louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01530828: IRT in Infants With Intestinal Perforation
Official title: Immunoreactive Trypsinogen in Infants With Intestinal Perforation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Intestinal Perforation
Necrotizing Enterocolitis
Keywords: Immunoreactive Trypsinogen
Nectrotizing Enterocolitis
Premature Infants
Serial IRT
Lead sponsor: Children's Hospitals and Clinics of Minnesota
Sponsor class: OTHER
First posted: 2012-02-10
Enrollment: 300
Sex: ALL
Minimum age (years): 1
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Premature infants less than 1000 grams, age 1-16 days

Brief summary: This study is designed to evaluate a novel tool to aid in the diagnosis of intestinal perforation in infants who are at high risk. Analysis of perforation rates of all infants in the three largest participating sites shows that the majority of infants with perforation will do so prior to day of life 21. This study will target the group of infants at highest risk for IP, those with birth weight less than 1000 grams, within the time frame most likely to capture the perforation. Hypothesis: An IRT value exists that can adequately differentiate premature infants with and without intestinal perforation in the first 3 weeks of life.

Detailed description: At least 300 infants age 1-16 days will be enrolled. IRT values will be obtained daily through day of life 21, if the infant is already having labs drawn that day. The primary outcomes will be intestinal perforation and/or death on or before day of life 21. Each patient will be followed until death or discharge. Discharge will be defined as the release of the infant to home. Infants who are transferred to another NICU may be followed if the receiving NICU is one of the investigational sites. Transfer includes the release of the infant to outside units or other units within the same hospital. The purpose of this follow up is to obtain serial IRT values through day of life 21.

Eligibility criteria: Inclusion Criteria:

* Informed consent
* Birth weight less than 1000 grams
* Admitted to investigative site within first 16 days of life.

Exclusion Criteria:

* Evidence of Intestinal perforation in utero
* Suspected or confirmed custic fibrosis
* Abdominal wall defect or intestinal atresia
* Concomitant medical condition that may create an unacceptable risk.

Primary outcomes:
measure: To determine the onset and duration of elevation in serum IRT in infants with intestinal perforation.
timeFrame: 3 years
Secondary outcomes:
measure: Determine if factors other than intestinal perforation affect serum IRT.
timeFrame: 3 years
Other outcomes:
Locations:
city: St. Paul
country: United States
facility: Children's Hospitals & Clinics of Minnesota
state: Minnesota
Study officials:
References:
Clinical trial NCT04165928: Multicenter Study of Tetanus Patients in Fujian Province of China
Official title: Multicenter Study of Tetanus Patients in Fujian Province of China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Tetanus
Keywords: neonatal tetanus
tetanus immunization program
drug-induced
tetanus antitoxin
critical care medicine
artificial airway
Lead sponsor: Fujian Provincial Hospital
Sponsor class: OTHER
First posted: 2019-11-18
Enrollment: 95
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study included all patients of all age groups and both sexes who presented with a clinical diagnosis of tetanus.

Brief summary: Background: Tetanus is a life-threatening disease in developing countries, and accompanied by a high mortality rate. China is the world's largest developing country, and Fujian Province is a typical coastal province in China with a relatively developed economy. Therefore, the purpose of this study was to investigate the epidemiology, incidence and management of tetanus in Fujian Province and to understand the current treatment and prognosis of tetanus patients in China.

Methods: This was a retrospective multicenter observational study of patients who presented with a clinical diagnosis of tetanus at 5 general hospitals in Fujian. Data was analyzed using computer software system.


Eligibility criteria: Inclusion Criteria:

* This study included all patients of all age groups and both sexes who presented with a clinical diagnosis of tetanus.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Outcomes of the tetanus patients
timeFrame: 2008-01-01~2018-10-31
Secondary outcomes:
measure: The hospitalization time.
timeFrame: 2008-01-01~2018-10-31
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: Fujian Provincial Hospital
state: Fujian
Study officials:
References:
Clinical trial NCT06004128: Provide Pre-approval Single-patient Expanded Access (Compassionate Use) of VYD222 for Patients With Symptomatic COVID-19 Refractory to Other Treatments
Official title: Provide Pre-approval Single-patient Expanded Access (Compassionate Use) of VYD222 for Patients With Symptomatic COVID-19 Refractory to Other Treatments
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: COVID-19
Lead sponsor: Invivyd, Inc.
Sponsor class: INDUSTRY
First posted: 2023-08-22
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT

Brief summary: Provide pre-approval single-patient Expanded Access (Compassionate Use) of VYD222 for patients with symptomatic COVID-19 refractory to other treatments.



Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05534828: Risk Factors for the Occurrence of Post Intensive Care Syndrome (PICS)
Official title: Risk Factors for the Occurrence of Post Intensive Care Syndrome (PICS) At 3 Months After a Stay in the Rangueil Multipurpose Resuscitation Unit of the Toulouse University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Post Intensive Care Syndrome
Lead sponsor: University Hospital, Toulouse
Sponsor class: OTHER
First posted: 2022-09-10
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: population of patients surviving a stay in polyvalent resuscitation

Brief summary: Monocentric, observational, descriptive RIPH3 study with prospective data collection.

Detailed description: A consultation in the form of a teleconsultation with video conference is proposed to all adult patients who have stayed more than 24 hours in the Rangueil intensive care unit.

This consultation is scheduled and will take place approximately three months after the end of the stay in the intensive care unit.

During this consultation, signs will be sought through questioning to detect or even diagnose the presence of a PICS.

We will also look for elements that will allow us to characterize people with CHIP.

If a PICS was detected during the consultation, the summary letter sent to the attending physician informs him/her of

1. The presence of a CHIP in his patient
2. The nature of this CHIP (CHIP with a purely psychological component, CHIP with a psychological and physical component, etc.) In this same summary letter, the attending physician will be offered a list of specialists practicing at the CHU who are likely to take charge of the patient's CHIP.

Eligibility criteria: Inclusion Criteria:

* adult patient
* hospitalized in the intensive care unit of Rangueil of the TOULOUSE University Hospital
* length of stay in intensive care equal or superior to 24 hours
* affiliated to a social security system
* having expressed no objection to participate in the study

Exclusion Criteria:

* minor patient
* no consent to the study
* patient not capable of expressing his "non opposition" to the study
* patient under guardianship, curatorship or safeguard of justice

Primary outcomes:
measure: Incidence at 3 months of PICS
timeFrame: month 3
Secondary outcomes:
Other outcomes:
Locations:
city: Toulouse
country: France
facility: University Hospital of Toulouse
Study officials:
References:
Clinical trial NCT04740528: Preference of Protein Intake and FTO rs1558902 Gene Polymorphism Among Women Obese
Official title: Department of Nutrition Science, Medical Faculty, Universitas Diponegoro Semarang, Indonesia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity Adult Onset
Keywords: woman Obese
fto-gen
rs1558902
protein intake
Lead sponsor: Universitas Diponegoro
Sponsor class: OTHER
First posted: 2021-02-05
Enrollment: 130
Sex: FEMALE
Minimum age (years): 35
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: healthy woman obese and pre menopause

Brief summary: The concept personalized gene-based nutrition combines genetic information with specific dietary intake that is crucial in managing obesity. Obesity experienced by adult women is generally caused by inapproriate diet and sedentary lifestyle. Variations in the fat mass and obesity-related gene (FTO) has been linked with susceptibility to obesity, but diet seems to change the relationship. A single nucleotide polymorphism (SNP) in the fat mass and obesity-associated gene (FTO) is a potent predictor of human obesity. Higher protein diets were more appropriate than standard protein diets, and frequently recommended as a weight loss plan as it prevents the loss of lean tissue mass. Nevertheless, high intakes of proteins may adversely affect metabolic functions. Multi studies have explored associated FTO polymorphisms with obesity in different populations. However, the contribution of the FTO common variants to obesity is controversial in Asian people, some studies showed rs1558902 was statistically associated with BMI, but other results reported FTO gene is not statistically associated with obesity. Given the diversity of Asian populations, the investigators generated a hypothesis whether relations between preference protein intake and FTO rs1558902 gene polymorphism exist in selected Indonesian obesity women

Detailed description: The sample size was calculated based on the difference in the proportion of variation of the gene FTO rs1558902 allele A between obese participants, which previous study estimated to be approximately 6% for populations from Malaysia. Using a power of 80% and a level of significance of 5%, the investigators required 100 obese participants.

BMI and body fat which were assessed by SECA body analyzer (SECA 201). Blood samples were collected after a 12-h minimum fast by Prodia Laboratory for DNA isolation and biochemical analysis

Eligibility criteria: Inclusion Criteria:

* Body Mass index \> 25 kg/m2
* waist circumference \> 80 cm

Exclusion Criteria:

* chronic disease
* have pregnancy
* consume diet supplement, drugs

Primary outcomes:
measure: fto gene rs 1558902
timeFrame: day 1
measure: interleukin-6
timeFrame: day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Semarang
country: Indonesia
facility: Etika Ratna Noer
state: Central Java
Study officials:
affiliation: Diponegoro University
name: Etika Noer, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02864628: RSV-MVA-BN Vaccine Phase I Trial, Intranasal Application in Adults.
Official title: A Partially Randomized, Partly Placebo Controlled Phase I Trial to Evaluate the Safety, Tolerability and Immunogenicity of the Recombinant MVA-BN® RSV Vaccine After Intranasal and Intramuscular Administration
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
Conditions: Respiratory Syncytial Virus Infections
Keywords: RSV Vaccines
Respiratory Syncytial Virus Vaccines
Lead sponsor: Bavarian Nordic
Sponsor class: INDUSTRY
First posted: 2016-08-12
Enrollment: 0
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: A total of 96 subjects will be recruited into 5 groups. Each subject will receive either two vaccinations with MVA-BN-RSV vaccine or placebo.


Eligibility criteria: Inclusion Criteria:

* signed and dated an informed consent form and HIPAA.
* Subjects without symptomatic cardiopulmonary and/or metabolic disease.
* Body mass index (BMI) ≥ 18.5 and ≤ 34.9.
* Negative human immunodeficiency virus antibody test (anti-HIV), HBsAG and HCV virus.
* Electrocardiogram (ECG) without clinically significant acute findings.
* WOCBP must have a negative serum pregnancy test at screening and a negative urine pregnancy test prior to each vaccination.

Exclusion Criteria:

* History of nasal or sinus surgery within six months prior to screening or planned nasal or sinus surgery during the trial
* Active or recent history (within 6 months prior to screening) of chronic sinusitis, nasopharyngeal abnormalities and/or symptoms such as polyps or deviated septum
* pregnant or breast-feeding women.
* History or current clinical manifestation of any serious medical condition.
* History of or active autoimmune disease.
* Known or suspected impairment of immunologic functions including, but not limited to chronic inflammatory bowel disorders, diabetes mellitus type I.
* Knowledge/history of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* History of anaphylaxis or severe allergic reaction to any vaccine.
* Chronic systemic administration defined as more than 14 days of \> 5 mg prednisone per day

Primary outcomes:
measure: Occurrence of serious adverse events
timeFrame: Screening up to week 34 after first vaccination
Secondary outcomes:
measure: RSV-specific humoral immune response
timeFrame: humoral immune response is measured up to week 34
Other outcomes:
Locations:
Study officials:
affiliation: Johnson County Clin-Trials (JCCT)
name: Carlos Fierro, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01569828: Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment vs. Matched Healthy Subjects With Normal Renal Function
Official title: An Open Label, Parallel-group Study to Determine Multiple Dose Pharmacokinetics of LCZ696 and Its Metabolites in Subjects With Severe Renal Impairment Compared to Matched Healthy Subjects With Normal Renal Function
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Pharmacokinetics
Renal Impaired
Healthy Volunteer
Keywords: LCZ696
pharmacokinetics
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-04-03
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: An open label, parallel-group study to determine multiple dose pharmacokinetics of LCZ696 and its metabolites in subjects with severe renal impairment compared to matched healthy subjects with normal renal function


Eligibility criteria: Inclusion Criteria:

-

Exclusion Criteria:

-

Primary outcomes:
measure: Time to Reach Maximum Peak Plasma Concentration (Tmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
timeFrame: 1 and 5 days
measure: (Cmax) After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
timeFrame: 1 and 5 days
measure: AUC 0-24h After Single Dose (Day 1), and After Multiple Dose Administration (Day 5)
timeFrame: 1 and 5 days
measure: T1/2 After Multiple Dose Administration (Day 5)
timeFrame: 5 days
measure: CL/F After Multiple Dose Administration (Day 5)
timeFrame: 5 days
measure: CLr After Multiple Dose Administration (Day 5)
timeFrame: 5 days
Secondary outcomes:
measure: 24 hr Sodium Urinary Excretion in Subjects With Severe Renal Impairment and Their Matched Healthy Volunteers
timeFrame: 5 days
Other outcomes:
Locations:
city: Neuss
country: Germany
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Belgrade
country: Serbia
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
Clinical trial NCT02236728: Observational Study in Parkinson's Disease of the Primary Care Population of Patients Treated With Pramipexole
Official title: Observational Study in Parkinson's Disease of the Primary Care Population of Patients Treated With Pramipexole by Neurologists in France (ETAP)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Parkinson Disease
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-09-11
Enrollment: 497
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: neurologists' population of patients treated with pramipexole and suffering from Parkinson's disease (so called 'primary care' population)

Brief summary: The primary objective of this study was to describe neurologists' population of patients treated with pramipexole and suffering from Parkinson's disease (so called 'primary care' population).

The secondary objectives were:

* Evaluate the mean dose of pramipexole prescribed under actual conditions of use depending on the severity of the disease.
* Evaluate the reasons for choosing pramipexole as treatment.
* Identify the patient profiles determining the choice of dose of pramipexole prescribed


Eligibility criteria: Inclusion Criteria:

* Patients suffering from idiopathic Parkinson's Disease and treated with pramipexole for at least two months, examined in consultation

Exclusion Criteria:

* Patient refusing to take part
* Patient taking part in a clinical trial

Primary outcomes:
measure: Assessment of Patient's demographic characteristics
timeFrame: 9 months
measure: Assessment of Parkinson's disease characteristics
timeFrame: 9 months
Secondary outcomes:
measure: Assessment of Severity of the Parkinson Disease (PD)
timeFrame: 9 months
measure: Assessment of Disease Stage Stage according to Hoehn and Yahr and Unified Parkinson Disease Rating Scale III (UPDRS III) scores
timeFrame: 9 months
measure: Description of the actual treatments of PD
timeFrame: 9 months
measure: Evaluation for reasons for choosing pramipexole as treatment
timeFrame: 9 months
measure: Assessment of Treatment history
timeFrame: 9 months
measure: Evaluation of the state of health perceived by the patient using the questionnaire EQ-5D
timeFrame: 9 months
measure: Number of patients with adverse events
timeFrame: 9 months
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06672328: Action Observation Training for Functional Performance in Children with Cerebral Palsy
Official title: Action Observation Training for Functional Performance in Children with Cerebral Palsy
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cerebral Palsy (CP)
Physical Functional Performance
Keywords: Balance
Cerebral Palsy
Physical Function Performance
Mobility
Spasticity
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2024-11-04
Enrollment: 30
Sex: ALL
Minimum age (years): 5
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study is a randomized control trial and aims to determine the effects of Action Observation on balance and mobility in patients with cerebral palsy compared to training without action observation.

Detailed description: Effetcs of Action observation will be assessed for functional performance which includes the parameters of balance and mobility.

Spastic CP children agd 5-12 will be recruited in the study. The participants would be assessed through Modified Ashworth scale, GMFCS, Pediatrics balance scale and GMFM-88 .

Informed Consent will ne taken after which the participants will be recruited into the two groups, where one group will recieve training with Action observation and other group will receive training without Action observation.

Baseline and Post-treatment measurements will be taken for analysis.

Eligibility criteria: Inclusion Criteria:

* Age 5-12.
* Spastic CP.
* Modified Ashworth Scale spasticity score 0-2
* GMFCS level I, II or III.
* Able to understand and follow commands, e.g. "Stand up, please".
* Able to sit to stand with or without assistance.

Exclusion Criteria:

* Any orthopedic procedure in the past 6 months, that could prevent exercise training.
* Any co-morbid condition such as spinal atrophy, osteogenesis imperfecta etc.
* History of chronic seizure attacks.
* Children with severe visual/hearing impairments.
* Presence of knee contractures

Primary outcomes:
measure: Static balance
timeFrame: 8 weeks
measure: Dynamic balance
timeFrame: 8 weeks
measure: Mobility
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Foundation University College of Physical Thrapy
Study officials:
References:
Clinical trial NCT00674128: Comparison of Cyanoacrylate Tissue Adhesive and Suture for Closure of Cardiac Device Pockets
Official title: Prospective Comparison of Cyanoacrylate Tissue Adhesive (Dermabond) and Suture (Vicryl) for Closure of Cardiac Device Pockets
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Cardiovascular Disease
Keywords: pacemaker
cardioverter-defibrillator
ICD
cardiac resynchronization device
cyanoacrylate
suture
Dermabond
Vicryl
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2008-05-07
Enrollment: 103
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether cyanoacrylate tissue adhesive is as effective as polyglactin 910 suture for surgical closure of cardiac device pockets.


Eligibility criteria: Inclusion Criteria:

* Scheduled for implantation of a pacemaker or ICD in the deltopectoral region at Mayo Clinic Hospital in Phoenix.

Exclusion Criteria:

* Allergy to one of the closure materials.

Primary outcomes:
measure: Reported Here Are the Number of Participants With Devices That Developed Infection
timeFrame: Within 3 months after surgery.
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Mayo Clinic
state: Arizona
Study officials:
affiliation: Mayo Clinic
name: Gregory Altemose, M.D.
role: PRINCIPAL_INVESTIGATOR
References: