louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01373177: Differences Between the Bayley-II and the Bayley-III in Very Preterm Infants at 2 Years
Official title: A Randomized Crossover Study to Evaluate Differences Between the Bayley-II and the Bayley-III in Very Preterm Infants at 2 Years
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant Development
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
First posted: 2011-06-14
Enrollment: 119
Sex: ALL
Minimum age (years): 18
Maximum age (years): 22
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The objective of this randomized study is to test the hypothesis that scores on the Bayley Scales of Infant Development-III (Bayley-III) are higher than scores on the Bayley Scales of Infant Development-II (BSID-II) in the same group of infants who were born very preterm.

Detailed description: The objective of this randomized crossover study is to test the hypothesis that scores on the Bayley Scales of Infant Development-III are higher than scores on the Bayley Scales of Infant Development-II in the same group of infants who were born very preterm. First, however, the investigators must demonstrate that significant "learning" does not occur when the tests are administered 4-8 weeks apart. The investigators hypothesize that scores on the Bayley-III will be higher than scores on the BSID-II, irrespective of the order in which the tests are administered.

Eligibility criteria: Inclusion Criteria:

* Birth weight \<2000 grams and \<32 weeks
* Corrected age of 18-22 months.

Exclusion Criteria:

* English is not the primary language in the child's home.
* Parent is unable to give informed consent for research participation.
* Parent is unable to commit to returning for follow-up testing in 4-8 weeks.
* Infant has severe medical illness or disability expected to impact his/her ability to participate in testing (ex: blindness, deafness, severe cerebral palsy, autism, tracheostomy).
* No exclusion for economic status, gender, race or ethnicity.
* Participation in a RCT that restricts timing and administration of developmental testing.

Primary outcomes:
measure: The primary outcome is the mean difference between BSID-II Mental Development Index (MDI) and Bayley-III Cognitive Score.
timeFrame: 18-22 months
Secondary outcomes:
measure: Mean difference between BSID-II Physical Development Index and Bayley-III Composite Motor Score.
timeFrame: 18-22 months
measure: Proportion of infants classified as having "developmental delay" (MDI <70 on BSID-II or either Language or Cognitive Score <70 on the Bayley-III).
timeFrame: 18-22 months
measure: The mean difference in scores between time point one and time point two (a measure of learning or training).
timeFrame: 18-22 months
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: The Children's Hospital of Philadelphia
state: Pennsylvania
Study officials:
affiliation: Children's Hospital of Philadelphia
name: Sara B. DeMauro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06578377: The Epidemiology of Acute Respiratory Distress Among Children, A Retrospective Cross-Sectional Study
Official title: The Epidemiology of Acute Respiratory Distress Among Children, A Retrospective Cross-Sectional Study From Iran
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress
Lead sponsor: Mofid Children Hospital
Sponsor class: OTHER
Collaborators: name: Dr Fatemeh Shojaeian, Dr seyed mohamadsadegh mousavi-kiasary, Dr Samira Sayyah
First posted: 2024-08-29
Enrollment: 154
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Observational model: CASE_CROSSOVER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From a total of 186 patients who visited the emergency room of Mofid Children's Hospital during the period of the study, 154 included in the study

Brief summary: l Respiratory distress is still a major concern in pediatric medicine. l In this study we evaluated the symptoms and causes of respiratory distress among children in a tertiary hospital.

l We found that tachypnea is the most common symptom and asthma is the most common cause of respiratory distress in children.


Eligibility criteria: Inclusion Criteria:

* patients older than one month
* signs or symptoms of respiratory distress, including tachypnea, bradypnea, cyanosis, respiratory muscle retraction, nasal flaring, tachycardia, and bradycardia

Exclusion Criteria:

* Patients older than 18 years old
* apnea
* known cardiac diseases

Primary outcomes:
measure: The most common symptom
timeFrame: six months
measure: The most common cause of respiratory distress
timeFrame: six months
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Mahdis Bayat
Study officials:
References:
Clinical trial NCT05184777: Evaluation of Salivary ELISA for Hormone Monitoring in IVF Patients
Official title: Evaluation of Salivary ELISA for Hormone Monitoring in IVF Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infertility, Female
Reproductive Sterility
Keywords: ELISA
Saliva
Progesterone
Oestradiol
Early follicular phase
Mild follicular phase
Late follicular phase
Lead sponsor: Instituto Valenciano de Infertilidad, IVI VALENCIA
Sponsor class: OTHER
Collaborators: name: MINT DIAGNOSTICS
First posted: 2022-01-11
Enrollment: 120
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective unicentric study
Primary purpose: DIAGNOSTIC

Brief summary: In assisted reproductive treatment (ART), it is necessary to follow closely the stimulation cycles of patients undergoing these treatments in order to monitor the number and size of developing follicles. Oestradiol (E2) and progesterone (P) are products of steroidogenesis and the concentrations of both hormones increase with the diameter of the growing follicle and accurate and reliable methods to measure E2 and P are essential to assess treatment response and support clinical decision. Measurement of both hormones, as well as monitoring of follicle growth through ultrasound measurements, is an important part of ovarian stimulation, requiring patients to undergo multiple blood draws. It is often a physically and emotionally painful process and the most convenient solution to this problem is the measurement of hormone concentration in other biological fluids. Salivary diagnostic tests are a less invasive, inexpensive and stress-free alternative to measurements of hormone concentration in other biological fluids. The current study pretends to evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations IVF patients. In addition, secondary objectives include the measurement of diurnal variability of salivary hormone levels and patient experience with saliva collection as users.


Eligibility criteria: Inclusion Criteria:

* Patients undergoing IVF/ICSI treatment
* Patients planned to embryo transfer (ET) undergoing hormonal replacement therapy
* Aged from18-45 years old.
* BMI 19-30 kg/m2
* Signed written informed consent

Exclusion Criteria:

• Patients suffering for any systemic disease or endocrine disorder will be excluded foe the study

Primary outcomes:
measure: To evaluate the correlation between salivary ELISA assays and serum determination of progesterone and oestradiol concentrations IVF patients.
timeFrame: 12 months
Secondary outcomes:
measure: Diurnal variability of salivary progesterone and oestradiol levels
timeFrame: 12 months
measure: Patient User Experience with saliva collection
timeFrame: 12 months
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: IVI Valencia
Study officials:
References:
Clinical trial NCT00742053: Electrocardiogram (ECG) Guided Peripherally Inserted Central Catheter (PICC) Placement
Official title: A Study of Electrocardiogram (ECG) Guidance for Placement of Peripherally Inserted Central Catheters (PICC)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Primary Focus: Adult Subjects Who Require PICC Placement
Keywords: ECG PICC
Patients undergoing PICC placement
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
First posted: 2008-08-27
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This study is designed to obtain information for design purposes on use of an ECG guided monitoring system to aid in the correct placement of PICC lines.

There is no formal study hypothesis.

Detailed description: PICC line placement is a common procedure, made more difficult by the need to ensure that catheter tip placement is in an acceptable location, typically the superior vena cava (SVC), and ideally at the junction of the SVC and right atrium. Tip location is determined at present by chest X-ray, which is performed after the procedure. If the tip location is incorrect, additional procedures and/or X-rays are needed until proper placement is ensured.

Use of an electrode placed inside the catheter during insertion has been reported to provide identifiable changes in the p-wave sufficient to guide placement. This study is designed to collect ECG and catheter depth information during routine PICC placement procedures, and to correlate these ECG changes to tip location as determined by contrast enhanced fluoroscopy.

Eligibility criteria: Inclusion Criteria:

* Require Power PICC placement as standard care
* Signed informed consent

Exclusion Criteria:

* Has an intracardiac device
* Does not have normal sinus rhythm
* Has known abnormality of central venous system
* Plasma creatinine \>=1.5 mg/dL
* Pregnancy
* Allergy or prior reaction to contrast material

Primary outcomes:
measure: Distance of Maximum P-wave Amplitude in Relation to Superior Vena Cava (SVC)/Right Atrium(RA) Junction
timeFrame: during catheter insertion
Secondary outcomes:
Other outcomes:
Locations:
city: Salt Lake City
country: United States
facility: University of Utah Health Science Center
state: Utah
Study officials:
affiliation: University of Utah Health Science Center
name: Andrew D Michaels, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith B, Neuharth RM, Hendrix MA, McDonnall D, Michaels AD. Intravenous electrocardiographic guidance for placement of peripherally inserted central catheters. J Electrocardiol. 2010 May-Jun;43(3):274-8. doi: 10.1016/j.jelectrocard.2010.02.003. Epub 2010 Mar 6.
Clinical trial NCT06872853: Evaluation of Rare and Complex Tumours of the Thoraco-Abdominal and Soft Tissue District
Official title: Evaluation of Rare and Complex Tumours of the Thoraco-Abdominal and Soft Tissue District - Observational Study With Retrospective and Prospective Phase
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Rare Malignant Neoplasm
Lead sponsor: IRCCS Azienda Ospedaliero-Universitaria di Bologna
Sponsor class: OTHER
First posted: 2025-03-12
Enrollment: 1100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Consecutive patients over 18 years of age with a diagnosis of histologically proven rare or highly complex malignant tumour

Brief summary: The goal of this observational study is to collect structured data about diagnosis, treatment and follow-up of rare and highly complex neoplasms.

The study has a rerospective part that will consist in gathering data on patients accessing IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico di S. Orsola from 01/01/2000 to 28/09/2017 and a prospective one ranging from 29/09/2017 to 31/12/2025.


Eligibility criteria: Inclusion Criteria:

* patients with histologic diagnosis of rare or highly complex malignant neoplasm
* informed consent

Exclusion Criteria:

* none

Primary outcomes:
measure: Incidence of different malignant rare neoplasms
timeFrame: Throughout the lenght of study, an average of 10 years
Secondary outcomes:
measure: Response rate (RR)
timeFrame: Throughout the lenght of study, an average of 10 years
measure: Local recurrence rate
timeFrame: Throughout the lenght of study, an average of 10 years
measure: Progression-free survival (PFS)
timeFrame: Throughout the lenght of study, an average of 10 years
measure: Overall survival (OS)
timeFrame: Throughout the lenght of study, an average of 10 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Oncology Unit, IRCCS AOUBO Policlinico di S. Orsola
state: BO
city: Bologna
country: Italy
facility: Thoracic Surgery Unit
state: BO
Study officials:
affiliation: Oncology Unit, IRCCS AOUBO
name: Maria A Pantaleo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00898053: Study of Tumor Samples From Patients With Ewing Sarcoma
Official title: Observational - Prognostic Value of p53 and/or p16 Alterations in Ewing Sarcoma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Localized Ewing Sarcoma/Peripheral Primitive Neuroectodermal Tumor
Lead sponsor: Children's Oncology Group
Sponsor class: NETWORK
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-05-12
Enrollment: 200
Sex: ALL
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Diagnosis of Ewing sarcoma

Brief summary: This laboratory study is looking at tumor samples from patients with Ewing sarcoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer

Detailed description: Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Prospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Samples collected from AEWS0031 and patients registered on AEWS08B1 Sampling Method: Non-Probability Sample

PRIMARY OBJECTIVES:

I. Determine if mutation of p53, and/or deletion of the p16 locus, have prognostic value in patients with Ewing sarcoma.

SECONDARY OBJECTIVES:

I. Estimate the incidence of p53 mutation in Ewing sarcoma samples collected from COG studies.

II. Estimate the incidence of p16 deletions in Ewing sarcoma samples collected from COG studies.

III. Prepare and archive amplified genomic DNA from Ewing sarcoma samples collected from COG studies for future biologic analysis.

OUTLINE: This is a multicenter study.

Previously archived tumor samples are analyzed for p53 mutations and p16 deletion by immunohistochemistry, FISH, PCR, and DNA sequencing.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of Ewing sarcoma
* Banked specimens from patients enrolled on AEWS0031

Primary outcomes:
measure: Event-free survival
timeFrame: Time from study entry until disease progression, death without progression of disease, occurrence of a second malignant neoplasm or last follow-up, assessed up to 3 years
Secondary outcomes:
measure: Incidence of p53 mutations using the model of Sather and Sposto
timeFrame: Baseline
measure: Incidence of p16 loss or deletion using the model of Sather and Sposto
timeFrame: Baseline
Other outcomes:
Locations:
city: Monrovia
country: United States
facility: Children's Oncology Group
state: California
Study officials:
affiliation: Children's Oncology Group
name: Stephen Lessnick, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06000553: Early Detection of Pancreatic Cancer in Patients With Papillary and Mucinous Intracanal Tumours of the Pancreas Papillary and Mucinous Tumours of the Pancreas
Official title: Early Detection of Pancreatic Cancer in Patients With Papillary and Mucinous Intracanal Tumours of the Pancreas Papillary and Mucinous Tumours of the Pancreas PCS-IPMN-IPC 2023-005
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: PAPILLARY AND MUCINOUS INTRACANAL TUMORS OF THE PANCREAS
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2023-08-21
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: the patient takes specific blood samples for the study
Primary purpose: OTHER

Brief summary: This trial is a prospective, exploratory and descriptive study. The primary objective is to identify early diagnostic biomarkers in patients with TIPMP based on the analysis of Treg lymphocyte subpopulations and epigenetic signatures, and the secondary objective is to characterize the biological processes underlying the transformation of a pre-neoplastic lesion into established ADPC.

Detailed description: To meet the objectives of the study, patients will have blood samples taken at the time of their TIPMP monitoring, i.e. at inclusion, 6 months, 1 year and 2 years. If echo-endoscopy is performed during MRI monitoring of their disease, and a sample is taken as part of the treatment, a tumor sample and an intra-cystic fluid sample will be collected as part of the protocol.

Eligibility criteria: Inclusion Criteria:

1. Age over 18
2. Patient with intermediate-risk or high-risk TIPMP according to the European Study Group on Cystic Tumours of the Pancreas (3)
3. Signed consent to participate
4. Affiliation with a social security scheme, or beneficiary of such a scheme.

Exclusion Criteria:

1. Pregnant or breast-feeding woman
2. Person in an emergency situation or unable to give consent.
3. Adult subject to a legal protection measure (adult under guardianship, curatorship or safeguard of justice),
4. Unable to undergo medical follow-up for geographical, social or psychological reasons.
5. contraindication to MRI.

Primary outcomes:
measure: the aim is to search for immune and metabolic abnormalities in patients with at-risk TIPMP in the blood or by echo-endoscopic sampling, then compare and combine them with the criteria used in clinical practice.
timeFrame: for two years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01336153: Clinical Study to Investigate the Safety and Efficacy of MLC601 in 150 Iranian Patients After Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Stroke
Keywords: Safety
Efficacy
MLC601
motor recovery
Lead sponsor: Shahid Beheshti University
Sponsor class: OTHER
Collaborators: name: Shahid Beheshti University of Medical Sciences
First posted: 2011-04-15
Enrollment: 150
Sex: ALL
Minimum age (years): 30
Maximum age (years): 72
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To investigate the safety and efficacy of MLC601 (NeuroAideTM) as a Traditional Chinese Medicine on motor recovery after ischemic stroke.

Detailed description: This is a double-blind, placebo-controlled clinical trial study on 150 patients with a recent (less than 3 month) ischemic stroke. All patients will give either MLC601 (100 patients) or placebo (50 patients), 4 capsules 3 times a day, as an add-on to standard medication of post stroke for 3 months. Motor improvement will be monitored using Fugl-Meyer Assessment FMA.

Eligibility criteria: Inclusion Criteria:

* age between 30-72 yars,
* \< one month after stroke,
* ischemic cerebral stroke,
* signed informed consent form.

Exclusion Criteria:

* treatment with thrombolytic after stoke,
* ischemic stroke combined with hemorrhage, severe renal or liver failure, dementia, psychosis and history of seizure disorder, history of previous stroke, and hemoglobin level less than 10mg/dl on admission.

Primary outcomes:
measure: Investigate the Safety and Efficacy of MLC601
timeFrame: 18 months
Secondary outcomes:
measure: Motor recovery of MLC601 in 150 Iranian Patients after Stroke
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01281553: A Study of Cisapride in Patients With Symptomatic Gastro-Oesophageal Reflux Disease
Official title: Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Assess the Efficacy and Safety of R051619 (Cisapride Oral Suspension 0.2 mg/kg q.i.d.) for the Treatment of Symptomatic Gastro-Oesophageal Reflux Disease (GORD) in Infants and Children
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Gastroesophageal Reflux
Keywords: Cisapride (PREPULSID)
Placebo
Gastroesophageal Reflux Disease (GERD)
Gastro-oesophageal Reflux Disease (GORD)
Lead sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Sponsor class: INDUSTRY
First posted: 2011-01-24
Enrollment: 6
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy and tolerability of cisapride with placebo in infants and children with gastro-oesophageal reflux disease (GORD).

Detailed description: This is a double-blind (neither patient nor study staff will know the identity of the assigned treatment) study evaluate the effectiveness and safety of cisapride in patients with gastro-oesophageal reflux disease (GORD) (also referred to as gastroesophageal reflux disease \[GERD\[) compared to a placebo (a identical in appearance to cisapride but does not contain active drug). Patients will receive placebo or cisapride suspension at 0.2 mg/kg (volumn determined by patient weight) four times per day (q.i.d.) (15 minutes before feeding 3 times a day and at bedtime) orally (by mouth) for 8 weeks.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of GORD based on protocol-specified characteristics
* Failed the 1st of 5 stepwise treatments for GORD recommended by the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN)
* Caregiver able to complete the I-GERQ-R questionnaire

Exclusion Criteria:

* Protocol-specified respiratory conditions requiring previous or current treatment with oral or intravenous corticosteroids (prior and concurrent use of inhaled corticosteroids is acceptable)
* Cause of vomiting/regurgitation other than GORD
* Prior history of cisapride intake

Primary outcomes:
measure: Caregiver's assessment of infant pediatric GORD symptoms
timeFrame: Up to 8 weeks (56 days)
Secondary outcomes:
measure: The number and type of adverse events reported
timeFrame: From time of first dose to the last dose (up to 8 weeks)
Other outcomes:
Locations:
Study officials:
affiliation: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
name: Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial
role: STUDY_DIRECTOR
References: