louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05736120: Persons With Obesity (PwO) Exploratory Research
Official title: Persons With Obesity (PwO) Exploratory Research - India
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Obesity
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2023-02-21
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study participants will be recruited to participate in 2 types of qualitative research. Online Bulletin Boards and Virtual Focus Groups

Brief summary: The purpose of this study is to understand the personal flow along the weight loss management journey. A range of variables will be addressed in a survey to explore the weight loss journey, barriers and management. Topics include weight loss strategies and challenges, HCP involvement, and perceptions towards weight loss medications.

Potential participants will be recruited using various online panels. Study participants will be recruited to participate in 2 types of qualitative research.

Phase I: Online bulletin boards (OBB) Phase II: Virtual focus groups (real-time)


Eligibility criteria: Inclusion Criteria:

1. Informed consent obtained before any study-related activities (study-related activities are any procedure related to recording of data according to the protocol).
2. Male or female, age above or equal to 18 years at the time of signing informed consent.
3. Current body mass index (BMI) of 25 or greater
4. Not currently pregnant
5. Does not participate in intense fitness or body building program
6. Weight loss not through illness or injury
7. At least somewhat concerned about current weight
8. If no plans for weight loss in the next six months, has made at least 1 weight loss effort in last 5 years
9. Struggling with weight for at least 3 years

Exclusion Criteria:

1. Previous participation in this study. Participation is defined as having given informed consent in this study
2. Mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation
3. Does not meet inclusion criteria.

Primary outcomes:
measure: Description of perceptions, behaviours and awareness related to obesity and obesity management among people living with obesity.
timeFrame: 5 days (Phase 1)
measure: Description of perceptions, behaviours and awareness related to obesity and obesity management among people living with obesity.
timeFrame: 1 day (Phase 2)
measure: Assessment of triggers for people with obesity to request medical therapy and expectations for both therapy available and their weight loss journey.
timeFrame: 5 days (Phase 1)
measure: Assessment of triggers for people with obesity to request medical therapy and expectations for both therapy available and their weight loss journey.
timeFrame: 1 day (Phase 2)
Secondary outcomes:
Other outcomes:
Locations:
city: Bengaluru
country: India
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Clinical Transparency (dept. 2834)
role: STUDY_DIRECTOR
References:
Clinical trial NCT06802120: Effects of Osteopathic Management on Disability and Quality of Life After Lumbar Arthrodesis
Official title: Effects of Osteopathic Management on Disability and Quality of Life After Lumbar Arthrodesis. A PARALLEL, RANDOMIZED AND DOUBLE-BLIND CONTROLLED PILOT STUDY
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chirurgical Intervention
Lead sponsor: Clinique Bizet
Sponsor class: OTHER
Collaborators: name: Institut De La Colonne Vertebrale Et Des Neurosciences
name: Ecole Supérieur d'Ostéopathie
First posted: 2025-01-31
Enrollment: 40
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: OTHER

Brief summary: The aim of our study is to assess the effect of a combined physiotherapy and osteopathy treatment versus a placebo on the management of disability and quality of life after lumbar arthrodesis. This study will provide a better assessment of the use of osteopathy as a non pharmacological approach to post-operative management.

For this purpose, We will analyze the effects of these two approaches, targeted and non-targeted osteopathy (TO vs. NTO), on patients' disability and quality of life after surgery.


Eligibility criteria: Inclusion Criteria:

* having experienced a lumbar arthrodesis (of one to three levels) four weeks before inclusion
* being under a stable pharmacological treatment over the last month
* who are suffering from postoperative mechanical pain (VAS ≥ 4)

Exclusion Criteria:

* neuropathic pain according to a DN4 score greater than or equal to 4/10,
* are suffering from fibromyalgia,
* algodystrophy,
* other somatic or neuropsychiatric diseases (other than depression and anxiety),
* have received osteopathic treatment over the last three month prior to inclusion,
* are included in another interventional research protocol during the study period

Primary outcomes:
measure: Disability will be assessed using the ODQ
timeFrame: baseline and Week 8
Secondary outcomes:
measure: Pain and disability measures
timeFrame: baseline, ans every week from 1 to 8
measure: The Osteopathic Dysfunction Palpation Assessment Scale
timeFrame: baseline and Week 8
Other outcomes:
Locations:
city: Paris
country: France
facility: Clinique Bizet
Study officials:
References:
Clinical trial NCT02761720: Mobile App for Mood in Pregnancy (Ginger iO)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mood Disorders
Depression
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Ginger.io
First posted: 2016-05-04
Enrollment: 72
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The Dickens Center provides prenatal care to women with Medicaid insurance and its predominantly African American (90%). The mean age of patients receiving prenatal care is 25 years in this site.

Brief summary: The Mobile Mood Tracking App study is a small randomized trial of acceptability and usability of a mobile phone mood tracking application (mobile app) among women with depressed mood in pregnancy. The study will be assessing the perceived value and usability of this tool in pregnancy over eight weeks to test whether women using this app are more likely to receive assessments and treatments of depressed mood than women not using it.


Eligibility criteria: Inclusion Criteria:

* Positive screening for elevated depression symptomatology (PHQ-9 score must be greater than or equal to 5.)

Exclusion Criteria:

* Women with pregnancies of less than 33 weeks gestation.

Primary outcomes:
measure: Evidence of increased provider intervention for the treatment of worsening depressive symptoms confirmed by the mobile mood tracking application.
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Dickens Center for Women's Health at the Hospital of the University of Pennsylvania
state: Pennsylvania
Study officials:
References:
Clinical trial NCT04930120: Assessing the Impact of COVID-19 Patients Long Distance Transfers Between Intensive Care Units
Official title: TRANSCOV Cohort. An Epidemiological Study Assessing the Impact of Critically Ill COVID-19 Patients Long Distance Transfers Between Intensive Care Units
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Covid19
Lead sponsor: Ecole des Hautes Etudes en Santé Publique
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 3060
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Severely ill COVID-19 patients

Brief summary: The TRANSCOV cohort is a multicentre observational retrospective study aiming at assessing the health impact of extra regional transfers of critically ill COVID-19 patients.

Detailed description: In spring 2020 four regions of France faced a surge of severe Coronavirus (COVID) patients which threatened to overflow local intensive care units (ICU) capacities. As an emergency response, between 03/13/2020 and 04/10/2020, an estimated 661 patients were transferred from overcrowded ICUs to other French regions and neighbouring countries. The study aims at assessing the impact of these inter-ICU transfers on the short and medium term physical and psychological outcomes in this population of severe COVID 19 patients.

All transferred patients between ICUs outside the origin region are invited to take part. For each transfer, up to four control patients will be selected among those admitted in the same ICU during the same period (+/-4 days of transfer date). Clinical data will be extracted from medical records and will include hemodynamic and respiratory parameters, as well as clinical severity scores before, during and after transfer. Data linkage with medico-administrative data will enrich the clinical database and allow follow-up up to one year after initial admission.

Eligibility criteria: Inclusion Criteria:

* COVID-19 patients diagnosed biologically or by imaging
* Admission in ICU between 03/13/2020 and 04/10/2020

Exclusion Criteria:

* none

Primary outcomes:
measure: Survival
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Rennes
country: France
facility: EHESP
Study officials:
affiliation: Ecole des Hautes Etudes en Santé Publique
name: Olivier Grimaud, Ph.D., M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00831220: Endothelial Dysfunction in Chronic Obstructive Pulmonary Disease
Official title: Endothelial Dysfunction in Chronic Obstructive Pulmonary Disease
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Obstructive Pulmonary Disease
Endothelial Dysfunction
Keywords: COPD
exacerbations
EPCs
Erythropoietin
C-RP
COPD and endothelial dysfunction
Lead sponsor: Hospital Universitari Son Dureta
Sponsor class: OTHER
Collaborators: name: Fondo de Investigacion Sanitaria
First posted: 2009-01-28
Enrollment: 99
Sex: MALE
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with an exacerbation of COPD admitted to our hospital, stable COPD recruited in an ambulatory basis, smokers or former smokers and never smokers recruited in our laboratory.

Brief summary: Objective: To investigate the potential role of endothelial dysfunction as a pathogenic mechanism of cardiovascular events in COPD. Hypothesis: endothelial function is abnormal in patients with COPD, particularly during exacerbations of the disease. Design: prospective and controlled study performed in an university hospital. Population: we compare 4 groups of subjects, 44 patients with stable COPD, 35 patients with acute exacerbation of COPD, 10 smokers or former smokers with normal lung function and 10 never smokers matched by physical activity and BMI. Study variables: a) clinical variables: clinical information, physical examination, pulmonary function tests, ECG and sputum culture; b) Biological variables: number of Circulating Endothelial Progenitor Cells, vascular growth factors (vascular endothelial growht factor and erythropoietin), systemic inflammation (C-reactive protein, white blood cells), peripheral venous blood test (including hemogram, biochemical analysis with glycemia, cholesterol, LDLcol, HDLcol); and c) systemic vascular reactivity assessment.


Eligibility criteria: Inclusion Criteria:

* Patients with moderate to very severe COPD admitted in the hospital because of an exacerbation, and,
* Patients with moderate to very severe COPD in stable condition.

Exclusion Criteria:

* Patients with an exacerbation of COPD who needed invasive or non invasive mechanical ventilation
* Patients with other chronic inflammatory diseases.
* Patients with other acute or active chronic systemic disease such as heart failure, renal insufficiency, etc.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Palma Mallorca
country: Spain
facility: Hospital Universitari Son Dureta
state: Illes Balears
Study officials:
affiliation: Servei de Pneumologia, Hospital Universitari Son Dureta
name: Ernest Sala, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03277820: Effect of Probiotics on Nasopharyngeal Microbiome of Children With Otitis Media With Effusion
Official title: Effect of Probiotics on Microbiome of Adenoid Tissue and Middle Ear Fluid of Children With Otitis Media With Effusion
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Otitis Media With Effusion
Probiotics
Adenoid Vegetations
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2017-09-11
Enrollment: 37
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The aim of this study is to investigate whether the microbiota in the upper respiratory tract (nasopharynx, adenoids and middle ear fluid) of otitis media with effusion (OME) patients is changed after 4 weeks of probiotic product intake. Therefore, bacterial DNA from swabs, fluid and tissue will be isolated via commercially available DNA extraction kits, followed by Illumina MiSeq sequencing in order to identify the bacterial species present in these samples. Furthermore, the concentration of specific pathogens will be monitored via qPCR.


Eligibility criteria: Inclusion Criteria:

* children with otitis media with effusion
* children with adenoid hypertrophy

Exclusion Criteria:

* no patients with trisomy 21

Primary outcomes:
measure: Microbiome differences
timeFrame: 4 years
Secondary outcomes:
measure: Differences in absolute concentration of otitis media pathogens
timeFrame: 4 years
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
References:
Clinical trial NCT06185920: PHAGEinLYON Clinic Cohort Study: a Descriptive Study of Severe Infections Treated With Phage Therapy at the HCL.
Official title: Non Interventional Retrospective and Prospective Single Center Descriptive Study of Severe Infections Treated With Phage Therapy at the Hospices Civils de Lyon (PHAGEinLYON Clinic Cohort Study).
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Severe Infection
Keywords: bacteriophage
severe infection
Lead sponsor: Hospices Civils de Lyon
Sponsor class: OTHER
First posted: 2023-12-29
Enrollment: 250
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 250 patients with severe infection treated with phagotherapy will be included in the study.

Brief summary: PHAGEinLYON Clinic cohort study is a single site non-interventional retrospective and prospective study, initiated by the Hospices Civils de Lyon. Population targeted are patients with a severe infection treated with bacteriophage in the Hospices civils de Lyon from 2015 to 2033. The primary objective is to describe the severe infections treated with phagotherapy. 250 patients will be included in the study.


Eligibility criteria: Inclusion Criteria:

* Patient with severe infection treated with bacteriophage in the Hospices Civils de Lyon from 01/01/2015 to 01/01/2033
* PHAGEinLYON Clinic cohort study information notice provided to the patient

Exclusion Criteria:

* Opposition of trial participant

Primary outcomes:
measure: Rate of each type of severe infection
timeFrame: through study completion (5years)
Secondary outcomes:
Other outcomes:
Locations:
city: Lyon
country: France
facility: Department of Infectious and Tropical Diseases of the Croix Rousse Hospital of the Civil Hospitals of Lyon
Study officials:
References:
Clinical trial NCT04438720: Bioequivalence of Extended Release Nifedipine Tablets in Healthy Chinese Subjects
Official title: Bioequivalence of Extended Release Nifedipine Tablets in Healthy Chinese Subjects: A Single-dose and Two-period Crossover Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Therapeutic Equivalency
Keywords: Extended Release Nifedipine Tablets
Lead sponsor: The Affiliated Hospital of Qingdao University
Sponsor class: OTHER
First posted: 2020-06-19
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: According to the relevant provisions of bioequivalence test, nifedipine sustained-release tablets (test preparation, t, 30mg / tablet) provided by Guangzhou bostao controlled release pharmaceutical Co., Ltd. were compared with Adalat ® GITS (reference preparation, R, 30mg / tablet) produced by Bayer Pharma AG to evaluate the bioequivalence of single dose in healthy subjects under fasting conditions.


Eligibility criteria: Inclusion Criteria:

* Healthy male or female aged 18-45.
* The body mass index is in the range of 18.6-28.5 kg/m2 (including the critical value). The weight of male is not less than 50.0 kg, and that of female is not less than 45.0 kg.
* The following examination show that the indicators are normal or abnormal without clinical significance. The examination including: Vital signs, physical examination, blood routine, blood biochemistry, urinalysis, pregnancy test for female, serological tests for hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), and syphilis virus, 12 lead ECG, breath test for alcohol, drug abuse test.
* The subjects have no family planning within 3 months and could select contraceptive method.
* Before the study, all subjects have been informed of the study's purpose, protocal, benefits, and risks, and signed the informed consent voluntarily.

Exclusion Criteria:

* Being allergy to the study medications, smoking, alcohol abuse.
* Participation in another clinical trial within 3 months.

Primary outcomes:
measure: Peak Plasma Concentration (Cmax)
timeFrame: 60 days
measure: Area under the plasma concentration versus time curve (AUC)0-t
timeFrame: 60 days
measure: Area under the plasma concentration versus time curve (AUC)0-∞
timeFrame: 60 days
Secondary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 60 days
measure: Incidence of abnormal blood pressure
timeFrame: 60 days
measure: Incidence of abnormal temperature
timeFrame: 60 days
measure: Incidence of abnormal pulse
timeFrame: 60 days
measure: Incidence of abnormal electrocardiogram waveform
timeFrame: 60 days
Other outcomes:
Locations:
city: Qingdao
country: China
facility: Phase I Clinical Research Center
state: Shandong
Study officials:
References:
Clinical trial NCT02594020: Comparison of Different Methods of Enamel Preparation Before Pit and Fissure Sealants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Enamel Lesions
Dental Caries
Keywords: suspected caries
initial enamel lesions
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2015-11-01
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This study concerns the prevention of dental caries by sealing pits and fissures of permanent molars with a photopolymerizable resin. It must compare these three techniques Microdentisty (air abrasion, abrasion and sound using small cutters) usually used to prepare micro cavities in the enamel and / or the outer third of the dentin. These three commonly used techniques have never been compared by retaining as endpoint retention of sealant. These techniques are painless and do not require local anesthesia.


Eligibility criteria: Inclusion Criteria:

* Affiliated with the Social Security
* Attendance at inspections
* Subject to high individual risk of caries
* Subjects with at least two pairs of molars and contralateral counterparts with the initial lesions of enamel (pits and fissures colored) or suspected of dentine caries (not highlighted by two clinical and radiographic examination usual)

Exclusion Criteria:

* Molar inaccessible, closed, sealed, or decayed (reaching the dentine

Primary outcomes:
measure: observation of quality of treatment
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU
city: Paris
country: France
facility: APHP
Study officials:
References:
Clinical trial NCT02854020: Comparison of Inflight First Aid Performed by Cabin Crew Members and Medical Volunteers
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Emergency
Keywords: Aircraft
Emergency
First aid
Cabin crew
Burn
Cardiac arrest
Lead sponsor: Seoul National University
Sponsor class: OTHER
First posted: 2016-08-03
Enrollment: 2818
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inflight medical emergencies from 2009 to 2013

Brief summary: Since the number of air travelers, including the elderly and passengers with an underlying disease, is increasing every year, the number of inflight emergency patients is expected to increase as well. The investigators attempted to identify the incidence and types of inflight medical emergencies and analyze the first aid performed by cabin crew members or medical volunteers in flights by an Asian airline. The investigators also investigated the causes of inflight deaths and aircraft diversions.


Eligibility criteria: Inclusion Criteria:

* Inflight medical emergencies from 2009 to 2013

Exclusion Criteria:

* Events that occurred before takeoff or after landing

Primary outcomes:
measure: Types of inflight medical emergencies confirmed by reviewing cabin reports submitted by cabin crew and medical records submitted by medical volunteers
timeFrame: 5 years (events during inflight, excluding events that occured before takeoff or after landing)
Secondary outcomes:
measure: Incidence of inflight medical emergencies confirmed by reviewing cabin reports submitted by cabin crew and medical records submitted by medical volunteers
timeFrame: 5 years (events during inflight, excluding events that occured before takeoff or after landing)
measure: The causes of inflight deaths and aircraft diversions confirmed by reviewing cabin reports submitted by cabin crew and medical records submitted by medical volunteers
timeFrame: 5 years (events during inflight, excluding events that occured before takeoff or after landing)
Other outcomes:
Locations:
Study officials:
References: