louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04521010: Staff Absenteeism and Delivery of Healthcare Services During the COVID-19 Pandemic
Official title: Staff Absenteeism and Delivery of Healthcare Services During the COVID-19 Pandemic at Wiktor Dega Orthopedic and Rehabilitation Clinical Hospital in Poznań
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Pandemic
Keywords: Staff absenteeism
healthcare services
Lead sponsor: Poznan University of Medical Sciences
Sponsor class: OTHER
First posted: 2020-08-20
Enrollment: 700
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 713 workers in 2019 and 747 workers in 2020.

Brief summary: Work attendance of more than 700 hospital workers was evaluated. The assessment of the number of medical services that were performed was based on monthly reports prepared for the national payer of health services.

Detailed description: A retrospective analysis of above-mentioned data, covering the period January-April 2019 and January-April 2020, was carried out. The evaluation of the staff's absence included all workers employed under an employment contract: 713 workers in 2019 and 747 workers in 2020. The variable number of employees was a result of the employment dynamics in the subsequent 2 years, due to variable quantity of healthcare services that were contracted with the national payer and changes in the form of employment of some hospital workers.Three types of analyses were carried out: global analysis, analysis taking into account division into specific professions and the analysis of absence in different hospital organizational units/areas. The absences due to medical reasons, holidays or childcare were analyzed together. The analysis of performing the contracted tasks was shown in relative values ( %). The analysis included the structure of contracted services dividing them into: Orthopedics (alloplasty and others), rehabilitation (person-day), rheumatology (drug trials and others). Considering the rehabilitation unit, it was subdivided into inpatient and outpatient wards due to temporary closure of the outpatient ward.

Eligibility criteria: Inclusion Criteria:

all workers employed under an employment contract Exclusion Criteria: not applicable

Primary outcomes:
measure: Number of days an individual person was absent
timeFrame: March and April 2019
Secondary outcomes:
Other outcomes:
measure: Number of days an individual person was absent
timeFrame: March and April 2020
Locations:
city: Poznań
country: Poland
facility: Department of Rehabilitation and Physiotherapy Rehabilitation,
Study officials:
affiliation: Department of Rehabilitation and Physiotherapy Rehabilitation
name: Ewa Chlebuś, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00487110: Clinical Confirmation of a Pharmacodynamic Interaction Between Tropisetron and Paracetamol
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pain
Keywords: Pain
serotonin
interaction
Patients with postsurgical pain, after ear surgery
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2007-06-15
Enrollment: 40
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: A previous study has shown that tropisetron inhibits the analgesic effect of paracetamol in healthy volunteers. This study aims at confirming this pharmacodynamic interaction in patients with post-surgery pain.

Detailed description: The study is a comparison of the analgesic action of paracetamol versus tropisetron + paracetamol in 30 patients who had surgery of the ear. The evaluation criteria will be the score on the visual analogue scale for pain evaluation.

Eligibility criteria: Inclusion Criteria:

* More than 18 years
* Men or women
* Ear surgery
* Written consent given

Exclusion Criteria:

* Paracetamol hypersensibility
* Tropisetron hypersensibility

Primary outcomes:
measure: Visual analogue scale score will be taken at 30min, 1h, 2h, 3h and compared for the two groups
timeFrame: at 30 min, 1h, 2h, 3h
Secondary outcomes:
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU
Study officials:
name: Pickering Gisele, MCU-PH
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01251510: Bile Acid-induced GLP-secretion. A Study in Cholecystectomized Subjects
Official title: Bile Acid-induced GLP-secretion. A Study in Cholecystectomized Subjects
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Lead sponsor: University Hospital, Gentofte, Copenhagen
Sponsor class: OTHER
First posted: 2010-12-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy subjects and cholcystectomised patients (chol)

Brief summary: PURPOSE

The goal of the present project is to unravel the importance of bile acid-induced GLP-1 secretion (via the G protein-coupled receptor TGR5) in human physiology.

In the present study the investigators examine the GLP-1 secretion in healthy subjects and cholecystectomised patients. Thereby the investigators aim to show, that cholecystectomised patients have reduced bileflow after a meal, and as a consequence exhibit a diminished GLP-1 response as compared to healthy subjects.


Eligibility criteria: Inclusion Criteria: (Healthy)

* Normal fasting plasma glucose
* Normal glucose tolerance
* Normal haemoglobin levels
* Informed content

Inclusion Criteria: (cholecystectomy group)

* Laparoscopic cholecystectomy \<6 months. Indication: Gallstones.
* Normal fasting plasma glucose
* Normal glucose tolerance
* Normal haemoglobin levels
* Informed content

Exclusion Criteria: (both groups)

* Diabetes
* Pre diabetes (impaired glucose tolerance or impaired fasting glucose)
* 1st degree relatives with diabetes
* Obesity (BMI \> 30)
* Inflammatory bowels disease
* Nephropathy
* Liver disease
* Medication which cannot be on hold for 24h

Primary outcomes:
measure: GLP-1 secretion
timeFrame: Postprandial
Secondary outcomes:
Other outcomes:
Locations:
city: Hellerup
country: Denmark
facility: Gentofte University Hospital
Study officials:
affiliation: Gentofte Hospital, University of Copenhagen
name: David P. Sonne, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sonne DP, Hare KJ, Martens P, Rehfeld JF, Holst JJ, Vilsboll T, Knop FK. Postprandial gut hormone responses and glucose metabolism in cholecystectomized patients. Am J Physiol Gastrointest Liver Physiol. 2013 Feb 15;304(4):G413-9. doi: 10.1152/ajpgi.00435.2012. Epub 2012 Dec 28.
Clinical trial NCT03716310: Platelet Reactivity in Septic Shock
Official title: Impaired Platelet Reactivity as an Early Biomarker for Sepsis-related Thrombocytopenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Septic Shock
Thrombocytopenia
Sepsis
Platelet Aggregation
Disseminated Intravascular Coagulation
Lead sponsor: Università degli Studi di Ferrara
Sponsor class: OTHER
First posted: 2018-10-23
Enrollment: 30
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: Patients in intensive care unit

Brief summary: Coagulation disorders and thrombocytopenia are common in patients with septic shock. Despite the clinical relevance of sepsis-induced thrombocytopenia, few studies have focused on the prediction of thrombocytopenia in this setting. The aim of this study was to evaluate whether platelets aggregometry and markers of platelets activation, such as mean platelet volume or platelet volume distribution width, could predict sepsis-induced thrombocytopenia in patients with septic shock and normal platelet count on the day of diagnosis.


Eligibility criteria: Inclusion Criteria:

* diagnosis of septic shock
* platelet count \>150\*103/mcL.

Exclusion Criteria:

* age \<18 years
* history of any hematologic disorder
* chronic liver failure
* previous chemotherapy
* transfusion of platelet during the previous 4 weeks
* renal replacement therapy before ICU admission
* history of antiplatelet therapy during the 8 days before inclusion
* history of heparin-induced thrombocytopenia (HIT) or other acquired or induced thrombocytopenia
* occurrence of HIT (defined as HIT score over 3)
* active bleeding

Primary outcomes:
measure: Occurence of sepsis-induced thrombocytopenia
timeFrame: 5 days after study inclusion
Secondary outcomes:
measure: life-threatening bleeding
timeFrame: After 28 days from study inclusion
measure: 90-day mortality
timeFrame: after 90 days from study enrollment
measure: number of Red blood cells (RBC) packs transfused during ICU stay
timeFrame: After 28 days from study inclusion
Other outcomes:
Locations:
city: Ferrara
country: Italy
facility: Università di Ferrara
Study officials:
References:
citation: Campo G, Valgimigli M, Gemmati D, Percoco G, Tognazzo S, Cicchitelli G, Catozzi L, Malagutti P, Anselmi M, Vassanelli C, Scapoli G, Ferrari R. Value of platelet reactivity in predicting response to treatment and clinical outcome in patients undergoing primary coronary intervention: insights into the STRATEGY Study. J Am Coll Cardiol. 2006 Dec 5;48(11):2178-85. doi: 10.1016/j.jacc.2005.12.085. Epub 2006 Nov 13.
citation: Dewitte A, Lepreux S, Villeneuve J, Rigothier C, Combe C, Ouattara A, Ripoche J. Blood platelets and sepsis pathophysiology: A new therapeutic prospect in critically [corrected] ill patients? Ann Intensive Care. 2017 Dec 1;7(1):115. doi: 10.1186/s13613-017-0337-7.
Clinical trial NCT02994810: Orientation Effects of Breastfeeding for Mothers
Official title: Orientation Effects of Breastfeeding for Mothers in a Private Hospital: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breastfeeding
Keywords: Breastfeeding
Orientation
Lead sponsor: Hospital Moinhos de Vento
Sponsor class: OTHER
First posted: 2016-12-16
Enrollment: 217
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The benefits of breastfeeding are increasingly known of the population and breastfeeding rates in the country have been increasing, but still are below satisfactory to the Ministry of Health (MH) and the World Health Organization (WHO).

Simple Strategies to guide and support the mother contributes to increasing knowledge about breastfeeding and can have positive impacts on breastfeeding rates.

Detailed description: Assess the impact of guidance on breastfeeding duration of exclusive breastfeeding in the first six months of a baby's life.

110 pairs of mother / baby - Recruitment: Private Hospital of Porto Alegre.

The first stage was carried out in the maternity - Orientation: Breastfeeding Importance Handle Correct, Positioning mother and baby, socioeconomic data and demographics. For the intervention group held three home visits:

10th day, 1st and 2nd month of the baby's life. At 6 months were made telephone contact for both groups.

Eligibility criteria: Inclusion Criteria:

* Mothers living in the city of Porto Alegre

Exclusion Criteria:

* Mothers who test positive for HIV, poor hearing, visual and mental disorders, preterm infants, twin hospitalized

Primary outcomes:
measure: Effects of Breastfeeding for Mothers measured by structured questionnaire
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Salete de matos
Study officials:
References:
Clinical trial NCT01958710: Outcome After Treatment of Pulmonary Aspergilloma
Official title: Outcome After Surgical Treatment or Bronchial Embolisation in Aspergilloma of the Lung: a Single Center Experience.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pulmonary Fungal Diseases
Keywords: Catheterization, Bronchial
Pneumonectomy
Lobectomy
Thoracoplasty
Lead sponsor: University Hospital, Gasthuisberg
Sponsor class: OTHER
First posted: 2013-10-09
Enrollment: 100
Sex: ALL
Minimum age (years): 1
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients in the database with following interventions will be screened for invasive aspergilloma in the final resection specimen:

Aspergilloma Fungal disease Lung bleeding Destroyed lung Empyema of the lung

Brief summary: Retrospective analysis of surgery and/or bronchial embolisation for pulmonary aspergilloma.

Detailed description: A retrospective chart analysis, based on the search results from a thoracic surgery database and an interventional radiology database. Outcome analysis of all surgically treated patients for a confirmed invasive aspergilloma. Comparisson with (preoperative) embolisation of the bronchial circulation.

Eligibility criteria: Inclusion Criteria:

* Histological proven Aspergilloma of the lung

Exclusion Criteria:

* Treatment limited to the use of systemic antifungal agents

Primary outcomes:
measure: survival after treatment
timeFrame: 10 years
Secondary outcomes:
measure: post treatment survival
timeFrame: 90 days
Other outcomes:
Locations:
city: Leuven
country: Belgium
facility: University Hospital Leuven
Study officials:
affiliation: UZ Leuven - dept. Thoracic Surgery
name: Herbert Decaluwé, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Katholic University Leuven
name: Laurence Bertrand, MSc
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01666210: Phase II Study Evaluating Safety/Efficacy of OTX-DP for Treatment of Ocular Inflammation and Pain After Cataract Surgery
Official title: A Prospective, Multicenter, Randomized, Parallel-Arm, Double-Masked, Vehicle Controlled Phase II Study Evaluating the Safety and Efficacy of OTX-DP for the Treatment of Ocular Inflammation and Pain After Cataract Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Ocular Inflammation and Pain
Lead sponsor: Ocular Therapeutix, Inc.
Sponsor class: INDUSTRY
First posted: 2012-08-16
Enrollment: 60
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the safety and efficacy of OTX-DP as a sustained release drug (dexamethasone) depot when placed in the canaliculus of the eyelid for the treatment of ocular inflammation and pain in subjects who have undergone cataract extraction with intra-ocular lens implantation.


Eligibility criteria: Inclusion Criteria:

* Has provided written informed consent, approved by the appropriate institutional review board; and is able to comply with study requirements and visit schedule
* Is greater than or equal to 21 years of age
* Has a cataract and is expected to undergo clear corneal cataract surgery with phacoemulsification and implantation of a posterior chamber intraocular lens

Exclusion Criteria:

* Any intraocular inflammation in the study eye present during the screening slit lamp examination
* Score greater than "0" on the Ocular Pain Assessment at Screening
* Compromised immune system or an autoimmune disease that in the opinion of the Investigator could affect the quality of the ocular surface

Primary outcomes:
measure: Absence of Cells in Anterior Chamber of Study Eye
timeFrame: Day 8
measure: Absence of Pain in the Study Eye
timeFrame: Day 8
Secondary outcomes:
Other outcomes:
measure: Adverse Events
timeFrame: Duration of each individual subject's participation in the study, up to 60 days
Locations:
city: Hoffman Estates
country: United States
facility: Chicago Cornea Consultants, Ltd.
state: Illinois
Study officials:
References:
Clinical trial NCT03473210: The Value of Amniopatch in Preterm Premature Rupture of Membranes
Official title: The Value of Amniopatch in Pregnancies Associated With Spontaneous Preterm Premature Rupture of Fetal Membranes:A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Preterm Premature Rupture of Membrane
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2018-03-22
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A randomized controlled trial that involved 100 women diagnosed with PPROM between 24 and 34 weeks of gestational age. Participants were randomized equally into 2 groups. Group I in which amniopatch was done (an amnioinfusion of platelet concentrate followed by fresh frozen plasma in addition to the routine management used in the control group. Group II were treated with routine management including antibiotics and corticosteroids

Detailed description: All patients were started on a regimen of hospital bed rest and received antibiotic prophylaxis consisting of ampicillin 2g IV every 6hours for 48 hours, followed by erythromycin 250mg every 6hours for 5days . Antenatal corticosteroids were given in the form of dexamethasone 8mg intramuscular every 12hours for 48 hours i.e. in four divided doses.

Fifty to two hundred ml of normal saline was infused to create an adequate pocket in which the infusion needle can be stabilized. After injection of normal saline, alternate infusions of 20 mL of platelets, normal saline (which does not contain Calcium, needed for the clotting process), and 20 mL of (FFP). The infused substances were warmed to a temperature of 37°c. Avoiding contact between the blood products prevents clotting in the lines.

During infusion, the fetal heart rate as well as the accumulation of amniotic fluid was monitored by ultrasound. Usually a total of around 60-80 mL of platelets, 100-150 mL of FFP and 100-150 mL of amnioinfusion fluid was used throughout the procedure

Eligibility criteria: Inclusion Criteria:

* healthy pregnant women
* gestational age of 24 to 34 weeks (calculated by the sure dates of the last menstrual period and confirmed by early 1st trimesteric ultrasound).

All women carried a normal healthy singleton fetus

Exclusion Criteria:

* established preterm labor at admission
* those with symptoms or signs suggestive of clinical chorioamnionitis.
* women with uncontrolled medical disorder e.g. severe hypertension, uncontrolled diabetes, chronic renal impairment
* women with vaginal bleeding regardless its cause.
* Pregnancies associated with major congenital fetal malformations
* placental insufficiency or anomalies
* anterior position of the placenta
* iatrogenic PPROM

Primary outcomes:
measure: Amniotic fluid index
timeFrame: one week after the procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Minya
country: Egypt
facility: Hany Hassan
Study officials:
affiliation: professor
name: Ahmed Maged
role: STUDY_DIRECTOR
References:
Clinical trial NCT07014410: Pyrotinib Combined With Dalpiciclib Combined With Letrozole in ER-positive and HER2-positive Advanced Breast Cancer
Official title: A Multicenter Phase II Clinical Study of Pyrotinib Combined With Dalpiciclib Combined With Letrozole in the Treatment of ER-positive and HER2-positive Advanced Breast Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: Zhejiang Cancer Hospital
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 63
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a a multicenter Phase II clinical study investigating efficacy of pyrotinib combined with dalpiciclib combined with letrozole in ER-positive and HER2-positive advanced breast cancer patients. The sample size is 63.

Detailed description: This is a a multicenter Phase II clinical study investigating efficacy of pyrotinib combined with dalpiciclib combined with letrozole in ER-positive and HER2-positive advanced breast cancer patients. Patients receive pyrotinib 320mg/d, dalpiciclib 125mg/d, d1-21, q28d. One cycle is 28d.

Eligibility criteria: Inclusion Criteria:

1. The subjects voluntarily joined the study, signed the informed consent, and had good compliance
2. Postmenopausal or premenopausal/perimenopausal women aged ≥18 years and ≤75 years
3. Patients with recurrent/metastatic breast cancer confirmed by histopathology with positive ER expression and positive HER2 expression
4. Have at least one extracranial measurable lesion that meets RECIST 1.1 criteria
5. At most one previous trastuzumab containing systemic therapy for recurrent metastatic breast cancer

Exclusion Criteria:

1. Subjects had untreated central nervous system metastasis
2. Bilateral breast cancer, inflammatory breast cancer, or latent breast cancer
3. Previous treatment with any CDK4/6 inhibitors
4. Inability to swallow, intestinal obstruction, or other factors affecting drug use and absorption
5. Subject has had other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within 5 years or at the same time

Primary outcomes:
measure: Objective response rate
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Progression Free Survival
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang Cancer Hospital
state: Zhejiang
Study officials:
affiliation: Zhejiang Cancer Hospital
name: Zhanhong Chen, Master
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02123810: Quality of Chest Compressions After a Night Shift
Official title: Weaker Chest Compression After Nightshift : The We CAN Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Arrest
Keywords: fatigue
motor skills
cardiopulmonary resuscitation
Lead sponsor: Bistro Study Group
Sponsor class: OTHER
First posted: 2014-04-28
Enrollment: 46
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: The investigators sought to evaluate the influence of fatigue after a night shift on the quality of Chest Compressions (CC) in CardioPulmonary Resuscitation (CPR), among physicians.

Detailed description: This is a non inferiority cluster randomized trial on three Emergency Departments (ED) and five Intensive Care Unit (ICU) from three urban academic hospital in Paris, France. The investigators evaluated the quality of CC with a low-fidelity manikin and its electronic feedback device. The investigators tested subjects on a 6-minutes CC-only CPR scenario, including 2 minutes of pause. Physicians were tested either on a control day then after a night shift, or after a night shift then on a control day.

Eligibility criteria: Inclusion Criteria:

* Resident / Physicians in emergency departement (ED) or taking night in ED
* Resident / Physicians in Intensive Care Unit (ICU) or taking night in ED
* Nightshift \> 18 hours

Exclusion Criteria:

* Stop chest compressions before 2 minutes

Primary outcomes:
measure: the proportion of CC with a depth higher than 50mm
timeFrame: 2 minutes of chest compressions
Secondary outcomes:
measure: Number of chest compressions
timeFrame: 2 minutes
Other outcomes:
measure: Factors associated with better chest compressions (CC)
timeFrame: 2 minutes
Locations:
city: Paris
country: France
facility: Hôpital Pitié-Salpêtrière; Hopital Saint Antoine; Hopital Tenon
Study officials:
affiliation: Emergency Department, Hôpital Pitié-Salpêtrière, 47-83 Boulevard de l'Hôpital, 75013 Paris, France.
name: Yonathan Freund
role: PRINCIPAL_INVESTIGATOR
References: