louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00531830: Assessment of Factors Which Predict Improvement in Children With PDD After a Year of Integrative Therapy
Official title: Assessment of Factors Which Predict Improvement in Children With PDD After a Year of Integrative Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pervasive Developmental Disorder
Keywords: children with PDD
Lead sponsor: BeerYaakov Mental Health Center
Sponsor class: OTHER_GOV
First posted: 2007-09-19
Enrollment: 60
Sex: ALL
Minimum age (years): 2
Maximum age (years): 6
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: RETROSPECTIVE

Brief summary: The aim of the current research is to assess the efficiency of the Integrative Therapy among children with PDD after a year of treatment in kindergartens in Ashdod, Israel.

An additional aim is to pinpoint specific changes in communication quality and functioning in different areas and recognize the prognostic factors, such as social interaction, affect and level of play. This analysis will contribute to developing more efficient treatment program, adapted to the needs of the treated children.

Detailed description: Integrative Therapy among children with PDD after a year of treatment in kindergartens in Ashdod, Israel.

An additional aim is to pinpoint specific changes in communication quality and functioning in different areas and recognize the prognostic factors, such as social interaction, affect and level of play. This analysis will contribute to developing more efficient treatment program, adapted to the needs of the treated children.

Eligibility criteria: Inclusion Criteria:

* Children with PDD
* Children aged from 2 years to 6 years

Exclusion Criteria:

* Children with severe retardation

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Mental health unit for preschoolers, Ashdod, Israel
name: Irit Orian, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Ben Gurion University, Beer-Sheva
name: Beatriz Priel, Prof.
role: STUDY_DIRECTOR
affiliation: Ben-Gurion University, Beer-Sheva
name: Alexander Rejba, M.A.
role: STUDY_CHAIR
References:
Clinical trial NCT06853730: Regional Distribution Mapping of Lymph Node Metastasis in Epithelial Ovarian Cancer
Official title: Regional Distribution Mapping of Lymph Node Metastasis in Epithelial Ovarian Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ovarian Cancer
Keywords: Lymph Node Metastasis
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
First posted: 2025-03-03
Enrollment: 654
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagnosed with epithelial ovarian cancer at the First Affiliated Hospital of Sun Yat-sen University from January 2014 to December 2022 were included in this retrospective study. The inclusion criteria were as follows: i) initial diagnosis and tumor cytoreductive surgery performed at the First Affiliated Hospital of Sun Yat-sen University; ii) confirmed postoperative pathology of epithelial ovarian cancer; iii) available lymph node status; and iv) accessible clinical features, including preoperative ultrasound and blood biochemistry tests. The exclusion criteria were: i) initial diagnosis or surgical treatment conducted at other hospitals; ii) absence of imaging results (CT/PET-CT/MRI) or postoperative pathology results for lymph node status. iii) presence of other cancers; and iv) incomplete medical history

Brief summary: The goal of this observational study is to investigate the metastatic pathways of lymph node involvement in ovarian cancer patients. The main question it aims to answer is: • What are the sequential patterns of lymph node metastasis in ovarian cancer, and are there specific clinical factors associated with different metastatic pathways? Participants diagnosed with ovarian cancer who have undergone lymphadenectomy as part of their standard treatment will have their postoperative pathological lymph node involvement analyzed. The study will retrospectively collect and analyze patient data, including lymph node metastasis patterns, to identify potential progression routes.


Eligibility criteria: Inclusion Criteria:i) initial diagnosis and tumor cytoreductive surgery performed at the First Affiliated Hospital of Sun Yat-sen University; ii) confirmed postoperative pathology of epithelial ovarian cancer; iii) available lymph node status; and iv) accessible clinical features, including preoperative ultrasound and blood biochemistry tests

Exclusion Criteria: i) initial diagnosis or surgical treatment conducted at other hospitals; ii) absence of imaging results (CT/PET-CT/MRI) or postoperative pathology results for lymph node status. iii) presence of other cancers; and iv) incomplete medical history

-

Primary outcomes:
measure: The incidence of lymph node metastasis in ovarian cancer patients and its association with clinical factors.
timeFrame: From enrollment to 6 months post-surgery
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01926730: Food and Crohn's Exacerbation Study (FACES)
Official title: Food and Crohn's Exacerbation Study (FACES)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Crohn's Disease
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
name: Crohn's and Colitis Foundation
First posted: 2013-08-21
Enrollment: 216
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 proposed study is a randomized controlled trial of a limited restriction diet compared to a regular diet among patients with Crohn's disease (CD) in remission. At baseline, patients will complete a semi-quantitative food frequency questionnaire assessing usual dietary patterns over the preceding month. Disease activity will be assessed with the abbreviated Crohn's Disease Activity Index (aCDAI)59. Self-reported disease status will be assessed during follow-up using an internet-based questionnaire. Repeat assessment of adherence to the study diets will be assessed with food frequency questionnaires (FFQs) administered after 20 weeks. Follow-up duration will be for 48 weeks. Statistical analysis will compare the time to relapse using Cox regression for patients in the two study arms. In the exploratory aim, we will compare outcomes among patients in the highest tertile for other food items and nutrients to those in the lowest tertile based on self-reported usual dietary patterns at baseline. Thus, the study population will be analyzed both as a randomized controlled trial and as a prospective cohort study.


Eligibility criteria: Inclusion Criteria:

1. Patients must have an established diagnosis of CD.
2. All patients must be in clinical remission at the time of entry into the study. Remission is defined as an aCDAI of less than 150.

Exclusion Criteria:

Inflammatory bowel disease (IBD) unspecified / Indeterminate colitis

Total or sub-total colectomy, ileostomy, or colostomy

Unable to read and speak English

No internet access

Steroids other than budesonide ≤6mg/day with the prior two weeks

Perianal fistula or abscess with more than scant drainage

Age less than 18 years

Pregnant or breastfeeding women

Unwilling to follow the study diet

Primary outcomes:
measure: Relapse of Crohn's Disease (CD)
timeFrame: Every 8 weeks during the 48 week study period
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: University of Pennsylvania
name: James D Lewis, MD, MSCE
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04268030: High Order Spectral Analysis of Local Field Potential Data on a Subgroup of Parkinson's Disease Patients Who Are Carriers of Mutations in the Glucocerebrosidase (GBA) Gene Undergoing DBS Electrode Placement
Official title: High Order Spectral Analysis of Local Field Potential Data on a Subgroup of Parkinson's Disease Patients Who Are Carriers of Mutations in the Glucocerebrosidase (GBA) Gene Undergoing DBS Electrode Placement
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Rush University Medical Center
Sponsor class: OTHER
First posted: 2020-02-13
Enrollment: 9
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Parkinson's disease (PD) with and without mutations in the GBA gene who already have an implanted deep brain stimulator (DBS) device or those patients with PD-GBA mutation carrier who will be undergoing placement of a DBS device using standard technique with sedation and local anesthesia.

Brief summary: The aim is to study a specific group of PD patients, carriers of mutations in the glucocerebrosidase (GBA) gene, which is the most common genetic risk factor for PD and is a harbinger of aggressive cognitive and motor decline. Approximately 12-17% of PD patients undergoing DBS are GBA mutation carriers. GBA mutation carriers with PD have a specific phenotype characterized by more significant motor dysfunction and reduced short-term visual memory function compared with their non-GBA counterparts. Thus as GBA mutation carriers have a "signature" phenotype, the investigators hypothesize that these GBA mutation carriers have a unique "signature" of oscillatory activity that can be distinguished from non-mutation carriers during motor activation and during cognitive tasks. Identification of this "signature" will provide critical information that is required to: 1) understand the underlying neurophysiological mechanisms responsible for the aggressive disease course of GBA associated PD, and 2) further develop customized adaptive DBS systems.


Eligibility criteria: Inclusion Criteria:

* undergoing bilateral STN-DBS
* diagnosis of Parkinson's disease

Exclusion Criteria:

* no Parkinson's disease

Primary outcomes:
measure: change in beta symmetry
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
Study officials:
References:
Clinical trial NCT00665730: Evaluation of the Safety and Effectiveness of Sepraspray™ in Reducing Post-surgical Adhesions
Official title: Evaluation of the Safety and Effectiveness of Sepraspray™ in Limiting the Formation of Postoperative Adhesions to Serosal Tissue (Abdominal Surgery)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Abdominal Adhesions
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2008-04-24
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study will examine the safety and efficacy of Sepraspray in the following model of abdominal surgery: total proctocolectomy and pelvic pouch with diverting ileostomy via laparotomy to treat ulcerative colitis or familial polyposis. Adhesion formation will be evaluated laparoscopically at ileostomy take down. NOTE: A decision was made to terminate this study in June 2008 due to low enrollment.


Eligibility criteria: Inclusion Criteria:

* Patients who are scheduled to undergo a total proctocolectomy and a pelvic pouch with diverting ileostomy.

Exclusion Criteria:

* Patients who are pregnant.
* Patients with ongoing abdominal abscess.
* Patients with ongoing bacterial peritonitis.

Primary outcomes:
measure: Efficacy: Primary efficacy endpoints include the incidence of adhesions to the midline incision
timeFrame: 8-14 weeks
Secondary outcomes:
measure: Secondary: efficacy endpoints include the extent of adhesions to the midline incision and the severity of adhesions to the midline incision.
timeFrame: 8-14 weeks
measure: Safety: safety endpoints include assessments of adverse events, vital signs, incisional wound healing, clinical laboratory evaluations, and concomitant medications.
timeFrame: 8-14 weeks
Other outcomes:
Locations:
city: Masarykova
country: Czech Republic
city: Praha
country: Czech Republic
city: Aarhus C
country: Denmark
city: Lille Cedex
country: France
city: Heidelberg
country: Germany
city: Cottingham
country: United Kingdom
state: East Yorkshire
Study officials:
affiliation: Genzyme, a Sanofi Company
name: Medical Monitor
role: STUDY_DIRECTOR
References:
Clinical trial NCT05774730: Evaluation of the Effectiveness of Predicting the Integrity of Interlobar Fissures Based on Chest Image AI Technology
Official title: Evaluation of the Effectiveness of Predicting the Integrity of Interlobar Fissures Based on Chest Image AI Technology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Chronic Obstructive Pulmonary Disease
Lead sponsor: China-Japan Friendship Hospital
Sponsor class: OTHER
First posted: 2023-03-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: chronic obstructive pulmonary diseases

Brief summary: The goal of observational study is to evaluate effectiveness of predicting the integrity of interlobar fissures based on chest image AI technology in patients with Chronic Obstructive Pulmonary Disease who will undergo lung volume reduction surgery with endobronchial valve implantation. The main question it aims to answer is: evaluation of the effectiveness of predicting the integrity of interlobar fissures based on chest image AI technology.

Participants will be evaluated by lung CT (quantitative analysis based on chest image AI technology and artificial analysis) and imported Chartis detection system.


Eligibility criteria: Inclusion Criteria:

* Patients with chronic obstructive pulmonary disease who meet the GOLD diagnostic criteria
* FEV1 ≤ 45% pred and FEV1/FVC\<70%
* TLC\>100% pred and RV\>175% pred
* CAT≥18
* \>50% of emphysema destruction
* Smoking prohibition\>6 months
* Sign the informed consent form

Exclusion Criteria:

* PaCO2\>8.0 kPa, or PaO2\<6.0 kPa
* 6-minute walking test\<160m
* Obvious chronic bronchitis, bronchiectasis or other infectious lung diseases
* Three hospitalizations due to pulmonary infection in the past 12 months before the baseline assessment
* Previous lobectomy, LVRS or lung transplantation
* LVEF\<45% and or RVSP\>50mmHg
* Anticoagulant therapy that cannot be stopped before surgery
* The patient has obvious immune deficiency
* Participated in other lung drug studies within 30 days before this study
* Pulmonary nodules requiring intervention
* Any disease or condition that interferes with the completion of the initial or subsequent assessment

Primary outcomes:
measure: Therapeutic effect of lung volume reduction surgery
timeFrame: 1 month after bronchoscopic valve lung volume reduction
measure: Therapeutic effect of lung volume reduction surgery
timeFrame: 3 months after bronchoscopic valve lung volume reduction
measure: Therapeutic effect of lung volume reduction surgery
timeFrame: 6 months after bronchoscopic valve lung volume reduction
measure: the integrity of interlobar fissure
timeFrame: Before bronchoscopic valve lung volume reduction
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00018330: Genetics, Metabolism and Weight Loss in Older, Obese Veterans
Official title: Genetics, Metabolism and Weight Loss in Older, Obese Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Behavioral
Weight Loss
Genetics
Lipoprotein lipase
Visceral fat
Lipoprotein
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2001-07-05
Sex: ALL
Minimum age (years): 50
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study is designed to determine whether sequence variation in the lipoprotein lipase (LPQ) gene affects the amount of weight loss and metabolic responses during a hypocaloric diet treatment for overweight and obese (BMI=25-35 kg/m2), older (50-65 yrs), sedentary veterans.

Detailed description: Veterans who are 50-65 yrs, non-smoking, sedentary and weight stable with a BMI between 25-35 kg/m2 (120-150% desirable body weight) are recruited and screened via telephone, medical history, and physical exam. Exclusion criteria are: diabetes, hypertriglyceridemia (\>400 mg/dl), history of cancer or myocardial infarction, clinical depression, renal, liver or hematologic disease, and medications that affect glucose or lipid metabolism (thiazides, estrogen replacement, beta-blockers). Changes in total and visceral body fat are measured by dual x-ray absorptiometry and computerized tomography, resting energy expenditure and fat oxidation rate by indirect calorimetry, and lipoprotein lipids by enzymatic assay. Glucose tolerance is assessed during a three-hour oral glucose tolerance test with measurement of glucose- and insulin levels every 30 minutes. LPL activity is measured in 3050mg pieces of subcutaneous abdominal and gluteal adipose tissue.

Eligibility criteria: * 50-65 yrs, non-smoking, sedentary and weight stable with a BMI between 25-35 kg/m2 (120-150% desirable body weight) are recruited and screened via telephone, medical history, and physical exam.

Exclusion criteria:

* Diabetes,
* Hypertriglyceridemia (\>400 mg/dl),
* History of cancer or myocardial infarction,
* Clinical depression,
* Renal, liver or hematologic disease, and
* Medications that affect glucose or lipid metabolism (thiazides, estrogen replacement, beta-blockers).

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: VA Maryland Health Care System
state: Maryland
Study officials:
References:
Clinical trial NCT05599230: Daily Monitoring of Respiratory Symptoms and Spirometry During ETI Treatment in Persons With Cystic Fibrosis.
Official title: Daily Monitoring of Respiratory Symptoms and Spirometry During ETI Treatment in Persons With Cystic Fibrosis.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cystic Fibrosis
Keywords: elexacaftor
time course
FEV1
Respiratory symptoms
Lead sponsor: CHC Montlegia
Sponsor class: OTHER
First posted: 2022-10-31
Enrollment: 20
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: CF patients aged 12 y or more, carrying at least one copy of F508del mutation, in stable condition, reliably performing spirometry

Brief summary: The goal of this observational study is to provide optimal monitoring and support when initiating ETI treatment in eligible persons with cystic fibrosis (aged 12 y +) and to document on a daily basis, from 72 hours before the start of treatment and then for 14 days i) i) FEV1 changes (home spirometry), ii) ii) respiratory symptoms changes, iii) any possible side effects. Through a dedicated electronic platform, these data will be monitored every day by the medical team, which will be fully available for any questions or concerns patients may have.


Eligibility criteria: Inclusion Criteria:

* Cystic fibrosis diagnosis
* At least 12 years old
* Carrier of at least one copy of F508del mutation
* Ability to perform reliable and reproducible spirometry
* Medical and psychological stability
* written consent
* owning a smartphone

Exclusion Criteria:

* Lung transplant
* FEV1 \> 120 % pr (%GLI) at the inclusion test
* Pulmonary exacerbation

Primary outcomes:
measure: FEV1 changes from baseline (3 days before treatment) to Day 14 under ETI
timeFrame: 17 days
Secondary outcomes:
measure: Respiratory symptoms score changes from baseline (3 days before treatment) to Day 14 under ETI
timeFrame: 17 days
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: Lebecque
Study officials:
affiliation: CHC Montlegia
name: Patrick Lebecque, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06260930: Value of Chest Ultrasonography in ILD Screening
Official title: Role od Chest Ultrasonography in Interstitial Lung Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Interstitial Lung Disease
Lead sponsor: Aswan University
Sponsor class: OTHER
First posted: 2024-02-15
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Eligible patients will be recruited from the Department of Chest, Aswan University Hospital

Brief summary: The main aim of this study is to detect the value of transthoracic ultrasonography in the diagnosis and assessment of ILDs in correlation to chest X- ray, blood gases, pulmonary function test and echocardiography and to compare it with high resolution CT (HRCT) as a golden diagnostic investigation.

Detailed description: Interstitial lung disease (ILD) refers to a group of disorders that are characterized by varying combinations of inflammation and fibrosis involving the space between the epithelial and endothelial basement membranes.

Eligibility criteria: Inclusion Criteria:

* Adults (≥18 years) diagnosed with ILD
* All patients must fulfil the 2018 criteria for HRCT chest finding for the diagnosis of Usual interstitial pneumonia (UIP) form

Exclusion Criteria:

* Patients with cardiac diseases (Left-sided Heart failure, pulmonary edema) \[they may have findings of multiple B lines on transthoracic ultrasound examination which mimic ILD findings\].
* Patients with chronic kidney diseases (as patients presented with nephrogenic pulmonary edema may have findings of multiple B lines on transthoracic ultrasound examination which mimic ILD findings).

Primary outcomes:
measure: Sensitivity and specificity of the lung sonography for interstitial lung disease screening
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
citation: Deconinck B, Verschakelen J, Coolen J, Verbeken E, Verleden G, Wuyts W. Diagnostic workup for diffuse parenchymal lung disease: schematic flowchart, literature review, and pitfalls. Lung. 2013 Feb;191(1):19-25. doi: 10.1007/s00408-012-9433-5. Epub 2012 Nov 13.