louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02161250: Effects of Resistant Starch in a Beverage on Post-prandial Glycemic and Insulinemic Responses
Official title: Effects of Resistant Starch in a Beverage on Post-prandial Glycemic and Insulinemic Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hyperglycemia, Diabetes, and Obesity
Lead sponsor: Purdue University
Sponsor class: OTHER
Collaborators: name: Ingredion Incorporated
First posted: 2014-06-11
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 29
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief summary: Hypothesis: A beverage with a resistant starch will blunt and sustain the post-prandial rise in blood glucose and insulin concentrations compared to beverage with maltodextrin (an easily digested carbohydrate).

Detailed description: * About two-thirds of adults in the United States are overweight or obese which can cause adverse health consequences for those individuals. Post-prandial hyperglycemia is one of these possible consequences and is associated with a higher risk for Type 2 Diabetes. Controlling hyperglycemia is important in the prevention of the onset of diabetes and obesity. Resistant starch is a dietary carbohydrate which is not completely digested in the gut and produces energy for the body to use. The investigators are interested in assessing the effects of resistant starch on postprandial blood glucose and insulin concentrations.
* Aim: To assess the effects of a resistant starch on post-prandial blood glucose and insulin concentrations.
* Hypothesis: A beverage with a resistant starch will blunt and sustain the post-prandial rise in blood glucose and insulin concentrations compared to a beverage with maltodextrin (an easily digested carbohydrate).

Eligibility criteria: Inclusion Criteria:

* Thirty healthy men and women (aged 18-29y) will be recruited from the greater Lafayette, IN region with the expectation that ≥20 subjects will complete the study. Subjects must weigh \>110 pounds, with a BMI between 20.0 and 29.9.

Exclusion Criteria:

* Weight change \> 3kg in the past 3 months
* Exercising vigorously over the past 3 months as well as no exercise 3 days prior to testing day
* Intestinal disorders including lipid mal-absorption or lactose intolerance
* Abnormal liver or kidney function tests; fasting blood glucose \>100mg/dL
* Smoking
* Drinking more than 2 alcoholic drinks per day
* Taking lipid-lowering medications or dietary supplements affecting plasma cholesterol concentration.
* Subjects must not be pregnant or lactating.

Primary outcomes:
measure: resistant starch effects
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
affiliation: Purdue University
name: Wayne Campbell, Phd
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01426750: Enteral Nutrition Support in Children and Adolescents With Cancer
Official title: Enteral Nutrition Support in Children and Adolescents With Cancer: a Non-randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Malnutrition
Cancer
Keywords: Nutritional support.
Cancer.
Malnutrition.
Child.
Adolescent
Lead sponsor: Grupo de Apoio ao Adolescente e a Crianca com Cancer
Sponsor class: OTHER
First posted: 2011-08-31
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: CONTEXT AND OBJECTIVE: Tumor and its therapy have adverse effects on the nutritional status of cancer patients, leading to nutritional support. The aim was to study enteral nutrition indications, as well as its compliance and the impact on nutritional status.

DESIGN AND SETTING: Clinical trial, IOP, Unifesp-EPM. METHODS: Patients older than 1 year followed during anticancer therapy were included from January 2002 to January 2004. They received industrialized oral supplementation - Nutren 1.0 or Jr (IOS) and were followed on a weekly basis and reevaluated on weeks 3, 8 and 12: at these times, if inadequate outcome was observed, tube feeding with the same supplement (TFR) was indicated.


Eligibility criteria: Inclusion Criteria:

* Were chemotherapy, age above one year and malnutrition
* A z-score of weight for height (zW/H) \< -1.0 to -2.0 in children26 and ≥ 5th to \< 15th of body mass index (BMI) in adolescents 27 were considered as mild malnutrition
* A zW/H \< -2.0 in children and \< 5th of BMI in adolescents as severe, respectively.28 In adults, the World Health Organization (WHO)29 cut-off values were applied: \< 18.5 mild and \< 17 severe malnutrition.

Exclusion Criteria:

* Were corticosteroid or hormonal therapy
* Swallowing abnormalities
* Parenteral or tube feeding therapy
* Palliative care and presence of non cancer-related diseases.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01914250: Pain Associated With Neonatal Frenotomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain
Keywords: Frenotomy
Pain
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2013-08-02
Enrollment: 40
Sex: ALL
Maximum age (years): 8
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The present study sought to examine the efficacy of two oral anesthetic drugs in reducing the pain associated with neonatal frenotomy.


Eligibility criteria: Inclusion Criteria:

infants diagnosed with ankyloglossia at the nursery of the RHCC, who will be referred by a qualified neonatologist to the OCAD for a routine tongue-tie frenotomy procedure because of breast feeding difficulties.

* Ankyloglossia type 1 or 2 Exclusion criteria
* Abnormal oral or nasopharyngeal anatomy
* Any known congenital malformations
* Ankyloglossia type 3 or 4

Exclusion Criteria:

-

Primary outcomes:
measure: Neonatal Facial Coding System (NFCS)
timeFrame: During procesure
Secondary outcomes:
measure: Cry Duration
timeFrame: Post procedure
Other outcomes:
measure: Visual Analog Score (VAS)
timeFrame: During procedure
Locations:
city: Haifa
country: Israel
facility: Rambam HealthCare Campus
Study officials:
affiliation: Chairman Craniofecial Department, Rambam Medical Center
name: Dror - Aizenbud, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Shavit I, Peri-Front Y, Rosen-Walther A, Grunau RE, Neuman G, Nachmani O, Koren G, Aizenbud D. A Randomized Trial to Evaluate the Effect of Two Topical Anesthetics on Pain Response During Frenotomy in Young Infants. Pain Med. 2017 Feb 1;18(2):356-362. doi: 10.1093/pm/pnw097.
Clinical trial NCT01383850: NCPAP + Heliox as a Treatment for Infant Respiratory Distress Syndrome (RDS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Distress Syndrome
Bronchopulmonary Dysplasia
Keywords: preterm infants
nasal continuous positive airway pressure
heliox
bronchopulmonary dysplasia.
Lead sponsor: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
Sponsor class: OTHER
First posted: 2011-06-28
Enrollment: 51
Sex: ALL
Minimum age (years): 28
Maximum age (years): 32
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Infants born between 28 and 32 weeks' gestation with radiological findings and clinical symptoms of moderate RDS, requiring respiratory support with Nasal Continuous Positive Airway Pressure (NCPAP) within the first hour of life, were randomized to receive either standard medical air or a Heliox/Oxygen mixture 80/20 (Heliox) during the first 12 hours of life, followed by medical air until NCPAP was needed. The aim of the study was to assess the therapeutic effects of breathing a low-density gas mixture (heliox: 80% helium and 20% oxygen) in premature babies with Respiratory Distress Syndrome (RDS), undergoing NCPAP in terms of reducing the rate of mechanical ventilation (MV).


Eligibility criteria: Inclusion Criteria:

* inborn infants between 28 and 32 weeks of GA
* Silverman score \> 5,
* radiological finding of RDS
* a requirement of inspiratory flow of oxygen (FiO2) \> 0,25 (SaO2 ) between 88-95% within the first hour of life.

Exclusion Criteria:

* major congenital malformations
* intraventricular hemorrhage (IVH) more than grade 2
* need of intubation in the delivery room or requirement of FiO2 \>0,4 during the first hour of life.

Primary outcomes:
measure: Efficacy in reducing need of MV
timeFrame: 7 days
Secondary outcomes:
measure: surfactant need
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 weeks
measure: major complications of prematurity
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 weeks
measure: ventilatory assistance
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 weeks
measure: length of stay
timeFrame: participants will be followed for the duration of hospital stay, an expected average of 10 weeks
Other outcomes:
Locations:
city: Milan
country: Italy
facility: NICU, Fondazione IRCCS Cà Granda - Ospedale Maggiore Policlinico, Università degli Studi di Milano
Study officials:
References:
citation: Colnaghi M, Pierro M, Migliori C, Ciralli F, Matassa PG, Vendettuoli V, Mercadante D, Consonni D, Mosca F. Nasal continuous positive airway pressure with heliox in preterm infants with respiratory distress syndrome. Pediatrics. 2012 Feb;129(2):e333-8. doi: 10.1542/peds.2011-0532. Epub 2012 Jan 30.
Clinical trial NCT05976750: Air Optix® Night and Day® Aqua Daily Wear
Official title: Air Optix® Night and Day® Aqua Daily Wear
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Refractive Errors
Myopia
Hyperopia
Lead sponsor: Alcon Research
Sponsor class: INDUSTRY
First posted: 2023-08-04
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators will enroll charts following a pre-identified process.

Brief summary: The purpose of this Post-Market Clinical Follow-Up (PMCF) study is to assess long term performance and safety of Air Optix® Night and Day® Aqua (AONDA) contact lenses in a real-world setting when worn as daily wear for vision correction.

Detailed description: This is a non-interventional/observational study designed as a retrospective chart review. Study sites will review charts within their existing database to identify subjects who wore AONDA contact lenses or PureVision® 2 (PV2) contact lenses in both eyes for approximately 1 year following their contact lens examination. The data collection period consists of any approximately 1-year timeframe since and including 2009.

The anticipated duration of the study is approximately 6 months.

Eligibility criteria: Inclusion Criteria:

* Normal eyes, as determined by the Investigator
* At the time of the 1-year visit, subject was prescribed and wearing AONDA contact lenses or PV2 contact lenses in both eyes in a daily wear modality for at least approximately 1 year without changing wear modality
* Baseline and 1-year visit charts available
* Other protocol-specified inclusion criteria may apply

Exclusion Criteria

* Any recurrent history or active anterior segment infection, inflammation, abnormality, or disease contraindicating regular contact lens wear present at Baseline
* Use of systemic or ocular medications contraindicating regular contact lens wear at Baseline
* History of refractive surgery or irregular cornea
* Other protocol-specified exclusion criteria may apply

Primary outcomes:
measure: Distance visual acuity by eye
timeFrame: Year 1
measure: Incidence of corneal infiltrative events
timeFrame: Up to Year 1
measure: Incidence of microbial keratitis
timeFrame: Up to Year 1
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Worth
country: United States
facility: Contact Alcon Call Center for Trial Locations
state: Texas
Study officials:
affiliation: Alcon Research, LLC
name: Clinical Trial Lead, CRD Vision Care
role: STUDY_DIRECTOR
References:
Clinical trial NCT02443350: Multicenter and Prospective Clinical Registry Study of Anti-N-methyl-D-aspartate Receptor Encephalitis in Beijing Area
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Anti-N-Methyl-D-Aspartate Receptor Encephalitis
Lead sponsor: Beijing Tongren Hospital
Sponsor class: OTHER
First posted: 2015-05-13
Enrollment: 400
Sex: ALL
Minimum age (years): 6
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The unexplained encephalitis patients in Beijing area

Brief summary: Anti N-methyl-D-aspartate receptor encephalitis is an autoimmune encephalitis，found in recent years，producing the specific IgG antibody induced by the NMDA receptors.It is the most common curable disease among the non infectious-autoimmune encephalitis,usually has been misdiagnosed as other causes of encephalitis.Our previous study found that there are differences between the Chinese and the foreign in anti-NMDA receptor encephalitis such as the sex ratio, the rate of combined tumor and clinical manifestations.As a new found disease,the incidence rate has been underestimated.Therefore,to establish the Registry Research Database for Chinese group of anti-NMDA receptor encephalitis is imminent.This study will combine Beijing area's hospitals and foreign experts,depending on multicenter, prospective and registry method,to understand the incidence in Beijing area,to summarize and analyze the clinical data of patients.So,there will make a solid foundation for the subsequent Beijing area detection platform and other research.


Eligibility criteria: Inclusion Criteria:

* Older than 6 months.
* Encephalopathy symptoms (change of mental state and consciousness level) persist for more than 24 hours;
* At least one or more clinical features of the followings: fever, epilepsy, focal neurological deficiency symptoms, changes in CSF(cerebrospinal fluid inflammatory), changes in EEG (electroencephalogram), radiographic abnormalities;
* Clinical suspected encephalitis, but conventional detected methods cannot make etiology clear

Exclusion Criteria:

* Infants less than 6 months;
* The metabolic encephalopathy;
* Infectious encephalitis with clinically clear pathogen, referring the specific pathogenic microorganisms, including: bacteria, virus, fungus, parasite, spirochete and so on;
* Non-infectious encephalitis with clinically clear diagnosis, including: multiple sclerosis, optic neuromyelitis, acute disseminated encephalomyelitis and so on.

Primary outcomes:
measure: death
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Tongren Hospital,Capital Medical Universiy
state: Beijing
Study officials:
References:
citation: Peng Y, Dai F, Liu L, Chen W, Yan H, Liu A, Zhang X, Wang X, He J, Li Y, Li C, Chen L, Zhao Y, Li L, Ma Q, Wang J. Validation of the NEOS score in Chinese patients with anti-NMDAR encephalitis. Neurol Neuroimmunol Neuroinflamm. 2020 Aug 5;7(5):e860. doi: 10.1212/NXI.0000000000000860. Print 2020 Sep.
Clinical trial NCT05958550: A Risk Prediction Model for Hypothermia After Laparoscopic Gastrointestinal Tumor Surgery
Official title: Construction and Validation of a Risk Prediction Model for Hypothermia After Laparoscopic Gastrointestinal Tumor Surgery Based on Machine Learning
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hypothermia; Anesthesia
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-07-24
Enrollment: 480
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: From June 2023 to January 2024, patients underwent laparoscopic gastrointestinal tumor surgery in the East Hospital of Renji Hospital, Shanghai Jiaotong University School of Medicine.

Brief summary: The incidence of postoperative hypothermia in patients with laparoscopic gastrointestinal tumors is high. Hypothermia increases the risk of postoperative complications and medical costs. Early warning can effectively reduce the incidence of postoperative hypothermia in patients. Multivariate prediction models help identify high-risk patients and reversible factors. At present, there are few reports on the risk factors and prediction models of postoperative hypothermia in patients with laparoscopic gastrointestinal tumors. Therefore, this study aims to clarify the risk factors of postoperative hypothermia in patients with laparoscopic gastrointestinal tumors. Four machine learning algorithms, traditional Logistic regression analysis, decision tree, random forest and naive Bayes, were used to establish risk prediction models. According to the TRIPOD statement, C-index, Hosmer-Lemeshow ( H-L ) test and decision curve analysis ( DCA ) were used to evaluate the prediction and fitting effects of the models in all aspects, and the optimal model was selected and verified. Provide reference for subsequent research.


Eligibility criteria: Inclusion Criteria:

* The types of surgery included laparoscopic radical gastrectomy for gastric cancer, duodenal cancer, colon cancer, rectal cancer and small bowel cancer. Age ≥ 18 years ; the anesthesia method was general anesthesia ; elective surgery.

Exclusion Criteria:

* Patients with abnormal body temperature such as fever and hypothermia before operation ; patients who need low temperature to protect organs during operation ; patients who were converted to laparotomy during the operation ; a clear diagnosis of sweat gland dysfunction ; patients with external auditory canal active disease ; reject participants.

Primary outcomes:
measure: Whether hypothermia occurs
timeFrame: Generally 1 ~ 3 hours, up to 3 hours can be observed.
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03140150: Safety Acceptability and Benefits of Tracking Cardiac Pacemakers by Carelink Express
Official title: Safety Acceptability and Benefits of Tracking Cardiac Pacemakers by Carelink Express
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Telecardiology
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
First posted: 2017-05-04
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

Brief summary: Follow-up strategy for patients implanted with a pacemaker.

Detailed description: This study seeks to verify that a follow-up strategy for patients implanted with a mono- or double-chamber pacemaker, stimuli-dependent or not, for 2 years, by means of data transmissions of the devices by Carelink Express during the usual consultations with the treating cardiologist significantly reduces the number of unnecessary consultations in the implant centers (without any change in treatment or pacemaker programming) compared to the usual follow-up mode recommended for this type of device.

Eligibility criteria: Inclusion Criteria:

* Any patient implanted with a Medtronic brand AAI (R), VVI (R) and DDD (R) cardiac pacemaker, allowing transmission via Carelink Express (Medtronic)
* and accepting inclusion in the study.
* The patient should be followed by a city cardiologist participating in the study.

Exclusion Criteria:

* Age \<18 years
* Pregnant or likely to become pregnant during the study
* Patient with an unstable medical condition, NYHA Class IV Heart Failure
* Presence of psychiatric illness, depression, anxiety disorder
* Presence of diseases, other than heart disease, responsible for a reduction in life expectancy for the duration of the study.
* Patient unable to follow protocol (respond to questionnaires)
* Change of residence planned during the study
* Participation in an interventional and therapeutic clinical study; Patient participation in an observational study is permitted.
* Patient not signed consent form
* Patient under legal protection

Primary outcomes:
measure: At least one unnecessary consultation during two years of follow-up
timeFrame: 2 years
Secondary outcomes:
measure: Occurrence of a serious adverse event
timeFrame: 2 years
measure: In-depth sociological study carried out through questionnaires and individual interviews
timeFrame: 2 years
measure: Quality of life
timeFrame: 2 years
measure: The medical economic evaluation to measure the efficiency of the device Carelink Express allowing patients' tele-monitoring implanted by a pacemaker
timeFrame: 2 years
Other outcomes:
Locations:
city: Brest
country: France
facility: CHRU Brest
city: Lorient
country: France
facility: CH Lorient
Study officials:
affiliation: University Hospital, Brest
name: Jacques Mansourati, Professor
role: PRINCIPAL_INVESTIGATOR
References: