louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01357148: A Post Marketing Safety Study of Sitagliptin Phosphate/Metformin Hydrochloride (JANUMET®) (MK-0431A-235)
Official title: Sitagliptin Phosphate/Metformin HCl (JANUMET®) Post Marketing Surveillance Protocol
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Diabetes Mellitus, Type 2
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2011-05-20
Enrollment: 143
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with type 2 diabetes mellitus who are treated with sitagliptin phosphate/metformin HCl as per the standard of care in a physician's practice

Brief summary: The primary objective of this study is to obtain safety information on the use of sitagliptin phosphate/metformin hydrochloride (HCl) (JANUMET®) from endocrinologists, diabetologists, internists, and general practitioners.


Eligibility criteria: Inclusion Criteria:

* Must be taking sitagliptin phosphate/metformin HCl (JANUMET®) for the treatment of type 2 diabetes mellitus
* Treating physician must agree to provide information regarding the participant's treatment

Primary outcomes:
measure: Number of Participants With an Adverse Event
timeFrame: Up to approximately 28 months
measure: Age of Participants Prescribed Sitagliptin Phosphate/Metformin HCl
timeFrame: Up to approximately 28 months
measure: Number of Participants With Concomitant Conditions
timeFrame: Up to approximately 28 months
measure: Number of Participants Taking Concomitant Medications
timeFrame: Up to approximately 28 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05951348: Comparing Delayed Cord Clamping and Umbilical Cord Milking During Elective Cesarean Section for the Neonatal Outcome
Official title: Comparing Delayed Cord Clamping and Umbilical Cord Milking During Elective Cesarean Section for the Neonatal Outcome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Umbilical Cord Milking
Keywords: cesarean section
umbilical cord milking
hemoglobin
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2023-07-19
Enrollment: 162
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief summary: the study is conducted on the different actions on umbilical cord clamping including immediate cord clamping (ICC) , delayed cord clamping (DCC) for 30 seconds and umbilical cord milking (UCM) for 10-15 seconds in females that are delivered by elective cesarean section , to assess the neonatal outcomes including Hemoglobin and Hematocrit levels after birth in the newborn and the bilirubin level after 72 hrs

Detailed description: the benefit of umbilical cord milking for 10-15 seconds maneuver in cesarean section, that short time can improve the hemoglobin level and prevent anemia in the newborn with improvement of the iron stores for months in infancy without affection on the bilirubin level and the need for phototherapy. This is significant because of the rising rate of cesarean section all over the world make more children are liable for anemia, and by this simple technique it can be prevented.

Eligibility criteria: Inclusion Criteria:

* mother's age (20-40) years.
* pregnancy with a healthy singleton
* gestational age of 38-41 0/7 weeks
* uncomplicated pregnancy

Exclusion Criteria

* Any medical or obstetrical complications like hypertension, pre-eclampsia, diabetes any special habits like smoking, and substance abuse
* Rh-negative mothers. The fetal exclusion criteria
* fetus with evidence of intrauterine growth restriction
* infant with serious congenital anomalies.

Primary outcomes:
measure: hemoglobin level
timeFrame: immediately after the intervention
Secondary outcomes:
measure: bilirubin level
timeFrame: 72 hours after delivery
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Tamer Ahmed Hosny
Study officials:
References:
Clinical trial NCT01081548: A Clinical Trial Study to Evaluate Efficacy and Safety of Atorvastatin in Korean Patients With Hypercholesterolemia
Official title: A Multi-center, Randomized, Open-labeled Clinical Trial to Evaluate Efficacy and Safety of Lipinon® 20mg Versus Lipitor® 20mg in Korean Patients With Hypercholesterolemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypercholesterolemia
Lead sponsor: Yonsei University
Sponsor class: OTHER
First posted: 2010-03-05
Enrollment: 17
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Intervention model: PARALLEL

Brief summary: The purpose of this study is to compare the efficacy and safety of atorvastatin generic product with reference drug.


Eligibility criteria: Inclusion Criteria:

* Age 20 \~ 79
* People who have not reached LDL-C targeted level in accordance with the guidelines for hyperlipidemia management released by Korean Society of Lipidology and Atherosclerosis
* In case of female participants taking combination HRT or oral contraceptive, they should maintain stable capacity and usage at least for 8 weeks before the visit 1.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
References:
Clinical trial NCT03460548: REMOGEN® Omega Versus Cationorm® in the Treatment of Patients Suffering From Dry Eye
Official title: A Multicentre Randomized Trial Comparing the Efficacy and Safety of REMOGEN® Omega Versus Cationorm® in the Treatment of Patients Suffering From Dry Eye
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Dry Eye
Lead sponsor: TRB Chemedica
Sponsor class: INDUSTRY
First posted: 2018-03-09
Enrollment: 26
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 efficacy and safety of Remogen® Omega in the treatment of dry eye signs and symptoms will be investigated in comparison to Cationorm®.


Eligibility criteria: Inclusion Criteria:

* With at least a 3-month documented history of bilateral dry eye
* With a score of ocular surface staining with fluorescein (OSSF) ≥ 4 and ≤ 9 on the Oxford scale
* With at least one objective sign of tear deficiency
* With Ocular Surface Disease Index (OSDI) score of ≥ 18

Exclusion Criteria:

* Refractive surgery within 12 months prior to selection
* Any other ocular surgery or ocular trauma within 6 months prior to selection
* Systemic or local use of one of the following medications: glucocorticosteroids, cyclosporine A, antibiotics, NSAIDs

Primary outcomes:
measure: OSSF
timeFrame: Day 28
Secondary outcomes:
Other outcomes:
Locations:
city: Paris
country: France
facility: Quinze-Vingts Hospital
Study officials:
affiliation: Quinze-Vingts Hospital, Paris, France
name: Christophe Baudouin, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04738448: Examining the Effects of Art Therapy in Reducing Burnout in Healthcare Providers
Official title: Examining the Effects of Art Therapy in Reducing Burnout in Healthcare Using the Maslach Burnout Inventory
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burnout, Professional
Keywords: Art Therapy
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
First posted: 2021-02-04
Enrollment: 28
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: In this study, the investigators aim to examine the effects of art therapy in reducing burnout in healthcare providers. Using the Maslach Burnout Inventory Human Services Survey for Medical Personnel, the investigators will measure burnout in Medical University of South Carolina (MUSC) providers before and after the administration of a 4-week art therapy group.


Eligibility criteria: Inclusion Criteria:

* Age: 18 years or older
* Employed at MUSC as a healthcare provider
* Able and willing to participate in all 4 art therapy sessions

Exclusion Criteria:

* Individual does not provide direct patient care at MUSC
* Individual works in the same department as the art therapist
* Inability or unwillingness of subject to give informed consent

Primary outcomes:
measure: Change in Burnout Symptoms
timeFrame: At start of therapy sessions and 4 weeks after therapy sessions
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
affiliation: Medical University of South Carolina
name: Marie Doll, MA
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06334731: Antimicrobial Resistance During the SARS-CoV-2 (COVID-19) Pandemic
Official title: What Happened? Antimicrobial Resistance During the SARS-CoV-2 (COVID-19) Pandemic
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: COVID-19
Lead sponsor: Methodist Health System
Sponsor class: OTHER
First posted: 2024-03-28
Enrollment: 400
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: Patients admitted to Methodist Richardson, Methodist Mansfield, Methodist Charlton, or Methodist Dallas Medical Centers between March 2018 and August 2021.

Brief summary: Assess the incidence and rates of resistant pathogens prior to and during the COVID-19 pandemic.

Detailed description: The COVID-19 pandemic accelerated/exacerbated resistance rates for key pathogens. Specifically, incidence of extended-spectrum beta-lactamase producing Enterobacteriaceae (ESBLPE), carbapenem-resistant bacteria (CRB), methicillin-resistant Staphyloccoccus aureus (MRSA), vancomycin-resistant Enterococci (VRE), and C. difficile infections (CDI) will be higher in the pandemic time period (Pandemic, March 2020 - February 2025) compared to the pre-pandemic period (Pre-Pandemic, March 2018 - February 2020).

Eligibility criteria: Inclusion Criteria:

* • Patients admitted to Methodist Richardson, Methodist Mansfield, Methodist Charlton, or Methodist Dallas Medical Centers between March 2018 and August 2021.

  * \>18 years old

Exclusion Criteria:

* • Outpatient visit

  * Not admitted to an inpatient or observation status

Primary outcomes:
measure: Incidence of third generation cephalosporin-resistant bacteria (3GCRB)
timeFrame: 5 Months
Secondary outcomes:
measure: Incidence of ESBLPE
timeFrame: 5 months
measure: Incidence of CRB
timeFrame: 5 Months
measure: Incidence of other pathogens
timeFrame: August 2021
measure: Incidence of nosocomial infections
timeFrame: 5 Months
measure: Incidence of clinical outcomes
timeFrame: 5 Months
Other outcomes:
Locations:
city: Dallas
country: United States
facility: Methodist Dallas Medical Center
state: Texas
Study officials:
affiliation: The Methodist Hospital Research Institute
name: Mathew Crotty, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02888431: Correlation of Arterial and Venous Lactate and Base Deficit Values
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Access
Peripheral Access
Central Venous Catheter
Keywords: pH
base deficit
lactate values
venous blood samples
arterial blood samples
Lead sponsor: Nationwide Children's Hospital
Sponsor class: OTHER
First posted: 2016-09-05
Enrollment: 50
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients requiring arterial access and peripheral access. Additionally, patients with a central venous catheter would be included.

Brief summary: The purpose of this study is to determine the correlation between pH, base deficit, and lactate values when comparing venous and arterial blood samples in the pediatric population.


Eligibility criteria: Inclusion Criteria:

* Patients requiring arterial access and peripheral access. Additionally, patients with a central venous catheter would be included.

Exclusion Criteria:

* Patients who not require arterial access.

Primary outcomes:
measure: lactate blood value
timeFrame: During surgery- approximately 15-20 minutes after induction in the operating room (OR)
measure: base deficit blood value
timeFrame: During surgery- approximately 15-20 minutes after induction in the operating room (OR)
measure: pH blood value
timeFrame: During surgery- approximately 15-20 minutes after induction in the operating room (OR)
Secondary outcomes:
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Nationwide Children's Hospital
state: Ohio
Study officials:
affiliation: Nationwide Children's Hospital
name: Joseph Tobias
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00490048: Assessment of Pulmonary Involvement inUlcerative Colitis by Induced Sputum
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ulcerative Colitis
Keywords: Ulcerative colits
lung
Induced sputum
Our aim to evaluate lung involvement in Ulcerative colitis patients by induced sputum
Lead sponsor: Hillel Yaffe Medical Center
Sponsor class: OTHER_GOV
First posted: 2007-06-22
Enrollment: 20
Sex: ALL
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: SCREENING

Brief summary: Ulcerative colitis is a systemic disease we assume that extra intestinal involvement as we describein our study( Fireman Z, Osipov A, Kivity S, Kopelman Y, Sternberg A Fireman E: Assessment of pulmonary involvement in Crohn's disease by induced sputum. Am J Gastroenterol 2000;95(30):730-734. )

Detailed description: Twenty Ulcerative colitis patients and 20 control subjects (all nonsmokers) without respiratory symptoms will be tested. The induce sputum by 20' inhalation of 3.5% saline using ultrasonic nebulizer. Samples will studied by differential counts of 200 cells on cytopreps stained by Giemsa. T-lymphocyte subset analyses were done by FACS using three monoclonal antibodies: CD3 = total T cells, CD4 = T helper cells, and CD8 = T suppressor-cytotoxic cells. CD4/CD8 \>2.5 was considered abnormal.

Eligibility criteria: Inclusion Criteria:

* All the ulceratvive colitis patients without lung involvmentage 18-75 years of age

Exclusion Criteria:

* Pregnant women
* Non cooperative patients
* Smoker
* Lung disease

Primary outcomes:
measure: lung involvment in Ulcerative colitis patients
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Hillel- Yaffe Med. Ctr
name: Zvi Fireman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fireman Z, Osipov A, Kivity S, Kopelman Y, Sternberg A, Lazarov E, Fireman E. The use of induced sputum in the assessment of pulmonary involvement in Crohn's disease. Am J Gastroenterol. 2000 Mar;95(3):730-4. doi: 10.1111/j.1572-0241.2000.01843.x.
Clinical trial NCT04348448: Observational Study, Use of Canakinumab Administered Subcutaneously in the Treatment COVID-19 Pneumonia
Official title: Observational Study on the Use of Canakinumab Administered Subcutaneously in the Treatment of Patients With COVID-19 Pneumonia
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: COVID-19
Lead sponsor: AUSL Romagna Rimini
Sponsor class: OTHER
First posted: 2020-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
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: patients with COVID 19

Brief summary: The study is configured as a retrospective and prospective observational study. The study will be multi-center and will involve all COVID-19 pneumonia patients treated with canakinumab administered subcutaneously.


Eligibility criteria: Inclusion Criteria:

* patients with COVID 19 who have received or are candidates to receive treatment with canakinumab subcutaneously
* Age\> 18 years
* Pneumonia diagnosed with Chest X-ray / or Chest CT

Exclusion Criteria:

* Patients with Covid19-related pathology in the context of another cause of major admission (trauma, surgery)

Primary outcomes:
measure: intensive care treatment
timeFrame: 9 months
Secondary outcomes:
measure: ICU stay times
timeFrame: 9 months
measure: % died after 1 month after treatment
timeFrame: 9 months
measure: hospitalization
timeFrame: 9 months
measure: adverse event
timeFrame: 9 months
Other outcomes:
Locations:
city: Ravenna
country: Italy
facility: Ausl della Romagna
Study officials:
References:
Clinical trial NCT03425448: Neutrolin Versus Heparin for Locking Hemodialysis Catheters
Official title: Neutrolin Versus Heparin for Locking Hemodialysis Catheters: A Multi-center, Double-Blind, Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hemodialysis Catheter Infection
Catheter Thrombosis
Lead sponsor: King Abdullah International Medical Research Center
Sponsor class: OTHER
First posted: 2018-02-07
Enrollment: 192
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Multi-center, double-blind, randomized controlled trial
Primary purpose: TREATMENT

Brief summary: Hemodialysis catheter related bacterial infections represent a major cause of mortality and morbidity in the hemodialysis population. Several locking agents had been tried with variable degree of success but not without side effects.

Neutrolin catheter locking agent comprises of heparin,citrate and trauolidine that had been studied in a prospective study in Germany, and it demonstrated a very good result in terms of reducing the catheter related infections and thrombosis.

This study is a multi-center, double-blind RCT comparing the hemodialysis catheter locking solution Neutrolin with heparin in reducing the rate of catheter related bacterial infection and thrombosis.


Eligibility criteria: Inclusion Criteria:

* New hemodialysis catheter
* Subject who will need chronic hemodialysis at least twice/week
* Subject likely to require for at least 120 days
* Subject or relative is likely to understand the nature of the study and sign the consent
* Age 18 years and older

Exclusion Criteria:

* Subject with unstable malignancy
* Subject with liver cirrhosis with encephalopathy
* Subject know to have allergy to heparin, citrate or traoulidine
* Documented history of arterial thrombosis or known to have hypercoagulable state
* Subjects with active skin infections and ulcers

Primary outcomes:
measure: Proportion of catheter related blood stream infections (CRBSI per 1000 CVC days)
timeFrame: 18 month
Secondary outcomes:
measure: Proportion of hemodialysis catheters with poor flow due to thrombosis
timeFrame: 18 month
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT04427748: Electrophysiology in Congenital Cataract After Lensectomy and Anterior
Official title: The Change of Electrophysiology in Congenital Cataract After Lensectomy and Anterior Vitrectomy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Congenital Cataract
Keywords: ERG
Lead sponsor: Wenzhou Medical University
Sponsor class: OTHER
First posted: 2020-06-11
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: congenital cataract age from 1.5 years to 15 years who underwent cataract surgery at least 1 year

Brief summary: In this prospective study , a cohort of 91 eyes with congenital cataract and 25 eyes normal eyes from Wenzhou medical university was erolled.91 eyes with congenital cataract was after lensectomy and anterior vitrectomy as test group, 25 normal eyes as control group. The a- and b-wave and PhNR related parameters was evaluated.

Detailed description: Secondary IOL implantation in aphika children and lensectomy and anterior vitrectomy and primary IOL implantation in children with congenital cataract were both performed by the same surgeon(Z.Y.E).

electroretinography and photopic negative response are performed to each patient.The research was to evaluate the relationship between the best corrected visionn and the related parameters of a- and b-wave and PhNR .

Eligibility criteria: Inclusion Criteria:

* phakic children diagnosed with congenital cataract who underwent secondary IOL implantation and children with congenital cataract who underwent lensectomy and anterior vitrectomy and primary IOL implantation

Exclusion Criteria:

* patients with mild cataracts do not require surgery

Primary outcomes:
measure: ERG
timeFrame: at least 1year after the surgery of congenital cataract
Secondary outcomes:
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Eye Hosptial of Wenzhou Medical College
state: Zhejiang
Study officials:
References:
Clinical trial NCT00870948: Phase 1 BA Study, Single Center With Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Keywords: Open Label
Healthy Volunteers
Lead sponsor: Abbott
Sponsor class: INDUSTRY
First posted: 2009-03-27
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: Single dose in healthy volunteers to assess bioavailability (amount of study drug in the system) between different formulations of ABT-874.


Eligibility criteria: Inclusion Criteria:

* Subjects must be healthy

Exclusion Criteria:

* Subjects who are not healthy, enrolled in another study, or who have received ABT-874 previously.

Primary outcomes:
measure: Bioavailability following single dose
timeFrame: Hours: 0, 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 144, 168, 240, 336, 504, 672, 1008, 1344 for Regimens A, C, D and additional hours 4 & 8 for Regimen B and hours 0.5 and 6 hours for Regimen E
Secondary outcomes:
measure: AEs, serious adverse events (SAEs), laboratory data, ADA and vital signs will be assessed throughout the study
timeFrame: Through Day 85 (and / or 45 days after study drug stoppped)
Other outcomes:
Locations:
city: Evansville
country: United States
facility: Site Reference ID/Investigator # 16001
state: Indiana
Study officials:
affiliation: Abbott
name: Joaquin Valdes, MD
role: STUDY_DIRECTOR
References: