louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT06048211: Impact of the Stool Color Scale on the Detection of Neonatal Cholestasis
Official title: Impact of the Stool Color Scale in the French Health Book on the Detection of Neonatal Cholestasis
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Neonatal Cholestasis
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 100
Sex: ALL
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: patient under 12 month with cholestasis who consult or was hospitalized for this reason.

Brief summary: The stool color scale was set in 2018 in the health books of French children. The study aim is to see if the scale is usefull for healthcare professionals and if this scale has advanced the detection of neonatal cholestasis.

Detailed description: The first part of the study consist in send a questionnaire to health professionnal to see their use of the stool color scale in the health book of newborn.

The second part of the study is to see the age of children with cholestasis at the date of the first consult with a specialist.

Eligibility criteria: Inclusion Criteria:

* cholestasis

Exclusion Criteria:

-

Primary outcomes:
measure: use of stool color scale
timeFrame: 4 month
Secondary outcomes:
Other outcomes:
Locations:
city: Nancy
country: France
facility: CHRU Nancy
Study officials:
References:
Clinical trial NCT04953611: Quantitative Study on HRCT Phenotype of COPD
Official title: Quantitative Study on HRCT Phenotype of the GOLD COPD Assessment Staging
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Pulmonary disease; chronic obstructive; Phenotype
Lead sponsor: Peking University Third Hospital
Sponsor class: OTHER
First posted: 2021-07-08
Enrollment: 150
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: consecutive outpatients

Brief summary: To explore the HRCT phenotype of the combined COPD assessment staging system

Detailed description: HRCT can be rapidly and safely deployed has enabled COPD research to move beyond FEV1 by facilitating and amplifying clinical phenotyping measurements, providing quantitative information, and detecting significant responses to therapy even in the absence of significant FEV1 improvements.

We explore the HRCT phenotype of the combined COPD assessment staging system,and found that:

1. Airway remodeling occurs in COPD patients. CT shows varying degrees of bronchial wall thickness, area increasing and emphysema as the new GOLD classification Group A-D arising.
2. The GOLD Combined assessment staging system helps doctors choose an individualized treatment for the COPD patients

Eligibility criteria: Inclusion Criteria:

1. Age between 40 and 80 (including 40 and 80)
2. It meets the diagnostic criteria for COPD
3. No language communication barriers, or the family members who know the condition can complete the questionnaire on behalf of the patient, and the data are reliable;
4. Voluntarily agree to participate in this study

Exclusion Criteria:

1. Older than 80 or younger than 40
2. Pregnant women
3. Complicating with other lung diseases, such as asthma, pneumonia, bronchiectasis, lung abscess, interstitial lung disease, confirmed and suspected lung cancer of lung shadow, active pulmonary tuberculosis, etc
4. Previous lung surgery
5. Cognitive dysfunction
6. Unable to cooperate with lung function test.

Primary outcomes:
measure: The severity of emphysema
timeFrame: Within an average of 3 days after diagnosis of COPD
measure: Indicator A of the severity of airway stenosis
timeFrame: Within an average of 3 days after diagnosis of COPD
measure: Indicator B of the severity of airway stenosis
timeFrame: Within an average of 3 days after diagnosis of COPD
measure: Indicator C of the severity of airway stenosis
timeFrame: Within an average of 3 days after diagnosis of COPD
measure: Indicator D of the severity of airway stenosis
timeFrame: Within an average of 3 days after diagnosis of COPD
Secondary outcomes:
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University Third Hospital
Study officials:
References:
Clinical trial NCT02110511: Body Responses to Bean Physical Form and "Beano"
Official title: Effects of Bean Form and Digestive Enzyme Availability on Postprandial Responses
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Appetite and Glucose Responses
Lead sponsor: Purdue University
Sponsor class: OTHER
First posted: 2014-04-10
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER

Brief summary: The aim of this study is to determine the effects of bean physical form (whole versus blended) and Beano on postprandial responses. The postprandial responses the investigators will examine include blood glucose, appetite, metabolic rate, physical symptoms, and mood. To accomplish this aim the investigators will conduct a randomized, placebo-controlled trial in overweight and obese but otherwise healthy (non-diabetic) men and women


Eligibility criteria: Inclusion Criteria:

* Aged 18-55 years old
* Body mass index (BMI) 18.5-40 kg/m2
* Generally healthy
* A non-smoker
* Any ethnicity
* Free of chronic diseases and not taking medications or dietary supplements known to affect energy regulation or appetite

Exclusion Criteria:

* Beano drug label warnings including galactosemia, severe liver or kidney disease, allergies or sensitivities to any of the ingredients in Beano
* Peri and postmenopausal women
* Pregnant or lactating women (currently and within the past 1 year)
* Currently dieting or consuming unusual or a medically prescribed diet
* Net weight loss or gain (\>5 lbs) within the last six months
* Consuming 1/2c per day or more of legumes, not including peanuts
* Having taken Beano any time in the past 3 months
* Extreme problems digesting beans
* Fasting glucose \>126 mg/dl
* Blood pressure \>140/90 mmHg
* Moderate intensity or higher intensity exercise \> 6 h/wk
* Predicted energy requirement \< 2000 kcal/d or \>4000 kcal/d

Primary outcomes:
measure: Appetite
timeFrame: 3 hours
Secondary outcomes:
measure: Blood glucose
timeFrame: 3 hours
measure: fasting and postprandial energy expentidure
timeFrame: 4 hours
measure: gastrointestinal symptoms
timeFrame: 3 hours
Other outcomes:
Locations:
city: West Lafayette
country: United States
facility: Purdue University
state: Indiana
Study officials:
References:
citation: Anguah KO, Wonnell BS, Campbell WW, McCabe GP, McCrory MA. A blended- rather than whole-lentil meal with or without alpha-galactosidase mildly increases healthy adults' appetite but not their glycemic response. J Nutr. 2014 Dec;144(12):1963-9. doi: 10.3945/jn.114.195545. Epub 2014 Oct 8.
Clinical trial NCT03540511: Postoperative Troponin in Renal Dysfunction After Cardiac Surgery
Official title: Prognostic Value of Postoperative Troponin in Patients With Renal Dysfunction Undergoing Cardiac Surgery
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Renal Dysfunction
Keywords: cardiac surgery
troponin
mortality
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2018-05-30
Enrollment: 5000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients with renal dysfunction who underwent cardiac surgery between 2004 and 2015 at Seoul National University Hospital

Brief summary: Elevated level of troponin is frequently observed among patients with renal dysfunction. Increase in troponin after cardiac surgery may predict postoperative outcome in cardiac surgery patients. However, the relationship between the increased troponin and outcome after cardiac surgery has not been fully elucidated in patients with renal dysfunction.

Detailed description: This is a retrospective observational study to evaluate the prognostic value of postoperative troponin in patients with renal dysfunction undergoing cardiac surgery. Electrical medical records of patients who underwent cardiac surgery between 2004 and 2015 will be assessed. Perioperative laboratory data including troponin and glomerular filtration rate, type of surgery, and outcome variables including mortality will be analysed to determine the prognostic value of postoperative value of postoperative troponin in patients with renal dysfunction undergoing cardiac surgery.

Eligibility criteria: Inclusion Criteria:

* Patients with renal dysfunction who underwent cardiac surgery between 2004 and 2015 at Seoul National University Hospital

Exclusion Criteria:

* Patients without laboratory information on glomerular filtration rate or troponin levels

Primary outcomes:
measure: mortality
timeFrame: through study completion, average 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Youn Joung Cho, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03059511: Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants
Official title: Pharmacokinetics of Nalbuphine After Intravenous and Intranasal Administration in Infants: A Single Center, Open-label, Prospective Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Pharmacokinetic
Lead sponsor: University Children's Hospital, Zurich
Sponsor class: OTHER
First posted: 2017-02-23
Enrollment: 51
Sex: ALL
Minimum age (years): 29
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To assess pharmacokinetics parameters for nalbuphine after intravenous and intranasal administration in infants. Also effect on pain score: Neonatal Infant Pain Score (NIPS) and safety will be evaluated with summary of Adverse Events.

Inclusion criteria are: Infants 29 days-3 months, minimum Body weight 3.0 kg, Indications: septical work up.

Exclusion criteria are: Infants who were born prematurely (before 37 weeks gestation), known kidney or liver disease, known chronic illness.


Eligibility criteria: Inclusion Criteria:

* Infants 29 days-3 months
* Minimum Body weight 3.0 kg
* Indications: septical work up
* Parent has been informed about the study and has signed Informed Consent Form

Exclusion Criteria:

* Infants who were born prematurely (before 37 weeks gestation)
* Known kidney or liver disease
* Known chronic illness
* Documented previous adverse reaction to nalbuphine
* Treatment with a depressant drug within 5 days prior to study
* Epistaxis, nose trauma (only for the intranasal application)
* Barriere of language

Primary outcomes:
measure: Pharmacokinetics (Area under the plasma concentration-time)
timeFrame: One Visit = approximately 6 hours
measure: Pharmacokinetics (Maximum Plasma concentration)
timeFrame: One Visit = approximately 6 hours
measure: Pharmacokinetics (Time to reach Maximum Plasma concentration)
timeFrame: One Visit = approximately 6 hours
measure: Pharmacokinetics (Half-life time)
timeFrame: One Visit = approximately 6 hours
measure: Pharmacokinetics (Bioavailability of Nalbuphine intranasal)
timeFrame: One Visit = approximately 6 hours
Secondary outcomes:
measure: Effect on pain (Neonatal Infant Pain Score)
timeFrame: One Visit = approximately 6 hours
measure: Adverse Events
timeFrame: One Visit = approximately 6 hours
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: Childens Hospital Zurich
Study officials:
affiliation: Chlidrens Hospital Zurich
name: Eva Berger, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pfiffner M, Gotta V, Pfister M, Vonbach P, Berger-Olah E. Pharmacokinetics and tolerability of intranasal or intravenous administration of nalbuphine in infants. Arch Dis Child. 2023 Jan;108(1):56-61. doi: 10.1136/archdischild-2022-323807. Epub 2022 Sep 13.
Clinical trial NCT04616911: Rerouting Seton Versus LIFT for Complex Anal Fistula
Official title: External Anal Sphincter-Sparing Seton After Rerouting Versus Ligation of Intersphincteric Fistula Tract (LIFT) In Treatment Of Complex Anal Fistula: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anal Fistula
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-11-05
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to compare the efﬁcacy of two surgical techniques in treatment of complex anal fistulas. The first technique involves rerouting of the fistula tract with placement of a vessel loop seton around the internal anal sphincter, sparing the external sphincter whereas the second technique entails ligation of inter-sphincteric fistulous tract (LIFT). The main objectives of the study are to assess the success rate, time to healing, change in quality of life, and complications of each procedure including fecal incontinence.


Eligibility criteria: Inclusion Criteria:

* Adult patients of either sex with complex anal fistula including high trans-sphincteric, supra-sphincteric, extra-sphincteric, and anterior fistula in female

Exclusion Criteria:

* Patients with simple anal fistulas, including intersphicnteric and low trans-sphincteric fistulas.
* ASA IV and V (The American Society of Anesthesiologists Physical Status classification system) unfit patients
* Patient with any grade of anal incontinence.
* Patients with concomitant anal pathology.

Primary outcomes:
measure: Clinical Healing of anal fistula
timeFrame: 12 months after surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Mansourah
country: Egypt
facility: Mansoura university hospital
state: Dakahlia
Study officials:
affiliation: Mansoura University
name: Sameh H Emile, M.D., FACS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04255511: Effects of Orthopedic Mandibular Advancement in Class II Division 1 Malocclusion on Pharyngeal Airway
Official title: Effects of Orthopedic Mandibular Advancement in Class II Division 1 Malocclusion Children on Pharyngeal Airway and Nocturnal Breathing ; Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ClassII Division 1 Malocclusion
Mandibular Retrognathism
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims at evaluating the effects of mandibular advancement on pharyngeal airway space and nocturnal breathing in children with skeletal class II division1 malocclusion. Fifty patients will be enrolled in the study divided into control and experimental groups.

Detailed description: The purpose of the present research is not only evaluate the effect of functional appliance on the pharyngeal airway space, but also evaluate its effect on nocturnal breathing of children with skeletal class II.

Eligibility criteria: Inclusion Criteria:

1. Skeletal class II division 1 malocclusion due to mandibular retrognathism.
2. Cephalometric angular measurements: SNA ≥ 82, SNB ≤ 78, ANB ≥ 4.
3. Overjet ≥ 6 mm.
4. Patient in circumpubertal stage CVM2 and CVM3.

Exclusion Criteria:

1. History of orthodontic treatment.
2. Presence of craniofacial anomalies or TMJ disorders.
3. Systemic problems that may affect craniofacial growth.
4. Abnormal oral habits.

Primary outcomes:
measure: Pharyngeal airway volume
timeFrame: One year
measure: Nocturnal breathing
timeFrame: One year
Secondary outcomes:
measure: Maximum expiratory pressure
timeFrame: One year
measure: Craniofacial changes
timeFrame: One year
measure: Craniofacial changes
timeFrame: One year
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University
Study officials:
affiliation: Mansoura University
name: Mona A Montasser, Phd
role: STUDY_CHAIR
affiliation: Mansoura University
name: Eman S Radwan, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00917228: A Wireless Lingual Feedback Device to Reduce Overpressures in Seated Posture: A Feasibility Study
Official title: A Wireless Lingual Feedback Device to Reduce Overpressures in Seated Posture: A Feasibility Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postural Behaviour
Overpressures Reductions
Lead sponsor: TIMC-IMAG
Sponsor class: OTHER
Collaborators: name: Olivier Chenu
name: Nicolas Vuillerme
name: Jacques Demongeot
name: Yohan Payan
First posted: 2009-06-10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young healthy subjects

Brief summary: This study evaluates the feasibility of a biofeedback system aimed at reducing overpressures during seated posture. The system consists of (1) a pressure sensors map, (2) a laptop that couples sensors with actuators, (3) a Tongue Display Unit (TDU) consisting of a wireless circuit embedded in a dental retainer with a matrix of electrodes. The principle of this biofeedback system consists in (1) detecting overpressures in people who are seated over long periods of time, (2) estimating a postural change that could reduce these overpressures and (3) communicating this change through directional information transmitted by the TDU.

It is hypothesized that overpressures are diminished after biofeedback.


Eligibility criteria: Inclusion Criteria:

* young healthy subjects

Exclusion Criteria:

* motor or sensory disabilities

Primary outcomes:
measure: Ability to reach a target posture
timeFrame: 10 seconds
measure: Decrease of the overpressures at the seat/body interface
timeFrame: 10 seconds
measure: Decrease of overpressures bigger for higher pressures
timeFrame: 10 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: La tronche
country: France
facility: Timc-Imag
Study officials:
References:
Clinical trial NCT06676111: Effectiveness of Probiotics in Relieving Allergic Rhinitis in Children
Official title: The Effectiveness of Probiotics in Relieving Allergic Rhinitis in Children and Their Regulatory Effect on the Gut Microbiota and Metabolic Profile
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Children With Allergic Rhinitis
Lead sponsor: Wecare Probiotics Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2024-11-06
Enrollment: 70
Sex: ALL
Minimum age (years): 4
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the clinical efficacy of probiotic gummies in the trial of allergic rhinitis in children compared to placebo, as well as the modulating effect on gut microbiota, serum metabolic profile, and occurrence of adverse reactions.


Eligibility criteria: Inclusion Criteria:

1. Age 4-14 years old;
2. Meet the diagnostic criteria for allergic rhinitis established in the Guidelines for the Diagnosis and Treatment of Allergic Rhinitis in Children (2022 Revised Edition);
3. Symptoms: 2 or more symptoms: sneezing, watery discharge, nasal itching and nasal congestion and other symptoms persist or accumulate for more than 1 hour per day, and may be accompanied by eye symptoms such as itching, watery eyes and red eyes;
4. Signs: pale and edema of the nasal mucosa, which may be accompanied by watery discharge;

Exclusion Criteria:

1. Drugs that affect the intestinal flora have been used continuously for more than 1 week within 1 month before screening;
2. Patients with pulmonary tuberculosis;
3. Combined with allergic asthma;
4. Those with nasal polyps or severe nasal septum deviation;
5. Patients with severe systemic diseases or malignant tumors;
6. Those with congenital genetic diseases and congenital immunodeficiency diseases;
7. Those who regularly use probiotics or prebiotics within 6 months before the screening period;
8. Those with severe digestive tract diseases (including severe diarrhea, inflammatory bowel disease, etc.);
9. Patients with metabolic syndrome (including obesity, dyslipidemia, hypertension, diabetes, etc.);
10. Patients with sinusitis, otitis media, or respiratory tract infection;
11. Those who are allergic to the probiotic-related ingredients used in this trial;
12. Subjects who are judged by other investigators to be insuitable to participate.

Primary outcomes:
measure: Total Nasal Symptom Score (TNSS)
timeFrame: 56 days
measure: Visual Analogue Scale (VAS)
timeFrame: 56 days
measure: Rhinoconjunctivitis-related quality of life questionnaire (RQLQ)
timeFrame: 56 days
measure: Medication scores
timeFrame: 56 days
Secondary outcomes:
Other outcomes:
Locations:
city: Luoyang
country: China
facility: Henan University of Science and Technology
state: Henan
Study officials:
References: