louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT05760105: Awareness of Osteoporosis in Ankylosing Spondylosis Patients
Official title: Awareness of Osteoporosis in Ankylosing Spondylosis Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Osteoporosis
Osteoporosis Risk
Ankylosing Spondylitis
Lead sponsor: Uskudar State Hospital
Sponsor class: OTHER_GOV
First posted: 2023-03-08
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged 18 to 90 years with a diagnosis of ankylosing spondylitis who gave consent to participate in the study

Brief summary: Osteoporosis is a condition that describes compromised skeletal microarchitecture in general, with clinical signs of decreased bone mineral density. Ankylosing spondylitis patients are at increased risk for developing osteoporosis. Identifying whether multiple sclerosis patients have information and awareness about this disease is crucial. This study is aimed to investigate awareness and knowledge of osteoporosis in ankylosing spondylitis patients.

Detailed description: Osteoporosis is a common disease of bone loss. The reduced bone strength predisposes an increased risk for fractures in older individuals. It can affect people from different ethnicity. Many factors increase the risk of osteoporosis, including age, postmenopausal state, glucocorticoid use, low body weight, calcium, vitamin D, immobility, and chronic inflammation. Patients with ankylosing spondylitis are at high risk of developing osteoporosis due to chronic inflammation and their medications. Patients' knowledge and awareness about osteoporosis are essential for early detection, implementation of lifestyle changes, and treatment compliance. This study aimed to investigate osteoporosis awareness and knowledge about osteoporosis in patients with ankylosing spondylitis.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ankylosing spondylitis
* Must be between the ages of 18 and 99
* Must give consent to participate in the study

Exclusion Criteria:

• Not giving consent

Primary outcomes:
measure: Revised Osteoporosis Knowledge Test
timeFrame: 1 day
Secondary outcomes:
measure: Osteoporosis Self-Efficacy Scale
timeFrame: 1 day
measure: Osteoporosis Health Belief Scale
timeFrame: 1 day
Other outcomes:
Locations:
Study officials:
affiliation: Uskudar State Hospital
name: Mustafa H Temel, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04958005: Salivary Interleukin-32, Interleukin-10, Interleukin-6 and Tumor Necrosis Factor-alpha Levels in Children
Official title: Evaluation of Salivary Interleukin-32, Interleukin-10, Interleukin-6 and Tumor Necrosis Factor-alpha Levels in Children With Early Childhood Caries.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Early Childhood Caries
Keywords: early childhood caries
Lead sponsor: Aydin Adnan Menderes University
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 58
Sex: ALL
Minimum age (years): 3
Maximum age (years): 70
Standard ages: CHILD
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 28 children with early childhood caries and 28 children without caries will be collected.

Brief summary: This study aimed to evaluate the levels of interleukin 10, interleukin 6, interleukin 32 and tumor necrosis factor-alpha (TNF-α) in saliva of children with early childhood caries.

Detailed description: Fifty six children ( 28 with early childhood caries and 28 without early childhood caries ; age range 3-6 years) will be recruited for the study. Probing pocket depth (PPD), gingival index (GI) and plaque index (PI) will be recorded and saliva samples will be collected. Interleukin-32, Interleukin-10, Interleukin-6 and TNF-α will be analyzed in saliva samples by ELISA.

Eligibility criteria: Inclusion Criteria:

* Children with untreated early chilhood caries
* Age between 3 and 6 years

Exclusion Criteria:

* Having a systemic problem or mental retardation
* Children with treated caries

Primary outcomes:
measure: IL-32
timeFrame: Baseline
measure: IL-10
timeFrame: Baseline
Secondary outcomes:
measure: IL-6
timeFrame: Baseline
measure: Tnf-Alpha
timeFrame: Baseline
Other outcomes:
Locations:
city: Aydın
country: Turkey
facility: Sultan KELEŞ
Study officials:
References:
Clinical trial NCT02048605: Training of Psychosocial Skills Based on Cognitive Behavioural Therapy for Patients With Parkinson's Disease
Official title: Basel Training Study II: Training of Psychosocial Skills for Patients With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Mild Cognitive Impairment
Lead sponsor: University Hospital, Basel, Switzerland
Sponsor class: OTHER
Collaborators: name: Parkinson Schweiz
name: Bangerter-Rhyner Foundation
name: AbbVie
First posted: 2014-01-29
Enrollment: 30
Sex: ALL
Minimum age (years): 45
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients with Parkinson's disease (PD) will be trained using a cognitive behavioral group-training-program to reduce stress and augment quality of life. An unspecific group with the same amount and frequency of meetings is used as a control group. For the evaluation of the training effects, scales to assess quality of life, analyses of psychopathological variations as well as neurocognitive tests will be used. Protocol amendment in 1-2017: addition of FU year 3 and year 5.


Eligibility criteria: Inclusion Criteria:

* Patients with idiopathic Parkinson's disease according to United Kingdom Parkinson's Disease Brain Bank Criteria, being either cognitively normal, suffering from Mild Cognitive Impairment or having mild dementia. Patients must be able to give their written informed consent.

Exclusion Criteria:

* Moderate or severe dementia (DMS-IV, Mini Mental Status (MMS) \<24), other neurological or psychiatric diseases of the brain not related to PD, secondary parkinsonism, physical impairment hindering the adequate execution of the training, insufficient knowledge of German or pregnancy are exclusion criteria. Deep Brain Stimulation (DBS) is no exclusion criterion.

Primary outcomes:
measure: Schedule for the Evaluation of Individual Quality of Life-Direct Weighting (SeiQol-DW)
timeFrame: Before and after 9 weeks of training, After 6-month
Secondary outcomes:
measure: Scale for the assessment of management of daily living (Alltagsbewältigungsskala: A-B-S)
timeFrame: Before and after 9 weeks training, after 6 month
Other outcomes:
measure: Burden questionnaire for Patients with Parkinson's Disease (Belastungsfragebogen)
timeFrame: Before and after 9 weeks of training, after 6 month
Locations:
city: Basel
country: Switzerland
facility: University Hospital Basel
Study officials:
affiliation: University Hospital, Basel, Switzerland
name: Peter Fuhr, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hadinia A, Meyer A, Bruegger V, Hatz F, Nowak K, Taub E, Nyberg E, Stieglitz RD, Fuhr P, Gschwandtner U. Cognitive Behavioral Group Therapy Reduces Stress and Improves the Quality of Life in Patients with Parkinson's Disease. Front Psychol. 2017 Jan 4;7:1975. doi: 10.3389/fpsyg.2016.01975. eCollection 2016.
Clinical trial NCT01267305: The Impact of Different Anticoagulant Therapy on Hemorrhage and Coagulation After Thoracic Surgery
Official title: The Impact of Different Anticoagulant Therapy on Hemorrhage and Coagulation After Thoracic Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lung Neoplasms
Esophageal Neoplasms
Venous Thromboembolism
Keywords: esophagectomy
lung resection
venous thromboembolism
low molecular weight heparin
chest drainage
TEG
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2010-12-28
Enrollment: 362
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this study is to determine whether the use of different dose of LMWH compared with fondaparinux for thromboprophylaxis is efficacious and safety after thoracic surgery.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of esophageal carcinoma and planned for esophagectomy
* clinical diagnosis of lung carcinoma and planned for lung resection
* general anesthesia combined with epidural anesthesia

Exclusion Criteria:

* blood clotting disfunction before surgery
* anticoagulating or antiplatelet history before surgery
* low blood platelets count
* hemorrhagic disease
* cerebral hemorrhage
* cerebral,spinal,ophthalmologic operation history
* peptic ulcer
* bleeding\>400ml in operation
* bleeding\>100ml/h after operation
* blood transfusion in or after operation
* severe renal or liver disfunction
* severe hypertension

Primary outcomes:
measure: TEG values
timeFrame: three days after surgery
Secondary outcomes:
measure: bleeding quantity of chest drainage
timeFrame: three days after surgery
measure: incidence rate of deep venous thromboembolism（DVT)
timeFrame: after surgery up to 7 days
measure: inhospital mortality
timeFrame: after surgery up to 28 days
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital
Study officials:
affiliation: Shanghai Zhongshan Hospital
name: Lizhen Xuan
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03820505: Observatory of Unintentional Births Hospital Extras
Official title: Observatory of Unintentional Births Hospital Extras in Hérault
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Unexpected Delivery Outside Maternity
Keywords: obstetrics
pre-hospital emergencies unannounced delivery outside maternity,
mortality-morbidity
reinforcement midwife in pre-hospital
Lead sponsor: University Hospital, Montpellier
Sponsor class: OTHER
Collaborators: name: SDIS34 - MONTPELLIER
name: SAMU CHU Montpellier
First posted: 2019-01-29
Enrollment: 350
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Unexpected delivery outside maternity in the Hérault department

Brief summary: In France, pre-hospital unexpected birth is a rare situation, but over the last ten years, the investigators have seen an increase in the number of these.

For this, the investigators realize an observatory of these deliveries and their care from the call for help and the investigators continue the follow-up and the future of patients and newborns until J7 postpartum.

Detailed description: As a result, the investigators also found a very high variability in the number of deliveries per month for the EMS 34 and the SSSM of the SDIS 34, which can reach up to 11 deliveries per month (May 2014 example).

Formalized expert recommendations were published in 2010 by SFAR, which then led to the establishment of a national observatory for IEA at the end of 2011, in which the investigators have been participating for 4 years.

Currently the national database lists 2000 unannounced deliveries including 230 in the Hérault.

This observational study allows us to evaluate the management of these patients and newborns, the risks and needs of pre-hospital teams, including the need for reinforcement and expertise of midwives.

The investigators can also assess mortality and morbidity, as well as the extension of hospital stays beyond J7

Eligibility criteria: Inclusion Criteria:

* Unexpected delivery outside maternity, presence of a medical team during the care

Exclusion Criteria:

* Absence of medicalization

Primary outcomes:
measure: number of unexpected hospital deliveries (AIE)
timeFrame: DAY 0 TO DAY 7 TO DELIVRERY
Secondary outcomes:
measure: Method of taking care of unannounced extra hospital deliveries
timeFrame: DAY 0 TO DAY 7 POST DELIVRERY
measure: Difficulties during an unexpected delivery outside maternity
timeFrame: DAY 0 TO DAY 7 POST DELIVRERY
measure: Risks during an unexpected delivery outside maternity
timeFrame: DAY 0 TO DAY 7 POST DELIVRERY
measure: Possible immediate complications during an unexpected delivery outside maternity
timeFrame: DAY 0 TO DAY 7 POST DELIVRERY
Other outcomes:
Locations:
city: Montpellier
country: France
facility: Uhmontpellier
Study officials:
affiliation: University Hospital, Montpellier
name: Christelle GRAF, wise woman
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04838405: A Study of CT-388 in Otherwise Healthy Overweight and Obese Adults and Patients with Type 2 Diabetes Mellitus
Official title: A Phase 1 Randomized, Double Blind, Placebo Controlled, Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of CT-388 in Otherwise Healthy Overweight and Obese Adult Participants and in Obese Patients with Type 2 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Diabetes
Lead sponsor: Carmot Therapeutics, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Carmot Australia First Pty Ltd
First posted: 2021-04-09
Enrollment: 129
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This is a first-in-human evaluation of CT-388 in a double blind, placebo controlled, randomized, SAD/MAD/MD, safety, tolerance, PK, and PD study when administered as a SC injection in otherwise healthy overweight and obese adult participants and obese participants with T2DM.


Eligibility criteria: Inclusion Criteria:

* Males or females
* 18-65 years old, inclusive
* BMI 27.0-40.0, inclusive
* Stable body weight for 2 months

Exclusion Criteria:

* Significant medical history
* Uncontrolled hypertension
* History of malignancy

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events as assessed by self-report
timeFrame: Baseline up to 24 weeks
Secondary outcomes:
measure: Area under the concentration versus time curve (AUC)
timeFrame: Baseline up to 24 weeks
measure: Maximum observed drug concentration (Cmax)
timeFrame: Baseline up to 24 weeks
measure: Elimination half-life
timeFrame: Baseline up to 24 weeks
measure: Change in mean body weight
timeFrame: Baseline up to 24 weeks
measure: Change in mean glucose levels
timeFrame: Baseline up to 24 weeks
measure: Change in mean insulin levels
timeFrame: Baseline up to 24 weeks
Other outcomes:
Locations:
city: Perth
country: Australia
facility: Carmot Clinical Research Unit 101
state: Western Australia
city: Monterrey
country: Mexico
facility: Carmot Clinical Research Unit 105
state: Nuevo Leon
Study officials:
affiliation: Carmot Therapeutics, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References:
Clinical trial NCT04548505: Recovery of Exertion Ability Following COVID-19 Infection in Military Staff
Official title: Recovery of Exertion Ability Following COVID-19 Infection in Military Staff
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV Infection
Keywords: physical activity
Lead sponsor: Direction Centrale du Service de Santé des Armées
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The population is composed of active military personnel of the Paris Fire Brigade who have been infected with COVID-19 and thus are benefiting or have benefited from the post-COVID medical car provided bay the French Armed Forces Health Service.

Brief summary: The Paris Fire Brigade staff have been particularly exposed to COVID-19 due to rescue and care activities for victims at risk in Paris area (where the virus was actively circulating). In addition, when the pandemic began in France, they had to take care of patients before procedures to protect caregivers were implemented.

The contamination of young military personnel, whose physical capacity was put into strain at work, raises the question of the consequences of COVID-19 on their physical fitness. At the time, the medium- and long-term evolution of this disease and its possible repercussions on physical fitness are unknown. Moreover, like any soldiers who have been confined, they may present at least a cardio-respiratory deconditioning (sometimes independent of the disease making it difficult to distinguish between a sequelae of the infection or rehabilitation).

Based on previous coronavirus epidemics (Sars-Cov 1 and Mers-Cov), it appears that long-term sequelae are possible even in mild forms and can result in an alteration of exertion ability.

In the current context and in the absence of national or international recommendations on the return to physical activity, the French Armed Forces Health Service has proposed a simple management plan aiming at: i) allowing mass screening for possible exercise intolerance and targeting at-risk personnel, ii) allowing individualized re-training and iii) guaranteeing that military personnel can carry out their mission without jeopardizing their health.


Eligibility criteria: Inclusion Criteria:

* Be an active military personnel of the Paris Fire Brigade
* Be at least 18 years of age
* Benefiting or having benefited from the post-COVID medical care provided by the French Armed Forces Health Service

Exclusion Criteria:

* Be under 18 years of age

Primary outcomes:
measure: Magnitude of the decrease in aerobic performance on return to work
timeFrame: Up to 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brétigny-sur-Orge
country: France
facility: Institut de Recherche Biomédicale des Armées
Study officials:
References:
Clinical trial NCT03568305: Characterization of Phenotypes of Occupational Asthma
Official title: Characterization of Phenotypes of Occupational Asthma: Descriptive Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Occupational Asthma
Keywords: asthma
occupational asthma
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2018-06-26
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient who performed a specific inhalation test with a positive result between january 2006 and december 2015.- Subject giving their consent for their participation

Brief summary: The general objective of this multicenter, international study is to perform a multivariate descriptive analysis of a large population of well-defined subjects with sensitizer-induced OA ascertained by a positive SIC result in order to provide more information on the characteristics of this condition.


Eligibility criteria: Inclusion Criteria:

* Adult Patient
* Patient who performed a specific inhalation test with a positive result between January 2006 and December 2015.- Subject giving their consent for their participation
* Patient agreeing to use his data for research purposes

Exclusion Criteria:

* Patient objecting to the use of his data for research purposes
* Subjects under safeguard of justice
* Subject under guardianship or curatorship

Primary outcomes:
measure: Retrospective study to perform a multi-varied descriptive analysis of a cohort of patients with occupational asthma confirmed by a specific inhalation test
timeFrame: The period from from January 1st, 2006 to December 31st, 2015 will be examined
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service de pneumologie, d'allergologie et de pathologie de l'environnement
Study officials:
affiliation: University Hospital, Strasbourg, France
name: Frédéric De Blay, MD, PhD
role: STUDY_DIRECTOR
References:
Clinical trial NCT00427505: Study to Investigate the Effect of Deferasirox on the Pharmacokinetics of Midazolam
Official title: An Open-label, One-sequence Cross-over Study to Investigate the Effect of Deferasirox on the Pharmacokinetics of Midazolam in Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Interaction
healthy volunteers
deferasirox
midazolam
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2007-01-29
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This is a study to investigate the pharmacokinetics of deferasirox


Eligibility criteria: Inclusion Criteria:

* Good health
* No evidence of iron deficiency
* Weight between 50 and 100 kg
* Body Mass Index between 19 and 29 kg/m2

Exclusion Criteria:

* Use of certain drugs, herbal remedies or nutrients

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: To assess the effect of deferasirox on the pharmacokinetics of midazolam
Secondary outcomes:
measure: Safety assessed by adverse events (AEs)
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_CHAIR
References:
Clinical trial NCT06510205: The Study is an Oberservational Post-market Follow-up Program to Evaluate Long Term(5 Years) Safety of Mentor Breast Implants in Chinese Population.
Official title: Post-Market Clinical Follow-up for Mentor Breast Implants
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Augmentation and Breast Reconstruction
Lead sponsor: Johnson & Johnson Medical (Shanghai) Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-19
Enrollment: 5000
Sex: FEMALE
Minimum age (years): 22
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All populations receiving Mentor breast implants

Brief summary: The Mentor Post-Market Clinical Follow-Up Study is a multicenter observational study conducted in China. It aims to collect safety data on Mentor breast implants over a 5-year follow-up period in the Chinese population. In addition to safety data, the study will also gather information on postoperative pain and participant satisfaction levels. The objective is to explore customers' clinical experiences and use them as a reference for future product development. The study intends to enroll a minimum of 300 subjects per license, with participation from three or more medical institutions.


Eligibility criteria: Inclusion Criteria:

1. Women who have received Mentor breast implants per product instructions;
2. Participants must possess the ability to comprehend the study procedures, give consent for the use of their preoperative and surgical data, and agree to take part in postoperative follow-up assessments. Additionally, they should possess the necessary civil capacity, be capable of reading and writing, and willingly provide informed consent by signing the consent form.
3. Participants must be at least 22 years old at the time of their implantation surgery.

Exclusion Criteria:

* Not applicable

Primary outcomes:
measure: Breast implant related AEs
timeFrame: Up to 5 years
Secondary outcomes:
measure: Numerical Pain Scale assessment
timeFrame: 1 month after surgery
measure: Customer Satisfaction Score measurement
timeFrame: Up to 5 years after surgery
Other outcomes:
Locations:
city: Chengdu
country: China
facility: Sichuan Huamei Zixin Medical Aesthetic Hospital
city: Shenzhen
country: China
facility: Shenzhen Yixing Medical Cosmetology Hospital
city: Shenzhen
country: China
facility: Shenzhen Junke Medical Cosmetology Clinic
Study officials:
affiliation: Shenzhen Junke Medical Cosmetology Clinic
name: Huimin Wu
role: STUDY_DIRECTOR
References: