louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03669991: Real World Assessment of Effects of Beta-blockers on Patients With Acute Coronary Syndrome
Official title: Real World Assessment of Effects of Beta-blockers on Patients With Acute Coronary
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Lead sponsor: Chinese Academy of Medical Sciences, Fuwai Hospital
Sponsor class: OTHER
First posted: 2018-09-13
Enrollment: 2200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with acute coronary syndrome

Brief summary: The study is aimed to optimized the dose-adjusted regimen of beta-blockers in patients with acute coronary syndrome by investigating therapeutic and curative results of target doses Beta-blockers using the dose-adjusted pathway of beta-blockers.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years
* Patients diagnosed as acute coronary syndromes including acute ST-segment elevation myocardial infarction (STEMI) and non-ST-segment elevated acute coronary syndrome (NSTE-ACS)
* Patients or whose legal representatives signed written informed consent form

Exclusion Criteria:

Patients should been excluded if they meet any of the following exclusion criteria:

* Patients with contraindications to the application of beta blockers, including: 1) cardiogenic shock or heart failure (Killip grade \> II level);2) sick sinus syndrome; 3) II degree atrioventricular block;4) unstable decompensation of cardiac failure (pulmonary edema, hypotension or low perfusion); 5) symptomatic hypotension or bradycardia (heart rate\<50 beats/min, blood pressure\<90/60mmHg); 6) contraindications to beta blockers or allergy to any ingredient of beta blocker; 7) active asthma should be treated by inhalation preparation treatment
* Pregnant or lactating women
* Patients without signed written informed consent
* Patients who was considered by the researcher inappropriate to participate in this study (for example, patients with a higher risk of cardiogenic shock, etc.)

Primary outcomes:
measure: Major adverse cardiovascular and cerebrovascular events (MACCE)
timeFrame: Within 1 year after surgery
Secondary outcomes:
measure: Resting heart rate
timeFrame: Within 1 year after surgery
measure: Blood pressure (systolic & diastolic)
timeFrame: Within 1 year after surgery
measure: Ejection fraction
timeFrame: Within 1 year after surgery
measure: Serum norepinephrine
timeFrame: Within 1 year after surgery
Other outcomes:
Locations:
city: Beijing
country: China
facility: Fuwai Hospital, Chinese Academy of Medical Sciences
state: Beijing
Study officials:
affiliation: Chinese Academy of Medical Sciences, Fuwai Hospital
name: Yi-Da Tang, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01248091: The Effect of Nitroprusside on Intrauterine Device (IUD) Insertion
Official title: The Effect of Nitroprusside on the IUD Insertion Experience in Nulliparous Women: a Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Pain
Pelvic Pain
Keywords: IUD, Insertion, Decrease, Pain
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
Collaborators: name: Society of Family Planning
First posted: 2010-11-25
Enrollment: 24
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Increasing accessibility of long-acting reversible contraceptive methods, like intrauterine devices (IUDs), is an important strategy to reduce the risk of unintended pregnancy. Unfortunately, fear of IUD insertion in women who have not had children is common among health care providers and women alike, and this limits IUD use. To increase acceptance of this highly effective contraceptive, there is need to investigate novel, low cost, easily applied and accessible techniques to improve the insertion experience. This is a pilot study to evaluate the efficacy and tolerability of nitroprusside gel applied intracervically as an intervention to improve the IUD insertion experience for both patient and provider.

Detailed description: Subjects who are have already scheduled an IUD insertion will be asked to join this study assessing whether or not nitroprusside gel helps with IUD insertion process. Only healthy, nulliparous women between the ages of 18 and 45 will be recruited. Nulliparous women report much more pain associated with IUD insertion than parous women so the possibility of being able to measure the effect of nitroprusside vs placebo is more likely. The primary outcome, pain with IUD insertion, and the secondary outcomes, such as satisfaction and provider ease of IUD insertion, will be compared between the study groups as well.

Eligibility criteria: Inclusion Criteria:

* age 18-45,
* Generally Healthy.
* requesting LNG-IUS for contraception as the primary indication

Exclusion Criteria:

* previous pregnancy beyond 20 weeks,
* previous IUD placement or attempted placement,
* allergy to nitroprusside,
* history of migraines,
* history of heart disease.

Primary outcomes:
measure: Evaluate the efficacy and tolerability of nitroprusside gel applied intracervically as an intervention to improve the IUD insertion experience for both patient and provider.
timeFrame: over one year
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
affiliation: Oregon Health and Science University
name: Paula Bednarek, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bednarek PH, Micks EA, Edelman AB, Li H, Jensen JT. The effect of nitroprusside on IUD insertion experience in nulliparous women: a pilot study. Contraception. 2013 Apr;87(4):421-5. doi: 10.1016/j.contraception.2012.10.030. Epub 2012 Dec 4.
Clinical trial NCT01968291: Use of Teach Back to Improve Comprehension of Discharge Instructions for Emergency Patients With Limited Health Literacy
Official title: The Impact of Teach-back on Comprehension of Discharge Instructions Among Emergency Patients With Limited Health Literacy: A Randomized, Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Conditions Influencing Health Status
Keywords: Health Literacy
Teach-back
Emergency
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2013-10-24
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: The purpose of this study was to determine whether use of teach-back discharge instructions improve patient satisfaction and patients' self-reported and objective comprehension of discharge instructions in the emergency department when compared to standard discharge instructions.


Eligibility criteria: Inclusion Criteria:

* patients being discharged from the emergency department
* A score of 6 or less on the Rapid Estimate of Adult Literacy in Medicine, Revised (consistent with Limited Health Literacy)

Exclusion Criteria:

* aphasia,
* non-English speaking,
* mental handicap,
* psychiatric chief complaint,
* too high acuity per physician,
* insurmountable communication barrier,
* evaluations for sexual assault,
* clinical intoxication.

Primary outcomes:
measure: Objective comprehension
timeFrame: Questions evaluating comprehension were administered during the discharge interview immediately following discharge from the ED at the index visit (Day 1).
Secondary outcomes:
measure: self-reported comprehension
timeFrame: Questions evaluating self-reported comprehension were administered during the discharge interview immediately following discharge from the ED at the index visit (Day 1).
Other outcomes:
measure: patient satisfaction
timeFrame: Questions evaluating satisfaction were administered during the discharge interview immediately following discharge from the ED at the index visit (Day 1).
Locations:
city: St. Louis
country: United States
facility: Barnes-Jewish Hospital Emergency Department
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Richard T Griffey, MD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Kim A Kaphingst, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04108091: Vyndaqel Capsules Special Investigation (ATTR-CM)
Official title: Vyndaqel Capsules Special Investigation - Investigation on Patients With Transthyretin Amyloid Cardiomyopathy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Transthyretin (TTR) Amyloid Cardiomyopathy
Keywords: transthyretin amyloid cardiomyopathy;
TTR Cardiomyopathy;
Transthyretin (TTR) Amyloid Cardiomyopathy;
Vyndaqel;
Tafamidis meglumine;
ATTR-CM;
Vynmac;
Lead sponsor: Pfizer
Sponsor class: INDUSTRY
First posted: 2019-09-27
Enrollment: 1214
Sex: ALL
Minimum age (years): 0
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: OTHER
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who are administered with this drug for the treatment of ATTR-CM

Brief summary: Secondary Data Collection : To confirm the safety and effectiveness profiles under the actual medical practice of Vyndaqel in Japan. This study is conducted in accordance with the protocol even when Vynmac is used, and information the use of Vynmac during the observation period is also collected.

Detailed description: To comprehend information on the long-term safety (e.g., onset status of adverse reactions), etc. of patients who are treated with Vyndaqel for the treatment of transthyretin amyloid cardiomyopathy. When Vynmac is used, conduct the study to grasp information on safety (e.g., onset status of adverse reactions),etc. during the observation period.

Eligibility criteria: Inclusion Criteria:

* Patients administered Vyndaqel for the treatment of ATTR-CM

Exclusion Criteria:

* N/A

Primary outcomes:
measure: The incidence of adverse drug reaction
timeFrame: 30 months
Secondary outcomes:
measure: Number of survival
timeFrame: 30months
Other outcomes:
Locations:
city: Tokyo
country: Japan
facility: Pfizer
Study officials:
affiliation: Pfizer
name: Pfizer CT.gov Call Center
role: STUDY_DIRECTOR
References:
Clinical trial NCT03442491: Hayman's Haemostatic Suture to Treat Severe Post-partum Haemorrhage
Official title: Efficacy of Hayman's Haemostatic Suture for the Treatment of Severe Post-partum Haemorrhage Resistant to Pharmacologic Therapy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Postpartum Hemorrhage
Keywords: Postpartum Hemorrhage
Hayman's Haemostatic Suture
Lead sponsor: Università degli Studi dell'Insubria
Sponsor class: OTHER
First posted: 2018-02-22
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women that had major Post-partum Haemorrhage, resistant to pharmacologic therapy, treated with Hayman's Haemostatic Suture.

Brief summary: Post-partum haemorrhage continues to be a leading cause of maternal mortality and morbidity, accounting for more than 125 000 deaths per year across the world. Prompt diagnosis and effective action are the cornerstones of management and are crucial to prevent fatal maternal haemorrhage.

Considering that published data are extremely limited, the aim of our study will be to evaluate retrospectively the efficacy of Hayman's Haemostatic Suture for the treatment of resistant post-partum hemorrhage resistant to pharmacological therapy.

Detailed description: Post-partum haemorrhage continues to be a leading cause of maternal mortality and morbidity, accounting for more than 125 000 deaths per year across the world. Prompt diagnosis and effective action are the cornerstones of management and are crucial to prevent fatal maternal haemorrhage.

The Hayman suture offers the potential advantages that can be applied fast and easy, a key point in an emergency situation, and avoids having to perform a lower segment hysterotomy when post-partum haemorrhage follows a vaginal delivery, therefore minimising the trauma to the atonic bleeding uterus.

Considering that published data are extremely limited, the aim of our study will be to evaluate retrospectively the efficacy of Hayman's Haemostatic Suture for the treatment of resistant post-partum hemorrhage resistant to pharmacological therapy.

Eligibility criteria: Inclusion Criteria:

* Women that had major Post-partum Haemorrhage, resistant to pharmacologic therapy, treated with Hayman's Haemostatic Suture.

Exclusion Criteria:

* None.

Primary outcomes:
measure: Fertility preservation
timeFrame: Within 24 hours after post-partum haemorrhage
Secondary outcomes:
measure: Blood transfusions
timeFrame: Within 24 hours after post-partum haemorrhage
measure: Subsequent pregnancies
timeFrame: 120 months from the date of post-partum haemorrhage.
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT01469091: Tobacco's Impact on Postoperative Complications in Acute Surgery
Official title: Tobacco's Impact on Postoperative Complications in Acute Vascular Surgery. A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Vascular Disease
Keywords: Acute admittance
Current smoker
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2011-11-10
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to see whether intensive smoking intervention on the day of operation can reduce per- and postoperative complications in patients operated for acute ischaemic disease compared to control group with no intervention.


Eligibility criteria: Inclusion Criteria:

* acute admittance in a vascular department
* current smoker
* surgery within 7 days
* informed/written consent

Exclusion Criteria:

* alcohol intake \> 35 units pr. week
* dementia or mental disease
* \> 90 years

Primary outcomes:
measure: Postoperative complications.
timeFrame: After 3 months.
Secondary outcomes:
measure: SF-36
timeFrame: After 3 months.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Vascular Clinic RK, Rigshospitalet
Study officials:
References:
citation: Kehlet M, Heeseman S, Tonnesen H, Schroeder TV. Perioperative smoking cessation in vascular surgery: challenges with a randomized controlled trial. Trials. 2015 Oct 5;16:441. doi: 10.1186/s13063-015-0965-x.
Clinical trial NCT01366391: Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome
Official title: Therapeutic Monitoring of Metformin in Women With Polycystic Ovary Syndrome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Polycystic Ovary Syndrome
Keywords: polycystic ovary syndrome
metformin
pharmacokinetic
Lead sponsor: Biocinese
Sponsor class: INDUSTRY
First posted: 2011-06-06
Enrollment: 24
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: Metformin is one of the most commonly prescribed drugs worldwide for the treatment of Type 2 Diabetes. It has been currently used for the treatment of: polycystic ovary syndrome, gestational diabetes, metabolic syndrome and obesity. In patients with polycystic ovary syndrome (PCOS) the adverse side effects are a frequent cause for treatment discontinuation. In every day medical practice lower doses of Metformin are administered searching for the continuation of the treatment.

However, there is no clinical study to support this assertion. The objective of this study is to monitor and correlate the therapeutic effect of Metformin on patients with PCOS taking daily doses of 1500mg and 1000mg.

Detailed description: Patients with PCOS diagnosis and that are able to attempt the inclusion criteria are divided in two groups: administration of metformin 500 mg tablet three times/day as well 1500 mg/day (group A)and administration of metformin 500 mg tablet twice/day or 1000 mg/day (group B). Blood samples were collected to the pharmacokinetic evaluation from first day of administration until 3 months after beginning of treatment. The patients are monitored during 3 months and all side effects are register. The efficacy of both treatment are analyzed by biochemical and physical evaluation.

Eligibility criteria: Inclusion Criteria:

* Patients aged between 18 and 40 years old, with no use of contraceptive drugs or insulin sensitizing agents for more than 3 months.
* PCOS diagnosis.
* Insulin resistance Index by the Homeostatic model Assessment Formula higher than 2.5.

Exclusion Criteria:

* Another diseases with androgen excess;
* Patients with history of serious adverse reaction or hypersensibility to any medicine;
* History or presence of renal, hepatic or gastrointestinal disorders.
* Continuous use of any pharmaco, inclusively metformin

Primary outcomes:
measure: Plasma concentration of metformin
timeFrame: First day after administration until 3 months after begining of treatment
Secondary outcomes:
measure: Number of adverse events
timeFrame: observation during 3 months of treatment
Other outcomes:
Locations:
city: Toledo
country: Brazil
facility: Biocinese
state: Parana
Study officials:
affiliation: Biocinese
name: Naura Angonese, Dr
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00338091: Long-Term Renoprotection of Optimal Antiproteinuric Doses of Benazepril and Losartan in Chronic Renal Insufficiency
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Renal Insufficiency,Chronic
Disease Progression
Proteinuria
Dose-Response Relationship,Drug
ACE Inhibitor
Angiotensin II Type 1 Receptor Blockers
Keywords: Renal Insufficiency,Chronic
Disease Progression
Proteinuria
Dose-Response Relationship,Drug
Benazepril
Losartan
Lead sponsor: Southern Medical University, China
Sponsor class: OTHER
First posted: 2006-06-20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The primary goal of the trial was to evaluate whether the optimal antiproteinuric doses of benazepril (an ACE inhibitor) or losartan (an ARB), as compared with their conventional doses, can safely improve the long-term renal outcome in nondiabetic patients with proteinuria and chronic renal insufficiency. The second aim was to compare the long-term renal protection between benazepril and losartan at similar clinical setting.


Eligibility criteria: Inclusion Criteria:

1. Serum creatinine concentration of 1.5 to 5.0 mg per deciliter (133 to 442 µmol/L)
2. Creatinine clearance of 20 to 70 ml per minute per 1.73m2, with variations of less than 30 percent in the three months before screening evaluation
3. nondiabetic renal disease
4. Persistent heavier proteinuria (defined by urinary protein excretion of more than 1.0 g per day for three or more months without evidence of urinary tract infection or overt heart failure \[a New York Heart Association class of Ⅲ or Ⅳ\])

Exclusion Criteria:

1. Immediate need for dialysis
2. Treatment with corticosteroids, non steroidal anti-inflammatory drugs, or immunosuppressive drugs
3. Hyper-or hypokalemia (serum potassium concentration 5.6 mmol per liter or more，or 3.5 mmol per liter or less)
4. Renovascular disease
5. Myocardial infarction or cerebrovascular accident in the year preceding the trial
6. Connective-tissue disease; and obstructive uropathy

Primary outcomes:
measure: The primary efficacy measure was the time to the first event of the composite endpoint of a doubling of the serum creatinine concentration, ESRD or death.
Secondary outcomes:
measure: Secondary endpoints included changes in urinary protein excretion rate and the progression of renal disease assessed by creatinine clearance and glomerular filtration rate as calculated by Modification of Diet in Renal Disease equation-4.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Renal Division, Nanfang Hospital,Southern Medical University
state: Guangdong
Study officials:
affiliation: Division of Nephrology, Nanfang Hospital,Southern Medical University,China
name: Fan Fan Hou, M.D.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04226391: Interruptions, Teamwork, Stress and Patient Outcomes in the Operating Room
Official title: Surgical Flow Disruptions Inside the Operating Room, Intra-operative Teamwork, Stress and Post-operative Patient-outcomes: An Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intraoperative Flow Disruptions
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients undergoing elective surgery in one of the participating departments

Surgical teams including surgeons, nurses and anesthetists

Brief summary: The operating theatre (OR) in hospitals is a highly complex working environment and can withstand a variety of stresses and strains for the surgical team. So-called "Flow Disruption Events" (FDs) with a potential risk to patient safety occur very often.

The aim of the planned study project is to determine the effects of flow disruption events in the operating theatre on patients, the OR team and the duration of the surgery. The investigators plan an observational study at two university hospital in Southern Germany. The study population includes the entire surgical team during selected surgical procedures as well as the patients treated. The planned sample size is 82 surgical procedures. The investigators intend to collect data in two surgical specialties: Urology and traumatology.

Selected surgeries are evaluated by a trained observer and the interruptions and distractions in the course of the surgery are observed with a standardized tool. In addition, non-technical skills of the OR team are recorded: all members of the OR team will complete a short standardized questionnaire that measures mental workload and stress during the procedure. Additionally, post-operative patient outcomes are recorded.


Eligibility criteria: Inclusion Criteria:

* Patients: Written consent, completed case
* OR Team: Written consent, at least 3 months working experience in the clinic, present for the majority of the procedure duration

Exclusion Criteria:

- OR visitors \& students

Primary outcomes:
measure: Intraoperative Teamwork
timeFrame: 4 Hours
measure: Stress, Mental Workload
timeFrame: 4 Hours
measure: Patient Outcomes
timeFrame: 3 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Urological Clinic and Outpatient Clinic, University hospital of the Ludwig-Maximilians-University (LMU) Munich
Study officials:
References: