louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03292744: Effect of Alfacalcidol to Respiratory Infection and Immune Response of Indonesian Elderly
Official title: Effect of Alfacalcidol Supplementation to Respiratory Infection, Inflammatory Markers and CD4/CD8 Ratio of Indonesian Elderly
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Frail Elderly Syndrome
Elderly Infection
Keywords: immunosenescence
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 110
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Vitamin D has been known to influence immune response through Vitamin D Receptor in Immune Cells, but only few has been known about the effect alfacalcidol, a vitamin D analog to immune system. In elderly, immune disregulation or immunosenecence have great impact to infection response. This study is aimed to determine the effect of alfacalcidol supplementation in vitro and in vivo to respiratory infection incidence and inflammatory markers, as well as T cell lymphocyte subset in Indonesian elderly patients.

Detailed description: This study consist of 2 designs. First is in vitro study to investigate the effect of alfacalcidol supplementation to IL-6, IL-10 and IFN gamma regulation in Peripheral Blood Mononuclear Cells (PBMC) of elderly and second design is randomised controlled trial to evaluate the effect of 3 months supplementation of alfacalcidol 0,5 mcg in respiratory infection, antibiotic use, inflammatory markers, CD4/CD8 ratio and CD8+ CD28+ in Indonesian elderly with various level of frailty syndrome.

Eligibility criteria: Inclusion Criteria:

* Elderly age more than 60
* Willing to join research

Exclusion Criteria:

* In acute infection
* Using NSAID or steroid
* Liver failure
* Hypercalcemia

Primary outcomes:
measure: upper respiratory tract infection incidence
timeFrame: 90 days
measure: lower respiratory tract infection incidence
timeFrame: 90 days
Secondary outcomes:
measure: inflammatory markers
timeFrame: day 90
measure: T cell subset
timeFrame: day 90
measure: antibiotic use
timeFrame: 90 days
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo National Hospital
Study officials:
affiliation: Universitas Indonesia / Cipto Mangunkusumo Hospital
name: Aulia Rizka, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04219644: Evaluation of the "Breatheasy" in Pre-hospital Care
Official title: Evaluation and Validation of the "Breatheasy" Respiratory Rate Monitor in Pre-hospital Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Respiratory
Lead sponsor: Sheffield Children's NHS Foundation Trust
Sponsor class: OTHER
First posted: 2020-01-07
Enrollment: 78
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: In the emergency department, a sick child is usually seen first by the nursing staff. Their job is to quickly assess how sick the child is and what immediate care is needed. The nurse will usually use suitable devices to check vital signs, such as body temperature, pulse rate and blood oxygen levels. However, normally the respiratory rate has to be manually counted (this is the average number of breaths taken each minute) because there is no suitable device which can automatically do this assessment. To overcome this problem we have produced a noncontact device that can automatically measure respiratory rate in children. The device has been designed using the latest technology and works by directly sensing the air coming from the nose or the mouth when held at about 20 cm from the face. It has been tested on adults and children and compared to the usual methods of measuring respiratory rate. We have used comments and Suggestions from members of the public and healthcare professionals from hospital, general practice and the ambulance service to help us develop the device. With this study, we explore the applicability and usefulness of the device in a range of difference clinical and nonclinical settings. Its performance will be carefully evaluated on children and adults in children's nurseries, schools, university, hospital emergency departments, general practice surgeries and ambulances. In the future, when using the device nursing staff will easily be able to measure each child's respiratory rate so that the most seriously ill children will be identified earlier and get correct treatment more quickly. This will ensure that the right children get admitted to intensive care units sooner and, in some cases, deaths will be prevented.


Eligibility criteria: Inclusion Criteria:

- Any adult or child within each setting, of any age with any clinical condition, as this will reflect clinical practice.

Exclusion Criteria:

* Patients deemed too unwell to consent to the procedures or requiring emergency treatment will not be approached.
* For the purposes of this feasibility study, families whose first language is not English will be excluded, to save translation and interpretation costs.

Primary outcomes:
measure: Respiratory rate using the prototype device
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02530944: Web-based Genetic Research on Lupus
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus
Systemic Lupus Erythematosus (SLE)
genetic
online
genome wide association
systemic lupus erythematosus
genome wide association study (GWAS)
Lead sponsor: 23andMe, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Pfizer
First posted: 2015-08-21
Enrollment: 5000
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: Community Sample

Brief summary: The goal of this new lupus research study is two-fold: first, to understand the genetic associations found between people's DNA and this disease, and second, to apply this understanding to drug development efforts with the investigator's partners at Pfizer.

Detailed description: Lupus is a difficult disease to diagnose and one that's difficult to manage, given the lack of specific medicines to treat lupus and the side-effects of current medications. The investigators believe genetics may play a critical role in developing better lupus diagnoses and treatments. If individuals are eligible to participate, the investigators will send a 23andMe DNA saliva kit at no cost. Participants will be asked to take a 15 minute online survey with questions about their lupus experience, symptoms and response to treatments, in addition to five additional bi-monthly short surveys and one final study survey during the 12-month participation. Learn more and join the lupus study today: https://www.23andme.com/lupus/

Eligibility criteria: Inclusion Criteria:

* diagnosed with lupus by a qualified physician.
* consents to have 23andMe (via a partner) contact the physician to obtain medical record information
* willing to submit a saliva sample for DNA testing and complete online surveys related to condition
* at least 6 years old (minors under 18 require parental consent to enroll)
* access to the internet
* resides in the United States

Exclusion Criteria:

-

Primary outcomes:
measure: Salivary DNA sample for genetic analysis
timeFrame: 12 months
measure: Online survey
timeFrame: 12 months
Secondary outcomes:
Other outcomes:
Locations:
city: Mountain View
country: United States
facility: Www.23Andme.Com/Lupus
state: California
Study officials:
References:
Clinical trial NCT00943644: Pre-biopsy With Dynamic Acquisitions
Official title: Determination of Sensitivity of a Dual-Headed Small Field of View Gamma Camera for the Detection of Small Breast Lesions
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: MBI
Breast
Breast Cancer
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Susan G. Komen Breast Cancer Foundation
First posted: 2009-07-22
Enrollment: 185
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients that are scheduled to have a biopsy at the Mayo Clinic in Rochester, MN and have a lesion less the 2 cm

Brief summary: This study is being done to test the ability of an investigational mammography camera to find small tumors in patients' breasts.

Detailed description: If you agree to take part in this study, you will be asked to remove your clothes from the waist up and put on a gown. A female technologist will give you an injection of Tc-99m sestamibi in a vein in your arm. This is a drug routinely used for breast imaging. About 10 minutes after your injection, you will be asked to sit in a chair for about 40 minutes. The technologist will position your breast between two small cameras. The cameras will apply a very light compression to your breast to make sure there is no movement during the picture. We will take two pictures of each breast. Each picture takes 10 minutes. You will also be asked to fill out a short questionnaire. If you are found to have additional breast lesions, your doctor and radiologist will be notified so that additional imaging or biopsies can be performed.

Eligibility criteria: Inclusion Criteria:

* Have a lesion on Mammogram, Ultrasound or MRI that measured \< 2 cm and considered suspicious or suggestive of malignancy
* Scheduled for biopsy of lesion
* \> 18 years of age
* Negative pregnancy test, postmenopausal, or surgically sterilized

Exclusion Criteria:

* Prior needle biopsy

Primary outcomes:
measure: To determine the sensitivity of the dual-head system relative to single-head for detection of sub 10 mm breast lesions, and to determine the number of images that need to be acquired.
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Michael K. O'Connor, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Deborah J. Rhodes, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Douglas A. Collins, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Carrie B. Hruska, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03171844: Early Skin to Skin in Neonatal Reanimation
Official title: Early Skin to Skin in Neonatal reanimation_Risk Assessment in the Newborn With an Umbilical Venous Catheter
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infant, Premature
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2017-05-31
Enrollment: 100
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: In the reanimation neonatal department of the Nice's hospital, 34% of newborns admitted have an umbilical vein catheter (KTVO). Their parents are admitted 24h/24h by their side, where everything is done to set up the Attachment (participation in care, skin to skin, support of breastfeeding, ...).

The benefits of skin to skin described in developmental care of the newborn in the neonatal health services are well established. Nevertheless, for supposed risks (infectious and displacement of the catheter), registered in the memory of the teams, this care is not currently carried out when the newborns are carrying an umbilical venous catheter.

Sometimes, because of the presence of an umbilical venous catheter, parents and their newborns could not enjoy this moment of well-being in the first days of life. We therefore propose a study evaluating the current risks of skin to skin with an umbilical venous catheter by reflecting on a new protocol for laying and fixing this medical device.


Eligibility criteria: Inclusion Criteria:

* Newborn of gestational age less than 37SA
* Admitted in neonatal reanimation department at Nice's hospital
* Born in the maternity ward of the Nice's hospital
* Carriers of an umbilical venous catheter.

Exclusion Criteria:

* All newborns with medical contraindications from skin to skin:

  * Controlled hypothermia protocol
  * Newborn under HFO (High Frequency Oscillation)
  * Carrying a diaphragmatic hernia
  * Thoracic drain holder
  * With major PAH (hypertensive pulmonary artery)
* Symptomatic mother of acute infectious disease
* Mother whose physical or psychiatric capacity is not compatible with travel to the neonatal reanimation service within 3 days of delivery.
* Minor mother

Primary outcomes:
measure: Bacteremia
timeFrame: 48h
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Florence CASAGRANDE, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06274944: Nasogastric/Orogastric Tube Placement Confirmation in Neonates Utilizing Self-contained pH Device, a Feasibility Study
Official title: Nasogastric/Orogastric Tube Placement Confirmation in Neonates Utilizing Self-contained pH Device, a Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Premature Birth
Keywords: prematurity
nasogastric
orogastric
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2024-02-23
Enrollment: 12
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Infants admitted to the University of Minnesota Masonic Children's Hospital neonatal intensive care unit.

Brief summary: This study is looking at using a self-contained pH device that will assist in confirming placement of a nasogastric or orogastric tube placed in the stomach of hospitalized infants.


Eligibility criteria: Inclusion Criteria:

* All patients admitted to the NICU at the University of Minnesota Masonic Children's Hospital, Minneapolis, MN requiring placement of an NG/OG tube are eligible to enroll.

Exclusion Criteria:

* Participant deemed unsuitable for study by the treating provider. Participants who are on the following medications: proton-pump inhibitor (PPI's) or H2 blockers within one week prior to the device assessment.

Primary outcomes:
measure: PH reading comparison
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Jonathan Strutt
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02377544: The Role of Bifidobacterium Animalis Ssp Lactis DR10 Supplementation in Women During Pregnancy and Lactation on Breast Milk IL-8 and Gut Mucosa Integrity in Infant
Official title: The Role of Bifidobacterium Animalis Ssp Lactis DR10 Supplementation in Women During Pregnancy and Lactation on Breast Milk IL-8 and Gut Mucosa Integrity in Infant
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bifidobacterium
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2015-03-03
Enrollment: 70
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: Hopefully this research can help to provide the optimal nutrition management from pregnancy so that the babies wiil born with better quality of health and reduce the morbidity and mortality.

Until now, there is no data regarding probiotics in Indonesien breastmilk and the role of probiotics supplementation on pregnant women to the baby especially from inflammation pathways. The investigators hope the result of this research can help reducing infant morbidity and mortality rate in Indonesia, also has a benefit for future research.


Eligibility criteria: Inclusion Criteria:

* pregnant women ,gestation age 32-34 weeks, normal pregnancy, plan to deliver spontaneously, no antibiotic
* tend to give exclusive breastfeeding
* want to join the research
* well doing baby

Exclusion Criteria:

* pregnant women with pre-eclampsia,bleeding,infection,premature rupture of the membrane or other chronic disease
* plan to deliver by caesarean section

Primary outcomes:
measure: Gastrointestinal microbiota examination by DNA extraction and real time PCR
timeFrame: 3 months
measure: Examination of IL-8 in breast milk
timeFrame: 3 months
measure: Examination of urine IFABP
timeFrame: 3 months
measure: Calprotectin examination in stool of infants aged 3 months
timeFrame: 3 months
measure: Alpha 1 antitrypsin
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Budi Kemuliaan Women and Children Hospital
state: Central Jakarta
Study officials:
References:
Clinical trial NCT03461744: Diagnostic Scoring for Small Bowel Obstruction
Official title: Diagnostic Scoring for Small Bowel Obstruction
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Small Bowel Obstruction
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2018-03-12
Enrollment: 482
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients presenting to surgical ER with abdominal complain are screened.

Brief summary: It is difficult to predict which patients with acute small bowel obstruction require operative intervention and which ones can be handled conservatively. Similarly, strangulation remains difficult decision. The rationale for this observative study is to collect prospective cohort of patients with small bowel obstruction to create scoring system to predict early 1) small bowel obstruction resistant to conservative therapy, 2) strangulation.


Eligibility criteria: Inclusion Criteria:

* Computed tomography verified acute small bowel obstruction

Exclusion Criteria:

* \< 18 years old
* Pregnant
* Abdominal surgery within 30 days prior recruitment
* Inflammatory bowel disease
* Small bowel tumor causing obstruction
* Peritoneal carcinosis
* Intraluminal obstruction (bile stone, bezoar, etc.)
* Large bowel obstruction
* Small bowel obstruction caused by abdominal wall hernia

Primary outcomes:
measure: Strangulation
timeFrame: Within hospital stay / 30 days from recruitment
measure: Need for surgery due to nonresolving small bowel obstruction
timeFrame: Within hospital stay / 30 days from recruitment
Secondary outcomes:
Other outcomes:
Locations:
city: Espoo
country: Finland
facility: Helsinki University Hospital, Jorvi hospital
city: Helsinki
country: Finland
facility: Helsinki University Hospital, Meilahti hospital
city: Hyvinkää
country: Finland
facility: Hyvinkää Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Ville Sallinen
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01201044: Study to Investigate Bronchial Arterrial Infusing (BAI) Plus Three-dimensional Conformal Radiotherapy (3DCRT) in Local Advanced Non-small Cell Lung Cancer (NSCLC)
Official title: A Randomized, Two Arm Study to Investigate Bronchial Arterrial Infusing (BAI) Plus Three-dimensional Conformal Radiotherapy (3DCRT) in Local Advanced Non-small Cell Lung Cancer (NSCLC)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Non-small Cell Lung Cancer
Keywords: BAI
3DCRT
Lead sponsor: Third Military Medical University
Sponsor class: OTHER
First posted: 2010-09-14
Enrollment: 80
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 purpose of this study is to investigate the efficacy of BAI Plus 3DCRT in local advanced NSCLC.


Eligibility criteria: Inclusion Criteria:

* stage IIIA\&IIIB NSCLC
* male or female, Age ≥18Years, ≤70Years
* Life expectation of at least 12weeks.
* PS performance 0-2
* Measurable disease according to the Response Evaluation Criteria in Solid Tumours ( RECIST)

Exclusion Criteria:

* Patient with prior chemotherapy or radiology for IIIA or IIIB NSCLC

Primary outcomes:
measure: Progression Free Survival
timeFrame: every 2 cycles
Secondary outcomes:
measure: Overall Survival
timeFrame: every 3 month after Progressive Disease
measure: Time to Progressive Disease (RECIST Criteria)
timeFrame: Every 2 cycles
Other outcomes:
Locations:
city: Chongqing
country: China
facility: The 3rd Affiliated Hospital of the 3rd Military Hospital
Study officials:
References:
Clinical trial NCT02195544: Use of Synvisc® in Knee Osteoarthritis - Survey on Practice
Official title: Use of SYNVISC in Knee Osteoarthritis. Survey on Practice. "U.S.A.G.E Pratique"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Osteoarthritis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2014-07-21
Enrollment: 70
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: rheumatological practice

Brief summary: Study of prescription methods in everyday medical practice, tolerance profile and effect of Synvisc® until six months of follow-up.


Eligibility criteria: Inclusion Criteria:

* not applicable

Exclusion Criteria:

* none

Primary outcomes:
measure: Change in clinical symptoms
timeFrame: up to 6 months
measure: Amount of medication consumed
timeFrame: up to 6 months
measure: Patient satisfaction on a 4-point verbal rating scale
timeFrame: up to 6 months
Secondary outcomes:
measure: Number of patients with adverse events
timeFrame: up to 6 months
Other outcomes:
Locations:
Study officials:
References: