louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06372951: Lung Ultrasound in Neonatal Intensive Care Units
Official title: Role of Lung Ultrasound in Assessment of Neonatal Respiratory Distress
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neonatal Respiratory Distress
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2024-04-18
Enrollment: 132
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nenates in the neonatal intensive care units who suffering from respiratory distress.

Brief summary: Identification of lung diseases causing neonatal respiratory distress by lung ultrasound as a tool that can replace x-ray .

Detailed description: * Lung disease is the most common cause of neonatal respiratory distress.
* It can result in respiratory failure and death in severe cases.
* The mortality rate is approximately 11%:32%.
* Identification of the etiology of lung disease is important for neonatologists.
* Traditionally, chest X-ray has been considered as the most valuable imaging modality for the diagnosis of lung diseases, but it unavoidably causes radiation damage to the patient.
* Neonates are susceptible to radiation because they have rapidly dividing cells that cannot repair mutated DNA.
* The risk of cancer induction in infants receiving a single small dose of radiation is 2-3 times higher than the average population and 6-9 times higher than the risk from an exposure of a 60-year-old patient.
* New imaging modalities have been introduced in clinical practice in recent years such as lung ultrasound.
* One of the most common causes of neonatal respiratory distress that can be diagnosed by ultrasound is :Respiratory Distress Syndrome:

  * Respiratory distress syndrome.. is a major cause of neonatal mortality.
  * It mainly occur in preterm infants due to structural and functional lung immaturity.
  * Pulmonary surfactant insufficiency is an important pathogenesis in respiratory distress syndrome.
  * The ultrasonic features of respiratory distress syndrome are: Compact B-Lines, white lung appearance, abnormality in pleural line (thick and irregular),lung consolidation.
* Lung ultrasound has the advantages of :

  * Non-ionizing.
  * Easy to operate.
  * Low coast.
  * Portable for bedside use.
  * The imaging is performed in real-time.
* Thus making it as a potential tool to be used in neonatal intensive care units.

Eligibility criteria: Inclusion Criteria:

* Neonates in neonatal intensive care units

Exclusion Criteria:

* Patients with poor-quality of lung ultrasound image.
* Subcutaneous emphysema.

Primary outcomes:
measure: Identifying causes of neonatal respiratory distress
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assiut University
name: Ihab Mansour Mohamed, Prof.
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Kawsar Abdel Halim Mohamed, Lecturer
role: STUDY_DIRECTOR
affiliation: Assiut University
name: Azhar Arabi Mohammed, Lecturer
role: STUDY_DIRECTOR
References:
Clinical trial NCT03688451: Intrathecal Rituximab With Standard Intrathecal Prophylaxis to Prevent CNS Relapse for CD 20+ Non Hodgkin Lymphoma
Official title: A Pilot Study to Access the Feasibility and Safety of Intrathecal Rituximab Added to Standard Intrathecal Prophylaxis to Prevent CNS Relapse for CD 20 Positive Non Hodgkin Lymphoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Non Hodgkin Lymphoma
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
First posted: 2018-09-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Sequential dose cohorts
Primary purpose: TREATMENT

Brief summary: The purpose of this research study is to learn if giving rituximab, the study drug, right into the spinal canal along with chemotherapy drugs like methotrexate is possible and safe.


Eligibility criteria: Inclusion Criteria:

* CD20 positive diffuse large b-cell lymphoma undergoing treatment with systemic rituximab in combination with CHOP, CHOEP, or EPOCH and deemed high risk of CNS relapse and eligible for central nervous system prophylaxis with intrathecal therapy.

Exclusion Criteria:

* Primary central nervous system lymphoma or established secondary central nervous system disease.
* History of spinal surgery and/or ineligible for intrathecal injections.

Primary outcomes:
measure: Ability to deliver greater than 80% of planned doses
timeFrame: 28 months
measure: Related Grade 3 or higher non-hematological toxicity
timeFrame: 28 months
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: UC Health
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Tahir Latif, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04153851: Study the Effect of Neurectomy of Nasopalatine Nerve on Sensation of Anterior Palate
Official title: Effect of Neurectomy of Nasopalatine Nerve on Sensation of Anterior Palate in Patient Undergoing Rehabilitation of Atrophic Anterior Maxillary Ridge With Dental Implant
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Missing Teeth
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2019-11-06
Enrollment: 1
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

Brief summary: Study the effect of neurectomy of nasopalatine nerve on the sensation of anterior palate in patients undergoing rehabilitation of anterior maxillary ridge with dental implant

Detailed description: Replacement of missing teeth in the anterior maxilla could be challenging if enlargement of the nasopalatine canal which is located in the midline of the palate posterior to the maxillary central incisors or ridge atrophy occur after tooth extraction. This could place the neurovascular content of the nasopaltine canal in the path of the dental implant which may lead to complications such as nasopalatine canal cyst, sensory dysfunction or implant failure. Technique to overcome this problem have evolved including neurectomy of the nasopalatine canal content and obliteration of canal with bone graft.

Loss of sensation in anterior palate following this procedure could be an annoying complication for patients. In recent studies regaining of sensation following such procedure have been reported, Confirmation of such results is essential to rule out the side effect of loss of sensation in the anterior palatal region

Eligibility criteria: Inclusion Criteria:

* • Adult patients requiring dental implants placement in the anterior region of maxilla and has insufficient horizontal bone .

  * Patients should be free from any systemic conditions that may affect soft tissue healing.

Exclusion Criteria:

* • Patients with systematic disease that may complicate healing.

  * Uncontrolled diabetic patient.
  * Patients with advanced osteoporosis.
  * Patients under bisphosphonates treatment.
  * Patients with neurological disorders (neuralgias, Parkinson's disease).
  * Patients with horizontal ridge atrophy (if the horizontal dimension of the residual ridge \<3mm as determined with ridge callipers).
  * Heavy smoker patients.

Primary outcomes:
measure: two point discrimination test
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university
Study officials:
References:
Clinical trial NCT04341051: Sciatic Block Increases Regional Saturation in Peripheral Artery Occlusive Disease.
Official title: Sciatic Block Increases Regional Saturation in Peripheral Artery Occlusive Disease Monitored by NIRS: a Prospective Monocentric Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Peripheral Artery Occlusive Disease
Popliteal Sciatic Nerve Block
Keywords: regional oxigen saturation
Lead sponsor: A.O.U. Città della Salute e della Scienza
Sponsor class: OTHER
Collaborators: name: San Salvatore Hospital of L'Aquila
First posted: 2020-04-10
Enrollment: 31
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients suffering from Peripheral Artery Occlusive Disease undergoing popliteal sciatic nerve block as analgesic procedure before revascularization surgery

Brief summary: We conducted Single-center prospective observational study to evaluate the improvement of peripheral vascular perfusion monitored with near-infrared spectroscopy, in patients undergoing endovascular surgery after performing sciatic nervous block.

Detailed description: The aims of that study is to check regional oxigen saturation variability in patients suffering from Peripheral Artery Occlusive Disease (IIa to III Fontaine classification) undergoing popliteal sciatic nerve block as analgesic procedure before vascular surgery. We want to evaluate the increase in regional microcirculation after the popliteal nerve blocks due to vasoplegic response and vasodilatation after performing regional anaesthesia. We will place NIRS electrode on the instep of the foot to evaluate regional oxigen saturation in the interested leg before the performing of popliteal sciatic nerve block and then during the surgery (after 5 minuts, 15 minuts, 30 minuts), and after the end of the procedure.

Eligibility criteria: Inclusion Criteria:

* age: \> 18 years
* Peripheral artery occlusive desease involving popliteal, tibial and/or peroneal artery
* Stadiation IIa to III in Fontaine classification
* Eligibility for PTA or Stenting

Exclusion Criteria:

* trophic alteration of the application site of the NIRS
* less than 18 years
* Pregnancy
* need of sedation during the procedure
* revascularization performed as emergency surgery
* Allergic reactions with local anaesthetic
* Previous surgery involving the interested artery

Primary outcomes:
measure: Regional Oxigen saturation downstream of popliteal region
timeFrame: 1 day
Secondary outcomes:
measure: Comparing the results between AOCP IIa to III (Fontaine Classification)
timeFrame: 1 day
measure: Comparing the results between patients with occlusion of a single arthery and patients with more occluded arthery
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: A.O.U. Città della Salute e della Scienza
name: Fabio Gobbi, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02856451: Risk Factors and Outcomes of Immune-Mediated Encephalitis Following Exposure to Nivolumab
Official title: Case Series Analyses of the Risk Factors and Outcomes of Immune-Mediated Encephalitis Following Exposure to Nivolumab
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Encephalitis
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2016-08-04
Enrollment: 486
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Case series reported to the sponsor from various health care facilities

Brief summary: A case series analysis of encephalitis events reported to the Sponsor for patients treated with nivolumab to assess the risk factors and outcomes of immune-mediated encephalitis.


Eligibility criteria: Inclusion Criteria:

* Moderate, severe, life-threatening or fatal encephalitis events occurring in patients treated with nivolumab and reported to the Sponsor

Exclusion Criteria:

* Encephalitis cases identified through literature reviews and not reported to the Sponsor
* Encephalitis cases identified from company-sponsored observational studies with secondary data collection
* Spontaneous reports not submitted directly to the Sponsor

Other protocol-defined inclusion/exclusion criteria apply

Primary outcomes:
measure: Outcomes of Encephalitis
timeFrame: 1 year
measure: Risk factors of Encephalitis
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: Local Institution
state: New Jersey
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT03112551: Safety and Efficacy of Twelve Hours Duration of MgSO4 in the Treatment of Eclampsia in Low Resource Setting in Sudan
Official title: Safety and Efficacy of Twelve Hours Duration of Magnesium Sulphate in the Treatment of Eclampsia in Low Resource Setting in Sudan
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pre-Eclampsia
Lead sponsor: Gadarif University
Sponsor class: OTHER
First posted: 2017-04-13
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: the investigators assume that magnesium sulphate for treating eclampsia can be safely reduced from 24 hours to shorter duration of therapeutic anticonvulsant effect for 12 hours. Short duration of drug exposure is suitable for low resource setting where there is little tools or busy staff for monitoring drug toxicity.

Detailed description: The idea of using 12 hours duration of magnesium sulphate for treating eclampsia may be effective and attractive, especially in settings with limited resources and where there is no availability of tools to monitor the serum level of magnesium sulphate. This is because the most common reported maternal adverse effects of magnesium sulphate are minor and may be confused with other symptom of eclampsia of even labor.The administration of Magnesium sulphate for 24 hours in the absence of monitoring of the serum magnesium sulphate might be life threatening in a resource- challenged situation , thus the current study is planned to be conducted to investigate the efficacy and safety of shorter duration (12 hours) of magnesium sulphate therapy in preventing development of convulsions in cases of eclampsia.

Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of eclampsia
* must accept to participate in the study

Exclusion Criteria:

* epilepsy

Primary outcomes:
measure: Number of patients who will receive magnesium sulfate and develop drug toxicity
timeFrame: 12 - 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Gadarif
country: Sudan
facility: Gadarif University
Study officials:
References:
Clinical trial NCT01265251: Computerized Neuropsychology in Idiopathic Normal Pressure Hydrocephalus (INPH)
Official title: Evaluation of a Computerised Neuropsychological Test Battery for Idiopathic Normal Pressure Hydrocephalus (INPH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Normal Pressure Hydrocephalus
Keywords: Normal Pressure Hydrocephalus
Neuropsychological Test
Assessment of cognitive disorders/dementia
Neuropsychological assessment
Lead sponsor: Umeå University
Sponsor class: OTHER
First posted: 2010-12-23
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Reliability: Healthy elderly Validity: Various diseases Feasibility: Possible INPH-patients

Brief summary: A computerised neuropsychological test battery to be used as a standardised tool assessing the cognitive domains affected by idiopathic normal pressure hydrocephalus INPH was developed. The aim of this study is to investigate the reliability, validity and feasibility of the battery.


Eligibility criteria: Inclusion Criteria:

* Probable INPH under investigation
* Healthy elderly
* Various diseases

Exclusion Criteria:

* (Healthy elderly) medications affecting nervous system
* (Healthy elderly)heart disease
* (Healthy elderly)diabetes
* (Healthy elderly)disease of the nervous system
* (Healthy elderly)MMSE \< 28
* (Healthy elderly)vascular risk factors (Two of: 1 hypertension, 2 smoking or 3 hyperlipidemia)
* (Healthy elderly)serious disease that may shorten life expectancy
* (Various diseases) Affected motor functions

Primary outcomes:
measure: Validity
timeFrame: Within 24 h
measure: Reliability
timeFrame: More than 7 days, within 2 months
measure: Feasibility
timeFrame: Within 24 h
Secondary outcomes:
Other outcomes:
Locations:
city: Umeå
country: Sweden
facility: Department of Clinical Neuroscience
state: Västerbotten
Study officials:
affiliation: Department of Clinical Neuroscience
name: Anders Behrens, M.D., M.Sc.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Behrens A, Eklund A, Elgh E, Smith C, Williams MA, Malm J. A computerized neuropsychological test battery designed for idiopathic normal pressure hydrocephalus. Fluids Barriers CNS. 2014 Sep 25;11:22. doi: 10.1186/2045-8118-11-22. eCollection 2014.
Clinical trial NCT03988751: Real-time Location System Feasibility Study
Official title: Real-time Location System Feasibility Study Part 2
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery
Mobility
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2019-06-17
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The proposed study will investigate the feasibility of using the Wake Forest Real-time Location System (RTLS) in monitoring patient movement during their in-hospital postoperative recovery. The study will involve patients who have undergone surgery requiring inpatient admission to the surgical ward. Actual patient movement will be monitored during their postoperative recovery and compared with data recorded by the Wake Forest location system.

In this small pilot study, a subgroup of participants will be randomized to two cohorts, continuous walking and interval walking. Tolerability of the varied walking intensity will be measured.


Eligibility criteria: Inclusion criteria

* Male or female patients between the ages of 18 and 90.
* Admitted to the Surgical Ward.
* Recovering from surgery.
* Ability to understand and the willingness to sign an Institutional Review Board-approved informed consent document.
* Ability to understand and complete the study survey instruments in English.

Exclusion criteria

* Non-surgical patient.
* Emergency surgical procedure.
* Anticipated discharge less than 24 hour.
* Unable to ambulate or ambulation not permitted by treating provider.
* Unable to understand and complete the study survey instruments in English.
* Post-operative complications that in the opinion of the study investigator would impair the ability of the patient to adhere to the study procedures.

Primary outcomes:
measure: Characterize Number of Participants Who Tolerate Continuous vs Interval 40m Walk.
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
References:
Clinical trial NCT00888251: Evaluation of a Weight Management Program
Official title: A Multicenter, Retrospective Study to Evaluate the Effectiveness of the OPTIFAST Weight Management Program
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Keywords: Obesity
Meal replacement
Obesity treatment
Weight management
Lead sponsor: Société des Produits Nestlé (SPN)
Sponsor class: INDUSTRY
First posted: 2009-04-27
Enrollment: 153
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: OPTIFAST Program participants

Brief summary: This retrospective chart review and data abstraction will evaluate and quantify the effectiveness of a comprehensive weight management program. The hypothesis is that the program will positively affect weight, weight-related comorbidities and medication use.


Eligibility criteria: Inclusion Criteria:

* Records of the first 40 study center participants who enrolled in the OPTIFAST Program from January 1, 2006 through June 30, 2006
* Records of subjects who completed the active weight loss phase of the program
* Records where data is available through the transitional phase of the program

Exclusion Criteria:

* Concurrent use of appetite suppressants or other weight loss medications

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Lutheran Weight Management Center
state: Indiana
city: Des Moines
country: United States
facility: Mercy Center for Weight Reduction
state: Iowa
city: East Lansing
country: United States
facility: Sparrow Weight Management Center
state: Michigan
city: Cincinnati
country: United States
facility: Jewish Hospital Weight Management Center
state: Ohio
Study officials:
References:
Clinical trial NCT00148551: Triamcinolone Acetonide as an Adjunctive to VPDT in ARMD.
Official title: Triamcinolone Acetonide as an Adjunctive Treatment to Verteporfin Therapy in Neovascular Age-Related Macular Degeneration: Randomized Placebo-Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Age-Related Macular Degeneration
Keywords: AMD
Triamcinolone
Macular Degeneration
Lead sponsor: Canadian Retinal Trials Group
Sponsor class: OTHER
Collaborators: name: University of British Columbia
name: QLT Inc.
name: Vancouver Hospital
First posted: 2005-09-08
Enrollment: 120
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A 24 - month Study looking at the the changes in visual acuity of patients receiving PDT therapy in conjunction with intravitreal triamcinolone.

Detailed description: This study will evaluate the effect of Triamcinolone Acetonide in conjunction with photodynamic therapy for the treatment of sub-foveal choroidal neovascular membranes secondary to age-related macular degeneration.

Eligibility criteria: Inclusion Criteria:

* Individuals with predominantly classic, subfoveal CNV secondary to AMD.
* No previous PDT Treatment in study eye.

Exclusion Criteria:

* CNV from conditions, other than AMD.
* Other disease that could be responsible for decreased vision.

Primary outcomes:
measure: Changes in visual acuity from baseline.
Secondary outcomes:
measure: Change in lesion characteristics from baseline.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Eye Care Centre
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: David A Maberley, M.D.
role: STUDY_DIRECTOR
References:
citation: Maberley D; Canadian Retinal Trials Group. Photodynamic therapy and intravitreal triamcinolone for neovascular age-related macular degeneration: a randomized clinical trial. Ophthalmology. 2009 Nov;116(11):2149-57.e1. doi: 10.1016/j.ophtha.2009.04.032. Epub 2009 Sep 12.