louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04491487: Pre-operative Counselling in Laryngectomized Patients
Official title: Effects of Pre-operative Speech-Language Pathology Counselling in Patients Undergoing to Total Laryngectomy: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Total Laryngectomy
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Sponsor class: OTHER
First posted: 2020-07-29
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The investigators aim to verify the effects of pre-operative Speech-Language Pathology (SLP) counselling on patients undergoing total laryngectomy in terms of levels of distress, post-traumatic stress symptoms, anxious-depressive symptoms, acquisition and acceptance of the new voice.

This is a randomized controlled trial (RCT) of patients undergoing total laryngectomy and primary tracheoesophageal puncture. Patients will be randomized into two groups: an Experimental group that will receive a pre-operative SLP counselling session and a Control group that will not receive it. The investigators will administer a structured interview and three questionnaires: the Impact of Event Scale - Revised (IES-R), the Psychological Distress Inventory (PDI), the Hospital Anxiety and Depression Scale (HADS). The data will be collected between the 5th and 7th day after surgery (T0), 1-month (T1) and 3-months (T2) after being discharged from hospital.


Eligibility criteria: Inclusion Criteria:

* age 18 years and over;
* patients waiting for TL and primary TEP;
* patients able and willing to provide written informed consent.

Exclusion Criteria:

* positive history for psychiatric or psychological disorders,
* neurological disorders,
* ineligibility for voice prosthesis rehabilitation.

Primary outcomes:
measure: Impact of Event Scale-revised
timeFrame: Between the fifth and seventh post-operative day (T0)
measure: Impact of Event Scale-revised
timeFrame: one month after being discharged from hospital (T1)
measure: Impact of Event Scale-revised
timeFrame: three months after being discharged from hospital (T2)
Secondary outcomes:
measure: Psychological Distress Inventory
timeFrame: Between the fifth and seventh post-operative day (T0)
measure: Psychological Distress Inventory
timeFrame: one month after being discharged from hospital (T1)
measure: Psychological Distress Inventory
timeFrame: three months after being discharged from hospital (T2)
measure: Hospital Anxiety and Depression Scale
timeFrame: Between the fifth and seventh post-operative day (T0)
measure: Hospital Anxiety and Depression Scale
timeFrame: one month after being discharged from hospital (T1)
measure: Hospital Anxiety and Depression Scale
timeFrame: three months after being discharged from hospital (T2)
Other outcomes:
Locations:
city: Roma
country: Italy
facility: Fondazione Policlinico Universitario A.Gemelli IRCCS
Study officials:
affiliation: Otolaryngology department
name: Longobardi
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05595187: Concomitant Tricuspid Repair in Patients With Left Heart Surgery
Official title: Concomitant Tricuspid Repair in Patients With Left Heart Surgery: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Tricuspid Regurgitation
Mitral Regurgitation
Cardiopulmonary Bypass
Lead sponsor: Nanjing Medical University
Sponsor class: OTHER
First posted: 2022-10-26
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Tricuspid regurgitation is common in patients with severe left heart diseases, such as degenerative mitral regurgitation. However, the evidence base is insufficient to inform a decision about whether to perform concomitant tricuspid-valve repair during left heart surgery in patients who have mild tricuspid regurgitation. To inform decision making, we will conduct a multicenter, randomized trial to assess the benefits and risks of tricuspid-valve repair at the time of left heart diseases in patients with mild tricuspid regurgitation who were undergoing surgery for left heart surgery.


Eligibility criteria: Inclusion Criteria:

1. Patients undergoing left heart valve surgery with mild tricuspid regurgitation;
2. Patients aged 18-80 years;
3. Agree to participate in this study and sign the informed consent form.

Exclusion Criteria:

1. Infective endocarditis within 3 months;
2. Primary tricuspid regurgitation;
3. Isolated tricuspid regurgitation
4. Lactating women and suspected pregnant or pregnant women;
5. Patients with mental disorders, drug and alcohol dependence;
6. Those who participated in other clinical trials one month before the trial;
7. Refusal to participate in this study without informed consent.

Primary outcomes:
measure: A composite of adverse cardiovascular events
timeFrame: 2 years after surgery at follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: The First Affiliated Hospital of Nanjing Medical University
Study officials:
References:
Clinical trial NCT01193387: Comparison of Two Identical NN1250 Formulations in Healthy Volunteers
Official title: A Trial to Test for Bioequivalence Between Identical NN1250 Formulations, IM1 and IM2, in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Healthy
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-09-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This trial is conducted in Europe. The aim of this clinical trial is to investigate if two identical formulations of NN1250 (insulin degludec, IDeg) have the same level of drug exposure to the body.


Eligibility criteria: Inclusion Criteria:

* Considered generally healthy upon completion of medical history, physical examination, vital signs and electrocardiogram (ECG), as judged by the Investigator
* Body mass index 18.0-27.0 kg/m\^2 (both inclusive)

Exclusion Criteria:

* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening
* Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day)
* Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period
* Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods (adequate contraceptive measures include sterilisation, hormonal intrauterine devices, oral contraceptives, sexual abstinence or vasectomised partner)

Primary outcomes:
measure: Area under the Insulin Degludec concentration-time curve
timeFrame: From 0 to 120 hours after single-dose
measure: Maximum observed Insulin Degludec concentration
timeFrame: From 0 to 120 hours after single-dose
Secondary outcomes:
measure: Area under the Insulin Degludec concentration-time curve
timeFrame: From 0 to infinity after single-dose
Other outcomes:
Locations:
city: Neuss
country: Germany
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452)
role: STUDY_DIRECTOR
References:
Clinical trial NCT02589587: Enteroendocrine Cells Before and After Sleeve Gastrectomy
Official title: Enteroendocrine Cells in Lean Controls and Healthy Subjects Before and After Sleeve Gastrectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obesity
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
First posted: 2015-10-28
Enrollment: 40
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: BASIC_SCIENCE

Brief summary: Morbidly obese patients exhibit impaired secretion of satiation hormones which may contribute to the development of obesity. Bariatric surgery is associated with weight loss and dramatic increase in the secretion of satiation hormones, but the underlying mechanism remains unknown. The investigator's goal is therefore to examine patients before and after sleeve gastrectomy and compare findings to lean controls.

Detailed description: Morbidly obese patients exhibit impaired secretion of satiation hormones cholecystokinin (CCK), glucagon-like peptide 1 (GLP-1) and peptide YY (PYY), which may contribute to the development of obesity. Bariatric surgery is associated with weight loss and dramatic increase in the secretion of satiation hormones, but the underlying mechanism remains unknown. A better understanding of mechanisms involved will assist in development of non-invasive therapeutic strategies. The investigator's goal is therefore to examine patients before and after sleeve gastrectomy and compare findings to lean controls. Gastric and intestinal mucosa will be collected by endoscopy from morbidly obese subjects before and 3 months after sleeve gastrectomy. In Addition, lean controls will be examined. Expression of various gut peptides will be assessed by immunohistochemistry and quantitative polymerase chain reaction (PCR).

Eligibility criteria: Inclusion Criteria:

Morbidly obese patients scheduled for sleeve gastrectomy

* BMI \> 35 kg/m2
* Age: \> 18-65 years Lean, healthy controls
* BMI \> 18 and \< 28kg/m2
* Age: \>18-40 years

Exclusion Criteria:

* Bleeding diathesis
* Previous surgery on the gastrointestinal tract (appendectomy acceptable)

Primary outcomes:
measure: Quantification of the enteroendocrine cell population
timeFrame: within 3 months after surgery
Secondary outcomes:
measure: Determination of tissue morphology (crypt depth, villus height)
timeFrame: within 3 months after surgery
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Christoph Beglinger, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06926387: Bioequivalence Study betweenYHP2407 and YHR2502 in Healthy Subjects
Official title: An Open-label, Randomized, Single-dose, Oral Administration, 2-sequence, 2- Period, Crossover Study to Evaluate Bioequivalence Between YHP2407 and YHR2502 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Volunteer
Keywords: Pharmacokinetics
Bioequivalence
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2025-04-13
Enrollment: 43
Sex: ALL
Minimum age (years): 19
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: A randomized, open-label, single-dose, 2-sequence, 2-period, crossover clinical trial to investigate the bioequivalence between YHP2407 and YHR2502 in healthy volunteers

Detailed description: 40 healthy subjects will be randomized to one of the 2 groups in the same ratio.

Subjects in group 1 will be administered "comparator" and "YHP2407" by crossover design on period 1, 2. Subjects in group 2 will be administered "YHP2407" and "comparator" by crossover design on period 1, 2.

Eligibility criteria: Inclusion Criteria:

* BMI 18-30 kg/m2
* Those without clinically significant congenital or chronic diseases

Exclusion Criteria:

* Those who have participated in a bioequivalence study or other clinical trials and have been administered with investigational products in 6 months prior to the first administration.
* Others who are judged ineligible to participate in the trial by the principal investigator.
* Female volunteers who are pregnant, suspected to be pregnant or breastfeeding.

Primary outcomes:
measure: Area under the plasma drug concentration-time curve [AUCt]
timeFrame: 0-6 hours
measure: Maximum plasma concentration [Cmax]
timeFrame: 0-6 hours
Secondary outcomes:
measure: Area under the plasma drug concentration-time curve from time 0 to infinity [AUCinf]
timeFrame: 0-6 hours
measure: Area under the plasma drug concentration-time curve/Area under the plasma drug concentration-time curve from time 0 to infinity [AUCt/AUCinf]
timeFrame: 0-6 hours
measure: Time of peak concentration [Tmax]
timeFrame: 0-6 hours
measure: Terminal phase of half-life [t1/2]
timeFrame: 0-6 hours
Other outcomes:
Locations:
city: Gimpo-si
country: Korea, Republic of
facility: Gimpo Woori Hospital
state: Gyeonggi-do
Study officials:
affiliation: Gimpo Woori Hospital
name: Hyejin Lim
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01500187: Fluoride Varnish for Treatment of White Spot Lesions
Official title: Fluoride Varnish Application for Treatment of White Spot Lesion After Fixed Orthodontic Treatment. A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: White Spot Lesions
Keywords: white spot lesions
fixed orthodontic brackets
fluoride varnish
fluoride gel
Lead sponsor: Solventum US LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Tennessee
name: 3M
First posted: 2011-12-28
Enrollment: 38
Sex: ALL
Minimum age (years): 12
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Study will look at ability of fluoride varnish to remineralize white spot enamel lesions that can occur around the edge of fixed orthodontic brackets.

Detailed description: To determine the efficacy of 5% sodium fluoride varnish with tricalcium phosphate in reverting white spot lesions after fixed orthodontic treatment, compared with a fluoride gel.

Eligibility criteria: Inclusion Criteria:

* no systemic disease
* has completed fixed orthodontic treatment, brackets debonded
* has at least two teeth with whitre spot lesions
* has received conventional periodontal therapy after orthodontic tretament

Exclusion Criteria:

* presence of enamel hypoplasia or dental fluorosis
* presence of tetracycline pigmentation
* periodontal pocketing of 3mm or greater
* taking antibiotics
* presence of carious cavities
* allergy to fluoride gel / varnish being used in study

Primary outcomes:
measure: DIAGNOdent Readings at Baseline, Three and Six Months - Intergroup Comparison
timeFrame: Baseline, Three and Six Month
Secondary outcomes:
Other outcomes:
Locations:
city: Memphis
country: United States
facility: College of Dentistry
state: Tennessee
Study officials:
affiliation: University of Tennessee
name: Franklin Garcia-Godoy, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04286087: Assessment of Clinical Outcomes in Closure of Deep Neck Space Infection Incisions
Official title: Assessment of Clinical Outcomes in Closure of Deep Neck Space Infection Incisions
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Deep Neck Space Infections
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2020-02-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
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 if closure of deep neck infection incisions at the time of extraoral drain removal has any impact on rates of reinfection and to determine if this treatment will have any impact on scar formation and qualitative measures of pain or impact on quality of life during the post-operative healing period.


Eligibility criteria: Inclusion Criteria:

* deep neck space infection
* who require a conservative unilateral submandibular neck incision to access affected deep fascial neck spaces

Exclusion Criteria:

* pregnant females
* cognitively impaired individuals
* deep neck space infections which require bilateral neck incisions, large neck apron incisions, or placement of negative pressure therapy.

Primary outcomes:
measure: Number of participants with reinfection
timeFrame: 1-2 weeks post intervention
Secondary outcomes:
measure: Number of participants requiring a scar revision surgery
timeFrame: 4-6 months post intervention
Other outcomes:
Locations:
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Craig Pearl, BDS
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04145687: Metformin In Prevention of Lupus Nephritis
Official title: Metformin In Prevention Of Lupus Nephritis In High Risk Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Lupus Nephritis
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2019-10-31
Enrollment: 30
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: PREVENTION

Brief summary: Lupus nephritis (LN) is a main manifestation of systemic lupus erythematosus (SLE), which will largely effect the prognosis of SLE patients. Our previous 10-year data showed that the development of LN is most common in the first year of SLE, occupying about 17%. And our group has established a prediction model to predict the 1-year probability of LN for SLE patients without renal involvement. Our previous proof-of-concept trial and multicenter, randomized, double-blind, placebo-controlled trial indicated that metformin seemed to have potential to reduce the new-onset of LN in SLE patients (Unpublished data, in review). So the investigators tried to illustrate whether metformin has effect to prevent the development of lupus nephritis in high risk SLE patients based on LN prediction model.


Eligibility criteria: Inclusion Criteria:

* New-onset of SLE (within 1 year)
* Meet the 1997 ACR criteria of SLE
* 1-year risk of developing LN higher than 50% based on LN prediction model.
* All the patients received standard care of therapy. (mycophenolate/azathioprine/cyclosporin/tacrolimus/methotrexate/leflunomide were allowed).
* Sign the informed consent.

Exclusion Criteria:

* Patients with kidney involvement at screening were excluded
* Patients with severe SLE were excluded, such as neuropsychiatric and cardiac involvement
* Cyclophosphamide or biologics were not allowed.
* Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) \> 2 times upper normal limits; creatinine clearance rate \< 60ml/min;
* Previous exposure of metformin within 30 days before screening; or previous history of intolerant to metformin;
* Patients who diagnosed of diabetes mellitus;
* Pregnancy or lactation.

Primary outcomes:
measure: Prevention of new-onset LN
timeFrame: 12 months
Secondary outcomes:
measure: Change of SLEDAI score
timeFrame: 12 months
measure: Change of Prednisone
timeFrame: 12 months
measure: Time to onset of LN
timeFrame: 12 months
measure: Change of proteinuria
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Fangfang Sun, MD
state: Shanghai
Study officials:
References:
Clinical trial NCT02714387: Non Traumatic Neuro-Vascular Diseases Critical Complications : a Prospective Cohort Study
Official title: Prospective Cohort of Patients Hospitalized in West French Intensive Care Units.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Non Traumatic Acute Brain Injury
Keywords: Non traumatic acute brain injury
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2016-03-21
Enrollment: 5000
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in ICU for Non Traumatic Neuro-Vascular Diseases

Brief summary: The purpose of this observational epidemiological study is to investigate the management and the complications associated with Non Traumatic Neuro-Vascular Diseases. Data will be analysed to answer pre-defined scientific projects and to improve management of these conditions.

Detailed description: Anonymous data will be collected by study coordinators in a secured e-database. Cross audit will be performed to check data.

Eligibility criteria: Inclusion Criteria:

* Non Traumatic Neuro-Vascular Diseases

Exclusion Criteria:

* Consent withdrawal

Primary outcomes:
measure: in ICU stay complications
timeFrame: Within the first 28 days after ICU admission date
Secondary outcomes:
measure: Duration in mechanical ventilation
timeFrame: in ICU (up to 90 days)
measure: ICU length of stay
timeFrame: in ICU (up to 90 days)
Other outcomes:
measure: Death
timeFrame: in ICU (up to 180 days)
Locations:
city: Angers
country: France
facility: Angers University Hospital
city: Brest
country: France
facility: CHU de Brest La Cavale Blanche
city: Nantes
country: France
facility: Nantes University Hospital
city: Poitiers
country: France
facility: Poitiers University Hospital
city: Rennes
country: France
facility: Rennes University Hospital
city: Tours
country: France
facility: Tours University Hospital
Study officials:
name: Karim Asehnoune, PhD, MD
role: STUDY_CHAIR
References:
Clinical trial NCT05909787: Prevalence of Oral Disorders in Children in ENT Pathologies
Official title: Prevalence of Oral Disorders in Children Identified by Parents in the Context of ENT Pathologies
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eating Disorders
Language Disorders
Keywords: Eating disorders
Language disorders
Childhood
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-06-18
Enrollment: 2000
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: Many children have eating and verbal oral disorders. Our research entitled: PREORA aims to study the prevalence of oral disorders presented in children consulting in ENT department for three months (n = 2000). This first study will be carried out by passing the MCH (Montreal Children's Hospital) feeding scale, a self-questionnaire completed by the parents, in order to assess the presence of disorders according to the parents and will allow us to present oral disorders (Score \> 70).

Detailed description: Over a period of inclusion of 3 months, the doctors of the departement ONT, Robert Debré Hospital, will give written and oral information to the holders of parental authority and to the child at the beginning of the consultation. After a 15-minute reflection period (consultation time), if they agree to participate, parents will answer the doctor's questions and then complete the self-questionnaire.

Eligibility criteria: Inclusion Criteria:

* Patients consulting at ENT departement Robert Debré Hospital
* Age 0-17 years
* Parents and children informed and given their oral consent for the study and speaking french

Exclusion Criteria:

* Refusal of parents/children to participate

Primary outcomes:
measure: Difficulty in feeding
timeFrame: 50 minutes
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Natacha TEISSIER, PhD
role: PRINCIPAL_INVESTIGATOR
References: