louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT00651846: Investigate Impact of Yasmin vs Microgynon on Hemostasis Parameters in Healthy Women
Official title: Single Center, Double Blind, Randomized, Crossover Study to Investigate the Impact of the Oral Contraceptive Yasmin (30 µg EE / 3 mg DRSP) Compared to Microgynon (30 µg / 150 LNG) on Hemostasis Parameters in 40 Female Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Healthy
Keywords: Contraception
Hemostasis
Blood Coagulation
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-04-03
Enrollment: 43
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The objective of this study was to investigate the impact of the oral contraceptive YASMIN (containing: drospirenone 3 mg/ethinyl estradiol 30 mcg) in comparison with the oral contraceptive MICROGYNON (containing: levonorgestrel 150 mcg/ethinyl estradiol 30mcg) on factors of blood coagulation and fibrinolysis in female subjects


Eligibility criteria: Inclusion Criteria:

* Clinically normal safety laboratory results

Exclusion Criteria:

* Standard contraindications for use of combined oral contraceptives (class label). Including:

  * Presence or history of thromboembolic process in veins (such as deep venous thrombosis, pulmonary embolism) or arteries (e.g., stroke, myocardial infarction) or a known genetic component (homozygous), venous thromboembolic event in a close relative (parents or siblings) at younger age (\</= 40 years)
* Acute and chronic severe liver dysfunction or disease. There should be an interval of at least 6 months between the subsidence of a viral hepatitis (normalization of the liver parameters) and the start of the study medication.
* Use of preparations where experience shows affect on the activity of hepatic enzymes.

Primary outcomes:
measure: Pro-coagulatory parameters: Factor VIII (activity), Fibrinogen
timeFrame: At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods
measure: Anti-coagulatory parameters: Protein C (activity), Antithrombin III(activity), APC resistance (factor V mutation)
timeFrame: At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods
Secondary outcomes:
measure: Rosing test: APC sensitivity ratio
timeFrame: At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods
measure: Pro-coagulatory parameters: Factor VIII (activity), Activation markers: D-dimer, Prothrombin fragment 1+2
timeFrame: At baseline and after wash out (period 2); after 7 cycles of treatment in each of the two study periods
Other outcomes:
Locations:
city: Berlin
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT05109546: Geriatric COVID-19 Serology
Official title: Geriatric COVID-19 Serology
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: COVID-19
Keywords: COVID-19
SARS-COV-2
Elderly people
Geriatric
RT-PCR SARS-CoV-2
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2021-11-05
Enrollment: 200
Sex: ALL
Minimum age (years): 76
Standard ages: OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patient hospitalized or resident in the geriatrics center from July 1, 2020 to November 30, 2021 having presented with COVID or having benefited from a COVID vaccination.

Brief summary: Coronaviruses are important human and animal pathogens. At the end of 2019, a new coronavirus was identified as the cause of a cluster of pneumonia cases in Wuhan, a city in China's Hubei province. It quickly spread, leading to an epidemic across China, followed by an increasing number of cases in other countries around the world. In February 2020, the World Health Organization designated the disease COVID-19, which stands for coronavirus disease 2019. The virus that causes COVID-19 is SARS-CoV-2.

The duration of protection during which a patient after infection and / or vaccination remains clinically protected and the evolution of their serology as well as their titre remains unknown


Eligibility criteria: Inclusion criteria:

* Age\> 75 years old
* Patient hospitalized or resident in the geriatrics center from July 1, 2020 to November 30, 2021 having presented with COVID or having benefited from a COVID vaccination.
* Subject not having expressed their opposition, after information, to the reuse of their data for the purposes of this research

Exclusion criteria:

* Subject having expressed opposition to participating in the study
* Impossibility of providing the subject with enlightened information (difficulties in understanding the subject, etc.)
* Subject under guardianship, curatorship or safeguard of justice

Primary outcomes:
measure: Retrospective study of COVID serologies in a geriatric population after infection or vaccination
timeFrame: Files analysed retrospectively from July 1, 2020 to November 30, 2021 will be examined]
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service SSR Gériatrique - Hôpitaux Universitaires de Strasbourg
Study officials:
affiliation: Service SSR Gériatrique - Hôpitaux Universitaires de Strasbourg
name: Maxence MEYER, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03947346: Biomarkers of Renal Dysfunction in Neuroblastoma Survivors
Official title: Biomarkers of Renal Dysfunction in Neuroblastoma Survivors
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Neuroblastoma Survivors
Keywords: Kidney Function
Biomarkers
19-160
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-05-13
Enrollment: 28
Sex: ALL
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Childhood cancer survivors followed by the Pediatric Long-Term Follow-Up (LTFU) Program will be recruited for the current study.

Brief summary: The main purpose of this study is to learn more about biomarkers of kidney function in the blood and urine of neuroblastoma survivors. A biomarker is a biological molecule found in blood, urine, other body fluids, or tissues that is a sign of a normal or abnormal process, or of a condition or disease. A biomarker may be used to see how well the body responds to a treatment for a disease or condition.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of neuroblastoma between 0-18 years of age
* \< 21 years of age at time of study enrollment
* Two or more years from completion of systemic chemotherapy and/or radiation therapy

Exclusion Criteria:

* Patients treated with observation only
* Patients with multiple primary cancers

Primary outcomes:
measure: indicators of renal injury
timeFrame: 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Danielle Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03210246: Drug-drug Interaction Study: Influence of Vilaprisan on Pharmacodynamics (PD) and Pharmacokinetics (PK) of a Combined Oral Contraceptive (COC)
Official title: A Randomized, Double-blind, Parallel-group, Multi-center Study to Investigate the Pharmacodynamics and Pharmacokinetics of a Combined Oral Contraceptive Containing Levonorgestrel (LNG) and Ethinylestradiol (EE) When Given Together With Vilaprisan Over 3 Months in Healthy Women of Reproductive Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Clinical Trial ,Phase I
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2017-07-06
Enrollment: 71
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: This study will be performed as a multi-center, randomized, double-blind study in 60 healthy women (2 groups of 30 women) to investigate ovarian activity during simultaneous intake of a COC (containing the estrogen EE and the progestin LNG) and the progesterone receptor modulator (PRM) vilaprisan.


Eligibility criteria: Inclusion Criteria:

* Healthy female premenopausal subjects
* Age: 18 to 35 years (inclusive)
* Body mass index (BMI) : ≥18 and ≤30 kg/m²
* Non-smoker for 3 months (former smokers who quit smoking \>3 months before the first study drug administration may be included)

Exclusion Criteria:

* Incomplete recovery from pre-existing disease for which it can be assumed that the absorption, distribution, excretion, and effect of the study drugs will not be normal
* presence or history of thrombophlebitis, venous or arterial thrombotic/thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident

Primary outcomes:
measure: Number of subjects with ovulation (i.e. Hoogland score = 6) or risk of ovulation (Hoogland score = 5)
timeFrame: treatment day 57 to day 84
measure: Number of subjects with a Hoogland score = 4
timeFrame: treatment day 57 to day 84
Secondary outcomes:
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Dinox GmbH Berlin
city: Berlin
country: Germany
facility: CRS Clinical Research Services Berlin GmbH
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
Clinical trial NCT01581346: Exercise Study in Patients With Lung Cancer
Official title: Pilot Study to Establish an Exercise Intervention in Patients With Lung Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Non Small Cell Lung Cancer
Keywords: NSCLC
exercise intervention
quality of life
Lead sponsor: German Cancer Research Center
Sponsor class: OTHER
Collaborators: name: Heidelberg University
First posted: 2012-04-20
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

Brief summary: In the course of their disease patients with Non small cell lung cancer (NSCLC) often experience impaired psychological and physical functioning resulting in a reduced quality of life (QoL). The aim of the study is to explore the feasibility and the effects of an eight weeks combined muscle strength and endurance training on physical capacity and QoL.

Detailed description: In this open, prospective, single center study 40 patients (pts) with NSCLC undergoing adjuvant or palliative chemo-/ or radiotherapy are enrolled. Physical status is assessed by using the 6 Minute Walk Test (6MWT) for endurance and by using the Handheld Dynamometer (HHDM) for strength (flexion and extension of elbow, hip and knee). Psychological performance is measured by standardized questionnaires (MFI, FACT-L, PHQ - 9). Data are collected at baseline (T0) and after the 8 weeks sports intervention (T1). Pts are instructed to train at least 5 times/ week in the inpatient setting. After discharge pts are instructed to train in a home-based setting at least 3 times/week for a period of 8 weeks. Feasibility is defined as an adherence of two trainings per week during at least 6 weeks (out of 8 weeks of the intervention).

Eligibility criteria: Inclusion Criteria:

* Male and female patients
* histological confirmed diagnosis of Non small cell lung cancer (NSCLC)
* current treatment: chemo-and/or radiotherapy
* age \> 18y
* Body Mass Index (BMI) \> 18
* written informed consent

Exclusion Criteria:

* acute infection
* immobility \> 2 days
* severe neurological impairment
* severe cardiac impairment
* severe pulmonal impairment
* severe renal impairment
* acute bleedings
* alcohol-/drug-abuse

Primary outcomes:
measure: - number of patients who are adherent to the exercise intervention
timeFrame: 8 months
Secondary outcomes:
measure: - effects of the exercise intervention on psychological symptoms (e.g. quality of life)
timeFrame: 8 months
measure: - effects of the exercise intervention on physical symptoms (muscle strength and endurance)
timeFrame: 8 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Thoracic Oncology Clinic for Thoracic Diseases
Study officials:
affiliation: Heidelberg University
name: Michael Thomas, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03661346: Esmolol vs. Labetalol in Endoscopic Sinus Surgery
Official title: Blood Loss and Visibility With Esmolol vs. Labetalol in Endoscopic Sinus Surgery: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Sinusitis
Lead sponsor: The University of Texas Medical Branch, Galveston
Sponsor class: OTHER
First posted: 2018-09-07
Enrollment: 28
Sex: ALL
Minimum age (years): 18
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 compare esmolol and labetalol bleeding and intra-operative visibility scores in functional endoscopic sinus surgery.

Detailed description: BACKGROUND: Improved intraoperative visibility during functional endoscopic sinus surgery (FESS) decreases the risk of serious orbital or skull base injuries. Beta blockers are among several methods used to reduce mean arterial pressure (MAP), heart rate (HR) and mucosal bleeding. Labetalol (mixed alpha-1-beta blocker) reduces HR and MAP; however, its alpha-1 blockade may mitigate topical epinephrine decongestant effects. Esmolol (selective beta-1 blocker) does not have direct antagonistic effects on topical epinephrine. This study compares the hemodynamic parameters (rate of blood loss, MAP control, HR) and intraoperative visibility during FESS between esmolol and labetalol.

Eligibility criteria: Inclusion Criteria:

* History of CRS with or without nasal polyps
* Undergoing FESS for CRS
* American Society of Anesthesiologists (ASA) physical status 1 (healthy) or 2 (patient with mild systemic disease).

Exclusion Criteria:

* Pregnancy
* Asthma
* COPD
* Bradycardia
* Heart failure
* End stage renal disease
* Cerebrovascular accident
* Diabetes mellitus
* Preoperative use of NSAIDs, aspirin, or beta-blockers
* Body mass index (BMI) greater than 40 kg/m2.

Primary outcomes:
measure: Intra-operative Surgical Visibility - Boezaart Scale
timeFrame: Duration of operation
measure: Intra-operative Surgical Visibility - Wormald Scale
timeFrame: Duration of operation up to 3 hours
Secondary outcomes:
measure: Rate of Blood Loss
timeFrame: Duration of operation up to 3 hours
measure: Average Mean Arterial Blood Pressure
timeFrame: Duration of operation up 3 hours/completion of operation
measure: Average Heart Rate
timeFrame: Duration of operation up to 3 hours/completion of surgery
Other outcomes:
Locations:
city: Galveston
country: United States
facility: University of Texas Medical Branch
state: Texas
Study officials:
affiliation: University of Texas
name: Mohamad Chaaban, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01923246: Development of IVR and WEB Alcohol Interventions
Official title: Development of IVR and WEB Alcohol Interventions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Consumption
Keywords: Alcohol consumption
Brief intervention
Automated techniques
Lead sponsor: Region Skane
Sponsor class: OTHER
First posted: 2013-08-15
Enrollment: 1672
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

Brief summary: The primary aim of the present study is to study the effect of a brief automated alcohol intervention in University students, and if there is a difference in effect between automated brief interventions delivered by internet (WEB) or Interactive Voice Response (IVR), and to study if there is difference in effect between single and repeated interventions.


Eligibility criteria: Inclusion Criteria:

* Females scoring 6 and above and males scoring 8 and above on AUDIT.

Exclusion Criteria:

* Females scoring 5 and below and males scoring 7 and below on AUDIT

Primary outcomes:
measure: ALCOHOL USE DISORDERS IDENTIFICATION TEST (AUDIT)
timeFrame: September 2011 - October 2011
Secondary outcomes:
measure: Daily Drinking Questionnaire (DDQ)
timeFrame: September 2011 - October 2011
Other outcomes:
Locations:
city: Malmö
country: Sweden
facility: Malmö university, Department of Criminology
state: Skane
Study officials:
affiliation: Malmö University, Department of Criminology
name: Claes Andersson, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02402946: Placebo-controlled, Randomized Trial of a Simplified Biofeedback Technique for the Treatment of Rumination
Official title: Valoración Objetiva y Tratamiento de la rumiación
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rumination Disorders
Lead sponsor: Hospital Universitari Vall d'Hebron Research Institute
Sponsor class: OTHER
First posted: 2015-03-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Rumination syndrome is characterized by effortless recurrent regurgitation of recently ingested food into the mouth, with consequent expulsión or re-chewing and swallowing. In a previous study we showed that rumination is produced by an unperceived, somatic response to food ingestión. After having identified the key mechanisms of rumination, we developed an original EMG guided biofeedback technique with specific targets for correction, based on EMG-guided control of abdomino-thoracic muscular activity, and in a pilot study we showed the potential effectivity of this treatment. In a subsequent study this technique was validated by a formal placebo-controlled, randomized trial. The current aim is to test the efficacy of a simplified biofeedback technique not requiring EMG-guided control.

Detailed description: Abdomino-thoracic muscle activity after a challenge meal will be recorded by EMG: in the biofeedback group, patients will be instructed to control muscle activity, whereas in the placebo group patients will not. In each patient 3 sessions will be performed over a 10-day period. Physiological (muscular activity by EMG) and clinical outcomes (number of rumination events by questionnaries administered daily for 10 days) will be measured before and after treatment.

Eligibility criteria: Inclusion Criteria:

* Rumination syndrome

Exclusion Criteria:

* relevant organic disease

Primary outcomes:
measure: Number of regurgitation episodes
timeFrame: 28 days
Secondary outcomes:
measure: Postprandial abdominal symptoms
timeFrame: 28 days
Other outcomes:
Locations:
city: Barcelona
country: Spain
facility: University Hospital Vall d'Hebron
state: Catalunya
city: Barcelona
country: Spain
facility: Fernando Azpiroz
Study officials:
affiliation: Hospital Universitary vall d'Hebron
name: Fernando Azpiroz, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barba E, Burri E, Accarino A, Malagelada C, Rodriguez-Urrutia A, Soldevilla A, Malagelada JR, Azpiroz F. Biofeedback-guided control of abdominothoracic muscular activity reduces regurgitation episodes in patients with rumination. Clin Gastroenterol Hepatol. 2015 Jan;13(1):100-6.e1. doi: 10.1016/j.cgh.2014.04.018. Epub 2014 Apr 24.
Clinical trial NCT06366646: Competency-based Intervention for Head Nurses
Official title: Impact of Competency-Based Intervention on Leadership Effectiveness of Head Nurses in Teaching Hospitals
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intervention
Knowledge, Attitudes, Practice
Keywords: leadership
Competency
Effectiveness
Intervention
Program
Head nurses
Lead sponsor: Matrouh University
Sponsor class: OTHER
First posted: 2024-04-16
Enrollment: 90
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A quasi-experimental design
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Head nurses have a crucial leadership role in managing their units and providing high-quality and safe nursing care. Head nurse leadership competency and effectiveness are very essential to manage nursing care practices and management activities in their hospitals. Development leadership competency intervention programs would improve the head nurse's competency and effectiveness.

Detailed description: Head nurses have a crucial leadership role in managing their units and providing high-quality and safe nursing care. Head nurse leadership competency and effectiveness are very essential to manage nursing care practices and management activities in their hospitals. Development leadership competency intervention programs would improve the head nurse's competency and effectiveness. This study aimed to evaluate the impact of the leadership competency intervention program on the leadership effectiveness of head nurses

Eligibility criteria: Inclusion Criteria:

* Head nurses

  * willing to participate in the study
  * work in general wards and toxicology, intensive and critical care units
  * Sign a consent

Exclusion Criteria:

* Head nurses

  * work in outpatient units
  * Did not sign a consent
  * Absent from training

Primary outcomes:
measure: Questionnaire to measure head nurses' knowledge of leadership competency
timeFrame: one month
measure: Questionnaire to measure head nurses' ability to use leadership competency
timeFrame: one month
measure: Questionnaire to measure leadership effectiveness
timeFrame: one month
Secondary outcomes:
Other outcomes:
Locations:
city: Mersa Matruh
country: Egypt
facility: Faculty of Nursing, Matrouh University
Study officials:
affiliation: Faculty of Nursing, Matrouh University, Egypt
name: Nagah Abd El-Fattah Mohamed Aly, Ph.D
role: PRINCIPAL_INVESTIGATOR
affiliation: Faculty of Nursing, Matrouh University, Egypt
name: Wael M. Lotfy, Ph.D
role: STUDY_DIRECTOR
affiliation: Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Alexandria University, Egypt
name: Safaa M. El-Shanawany, Ph.D
role: STUDY_CHAIR
affiliation: Forensic Medicine and Clinical Toxicology, Faculty of Medicine, Alexandria University, Egypt
name: Maha Ghanem, Ph.D
role: STUDY_CHAIR
affiliation: Psychatric Nursing and Mental health , Faculty of Nursing, Alexandria University, Egypt
name: Elham Abd El KaderFayad, Ph.D
role: STUDY_CHAIR
References: