louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04606589: Feasibility Study Evaluating the Efficacy of a Wireless Vital Signs Monitor for Critically Ill Newborns in Kenya
Official title: Feasibility Study Evaluating the Efficacy of a Wireless Vital Signs Monitor for Critically Ill Newborns in Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Newborn Morbidity
Newborn Complication
Keywords: Newborn health
Newborn morbidity
Newborn critical care
Lead sponsor: Neopenda, PBC
Sponsor class: INDUSTRY
Collaborators: name: Center for Public Health and Development
First posted: 2020-10-28
Enrollment: 167
Sex: ALL
Minimum age (years): 1
Maximum age (years): 28
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: This is a simple pre/post interventional study model.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The neoGuard device is a 4-in-1 wearable vital signs monitor designed to continuously measure temperature, pulse rate (PR), respiratory rate (RR) and blood oxygen saturation (SpO2) in newborns. In this study, researchers will evaluate the feasibility of the neoGuard device at two rural health facilities in Western Kenya and assess the preliminary efficacy of the technology in improving health outcomes for newborns.

This is a pre/post intervention study. The standard-of-care arm (n=223) will be enrolled between 20 Oct - 20 Nov, 2020 and the neoGuard intervention arm (n=223) will be enrolled between 1 - 31 Dec, 2020.


Eligibility criteria: Inclusion Criteria:

* Age \<28 days
* Admitted to the neonatal intensive care unit
* Weight at birth/admission ≥2000 g
* Low-to-moderate disease severity as determined by the Signs of Inflammation in Children that Kill (SICK) score card (SICK score ≤2.4 at admission is eligible)
* Parent/guardian willing to provide informed consent for their newborn to participate in study

Exclusion Criteria:

* Age \>28 days
* Has a condition that impairs them from wearing the device, such as hydrocephaly.
* Weight at birth \<2000 g
* Very severe disease status (SICK score \>2.4 at admission)

Primary outcomes:
measure: In-hospital newborn mortality
timeFrame: From date of admission to date of discharge or referral or death, up to 28 days
Secondary outcomes:
measure: Complication rate
timeFrame: From date of admission to date of discharge or referral or death, up to 28 days
measure: Length of stay in hospital
timeFrame: From date of admission to date of discharge or referral or death, up to 28 days
Other outcomes:
measure: Mean alarm-response time
timeFrame: From date of admission to date of discharge or referral or death, up to 28 days
Locations:
city: Kakamega
country: Kenya
facility: Kakamega County Referral Hospital
Study officials:
affiliation: Center for Public Health and Development
name: Bernard Olayo, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05759689: Fat Supplementation on Dumping Syndrome Related Symptoms After Gastric Surgery
Official title: The Effect of Fat Supplementation on the Appearance of Symptoms Associated With Dumping Syndrome in Patients Undergone Gastric Surgery
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dumping Syndrome
Gastric Surgery
Keywords: Dumping syndrome
Fat supplement
Gastric surgery
Lead sponsor: Larissa University Hospital
Sponsor class: OTHER
First posted: 2023-03-08
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The purpose of the study is the investigation of the effect of fat supplement on gastric emptying rate and the appearance of symptoms of Dumping Syndrome in patients who have undergone gastrointestinal- duodenal surgery. Patients who have undergone bariatric surgery have been examined for the presence of the Dumping syndrome, with glucose measurements, the Sigstad's questionnaire and questionnaire of Arts. Patients diagnosed positive, reiterated the examination process in a second meeting consuming an extra fat supplement. The data obtained on the different appointments were compared between the two groups in a cross over design.


Eligibility criteria: Inclusion Criteria:

* Patients with Dumping Syndrome

Exclusion Criteria:

* Patients with diabetes mellitus type 1 and 2
* Patients with impaired balance of fluids and electrolytes
* Patients on diuretics pills or corticosteroids or hypoglycemic tablets and Insulin.

Primary outcomes:
measure: Glucose Levels
timeFrame: before the ingestion of the carbohydrate and fat supplement (baseline)
measure: Glucose Levels
timeFrame: 30 minutes after the ingestion of the carbohydrate and fat supplement
measure: Glucose Levels
timeFrame: 60 minutes after the ingestion of the the carbohydrate and fat supplement
measure: Glucose Levels
timeFrame: 90 minutes after the ingestion of the the carbohydrate and fat supplement
measure: Glucose Levels
timeFrame: 120 minutes after the ingestion of the the carbohydrate and fat supplement
measure: Sigstad's Questionnaire
timeFrame: 1st hour after the ingestion of the supplements
measure: Sigstad's Questionnaire
timeFrame: 2nd hour after the ingestion of the supplements
measure: Arts's Questionnaire
timeFrame: 1st hour after the ingestion of the supplements
measure: Arts's Questionnaire
timeFrame: 2nd hour after the ingestion of the supplements
Secondary outcomes:
Other outcomes:
Locations:
city: Larissa
country: Greece
facility: University Hospital Larissa
Study officials:
References:
Clinical trial NCT01820689: Tympanometric Analysis in Cleft Palate
Official title: Tympanometric Analysis in Post Surgical Individuals With Cleft Palate
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bilateral Complete Cleft Lip and/or Alveolus
Lead sponsor: Centro de Diagnostico Auditivo de Cuiaba
Sponsor class: OTHER
Collaborators: name: Federal University of Mato Grosso
First posted: 2013-03-29
Enrollment: 16
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Purpose: Characterize the profile of tympanometric patients with cleft lip and palate in the post surgery period and correlate it with the time of palatoplasty. Methods: The sample consisted of 16 patients with cleft lip or palate totaling 32 ears treated at a Public University Hospital in Cuiabá (MT)- Brazil, in the post surgery moment that varied from three months to 33 years. Were sampled patients of both sexes, pediatrics and adults.


Eligibility criteria: Inclusion Criteria:

* cleft incisive trans unilateral or bilateral
* post-foramen complete or incomplete

Exclusion Criteria:

* isolated cleft lip
* associated syndromes
* malformation of ear

Primary outcomes:
measure: Tympanic membrane mobility
timeFrame: 3 months to 33 years
Secondary outcomes:
measure: Time of palatoplasty
timeFrame: 3 months to 33 years
Other outcomes:
Locations:
Study officials:
affiliation: HUJM
name: P A Rodrigues, Doctor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01615289: Neural Effects of Green Tea Extract on Dorsolateral Prefrontal Cortex
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Exploratory Behavior
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2012-06-08
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: Green tea is being recognized as a beverage with potential benefits for human health and on cognitive function. In vitro and in vivo studies provide preliminary evidence that green tea intake may play a positive role in improving effects on cognitive functions. The investigators aim to examine the neural effects of green tea extract on brain activation in humans.

Detailed description: As functional neuroimaging provides a means of examining how green tea extract acts on the brain, we used functional magnetic resonance imaging (fMRI) to study healthy volunteers while they performed a working memory task following intra-gastric administration of either 250 ml or 500 ml Rivella green® (RG), a milk whey based green tea extract containing soft drink, or Rivella blue® (RB), a milk whey based soft drink without green tea extract as sham condition in a double-blind, controlled design. Based on the literature on pharmacological and behavioural effects of green tea, we hypothesized - a priori - that green tea extract would subtly modulate the engagement of the dorsolateral prefrontal cortex (DLPFC), a brain region critically involved in many cognitive functions such as working memory processing.

A double-blind, controlled, within-subject study with counterbalanced order of substance administration using an established protocol (6-8) was conducted over 4 sessions (250 ml or 500 ml Rivella green® (including green tea extract; RG), 250 or 500 ml Rivella blue® (RB). Each participant was scanned four times with a one-week interval between scans. The order of substance administration across sessions was counterbalanced across subjects, such that equal numbers followed each substance sequence.

Eligibility criteria: Inclusion Criteria:

* right-handed healthy males, no drugs, non-smoking

Exclusion Criteria:

* drug abuse, smoker, left-handed

Primary outcomes:
measure: Functional magnetic resonance imaging (fMRI) in healthy volunteers while they performed a working memory task
timeFrame: 0 and 45 min
Secondary outcomes:
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Christoph Beglinger, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02664389: Targeted Next-generation Sequencing Panel for Identification of Germline Mutations in Early Onset Cancers With Sporadic or Hereditary Presentation
Official title: Targeted Next-generation Sequencing Panel for Identification of Germline Mutations in Early Onset Cancers With Sporadic or Hereditary Presentation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Ovarian Cancer
Colorectal Cancer
Pediatric Cancers
Multiple Primary Malignant Tumours
Lead sponsor: University Hospital, Rouen
Sponsor class: OTHER
First posted: 2016-01-27
Enrollment: 289
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: Despite relevant clinical and/or familial presentations suggesting a hereditary predisposition (early-onset, multiple primary tumors, familial aggregation), targeted genomic analysis based on the phenotype are often non contributive. As somatic cancer genes are limited, the hypothesis is that the targeted next-generation sequencing of 200 genes, selected for their implications in cancers may contribute to the understanding of many selected patients' presentation by the identification of germline deleterious mutations, and may identified phenotype overlapping and/or mosaicisms. The focus will be put on early-onset breast, ovarian, colorectal cancer or pediatric cancers and multiple primary tumors.


Eligibility criteria: Inclusion Criteria :

* Older than 18 or parental agreement in case of children.

For patient with early-onset breast cancer :

* Invasive breast cancer, regardless of histological type or stage, diagnosed before 31 years.
* Sporadic or familial presentation
* No genomic alterations of BRCA1, BRCA2 or TP53

For patient with early-onset ovarian cancer :

* Invasive ovarian cancer, regardless of histological type or stage, diagnosed before 41 years.
* Sporadic or familial presentation
* No genomic alterations of BRCA1, BRCA2

Patient with early-onset colorectal cancer :

* Invasive colorectal cancer diagnosed before 31 years.
* Sporadic or familial presentation
* No genomic alteration of MSH2, MLH1 or MSH6 in case of HNPCC presentation
* No genomic alteration of APC, MUTYH, SMAD4, BMPR1A, PTEN or STK11 in case of adenomatous polyposis or hamartoma presentation

Patient with pediatric cancer :

* Non haematological tumour diagnosed before 16 years, with Li-Fraumeni presentation.
* No genomic alteration of TP53

Patient with Multiple primary malignant tumours :

* Multiple synchronous or metachronous primary malignant tumors with early-onset
* No syndromic presentation

Exclusion Criteria:

* Any already known deleterious mutations according to the patient's phenotype

Primary outcomes:
measure: Frequency of germline deleterious mutations
timeFrame: Day 1
Secondary outcomes:
Other outcomes:
Locations:
city: Rouen
country: France
facility: Rouen University Hospital
Study officials:
affiliation: University Hospital, Rouen
name: Thierry FREBOURG, Pr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01017289: Intramedullary Fixation of Humerus Fractures
Official title: A Study Evaluating the Quantum - Composite Nailing System for Intramedullary Fixation of Humerus Fractures
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Humeral Fractures
Pathological Fractures
Lead sponsor: N.M.B. Medical Applications Ltd
Sponsor class: INDUSTRY
First posted: 2009-11-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to evaluate the safety and efficacy of the composite Nail - the Quantum interlocking intramedullary nailing system in the reduction of humeral fractures.

Detailed description: The study will include 20 patients who have an acute mid shaft diaphyseal humeral fracture due to injury. The patients will undergo lateral and AP X- ray evaluation of the fracture. Following General anesthesia, closed reduction of the fracture will be performed. It will be followed by nail insertion, percutaneously, according to standard surgical techniques, with the help of the insertion handle. Following insertion the nail will be locked both distally and proximally using interlocking screws. The nail and screws insertion will be monitored by fluoroscopy. Patients will remain under follow up for 6 months following the procedure. In the follow up sessions the fracture will be evaluated by fluoroscopy or X-ray for correct bone alignment, callus formation, and fracture union.

Eligibility criteria: Inclusion Criteria:

* Above 18 years old.
* Mid shaft diaphyseal fracture
* Acute fracture

Exclusion Criteria:

* Patients with metabolic or hormonal diseases that could affect bone healing such as diabetes.
* Ongoing infection in fracture site.

Primary outcomes:
measure: Bone union and callus formation
timeFrame: up to 6 months
measure: Bone alignment
timeFrame: up to 6 months
measure: Nail and screws resistance over time
timeFrame: up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
Study officials:
affiliation: Rabin hospital
name: Michael Berenstein, md
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06165289: Endoscopic Balloon Dilatation Combined With PRP Injection in Colonic Stenosis in Crohn's Disease
Official title: Efficacy and Safety of Endoscopic Balloon Dilatation Combined With Autologous Platelet-rich Plasma (PRP) Injection in Colonic Stenosis in Crohn's Disease
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Crohn Disease
Lead sponsor: Sixth Affiliated Hospital, Sun Yat-sen University
Sponsor class: OTHER
First posted: 2023-12-11
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aim was to investigate whether endoscopic balloon dilatation combined with PRP injection can help prevent or prolong restenosis in patients with Crohn's disease with colonic stenosis, and to explore the concentration of PRP. The study was a single-center, randomized, non-controlled study. Experimental group of patients underwent endoscopic balloon dilation and submucosal injection of PRP (PRP prepared by the blood transfusion department of our hospital) at the wound edge, historical control was used, and the patients included in the study were randomly divided into high concentration group and low concentration group.


Eligibility criteria: Inclusion Criteria:

* Diagnosed as CD;

  * Stenosis of the colon was found during colonoscopy, and surgery was not considered for the time being; ③ Imaging stenosis was found, that is, CTE suggested stenosis with proximal intestinal dilatation \>3cm;

    * Narrow length \<5cm; ⑤ The patients agreed to undergo endoscopic balloon dilatation and voluntarily signed the informed consent to participate in this study, and were capable of complying with the agreement.

Exclusion Criteria:

* The patient has contraindications for endoscopic therapy, such as coagulation disorder, severe cardiopulmonary dysfunction, active bleeding, and inability to cooperate.

  * Deep and large active ulcer was found in the stenosis;

    * \< 18 years old;

      ④ Foreign patients;

      ⑤ Patients with a history of malignant tumors, including melanoma (except local skin cancer);

      ⑥ Pregnant or nursing patients;

      ⑦ Patients who could not be followed at all nodes of the primary outcome indicator; Other diseases that researchers believe could put patients at risk;

      ⑧ Other diseases that researchers believe could put patients at risk.

Primary outcomes:
measure: restenosis rate
timeFrame: 3 months after endotherapy
Secondary outcomes:
measure: Changes in intestinal ultrasound
timeFrame: 3 months after endotherapy
measure: Proportion of surgery
timeFrame: 1 year after endotherapy
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00688389: Investigation of the Immuno-regulation and Viral Hepatitis Among Patients With or After Dengue Fever Infection
Official title: Follow-up the Health Condition , Investigation of the Immuno-regulation , and the Study for Interaction of Viral Hepatitis--- Among Patients With or After Dengue Fever Infection
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Dengue Fever
Keywords: Dengue fever, CLEC5A, Mannose receptor, DC-SIGN, NALP,
decoy receptor 3 (DcR3), Toll-like receptors(TLRs),
(Nod)-like receptors (NLRs)
Lead sponsor: Kaohsiung Medical University Chung-Ho Memorial Hospital
Sponsor class: OTHER
Collaborators: name: Centers for Disease Control and Prevention
First posted: 2008-06-02
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The samples are obtained from the Kaohsiung Medical University Chung-Ho Memorial Hospital in Kaohsiung, Taiwan.

Brief summary: The study will collect the blood samples from 350 healthy persons and 350 persons infected with dengue fever.

Detailed description: Research has showed that CLEC5A interacts with dengue virion directly, and is responsible for dengue virus (DV)-induced DAP12 phosphorylation. Data suggests that CLEC5A is a potential therapeutic target for dengue hemorrhagic fever (DHF)/dengue shock syndrome (DSS). This project will study the genes of CLEC5A, Mannose receptor, DC-SIGN, NALP, decoy receptor 3 (DcR3), Toll-like receptors(TLRs), and (Nod)-like receptors (NLRs) for both DF and DHF groups. In addition, serum level of decoy receptor 3 (DcR3) will be tested. The study will collect the blood samples from 350 healthy persons and 350 persons infected with dengue fever.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of Dengue fever

Exclusion Criteria:

* none

Primary outcomes:
measure: 檢查肝臟、腎臟及其他生化功能，並分析宿主免疫調控及血小板變化機致
timeFrame: 2007/7/1
Secondary outcomes:
Other outcomes:
Locations:
city: Kaohsiung
country: Taiwan
facility: Kaoshing Medical University Chung-Ho Memorial Hospital
Study officials:
References:
Clinical trial NCT03617289: Efficacy of Magnesium Sulfate on Reducing Renal Colic in the Emergency Department
Official title: Efficacy of Magnesium Sulfate on Reducing Renal Colic in the Emergency Department
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Renal Colic
Lead sponsor: Henry Ford Health System
Sponsor class: OTHER
First posted: 2018-08-06
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To determine if magnesium sulfate paired with an analgesic medication will improve patient pain from renal colic compared with analgesic alone.


Eligibility criteria: Inclusion Criteria:

* Age \>18 years old and \<100 years old.
* Patients seen in the Emergency Department at Henry Ford Macomb hospital.
* Patients that are A+Ox3.
* Patients who have typical presentation for renal colic.

Exclusion Criteria:

* Age \<18 years.
* Patients with a history of dementia, acute delirium or altered mental status.
* Patients with inability to consent to study or inability to fill questionnaire independently.
* Patients with chronic kidney disease and allergies to study drugs.
* Patients that are pregnant (women who are of child-bearing potential will be screened with a urine BHCG).
* Patients with stroke activation or symptoms.
* Patients with trauma activations.
* Patients over the age of 100 years old are excluded as they make up a small percentage of the population and may become identifiable because of their age.
* Imaging study does not show evidence of ureteral stone.

Primary outcomes:
measure: Pain Score Change
timeFrame: 1 hour after the completion of treatment medication (Placebo or Study Drug)
Secondary outcomes:
measure: Percentage of Participants Requiring Opiates for Additional Pain Control
timeFrame: Any opiate administration required after re-evaluation of pain score after initial treatment with either placebo or study drug
Other outcomes:
Locations:
Study officials:
References: