louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00927745: Clinical Evaluation of AutoFlow Mode During Mechanical Ventilation
Official title: Long Term Clinical Evaluation of AutoFlow Mode During Assist-Controlled Ventilation in ICU Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ventilation, Mechanical
Keywords: Respiration Artificial
Positive-Pressure Respiration
Critical Care
Intensive Care Units
Lead sponsor: Centre Hospitalier Victor Dupouy
Sponsor class: OTHER
First posted: 2009-06-25
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The purpose of this study is to evaluate the long term use of AutoFlow mode during mechanical ventilation in ICU patients

Detailed description: Many new mechanical ventilation modes are proposed without clinical evaluation. Among them, "dual-controlled" modes, as AutoFlow, are supposed to improve patient-ventilator interfacing, and could led to lesser alarm. This study is a long term clinical evaluation of AutoFlow during assist-controlled ventilation, focusing on its efficacy (on gas exchange and outcome) and on ventilator alarms.

Eligibility criteria: Inclusion Criteria:

* adult patients under assist-controlled ventilation with an Evita 4 ventilator (Dräger, France) for an expected duration of more than two days

Exclusion Criteria:

* coma
* ventilation longer than 12 hours prior to inclusion
* pregnancy
* inclusion in another study

Primary outcomes:
measure: gas exchange
timeFrame: daily during mechanical ventilation
measure: sedation length
timeFrame: ICU discharge
measure: ventilator alarm rates
timeFrame: daily during mechanical ventilation
Secondary outcomes:
measure: length of mechanical ventilation
timeFrame: ICU discharge
measure: ventilator asssociated pneumonia rate
timeFrame: ICU discharge
measure: SOFA score
timeFrame: daily during mechanical ventilation
measure: death rate
timeFrame: ICU discharge
measure: cumulative sedation drugs dosage
timeFrame: ICU discharge
Other outcomes:
Locations:
city: Argenteuil
country: France
facility: Centre Hospitalier Victor Dupouy
Study officials:
affiliation: Centre Hospitalier Victor Dupouy
name: Hervé MENTEC, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT05265845: Using Digital Health Technologies to Prevent Rapid Infant Weight Gain.
Official title: Using Digital Health Technologies to Prevent Rapid Infant Weight Gain.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breastfeeding
Bottle Feeding
Child Obesity
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2022-03-04
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: A digital intervention to provide supplemental infant feeding support to mothers enrolled in WIC. The trial begins prenatally and continues through 3-months postpartum and tests the feasibility and acceptability of a text messaging intervention aimed at increasing responsive bottle feeding as well as breastfeeding duration and exclusivity among mothers enrolled in WIC using evidence-based components such as interactive self-monitoring and feedback.

Recruitment and enrollment never started at Duke for the Intervention represented in this record. The overall status of recruiting and actual start date were previously entered in error.


Eligibility criteria: Inclusion Criteria:

* Enrolled in WIC, English or Spanish speaking, at least 18 years old, between 18-28 weeks' gestation, and planning to remain enrolled in WIC for 6 months, intention to breastfeed or undecided about breastfeeding, and willingness to send and receive daily text messages.

Exclusion Criteria:

* Postpartum exclusions include infant prematurity (\<37 weeks), \>3 days in neonatal intensive care unit, major medical problem affecting breastfeeding (i.e., maternal HIV), or birth weight \<5 lbs.

Primary outcomes:
measure: Engagement
timeFrame: 32 weeks gestation to 3 months postpartum
Secondary outcomes:
measure: Breastfeeding duration
timeFrame: 0 to 3 months postpartum
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center - with Piedmont Health Services, Inc.
state: North Carolina
Study officials:
affiliation: Duke University
name: Melissa C Kay, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06459245: Resistance Training to Prevent Lymphedema After Breast Cancer Surgery Randomized Controlled Study
Official title: Resistance Training to Prevent Lymphedema After Breast Cancer Surgery Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Breast Cancer Female
Keywords: Breast cancer
resistance training
lymphedema
randomized control
Lead sponsor: Peking University First Hospital
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Breast cancer-related lymphedema is one of the most common chronic complications of breast cancer survivors. In existing studies, the reported incidence of lymphedema ranges from 2.5% to 42.9% . At present, there is no cure for lymphedema. Resistance training has been proved by many studies to alleviate the symptoms of lymphedema, improve the muscle strength of the upper limbs of patients, and improve the quality of life of patients, while not worsening lymphedema. Based on the best evidence, this study intends to construct resistance appropriate for this clinical scenario Training program: Conduct 3-month intervention for patients after breast cancer surgery to explore the effect of resistance training on the grip strength of the affected limb, the range of motion of the shoulder joint of the affected limb, the occurrence of lymphedema of the affected limb, quality of life, etc.


Eligibility criteria: Inclusion Criteria:

It was first diagnosed as grade I to III unilateral breast cancer by pathological examination； Breast cancer surgery was completed and axillary lymph node dissection was performed; To receive postoperative adjuvant treatment and follow-up in the outer fourth ward; Be able to communicate and exchange normally; Volunteer to participate in this research

Exclusion Criteria:

Extreme fatigue, severe anemia, ataxia, etc.; The presence of upper limb or shoulder problems from breast cancer treatment; Edema is in a non-stable stage (stable stage of edema means no treatment for edema in the past 3 months; No inflammation of the upper extremities requiring anti-infective treatment; No change in daily activities; Limb circumference change \< 10%) ； Limited limb movement due to trauma, shoulder periarthritis, etc.; Limb braking is required for health reasons. Patients are lost to follow-up

Primary outcomes:
measure: Lymphedema occurrence
timeFrame: 3 months after intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University First Hospital
Study officials:
References:
Clinical trial NCT05321745: Fecal Microbiota Transplantation in Pediatric Crohn's Disease
Official title: Repeated and Periodic Fecal Microbiota Transplantation in Children With Active and Refractory Crohn's Disease
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Crohn Disease
Keywords: fecal microbiota transplantation , Crohn Disease
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
First posted: 2022-04-11
Enrollment: 40
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Partial enteral nutrition,FMT
Primary purpose: TREATMENT

Brief summary: This study will test the safety and effectiveness of fecal microbiota transplantation (FMT) plus partial enteral nutrition (PEN) in refractory pediatric Crohn's disease (CD) who have failed conventional treatment

Detailed description: Recent studies have suggested that gut imbalance and deregulation of immunological responses plays a pivotal role in the disease development of Crohn's disease (CD), and that FMT could be a useful treatment. Our study is aims to repeated and multiple FMTs plus PEN in the treatment of refractory pediatric CD. In the induction stage of CD, standard therapy remained unchanged, FMT and PEN were added, and FMT was given 1-2 courses, 3-6 times per course. In the maintaining stage, FMT was performed every 3 months, with the same 3-6 times of FMT treatment for each course, and the withdrawal of conventional drug therapy was gradually reduced. Refractory CD was defined as refractory to standard therapy (e.g., steroids, immunomodulators, cyclosporine, tacrolimus, or anti-TNF agents).

Eligibility criteria: Inclusion Criteria:

Aged 2-16 years and without genetic diseases; All refractory pediatric with mild-to-moderate CD; Mild-to-moderate CD, defined by the pediatric Crohn's disease activity index (PCDAI) \>10 and ≤40 and Simple Endoscopic Score for CD (SES-CD) \> 3 were enrolled in the study; refractory CD, defined by children who failed conventional treatment (hormone, immunosuppressant, biologics)

Exclusion Criteria Children who were treated by PEN (80%) less than 8 weeks; follow up less than 3 months; known contraindication to all FMT infusion method such as nasoduodenal tube insertion, oesophago-gastro-duodenoscopy (OGD), enteroscopy, colonoscopy, enema and Fecal capsule; unwilling to give informed consent/assent

Primary outcomes:
measure: Clinical remission
timeFrame: 8-12 weeks after FMT
measure: Endoscopic remission
timeFrame: 8-12 weeks after FMT
measure: Mucosal healing
timeFrame: 8-12 weeks after FMT
Secondary outcomes:
measure: Adverse events
timeFrame: 2 and 8 weeks after FMT
Other outcomes:
measure: gut microbial
timeFrame: before treatment and 4-8 weeks after treatment
Locations:
city: Wuhan
country: China
facility: Tongji Hospital
state: Hubei
Study officials:
affiliation: Tongji Hospital
name: Sainan Shu, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00763945: Infarction Register
Official title: Aachen Digital Myocardial Infarction Register
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Coronary Syndrome
Keywords: Acute coronary Syndrome
STEMI
NSTEMI
Registry
Lead sponsor: RWTH Aachen University
Sponsor class: OTHER
First posted: 2008-10-01
Enrollment: 5000
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: Patients who present to the hospital with acute coronary syndrome

Brief summary: The Aachener Digitale Myokardinfarkt Register (ADMIRE) is a prospektive registry study which was designed in order to obtain data of patients with acute coronary syndrome and herewith control and optimize guideline conform therapy of these patients.

Detailed description: Aims of this registry stdy are

documentation of the characteristics of all patients representing to the RWTH Aachen University Hospital (UKA) with STEMI or NSTEMI documentation of the invasive and adjuvant medicinal therapy of STEMI and NSTEMI at UKA documentation of the in-hospital mortality documentation of the procedure-associated complications documentation of therapeutic principals for patients with STEMI or NSTEMI at UKA and investigation conformity of treatment with already established guidelines

Eligibility criteria: Inclusion Criteria:

* acute coronary syndrome

Exclusion Criteria:

* under age or not able to give informed consent

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Aachen
country: Germany
facility: Department of Medicine, Division of Cardiology, Pulmonary Diseases and Vascular Medicine at the University Hospital, RWTH Aachen
state: NRW
Study officials:
affiliation: Medical Faculty of the RWTH Aachen University
name: Verena Deserno, M.Sc.
role: STUDY_DIRECTOR
affiliation: RWTH Aachen University Hospital
name: Rainer Hoffmann, MD, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02684045: Retrospective Chart Review to Assess Outcomes in Subjects That Received MAGNIFUSE® in the Posterolateral Lumbar Spine
Official title: A Retrospective Review of Charts to Assess Outcomes in Subjects That Received MAGNIFUSE® DBM in the Posterolateral Lumbar Spine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Subjects Received MAGNIFUSE in Posterolateral Lumbar Spine
Lead sponsor: Medtronic Spinal and Biologics
Sponsor class: INDUSTRY
First posted: 2016-02-17
Enrollment: 76
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: Subjects who underwent a posterolateral surgical procedure with MAGNIFUSE in the lumbar spine.

Brief summary: The purpose of this chart review is to assess outcomes in subjects that received MAGNIFUSE in the posterolateral lumbar spine at 1 or 2 continuous levels from L1-S1.


Eligibility criteria: Inclusion Criteria:

A subject's medical record must contain the following for the subject to be included:

1. Posterolateral surgical procedure using MAGNlFUSE with local autograft and/or iliac crest bone graft at one or two continuous lumbar levels from L1-S1.
2. Radiographs available for fusion assessment by clinician at 12 and/or 24 month post-surgery visits.
3. Subject must be at least 18 years old at the time of index procedure.

Exclusion Criteria:

The subject data will be excluded from this study if the medical record indicates:

1. Additional surgical treatment adjacent to the initial lumbar levels treated per Inclusion Criterion 1.
2. Infection at index level(s) at time of surgery.
3. Extant tumor (evident at any level), spinal metastasis, or spinal tumor at the time of surgery.
4. Pregnant at time of surgery.
5. Surgery is due to trauma (e.g., motor vehicle accident or high impact fall).
6. Use of growth factors or growth peptide (BMP2, BMP7, or iFactor) in the index-level fusion surgery.
7. Procedure is a revision surgery for previously failed fusion at the surgery index level(s).
8. Subjects with body mass index \> 40 at the time of surgery.

Primary outcomes:
measure: Fusion status at 12 or 24 months
timeFrame: 12 or 24 months
Secondary outcomes:
measure: Back pain and leg pain measured by visual analog scale (VAS)
timeFrame: 12 or 24 months
measure: Pain and Disability status measured by Oswestry Disability Index (ODI)
timeFrame: 12 or 24 months
measure: Quality of life measured by EQ-5D
timeFrame: 12 or 24 months
Other outcomes:
measure: complications of interest
timeFrame: 12 or 24 months
Locations:
city: Peoria
country: United States
facility: Midwest Ortho. Center
state: Illinois
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
References:
Clinical trial NCT05094245: Stellate Gnaglion Block in Refractory Bell's Palsy
Official title: Stellate Gnaglion Block Versus Conventional Therapey in Refractory Bell's Palsy; A Rondomized Single Blind Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facial Palsy
Neuropathy
Keywords: neuropathy
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-10-26
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Idiopathic facial nerve palsy (Bell's palsy) is caused by damage to the facial nerve at any site of the peripheral branches after the facial nucleus.Stellate ganglion block is inteneded to increase blood flow and promotes nerve regeneration.

Detailed description: the conventional systemic corticosteroid treatment for acute peripheral facial nerve palsy in patients can induce hyperglycemia, and an alternative local therapy may be necessary and some time may ve ineffective.

Our purpose in this study is to evaluate therapeutic effects of stellate ganglion block (SGB) on idiopathic persistant facial nerve palsy.

Eligibility criteria: Inclusion Criteria:

* Diagnosed by clinical and neurological assessment as one-sided idiopathic facial palsy
* Age 18 to 60
* ASA Ⅰ\~Ⅲ

Exclusion Criteria:

* diabetic
* coagulation dysfunction
* mental or cognitive dysfunclion
* allergy to injected medication

Primary outcomes:
measure: House Brackmann grading scale
timeFrame: Baseline ,change from baseline House-Brackmann at 7th day,one month,two month, three month
Secondary outcomes:
measure: Likert scale
timeFrame: before intervention , and directly after intervention
Other outcomes:
Locations:
city: Assiut
country: Egypt
facility: Emad Zarief Kamel Said
Study officials:
References:
Clinical trial NCT03536845: Vitamin D Supplementation to Prevent Vitamin D Deficiency for Children With Epilepsy
Official title: Vitamin D Supplementation to Prevent Vitamin D Deficiency for Children With Epilepsy: a Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Epilepsy
Vitamin D Deficiency
Lead sponsor: King Saud University
Sponsor class: OTHER
Collaborators: name: Dallah hospital
First posted: 2018-05-25
Enrollment: 116
Sex: ALL
Minimum age (years): 2
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To determine the maintenance dose of vitamin D supplementation required for children with epilepsy to maintain normal vitamin D level.

Detailed description: children aged 2-16 years diagnosed with idiopathic epilepsy will be randomized to receive either cholecalciferol doses (400IU vs 1000IU) with follow up at 3 and 6 months post supplementation.

Eligibility criteria: Inclusion Criteria:

1. Children aged between 2-16 years who were diagnosed with Epilepsy and being treated with AEDs
2. Followed up in the outpatient pediatric neurology clinic at King Khalid University Hospital during the period of two years.

Exclusion Criteria:

1. Children with pre-existing vitamin D metabolism problems; because they are known to need different vitamin D doses and monitoring for clinical improvement:

   * Vitamin D dependent rickets
   * Malabsorption syndromes like celiac disease, inflammatory bowel disease
   * Renal disease
   * Hepatic disease
2. Children who are not safe to start vitamin D supplementation; because vitamin D supplementation will causes toxicity and induces nephrocalcinosis:

   * Hypercalcemia at baseline total corrected calcium \>2.5mg/dl
   * Vitamin D level \> 250 nmol/L
   * Urine calcium: creatinine ration \> 1.2 mol/mol, or \> 0.41g/g.

Primary outcomes:
measure: Vitamin D level < 75 nmol/L
timeFrame: 6 months of supplementation
Secondary outcomes:
measure: Seizure rate
timeFrame: 6 months of supplementation
measure: bone mineral density (BMD) measurement
timeFrame: 6 months of supplementation
measure: Cost- effectiveness of vitamin D supplementation
timeFrame: 6 months of supplementation
measure: Safety: Prevalence of hypercalcemia total calcium >2.7mg/dl, 25 OH vit D level> 250 nmol/l, and Urine calcium: creatinine ration > 1.2 mol/mol, or > 0.41g/g.
timeFrame: 6 months of supplementation
Other outcomes:
measure: Vitamin D level < 75 nmol/L
timeFrame: 6 months of supplementation
measure: Vitamin D level < 75 nmol/L
timeFrame: 6 months of supplementation
Locations:
city: Riyadh
country: Saudi Arabia
facility: Reem ALKhalifah
Study officials:
affiliation: King Saud University
name: Reem Al Khalifah
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02832505: Applications of MRI in Kidney Disease
Official title: Applications of MRI in Kidney Disease
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Chronic Kidney Disease
End-stage Kidney Disease
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2016-07-14
Enrollment: 0
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include three main cohorts of patients: 20 ESRD patients with their transition to dialysis treatment, 20 CKD controls and 20 non-CKD controls. Based on the investigators previous experience, about 20% of recruited subjects may not be able to finish the proposed studies. Therefore, a conservative estimate of the total number of subjects to be recruited is 72.

Brief summary: This study has two major purposes:

1. To test developed multiple anatomic and functional MRI methods;
2. To evaluate the potentials of these MRI methods in the diagnosis, prognosis, and monitoring of the progression of renal dysfunction.

These purposes will be achieved by performing pilot studies with cohorts of patients.

Detailed description: This study is observational with no intervention applied for the patients. In this study, multiple anatomic and functional MRI methods will be performed with three cohorts of patients. In addition to anatomic MRI methods, non-contrast enhanced functional MRI methods will also be applied to evaluate tissue perfusion and vascular reactivity in these patients.

Eligibility criteria: Inclusion Criteria:

1. English-speaking as primary language
2. Able to complete an approximately 75 to 90 minute cognitive and/or physical tests
3. Capable to consent to studies

Exclusion Criteria:

1. Acute psychiatric illness that would impede cognitive testing
2. Active chemical dependence, such as alcohol, narcotics or other drugs
3. Legally blind or unable to complete cognitive tests due to visual loss or deafness
4. Renal transplant recipient at time of screening or baseline
5. Severe CI unable to complete the Modified Mini-Mental State Examination \[3MSE\]
6. Chronic and acute pulmonary disease

Primary outcomes:
measure: MRI measured perfusion for each patient group
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Medical Center
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Xiufeng Li
role: PRINCIPAL_INVESTIGATOR
References: