louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00741520: Cardiovascular Impact of Obstructive Sleep Apnea Treatment in Normotensive Patients
Official title: Cardiovascular Impact of Obstructive Sleep Apnea in Normotensive Patients and the Effects of Continuous Positive Airway Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea
Blood Pressure
PreHypertension
Masked Hypertension
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2008-08-26
Enrollment: 36
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Recent evidences suggest that obstructive sleep apnea (OSA) can contribute to cardiovascular disease even in the absence of hypertension. However, there are few data regarding the impact of OSA on the preHypertension and Masked Hypertension in apparently normotensive patients with OSA as well as the impact of treatment with continuous positive airway pressure.


Eligibility criteria: Inclusion Criteria:

* Severe OSA patients

Exclusion Criteria:

* Smoking
* Sustained Hypertension
* Heart failure
* Diabetes
* Renal diseases
* Under use of any medication
* Under treatment for OSA

Primary outcomes:
measure: Office Blood Pressure
Secondary outcomes:
measure: 24 Hour Ambulatory Blood Pressure Monitoring
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Heart Institute (InCor)
Study officials:
References:
Clinical trial NCT01617720: MITRAFIT- Cardinal Adjustable Mitral Repair Follow-up International Postmarketing Surveillance (PMS)
Official title: MITRAFIT Cardinal Adjustable Mitral Repair Follow-up International Postmarketing Surveillance (PMS)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mitral Regurgitation
Keywords: mitral
valve
annuloplasty
mitral regurgitation
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2012-06-12
Enrollment: 45
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are candidate for mitral valve repair, with our without concomitant procedures.

Brief summary: This Study is designed to observe the clinical outcomes of patients requiring mitral repair that were treated with the CE certified Cardinal System.


Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Patient is a candidate for mitral valve repair, with our without concomitant procedures.
* Subject is willing to give informed consent for collection of his/her clinical data.

Exclusion Criteria:

* Severe organic lesions with retracted chordae
* Congenital malformations with lack of valvular tissue
* Severe valvular calcifications
* Evolving bacterial endocarditis
* Known Sensitivity to Nickel or Chromium

Primary outcomes:
measure: • Ability of the Cardinal ring to reduce mitral valve regurgitation
timeFrame: 30 day
measure: • Percentage of patients in whom the size of the ring is adjusted
timeFrame: 6 months
measure: • Technical feasibility of adjustment.
timeFrame: 6 months
measure: • The occurrence of serious device related adverse events in all patients.
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Stuttgart
country: Germany
facility: SANA Herzchirurgie
city: Milan
country: Italy
facility: Hospital San Rafaele
Study officials:
affiliation: Hospital San Raffaele, Milan, Italy
name: Ottavio Alfieri, Prof, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: SANA Herzchirurgie Stuttgart , Germany
name: Nicolas Doll, Prof, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sheba Medical Center
name: Ehud Raanani, Prof, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Bichat Hospital, Paris, France
name: Patrik Nataf, Prof, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Zurich University, Zurich, Switzerland
name: Volkmar Falk, Prof, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sundermann SH, Czesla M, Kempfert J, Walther T, Nataf P, Raanani E, Jacobs S, Alfieri O, Maisano F, Falk V. Results of mitral valve repair with an adjustable annuloplasty ring 2 years after implantation. Heart Vessels. 2017 Jul;32(7):843-849. doi: 10.1007/s00380-016-0934-7. Epub 2016 Dec 23.
Clinical trial NCT02062320: Establishment and Evaluation of a Post Caesarean Acute Pain Service (PCAPS)
Official title: Establishment and Evaluation of a Post Caesarean Acute Pain Service
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: The Efficacy of Analgesic Methods After Caesarean Section
Keywords: Acute Pain Service
postoperative analgesia
Caesarean Section
non-opioid analgesia
opioid analgesia
epidural analgesia
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
First posted: 2014-02-13
Enrollment: 407
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: We evaluated all patients undergoing delivery via Caesarean Section under anaesthesia in the period 10/2009 - 10/2011.

Brief summary: The aim of this study is to compare the efficacy of analgesic methods after Caesarean Section before and after Post Caesarean Acute Pain Service establishing.


Eligibility criteria: Inclusion Criteria:

* Caesarean Section performed from October 2009 to October 2011 (study period)
* completed "Evaluation of postoperative analgesia after Caesarean Section" form.

Exclusion Criteria:

* Not completed "Standard Evaluation of postoperative analgesia after Caesarean Section" form.

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 72 hours after Caesarean Section (CS)
Secondary outcomes:
measure: VAS score above 4
timeFrame: 72 hours after CS
measure: Additional Analgesic Requests (AAR) Count
timeFrame: 72 hours after CS
measure: Analgesia related complication Rate
timeFrame: 72 hours after CS
Other outcomes:
Locations:
city: Brno
country: Czech Republic
facility: Faculty Hospital Brno
state: Jihomoravský Kraj
Study officials:
affiliation: Brno Faculty Hospital, departement of anesthesiology and intensive care medicine
name: Petr Štourač, MD, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Pan PH. Post cesarean delivery pain management: multimodal approach. Int J Obstet Anesth. 2006 Jul;15(3):185-8. doi: 10.1016/j.ijoa.2006.04.004. No abstract available.
citation: Ismail S, Shahzad K, Shafiq F. Observational study to assess the effectiveness of postoperative pain management of patients undergoing elective cesarean section. J Anaesthesiol Clin Pharmacol. 2012 Jan;28(1):36-40. doi: 10.4103/0970-9185.92432.
citation: Stourac P, Suchomelova H, Stodulkova M, Huser M, Krikava I, Janku P, Haklova O, Hakl L, Stoudek R, Gal R, Sevcik P. Comparison of parturient - controlled remifentanil with epidural bupivacain and sufentanil for labour analgesia: randomised controlled trial. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2014 Jun;158(2):227-32. doi: 10.5507/bp.2012.073. Epub 2012 Oct 31.
Clinical trial NCT06668974: Causal Associations Between Allergic Rhinitis and Asthma
Official title: Bidirectional Mendelian Randomization Study Reveals Causal Associations Between Allergic Rhinitis and Asthma
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Allergic Rhinitis
Asthma
Keywords: Mendelian Randomization
Genetic Association
Bidirectional Causality
Genome-Wide Association Study (GWAS)
Respiratory Diseases
Lead sponsor: Guangzhou Institute of Respiratory Disease
Sponsor class: OTHER
First posted: 2024-11-01
Enrollment: 239607
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study includes individuals diagnosed with allergic rhinitis or asthma from the UK Biobank and Finnish biobank databases.

Brief summary: This study investigates the causal relationship between allergic rhinitis and asthma using a bidirectional two-sample Mendelian randomization approach. Genetic data were derived from UK Biobank for allergic rhinitis and from Finnish biobank for asthma. This analysis aims to clarify the potential causal link between these two conditions.

Detailed description: This observational study utilizes a bidirectional two-sample Mendelian randomization (MR) analysis to examine the causal association between allergic rhinitis and asthma. The genetic data for allergic rhinitis were obtained from the UK Biobank, encompassing 18,934 cases and 64,595 controls, while asthma data were derived from a Finnish biobank, including 20,629 cases and 135,449 controls. The Mendelian randomization analysis was performed using inverse-variance weighting (IVW), Mendelian randomization-Egger (MR-Egger), and weighted median methods to ensure robust causal inference. Additional tests, such as Cochrane's Q test and Mendelian randomization pleiotropy residual sum and outlier (MR-PRESSO), were applied to assess heterogeneity and pleiotropy, enhancing the reliability of the findings. The results are expected to provide insights into the bidirectional causal relationship between allergic rhinitis and asthma, potentially informing future prevention and treatment strategies.

Eligibility criteria: Inclusion Criteria:

* Individuals diagnosed with allergic rhinitis or asthma.
* Availability of genetic data in the UK Biobank or Finnish biobank.

Exclusion Criteria:

* Individuals without genetic data.
* Participants with incomplete phenotype or genotype data.

Primary outcomes:
measure: Causal Effect of Allergic Rhinitis on Asthma Risk
timeFrame: Oct 24 2024
measure: Causal Effect of Asthma on Allergic Rhinitis Risk
timeFrame: Oct 24 2024
Secondary outcomes:
measure: Sensitivity Analysis Using MR-Egger Intercept Test
timeFrame: Oct 24 2024
measure: Sensitivity Analysis Using Leave-One-Out Test
timeFrame: Oct 24 2024
measure: Sensitivity Analysis Using MR-PRESSO
timeFrame: Oct 24 2024
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Guangzhou Institute of Respiratory Diseases, the First Affiliated Hospital of Guangzhou Medical University
state: Guangdong
Study officials:
References:
Clinical trial NCT00846274: Phase1 Syudy to Evaluate the Safety and PK/PD of Human Antithrombin III
Official title: Single-Dose, Open Label, Randomized Comparative Clinical Trial to Evaluate the Tolerability, Safety and PK/PD of Human ATIII Products, "SKATIII Injection" and"ATIII Injection" in Healthy Male Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Healthy Male subjects
Lead sponsor: SK Chemicals Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Korea University Anam Hospital
First posted: 2009-02-18
Enrollment: 20
Sex: MALE
Minimum age (years): 19
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: To evaluate the PK/PD of single injected human ATIII Products, SKATIII and ATIII, phase1 study in healthy male subjects was designed


Eligibility criteria: Inclusion Criteria:

* ages 19 to 40
* Body weight: More than 50kg
* Healthy male subject

Exclusion Criteria:

* Hb\<14g/dL, Hct\<42%
* ATIII hypersensitivity

Primary outcomes:
measure: ATIII activity
timeFrame: within 20min after injection ATIII
Secondary outcomes:
measure: ATIII antigen
timeFrame: within 20min after injection ATIII
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: SK chemicals
Study officials:
affiliation: Korea University Anam Hospital
name: Ji Young Park, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim KA, Lim YY, Kim SH, Park JY. Bioequivalence of two intravenous formulations of antithrombin III: a two-way crossover study in healthy Korean subjects. Clin Ther. 2013 Nov;35(11):1752-61. doi: 10.1016/j.clinthera.2013.08.018. Epub 2013 Oct 1.
Clinical trial NCT03149874: Accelerated Vaccination Schedule Against Hepatitis B Virus With Combined Hepatitis A and B Vaccine Among Hemodialysis Patients
Official title: Accelerated Vaccination Schedule Against Hepatitis B Virus With Combined Hepatitis A and B Vaccine Among Hemodialysis Patients, Does it Works?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatitis B
Hemodialysis Complication
Lead sponsor: Benha University
Sponsor class: OTHER
Collaborators: name: New Jeddah Clinic Hospital
First posted: 2017-05-11
Enrollment: 114
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Patient seuentially randomized to either vaccine
Primary purpose: PREVENTION

Brief summary: The aim of this study is to examine the result of seroprotection using the accelerated vaccination schedule in vaccination of hemodialysis patient through using combined hepatitis A and B vaccine.


Eligibility criteria: Inclusion Criteria:

* Age was above 18 years
* Hemodialysis patient
* All patients had undetectable hepatitis B virus surface antigen and antibody

Exclusion Criteria:

* A positive serum hepatitis B virus surface antigen and antibody
* patient received a previous course of hepatitis B virus vaccine

Primary outcomes:
measure: Hepatitis B virus Seroprotection after one month
timeFrame: one month after third dose of the vaccine
measure: Hepatitis B virus Seroprotection after three months
timeFrame: three months after third dose of the vaccine
Secondary outcomes:
measure: Fever
timeFrame: 4 Days after each vaccination dose
measure: Pain scale
timeFrame: 1 Hour after each vaccination dose
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT06587074: Features of the Clinical Course and Prognosis in Patients With Idiopathic Pulmonary Hypertension When Using Modern Strategies of Specific Therapy
Official title: Features of the Clinical Course and Prognosis in Patients With Idiopathic Pulmonary
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Idiopathic Pulmonary Arterial Hypertension
Lead sponsor: Russian Cardiology Research and Production Center
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: IPAH diagnosed patients in 2004-2023

Brief summary: This study will be performed based on a retrospective analysis of the cases of 150-170 patients with IPAH observed at the Research Institute of Clinical Cardiology over the past 10 years, for a comparative assessment of the survival of groups of patients with IPAH diagnosed in the period 2004-2013 and 2014-2023.

The demographic, clinical, functional, hemodynamic characteristics of patients, comorbidity, blood biomarker levels, received PAH-specific and symptomatic therapy will be assessed in order to determine the clinical characteristics of patients with IPAH.

The prospective part of study will include 50 patients with IPAH.


Eligibility criteria: Inclusion Criteria:

* age over 18 years;
* verified diagnosis of IPAH

Exclusion Criteria:

* age under 18 years;
* Other etiology op PAH,
* ischemic heart disease confirmed by MSCT of the coronary arteries or coronary angiography;
* diseases of the musculoskeletal system that prevent 6MWT
* severe liver dysfunction (more than 9 points on the Child-Pugh scale, class C)
* severe renal dysfunction (CC less than 15 ml/min), need for hemodialysis

Primary outcomes:
measure: Mortality in 3 years after diagnosed IPAH
timeFrame: 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Russian National Cardilogy Reasearch Center
Study officials:
affiliation: Russian National Cardiology Research Center
name: Tamila V Martyunuk, Yes
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03959774: Assessment of Outpatient Digital Follow-up of Patients Over 70 Years of Age Undergoing Chemotherapy Treatment
Official title: Assessment of Outpatient Digital Follow-up of Patients Over 70 Years of Age Undergoing Chemotherapy Treatment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Breast Cancer
Colorectal Cancer
Lung Cancer
Keywords: Elderly population
digital monitoring
Lead sponsor: Institut Paoli-Calmettes
Sponsor class: OTHER
First posted: 2019-05-22
Enrollment: 119
Sex: ALL
Minimum age (years): 70
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

Brief summary: adherence of digital follow-up in a population of elderly patients.

Detailed description: The use of digital self-questionnaires adapted to elderly patients but also to BrC and Bac could detect the toxicities of chemotherapy and we formulate the hypothesis that the continuous monitoring of these different variables in elderly patients treated with chemotherapy is possible and acceptable to this population.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 70 years,
2. Patient with an indication of adjuvant chemotherapy showing:

   * Breast cancer
   * Colorectal cancer
   * lung cancer

4. WHO ≤ 3 (WHO index - World Health Organization) 5. Estimated life expectancy\> 6 months 6. patients with a smartphone or tablet with an internet connection. It can also be offered to patients whose primary caregiver or the person of trust (including the partner) has a smartphone, an internet connection or a tablet provided that he or she is present more than three times during the week. during chemotherapy to ensure smooth weekly data transfer and filling of questionnaires 7. Signed consent to participation 8. Affiliation to, or beneficiary of, a social security scheme

Exclusion Criteria:

1. Person in emergency situation, person of legal age subject to a legal protection measure (major under guardianship, guardianship or court order), or unable to express his / her consent
2. Impossibility of submitting to the medical examination of the test for geographical, social or psychological reasons
3. Contraindications to the procedure of the study: patient or caregiver living with a patient who does not have a smartphone with an internet connection (patient or caregiver living with a patient)
4. Concurrent participation in another clinical trial
5. Patient unable to understand the quality of life survey and Patient Reported Outcome

Primary outcomes:
measure: demonstrate that the adherence rate of digital follow-up is greater than 70% in a population of elderly patients.
timeFrame: 12 months after the last chemotherapy received by the patient
Secondary outcomes:
Other outcomes:
Locations:
city: Avignon
country: France
facility: Institut Sainte Catherine
city: Gap
country: France
facility: CHI des Alpes du Sud
city: Marseille
country: France
facility: Institut Paoli-Calmettes
city: Nice
country: France
facility: CHU Nice
Study officials:
affiliation: Institut Paoli-Calmettes
name: Louis Tassy, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04200274: Physical Activity Recommendation Behaviour in German Mental Health Nurses
Official title: Physical Activity Recommendation Behaviour in German Nurses Working with Patients with Mental Disorders
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Mental Disorder
Physical Activity
Keywords: Physical Activity
Mental Disorder
Recommendation Behaviour
Mental Health
Exercise
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2019-12-16
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nurses that currently work with patients with mental disorders in Germany.

Brief summary: The purpose of this study is to examine the physical activity recommendation behaviour, beliefs, barriers and exercise participation in German nurses working with patients with mental disorders.

Detailed description: Physical activity plays an important role in the prevention and treatment of mental disorders. Despite the potential mental health benefits, large proportions of patients with mental disorders do not meet the physical activity recommendations.

Nurses play a key role in the recommendation of physical activity to their patients. There are no previous studies that examine physical activity recommendation behaviour in German nurses.

The purpose of this study is to examine the physical activity recommendation behaviour, beliefs, barriers and exercise participation in German nurses working with patients with mental disorders.

Eligibility criteria: Inclusion Criteria:

* Nurse
* Currently working with patients with mental disorders
* At least 18 years old
* Sufficient German skills for answering the questionnaire

Exclusion Criteria:

None

Primary outcomes:
measure: Exercise in Mental Illness Questionnaire (EMIQ) - German Version
timeFrame: 1 day
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Charité Universitätsmedizin Berlin - Department for Psychiatry and Psychotherapy - Charité Campus Mitte
Study officials:
affiliation: Charité Universitätsmedizin Berlin- Charité Campus Mitte - Department for Psychiatry and Psychotherapy
name: Moritz B Petzold, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00700674: Effect of Usage of Electroencephalogram (EEG) Entropy on the Incidence of Postoperative Cognitive Dysfunction in Geriatric Patients
Official title: Is the Ese of EEG Entropy as Intra-operative Monitor Improves Postoperative Cognitive Dysfunction
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Cognitive Dysfunction
Keywords: EEG entropy
Elderly
Decreases
POCD
Use of EEG entropy
Geriatric
Lead sponsor: King Khaled Eye Specialist Hospital
Sponsor class: OTHER_GOV
First posted: 2008-06-19
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 60 Elderly patient, ASA 1-2

Brief summary: To determine if the usage of EEG Entropy helps to reduces the incidence of POCD in elderly patients after general anesthesia.


Eligibility criteria: Inclusion Criteria:

* ASA physical status I-II.
* scheduled for retinal surgery expected to take 2-3 hours under general anesthesia.
* orotracheal intubation.

Exclusion Criteria:

* history of cardiac, pulmonary, liver or renal disease.
* significant obesity (body mass index \>30.
* Long-term user of central nervous system activator drugs, benzodiazepines and/or opiates.
* dementia, brain atrophy and other neurological disorder.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Khaled Eye Specialist hospital
Study officials:
affiliation: King Khaled Eye Specialist Hospital
name: Waleed Riad, MD,AB,SB
role: PRINCIPAL_INVESTIGATOR
References: