louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01519440: Randomized Comparison of Sharp Versus Blunt Techniques at Cesarean
Official title: Unintended Extension of the Lower Segment Uterine Incision at Cesarean Delivery;A Randomized Comparison of Sharp Versus Blunt Techniques
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Disruption of Uterine Incision After Cesarean Section
Keywords: unintended extension
blunt
sharp
maternal blood loss
Lead sponsor: Istanbul Bakirkoy Maternity and Children Diseases Hospital
Sponsor class: OTHER_GOV
First posted: 2012-01-27
Enrollment: 1076
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: elective cesarean delivery cases

Brief summary: The purpose of this study is to determine whether a specific surgical technique, blunt compared with sharp expansion of the transverse lower uterine incision, is associated with risk of unintended extension of uterine incision


Eligibility criteria: Inclusion Criteria:

1. Term pregnancy(\> 38 weeks of gestation)
2. Required elective cesarean delivery
3. maternal age between 18-40 years

Exclusion Criteria:

1. Required emergency cesarean delivery
2. Abnormal presentation
3. Planned cesarean hysterectomy
4. History of low segment vertical uterine incision
5. History of classical upper segment uterine incision
6. multiple pregnancy
7. cases with a high risk for bleeding(HELLP send, preeclampsia, placental insertion anomalies)
8. Grand multiparity(parity\>5)

Primary outcomes:
measure: unintended extension of uterine incision
timeFrame: during the operation
Secondary outcomes:
measure: intraoperative maternal blood loss
timeFrame: after 48 hours than operation
Other outcomes:
Locations:
city: İstanbul
country: Turkey
facility: İstanbul Bakırköy Maternal and Childrens Hospital
state: Bakırköy
Study officials:
References:
citation: Magann EF, Chauhan SP, Bufkin L, Field K, Roberts WE, Martin JN Jr. Intra-operative haemorrhage by blunt versus sharp expansion of the uterine incision at caesarean delivery: a randomised clinical trial. BJOG. 2002 Apr;109(4):448-52. doi: 10.1111/j.1471-0528.2002.01296.x.
Clinical trial NCT02814240: Hepatic Steatosis and Pituitary Gland Failure, Evaluation by Nuclear Magnetic Resonance (NMR) Imaging
Official title: Hepatic Steatosis and Pituitary Gland Failure, Evaluation by NMR Imaging
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hepatic Steatosis
Pituitary Gland Failure
Lead sponsor: Centre Hospitalier Universitaire Dijon
Sponsor class: OTHER
First posted: 2016-06-27
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The investigator put forward the hypothesis that liver fat mass in patients with pituitary gland failure is greater than that in a control population. Failure of the anterior pituitary and more particularly impaired production of growth hormone (GH) could be the principal mechanism responsible for increased liver fat mass in these patients.


Eligibility criteria: Inclusion Criteria:

* Patients who have provided consent
* Patients over 18 years
* Patients with pituitary disease (Pituitary adenoma, anterior pituitary failure, craniopharyngioma, empty sella syndrome, hypophysitis, infiltration of the stalk) requiring Magnetic Resonance Imaging (MRI) of the pituitary.

Exclusion Criteria:

* Persons without national health insurance
* Pacemaker (Contra-Indication for MRI)
* Alcohol consumption greater than 4 glasses a day
* Any treatment able to increase liver fat content (glitazones, systemic corticoids, immunosuppressants) are forbidden
* Presence of metallic implants (Contra-Indication for MRI)
* Claustrophobia
* Adult under guardianship
* Pregnant or breast-feeding women
* Patients with a liver disease other than non-alcoholic steatosis

Primary outcomes:
measure: Measurement of liver fat mass by Magnetic Resonance Imaging (MRI)
timeFrame: Measured at Day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Dijon
country: France
facility: CHU Dijon Bourgogne
Study officials:
References:
Clinical trial NCT04649840: Estimation of Dynamics of Humoral and Cellular Immunity in COVID-19 Patients
Official title: Estimation of Dynamics of Humoral and Cellular Immunity in COVID-19 Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Covid19
Keywords: COVID-19
Lead sponsor: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Sponsor class: OTHER_GOV
Collaborators: name: Belarusian State Medical University
name: The Republican Research and Practical Center for Epidemiology and Microbiology
First posted: 2020-12-02
Enrollment: 274
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients recovered from the COVID-19 associated pneumonia (moderate and severe)

Brief summary: The goal of the project: to study the dynamics of the humoral and cellular immunity in patients after pneumonia caused by the SARS-CoV-2 virus at different time intervals, in order to predict the duration of immune protection

Detailed description: * to form study groups of patients (at least 60 patients in total) who have recovered from pneumonia of varying severity caused by the SARS-CoV-2 virus (at least 30 patients in each of the groups of patients who have had pneumonia in moderate and severe forms);
* to investigate the parameters of cellular immunity (the content of antigen-specific T-cells to the main viral antigens - proteins S, N, M) in patients of different groups included in the trials, in dynamics 3, 6, 9 and 12 months after the COVID-19-associated pneumonia;
* to investigate the indicators of humoral immunity (the content of IgG to the main viral antigens - proteins S, N, M) in patients of different groups included in the trials, in dynamics 3, 6, 9 and 12 months after the COVID-19-associated pneumonia.

Eligibility criteria: Inclusion Criteria:

* patients recovered from the COVID-19 associated pneumonia (moderate and severe) in 1-3 month interval before inclusion into the trial;

Exclusion Criteria:

* cancer;
* drug and alcohol addiction;
* autoimmune diseases.

Primary outcomes:
measure: The dynamics of humoral and cellular immunity
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Minsk
country: Belarus
facility: Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study officials:
affiliation: Director
name: Andrei Hancharou, MD, PHD
role: STUDY_DIRECTOR
References:
Clinical trial NCT03175640: Prescribe to Save Lives
Official title: Implementation to Motivate Physician Response to Opioid Dependence in HIV Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Opioid-Related Disorders
Drug Overdose
Lead sponsor: Baystate Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: The Miriam Hospital
name: Boston Medical Center
name: Rhode Island Hospital
First posted: 2017-06-05
Enrollment: 294
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The U.S. is in the midst of an epidemic of opioid overdose deaths. The common use of opioids among persons living with HIV, along with their common use of benzodiazepines, has resulted in high rates of opioid overdose among this population. This study will test the implementation of evidence-based training, mentoring, technical support, and academic detailing to encourage HIV physicians to adopt evidence-based interventions to reduce overdose risk and treat opioid addiction.


Eligibility criteria: Inclusion Criteria:

Clinicians and staff of HIV practice sites that:

* Receive Ryan White Funding;
* Treat adults with HIV;
* Have 3 or more prescribing clinicians;
* Have an electronic medical record (EMR) with an electronic medication list.

Exclusion Criteria:

* Sites located in states with fewer than 500 Persons Living With HIV (PLWH) will be excluded

Primary outcomes:
measure: Change in naloxone prescribing behavior
timeFrame: baseline to 6 months
Secondary outcomes:
measure: Change in perception about pharmacotherapy for opioid use disorder; 6-month
timeFrame: baseline to 6 months
measure: Change in perception about pharmacotherapy for opioid use disorder; 12-month
timeFrame: baseline to 12 months
measure: Change in prescribing motivation; 6 months
timeFrame: baseline to 6 months
measure: Change in prescribing motivation; 12 months
timeFrame: baseline to 12 months
measure: Change in prescriber training
timeFrame: baseline to 12 months
measure: Change in buprenorphine prescribing behavior
timeFrame: baseline to 12 months
Other outcomes:
Locations:
city: Springfield
country: United States
facility: University of Massachusetts Medical School - Baystate
state: Massachusetts
city: Providence
country: United States
facility: The Miriam Hospital
state: Rhode Island
Study officials:
affiliation: University of Massachusetts Medical School - Baystate
name: Peter D Friedmann, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: The Miriam Hospital
name: Josiah D Rich, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jawa R, Walley AY, Wilson DJ, Green TC, McKenzie M, Hoskinson R Jr, Bratberg J, Ramsey S, Rich JD, Friedmann PD. Prescribe to Save Lives: Improving Buprenorphine Prescribing Among HIV Clinicians. J Acquir Immune Defic Syndr. 2022 Aug 15;90(5):546-552. doi: 10.1097/QAI.0000000000003001.
Clinical trial NCT00238940: Extension Study of Enteric-coated Mycophenolate Sodium in Combination With Full Dose or Reduced Dose Cyclosporine Microemulsion in Patients With de Novo Kidney Transplants
Official title: A One-year, Randomized, Open Label, Parallel Group Study to Investigate the Safety and the Effect of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Either Full Dose or Reduced Dose Cyclosporine Microemulsion in de Novo Kidney Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Renal Transplantation
Keywords: Renal transplantation, Enteric-Coated Mycophenolate Sodium (EC-MPS)
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-10-14
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.


Eligibility criteria: Inclusion/ Exclusion criteria

- All patients who completed study CERL080A2405-DE01 and who are willing to continue treatment with EC-MPS.

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Efficacy based on level of serum creatinine and calculated creatinine clearance 6 months post transplantation.
Secondary outcomes:
measure: Efficacy based on the level of serum creatinine and calculated creatinine clearance 12 months post transplantation.
measure: Safety and tolerability of enteric-coated mycophenolate sodium at 6 and 12 months post transplantation
measure: Pharmacokinetics enteric coated mycophenolate sodium in a randomized subgroup
measure: Efficacy based on the incidence of biopsy-proven acute rejection, graft loss or death 6 and 12 months post transplantation.
measure: Efficacy based on the incidence of biopsy-proven acute rejection at 6 and 12 months post transplantation.
Other outcomes:
Locations:
Study officials:
affiliation: Novartis
name: Novartis
role: STUDY_DIRECTOR
References:
Clinical trial NCT03811340: Female Patient Preferences Regarding Physician Gender
Official title: Female Patient Preferences Regarding Physician Gender; is There a Difference? A National Survey
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Female Patient Preference
Lead sponsor: TriHealth Inc.
Sponsor class: OTHER
First posted: 2019-01-22
Enrollment: 1015
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Female population residing in the USA

Brief summary: This is a cross sectional survey study to describe female patient preferences when choosing their OB/GYN and other providers.

Detailed description: The American College of Obstetricians and Gynecologists (ACOG) published that as of 2009, 79.7% of the Obstetrics and Gynecology residents were female. Given the striking decline in male providers selecting OB/GYN in more recent years, it is critical to characterize patient preferences in the current environment.

Nevertheless, it is not clear that females have strong preferences regarding gender. We hope to better understand the influence of bias on physician gender in present day.

The purpose of this study is to describe female population preference based on physician gender and specialty.

The study will be conducted on an online platform distributed across the United States by the aid of SurveyMonkey® .

Eligibility criteria: Exclusion Criteria:

* Unwillingness to participate in the study
* Lack of access to the internet
* Non-English speaking

Primary outcomes:
measure: Proportion of Female Respondents Having Their Preferences Based on Physician Gender for the OB/GYN Care
timeFrame: During a 10 minute period of completing the survey electronically
measure: Proportion of Female Respondents Having Their Preferences Based on Physician Gender for the Primary Care Physician
timeFrame: During a 10 minute period of completing the survey electronically
Secondary outcomes:
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Urogynecology Associates
state: Ohio
Study officials:
affiliation: TriHealth - Cincinnati Urogynecology Associates
name: Rachel Pauls, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05566340: Treatment of Moderate FMR During AVR
Official title: Surgical Treatment of Aortic Valve Disease With Moderate Functional Mitral Regurgitation
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Functional Mitral Regurgitation
Keywords: functional mitral regurgitation
aortic valve replacement
mitral valve repair
Lead sponsor: Fuwai Yunnan Cardiovascular Hospital
Sponsor class: OTHER
First posted: 2022-10-04
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: A total of 154 patients with moderate FMR undergoing isolated AVR or AVR + MVr will be prospectively enrolled.

Brief summary: Debates exist on the treatment of moderate functional mitral regurgitation (FMR) in patients undergoing aortic valve replacement (AVR) for aortic valve disease. This study aims to evaluate the left ventricular function, which was evaluated through global longitudinal strain, after isolated AVR and AVR + mitral valve repair (MVr) in this group of patients.


Eligibility criteria: Inclusion Criteria:

1. Patients who received AVR (with or without concomitant MVr) from two center (Fuwai Yunnan Cardiovascular Hospital and Fuwai Hospital, Chinese Academy of Medical Sciences).
2. Age more than 18 years.

Exclusion Criteria:

1. Those with a history of rheumatic valvular disease or infective endocarditis.
2. Primary mitral valve lesions.
3. Patients receiving mitral valve replacement.
4. Patient who refuse to participate in this study, or cannot complete 6-month follow-up after surgery.
5. Age \< 18 years.

Primary outcomes:
measure: left ventricular global longitudinal strain
timeFrame: 10/10/2022-10/10/2023
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT02550340: Munich Study for Beer Related ECG Change Workup
Official title: Munich Study for Beer Related ECG Change Workup
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arrhythmias, Cardiac
Keywords: Arrhythmia
Alcohol
ECG
Lead sponsor: LMU Klinikum
Sponsor class: OTHER
First posted: 2015-09-15
Enrollment: 3029
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants of the Munich Octoberfest and similar events

Brief summary: The study aims to determine if acute recreational alcohol intake is associated with the occurence of ECG changes and arrhythmias.

Detailed description: Both regular and acute excessive alcohol intake may deteriorate health. Possible sequelae include cardiac arrhythmias. For acute alcohol intake in particular it is insufficiently understood to what extent cardiac arrhythmias and other ECG changes occur, if the occurence depends on alcohol levels, and if there is a cut off value for occurence. Munich BREW aims to help clarifying these questions.

Participants of Munich BREW are identified and invited as visitors of the Munich Octoberfest and similar events. Participants need to be 18 years of age and over and need to declare theri will to participate. Following enrollment, participants will answer astudy questionnaire and will subsequently undergo recording of a 30 sec smart phone based ECG. Ultimately, the alcohol level is determined using a breath alcohol analyzer.

Eligibility criteria: Inclusion Criteria:

* 18 years of age and older
* informed conset signature

Exclusion Criteria:

* Incapability of contracting according to German law (BGB §105, paragraph 2)
* contraindications against ECG recording or alcohol breath test
* denial of informed consent

Primary outcomes:
measure: Occurence of cardiac arrhythmias
timeFrame: 30 sec
Secondary outcomes:
measure: Alcohol related changes in ECG intervals
timeFrame: 30 sec
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Klinikum der Universitaet Muenchen, Department of Medicine I
Study officials:
affiliation: LMU Klinikum
name: Stefan Brunner, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brunner S, Drobesch C, Herbel R, Sinner MF. Effects of acute alcohol consumption on cardiac excitation, conduction, and repolarization: results from the Munich Beer Related Electrocardiogram Workup Study (MunichBREW). Clin Res Cardiol. 2021 Jun;110(6):916-918. doi: 10.1007/s00392-021-01839-6. Epub 2021 Mar 18. No abstract available.
citation: Brunner S, Herbel R, Drobesch C, Peters A, Massberg S, Kaab S, Sinner MF. Alcohol consumption, sinus tachycardia, and cardiac arrhythmias at the Munich Octoberfest: results from the Munich Beer Related Electrocardiogram Workup Study (MunichBREW). Eur Heart J. 2017 Jul 14;38(27):2100-2106. doi: 10.1093/eurheartj/ehx156.
Clinical trial NCT06199440: Azithromycin Versus Doxycycline on Restistin Level in Periodontitis Patients With Type 2 Diabetes
Official title: Azithromycin Versus Doxycycline on Resistin Level in Periodontitis Patients With Type 2 Diabetes. A Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Periodontal Diseases
Type 2 Diabetes
Lead sponsor: King Abdulaziz University
Sponsor class: OTHER
First posted: 2024-01-10
Enrollment: 15
Sex: ALL
Minimum age (years): 25
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: The aim of this study is to evaluate the adjunctive effects of systemic antibiotics used in nonsurgical periodontal treatment (NSPT), compared with NSPT alone, on the periodontal clinical parameters and resistin level in diabetic patients with periodontitis, in order to identify which, one provides an additional effect to non-surgical periodontal therapy


Eligibility criteria: Inclusion Criteria:

Patients were clinically diagnosed as having at least three site with CAL ≥ 5mm; moderate to advanced chronic periodontitis according to the criteria of American Academy of Periodontology.

* Free from any other systemic conditions that affect the periodontium except for Diabetes mellitus type II.
* No periodontal therapy, systemic antibiotics or non-steroidal anti-inflammatory agents during the preceding 6 months.
* Non-smokers.
* Non-pregnant.

Exclusion Criteria:

-

Primary outcomes:
measure: Primary Outcome
timeFrame: 3 months
Secondary outcomes:
measure: Secondary Outcome
timeFrame: 3 months
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: King Abdulaziz University
Study officials:
References:
Clinical trial NCT03014440: Study of Cannabidiol for Drug-Resistant Epilepsies
Official title: A Phase 1/2, Safety, Tolerability, and Dose-Finding Study of Cannabidiol for Drug-Resistant Epilepsies
Study type: EXPANDED_ACCESS
Overall status: NO_LONGER_AVAILABLE
Conditions: Drug Resistant Epilepsy
Lead sponsor: Children's Hospital of Philadelphia
Sponsor class: OTHER
Collaborators: name: University of Pittsburgh
name: Geisinger Clinic
First posted: 2017-01-09
Sex: ALL
Minimum age (years): 1
Maximum age (years): 20
Standard ages: CHILD
ADULT

Brief summary: The purpose of this study is to determine if cannabidiol is safe and effective at different doses as an additional treatment for pediatric drug-resistant epilepsy. Pure cannabidiol has potentially therapeutic properties, such as anti-convulsant effects, that may reduce seizure frequency. There are only a few open label studies that have demonstrated the safety and tolerance of cannabiodiol in both adult and pediatric epileptic populations--these studies were performed either retrospectively or with varying cannabidiol preparations. There are no well-documented studies and completely analyzed data for pediatric epileptic patients.


Eligibility criteria: Inclusion Criteria:

1. Ages between 1 year old and 20 years old, male or female at the first visit, Week -4 (at time informed consent form is signed)
2. Documentation of a diagnosis of drug-resistant epilepsy as proven by and documented with medical records and/or the following clinical features (must have all 3 of the following):

   1. Failure to control seizures despite appropriate trial of 3 or more AEDs at therapeutic doses
   2. An intractable childhood epilepsy including, Dravet Syndrome or Lennox-Gastaut Syndrome
   3. Must report at least 3 countable (non-countable seizures includes absence and myoclonic) seizures per month
3. Between 1-3 baseline AEDs . Vagus nerve stimulator (VNS), ketogenic diet, and modified Atkins diet do not count towards this limit.
4. VNS must be on stable settings for a minimum of 3 months.
5. If on the ketogenic diet, must be on stable ratio for a minimum of 3 months.

Exclusion Criteria:

1. Epilepsies associated with neurodegenerative diseases, including neuronal ceroidolipofuscinosis, progressive myoclonus epilepsies, Rasmussen encephalitis, and tumors
2. Epilepsies associated with an inborn error of metabolism, including mitochondrial disorders
3. Felbatol initiated within the past 12 months
4. Use of any Cannabis-related product (including hemp oil) in the past 12 months as assessed by parental questioning.
5. Laboratory values on comprehensive metabolic panel (CMP) and complete blood count (CBC) testing that are Class 3 or higher according to the CTCAE v4.0.
6. Positive pregnancy test.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: