louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04180410: Monitoring of Regional Lung Ventilation by Chest Electrical Impedance in the Course of Extubation
Official title: Monitoring of Regional Lung Ventilation by Chest Electrical Impedance in the Course of Extubation
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Respiratory Disease
Lead sponsor: BioSerenity
Sponsor class: INDUSTRY
First posted: 2019-11-27
Enrollment: 60
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: No-randomized,no-comparative study
Primary purpose: OTHER

Brief summary: The Electrical Impedance Tomography (EIT) is a non-invasive exam. This exam performed on the lung continuously produces cross-sectional images of lung function. It may be relevant in lung description.

Detailed description: The aim is to follow the patients after extubation for the lung description.

EIT exam is performed before extubation, during follow-up visits and 48H after extubation

Eligibility criteria: Inclusion Criteria:

1. Age\> 65 years
2. Invasive mechanical ventilation time greater than 48 hours
3. known or suspected Chronic obstructive pulmonary disease
4. Known or suspected heart failure
5. Success in the spontaneous ventilation and extubation test scheduled by the doctor in charge
6. Patient or trusted person who has been informed of the study and has consented to participate

Exclusion Criteria:

1. Pregnant women, minor patients
2. Patients under extracorporeal circulatory assistance (ECMO)
3. Refusal of the patient
4. Contraindications to the realization of the phrenic nerve stimulation technique:

   * Pacemaker, implantable cardiac defibrillator and other pacemakers
   * Spinal implants, thoracic drains ...
   * Copper allergy
   * Epileptic patients
5. Patients performing uncontrolled body movements
6. Contraindications to the realization of the technique of Electrical Imaging Tomography:

   * Breast circumference not between 70 cm and 150 cm.
   * Body mass index (BMI) greater than 50
   * Impossibility of placing the CT belt at the level of the chest skin (lesions, bandages, dressings, chest drains ...)
   * Patients with unstable spinal lesions or fractures
   * Allergy to tomography belt materials: silicone, brass, stainless steel
   * Pacemaker, implantable cardiac defibrillator and other pacemakers
7. Patients under legal protection (tutorship / guardianship)

Primary outcomes:
measure: acute respiratory failure
timeFrame: 48 hours
Secondary outcomes:
measure: pulmonary ventilation
timeFrame: 48 hours
Other outcomes:
Locations:
city: Paris
country: France
facility: Aphp_La Pitie Salpetriere
Study officials:
References:
Clinical trial NCT03098810: Effect of Zinc Supplementation on Appetite and Growth in Primary Malnourished Children
Official title: Effect of Zinc Supplementation on Appetite and Growth of Primary Malnourished Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Appetite Disorders
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2017-04-04
Enrollment: 50
Sex: ALL
Minimum age (years): 2
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Zinc supplementation effect on appetite and growth of malnourished children

Detailed description: The investigators will do s. Zinc and letting before and after zinc supplementation

Eligibility criteria: Inclusion Criteria:

* primary malnourished

Exclusion Criteria:

* zinc supplementation in the previous 3 months Children with chronic disease

Primary outcomes:
measure: Appetite
timeFrame: From start of supplementation to the end of the three months of supplementation
Secondary outcomes:
measure: Weight
timeFrame: From start of supplementation to the end of the three months of supplementation
measure: Height
timeFrame: From start of supplementation to the end of the three months of supplementation
Other outcomes:
Locations:
Study officials:
affiliation: Ain Shams University
name: Marian Girgis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00141310: Sildenafil Citrate for the Treatment of Established Pre-Eclampsia
Official title: A Randomised, Double-Blind, Placebo-Controlled, Flexible-Dose, Parallel-Group Study to Evaluate the Efficacy, Safety and Toleration of Oral Sildenafil Citrate Administered in the Dose Range of 20 - 80 Mg TID for the Treatment of Pre-Eclampsia. (PET)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Pre-eclampsia
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2005-09-01
Enrollment: 76
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine the efficacy and safety of sildenafil citrate in the treatment of established pre-eclampsia


Eligibility criteria: Inclusion Criteria:

* Subjects with pre-eclampsia defined as new hypertension with a diastolic BP of \> or = 90 mmHg on two occasions separated by at least 4 hrs arising after 20 weeks of pregnancy, associated with \>500 mg/24 hr proteinuria. Subjects with pre-existing hypertension (on treatment) need only fulfill proteinuria requirement.
* Gestational age 24-34 w
* Singleton pregnancy

Exclusion Criteria:

* Where urgent delivery is indicated
* Where the fetus is suspected to have a structural or chromosomal abnormality

Primary outcomes:
measure: Primary endpoint is the time from randomization to delivery.
Secondary outcomes:
measure: Individualised birth-weight ratio at delivery, Placental weight, Umbilical artery pulsatility index, Other indices of PET (incl. uric acid and maternal BP), Safety and toleration, Population PK, Fetal exposure (PK)
Other outcomes:
Locations:
city: Pembury
country: United Kingdom
facility: Pfizer Investigational Site
state: Kent
city: Royal Tunbridge Wells
country: United Kingdom
facility: Pfizer Investigational Site
state: Kent
city: Ashton under Lyne
country: United Kingdom
facility: Pfizer Investigational Site
state: Lancs
city: Bolton
country: United Kingdom
facility: Pfizer Investigational Site
city: Dundee
country: United Kingdom
facility: Pfizer Investigational Site
city: Fife
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: London
country: United Kingdom
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
city: Manchester
country: United Kingdom
facility: Pfizer Investigational Site
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
citation: Samangaya RA, Mires G, Shennan A, Skillern L, Howe D, McLeod A, Baker PN. A randomised, double-blinded, placebo-controlled study of the phosphodiesterase type 5 inhibitor sildenafil for the treatment of preeclampsia. Hypertens Pregnancy. 2009 Aug;28(4):369-82. doi: 10.3109/10641950802601278.
Clinical trial NCT01616810: Lower Urinary Tract Symptoms Screening Questionnaire
Official title: Lower Urinary Tract Symptoms Screening Questionnaire Validation STudy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cystocele
Keywords: urinary tract
Lead sponsor: Unity Health Toronto
Sponsor class: OTHER
First posted: 2012-06-12
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy participants, 18 years of age and older with any gynecological symptoms other than lower urinary tract symptoms or pelvic floor dysfunction

Brief summary: The purpose of this study is to determine the validity of a screening tool which has been designed to detect the presence or absence of lower urinary tract symptoms in the general female population.


Eligibility criteria: Inclusion Criteria:

* Healthy participants, 18 years of age and older with any gynecological symptoms

Exclusion Criteria:

* Patients with lower urinary tract symptoms and pelvic floor dysfunction

Primary outcomes:
measure: Presence or absence of lower urinary tract symptoms in the general female population
timeFrame: Five years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Unity Health Toronto
name: Dana Soroka, MD, FRCS(C)
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05563610: Oral Penicillin Challenge and Allergy De-labeling in Children
Official title: Oral Penicillin Challenge and Allergy De-labeling in the Phoenix Children's Hospital Emergency Department
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Penicillin Allergy
Keywords: penicillin
anaphylaxis
allergy
oral challenge
amoxicillin
pediatric
emergency department
Lead sponsor: Phoenix Children's Hospital
Sponsor class: OTHER
First posted: 2022-10-03
Enrollment: 31
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The primary purpose of this study is to investigate the portion of penicillin allergy labels that are not true allergies using oral amoxicillin challenges among pediatric patients. The secondary purpose is to evaluate the safety and feasibility of administering oral penicillin allergy challenges in the Pediatric Emergency Department.


Eligibility criteria: Inclusion Criteria:

1. Patients in the pediatric emergency department who are 2-17 yo and labeled as penicillin-allergic (including amoxicillin or other penicillin allergies)
2. Patients at low risk of anaphylaxis as determined by the study questionnaire
3. Patients who would normally be prescribed amoxicillin, amoxicillin-clavulanate or another penicillin for their current bacterial infection, including otitis media, Group A Streptococcal pharyngitis, pneumonia. sinusitis, dog and cat bite wounds, regimens for Helicobacter pylori eradication, or other acute infections deemed susceptible.
4. Patients who are interested in participating
5. Patients who have an acceptable surrogate to give consent on the subject's behalf
6. Patients whose surrogate (parent/caregiver) speaks English or Spanish

Exclusion Criteria:

1. Patients who are uninterested in participating, or their parents/caregivers are not interested in having them participate
2. Patients who have multiple drug allergies

Primary outcomes:
measure: True Penicillin Allergies
timeFrame: 24 hours after amoxicillin oral challenge
Secondary outcomes:
measure: Amoxicillin Oral Challenge Safety - High-Risk Reactions
timeFrame: 24 hours after amoxicillin oral challenge
measure: Amoxicillin Oral Challenge Safety - Admissions
timeFrame: 24 hours after amoxicillin oral challenge
measure: Amoxicillin Oral Challenge Safety - Re-admissions
timeFrame: 24 hours after amoxicillin oral challenge
measure: Amoxicillin Oral Challenge Safety - Deaths
timeFrame: 24 hours after amoxicillin oral challenge
measure: Amoxicillin Oral Challenge Feasibility
timeFrame: 24 hours after amoxicillin oral challenge
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Phoenix Children's
state: Arizona
Study officials:
affiliation: Emergency Department Attending Physician
name: Diane E Hindman, MD PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00922610: A Study of Mircera in Renal Anemia Among Filipino Chronic Kidney Disease Patients
Official title: An Open-label Study of the Effect of Mircera on Hemoglobin Levels in Filipino Chronic Kidney Disease Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Anemia
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2009-06-17
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the efficacy and safety of once monthly administration of Mircera in Filipino patients with chronic kidney disease who are either on dialysis or predialysis, and not receiving erythropoiesis stimulating agents.Patients will receive Mircera at a starting dose of 0.6 micrograms/kg sc every 2 weeks, with dose adjustments until a target hemoglobin level is achieved, and then dosing will continue every 4 weeks. The anticipated time on study treatment is 3-12 months, and the target sample is \<100 individuals.


Eligibility criteria: Inclusion Criteria:

* adult patients, \>=18 years of age;
* chronic kidney disease;
* anemia (Hb \>8 and \<11 g/dL);
* regular dialysis or predialysis, not treated with ESA.

Exclusion Criteria:

* transfusion of red blood cells during previous 8 weeks;
* poorly controlled hypertension;
* overt gastrointestinal bleeding, or other bleeding necessitating transfusion during previous 8 weeks;
* active malignant disease (except melanoma of skin).

Primary outcomes:
measure: Increase in Hb >1.0g/dL from baseline, and Hb conc. >11g/dL without red blood cell transfusion, for dialysis patients;Hb conc >11-12 g/dL for pre-dialysis patients
timeFrame: 24 weeks after first dose, through week 25
Secondary outcomes:
measure: >=60% responders with target Hb >11g/dL for dialysis patients; Hb conc >11-12g/dL for pre-dialysis patients;incidence of RBC transfusions; no. of patients with dose adjustments
timeFrame: At end of 24 weeks treatment
Other outcomes:
Locations:
city: Cavite
country: Philippines
city: Makati City
country: Philippines
city: Manila
country: Philippines
city: Marikina
country: Philippines
city: Pasig City
country: Philippines
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT03964610: Multimodal Retinal Imaging of Cerebrovascular Stroke
Official title: Multimodal Retinal Imaging of Cerebrovascular Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Cerebrovascular Accidents
Keywords: optical coherence tomography (OCT-A)
color fundus photography (CFP)
Retinal microvascularization
Cerebral microangiopathy
Lead sponsor: Fondation Ophtalmologique Adolphe de Rothschild
Sponsor class: NETWORK
First posted: 2019-05-28
Enrollment: 62
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Acute patients with a stroke will be included

Brief summary: The hypothesis is that in patients with stroke, abnormalities of retinal microvascularization shown on color fundus photography and the depletion of retinal capillary density evaluated by OCT-A are markers of acute impairment of microcirculation of the central nervous system and are correlated with lesions on brain imaging.

Patients hospitalized for stroke MRI-confirmed, will be included. An ophthalmologic assessment including color fundus photography (CFP) and OCT-A will be carried out after stabilization and at 3 months follow-up. Outcomes assessor will be blinded.


Eligibility criteria: Inclusion criteria:

* Acute ischemic stroke
* With cerebral microangiopathy (defined by a SVD score \> 1)

Exclusion criteria:

* Acute hemorrhagic stroke
* Anophthalmia

Primary outcomes:
measure: Presence of an anomaly in color fundus photography or an anomaly of retinal capillary density to OCT-A
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Fondation A de Rothschild
Study officials:
References:
Clinical trial NCT00908310: Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive Omniscan for Contrast-enhanced Magnetic Resonance Imaging (MRI)
Official title: A Post-marketing Safety Study in Patients With Moderate Renal Insufficiency Who Receive OMNISCAN (Gadodiamide Injection) for Contrast-enhanced Magnetic Resonance Imaging.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Renal Insufficiency
Keywords: CKD - Chronic Kidney Disease
GBCA - Gadolinium-based contrast agent
GFR - Glomerular Filtration Rate
MRI - Magnetic Resonance Imaging
NSF - Nephrogenic Systemic Fibrosis
Known or suspected CKD with an eGFR greater than or equal to 30mL & less than 60 mL/min/1.73m2 as measured within 30 days prior to the OMNISCAN.
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: i3 Statprobe
First posted: 2009-05-25
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: This will be an international, multi-center, post-marketing surveillance study in patients with moderate renal insufficiency who are administered gadodiamide, Omniscan, during a MRI. Omniscan will be administered intravenously at the medical discretion of the prescribing physician.


Eligibility criteria: Inclusion Criteria:

* The subject has been referred for a clinically indicated MRI examination with a gadolinium-based contrast agent.
* The subject has known or suspected chronic kidney disease with an eGFR greater than or equal to 30mL and \<60 mL/min/1.73 m2 as measured within 30 days prior to the planned index OMNISCAN administration.
* The subject agrees to be contacted for follow-up for 24 months.

Exclusion Criteria:

* Patients with known or suspected NSF based on biopsy confirmation or the onset of signs and symptoms of NSF lasting at least 7 days as follows:

  1. skin - swelling, hardening and tightening; reddened or darkened patches; burning or itching;
  2. eyes - yellow raised spots on whites of eyes; or
  3. bones and muscle - stiffness in joints; difficulty in moving or straightening of arms, hands, legs or feet; bone pain especially in hips and ribs or muscle weakness.
* Patients allergic to any GBCA.
* Patients with chronic renal disease with a GFR \<30 mL/min/1.73 m2 as measured within 30 days prior to the planned OMNISCAN administration.
* Patients with acute renal insufficiency of any severity due to the hepato-renal syndrome or in the peri operative liver transplantation period.

Primary outcomes:
measure: Capture of Post-marketing Safety Information in Patients With Moderate Renal Insufficiency Undergoing Routine Contrast-enhanced MRI With Administration of OMNISCAN in Order to Assess the Risk for Developing Nephrogenic Systemic Fibrosis (NSF).
timeFrame: Greater than or equal to 7 days post contrast administration.
Secondary outcomes:
Other outcomes:
Locations:
city: Princeton
country: United States
facility: GE Healthcare
state: New Jersey
Study officials:
affiliation: GE Healthcare
name: Rubin Sheng, MD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03507010: Ledderhose Disease: Radiotherapy or Not?
Official title: Ledderhose Disease: Radiotherapy or Not? A Randomised, Multicentre, Prospective, Double Blind Phase III Trial Investigating the Effect of Radiotherapy on Patients With Ledderhose Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Ledderhose Disease
Keywords: Radiotherapy
Pain
Lead sponsor: University Medical Center Groningen
Sponsor class: OTHER
Collaborators: name: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
name: Catharina Ziekenhuis Eindhoven
name: Rijnstate Hospital
First posted: 2018-04-24
Enrollment: 84
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of the LedRad trial is to determine the efficacy and durability of radiotherapy as treatment for patients with Ledderhose disease and to compare this to the natural course of Ledderhose disease.


Eligibility criteria: Inclusion Criteria:

* Patients with painful Ledderhose disease. The pain score measured with the VAS score and is at least 2 on the 11-point scale (0 = no pain to 10 = worst imaginable pain).
* Age ≥ 18 years
* WHO performance status 0, 1 or 2 (Appendix, section 18)
* Before patient randomisation, written informed consent must be given according to ICH/GCP, and WMO requirements.
* Controlling the Dutch language (speaking and reading).
* Able and willing to complete quality of life questionnaires in Dutch
* Must be accessible for treatment follow-up

Exclusion Criteria:

* Surgical intervention before for Ledderhose disease
* Previous radiation treatment for Ledderhose disease
* Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
* Not able to lay prone for at least fifteen minutes
* Females who are pregnant at entry or who want to become pregnant within six months.

Primary outcomes:
measure: Numeric Rating Scale
timeFrame: 12 months
Secondary outcomes:
measure: Numeric Rating Scale
timeFrame: 6 and 18 months
measure: Size of ledderhose nodules
timeFrame: 12 months
measure: Walking distance
timeFrame: 6, 12 and 18 months
measure: Walking motion
timeFrame: 12 months
measure: Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
timeFrame: 18 months
measure: Quality of life (1)
timeFrame: 6, 12 and 18 months
measure: Quality of life (2)
timeFrame: 6, 12 and 18 months
measure: Quality of life (3)
timeFrame: 6, 12 and 18 months
measure: Cost-effectiveness analysis (CEA)
timeFrame: 6, 12 and 18 months
Other outcomes:
Locations:
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
Study officials:
References: