louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00984607: Measurement of Gastric Band Stoma Diameter
Official title: Accurate Fluoroscopic Measurement of Adjustable Laparoscopic Gastric Band Stoma Diameter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Keywords: Laparoscopic Gastric Band
LAP BAND system
Lead sponsor: Saint Raphael Healthcare System
Sponsor class: OTHER
First posted: 2009-09-25
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of this study is to correlate accurate fluoroscopic measurement of gastric band stoma diameter with patient symptoms for optimal band stoma adjustment. Administration of a barium tablet to gastric band patients with dilute liquid barium allows the accurate measurement of the band stoma diameter. The technique is quick, easy to perform, and eliminates magnification error intrinsic to fluoroscopy. The study data suggests the optimal calibrated gastric band stoma diameter is 3.0 mm. The accurate fluoroscopic measurement of gastric band stoma diameter can optimize band stoma adjustment and improve patient outcomes.

Detailed description: Ten patients presenting for an upper GI series with laparoscopically placed gastric bands were enrolled after informed consent. After a standard upper GI evaluation, oral administration of a standard 13 mm barium sulfate tablet was performed and swallowed with dilute liquid barium during fluoroscopic monitoring. A spot radiograph was obtained once the barium tablet was in the gastric pouch and the dilute liquid barium was passing through the gastric band stoma. Post-processing software used the longest radiographic dimension of the 13 mm barium tablet as the size reference to calibrate measurement of the gastric band stoma diameter.

Eligibility criteria: Inclusion Criteria:

* eating
* s/p LAP BAND placement

Exclusion Criteria:

* immediately post operative
* s/p LAP BAND placement
* significant abnormality found on preceding standard upper GI series

Primary outcomes:
measure: Correlate accurate fluoroscopic measurement of gastric band stoma diameter with patient symptoms for optimal band stoma adjustment.
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Hospital of Saint Raphael
state: Connecticut
Study officials:
affiliation: Hospital of Saint Raphael
name: Robert G Hayter, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04810507: MAGE of Anagliptin Compared With Sitagliptin With Type 2 Diabetes Mellitus
Official title: A Multi-center, Active Controlled, Randomized, Double-blinded, Parallel, Phase IV Study to Evaluate the Effect of Improving Glycemic Variability of Anagliptin Compared With Sitagliptin in Patients With Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 2 Diabetes
Lead sponsor: JW Pharmaceutical
Sponsor class: INDUSTRY
First posted: 2021-03-23
Enrollment: 89
Sex: ALL
Minimum age (years): 19
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A Multi-center, Active controlled, Randomized, Double-blinded, Parallel Study
Primary purpose: TREATMENT

Brief summary: An exploratory study to evaluate the Effect of Improving Glycemic Variability of Anagliptin Compared with Sitagliptin in Patients with Type 2 Diabetes Mellitus

Detailed description: This clinical trial is an exploratory study, and does not calculate the subject number based on statistical assumptions, and enrolls 50 subjects per group and a total of 100 subjects are registered to evaluate the effect of improving blood glucose variability in type 2 patients with anagliptin 100 mg twice a day(BID) and sitagliptin 100 mg once a day(QD).

Eligibility criteria: Inclusion Criteria:

* Type 2 DM
* Metformin monotherapy for more than 8 weeks and metformin ≥ 1000 mg daily for more than 8 weeks.
* 6.5% ≤HbA1c\< 8.5%
* Agreed Therapeutic Lifestyle change during the study period
* Obtained Informed Consent Form

Exclusion Criteria:

* Type 1 diabetes mellitus,
* History of intestinal obstruction
* NYHA class III to IV congestive heart failure,
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3 X upper limit of normal (ULN) or Total bilirubin \> 3 X ULN
* Creatinine clearance (CrCl)\* \< 50 mL/min
* Thyroid-stimulating hormone (TSH) ≥ 1.5 X ULN
* Allergic history for Anagliptin 또는 sitagliptin
* Being pregnant or nursing or suspected of being pregnant, or
* History of participation in other clinical studies in the preceding 3 months.

Primary outcomes:
measure: Effect of Improving Glycemic Variability
timeFrame: 3 days after 12 weeks treatment
Secondary outcomes:
measure: Average nighttime (18:00~07:59) blood glucose change after 12 weeks compared to baseline
timeFrame: after 12 weeks treatment
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Kangdong Sacred Heart Hospital
Study officials:
affiliation: JWPharmaceuticals
name: Jaewan Park
role: STUDY_DIRECTOR
References:
Clinical trial NCT05235607: Personalized Immune Cell Therapy Targeting Neoantigen of Malignant Solid Tumors
Official title: Personalized Immune Cell Therapy Targeting Neoantigen of Malignant Solid Tumors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Carcinoma
Melanoma
Bladder Cancer
Colorectal Cancer
Keywords: Melanoma
Bladder Cancer
Colorectal Cancer
tumor neo-antigen DC vaccine
safety
clinical efficacy
Lead sponsor: Sichuan University
Sponsor class: OTHER
First posted: 2022-02-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This single center, single arm and prospective study aimed to establish gene mutation database and select the neoantigens in patients with advanced malignant melanoma, bladder cancer and colorectal cancer. Then, we intended to explore the safety and efficacy of individual tumor antigen-sensitized DC vaccine and their sensitized T cells in these solid cancers.


Eligibility criteria: Inclusion Criteria:

* Age:18-75 years
* Pathologically diagnosed advanced (stage IV) malignant melanoma, bladder cancer or colorectal cancer with measurable lesions;
* Failed in the previous standard therapy;
* ECOG PS (Eastern Cooperative Oncology Group performance status) score 0-2 points;
* The estimated survival period is ≥3 months;
* Rehabilitate from previous therapy;
* Adequate organ functions;
* Patient's written informed consent;

Exclusion Criteria:

* Tumor emergencies;
* Abnormal coagulation function;
* Contagious diseases, such as HIV, HBV, HCV infection;
* Mental disorders;
* Concomitant tumors;
* Immunological co-morbidities

Primary outcomes:
measure: Number of participants with treatment-related adverse events as events as assessed by CTCAE v4.0
timeFrame: 3 months after the last administration of cells
Secondary outcomes:
measure: Number of participants with Overall survival as assessed by RECIST1.1
timeFrame: through study completion, an average of 1 year
Other outcomes:
Locations:
city: Chengdu
country: China
facility: West China Hospital
state: Sichuan
Study officials:
affiliation: Sichuan University
name: Ji-Yan Liu
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06665607: Foot Muscles Training in Sclerosis
Official title: Effects of Intrinsic Foot Muscles Training in Improving Stability in Multiple Sclerosis Patients
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Multiple Sclerosis
Muscle Weakness
Training Group, Sensitivity
Lead sponsor: University of Salamanca
Sponsor class: OTHER
First posted: 2024-10-30
Enrollment: 34
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study tries to assess the efficacy of an 8-week IFM training programme on stability in patients diagnosed with Multiple Sclerosis


Eligibility criteria: Inclusion Criteria:

* Patients with moderate neurological disability as scored by the Expanded Disability Status Scale (EDSS), ranging from 3.0 to 6.0

Exclusion Criteria:

* Cognitive disturbances that could affect the performance of any of the tests or questionnaires included in the study
* Diagnosis of visual or vestibular disorders that could affect patient stability
* Change in Multiple Sclerosis-specific medication in the 2 months prior to the start of the study
* Acute relapse in the 2 months prior to the start of the study
* Traumatologic or orthopaedic disorders that could negatively affect balance.

Primary outcomes:
measure: Four Square Step Test (FSST): dynamic stability assessment test.
timeFrame: Initial and after 8 weeks
measure: Six Spot Step Test (SSST): test that quantitatively assesses lower limb function
timeFrame: Initial and after 8 weeks
measure: The Frailty and Injuries: Cooperative Studies of Intervention Tecnhiques (FICSIT-4 test): Test of static balance
timeFrame: 0-9 points. Initial and after 8 weeks
measure: Activities-specific Balance Confidence scale (AsBC)
timeFrame: Initial and after 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: Universidad de Valladolid
Study officials:
References:
Clinical trial NCT06700707: Turkish Adaptation, Validity and Reliability Study of the Athlete Disability Index Questionnaire
Official title: Turkish Adaptation, Validity and Reliability Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Low Back Pain
Disability
Athlete
Sport
Lead sponsor: Medipol University
Sponsor class: OTHER
First posted: 2024-11-22
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Male and female elite athletes from different sports with low back pain

Brief summary: This survey study aims to analyze the cultural adaptation, validity, and reliability of a scale originally in English and currently being translated into Turkish, which allows athletes with low back pain to assess their functional disabilities in sports and exercise activities as well as their disabilities in daily living activities. Athletes with low back pain will be asked to fill out 3 questionnaires.

Detailed description: In the study, firstly, the translation of the Athlete Disability Index Questionnaire (ADI) into the target language, comparison of the two translated versions of the scale, back translation of the preliminary version, synthesis, pilot test of the pre-final version and psychometric test studies will be carried out by 3 independent translators and 2 linguists in 6 stages.

Then, 120 athletes with low back pain will be asked to fill out the ADI, Roland Morris Disability Questionnaire (RMDQ) and Oswestry Low Back Pain Disability Index (ODI). 7 days later, the ADI will be filled out again by 60 athletes.

After the surveys are completed, the structural validity of the scale will be tested, and reliability will be measured by performing test-retest reliability and internal consistency analyses.

Eligibility criteria: Inclusion Criteria:

* Low back pain that has persisted for at least 6 weeks
* Pain that worsens with changes in posture, movement, or physical activity
* Elite athletes with a regular training/match schedule of more than 10 hours per week

Exclusion Criteria:

* Not knowing Turkish
* Acute inflammatory conditions
* Acute musculoskeletal trauma
* Long-term corticosteroid use

Primary outcomes:
measure: Athlete Disability Index Questionnaire (ADI)
timeFrame: 7 days
Secondary outcomes:
measure: Oswestry Low Back Pain Disability Index (ODI)
timeFrame: 1 day
measure: Roland Morris Disability Questionnaire (RMDQ)
timeFrame: 1 day
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Gülay Aras Bayram
state: Beykoz
Study officials:
affiliation: Medipol University
name: Gülay Aras Bayram, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zamani E, Kordi R, Nourian R, Noorian N, Memari AH, Shariati M. Low back pain functional disability in athletes; conceptualization and initial development of a questionnaire. Asian J Sports Med. 2014 Dec;5(4):e24281. doi: 10.5812/asjsm.24281. Epub 2014 Nov 10.
Clinical trial NCT02384707: Master Allergen Child Nutrition. Reintroduction of Small Doses
Official title: Reintroduction of Small Doses of Food in Allergic Children to Lightening the Elimination Diet.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Food Allergies
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2015-03-10
Enrollment: 400
Sex: ALL
Minimum age (years): 9
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: Reintroduction of small doses of food in allergic children to lightening the elimination diet.

Detailed description: In four groups of allergic children (peanuts, wheat , milk and egg), a reintroduction of 4 small increasing doses of allergen is carried out progressively double-blind placebo- cons , randomized, during a hospitalization.

The procedure for reintroduction of small doses (MPD) is stopped at the appearance of intolerance (in taking a dose of allergen or placebo) defined by the onset of allergic symptoms or objective severe abdominal pain within 45 minutes of taking.

Eligibility criteria: Inclusion Criteria:

* Allergic children 1 and 16 years for peanut, egg and wheat. So, for milk between 9 months and 16 years.
* Accurate diagnostic
* Allergic react rapidly and acute

Exclusion Criteria:

* severe disease

Primary outcomes:
measure: Tolerance for each ingested dose is assessed by a clinical score
timeFrame: 45 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Angers
country: France
facility: Denise Jolivot
state: Pays de Loire
Study officials:
affiliation: University Hospital, Angers
name: Martine Drouet
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00434707: Outcome of Small Pupil Phacotrabeculectomy in Persons With Glaucoma and Cataract
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Glaucoma
Cataract
Keywords: glaucoma
catarat
small pupils
Lead sponsor: Aravind Medical Research Foundation
Sponsor class: OTHER
First posted: 2007-02-13
Enrollment: 70
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: OTHER

Brief summary: Small pupils are not uncommon in situations requiring surgical intervention for glaucoma and cataract. Inadequate binocular view during combined trabeculaectomy and glaucoma surgery needs to be overcome by additional iris manupulations to dilate the pupils which increase the liklihood of inflammation, inraocular pressure rise after surgery and enhnced liklihood of failure of glaucoma surgery. The proposed trial is an observational study to analyse post operative outcome of eyes undrgoing trabeculectomy and phacoemulsification with intraocular lens implantation with small pupils in persons with glaucoma coexisting with cataract.

Detailed description: Small pupils are not uncommon in situations requiring surgical intervention for glaucoma and cataract. Inadequate binocular view during combined trabeculaectomy and glaucoma surgery needs to be overcome by additional iris manupulations to dilate the pupils which increase the liklihood of inflammation, inraocular pressure rise after surgery and enhnced liklihood of failure of glaucoma surgery. The proposed trial is an observational study to analyse post operative outcome of eyes undrgoing trabeculectomy and phacoemulsification with intraocular lens implantation with small pupils in persons with glaucoma coexisting with cataract

Eligibility criteria: Inclusion Criteria:

* Individuals with visually significant cataracts and medically uncontrolled primary open angle, angle clsoure, exfolaitive glaucoma

Exclusion Criteria:

* Complicated catracts and secondary glaucoma

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Aravind Eye Hospital
name: Ramasami Krishnadas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02926807: Trial on Vascular Inflammation in Atopic Dermatitis
Official title: Vascular Inflammation and Coronary Atherosclerosis Risks in Subjects With Atopic Dermatitis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atopic Dermatitis
Vascular Inflammation
Coronary Atherosclerosis
Keywords: Atopic Dermatitis
Vascular Inflammation
Coronary Atherosclerosis
Ascending aorta
Pet scan
Lead sponsor: Innovaderm Research Inc.
Sponsor class: OTHER
Collaborators: name: Montreal Heart Institute
name: Icahn School of Medicine at Mount Sinai
First posted: 2016-10-06
Enrollment: 57
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Approximately 30 subjects with atopic dermatitis and 30 subjects without AD will be included in this study.

Brief summary: A total of 30 subjects with moderate to severe atopic dermatitis. Thirty subjects without AD matched for sex, age and coronary artery disease risk factor with the AD subjects will also be included. All subjects will undergo the following imaging procedures: a 18FDG-PET to quantify vascular inflammation in the ascending aorta and carotids and a MDCT to calculate the Agatston score. Skin and blood biomarkers will also be assessed.


Eligibility criteria: Main inclusion Criteria:

* Men or women
* 18 years of age or older at time of consent.
* For AD subjects only: Confirmed clinical diagnosis of active AD according to Hanifin and Rajka criteria, BSA, EASI and IGA.
* For AD subjects only: Diagnosis of atopic dermatitis for at least 5 years.
* Women of childbearing potential is willing to use effective contraceptive method.
* Women of childbearing potential must have a negative urine pregnancy test.

Main exclusion Criteria:

* Has known cardiovascular arterial disease, a pacemaker, psoriasis, uncontrolled diabetes.
* Presence of an unstable co-morbidity that could have an effect on vascular inflammation.
* Heart rate restriction for patients with asthma or COPD.
* Use of any topical medication for atopic dermatitis on the site to be biopsied.
* Use of systemic treatments for atopic dermatitis.
* Use of phototherapy, tanning booth or other ultraviolet light sources.
* Use of biologics.
* Use of experimental medications.

Primary outcomes:
measure: Target to background ratio (TBR) from the ascending aorta
timeFrame: 0 Days
Secondary outcomes:
measure: Target to background ratio (TBR) from the carotids
timeFrame: 0 Days
measure: Agatston score
timeFrame: 0 Days
Other outcomes:
measure: Correlation between target to background ratio (TBR) and biomarkers, AD severity measurements (EASI, BSA, IGA and SCORAD), endothelial cell-derived micro particles.
timeFrame: 0 Days
Locations:
city: Montreal
country: Canada
facility: Innovaderm Research Inc
state: Quebec
Study officials:
affiliation: Innovaderm Research clinical site
name: Innovaderm Research clinical site
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05274607: Pneumonia and Empyema in Emergency Departments in Children
Official title: French Epidemiological Pediatric Study on Pneumonia and Empyema in Emergency Departments in Children 1 Month to 15 Years
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pneumonia
Pleural Effusion
Keywords: children
pneumococcal conjugate vaccine
Lead sponsor: Association Clinique Thérapeutique Infantile du val de Marne
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2022-03-10
Enrollment: 20000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 15
Standard ages: CHILD
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Hospitalized children presenting with pneumonia or pleural effusion

Brief summary: Describe the epidemiology of hospitalized pediatric pneumonia and pneumonia with pleural effusion: frequency, clinical and biological characteristics, responsible bacteria and pneumococcus place, antibiotic resistance, treatment, vaccine status.

Detailed description: The pneumonia observatory began in June 2009 and has included more than 15,000 children with pneumonia or pneumonia with pleural effusion (hospitalized or not) until May 2019. This study led to the publication of many articles in international peer-reviewed journals. Since June 2019, the scientific committee of the study met at the ESPID congress has decided to include only hospitalized patients. This amendment is justified for three reasons:

* Change in criteria for diagnosing pneumonia with increasing use of chest ultrasound
* Logistical aspects and workload of investigating centers too important
* Long-term impact of pneumococcal vaccine 13-valent especially marked for the most severe cases In this context, the purpose of this amended study is to enroll only the most severe cases of pneumonia, i.e. requiring hospitalization, in ICU or not. Since this study began in 2009, we have already enrolled hospitalized cases, we will have a baseline prior to the introduction of third-generation PCVs (pneumococcal conjugate vaccines) and we will be able to continue monitoring with data since 2009.

Eligibility criteria: Inclusion Criteria:

* ages between 1 month and 15 years
* presence of parenchymatous condensation and/or pleural effusion on chest x-rays and/or ultrasounds and/or CT scans
* fever ≥38.5 °C if age ≥3 months since the onset of symptoms or ≥38 °C if the child is less than 3 months old.
* Hospitalization

Exclusion Criteria:

* Refusal of participation by the patient, his or her relative or legal representative (depending on the situation)

Primary outcomes:
measure: Epidemiology of hospitalized pediatric pneumonia and pneumonia with pleural effusion
timeFrame: 15 years
Secondary outcomes:
measure: Impact of pneumococcal conjugate vaccines
timeFrame: 15 years
measure: Treatments
timeFrame: 15 years
Other outcomes:
Locations:
city: Créteil
country: France
facility: ACTIV
Study officials:
affiliation: Groupe de Pathologies Infectieuses Pédiatriques (GPIP)
name: Robert Cohen, MD
role: STUDY_DIRECTOR
References: