louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02340143: Assessing Early Behavioral Indicators of Formula Tolerance
Official title: Assessing Early Behavioral Indicators of Formula Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tolerance
Lead sponsor: Mead Johnson Nutrition
Sponsor class: INDUSTRY
Collaborators: name: Baylor College of Medicine
First posted: 2015-01-16
Enrollment: 71
Sex: ALL
Minimum age (years): 14
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL

Brief summary: The study is intended to assess the amount of crying and fussiness in infants fed an infant formula containing probiotics.


Eligibility criteria: Inclusion Criteria:

* Singleton at birth
* Term infant with birth weight of 2500 g or more
* Crying or fussing for 3 or more hours per day
* Consuming mostly infant formula
* Signed Informed Consent and Protected Health Information authorization

Exclusion Criteria:

* Current use of extensively hydrolyzed or amino acid infant formula
* Planned use of probiotics during the study
* History of underlying metabolic or chronic disease, congenital malformation, or immunocompromised
* Enrollment in another interventional clinical research study

Primary outcomes:
measure: Infant Behavior Diary
timeFrame: 21 Days
Secondary outcomes:
measure: Recall of Tolerance Questionnaire
timeFrame: Baseline and Day 21
measure: Body Weight
timeFrame: Baseline and Day 21
measure: Infant Behavior Questionnaire - Revised
timeFrame: Baseline and Day 21
measure: Recall of formula intake at each visit
timeFrame: Baseline, Day 10, and Day 18
measure: Fecal microbiome and Fecal calprotectin
timeFrame: Baseline and Day 21
measure: Medically-confirmed Adverse Events
timeFrame: 21 Days
Other outcomes:
Locations:
city: Houston
country: United States
facility: Children's Nutrition Research Center
state: Texas
Study officials:
affiliation: Mead Johnson Nutrition
name: Carol Lynn Berseth, M.D.
role: STUDY_DIRECTOR
References:
citation: Shulman RJ, Chichlowski M, Orozco FG, Harris CL, Wampler JL, Bokulich NA, Berseth CL. Infant behavioral state and stool microbiome in infants receiving Lactocaseibacillus rhamnosus GG in formula: randomized controlled trial. BMC Pediatr. 2022 Oct 7;22(1):580. doi: 10.1186/s12887-022-03647-x.
Clinical trial NCT02082743: Vision Care Intervention for Lower Grade School Children in Taiwan
Official title: Intervention Program for Vision Care in Lower Grade Schoolchildren
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Outdoor Activity
Policy of Recess Outside Classroom
Keywords: Myopia
Outdoor activity
Recess outside classroom
Lead sponsor: Chang Gung Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Ministry of Health and Welfare, Taiwan
First posted: 2014-03-10
Enrollment: 1020
Sex: ALL
Minimum age (years): 6
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is making use of school policy- recess outside classroom (ROC7-11) for increasing the time spent outdoor during recess and encouraging children spent time outdoor up to 11 hours in each week to investigate the vision change, myopia onset and progression in these schoolchildren.


Eligibility criteria: Inclusion Criteria:

All the students in Grade 1

Exclusion Criteria:

No

Primary outcomes:
measure: Cycloplegic refraction
timeFrame: 1 year
Secondary outcomes:
measure: Axial length
timeFrame: 1 year
Other outcomes:
measure: data from light meter recorder
timeFrame: 1 week
measure: questionnaire
timeFrame: 1 week
Locations:
city: Kaohsiung
country: Taiwan
facility: Department of Ophthamology, Kaohsiung Chang Gung Memorial Hospital and Chang Gung university College of Medicine
Study officials:
References:
Clinical trial NCT01671943: Cryotherapy for Breast Cancer Trial
Official title: Evaluation of Safety and Feasibility of ICE-SENSE3TM , a Cryotherapy Device for Office-based Ultrasound- Guided Treatment of Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Carcinoma
Keywords: small malignant invasive breast tumors
Lead sponsor: IceCure Medical Ltd.
Sponsor class: INDUSTRY
First posted: 2012-08-24
Enrollment: 4
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the clinical feasibility and safety of the ICESENSE3TM cryotherapy system for the ablation of small malignant invasive breast tumors.


Eligibility criteria: Inclusion Criteria:

* Unifocal primary invasive ductal breast carcinoma diagnosed by core needle biopsy. Patients with contralateral disease will remain eligible. Note: Results of ER, PR, HER-2/neu must be obtained on pre-registration needle core biopsy material.
* Tumor size ≤ 2.0 cm in greatest diameter as measured by breast ultrasound, MRI and mammogram. The largest dimension measured will be used to determine eligibility.
* Tumor enhancement on MRI
* Tumor with \<25% intraductal components in the aggregate.
* Non-pregnant and non-lactating patients. Patients of childbearing potential must have a negative serum or urine pregnancy test. NOTE: Peri-menopausal women must be amenorrheic for \> 12 months to be considered not of childbearing potential.
* Adequate breast size for safe cryoablation. Patients with breasts too small to allow safe cryoablation are not eligible as the minimal thickness of the breast tissue does not lend itself to cryoablation. NOTE: The minimal distance of tumor margins from the breast skin should be analogous to the surgical margins of a lumpectomy.

Exclusion Criteria:

* Patients with multifocal and/or multicentric ipsilateral breast cancer, multifocal calcifications, or evidence of excessive DCIS.
* History of rotational vacuum assisted core biopsies, en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer.
* Prior or planned neoadjuvant chemotherapy for breast cancer.
* Patients with thrombocytopenia and or any other coagulation abnormality

Primary outcomes:
measure: The rate of complete tumor ablation in patients treated with cryoablation, with complete tumor ablation defined as no remaining invasive or in-situ carcinoma present upon pathological examination of the surgical resection specimen
timeFrame: One month
Secondary outcomes:
measure: Adverse events
timeFrame: One month
measure: Pain assessment
timeFrame: One month
Other outcomes:
Locations:
city: Prague
country: Czech Republic
facility: Oncogynecological Center, Department of Obstetrics and Gynecology, First Faculty of Medicine, Charles University in Prague and General University Hospital in Prague Prague, Czech Republic
Study officials:
name: David Pavlista, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05679843: Clinical Characteristics and Prognosis of STEMI Patients Undergoing Primary Percutaneous Coronary Angioplasty and Angiographic Data
Official title: Characteristics and Prognosis of STEMI Patients Undergoing Primary PCI According to Coronary Occlusion Physiopathogeny and/or Atherosclerotic Burden
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: STEMI - ST Elevation Myocardial Infarction
Keywords: STEMI, Gensini,
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-01-11
Enrollment: 3000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with STEMI underwent primary PCI within 24 hours after first symptoms in our hospital

Brief summary: Gensini score (GS) provides valuable information on severity and prognosis of coronary artery disease (CAD). We aim to evaluate the relationship between the severity of CAD determined by the GS and short and long term of ST-elevation myocardial infarction (STEMI) patients undergoing primary percutaneous coronary intervention.


Eligibility criteria: Inclusion Criteria:

* Patients with STEMI underwent primary PCI within 24 hours after first symptoms

Exclusion Criteria:

Patients with STEMI 24 hours after first symptoms Pregnant patient \<18 years old

Primary outcomes:
measure: Composite outcome including all cause death and re myocardial infarction
timeFrame: 6 years
Secondary outcomes:
measure: ST resolution on ECG after primary PCI
timeFrame: 1 hour
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02899143: Short-course Antimicrobial Therapy in Sepsis
Official title: Trial of Short-Course Antimicrobial Therapy for Sepsis in Intensive Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Infection
Sepsis
Severe Sepsis
Septic Shock
Lead sponsor: Ospedale Santa Maria delle Croci
Sponsor class: OTHER
First posted: 2016-09-14
Enrollment: 320
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effect of a short course antimicrobial therapy (5-days) versus a 10-days therapy on sepsis-related organ dysfunction.


Eligibility criteria: Inclusion Criteria:

* Patients who received antibiotics for presumed infection

Exclusion Criteria:

* Prolonged therapy (eg, endocarditis)
* Severe immunosuppression
* Severe infections (due to viruses, parasites, or Mycobacterium tuberculosis)
* Patients previously infected or colonized with multidrug resistant pathogens and moribund patients.

Primary outcomes:
measure: sepsis-related organ dysfunction
timeFrame: 14-days
Secondary outcomes:
measure: Hospital mortality
timeFrame: 30-days
Other outcomes:
Locations:
city: Lugo
country: Italy
facility: Ospedale Umberto I
state: Ravenna
city: Cuneo
country: Italy
facility: Azienda Ospedaliera S.Croce e Carle - Ospedale S.Croce
city: Milano
country: Italy
facility: ASST Fatebenefratelli Sacco
city: Ravenna
country: Italy
facility: Ospedale Santa Maria Delle Croci
Study officials:
affiliation: Ospedale Santa Maria Delle Croci, Ravenna, AUSL Romagna
name: Vincenzo De Santis
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01853943: Hand Grip Test and Transradial Coronary Procedures
Official title: Hand Grip Test After Transradial Percutaneous Coronary Procedures
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Radial Artery Occlusion
Keywords: Transradial approach
radial occlusion
hand grip
coronary angiography
Lead sponsor: Ospedale Sandro Pertini, Roma
Sponsor class: OTHER
First posted: 2013-05-15
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stable patients who undergo elective percutaneous transradial coronary procedures

Brief summary: Transradial coronary procedures are gaining in popularity worldwide. A possible complication of transradial approach is the occlusion of the radial artery that in most cases is asymptomatic. However the investigators do not know if the radial artery occlusion may impact over the muscle force of the hand or fingers.

To evaluate if transradial approach for percutaneous coronary procedures may affect muscle force of the hand, thumb and index finger the investigators use a standardized hand-grip manometer and a pinch gauge before the transradial procedure, the day after the procedures and after few months.


Eligibility criteria: Inclusion Criteria:

Stable patients who undergo elective percutaneous transradial coronary procedures

Exclusion Criteria:

* hemodynamic instability,
* acute coronary syndromes,
* haemodialysis patients with an arteriovenous fistula,
* sheath diameter \> 6 French,
* age \< 18 years

Primary outcomes:
measure: Hand grip strength
timeFrame: 3 months
Secondary outcomes:
measure: Radial occlusion
timeFrame: 3 months
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Ospedale Sandro Pertini - ASL RMB
Study officials:
affiliation: Ospedale Sandro Pertini - ASL RMB
name: Alessandro Sciahbasi, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01850043: The Epidemiology of TST Change in Korea
Official title: The Trend of Tuberculin Skin Test in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tuberculosis
Latent Tuberculosis
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2013-05-09
Enrollment: 5552
Sex: MALE
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: ECOLOGIC_OR_COMMUNITY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A term of whole military conscripts per year

Brief summary: TST will be analyzed in young general population in Korea. Young adults undertake TST as CDC recommendation. Participants with chest radiograph showing active TB lesion are excluded from this study.

Detailed description: Enroll criteria

* A term of whole military conscripts per year in one Reserve Force Battalion
* Military conscripts gather from all around area in Korea randomly
* Each participant undertake a chest X-ray (CXR) and blood tests including human immunodeficiency virus (HIV) at the start of initiatory training.

Exclusion Criteria

* Chest X-ray suggesting active TB
* HIV positive in serology

Design

* After giving informed consent, all participants receive one-step TST following standard procedures.
* The largest transverse diameter of induration is measured 48-72hr after injection.
* The investigator and these trained nurses were blinded to the status of their demographic characteristics.

Eligibility criteria: Inclusion Criteria:

* Military Conscripts age 18-29 years old

Exclusion Criteria:

* Chest X-ray suggests active TB
* Positive HIV in serology

Primary outcomes:
measure: TST positivity TST rate
timeFrame: Two days after tuberculin injection
Secondary outcomes:
measure: BCG scar rates
timeFrame: The day of tuberculin injection
Other outcomes:
Locations:
city: Osong
country: Korea, Republic of
facility: The Korean Institute of Tuberculosis
state: Chungcheongbuk-Do
Study officials:
affiliation: The Korean Institute of Tuberculosis
name: HeeJin Kim, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02877043: Study of the Quality of Lung Resection
Official title: Measurement of the Quality: Application to Lung Resection for Cancer Using a National PMSI Database
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchial Cancer
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-08-24
Enrollment: 72000
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: patients undergoing lung resection

Brief summary: In 2009, centres that carried out lung resection for cancer were required to obtain authorization following the first cancer plan. One of the criteria to obtain authorization was the volume of activity: the centre had to carry out at least 30 lung resections per year for cancer. Five years later, it would be useful to know the impact of this new organization of oncology on the quality of care. To answer this question, the PMSI database is an ideal source of an indicator of quality: in-hospital mortality. This observational cohort study will be conducted using the national PMSI database with data covering the period from 1st January 2005 to 31st December 2013. It will be limited to hospitalization for lung resection. The time will be divided into 3 periods: 2005-2007, 2008-2010 and 2011-2013; the period 2008-2010 includes the implementation of authorizations for cancer surgery.


Eligibility criteria: Inclusion Criteria:

Any patients who underwent lung resection for bronchial cancer will be included in this study. The PMSI (Programme de Médicalisation des Systèmes d'Information) database will be searched for all patients with:

* A principal diagnosis of ICD10 (international classification of diseases) codes for bronchial cancer
* And CCAM (Classification Commune des Actes médicaux ) procedure codes for lung resection (segmentectomy, lobectomy, pneumonectomy).

Exclusion Criteria:

* none

Primary outcomes:
measure: number of deaths during hospitalization
timeFrame: 9 years
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT05949138: Clinical Data Collection and Evaluation of ECG-Less Cardiac CT
Official title: Clinical Data Collection and Evaluation of ECG-Less Cardiac CT
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac CT
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
Collaborators: name: University of Chicago
name: University of Washington
First posted: 2023-07-17
Enrollment: 56
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: The subject population will consist of adults that are 18-years of age or older, and who are scheduled for a clinically indicated cardiac CT exam that will include contrast administration.

Brief summary: The primary objective of this study is to collect CT scan data without ECG-leads attached to the human subject. This data is intended to represent a typical range of clinical scenarios in which Cardiac CT imaging is used.

Detailed description: Data collected in this study will be used for technology development, scientific evaluation, marketing and education, and regulatory submissions for future products. This is a pre-market, prospective, open-label, non-randomized, single arm data collection clinical study conducted at one site in the United States of America.

Eligibility criteria: Inclusion Criteria:

Subjects may be included in this study if they meet the following criteria:

1. Who are 18 year of age or older;
2. Able to sign and date the informed consent form; AND
3. Who are scheduled for a clinical-indicated Cardiac CT exam that will include contrast administration.

Exclusion Criteria:

Subjects may be excluded from participating in study if they meet any of the following criteria:

1. Who are pregnant or lactating;
2. Who were previously enrolled in this study;
3. Anyone with known or suspected allergy to iodinated contrast agents;
4. Anyone with known or suspected renal insufficiency as determined by site medical personnel;
5. Who are scheduled for a CT cardiac calcium scoring test;
6. Who are in need of urgent or emergent care;
7. Who have any conditions that, in the opinion of the PI or designee, would interfere with the evaluation of the results or constitute a health hazard for the subject; AND
8. Who are unwilling to have GEHC personnel present for the CT exam.

Primary outcomes:
measure: Data Collection
timeFrame: Through study completion, an average of 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago
state: Illinois
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: GE Healthcare
name: Kayla Matcheck
role: STUDY_DIRECTOR
References:
Clinical trial NCT00327938: Genetic Variation - The Need for Opioids During Surgery
Official title: Genetically Variation - May the Need of Opioids During Surgery be Known Beforehand by Giving Noxious Stimulation and Measure the Skin Conductance Response Before Surgery?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Remifentanil
Skin Conductance
Anesthesia
Analgesics, Opioid
Lead sponsor: Rikshospitalet University Hospital
Sponsor class: OTHER
First posted: 2006-05-19
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to find out if the tetanic noxious stimuli and the measured skin conductance response can be used as a test in patients before surgery to have an indication about what amount of analgesics the patient will need during surgery.

Detailed description: Skin Conductance (SC) shows the emotional state as reflected in changes in the sympathetic nervous system. During sleep or other states of low basic sympathetic activity, activation of the sympathetic nervous system results in filling of the palmar and plantar sweat glands, and the SC increases transiently before the sweat is removed and the SC decreases again. When a short lasting outgoing sympathetic nervous burst occurs, fluctuations of SC will follow. An increase in the number of SC fluctuations (NSCF) can therefore be interpreted as increased activity in this part of the sympathetic nervous system. When remifentanil, an opioid analgetic is given, NSCF is reduced.

Genetic variation influences the pharmacokinetics and the pharmacodynamics of analgesics like morphine derivates and remifentanil. 50 female patients will therefore be blood tested to study if they are Val/Val or Met/Met for the COMT gene, or if they are homozygous or heterozygous for the 118G allele and the 118A allele.

This study will show if skin conductance can be used to measure noxious stimulation response before surgery (by giving a tetanic stimuli), and then predict what level of analgesic a patient will need during surgery.

Eligibility criteria: Inclusion Criteria:

* Women in American Society of Anesthesiologists (ASA) group 1-2 and with body mass index between 20 and 30 and going through laparoscopic surgery at the Gynecological Department, Ullevål University Hospital.
* Normal renal and hepar function (serum albumin and serum creatinine should be within the normal limit).

Exclusion Criteria:

* Chronic pain in the last 6 months or recent use and abuse of analgesics.

Primary outcomes:
measure: skin conductance response
Secondary outcomes:
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Ulleval University Hospital
Study officials:
affiliation: Rikshospitalet University Hospital
name: Hanne Storm, PhD
role: STUDY_DIRECTOR
References: