns present a greater brain vulnerability, a consequence of the pathology itself with cerebral hypoxia but also invasive and aggressive therapies. Although current scientific evidence indicates a correlation with the existence of neurological developmental disorders, the understanding of the long-term neurological outcome of these babies remains poorly documented. Better knowledge of remote neuro-psychomotor development of the critical period


Eligibility criteria: Inclusion Criteria:

* All parenting authority holders of children aged 1 to 5 years, born after 34 weeks of amenorrhea and having been cared for neonatal PAH in paediatric resuscitation

Exclusion Criteria:

* Holders of parental authority who cannot answer the questionnaire because they do not speak French.
* Opposition of one of the two holders of parental authority
* Minor parental authority holders
* Holders of parental authority under safeguarding of justice, guardianship or guardianship
* Newborns with neonatal PAH with an associated diagnosis of diaphragmatic hernia or cyanogenic congenital heart disease
* Newborns with neonatal PAH not treated with nitrogen monoxide

Primary outcomes:
measure: Describe the association between the occurrence of neuro-psychomotor developmental disorders and initial management in resuscitation.
timeFrame: Between one and 5 years after hospitalization in resuscitation.
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: CHU Toulouse
Study officials:
affiliation: CHU Toulouse
name: Sophie BREINIG, MD
role: PRINCIPAL_INVESTIGATOR
References: